Health Technical

Memorandum 2010
Part 1: Management policy

Sterilization

London: HMSO
© Crown copyright 1994
Applications for reproduction should be made to HMSO
First published 1994

ISBN 0 11 321739 0

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About this publication

Health Technical Memoranda (HTMs) Part 2 – Design considerations –

give comprehensive advice and guidance contains information relevant to the
on the design, installation and operation specification and installation of new
of specialised building and engineering sterilizing equipment. It discusses the
technology used in the delivery of requirements for each type of
healthcare. sterilizer and outlines the
specifications to be included in any
They are applicable to new and existing contract. Practical considerations for
sites, and are for use at various stages the installation of sterilizers are
during the inception, design, construction, discussed, including siting, heat
refurbishment and maintenance of a emission, ventilation, noise and
building. vibration, and mains services with an
emphasis on steam quality;
Health Technical Memorandum 2010

HTM 2010 is being published in five Part 3 – Validation and

parts: verification – covers all aspects of
validation and periodic testing of
this volume (Part 1) – Management sterilizers. It includes detailed
policy – is a summary of the schedules and procedures for tests
information required by non-technical and checks to be carried out for
personnel responsible for the commissioning and performance
management of sterilization services. qualification, and for subsequent
It discusses the various types of periodic testing;
sterilizer, for both clinical and
laboratory use, and contains guidance Part 4 – Operational
on legal and policy matters, and on management – covers all aspects of
the appointment and responsibilities the routine operation and
of personnel. It should be read by maintenance of sterilizers, stressing
anyone consulting this memorandum the need for a planned maintenance
for the first time; programme along with the type of
records to be kept. Advice on the safe
and efficient operation of sterilizers is
 given, as well as procedures for a. the Welsh Office for the NHS in
reporting defects and accidents; Wales;

Part 5 – Good practice guide – b. the Health and Personal Social

provides advice on the fatigue life of Services Management Executive in
pressure vessels, operational Northern Ireland;
procedures guidance on the control
of sterilizers, and use of the C. the National Health Service in
supplementary publications (logbooks Scotland Management Executive.
etc.). It also includes a comprehensive
bibliography. References to legislation appearing in the
main text of this guidance apply to the
The contents of this HTM in terms of United Kingdom as a whole, except
management policy and operational where marginal notes indicate variations
policy are endorsed by: for Scotland or Northern Ireland.
Contents

About this publication 3.20 Manual Handling Operations Regulations

1992
1 Sterilization and the role of 3.22 Personal Protective Equipment at Work
management page 3 Regulations 1992
1.1 Introduction 3.23 Medicinal products
1.4 The European Union Directives on medical devices 3.23 Medicines Act 1968
1.6 Definition of medical device 3.24 Medicines (Standard Provisions of Licences
1.8 The three Directives and Certificates) Amendment (No 3)
1.9 The regulatory framework Regulations 1977
1.13 Impact on sterilization 3.25 Medicines (Standard Provision of Licences
1.15 Summary of management responsibilities and Certificates) Amendment Regulations
1992
2 Sterilizers – an overview page 7 3.26 Consumer protection
2.1 Introduction 3.27 Consumer Protection Act 1987
2.7 Clinical sterilizers using high-temperature steam 3.29 Electromagnetic Compatibility Regulations 1992
2.10 Porous loads 3.32 Active Implantable Medical Devices Regulations
2.13 Fluids 1992
2.16 Unwrapped instruments and utensils
2.20 Clinical sterilizers using hot air 4 British and European standards page 18
2.24 Clinical sterilizers using low-temperature steam 4.1 Introduction
and formaldehyde 4.4 European standards
2.28 Clinical sterilizers using ethylene oxide
2.35 Laboratory sterilizers/autoclaves 5 Personnel page 19
2.38 Operating cycles 5.1 Introduction
2.42 Culture media preparator 5.2 Training
2.45 Koch steamer 5.5 Functional responsibility
2.46 Animal house sterilizer 5.11 Key personnel
5.12 Management
3 Statutory requirements page 13 5.13 User
3.1 Introduction 5.16 Competent person (pressure vessels)
3.2 Health and safety 5.22 Authorised person (sterilizers)
3.5 Health and Safety at Work etc Act 1974 5.27 Test person (sterilizers)
3.6 Management of Health and Safety at 5.30 Maintenance person (sterilizers)
Work Regulations 1992 5.34 Microbiologist (sterilizers)
3.8 Workplace (Health, Safety and Welfare) 5.37 Personnel for medicinal products
Regulations 1992 5.38 Production manager
3.10 Provision and Use of Work Equipment 5.39 Quality controller
Regulations 1992 5.43 Other personnel
3.12 Pressure Systems and Transportable Gas
Containers Regulations 1989 Other publications in this series page 25
3.14 Control of Substances Hazardous to
Health Regulations 1988 About NHS Estates page 26
3.17 Reporting of Injuries, Diseases and
Dangerous Occurrences Regulations 1985
1.0 Sterilization and the role of
management

Introduction

“The fundamental cause of this disaster is to be found in human failings

ranging from simple carelessness to poor management of men and plant. The
Committee heard of no imminent technological advance in the field of
production of intravenous fluids which will eliminate the need for skilful men
devoted to their work . . . Too many people believe that sterilization of fluids is
easily achieved with simple plant operated by men of little skill under a minimum
of supervision . . . Public safety in this, as in many other technological fields,
depends ultimately on untiring vigilance . . . ”

1.1 The quotation above comes from the principal conclusions of the
committee chaired by Sir Cecil Clothier and appointed to investigate an incident
in which five patients died as a result of a faulty sterilizer. The tragedy led to a
thorough overhaul of the methods of managing sterilizers, among which was
the revision of this Health Technical Memorandum (then HTM 10), the last
edition of which was published in 1980.

1.2 No disaster on a comparable scale has been reported since. Nonetheless,

both the law and public opinion are now less forgiving of lapses than they were
two decades ago. Tighter statutory control, resulting from new European Union
(EU) Directives, will soon extend to almost every aspect of sterilization, and
practices which were common a few years ago will no longer be acceptable or
even lawful.

1.3 The science and art of sterilization are complex and subtle. The testing,
maintenance and reporting procedures described in this HTM may seem
excessive to some, but they are based upon good practice in both the UK and
Europe, as formalised in European Standards designed to support the new EU
Directives.

The European Union Directives on medical devices

1.4 Until now, statutory controls on the practice of sterilization, other than in
the manufacture of medical products, have been few. The major Acts and
Regulations which are likely to affect the management of a sterilizer are
described in Chapter 3, but specific references to sterilization in the legislation
are rare. This will change as a series of three EU Directives come into effect
regulating the safety, quality and effectiveness of medical devices.

1.5 This section summarises basic information about the Directives. Further
details are available from the Medical Devices Agency of the Department of
Health.

Definition of medical device

1.6 The Directives define a medical device as any instrument, apparatus,

appliance, material or other article, whether used alone or in combination,
including the software necessary for its proper application intended by the
manufacturer to be used on human beings for the purpose of:

Previous page
is blank
1.0 Sterilization and the role of management

a. diagnosis, prevention, monitoring, treatment or alleviation of disease;

b. diagnosis, monitoring, treatment, alleviation or compensation of an injury

or handicap;

c. investigation, replacement or modification of the anatomy or of a

physiological process;

d. control of conception;

and which does not achieve its principal intended action in or on the human
body by pharmacological, immunological or metabolic means, but which may be
assisted in its function by such means (Council Directive 93/42/EEC).

1.7 The Directives apply equally to “accessories”. An accessory is defined as

“an article which, whilst not being a device, is intended specifically by its
manufacturers to be used together with a device to enable it to be used in
accordance with the use of the device intended by the manufacturer of the
device”.

The three Directives

1.8 The three EU directives are as follows:

a. the Active Implantable Medical Devices Directive (Council Directive 90/385/

EEC) covers all powered implants or partial implants that are left in the
human body. (Heart pacemakers are the most common example of
powered implants.) The directive was adopted by the EU council on 20
June 1990 and came into effect in the UK on 1 January 1993 as the Active
Implantable Devices Regulations 1992 (see paragraph 3.32);
b. the Medical Devices Directive (Council Directive 93/94/EEC) covers most
other medical devices ranging from first aid bandages and tongue
depressors through to hip prostheses and will therefore have a wide
impact on sterilization. The directive was adopted by the EU council on
14 June 1993. It will take effect on 1 January 1995, though the UK
regulations have not yet been published;
c. the In-vitro Diagnostic Medical Devices Directive will cover any medical
device, reagent product, kit, instrument, apparatus or system which is
intended to be used in-vitro for the examination of substances derived
from the human body. Some examples of in-vitro diagnostic devices are
blood group reagents, pregnancy test kits, and hepatitis B test kits.

The regulatory framework

1.9 The Directives set out the essential requirements that devices must not
compromise the health or safety of the patient, user or any other person and
that any risks associated with the device are compatible with patient health and
protection. Any side-effects must be acceptable when weighed against the
intended performance.

1.10 Devices meeting these requirements will be entitled to carry the “CE”
marking, signifying that the device satisfies the requirements essential for it to
be fit for its intended purpose. All devices except custom-made devices and
devices intended for clinical trials (“investigations” in the directive), whether used
in public-sector or private-sector hospitals and nursing homes, or sold in retail
outlets, will have to carry the “CE” marking.

1.11 Adoption of the Directives will mean that the UK’s voluntary system of
manufacturer registration and product approval for controlling certain medical
devices used by the NHS will eventually be replaced by a more comprehensive
statutory system covering all devices used in the UK. The Medical Devices
Agency (MDA) of the Department of Health, will be the competent authority to
carry out the requirements of the Directives in the UK. The main role of the
MDA will ensure compliance with the UK regulations, evaluate vigilance reports
received from manufacturers, and carry out a preclinical assessment of devices
intended for clinical investigation. The MDA is also responsible for approving the
independent certification organisations (the notified bodies) that will check and
prove that defined classes of medical devices meet the essential requirements
and thus enable manufacturers to apply the “CE” marking to their products.

1.12 The Medical Devices Directive includes a classification system whereby the
level of regulatory control applied to devices is proportional to the degree of risk
inherent in the device. The strictest controls will therefore only apply to the
limited number of high-risk products.

Impact on sterilization

1.13 At the time of writing the effect of the Medical Devices Directive is being
studied and will become clear when the UK regulations implementing the
Directive are published. Most of the non-medical items currently processed in
sterilizers are encompassed by the definition of a medical device but it is
uncertain whether a sterile device emanating from, for example, a sterile services
department (SSD) is to be construed as having been placed on the market by the
department.

1.14 Managers who ensure that their machines and procedures comply with
the guidance in this HTM should have no difficulty in complying with the
Directive if and when it applies to them.

Summary of management responsibilities

1.15 HTM 2010 will assist managers and other personnel to ensure that
sterilizers are operated safely and effectively and in compliance with existing and
anticipated legislation and standards. To this end, the major responsibilities of
management can be summarised as follows:

a. to ensure that sterilization is carried out in compliance with the law and
with the policy of the UK health departments;

b. to ensure that all personnel connected with sterilization, whether NHS

employees or contract personnel, are suitably qualified and trained for
their responsibilities;

c. to ensure that purchased sterilizers conform to legal requirements, the

minimum specifications set out in British and European standards, and any
additional requirements of the UK health departments;

d. to ensure that sterilizers are installed correctly and safely with regard to
proper functioning, safety of personnel and environmental protection;

e. to ensure that newly installed sterilizers are subject to a documented

scheme of validation comprising installation checks and tests,
commissioning tests and performance qualification tests before they are
put into service;

f. to ensure that sterilizers are subject to a documented scheme of periodic

tests at yearly, quarterly, weekly and (in some cases) daily intervals;
g. to ensure that sterilizers are subject to a documented scheme of
preventative maintenance;

h. to ensure that procedures for production, quality control and safe working
are documented and adhered to in the light of statutory requirements and
accepted best practice;

j. to ensure that procedures for dealing with malfunctions, accidents and

dangerous occurrences are documented and adhered to.
2.0 Sterilizers - an overview

Introduction

2.1 This Health Technical Memorandum groups sterilizers into two broad
categories according to their use:

a. clinical sterilizers are designed to process medical devices, medicinal

products and other goods and materials that are used in the clinical care
of patients;

b. laboratory sterilizers are designed to process goods and materials and

are not directly used in the clinical care of patients.

2.2 Their operation should be kept strictly separate. Loads intended for
processing in a clinical sterilizer should not be put into a laboratory sterilizer, and
vice-versa.

2.3 Sterilizers can also be classified according to the sterilizing agent (the
sterilant) used:

a. high-temperature steam;
b. low-temperature steam and formaldehyde;

c. ethylene oxide.

2.4 High-temperature steam is the sterilant of choice because of its superior

performance. Machines using other sterilants should be reserved either for loads
which would be damaged by exposure to high-temperature steam (such as
certain surgical devices) or for loads that would not be sterilized by exposure to
high-temperature steam (such as certain non-aqueous fluids).

2.5 Clinical sterilizers are available employing any one of the four sterilants.
The laboratory sterilizers described in this HTM use only high-temperature steam.

2.6 Guidance on selection and specification, operational management,

validation and verification is given in the other volumes of this HTM.

Clinical sterilizers using high-temperature steam

2.7 These are by far the most common sterilizers used in the NHS, and are
manufactured in three basic types according to the nature of load they are
designed to process: porous loads, fluids, or unwrapped Instruments and
utensils. The operating cycles are designed to cope with the differing properties
of the various types of load. It is essential that a sterilizer is used only for the
type of load for which it is designed.

2.8 High-temperature steam inactivates pathogens by a combination of

moisture and heat. The process is well understood and the attainment of
sterilization conditions can normally be confirmed by simple physical
measurements. (This is not so for sterilizers using chemical sterilants, where
microbiological test procedures are necessary.)

2.9 High-temperature steam sterilizers are large machines requiring

permanently installed engineering services (including good-quality steam) and
purpose-built accommodation. Some smaller model s are transportable and
generate steam from an internal reservoir.

Porous loads

2.10 Clinical sterilizers using high-temperature steam to process porous loads

are commonly known as “porous load sterilizers”. They are intended to deal with
porous items such as towels, gowns and dressings; and medical and surgical
equipment, instruments and utensils packaged or wrapped in porous materials
such as paper or fabrics.

2.11 Sterilization is achieved by direct contact of the load items with good-
quality saturated steam at a preferred sterilization temperature of 134°C.

2.12 As porous loads trap both air and moisture, an efficient and reliable air
removal system is essential. An air detector is fitted to ensure that the operating
cycle does not proceed until sufficient air and other non-condensable gases have
been removed from the chamber and load. The correct functioning of the air
detector is crucial to the performance of the sterilizer.

Fluids

2.13 Clinical sterilizers using high-temperature steam to process aqueous fluids

are commonly known as “fluids sterilizers”. They are used to sterilize fluids in
sealed containers (normally bottles) of either glass or plastic. They operated at a
preferred sterilization temperature of 121°C.

2.14 Fluids in glass containers can be hazardous. At a temperature of 121°C

the pressure inside a one-litre bottle having a normal fill of fluid is approximately
4 bar. If the door were to be opened at this temperature, and the load exposed
to ambient air, the thermal stresses arising in the glass would be sufficient to
crack the bottle and cause an explosion. A temperature of 80°C is regarded as a
safe maximum at which the door can be opened (even at this temperature the
pressure inside a one-litre bottle is still 1.8 bar). Fluid sterilizers are fitted with a
thermal door-lock to ensure that when glass containers are being processed the
door cannot be opened until the temperature inside all the containers has fallen
below 80°C. Failure to observe this requirement has led to serious accidents
resulting from the explosion of glass containers.

2.15 Fluids in plastic containers present less of a hazard. Operating cycles for
plastic containers allow the door to be opened when the temperature inside the
containers falls below 90°C.

Unwrapped instruments and utensils

2.16 This type of sterilizer is used to process unwrapped surgical components

intended for immediate use. Sterilization is achieved by the direct contact of the
component with saturated steam at a preferred sterilization temperature of
134°C.

2.17 These sterilizers should not be used to process wrapped instruments and
utensils, where the wrapping could inhibit the removal of air and the
penetration of steam. Neither should they be used for unwrapped instruments
and utensils with narrow lumens, where air removal and steam penetration
would similarly be impaired.
2.18 Since the sterilized instruments and utensils are exposed to the air
on being removed from the chamber, they are susceptible to immediate
recontamination. These sterilizers are therefore suitable for clinical use only
within the immediate environment in which the instruments are to be used.
Wherever possible, instruments and utensils should be wrapped and processed
in a porous load sterilizer.

2.19 Transportable (bench-top) models are electrically heated, requiring only a

13 A socket-outlet and no piped services. They are commonly used in theatre
suites where there is no central supply service and in primary healthcare units
such as general practitioners’ and dentists’ surgeries.

Clinical sterilizers using hot air

2.20 Clinical sterilizers using hot air as a sterilant are correctly known as “dry-
heat sterilizers”, and sometimes as “hot-air sterilizers” or “sterilizing ovens”. They
are intended to process materials such as oils, powders and some ophthalmic
instruments, which can withstand high temperatures but are likely to be
damaged or not sterilized by contact with steam. They operate at a preferred
sterilization temperature of 160°C.

2.21 They are not suitable for use as drying cabinets (see BS2648 for
specifications for drying cabinets).

2.22 Dry-heat sterilizers are essentially electric ovens and are therefore simpler
than the other pressure sterilizers described in this HTM. A filter and fan are
used to maintain the chamber slightly above atmospheric pressure to ensure that
the sterility of the product and the integrity of the clean-room environment are
not compromised. Although the cycle is under automatic control, the operator is
allowed considerable freedom in selecting the required combination of
sterilization temperature and time. Recommended combinations are shown in
Table 2.1 and advice on their selection is given in Part 4 of this HTM (in
preparation).

2.23 Dry-heat sterilizers are not efficient. It is difficult to obtain an even

temperature distribution within the chamber, air circulation is inhibited when the
chamber is full (even with a circulating fan), and heat transfer from the air to the
load can be very slow. A complete cycle, including cooling to 80°C, takes
approximately eight hours for a full test load as described in Part 3 of this HTM.
If this time is unacceptable, a sterilizer fitted with assisted cooling is
recommended, reducing the cycle time for the same load to approximately five
hours.

Clinical sterilizers using low-temperature steam and

formaldehyde

2.24 Heat-sensitive materials (wrapped or unwrapped) which will withstand

saturated steam at temperatures up to 80°C are normally processed in either
low-temperature steam disinfectors (“LTS disinfectors”) or low-temperature
steam and formaldehyde sterilizers (“LTV sterilizers”). Sterilizers designed for
LTSF will normally incorporate an LTS disinfection cycle.

2.25 Disinfection is achieved by the direct contact of the load with saturated
steam at a minimum temperature of 71°C at sub-atmospheric pressure.
Sterilization is achieved by contact with both saturated steam and formaldehyde
gas. Either process may also be used to decontaminate soiled surgical
components before they are washed and reprocessed.
2.26 Formaldehyde is a toxic gas. Part 5 of this HTM contains safety
information.

2.27 Since the sterilization process is ultimately dependent on chemical action, In Scotland LTSF sterilizers are
microbiological test methods are required to confirm that sterilization conditions considered to be disinfectors
have been attained.

Clinical sterilizers using ethylene oxide

2.28 Clinical sterilizers using ethylene oxide gas as a sterilant are commonly
known as “ethylene oxide sterilizers” or “EO sterilizers”.

2.29 EO sterilizers are used to process heat-sensitive materials and devices

which cannot withstand low-temperature steam. They should not be used to
process items which can be sterilized by alternative methods, that is, by high-
temperature steam, dry heat or LTSF. They should not be used to re-sterilize
items which have been sterilized by irradiation.

2.30 EO sterilizers are used extensively in industrial manufacture of sterile

medical devices but are relatively uncommon in hospitals. Two classes of EO
sterilizers are suitable for NHS use:

a. small sterilizers, of chamber volumes around 150 litres, where the sterilant
is pure EO at sub-atmospheric pressure supplied from a disposable
cartridge contained within the chamber;

b. large sterilizers, of chamber volume up to 500 litres, where the sterilant is

either pure EO or EO diluted with another gas, supplied from cylinders. EO
sterilizers have the potential to cause serious environmental pollution.
Sterilizers using chlorofluorocarbon (CFC) gases as diluents should no
longer be installed.

2.31 EO is a highly reactive liquid and gas which is toxic, flammable and
explosive. The safe operation of EO sterilizers requires careful consideration of all
aspects of the installation and operation of equipment.

2.32 The entire EO process is complex and requires specialised facilities for
washing, packaging and preconditioning loads before processing and degassing
before use. Large sterilizers will also require additional plant to dispose safely of
exhaust products.

2.33 The efficacy of the process IS affected by the packaging used to wrap
goods for sterilization. Since the sterilization process is ultimately dependent
upon chemical action, microbiological test methods are required to confirm that
sterilization conditions have been attained.

2.34 Managers considering installing EO sterilizers should be aware of the

following points:

a. the difficulty in validating and monitoring suitable cleaning processes for

loads before they are sterilized;

b. the difficulty in carrying out representative performance qualification tests

for the wide variety of loading conditions that may be used;

c. the difficulty in carrying out meaningful bioburden studies on small

numbers of widely differing devices to be sterilized;

d. the problems associated with determining the levels of residual EO and its
reaction products when small numbers of widely differing devices are
processed.
Laboratory sterilizers/autoclaves

2.35 Laboratory sterilizers, also known as autoclaves, are used for making-safe
discard material and processing apparatus and materials to be used within
clinical laboratories. They are not intended for the sterilization of medical devices
or medicinal products intended for the clinical care of patients.

2.36 Unlike clinical sterilizers, the laboratory sterilizers covered in this HTM are
designed for use only with high-temperature steam. No chemical sterilants are
used.

2.37 Certain common laboratory operations may be carried out more

economically with specialised machines designed for the purpose, and these are
described below.

Operating cycles

2.38 Laboratory sterilizers are often required to process a wide range of

materials and objects, and they are equipped with one or more operating cycles
each designed for a particular application. Different types of load generally
require different operating cycles. Cycles are normally preset, and proceed
automatically once selected and started.

2.39 The range of cycles that a sterilizer can provide will depend on details of
its construction. For example, the methods used to remove air from the
chamber, the means employed to cool and dry the load, and the provision of
safety features.

2.40 Laboratory sterilizers may be equipped with one or more of the following
operating cycles:

a. make-safe of small plastic discard;

b. make-safe of contained fluid discard;

C. sterilization of culture media;

d. disinfection of fabrics;

e. sterilization of glassware and equipment;

f. free steaming.

2.41 Guidance on the specification of operating cycles is given in Part 2 of this

HTM.

Culture media preparator

2.42 Many of the problems which relate to sterilizing culture media can be
solved by the use of small sterilizers in which the media constituents are placed
directly into the chamber, thus avoiding the use of glass containers and their
attendant hazards.

2.43 The machine consists of two or three modules incorporated into a system
designed to provide controlled preparation, sterilization, cooling and dispensing
of culture media with a minimum of attention by the operator. The system may
also include a module which automatically stacks the completed culture plates.

2.44 The sterilizer module is essentially a pressure-cooker in which water and

dehydrated culture media are mixed, sterilized and then cooled to below 80°C.
This type of sterilizer is particularly suitable for manufacturing batches of culture
media in volumes between 1 and 20 litres.

Köch steamer

2.45 A Koch steamer is designed to expose a load to steam at near-

atmospheric pressure and is commonly used for melting solidified agar. Steamers
are not sterilizers and the product cannot be regarded as sterile. No further
information specific to Koch steamers is given in this HTM.

Animal house sterilizer

2.46 The very wide range of materials and Implements used in the care of
laboratory animals is often catered for by specialised sterilizers with capacities as
high as 10 m3, which run several operating cycles. Examples of loads include
bedding for discard, fresh bedding, feed bottles, food and water, cages, and
tools and Implements for use by personnel in the animal house. In view of the
specialised nature of these machines, no further information specific to animal
house sterilizers is given in this HTM. Users are advised to adapt the guidance on
laboratory sterilizers to their circumstances in consultation with the authorised
person.

High-temperature steam Dry heat LTS LTSF Ethylene

oxide

Sterilization temperature (°C) (a) 115 121 126 134 160 170 180 71 71 30-56
(b)

Maximum allowable temperature (“C) 118 124 129 137 170 180 190 80 80 (c)

Minimum holding time (min) 30 15 10 3 120 60 30 10 180 (e)

(d)

Table 2 Sterilization temperature bands

Notes: a. The temperature setting on the automatic controller will not generally be the sterilization temperature, but a higher
temperature within the sterilization temperature band.
b. Disinfection temperature.
c. For EO, the maximum allowable temperature will normally be 4°C above the sterilization temperature.
d. For LTSF, the sterilization conditions may specify either a continuous holding time or the number of pulses for formaldehyde
required to achieve sterilization.
e. For EO, the “gas exposure time” is determined for each sterilizer by microbiological methods during commissioning but is
typically 2-7 hours depending upon sterilization temperature and gas concentration.
 3.0 Statutory requirements

Introduction

3.1 So far as sterilization is concerned, the chief areas of legislation with which
managers should be familiar are health and safety, medicinal products and
consumer protection.

Health and safety

The Health and Safety at Work 3.2 The largest body of law with which managers need to be familiar concerns
(Northern Ireland) Order 1978 health and safety, in particular the Health and Safety at Work etc Act 1974 (the
applies in Northern Ireland HSW Act) and its various regulations.

3.3 The HSW Act and its regulations require employers to assess the risk to
their employees. Attention is drawn to the following hazards which are implicit
in the practice of sterilization:

a. the hazard of scalding from escaping steam;

b the high temperatures (up to 200°C) at which sterilizers are operated;

c. the stored energy hazards associated with the operation of pressure

vessels contained within all steam and some EO sterilizers;

d. the stored energy hazards associated with the pressurised containers in

which EO gas is transported;

e. the explosive hazards associated with the sterilization of fluids in sealed

glass bottles;

f. the toxic properties of formaldehyde gas used in low-temperature steam

and formaldehyde (LTSF) sterilizers;

g. the toxic and explosive properties of ethylene oxide gas used in ethylene
oxide (EO) sterilizers;

h. the infection hazard associated with the microbial pathogens that may be
handled by personnel using certain laboratory sterilizers;

j. the hazard of infection to patients and staff by the inadvertent release of

an unsterile load due to the failure of a sterilization and quality control
process;
k. the hazards associated with the handling of heavy and hot loads while
loading and unloading sterilizers.

3.4 The guidance given throughout this HTM is designed to ensure that these
hazards are minimised and that sterilization procedures comply with the relevant
legislation and established good practice.

Health and Safety at Work etc Act 1974

3.5 The HSW Act sets out the basic legal responsibilities of employers and
employees with regard to health and safety at work.
Management of Health and Safety at Work Regulations 1992

3.6 The Management of Health and Safety at Work Regulations 1992 (SI The Management of Health and
1992/2051) expand upon the principles of the HSW Act. Safety at Work Regulations (Northern
Ireland) 1992 apply in Northern
Ireland

3.7 The core of the regulations is a requirement of employers to make a

systematic assessment of the risks to health and safety of their employees and
others, arising from work activities.

Workplace (Health, Safety and Welfare) Regulations 1992

3.8 The Workplace (Health, Safety and Welfare) Regulations 1992 (SI The Workplace (Safety, Health and
1992/3004) aim to ensure that workplaces meet the health, safety and welfare We/fare) Regulations (Northern
needs of each member of the workforce, including people with disabilities. Ireland) 1993 apply in Northern
Ireland

3.9 Most of the regulations deal with the physical requirements of the
workplace. Managers concerned with the operation of sterilizers should pay
particular attention to the regulations and maintenance, ventilation,
temperature, lighting, cleanliness, room dimensions and space, floors, doors and
traffic routes.

Provision and Use of Work Equipment Regulations 1992

3.10 The Provision and Use of Work Equipment Regulations 1992 (SI The Provision and Use of Work
1992/2932) aim to ensure the provision of safe work equipment and its safe use. Equipment Regulations (Northern
Ireland) 1993 apply in Northern
Ireland

3.11 Work equipment, defined to Include “any machinery, appliance,

apparatus or tool”, clearly covers sterilizers and associated equipment. The
requirements are numerous, and managers should ensure that all equipment first
provided for use on or after 1 January 1993 complies with them. Older
equipment is partly exempt until 1 January 1997.

Pressure Systems and Transportable Gas Containers Regulations 1989

3.12 The regulations on pressure systems apply to all steam sterilizers, to EO The Pressure Systems and
sterilizers operating above 0.5 bar, and to the steam and compressed air services. Transportable Gas Containers
They replace the sections of the Factories Act 1961 that were relevant to steam Regulations (Northern Ireland) 1991
sterilizers. The regulations on transportable gas containers apply to cartridges apply in Northern Ireland
and cylinders used to supply sterilant or purging gas to EO sterilizers.

3.13 The regulations also define the duties of the competent person: a person NHS Estates has published a Health
or organisation responsible in law for advising on the scope of a written scheme Guidance Note, ‘The pressure
of examination of a pressure system, drawing up the scheme, certifying the systems and transportable gas
scheme as being suitable, and carrying out examinations under the scheme. containers regulations 1989’, which
concerns the applications of the
regulation within the NHS

Control of Substances Hazardous to Health Regulations 1988

3.14 Schedule 1 of the Control of Substances Hazardous to Health (COSHH) The Control of Substances Hazardous
Regulations lists ethylene oxide and formaldehyde as two substances hazardous to Health Regulations (Northern
to health which are subject to a maximum exposure limit for inhalation. These Ireland) 1990 apply in Northern
limits are reviewed annually and updated by amendments to the regulations. The Ireland
current limits (1994) are given in Table 3.1. These limits must not be regarded as
safe work exposures.
 3.15 The Health and Safety Executive (HSE) publishes an annually updated
guidance note on current exposure limits – ‘Occupational exposure limits (EH
40)’.

3.16 Users of laboratory sterilizers should note that a “substance hazardous to

health” may include a micro-organism which creates a hazard to the health of
any person. Guidance on the precautions to be taken when handling micro-
organisms may be found in the Health and Safety Council (HSC) documents
‘Categorisation of pathogens according to hazard and categories of
containment’, (second edition 1990) complied by the Advisory Committee on
Dangerous Pathogens, and ‘Safe working and the prevention of infection in
clinical laboratories’, compiled by the Health Services Advisory Committee.

Reporting of Injuries, Diseases and Dangerous Occurrences Regulations

1985

The Reporting of Injuries, Diseases 3.17 Commonly known as RIDDOR, these regulations impose duties on
and Dangerous Occurrences persons responsible for the activities of persons at work, and on self-employed
Regulations (Northern Ireland) 1986 persons, to report accidents resulting in death or major injury arising out of or in
apply in Northern Ireland connection with work, and to report specified dangerous occurrences. They also
require certain particulars of accidents at work to be reported both to the
Department of Health and also to the Health and Safety Executive, and require
records to be kept.

3.18 Steam and certain EO sterilizers contain pressure vessels as defined under
Part 1 of Schedule 1.

3.19 Poisoning by ethylene oxide is a reportable disease listed under

Schedule 2.

Manual Handling Operations Regulations 1992

The Manual Handling Operations 3.20 The regulations require employers to make an ergonomic assessment of
Regulations (Northern Ireland) 1992 all manual handling operations which involve a risk injury, and to reduce the risk
apply in Northern Ireland as far as is reasonably practicable. Factors to be assessed Include the nature of
the task, the load, the working environment and individual capability.

3.21 Managers should assess the risks associated with loading and unloading
sterilizers, whether by loading trolleys or by hand. Top-loading sterilizers can be
especially hazardous if lifting equipment is not available. The mass of the load is
not the only source of risk; the temperature and other factors should be taken
into account. Risks associated with maintenance and overhauling should also be
assessed.

Personal Protective Equipment at Work Regulations 1992

The Personal Protective Equipment at 3.22 Managers should assess whether the risks associated with sterilization
Work Regulations (Northern Ireland) require the use of personal protective equipment (PPE). Some examples Include
1993 apply in Northern Ireland heat-resistant gloves for use when hot loads are removed from sterilizers,
protective gloves for use when handling discard material in laboratones, eye or
face protection when testing sterilizers containing fluids in glass bottles, and
foot protection of operators loading and unloading sterilizers.

Medicinal products

Medicines Act 1968

3.23 Where a sterilizer is to be used to sterilize medicinal products, the

licensing provisions of the Medicines Act 1968 apply. Further information may
be found in ‘Guidance to the NHS on the licensing requirements of the
Medicines Act 1968’, published by the Medicines Control Agency.

Medicines (Standard Provisions of Licences and Certificates) Amendment

(No 3) Regulations 1977

3.24 The Medicines (Standard Provisions of Licences and Certificates)

Amendments (No 3) Regulations 1977 introduced a qualified person who, in
certain circumstances, has statutory responsibility for quality control in the
manufacture of medicinal products (see Chapter 5). This will include decisions on
release of a sterilized product.

Medicines (Standard Provision of Licences and Certificates) Amendment

Regulations 1992

3.25 The Medicines (Standard Provisions of Licences and Certificates)

Amendment Regulations 1992 (SI 1992/2846) give statutory force to the
commission document ‘The rules governing medicinal products in the European
Community Volume IV: Guide to good manufacturing practice for medicinal
products’. All provisions in the guide came into force on or before 1 January
1993. The annex on sterilization contains requirements that are implemented by
the guidance in this HTM.

Consumer protection

3.26 In recent years, new legislation has been Introduced affording protection
to persons who may be harmed by unsafe goods supplied to them. In certain
circumstances this may include products from sterilizers.

Consumer Protection Act 1987

3.27 Part 1 implements EU Council Directive 85/374/EEC (the Product Liability The Consumer Protection (Northern
Directive) providing for compensation to be paid to persons injured by a Ireland) Order 1987 applies in
defective product. Under the Act a product is defective “if the safety of the Northern Ireland
product is not such as persons generally are entitled to expect”, taking the
circumstances into account. It is likely that civil action for damages could be
taken against a hospital for supplying, for example, “sterile” products that were
not in fact sterile and caused the infection of a patient.

3.28 Part 2 introduces a “general safety requirement” on the suppliers of

“consumer goods” only. It is a criminal offence to supply unsafe consumer
goods, whether or not actual harm has been caused. Consumer goods are
defined as “any goods which are ordinarily intended for private use or
consumption”, and are regarded as unsafe when “they are not reasonably safe
having regard to all the circumstances”. It is not clear whether products from
hospital sterilizers are to be regarded as consumer goods. (Controlled drugs and
licensed medicinal products are exempt from Part 2 since they are governed by
other legislation.)

Electromagnetic Compatibility Regulations 1992

3.29 The Electromagnetic Compatibility Regulations (SI 1992/2372) (the EMC

Regulations), impose requirements concerning the electromagnetic compatibility
of most types of electrical and electronic apparatus which must be complied
with, before such apparatus is to be supplied or taken into service.

3.30 A sterilizer (and any ancillary equipment) is a “relevant apparatus” within

the terms of the regulations, and will have to meet standards of emission of an
 immunity to electromagnetic disturbance. Note that it is an offence not only to
supply but also to “take into service” a sterilizer that does not conform to the
regulations.

Detailed guidance on the application 3.31 The regulations do not apply to any sterilizer supplied to be taken into
of the EMC regulations in healthcare service in the EU before 28 October 1992. A sterilizer supplied or taken into
premises may be found in HTM service in the UK on or before 31 December 1995 is not required to comply with
2014 – ‘Abatement of electrical the regulations provided it complies with the requirements of the Wireless
interference’ Telegraphy Acts listed in Schedule 1 of the regulations.

Active Implantable Medical Devices Regulations 1992

3.32 The Active Implantable Medical Devices Regulations 1992 (SI 1992/3146)
set out the essential requirements which active implantable medical devices
(such as heart’ pacemakers) must satisfy before they can be placed on the market
or put into service.

3.33 Schedule 2, paragraph 7 requires such devices to be designed,

manufactured and packed in a non-reusable packaging according to procedures
which are sufficient to ensure that:

a. the device is sterile when placed on the market; and

b. if handled in accordance with conditions as to storage and transport laid
down by the manufacturer, the device remains sterile until the packaging
is removed and the device is implanted.

3.34 Schedule 2, paragraph 14 sets out requirements for the labelling of sterile
packs.

Gas Short-term exposure limits Long-term exposure limits

-3
[ppm] [mg m-3] [ppm] [mg m ]
Formaldehyde 2 2.5 2 2.5

Ethylene oxide 15 30 5 10

Table 3.1 Maximum exposure limits at atmospheric formaldehyde and ethylene oxide
Notes: The short-term exposure limit (STEL) is the average exposure over any 15-minute
period.
The long-term exposure limit (STEL) is the exposure over any 24-hour period expressed as a
single uniform exposure over an 8-hour period.
COSHH does not specify a STEL for EO. In such cases the STEL is deemed to be three times
the LTEL in accordance with the recommendations of the Health and Safety Executive.
Source: HSE guidance note EH40 (1994).
4.0 British and European standards

Introduction
4.1 Industry standards for sterilization have developed rapidly since the last
edition of this HTM in 1980. British standards which existed at that time have
been thoroughly revised and extended. New European standards now in
preparation will cover not only design, construction, performance and safety, but
also validation, routine testing and operation.

4.2 British and European standards, supplemented by specific requirements for

the NHS, form the basis of the guidance given in the “Design considerations”
volume of this HTM.

4.3 The main standards for sterilizers are BS3970 for clinical sterilizers and
BS2646 for laboratory sterilizers.

European standards

4.4 European standards on sterilization will be more extensive than British

standards in specifying not only design, construction, performance and safety
requirements of sterilizers, but also that persons responsible for sterilization
operate a quality system and that part of that system is validation and routine
testing of the process.

4.5 This edition of HTM 2010 has been written while most of the new
standards are still in the course of development. While the guidance given here
is designed to conform broadly with draft standards, HTM 2010 must not be
regarded as a substitute for the standards themselves.
5.0 Personnel

Introduction

5.1 This chapter introduces the personnel who may share the responsibility for
th e safe and efficient operation of sterilizers. It gives guidance on qualifications
and training and summarises areas of responsibility.

Training

5.2 It is essential that personnel at all levels have a sound general knowledge
of the principles, design and functions of sterilizers. They should be trained on
those types and models of sterilizers with which they are concerned. They
should have some knowledge of the basic elements of microbiology in order to
ensure personal safety, safety of others and general safety. Training given to
individuals should be recorded and reviewed regularly.

5.3 Accredited courses on sterilization, suitable for personnel at all levels, are
run at the NHS Training Centre at Eastwood Park. Further information is
available from NHS Estates and the authorised persons (sterilizers).

5.4 Detailed training on particular models of sterilizer is usually available from

the manufacturer, either on-site (such as during validation) or by courses at their
premises.

Functional responsibility

5 . 5 Since the last edition of this HTM there have been profound changes in the
management philosophy of the NHS. Many hospitals have become self-
governing trusts, many general practices have become fund-holders, and there is
a trend towards deregulation and contracting-out of services. It is not possible to
prescribe a management structure of sterilization that is universally applicable
given the wide range of circumstances in which a sterilizer may be employed,
from a busy sterile services department in a major general hospital to a small
rural dental practice.

5 . 6 The approach chosen for this HTM is to identify the distinct functions that
need to be exercised and the responsibilities that go with them. The titles given
are therefore generic; they describe the individual’s role in connectron with
sterilization, but are not intended to be prescriptive job titles for terms of
employment, Indeed, many of the personnel referred to may not be resident
staff but employed by outside bodies and working on contract. Some of them
will have other responsibilities unconnected with sterilization and in some cases
the same individual may take on more than one role.

5.7 In every case, however, it is possible to identify a user who is responsible

for the day-to-day management of the sterilizer. The philosophy of this HTM is
to Invest the user with the responsibility for seeing that the sterilizer is operated
safely and efficiently.

5.8 The law requires that a competent person (pressure vessels) who is not
th e user is designated to exercise certain responsibilities of inspection for all
steam sterilizers and other sterilizers containing pressure vessels.
5.9 For small installations where the user is qualified to perform all required
test and maintenance functions, no other personnel may be necessary. This may
be satisfactory for small sterilizers run by dentists or general practitioners.
However, it is strongly recommended that in all cases the user receive
professional advice from an authorised person (sterilizers), and that testing
and maintenance be carried out by a suitably qualified test person (sterilizers)
and a maintenance person (sterilizers) with assistance from a microbiologist
(sterilizers) where microbiological testing is required.

5.10 Where the sterilizer is used to manufacture medicinal products, the

functions of the user are exercised by a production manager and a quality
controller.

Key personnel
5.11 For the purposes of HTM 2010, the following are the key roles in the
management of sterilization.

Management

5.12 Management is defined as the owner, occupier, employer, general

manager, chief executive or other person who is ultimately accountable for the
sole operation of its premises.

User

5.13 The user is defined as the person designated by management to be

responsible for the sterilizer.

5.14 In a hospital, the user could be a sterile services department manager,

laboratory manager or theatre manager; in primary care he or she could be a
general practitioner, dentist, or other health professional. Where a sterilizer is
used to process medicinal products, the user is normally the production manager
in charge of the entire manufacturing process.

5.15 The principal responsibilities of the user are as follows:

a. to certify that the sterilizer is fit for use;

b. to hold all documentation relating to the sterilizer, including the names of

other key personnel;

c. to ensure that the sterilizer is subject to periodic testing and maintenance;

d. to appoint operators where required and ensure that they are adequately
trained;

e. to maintain production records;

f. to establish procedures for product release (for medical products, in

cooperation with the quality controller).

Competent person (pressure vessels)

5.16 The competent person (pressure vessels) is defined as a person or

organisation designated by the management to exercise certain legal
responsibilities with regard to the written scheme of examination of any pressure
vessel associated with a sterilizer described in the Pressure Systems and
Transportable Gas Containers Regulations 1989. The shorter term “competent
person” is used in this HTM.
5.17 The competent person should not be the user, nor any of the other key
personnel associated with the sterilizer in question.

5.18 The following guidance on the qualifications of the competent person is

based on the HSC Approved Code of Practice ‘Safety of pressure systems’:

a. where required to draw up or certify schemes of examination, the

competent person should be qualified at least to technician engineer level,
with adequate relevant experience and knowledge of the law, codes of
practice, examination and inspection techniques and understanding of the
effects of operation for the pressure vessel concerned. He or she must
have established access to basic design and plant operation advice,
materials engineering and non-destructive testing facilities. The competent
person must have sufficient organisation to ensure a reasonable data
storage and retrieval system with ready access to relevant law, technical
standards and codes;
b. where required to carry out examinations, the competent person should
have sufficient practical and theoretical knowledge and actual experience
of the type of pressure vessel which is to be examined to enable defects or
weaknesses to be detected and their importance in relation to the integrity
and safety of the sterilizer to be assessed.

5.19 The principal duties of the competent person under the regulations are as
follows (they need not all be exercised by the same individual):

a . advising on the scope of the written scheme of examination;

b . drawing up the written scheme of examination or certifying the scheme as

being suitable;

c . carrying out examinations in accordance with the written scheme,

assessing the results and reviewing the written scheme for its suitability.

5 . 2 0 Most insurance companies maintain a technical division able to advise on

appointing a competent person. The authorised person (sterilizers) will also be
able to provide advice.

5.21 Further information about the written scheme of examination will be

found in Part 4 of this HTM.

Authorised person (sterilizers)

5.22 The authorised person (sterilizers) is defined as a person designated by
management to provide independent auditing and advice on sterilizers and
sterilization and to review and witness documentation on validation. The shorter
term “authorised person” is used in this HTM.

5.23 The authorised person should:

a . have a minimum of two years’ recent experience in the validation of
sterilization processes to modern standards;

b. have a degree in a relevant scienc subject

e or corporate membership of a
relevant professional institution;

c. hav e complete d an accredited course fo authorised

r persons (sterilizers
and successfull ypassed the examination;

or alternatively, should:
d. have applied for registration as an authorised person (sterilizers) no later
than 31 December 1994;
 e. have at least ten years’ experience in the validation of porous load and
laboratory sterilization processes;

f. have two years’ experience in a responsible position;

g. successfully pass an accredited examination for authorised persons

(sterilizers) within five years of registration.

5.24 The authorised person is required to liaise closely with other professionals
in various disciplines and consequently, the appointment should be made known
in writing to all interested parties. He or she should have direct contact with the
user and other key personnel.

5.25 The principal responsibilities of the authorised person are as follows:

a. to provide general and impartial advice on all matters concerned with

sterilization;

b. to advise on programmes of validation;

c. to audit reports on validation, revalidation and yearly tests prepared by the

test person;

d. to advise on programmes of periodic tests and periodic maintenance;

e. to advise on operational procedures for routine production.

5.26 A register of suitably qualified authorised persons is maintained by the

Institution of Hospital Engineering.

Test person (sterilizers)

5.27 The test person (sterilizers) is defined as a person designated by
management to carry out validation and periodic testing of sterilizers. The
shorter term “test person” is used in this HTM.

5.28 The test person should:

a. be qualified to at least HNC in engineering or microbiological sciences;

b. have completed an accredited course for test persons (sterilizers) and

successfully passed the examination;

c. have been recently employed in an NHS hospital with responsibility for

validation and periodic testing for one or more sterilization processes;

or alternatively:

d. have a certificate demonstrating satisfactory completion of an accredited

course (City and Guilds or equivalent) in the validation and periodic testing
of at least two sterilization processes;

e. have at least three years e

’ xperience in the validation and periodic testing
of porous load sterilizer and
s at least one other sterilization process.

5.29 The principal responsibilities of the test person are as follows:

a. to conduct the validation tests specified in Part 3 of this HTM and to
prepare the validation report;

b. to conduct the periodic tests specified in Part 3 and to prepare reports as

required by the user;

c. to conduct any additional tests at the request of the user.

Maintenance person (sterilizers)
5.30 The maintenance person (sterilizers) is defined as a person designated by
management to carry out maintenance duties on sterilizers. The shorter term
“maintenance person” is used in this HTM.

5.31 The maintenance person should be a fitter or an electrician with

documentary evidence to demonstrate competence in the maintenance of one
or more types of sterilizer. He or she should be in a positron to deal with any
breakdown in an emergency and have the ability to diagnose faults and carry
out repairs or to arrange for repairs to be carried out by others.

5.32 The principal responsibilities of the maintenance person are as follows:

a. to carry out the maintenance tasks outlined in Part 4;

b. to carry out additional maintenance and repair work at the request of the
user.

5.33 A maintenance person who has a minimum of two years’ experience in

the maintenance of sterilizers and who has obtained a recognised qualification
in the testing of sterilizers may perform the duties of the test person for the
daily, weekly and quarterly tests described in Part 3.

Microbiologist (sterilizers)
5.34 The microbiologist (sterilizers) IS defined as a person designated by
management to be responsible for advising the user on microbiological aspects
of the sterilization of non-medical products. The shorter term “microbiologist” is
used in this HTM.

5.35 The microbiologist should have a relevant degree (for example

microbiology or medicine) and will normally be a member of the hospital staff.

5.36 The principal responsibilities of the microbiologist are as follows:

a. to advise the user on the microbiological aspects of sterilization procedures

for non-medicinal products;

b. to arrange for the culturing of biological indicators used in microbiological

tests (normally low-temperature steam and formaldehyde (LTSF) and
ethylene oxide (EO) sterilizers);

c. to audit the documentation from all sterilizers which have been tested by
microbiological methods.

Personnel for medicinal products

5.37 Where a sterilizer is to be used in the productron of medicinal products,
the provisions of the Medicines Act 1968 apply. The responsibilities that would
otherwise be exercised by the user are divided between the production manager
and the quality controller. Guidance on the duties of each can be found in the
EU commission document ‘Guide to good manufacturing practice for medicinal
products’.

Production manager
5.38 The production manager is defined as a person designated by
management to be responsible for the production of medicinal products
Quality controller

5.39 The quality controller is defined as a person designated by management

to be responsible for quality control and medicinal products with authority to
establish, verify and implement all quality control and quality assurance
procedures.

5.40 He or she should have the authority, independent of the production

manager, to approve materials and products and to reject, as seen fit, raw
materials, packaging materials, and intermediate, bulk and finished products not
complying with the relevant specification or not manufactured in accordance
with approved procedures.

5.41 The quality controller should be professionally qualified (for example in

pharmacy). Any additional qualifications will depend on the type of licence
which is held, for example:

a. where a product licence is held, the quality controller should satisfy the
requirements of the qualified person as defined in the Medicines (Standard
Provisions of Licences and Certificates) Amendment (No. 3) Regulations
1977. If the quality controller does not meet these requirements, a
qualified person should be designated to exercise the functions specified in
the regulations;
b. where the manufacturer's licence "specials" is held, as is generally the case
in hospitals, the quality controller need not satisfy the requirements of a
qualified person.

5.42 Further information about qualified person can be found in MAL 45

Medicines Acts 1968, 1971.

Other personnel

5.43 The following personnel are also mentioned in this HTM.

5.44 The laboratory safety officer is defined as a person designated by

management to be responsible for all aspects of laboratory safety including
equipment, personnel and training relating to safety issues, and ensuring
compliance with safety legislation and guidelines.

5.45 An operator is defined as any person with the authority to operate a

sterilizer, including the noting of sterilizer instrument readings and simple
housekeeping duties.

5.46 The manufacturer IS defined as a person or organisation responsible for

the manufacturer of a sterilizer.

5.47 The contractor is defined as a person or organisation designated by

management to be responsible for the supply and installation of the sterilizer,
and for the conduct of the installation checks and tests. The contractor is
commonly the manufacturer of the sterilizer.
Other publications in this series

(Given below are details of all Health Technical Component Data Base (HTMs 54 to 70)
Memoranda available from HMSO. HTMs marked (*) are
54.1 User manual, 1993.
currently being revised, those marked (t) are out of print.
55 Windows, 1989.
Some HTMs in preparation at the time of publication of
56 Partitions, 1989.
this HTM are also listed.)
57 Internal glazing, 1989.
1 Anti-static precautions: rubber, plastics and 58 Internal doorsets, 1989.
fabrics*† 59 Ironmongery, 1989.
2 Anti-static precautions: flooring in anaesthetising 60 Ceilings, 1989.
areas (and data processing rooms)*, 1977. 61 Flooring, 1989.
3 - 62 Demountable storage systems, 1989.
4 - 63 Fitted storage systems, 1989.
5 Steam boiler plant instrumentation† 64 Sanitary assemblies, 1989.
7 Protection of condensate systems: filming amines† 65 Signs†
2007 Electrical services: supply and distribution, 1993. 66 Cubicle curtain track, 1989.
8 - 67 Laboratory fitting-out system, 1993.
9 - 68 Ducts and panel assemblies, 1993.
2011 Emergency electrical services, 1993. 69 Protection, 1993.
12 - 70 Fixings, 1993.
13 - 71 to80 -
2014 Abatement of electrical interference, 1993.
2015 Bed head services, 1994.
16 - Firecode
17 Health building engineering installations: 81 Firecode: fire precautions in new hospitals, 1987.
commissioning and associated activities, 1978. 81 Supp 1 1993.
18 Facsimile telegraphy: possible 82 Firecode: alarm and detection systems, 1989.
DGHs† 83 Fire safety in healthcare premises: general fire
19 Facsimile telegraphy: the transmission of pathology precautions, 1994.
reports within a hospital - a case study† 85 Firecode: fire precautions in existing hospitals,
2020 Electrical safety code for low voltage systems, 1994.
1993. 86 Firecode: fire risk assessment in hospitals, 1994.
2021 Electrical safety code for high voltage systems, 87 Firecode: textiles and furniture, 1993.
1993. 88 Fire safety in health care premises: guide to fire
2022 Medical gas pipeline systems, 1994. precautions in NHS housing in the community for
23 Access and accommodation for engineering mentally handicapped/ill people, 1986.
services†
24 -
2025 Ventilation in healthcare premises, 1994. New HTMs in preparation
26 Commissioning of oil, gas and dual fired boilers: Lifts
with notes on design, operation and maintenance† Combined heat and power
27 Cold water supply storage and mains distribution* Washers for sterile production
[Revised version will deal with water storage and
distribution], 1978. Health Technical Memoranda published by HMSO can be
28 to 39 - purchased from HMSO bookshops in London (post orders
2040 The control of legionellae in healthcare premises - to PO Box 276, SW8 5DT), Edinburgh, Belfast, Manchester,
a code of practice, 1993. Birmingham and Bristol, or through good booksellers.
41 to 49 - HMSO provide a copy service for publications which are
2050 Risk management in the NHS estate, 1994. out of print; and a standing order service.
51 to 54 -
2055 Telecommunications (telephone exchanges), 1994. Enquiries about Health Technical Memoranda (but not
orders) should be addressed to: NHS Estates, Department
of Health, Marketing and Publications Unit, 1 Trevelyan
Square, Boar Lane, Leeds LS1 6AE.
About NHS Estates

NHS Estates IS an Executive Agency of the Department of Health Facilities Notes - debate current and topical
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has a dynamic fund of knowledge which it has acquired
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knowledge NHS Estates has developed products which are publications which respond to changes in Department of
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Enquiries should be addressed to: NHS Estates, 1 Trevelyan Encode - shows how to plan and implement a policy of
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Some other NHS Estates products aspects of fire precautions. HMSO

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Design Guides - complementary to Health Building advice used in briefing consultants, contractors and
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Estatecode - user manual for managing a health estate. Items noted “HMSO” can be purchased from HMSO
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Works Information Management System - Designed to meet a range of needs from advice on the
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Health Building Notes - advice for project teams Enquiries should be addressed to: NHS Estates,
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 Health Technical
Memorandum 2010
Part 2 : Design considerations

Sterilization

London : HMSO
© Crown copyright 1995
Applications for reproduction should be made to HMSO Copyright Unit
First published 1995

ISBN 0 11 322182 7

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BOOKS (PC 13A/1), Publications Centre, PO Box 276,
London SW8 5DT quoting reference 14.02.017. The
standing order service also enables customers to receive
automatically as published all material of their choice
which additionally saves extensive catalogue research. The
scope and selectivity of the service has been extended by
new techniques, and there are more than 3,500
classifications to choose from. A special leaflet describing
the service in detail may be obtained on request.
About this publication

Health Technical Memoranda (HTMs) • Part 2 - Design considerations

give comprehensive advice and guidance - contains information relevant to
on the design, installation and operation the specification and installation
of specialised building and engineering of new sterilizing equipment. It
technology used in the delivery of health discusses the requirements for
care. each type of sterilizer and
outlines the specifications to be
They are applicable to new and existing included in any contract. Practical
sites, and are for use at various stages considerations for the installation
during the inception, design, of sterilizers are discussed,
construction, refurbishment and including siting, heat emission,
maintenance of a building. ventilation, noise and vibration,
and mains services with an
Health Technical Memorandum 2010 emphasis on steam quality;
HTM 2010 is being published in five
parts: • Part 3 - Validation and
verification - covers all aspects
• Part 1 - Management policy - of validation and periodic testing
is a summary of the information of sterilizers. It includes detailed
required by non-technical schedules and procedures for
personnel responsible for the tests and checks to be carried out
management of sterilization for commissioning and
services. It discusses the various performance qualification and for
types of sterilizer, for both clinical subsequent periodic testing;
and laboratory use, and also
contains guidance on legal and • Part 4 - Operational
policy matters, and on the management - covers all
appointment and responsibilities aspects of the routine operation
of personnel. It should be read by and maintenance of sterilizers,
anyone consulting this stressing the need for a planned
memorandum for the first time; maintenance programme along
with the type of records to be
 kept. Advice on the safe and b. the Health and Personal Social
efficient operation of sterilizers is Services Management Executive in
given, as well as procedures for Northern Ireland;
reporting defects and accidents;
c. the National Health Service in
• Part 5 - Good practice guide - Scotland Management Executive.
provides supplementary advice on
a number of matters concerned References to legislation appearing in
with the effective usage of the main text of this guidance apply to
sterilizers. the United Kingdom as a whole, except
where marginal notes indicate variations
The contents of this HTM in terms of
for Scotland or Northern Ireland. Where
management policy and operational
appropriate, marginal notes are also
policy are endorsed by:
used to amplify the text.
a. the Welsh Office for the NHS in
Wales;
 Preface

HTM 2010 gives guidance on the choice, specification, purchase, installation,

validation, periodic testing, operation and maintenance of the following types of
sterilizer in use in the National Health Service:

a. clinical sterilizers:
(i) high-temperature steam sterilizers used for processing porous loads
(including instruments and utensils wrapped in porous materials);
(ii) high-temperature steam sterilizers used for processing aqueous
fluids in sealed containers;
(iii) high-temperature steam sterilizers used for processing unwrapped
solid instruments and utensils;
(iv) dry-heat sterilizers (hot-air sterilizers);
In Scotland LTSF sterilizers are (v) low-temperature steam (LTS) disinfectors and low-temperature
considered to be disinfectors steam and formaldehyde (LTSF) sterilizers;
(vi) ethylene oxide (EO) sterilizers;

b. laboratory sterilizers:
(i) high-temperature steam sterilizers used with one or more
specialised operating cycles;
(ii) culture media preparators.

No guidance is given on sterilization by irradiation, hydrogen peroxide, gas

plasma or filtration. Users who wish to employ these processes bear the
responsibility of ensuring that the validation procedures comply with the
principles outlined in Part 3 of this HTM - ‘Validation and Verification’ - and that
the intended operating procedures will ensure an efficacious process for the
different types of load.

This HTM is intended primarily as a guide for technical personnel, whether

specialists in sterilizers and sterilization procedures or those responsible for
maintenance and testing. It is also intended for those responsible for the day-to-
day running of sterilizers, and will also be of interest to supplies officers,
architects, estates managers and others in both the public and private sectors.

Scottish Health Planning Note 13, Detailed information on the planning and design of a sterile services
‘Sterile services department’, applies in department, including the level of provision of sterilizers, is given in Health
Scotland Building Note 13 - ‘Sterile services department’. Guidance for laboratory
installations can be found in Health Building Note 15 - ‘Accommodation for
pathology services’.

Although this edition of HTM 2010 reflects established sterilizer technology, it is

recognised that considerable scope exists for the utilisation of emerging
technology in the management of sterilizers. This will be kept under review with
the aim of introducing recommendations for such technology at the earliest
opportunity so that the procedures essential for the efficient, safe and effective
operation of sterilizers can be optimised.

Most of the British Standards for sterilizers which were applicable at the time of
the last edition of this HTM, in 1980, have been either withdrawn or radically
revised. Some of them, in turn, are now being replaced by European Standards
which will be published during the currency of this edition of HTM 2010. Some
of these European Standards support new European Union Directives on medical
 devices which will have a major impact on sterilization. Where practicable, the
information in this HTM has been aligned with existing or anticipated standards
and advice is offered where no standard has yet been formulated.

Information about Hazard Groups may The sterilizers described in this HTM may not be suitable, without modification,
be found in the HSC document for safely processing articles infected either with Hazard Group 4 pathogens or
‘Categorisation of pathogens according with agents, such as those associated with transmissable spongiform
to hazard and categories of encephalopathies, which are unusually resistant to sterilization. Design
containment’ (second edition 1990) considerations for sterilizers intended to process articles infected with such
compiled by the Advisory Committee on organisms are discussed in Chapter 14.
Dangerous Pathogens
Contents

About this publication 4.45 Loading systems

4.46 Invitation to tender
Preface page 1 4.51 Contract
4.55 Delivery
1 General page 5
1.1 Introduction 5 Siting page 26
1.4 Legal frameworks for sterilization 5.1 Introduction
1.8 Medicinal products 5.5 Accommodation
1.12 Medical devices 5.9 Plant room
1.19 Personnel 5.13 Loading area
1.37 Safety 5.14 Free-standing sterilizers
5.16 Transportable sterilizers
2 Procurement of a sterilizer - an 5.21 Noise and vibration
overview page 10 5.27 Lighting
2.1 Introduction 5.28 Electromagnetic compatibility
2.2 Purchasing a sterilizer
2.3 What type of load needs to be processed? 6 Engineering services page 30
2.4 What type of sterilizer is required? 6.1 Introduction
2.5 What models are available? 6.5 Electricity
2.6 Where will the sterilizer be sited? 6.10 Water
2.7 What services are available? 6.18 Compressed air
2.8 How big and how many? 6.20 Mains supply
2.9 What other equipment will be needed? 6.22 Local compressors
2.10 What specification? 6.25 Air quality
2.11 What sort of contract? 6.26 Drainage
2.12 Which manufacturer? 6.29 Non-hazardous effluents
2.13 What happens after delivery? 6.34 Hazardous effluents
6.39 Ventilation
3 Choice of sterilizer page 12 6.44 General room ventilation
3.1 Introduction 6.49 Room ventilation for LTSF and EO sterilizers
3.2 Types of sterilizer 6.54 Local exhaust ventilation
3.4 Sterilants 6.62 Chamber exhaust ventilation
3.11 Choice of sterilizer 6.68 Ethylene oxide gas
3.16 Sterilization conditions 6.69 Supply from cartridges
3.25 Sizes and numbers 6.70 Supply from cylinders
3.27 Cycle time and performance class
3.29 Chamber size 7 Steam supply page 41
3.32 Sizing calculation 7.1 Introduction
7.6 Engineering considerations
4 Specification and contract page 19 7.8 Capacity
4.1 Introduction 7.9 Pipework
4.2 Preparing a specification 7.16 Materials
4.9 General design considerations 7.18 Dryness
4.14 Safety features 7.22 Excessive moisture
4.20 Instrumentation 7.24 Superheating
4.28 Programmable electronic systems 7.28 Non-condensable gases
4.31 Overpressure protection
4.33 Access to chamber drain 8 Porous-load sterilizers page 48
4.34 Doors 8.1 Introduction
4.38 Materials of construction 8.5 Standard specifications
4.40 Fatigue life of pressure vessel 8.6 Additional specifications
4.43 Integral air compressors 8.7 Air detector
4.44 Integral steam generators 8.10 Port for air-flow metering device
 8.11 Absolute pressure indicator 13.21 Preconditioning facilities
8.12 Bowie-Dick test cycle 13.26 Preconditioning chamber
8.13 Extended drying 13.30 Preconditioning room
13.35 Degassing facilities
9 Fluid sterilizers page 50 13.39 Disposal of EO
9.1 Introduction 13.45 Gas monitoring system
9.5 Standard specifications
9.7 Additional specifications 14 Laboratory sterilizers page 63
9.8 Cycle for plastic containers 14.1 Introduction
9.10 Heat exchanger 14.4 Provision of laboratory sterilizers
9.12 Monitoring and control by FO 14.13 Design considerations
14.15 Air removal
10 Sterilizers for unwrapped instruments and 14.16 Cooling and drying
utensils page 53 14.17 Thermal door locks
10.1 Introduction 14.18 Standard specifications
10.7 Transportable sterilizers 14.23 Additional specifications
10.10 Fixed sterilizers 14.24 Instruments and controls
10.11 Standard specifications 14.26 Thermal door-lock override
10.13 Additional specifications 14.29 Load-temperature probe
10.14 Operating cycle 14.30 Steam generators
10.15 Temperature recorder 14.33 Chamber drain
14.35 Top-loading sterilizers
11 Dry-heat sterilizers page 55 14.36 Operating cycles
11.1 Introduction 14.38 Make-safe of small plastic discard
11.6 Standard specifications 14.42 Make-safe of contained fluid discard
11.7 Additional specifications 14.45 Sterilization of culture media
14.49 Disinfection of fabrics
12 Low-temperature steam disinfectors and low- 14.53 Sterilization of glassware and equipment
temperature steam and formaldehyde 14.55 Free steaming
sterilizers page 56 14.56 Culture media preparators
12.1 Introduction 14.60 Discard boxes
12.8 Standard specifications
12.10 Additional specifications Glossary page 73
12.11 Room ventilation
12.12 Local exhaust ventilation Abbreviations page 80
12.13 Formalin supply
12.15 Degassing facilities Bibliography page 82
12.16 Gas monitoring system
Appendix 1 - Useful addresses page 88
13 Ethylene oxide sterilizers page 58
13.1 Introduction Appendix 2 - Information to be supplied by the
13.10 Types of sterilizer manufacturer page 89
13.11 Low-pressure sterilizers
13.13 High-pressure sterilizers Other publications in this series page 92
13.16 Standard specifications
13.18 Additional specifications About NHS Estates page 93
13.19 Room ventilation
13.20 Local exhaust ventilation
1.0 General

Introduction

1.1 This Part of HTM 2010 covers the specification, purchase and installation of
the various types of sterilizer used in hospitals, laboratories and other healthcare
facilities.

1.2 Terminology used in sterilization has long been inconsistent and

occasionally ambiguous. This HTM introduces a set of terms consistent with new
European Standards (see paragraph 1.14) which, it is hoped, will in time be
adopted by sterilization workers in the NHS. The Glossary contains definitions
referred to in this Part.

1.3 The Bibliography contains full references for all the documents referred to
in this Part and for selected documents of which the reader should be aware.

Legal frameworks for sterilization

1.4 There are now two legal frameworks applying to products from sterilizers.
The long-standing legislation on medicinal products has now been joined by
new EU Directives on medical devices.

1.5 Purchasers must be clear as to whether the load items they intend to
process in a sterilizer are classified as medicinal products or medical devices.
While the practical requirements have much in common, their implementation is
very different.

1.6 For the guidance given in this HTM, the various types of sterilizer are
presumed to be used primarily as follows:

a. for medicinal products: fluid sterilizers, dry-heat sterilizers;

b. for medical devices: porous load sterilizers, sterilizers for unwrapped

instruments and utensils, dry-heat sterilizers, low-temperature steam (LTS)
disinfectors, low-temperature steam and formaldehyde (LTSF) sterilizers,
ethylene oxide (EO) sterilizers.

1.7 Where a sterilizer is purchased with the intention of processing both

medicinal products and medical devices, purchasers should ensure that the
requirements for both types of load are met.

Medicinal products

1.8 The manufacture and supply of medicinal products are controlled by a

large body of legislation stemming from the EU Directives on medicinal products
and enacted by the UK Medicines Acts and numerous Regulations. Further
details can be found in Part 1 of this HTM - ‘Management policy’.

1.9 The requirements for the manufacture of medicinal products are set out in
the ‘Guide to good manufacturing practice for medicinal products’ published in
Volume IV of ‘The rules governing medicinal products in the European
Community’ (see Bibliography). This document is referred to as the ‘GGMP’ in
this HTM.
1.10 The GGMP contains an Annex on the ‘Manufacture of sterile medicinal
products’ which has considerable implications for the design of sterilizers and
the premises in which they are used. Where purchasers are considering installing
a sterilizer for the processing of medicinal products, the GGMP should be
consulted at an early stage. Attention is drawn to these requirements in the
relevant chapters of this HTM.

1.11 Guidance on the application of medicines legislation to particular cases is

beyond the scope of this HTM and advice should be sought from the Medicines
Control Agency (MCA).

Medical devices
1.12 Part 1 of this HTM discusses the three EU Directives on the manufacture
and supply of medical devices, active implantable medical devices and in-vitro
diagnostic medical devices, which are being implemented by UK Regulations in
stages from 1993 onwards. While the full implications of the legislation for the
NHS are not yet clear, it is likely that all or most products for clinical use that are
not classified as medicinal products will be classified as medical devices. Whether
such medical devices will be subject to the Regulations is a complex issue turning
on the relationship between the producer and the user of the devices and is
beyond the scope of this HTM.

1.13 One of the essential requirements of the directives is that “devices

delivered in a sterile state must have been manufactured and sterilized by an
appropriate, validated method”. There is no equivalent of the GGMP for medical
devices. Instead, the European Committee for Standardisation (Comité Européen
de Normalisation, CEN) has prepared a number of draft European Standards on
the manufacture of medical devices. These are known as “mandated” standards.
Compliance with a mandated standard is considered to be a legal presumption
of compliance with the essential requirements of the Directive it supports.
Official notification of mandated European Standards supporting EU Directives is
published in the Official Journal of the European Communities and in the
London, Edinburgh and Belfast Gazettes.

1.14 Although compliance with a mandated standard is not the only way of
complying with the directives, it is the simplest. Purchasers intending to process
sterile medical devices in compliance with the directives should therefore ensure
that their processes conform with one of the mandated standards. The following
European Standards on the validation and control of sterilization processes are
expected to be mandated in the near future and are discussed in Part 3 -
‘Validation and ventication’ - and Part 4 - ‘Operational management’ - of this
HTM:

a. EN 556 covering the requirements for a device to be labelled “STERILE”;

b. EN 554 covering sterilization by “moist heat” (that is, steam);

c. EN 550 covering sterilization by ethylene oxide.

1.15 These standards are themselves supported by the following standards for
the specification of sterilizers which are discussed in this Part of this HTM:

a. EN 285 covering “large” porous load sterilizers;

b. EN 1422 covering EO sterilizers,

1.16 There are no European Standards, as yet, for fluid sterilizers, sterilizers for
unwrapped instruments and utensils, dry-heat sterilizers, LTS disinfectors, LTSF
sterilizers or laboratory sterilizers. CEN working group TC102 is developing
standards for “small” steam sterilizers which will cover certain porous load
sterilizers and also sterilizers for unwrapped instruments and utensils. A list of
European Standards specific to sterilization is given in the Bibliography.
 1.17 This edition of HTM 2010 has been written while the new standards are
in the course of development. While the guidance given here is designed to be
broadly consistent with the emerging standards, HTM 2010 should not be
regarded as a substitute for the standards themselves when ascertaining
compliance with EU Directives and the UK Regulations that implement them.

1.18 Guidance on the application of medical devices legislation to particular

cases is beyond the scope of this HTM and advice should be sought from the
Medical Devices Agency (MDA).

Personnel

1.19 The following personnel are referred to in this Part of HTM 2010. Further
information, including qualifications and areas of responsibility, can be found in
Part 1.

1.20 Management is defined as the owner, occupier, employer, general

manager, chief executive or other person of similar authority who is ultimately
accountable for the sole operation of the premises.

1.21 Depending on the nature of the organisation, this role may be filled by
the general manager, chief executive, laboratory director or other person of
similar authority. In small, autonomous installations the user may take on this
function.

1.22 The User is defined as the person designated by management to be

responsible for the management of the sterilizer.

1.23 In a hospital the user could be a sterile services department manager,

laboratory manager or theatre manager; in primary care he or she could be a
general practitioner, dentist, or other health professional. Where a sterilizer is
used to process medicinal products, the user is normally the production manager
(see paragraph 1.30) in charge of the entire manufacturing process.

The Pressure Systems and Transportable 1.24 The Competent Person (Pressure Vessels) is defined as a person or
Gas Containers Regulations (Northern organisation designated by management to exercise certain legal responsibilities
Ireland) 1991 apply in Northern Ireland with regard to the written scheme of examination of any pressure vessel
associated with a sterilizer described in the Pressure Systems and Transportable
Gas Containers Regulations 1989 (see Part 1). The shorter term “competent
person” is used in this HTM.

1.25 The Authorised Person (Sterilizers) is defined as a person designated

by management to provide independent auditing and advice on sterilizers and
sterilization and to review and witness documentation on validation. The shorter
term “authorised person” is used in this HTM.

1.26 A list of suitably qualified authorised persons IS maintained by the

Institute of Hospital Engineering (see Appendix 1).

1.27 The Test Person (Sterilizers) is defined as a person designated by

management to carry out validation and periodic testing of sterilizers. The
shorter term “test person” is used in this HTM.

1.28 The Maintenance Person (Sterilizers) is defined as a person designated

by management to carry out maintenance duties on sterilizers. The shorter term
“maintenance person” is used in this HTM.
1.29 The Microbiologist (Sterilizers) is defined as a person designated by
management to be responsible for advising the user on microbiological aspects
of the sterilization of non-medicinal products. The shorter term “microbiologist”
is used in this HTM.

1.30 The Production Manager is defined as a person designated by

management to be responsible for the production of medicinal products.

1.31 The Quality Controller is defined as a person designated by

management to be responsible for quality control of medicinal products with
authority to establish, verify and implement all quality control and quality
assurance procedures.

1.32 The Laboratory Safety Officer is defined as a person designated by

management to be responsible for all aspects of laboratory safety including
equipment, personnel and training relating to safety issues, and ensuring
compliance with safety legislation and guidelines.

1.33 An Operator is defined as any person with the authority to operate a

sterilizer, including the noting of sterilizer instrument readings and simple
housekeeping duties.

1.34 The Manufacturer is defined as a person or organisation responsible for

the manufacture of a sterilizer.

1.35 The Contractor is defined as a person or organisation designated by

Management to be responsible for the supply and installation of the sterilizer,
and for the conduct of the installation checks and tests. The contractor is
commonly the manufacturer of the sterilizer.

1.36 The Purchaser is defined as the person or organisation who orders the
sterilizer and is responsible for paying for it.

Safety

1.37 Extensive guidance on the safe operation of the various types of sterilizer
is given in Part 4 of this HTM. Guidance on safe practices in the testing of
sterilizers is given in Part 3.

1.38 LTSF sterilizers and EO sterilizers both use toxic gases in the sterilization
process. Occupational exposure to formaldehyde and EO is controlled by the
Control of Substances Hazardous to Health Regulations 1994. Maximum
exposure limits are set out in the annual Guidance Note EH40, ‘Occupational
exposure limits’, published by the Health and Safety Executive (see Bibliography).
At the time of writing (1994) the limits are as shown in Table 1. These limits are
statutory maxima but should not be regarded as representing a safe working
exposure; employers have a legal obligation to ensure that the level of exposure
is reduced so far as is reasonably practicable and in any case below the
maximum exposure limit.

1.39 The COSHH Regulations 1994 also introduce new controls on biological
agents which are of relevance to purchasers of laboratory sterilizers.
Table 1 Maximum exposure limits for atmospheric formaldehyde and ethylene oxide

Short-term maximum Long-term maximum

exposure limit exposure limit
Gas ppm mg m-3 ppm mg m-3

Formaldehyde 2 2.5 2 2.5

Ethylene oxide 15 30 5 10

The short-term maximum exposure limit (STMEL) is the average exposure over
any 15 min period.

The long-term maximum exposure limit (LTMEL) is the exposure over any 24 h
period expressed as a single uniform exposure over an 8 h period.

COSHH does not specify a STMEL for EO. In the above table the STMEL is
deemed to be three times the LTMEL in accordance with the recommendations
of the Health and Safety Executive.

Source: COSHH Regulations 1994, HSE Guidance Note EH40 (1994).

2.0 Procurement of a sterilizer -
an overview

Introduction

2.1 This chapter gives a short overview of the process of purchasing a sterilizer.
It refers to more detailed information in subsequent chapters, including
information specific to each type of sterilizer given in Chapters 8 to 14.

Purchasing a sterilizer

2.2 The purchase of a sterilizer can be broken down into the following
sequence of steps.

What type of load needs to be processed?

2.3 Knowing the load is the first step in making the correct decision about
which sterilizer to purchase. Different loads require different processes. Some
loads are degraded by prolonged exposure to heat, others cannot withstand
moisture or chemical sterilants, while others, owing to their materials or
construction, cannot reliably be sterilized by conventional techniques.

What type of sterilizer is required?

2.4 In this HTM sterilizers are classified as either clinical or laboratory sterilizers.
Clinical sterilizers can use one of four different sterilizing agents (“sterilants”):
high-temperature steam, hot air (dry heat), low-temperature steam and
formaldehyde (LTSF) or ethylene oxide (EO). High-temperature steam sterilizers
are specialised for processing porous loads, fluids or unwrapped instruments and
utensils. They are also used in laboratory applications. Guidance on the selection
of a sterilizer is given in Chapter 3.

What models are available?

2.5 Once the type of sterilizer has been settled, brochures and data sheets
should be obtained from a number of manufacturers. The internal market in the
European Union, supported by European Standards on sterilization, has
considerably widened the choice open to purchasers. Guidance on what
information to look for is given in Chapter 4.

Where will the sterilizer be sited?

2.6 Decide on the location of the sterilizer. Some sterilizers will require
considerable building work. Guidance on siting is given in Chapter 5.

What services are available?

2.7 A sterilizer will require one or more of the following services: steam,
electricity, water, compressed air, drainage, ventilation and sterilant gas supply.
The manufacturers’ data will show which services are required for each model.
Determine which of these are available at the proposed site and the capacities of
each service. It may be necessary to plan for a new service which would add
greatly to the cost of the installation. Further information about services may be
found in Chapter 6. Steam supply is crucial and is discussed in detail in
Chapter 7.
How big and how many?

2.8 Establish the likely weekly workload that the sterilizer will have to process.
Calculate the size and number of sterilizers required to process the workload. A
judgment has to be made on the trade-off between size and number. Guidance
on how to do this is given in Chapter 3.

What other equipment will be needed?

2.9 A sterilizer installation may require auxiliary equipment such as steam

generators, air compressors, preconditioning facilities, degassing facilities and
gas disposal plants. If required, these are discussed in Chapters 8 to 14.

What specification?

2.10 Most sterilizers will be constructed to either a European Standard or a

British Standard. In some cases additional specifications will be required and
these are detailed in Chapters 8 to 14. Advice on preparing a detailed
specification for the sterilizer is given in Chapter 4.

What sort of contract?

2.11 Once the specification has been completed, a contract should be drawn
up for the supply and installation of the sterilizer. Guidance on suitable forms of
contract is given in Chapter 4.

Which manufacturer?

3.12 Invite a number of manufacturers to tender for the supply of the sterilizer.
Guidance on tendering is given in Chapter 4.

What happens after delivery?

2.13 Chapter 4 contains advice on the documentation that the manufacturer

should include with the sterilizer. After delivery the sterilizer is subject to a
programme of validation. This is discussed in detail in Part 3 of this HTM.
3.0 Choice of sterilizer

Introduction

3.1 This chapter contains information relevant to the choice of a new sterilizer.
It discusses the types of sterilizer and the loads for which they are suitable, and
gives guidance on selecting the size and number of sterilizers required for a
given application.

Types of sterilizer

3.2 This HTM groups sterilizers into two broad categories according to the use
to which they are put:

a. clinical sterilizers are designed to process medical devices or medicinal

products;

b. laboratory sterilizers are designed to process laboratory goods and

materials that are neither medical devices nor medicinal products and are
not intended for use in the clinical care of patients.

3.3 The operation of sterilizers in the two categories should be kept strictly
separate. Loads intended for processing in a clinical sterilizer should not be put
into a laboratory sterilizer and vice versa.

Sterilants

3.4 Sterilizers can also be classified according to the agent (the sterilant) used
to effect sterilization. The following sterilants are in common use in the NHS:

a. high-temperature steam;

b. dry heat (hot air);

c. low-temperature steam and formaldehyde (LTSF);

d. ethylene oxide (EO).

3.5 Because of its superior sterilizing qualities, high-temperature steam is the

sterilant of choice. Machines using other sterilants should be reserved either for
loads which would be damaged by exposure to high-temperature steam (such as
certain surgical devices) or for loads that would not be sterilized by exposure to
high-temperature steam (such as non-aqueous fluids).

3.6 Low-temperature steam used without formaldehyde is not considered to

be a sterilant but is commonly used for disinfection.

3.7 Clinical sterilizers may employ any one of the four sterilants. The laboratory
sterilizers described in this HTM use only high-temperature steam.

3.8 High-temperature steam sterilizers are by far the most common sterilizers
used in the NHS, and are manufactured in three basic types according to the
nature of load they are designed to process: porous loads, fluids, or unwrapped
instruments and utensils. The operating cycles are designed to cope with the
differing properties of the various types of load, and it is essential that a sterilizer
is used only for the type of load for which it is designed.
 3.9 High-temperature steam inactivates pathogens by a combination of
moisture and heat; water molecules combine with proteins and genetic material,
which are then susceptible to thermal disruption. The process is well understood
and the attainment of sterilization conditions can normally be confirmed by
simple physical measurements. (This is not so for sterilizers using gaseous
sterilants, where microbiological test procedures are necessary.)

3.10 Many high-temperature steam sterilizers are large machines requiring

permanently installed engineering services (including good-quality steam) and
purpose-built accommodation. Smaller models are transportable and generate
steam from an internal water reservoir.

Choice of sterilizer
3.11 The choice of sterilizer will be governed by the nature of the loads
required to be sterilized. Table 2 summarizes the type of load that can and
cannot be processed in each type of machine. More detailed guidance on

Table 2 Suitable and unsuitable loads for different types of sterilizer

Type of sterilizer Suitable loads Unsuitable loads

Porous load (high-temperature Porous items; items with narrow lumens Items which would be damaged by
steam) that may trap air and inhibit the exposure to steam at 121 - l37°C
penetration of steam. Examples: any
item with porous wrapping, dressings,
clothing, towels

Fluid (high-temperature steam) Aqueous fluids in sealed glass or plastic Non-aqueous fluids
containers. Examples: intravenous fluids

Unwrapped instruments and Solid metal items. Examples: surgical or Items with narrow lumens that may trap
utensils (high-temperature steam) dental instruments, bowls air and inhibit the penetration of steam.
Examples: ENT suction tubes,
laparoscopic instruments, orthopaedic
reamers

Dry heat Items which would not be sterilized by Aqueous fluids and items which would
high-temperature steam, or would be be damaged by prolonged exposure to
damaged by doing so. Examples: solids, dry heat at 160-200°C. Examples: fibre
powders, non-aqueous fluids, optics, rubber, plastics
ointments, ophthalmic instruments,
items in closed containers

Low-temperature steam and Wrapped or unwrapped items which Items which would be damaged by
formaldehyde (LTSF) would be damaged or not sterilized by exposure to steam or formaldehyde gas
high-temperature steam or dry heat. at 71-80°C; sealed, oily or greasy items;
Examples: certain items containing items contaminated with body fluids
plastic components, electromedical
equipment

Ethylene oxide (EO) Wrapped or unwrapped items which Items which can be sterilized by other
would not be sterilized by steam or dry means; soiled items; items previously
heat or would be damaged by doing so. sterilized by irradiation. Examples:
Example: heat-labile plastic items, heart ventilatory and respiratory equipment
valves, electromedical equipment

Laboratory Laboratory materials and equipment. Medical devices, medicinal products and
(high-temperature steam) Example infected materials to be made other items to be used in the clinical
safe, culture media, glassware and other care of patients
equipment
appropriate processes for different load items can be found in ‘Sterilization,
disinfection and cleaning of medical equipment: Part 1: Principles’, published by
the Medical Devices Agency, ‘Sterilization and disinfection of heat-labile
equipment’ published by the Central Sterilising Club, and in Part 4 of this HTM.

3.12 Purchasers should be aware that items suitable for a particular type of 1
sterilizer may still require different operating cycles, which need to be specified
before purchase. For example, a porous-load sterilizer is required for wrapped
instruments and microbiological filters. However, a cycle suitable for instruments
may be harmful to the filters unless the rate of change of pressure is reduced to
prevent rupture of the membrane. Similarly, a container with a small orifice will
also require a porous-load sterilizer but the duration of each air removal pulse
will need to be extended to allow for pressure equilibration; otherwise the air
will remain in the container and sterilization will not be achieved. Guidance on
the modification of operating cycles to suit particular loads (process
development) is given in Part 4 of this HTM.

3.13 More information about the different types of sterilizer is given in

Chapters 8 to 14.

Table 3 Suggested information to be obtained from manufacturers before inviting tenders

Information required Objective

The standards (BS or EN) to which the sterilizer is designed To confirm that the sterilizer meets recognized
and constructed and a statement of compliance specifications for design, construction, performance and
safety

Installation data, including the overall dimensions and To enable the user to establish whether the proposed
mass of the sterilizer; the number of supports and the location is suitable for the sterilizer and the extent of any
maximum floor loading at each support; the clearance building work required (see Chapter 5)
required for access and the masses of the principal heavy
components

The volume of the usable chamber space expressed both To enable the user to determine the capacity of the
in litres and an integral number of sterilization modules, sterilizer and hence the number of sterilizers required to
and its principal dimensions in metres process the workload

Specifications for each of the engineering services To enable the user to establish that the demands of the
required by the sterilizer sterilrzer are within the capacity of the services in the
proposed location (see Chapters 6 and 7)

A description of the operating cycles offered with the To enable the user to confirm that the cycles are
sterilizer, including numerical and graphical representations appropriate for the anticipated loads
of typical values of cycle variables throughout each cycle
and the extent to which pre-set variables may be adjusted

For each operating cycle and sterilization temperature the To enable the user to determine the capacity of the
cycle time and corresponding performance class for the sterilizer and hence the number of sterilizers required to
relevant full load tests specified in Part 3 of this HTM process the workload

The mean and peak sound power levels generated by the To enable the contractor to confirm that the sound pressure
sterilizer, expressed as an A-weighted sound power level level after installation, as measured by the method given in
measured as described in Appendix D of BS3970: Part 1 or Part 3 of this HTM, will not exceed that specified for the
in Part 5 of this HTM - ‘Good practice guide’ location (see Chapter 5)

The fatigue life of the pressure vessel To enable the user to estimate the working life of the
sterilizer (see Chapter 4)

The type of doors and information on the necessary space To enable the user to make the necessary provisions in the
required for the movement of the doors (see Chapter 4) design of the loading area (see Chapter 5)
3.14 Advice on individual cases should be sought from the authorized person
before any decision is made. Where an LTSF or EO sterilizer is being considered
the microbiologist should also be consulted.

3.15 Once the type of sterilizer has been decided, preliminary enquires should
be made with a number of manufacturers to obtain specifications and price lists.
Table 3 indicates some of the information that will be useful for planning
purposes and which should be obtained at this stage.

Sterilization conditions
3.16 For the purposes of this HTM the following definitions have been
adopted.

3.17 The cycle variables are the physical properties, such as time,
temperature, pressure, humidity and sterilant gas concentration, that influence
the efficacy of the sterilization process.

3.18 Most operating cycles have a stage in which the load is exposed to the
sterilization (or disinfection) conditions for a specified length of time. This period
is known as the holding time.

3.19 The sterilization conditions are the ranges of the cycle variables which
may prevail throughout the chamber and load during the holding time.

3.20 The holding time is preceded by a period in which the sterilization

conditions are present in the chamber but not yet present throughout the load.
This is known as the equilibration time.

3.21 Together, the equilibration time and the holding time constitute the
plateau period. While the plateau period can always be determined from the
recorded chamber temperature, the equilibration and holding times cannot be
distinguished unless the temperature in the part of the load that is slowest to
reach the sterilization temperature IS also being recorded or measured.

3.22 Certain LTSF sterilizers may achieve sterilization by exposing the load to a
series of pulses of formaldehyde rather than a single holding time.

3.23 For EO sterilizers the plateau period is equivalent to the gas exposure
time. The holding time cannot be determined by thermometry and is therefore
of no practical interest.

3.24 For steam and dry heat sterilizers, the sterilization conditions are specified
by a sterilization temperature band, defined by a minimum acceptable
temperature, known as the sterilization temperature, and a maximum
allowable temperature. The higher the sterilization temperature, the shorter the
holding time and the more rapidly the cycle is completed. A sterilization
temperature band can also be quoted for LTSF and EO sterilizers, but since these
processes depend primarily upon chemical action such a band is not a complete
specification of the sterilization conditions. Bands for the different types of
sterilizer are listed in Table 4.
Table 4 Sterilization temperature bands

High-temperature steam Dry heat LTS LTSF EO

Sterilization temperature [°Cl” 115 121 126 134 160 170 180 71b 71 30-56
Maximum allowable
temperature [°Cl 118 124 129 137c 170 180 190 80 80 d
Minimum holding time [min] 30 15 10 3 120 60 30 10 180 e f

a The temperature setting on the automatic controller will not generally be the sterilization temperature, but a higher temperature
within the sterilization temperature band.
b Disinfection temperature.
c British Standards permit 138°C.
d For EO, the maximum allowable temperature will normally be 4°C above the sterilization temperature.
e For LTV, the sterilization conditions may specify either a continuous holding time or the number of pulses of formaldehyde required to
achieve sterilization.
f For EO, the “gas exposure time” is determined for each sterilizer by microbiological methods during commissioning, but is typically
2-7 h depending upon sterilization temperature and gas concentration.

Sizes and numbers

3.25 It is difficult to give precise information on the sizes and number of

sterilizers required for particular installations since in practice there are significant
variations in patterns of use. The following guidance is applicable to all types of Scottish Health Planning Note 13 -
sterilizer. More detailed advice and examples of how to calculate sizes and ‘Sterile services department’, applies in
numbers of sterilizers in a Sterile Services Department (SSD) is given in HBN 13 Scotland
for porous loads, and in Supplement 1 to HBN 13 for EO sterilizers.

3.26 The number of sterilizers required will depend on two critical properties
of the machine: the cycle time (denoted by a performance class) and the
chamber size (denoted by the volume of the usable chamber space).

Cycle time and performance class

3.27 The time required to complete an operating cycle depends both on the
design of the sterilizer (especially the methods used to remove air from the
chamber and to heat and cool the load) and on the type and size of load to be
processed. An operating cycle is assigned a performance class which is related to
the time required to process a standard full load, as specified in the tests
described in Part 3 of this HTM. A Class 1 cycle will be complete in less than
10 min, while a Class 20 cycle will take over 13 h. The relation between cycle
time and performance class is given in Table 5. If the cycle time is to be extended
to dry difficult loads, this should be allowed for when calculating the number of
sterilizers required.

Table 5 Performance classes for sterilizers

Full load cycle Full load cycle Full load cycle Full load cycle
Class time [mins] Class time [mins] Class time [mins] Class time [mins]

1 0-10 6 61-90 11 241-300 16 541-600

2 11-15 7 91-120 12 301-360 17 601-660
3 16-30 8 121-150 13 361-420 18 661-720
4 31-45 9 151-180 14 421-480 19 721-780
5 46-60 10 181-240 15 481-540 20 over 780
3.28 Loading conditions that present a greater challenge to the cycle than the
full loads specified in Part 3 of this HTM will require further investigation and
performance qualification to establish a cycle time. The authorised person will
advise on this.

Chamber size

3.29 The size of a sterilizer is denoted by the volume of the usable chamber
space, commonly expressed in litres. The usable chamber space is the space
inside the chamber which is not restricted by chamber furniture and which is
available to accept the load. It should be distinguished from the total chamber
volume, which is equal to the volume of water required to fill the chamber and
is therefore larger than the usable chamber space.

3.30 With the gradual introduction of European Standards on sterilization, the

size of larger sterilizers will be denoted by an integer number of sterilization
“modules” which can be accommodated within the usable chamber space. One
module is a rectangular box measuring 300 x 300 x 600 mm, of volume 54
litres. In the European Standards a “large” sterilizer can accommodate one or
more modules; a “small” sterilizer has a capacity of less than one module.
Table 6 lists the recommended sizes for different types of sterilizer.

3.31 In the case of sterilizers for unwrapped instruments and utensils and
laboratory sterilizers, small transportable units of capacity less than one module
are available and may be the most economical solution where workloads are
light.

Sizing calculation

3.32 Once the cycle time is known, the size and number of sterilizers to be
purchased can be calculated. Size and number are complementary: in principle,
the same workload can be processed by a single large sterilizer or a number of
smaller sterilizers.
3.33 The first step in making this decision is to establish the workload which
the sterilizer is intended to process, expressed in modules per week. (For some
types of sterilizer it may be more appropriate to express the workload in other
units; for example trays or discard boxes per week.) This is not simply the bulk
volume of goods to be processed, but the volume they will occupy inside the
sterilizer allowing for spacing within the chamber. Spacing IS particularly
important for sterilizers using mixtures of steam and air and for dry-heat
sterilizers. An item which cannot be fitted into a single module should be
allowed two or more modules as appropriate.

3.34 Once the workload is established, the capacity for a sterilizer of given size
can be calculated from

V fv x T fT
capacity = 60 modules/week
tC

where
V = the volume of the usable chamber space (modules);
fv = the loading factor, the average fraction of the usable chamber space
occupied by a load (typically 0.5 for an SSD);

T = the “open hours”, the number of hours each week for which the
sterilizer unit will be operational;

fT = the utilisation factor, the fraction of the open hours for which the
sterilizer is available to process loads. This should allow for loading and
unloading, periodic testing and maintenance, and warm-up cycles. It
should be chosen so that a sterilizer may be withdrawn from service for
planned maintenance and periodic testing without jeopardising
production. For an SSD the utilisation factor is typically 0.55;

fc = the cycle time for the selected operating cycle (minutes).

3.35 The minimum number of sterilizers required to process the workload can
then be calculated from

Number of sterilizers required ³ workload

capacity

3.36 Purchasers should make the above calculation for a number of different
sizes of sterilizer to establish the combinations of size and number that will
satisfy the workload requirement.

3.37 In practice, the number of sterilizers of the same type in a single

installation will be usually at least two and rarely more than four.

3.38 Where more than one sterilizer of the same type is Installed, they should
be of the same size and from the same manufacturer. This will allow common
loading systems to be used.

3.39 If further sterilizers are likely to be purchased in the future, then

consideration should be given to the extra space required both in the plantroom
and in the loading area.

3.40 Special considerations for laboratory sterilizers are discussed in

Chapter 14.
4.0 Specification and contract

Introduction

4.1 This chapter discusses general specifications for sterilizers and the steps to
be taken in inviting tenders and issuing a contract. The validation procedure,
which begins on installation of the sterilizer, is discussed in detail in Part 3 of this
HTM.

Preparing a specification

4.2 Purchasers are strongly recommended to seek assistance from the

authorised person when preparing a specification for a sterilizer.

4.3 To keep abreast of changing requirements, purchasers should ensure that

they consult the latest editions of any standards and other specification
documents, including any amendments issued after publication. The authorised
person will advise on this.

4.4 Most sterilizers are constructed either to a European Standard (EN) or a

British Standard (BS). A summary of relevant standards is given in Table 7. As
many British Standards will be replaced by European Standards in due course,
purchasers should specify a European Standard where one exists. The relevant
standards are discussed in the ‘Standard specifications’ section of each chapter.

Table 7 British and European Standards on sterilizers

Topic British Standard European Standard

Clinical sterilizers
Porous load BS 3970: Parts 1 & 3 EN 285
Fluid BS 3970: Parts 1 & 2 Planned
Unwrapped instruments BS 3970: Parts 1 & 4 In development
Dry heat - -
LTS BS 3970: Parts 1 & 5 -
LTSF BS 3970: Parts 1, 5 & 6 -
EO - EN 1422
Laboratory sterilizers BS 2646: Parts 1-5 In development
Electrical safety EN 61010: Part 1
Steam - EN 61010: Part 2-041
Dry heat - EN 61010: Part 2-043
LTSF and EO - EN 61010: Part 2-042

In the UK, European Standards will be published by the British Standards

Institution with BS EN prefixes.
Full references for these standards are given in the Bibliography.

4.5 In some cases the standard specifications may not be adequate for
sterilizers to be used in the public service. In these cases, additional specifications
are listed below for general design considerations (see paragraphs 4.9 onwards)
and, if appropriate, in an ‘Additional specifications’ section of each chapter.
4.6 Purchasers are strongly advised to use the NHS Model Engineering
Specification C14, ‘Sterilizers’ and the ‘C14 User Guide’, both published by NHS
Estates, when ordering sterilizers. C14 is an exhaustive, detailed statement of
specifications, conforming both with current standards and with the
recommendations of this HTM. There should be no need for any further
documentation, alterations or additions to be included in the tender documents.

4.7 Details of the proposed location for the sterilizer should be stated clearly in
the specification.

4.8 Except when the manufacturer is responsible for the installation of the
machine, the type and standard of packing for delivery of the sterilizer should be
specified. Where site conditions are likely to be poor and damage could occur, a
substantial dustproof transit case may be necessary.

General design considerations

4.9 The following design considerations are applicable to all or most types of
sterilizer, but are not necessarily required by the current standards. Where
applicable they should be included in the specification for any sterilizer to be
operated in the NHS.

4.10 All sterilizers and associated equipment are classed as “work equipment”
and should comply with the Provision and Use of Work Equipment Regulations
1992 (see Part 1 of this HTM). Purchasers are reminded that under the
Regulations it is the responsibility of the employer, not the manufacturer, to
provide a sterilizer that is “suitable for the purpose for which it is used or
provided”.

4.11 All sterilizers made or sold in the UK from 1 January 1996 should
conform to the emission and immunity requirements of the Electromagnetic
Compatibility Regulations 1992. This may be achieved by compliance with
EN 50081 (emission) and EN 50082 (immunity). The manufacturer should be
informed of any local sources of electromagnetic disturbance which may affect
the operation of the sterilizer (see Chapter 5).

4.12 For maintenance purposes, side, back and top panels for free-standing
sterilizers should be easily removable and replaceable.

4.13 Special foundations are not normally required. The weight of the sterilizer,
which can be as much as 2.5 tonnes when fully loaded, should be borne by at
least four pads, each measuring at least 150 x 150 mm. Floor mountings should
be designed to minimise vibration.

Safety features

4.14 Safety features should be designed in accordance with the British

Standard code of practice for safety of machinery, BS5304, and the European
Standard for the safety of electrical equipment, EN 61010.

4.15 The design of the control system should ensure that the door cannot be
opened except by a key code or tool until the cycle is either complete or
returned to a safe condition and a fault is indicated.

4.16 The sterilizer should conform to the requirements listed under

‘Safeguards’ and ‘Interlocking’ in HSE Guidance Note PM73, ‘Safety at
autoclaves’.
4.17 The manufacturer should provide a list of all safety devices together with
their settings and methods of adjustment.

4.18 All safety devices should be designed to fail in a manner which does not
cause a safety hazard to personnel.

4.19 A safety hazard not be caused by an error in the control or

indication system.

Instrumentation

4.20 Whilst it is preferable that the recording system is wholly independent of

control and indication, a system which combines both control and
instrumentation may be used, providing that any fault which could cause a
failure to attain specified parameters within all parts of the load is either
indicated or recorded. If this requirement cannot be met, an independent
recording system should be provided. (See also paragraph 4.30.)

4.21 Where an instrument has a facility for adjusting one or more preset
variables (such as a thermostat) the adjustment should be by means of a key,
code or tool not available to the operator.

4.22 Where more than one instrument is fitted in the same area, every effort
should be made to obtain a uniform appearance. As an alternative to discrete
instruments, any or all of the required displays may be provided by a single
display unit.

4.23 Where a fault is indicated in the form of an error message shown on a

visual display unit, it should be clearly distinguishable from normal messages, for
example, by use of a different colour or larger size of text. The indication should
remain displayed until acknowledged by the operator.

4.24 The sterilizer contractor should be required to carry out adjustments to

the instruments on site so that the accuracies specified at the sterilization
temperature can be met with the plant running and under the conditions
normally prevailing on site.

4.25 An indicator should show which stage of the operating cycle is in

progress and indicate “cycle complete” at the end of the cycle.

4.26 A five-digit counter should be provided to indicate the cumulative total of

cycles started. The counter should be tamper-evident of sealed.

4.27 Provision should be made for the attachment of the test instruments
required for the tests specified in Part 3 of this HTM.

a. For temperature testing, a connection should be provided to permit the

entry of sensors into the chamber, as described in EN 285. A suitable gland
for attachment to the connection is illustrated in Part 3 of this HTM.

b. For pressure or humidity testing, test tees and valve cocks with sealing
plugs should be fitted to permit connection of test instruments for the
verification and calibration of all pressure and humidity instruments
permanently fitted to the sterilizer. The connection should be as described
in EN 285.

Programmable electronic systems

4.28 Modern sterilizers frequently use programmable electronic systems (PES)

for control and data recording. Where such systems are used, they should be
designed in accordance with the principles set out in the two parts of the HSE
document ‘Programmable electronic systems in safety related applications'.

4.29 Where a PES is used for control or monitoring of the process, the values of
cycle variables critical to process performance and determined during validation
should be documented in the validation report regardless of whether or not they
are held in the PES memory. The version number of the software should be
available for display when required.

4.30 Combined control and instrumentation systems that are wholly operated
by means of PESs should incorporate at least two timing systems, independent
of each other, such that the timer used to control the holding time is verified by
the other timer.

Overpressure protection

4.31 Overpressure safety valves should be fitted to protect components that

may be damaged by inadvertent high pressures. These include the chamber,
jacket, pressurised door-sealing system, heat exchanger system and ballast air
system. The discharge from safety valves should be terminated in a safe position
(see paragraph 7.15).

4.32 The steam pipework should include a pressure-reducing system with a

separator on the high-pressure side. The system should be fitted with a strainer
and trap to prevent condensate accumulating in the system.

Access to chamber drain

4.33 For steam sterilizers, the chamber drain should be positioned so that any
debris caught on the strainer can be seen and removed by the operator without
the need to dismantle any part of the sterilizer.

Doors

4.34 A single door is preferred. Sterilizers with a door at each end (“double-
ended” sterilizers) create problems of maintenance and ventilation and should
only be considered where alternatives have been discounted.

4.35 Power-operated doors are desirable on sterilizers of 300-litre capacity and

over. The following designs are available:

a. sliding doors (vertical or horizontal);

b. side-hinged doors;
c. bell-shaped sterilizer, where the chamber is raised vertically from a fixed
bedplate.

4.36 The choice of design for any particular installation will depend on the
workload, space restrictions, price and ease of maintenance. With side-hinged
doors there is a risk of the operator touching the hot inside face as the door is
opened. If hinged doors are required, the specification should state whether they
are to be hinged on the left-hand or right-hand side of the opening. Bell-shaped
sterilizers require special guards to ensure the safety of the operator when the
chamber is being lowered.

4.37 It should be possible to clean the contact surfaces of the door seal
without removing parts of the sterilizer.
Materials of construction
4.38 Table 8 summarises the materials to be used for clinical sterilizers and for
laboratory sterilizers

Table 8 Recommended materials of construction

Components Clinical Laboratory

sterilizers sterilizers

Pressure vessel and steam generator Group A Group A, B or C

Pipework for circulating media coming into Group E Group G
contact with load
Pipework for circulating media not coming Group J or K Group H, J or K
into contact with load

Groups are defined in Annex 1 of EN 285.

4.39 The fatigue life of sterilizer vessels (see paragraph 4.40) constructed from
dissimilar materials welded together can be considerably reduced by
unpredictable high stresses caused by differential expansion and weld
inconsistencies. For this reason the use of carbon-steel jackets or stiffeners
should be avoided on stainless-steel chamber shells.

Fatigue life of pressure vessel

4.40 The fatigue life of a sterilizer vessel will depend on the level of alternating
stresses caused by the following:

a. changes of pressure within the chamber;

b. differential temperature changes within the chamber and jacket (if fitted);

c. differential expansion;

d. stresses “locked” within the pressure-retaining parts of the vessel.

4.41 Vessels should be designed to withstand 25,000/tC operating cycles,

where tC is the minimum cycle time (in hours) corresponding to the performance
class quoted by the manufacturer.

4.42 The manufacturer should determine the fatigue life by the method given
in Part 5 of this HTM (reprinted from BS3970: Part 1).

Integral air compressors

4.43 European and British Standards permit the use of built-in air compressors
for sterilizers but do not give specifications, Current experience indicates,
however, that certain small compressors of the type fitted to domestic
refrigerators are not suitable for use in sterilizers. Unless they are meticulously
maintained, a small air leak can cause them to run continuously, causing rapid
carbonisation of the oil and consequent failure of the sterilizer pneumatic
system.

Integral steam generators

4.44 Where an integral steam generator is fitted to the sterilizer, it should be
equipped with blow-down facilities to enable sludge to be expelled from the
boiler.
Loading systems

4.45 Sterilizer loading systems should be designed with regard to the Manual
Handling Operations Regulations 1992.

Invitation to tender
4.46 Once detailed specifications have been drawn up, manufacturers should
be invited to tender for the supply and, if required, the installation of the
sterilizer.

4.47 When inviting tenders, purchasers should follow the principles described
in Section 2 of ‘Contracts and commissions for the NHS estate’, published by
NHS Estates.

4.48 The purchaser should specify that the sterilizer manufacturer operates a
quality system in accordance with the principles described in the EN 29000 series
(formerly BS5750). If the manufacturer has both designed and manufactured the
sterilizer, the quality system should conform with EN 29001. If the sterilizer has
been manufactured to a design supplied by a third party, the manufacturer’s
quality system should conform to EN 29002. In either case the manufacturer
should ensure that each supplier of accessories, fittings and other materials also
operates an appropriate quality system.

4.49 Prospective contractors should be given the following information:

a. that each sterilizer will be subject to a validation process as described in

Part 3 of this HTM;

b. unless otherwise specified, that the installation checks and tests specified
in the validation process must be satisfactorily completed before the
sterilizer can be accepted;

c. whether the installation checks and tests are to be witnessed by the

purchaser’s representative (normally the test person);

d. the date by which all services will be available;

e. the date by which the validation process is expected to be completed.

4.50 In assessing tenders, purchasers should not automatically opt for the
lowest quoted price. An unusually low tender should not be chosen without
further investigation into the financial circumstances of the prospective
contractor.

Contract

4.51 For procurement of sterilizers the following NHS Conditions of Contract

(available from the NHS Supplies Authority, see Appendix 1) may be used.
Modifications to suit local purchasing policy may be required:

a. National Health Service - Conditions of Contract for the Purchase of

Goods;

b. National Health Service - Conditions of Contract for the Supply and

Installation of Equipment;

c. National Health Service - Conditions of Contract for the Maintenance of

Equipment.
4.52 Consideration may also be given to the use of alternative forms of
contract, for example MF/1 (available from the Institution of Electrical Engineers,
the Institution of Mechanical Engineers or the Association of Consulting
Engineers) or the Joint Contracts Tribunal (JCT) suite of documents (available
from RIBA Publications). Addresses are given in Appendix 1.

4.53 Purchasers using other forms of contract are strongly advised to seek legal
advice, especially where a contract proposed by the prospective contractor is
being considered.

4.54 Other contracts, notably for the authorised person, the test person, the
maintenance person, the competent person and the microbiologist, may need to
be considered at this time (see Part 1 of this HTM). In awarding these contracts,
purchasers should ensure that there is no conflict of interest that would
compromise the validation process set out in Part 3 of this HTM.

Delivery

4.55 On or before delivery of the sterilizer, the manufacturer should provide

the purchaser with the information specified in Appendix 2.

4.56 Sterilizers for a particular scheme should not be ordered and stored on
site for long periods prior to installation and validation. Disregard of this
recommendation could result in the installation of a technically obsolescent
sterilizer. Where a long delay is unavoidable, conditions for storage should be
agreed with the manufacturer.
5.0 Siting

Introduction

5.1 This chapter sets out some of the considerations to be taken into account Scottish Health Planning Note 13,
when siting a sterilizer. A thorough discussion of the planning requirements for a ‘Sterile Services Department’, applies
sterile services department (SSD) is given in HBN 13. Additional guidance on the in Scotland
siting of ethylene oxide (EO) sterilizers may be found in Chapter 13 and in HBN
13, Supplement 1; ‘Ethylene oxide sterilization section’. Guidance on the siting
of laboratory sterilizers is given in Chapter 14 and in BS2646: Part 2. Guidance
on accommodation for ethylene oxide gas cylinders, manifolds and canisters is
given in Part 5 of this HTM.

5.2 The room in which a sterilizer is installed should meet the requirements of
the Workplace (Health, Safety and Welfare) Regulations 1992, which have far-
reaching implications for the design of sterilizer accommodation.

5.3 Fire safety precautions should comply with ‘Fire Safety Approved
Document B’, published by the Department of the Environment and the Welsh
Office, and the ‘Firecode’ series of guidelines published by NHS Estates.

5.4 Where possible, sterilizers should be transported as a whole and not

partially stripped.

Accommodation

5.5 Except where sterilizers are free-standing (paragraph 5.14) or transportable

(paragraph 5.17), a sterilizer installation will normally be separated into two
areas: a plantroom containing the sterilizer itself, services and ancillary
equipment; and an adjacent loading area from which the sterilizer is loaded and
unloaded. The areas are divided by a partition wall into which the front panel
and door of the sterilizer are set.

5.6 The wall aperture should meet the tolerances quoted in EN 285. The
contractor should be required to provide the trim to the wall or provide the
panelling. Fascia panels should be adequately supported and insulated to
minimise vibration and heat transmission from the plantroom to the loading
area. Foamed plastic materials which are either combustible or subject to
degradation at the operating temperatures should not be used, nor should
asbestos products. Suitable specifications for such insulation may be found in
NHS Model Engineering Specifications CO2, ‘Thermal insulation’.

5.7 Maintenance staff should be able to enter the plantroom without passing
through the loading area. Direct access between the plantroom and loading area
should be provided for use during testing. Operators will normally require access
to the loading area only.

5.8 If a sterilizer with a door at each end is installed (a “double-ended”

sterilizer), arrangements for maintenance should be from the “dirty” end. Except
where the product would be jeopardised or a microbiological hazard created,
maintenance access from the “clean” end should also be provided.
Plantroom

5.9 Wherever practicable the sterilizer should be located on the ground floor
and the plantroom should have an outside wall. This arrangement will facilitate
easy access for engineering staff and for plant replacement. It will also simplify
safety requirements for ventilation and drainage, particularly for low-
temperature steam and formaldehyde (LTSF), EO and laboratory sterilizers.

5.10 The plantroom floor should be non-slip and waterproofed to avoid

damage to rooms and equipment which may be below the sterilizers. To
facilitate cleaning, the floor should fall naturally to a drain.

5.11 Adequate clearance around the machines is essential for access and
maintenance. The minimum clearance should be 1.0 m around all parts to which
access for routine maintenance is necessary. The minimum ceiling height is
2.7 m above floor level. Spacing should be such that it is possible to replace any
sterilizer without disturbing others in the same installation. Particular care should
be taken to ensure that sufficient clearance is allowed for large items, such as
vacuum pumps, to be withdrawn from the sterilizer frames.

5.12 Extra space should be allowed for installation and maintenance of free-
standing equipment such as steam generators, air compressors and water
conservation systems. Possible future expansion should be considered. For EO
sterilizers, a separate but adjacent manifold room will be required for gas
cylinders (see paragraph 6.74).

Loading area

5.13 Where carriage or trolley loading is used, the minimum clearance for
access to the sterilizer should be 3.0 m or twice the length of the carriage
loading system, whichever is the greater. Careful attention should be paid to
height adjustment, so that all sterilizers in a group can be served wherever
possible by a common loading system.

Free-standing sterilizers

5.14 Certain permanently installed sterilizers, such as smaller laboratory

machines, may be “free standing”, that is, installed in a room with no separation
into plantroom and loading area. Such installations may present problems of
safety and access, and are not recommended where a more conventional
arrangement is possible. Where a free standing installation is unavoidable, the
authorised person should be consulted at an early stage to ensure that adequate
safety precautions are taken.

5.15 A free-standing sterilizer may not meet the environmental quality control
standards required for the manufacture of medicinal products or medical devices
(see Chapter 1). Advice may be obtained from the authorised person.

Transportable sterilizers

5.16 Benches on which transportable sterilizers are placed should comply with
HTM 67 - ‘Laboratory fitting-out system’.

5.17 The sterilizer should be placed within 2 m of a switched 13 A socket

outlet. Extension flexes should not be used.

5.18 The pressure relief valve should be able to discharge freely and safely.
Equipment which could be damaged by steam or moisture should not be placed
near the sterilizer.
5.19 It has been known for the door of a transportable sterilizer to be blown
off with considerable force; the sterilizer should therefore be sited so that a
safety hazard is not created in the event of an accident. Sterilizers in dental
practices should preferably be sited in a different room to that used for
operating. If this is impossible, the sterilizer door should face in such a direction
that there is no hazard to patients or staff.

5.20 Users should be aware of the heat and water vapour that may be emitted
in normal operation by even a small sterilizer and make appropriate provision for
ventilation (see Chapter 6). The authorised person will advise on suitable
arrangements.

Noise and vibration

5.21 Sound pressure levels sensed in a room are a function of the sound
power generated by the sterilizer and the acoustic design of the room in which
the sterilizer is installed.

5.22 European and British Standards do not specify permitted sound power
levels. The sterilizer manufacturer should state at the time of tendering the
A-weighted sound power level determined in accordance with the method
detailed in Part 5 of this HTM. Purchasers should be aware that the uncertainty
inherent in this method can amount to a standard deviation of 5 dB for sources
containing discrete tones and 4 dB for wide-band noise sources. These
uncertainties should be taken into account in the acoustic design of the room in
which the sterilizer is installed. The design should ensure that sound pressure
levels stated in the sound pressure test described in Part 3 are not exceeded.

5.23 The sound pressure levels specified in Part 3 are for an area or space
where the sterilizer is operating under normal working conditions. The levels
include noise from all sources including the sterilizer.

5.24 The room in which the sterilizer is to be installed should be located and
designed so that the noise transmitted from the room does not increase the
sound pressure levels in adjacent rooms in excess of the levels specified in
HDN 4, ‘Noise control’ (amended by HN(76)126). Account should be taken of all
transmission paths, including open windows and building structures. A fascia
panel should not be used to separate a noise-sensitive area from the operating
parts of the sterilizer without additional insulation (this may double as thermal
insulation - see paragraph 5.6).

5.25 If the sterilizer is in or adjacent to a main building or a noise-sensitive

area, open louvres in internal doors and partitions should be avoided; doors
should be solid, self-closing and a good fit in their frames, preferably with
compressed rubber seals. If this affects natural ventilation, mechanical ventilation
may be required (see Chapter 6). The need for such a solution can usually be
avoided in the planning stage.

5.26 Vibration transmitted to the building structure is generally produced by

pumps, motors and on/off valves connected to the services. If vibration is likely
to be a problem the following measures are recommended:
a. transmission of vibration through service connections can be avoided by
the use of flexible connections;
b. pumps and motors associated with sterilizers should be resiliently
mounted, whether or not they are integral with the sterilizer;
c. the forcing frequency of the vibration generator should be taken into
account when designing vibration isolators.
Lighting

5.27 Fluorescent lighting should be used. The stroboscopic effect of the

lighting should be minimised in the plantroom by the use of two tube fittings
suitably adapted for this purpose or by the use of two phases for the lighting
circuits. The fittings should be sited longitudinally between the sterilizers. Further
guidance on lighting may be found in ‘Lighting guide: hospitals and health care
premises’, published by the Chartered Institution of Building Services Engineers
(CIBSE).

Electromagnetic compatibility
5.28 Although a new sterilizer will be designed to comply with the
Electromagnetic Compatibility Regulations 1992, purchasers should establish
whether existing equipment on the premises is likely to give rise to
electromagnetic disturbance at the intended location of the sterilizer. If so, the
sterilizer manufacturer should be informed at an early stage. Further guidance
may be found in HTM 2014 - ‘Abatement of electrical interference’.
6.0 Engineering services

Introduction

6.1 A sterilizer installation will require one or more external services including
steam, electricity, water, compressed air, drainage, ventilation and ethylene oxide
gas. The manufacturer should make clear at an early stage which services will be
needed and the detailed requirements for each, as outlined in Table 9. Steam
supply is the most critical of the services and is considered in detail in Chapter 7.

6.2 If the services are to be installed by a contractor other than the contractor
installing the sterilizer, care must be taken to ensure that the size and location of
terminations are agreed before the contracts are placed.

Table 9 Information on services to be obtained from the sterilizer manufacturer

Steam a. the maximum flow and usage rate;

b. the acceptable range of steam supply pressures;
c. where steam is generated within the sterilizer, the
maximum hardness value, the range of pH and the
conductivity of the boiler feed water.
Electricity a. type of supply, e.g. AC or DC;
b. number of phases (normally one or three) and whether
neutral is required for a 3-phase supply;
c . supply voltage and frequency including acceptable
minimum and maximum values;
maximum continuous power in kW or kVA.
Water a. the minimum and maximum supply pressure;
b. the flow at minimum pressure;
c. the volume used per cycle;
d. the maximum temperature of the water;
e. the maximum permissible chlorine and chloride content.
Compressed air a. the minimum and maximum supply pressure;
b. the flow at minimum pressure;
c. the volume of air used for each cycle.
Sterilant gas For EO sterilizers, details of the type of sterilant supply
required and the quantity required for a single cycle.
Drainage a. the maximum flow of effluent (water and condensed
steam) to the hospital drain;
b. the maximum temperature of the effluent on leaving the
sterilizer;
c. the sources of effluent contributing to the total outflow.
Ventilation The following quantities should be given as peak values during
the cycle and as average values over a complete cycle:
a. the heat (in watts) transmitted to the environment when
the sterilizer is operated in a nominal ambient temperature
of 23 ± 2°C in still air with the doors closed;
b. for a recessed sterilizer, the heat (in watts) transmitted to
the loading area when the sterilizer is operated in a
nominal ambient temperature of 23 ± 2°C in still air with
the doors closed.
6.3 All services should be terminated within the plantroom by appropriate
valves and isolators within 2.0 m of the sterilizer.

6.4 Care should be taken to ensure that pipework and cables used to connect
the sterilizer to the service terminations are of adequate size to meet the
demands of the sterilizer. Inadequate services may cause malfunctioning.
Pipework and cables should be installed close to a wall and not over the top of a
sterilizer.

Electricity

6.5 The electrical power requirements will depend on a number of factors,

such as the type of sterilizer and the method used to generate steam. (Local or
integral electrical steam generators will result in a high electrical load.) Some
sterilizers will require a three-phase supply. The manufacturer should provide
details of the type of supply (AC or DC), number of phases, frequency, and
voltages with tolerances and loading.

6.6 Each sterilizer should be connected via an isolator. The type of isolator will
depend on the nature of the supply:

a. isolators for transportable sterilizers with a maximum current demand of

13 A may be of the simple plug and socket-outlet type, with the plug
correctly fused and the socket outlet switched;
b. where a three-phase-and-neutral supply is necessary, or where a maximum
single-phase current demand is more than 13 A, the sterilizer should be
wired directly to the isolator. The switch should isolate all poles
simultaneously and each pole should be fused separately. The cable from
isolator to sterilizer should be fixed and protected from the effects of heat,
water and steam.

6.7 Within the loading area an additional switch should be provided so that
the operator can electrically isolate the sterilizer or group of sterilizers in the
event of an emergency. The switch should be placed between the normal
operating position and the exit door.

6.8 Sterilizers used to process heat-sensitive loads should be connected to the

essential supplies circuit, if available, to avoid heat damage in the event of a
power failure. Guidance on the supply of electricity in the event of a failure of
the normal supply is given in HTM 2011 - ‘Emergency Electrical Services’.

6.9 All electrical installations should conform to the IEE Regulations contained
in BS7671. Further guidance is given in HTM 2007 - ‘Electrical services: supply
and distribution’ and HTM 2020 - ‘Electrical safety code for low voltage systems’
(Escode - LV).

Water

6.10 A water supply of potable quality may be needed for equipment such as
condensers, heat exchangers and water-sealed vacuum pumps (feed-water for
steam generation is discussed in Chapter 7). Details of the water-quality
requirements, the maximum pressure, minimum pressure and maximum flow
rate should be obtained from the sterilizer manufacturer.

6.11 To prevent possible contamination of the water main, the supply should
be connected to the sterilizer via a backflow protection device, such as a break
tank.
6.12 The temperature of water used for sterilizers with vacuum systems should
not normally exceed 15°C. Higher water temperatures will reduce the efficiency
of vacuum pumps and compromise the specified vacuum levels.

6.13 Performance will also deteriorate if the water is very hard or contains
large quantities of solids in suspension. The hardness of the water should be in
the range 0.7-2.0 mmol litre-1. Hardness values outside these limits may cause
scaling and corrosion problems. This can be overcome by the installation of
simple water-treatment plant at the sterilizer site.

6.14 Water economy devices, which sense the temperature of cooling water
and adjust the flow rate accordingly, should be fitted to reduce water
consumption.

6.15 Chlorine and chlorides may cause corrosion of stainless steel in the
presence of heat. Advice on maximum permissible levels should be obtained
from the sterilizer manufacturer.

6.16 A copious supply of piped water is required for emergency use in any
area where a spillage of liquid EO may occur. The supply should be capable of
delivering at least 18 litre min-1 at a minimum pressure of 1.5 bar.

6.17 Further guidance on water supply is given in HTM 2027, ‘Hot and cold
water supply and distribution’.

Compressed air

6.18 A compressed-air supply may be required for the operation of controls

and also for pressure ballasting in certain fluid and laboratory sterilizers. Where
the sterilizer does not contain an integral air compressor (see paragraph 4.43),
the air may be supplied from a mains supply or from a local compressor

6.19 If pressure ballasting is required, additional reservoir capacity or

compressors will be needed. The system should be capable of delivering at least
12 m3h -1 at 8 bar.

Mains supply

6.20 If air is supplied by pipeline from a central air-compressor system, a

pressure gauge, of the Bourdon type complying with EN 837, should be fitted
inside the plantroom and terminated with an isolation valve.

6.21 A reducing valve or other automatic device should be fitted to reduce the
pressure of the air delivered to the sterilizer to not more than the maximum
working pressure of the sterilizer. A pressure relief valve will normally be
required.

Local compressors

6.22 Where it is not practicable to obtain compressed air from a mains supply,
a dedicated compressed-air facility should be installed to supply the sterilizers
and other equipment. At least two compressors should be provided, with
autochange between the two. The system should be sized to meet all the
compressed air requirements of the unit and give priority to the sterilizers.

6.23 The compressors are likely to be too noisy to be installed in the sterilizer
plantroom, and it is better to place them in a dedicated location away from any
noise-sensitive areas.
6.24 Components which require servicing or maintenance, such as dryers and
filters, should be installed in locations where they can be readily serviced or
exchanged.

Air quality

6.25 Quality of air is critical and certain types of sterilizer will incorporate the
appropriate filters. If the purchaser is to be responsible for supplying filtered air,
note the following points:

a. air for controls should be free of liquid water, filtered to 25 µm (5 µm for

precision controls) and lubricated with micro-fog oil particles of 2 µm or
less;

b. air that could come into direct contact with the load, such as air for
pressure ballasting or door seals, should be filtered to remove
contaminating oil-mist and micro-organisms. It should have not more than
0.5 mg of oil per cubic metre of free air (measured at 1013 mbar and
20°C; see IS0 554), be filtered to an efficiency of at least 95% when
tested in accordance with BS3928 and be free of bacteria.

Drainage

6.26 Condensate from the jacket, heat exchangers and steam traps is suitable
for recovery and should be returned to the steam generating plant where there
are means for recovery.

6.27 All other effluent from a sterilizer is potentially contaminated and should
be disposed of to the main drain. Effluent may originate from one or more of
the following sources:
a. air, condensate and steam from the chamber drain, which may contain
chemicals and micro-organisms, especially those from a make-safe process;

b. discharge from a water-sealed vacuum pump, ejector or chamber vent,

which may also contain micro-organisms;

c. water from a chamber cooling system;

d. water introduced to cool and dilute the discharge from the chamber.

6.28 Drainage requirements for different types of sterilizer are summarised in

Table 10 and discussed below.

Non-hazardous effluents

6.29 Effluent from steam-only sterilizers should pass via an air break into a tun-
dish or tank before being discharged to the drain. The air break should be
preserved at all times so that the sterilizer and its associated piping cannot be
contaminated by reverse flow from the drainage system. This can be achieved by
ensuring that under all working conditions the discharge rate from the tun-dish
is such that the maximum flow rate of effluent from the sterilizer will not cause
the water level in the tun-dish to rise to the level of the outlet from the sterilizer.
For clinical sterilizers the above equipment is normally provided by the
manufacturer and contained within the sterilizer itself, but for certain laboratory
sterilizers it is the responsibility of the purchaser to install it in the plantroom.

6.30 The drain system from the plantroom should be trapped and designed to
pass the flow rate of water, air and condensed steam specified by the
manufacturer, with account taken of peak demands during the operating cycle.
Table 10 Discharge and ventilation requirements for different types of sterilizer

Type of sterilizer Effluent discharge Ventilation

LTSF sterilizers Trapped and vented, General room ventilation

sealed to main drain. No ten changes/hour, non-
open gulleys recirculating. Discharge
to stack
LEV on sterilizer door,
Discharge to stack

EO sterilizers Small - no drainage General room ventilation

required ten changes/hour, non-
Large - Trapped and recirculating. Discharge
vented, sealed to main to stack
drain. No open gulleys. Small - chamber exhaust
Very large sterilizers may to stack
require fan-assisted LEV on sterilizer door,
venting of drain aeration facility door and
manifold room.
Discharge to stack

Laboratory sterilizers Trapped and vented, General room

sealed to main drain. No ventilation, non-
open gulleys recirculating. Filtered
discharge for Category 3
and 4 laboratories

Other sterilizers Direct to main drain General room

ventilation. No special
requirements

6.31 Means should be provided to prevent, as far as possible, flash steam

being liberated into the atmosphere or causing condensation on electrical
equipment.

6.32 The discharge temperature from a steam sterilizer is unlikely to exceed

80°C, but in the event of failure of the diluting and cooling system it might
reach 100°C. The materials used for the construction of the drainage system
should be chosen to withstand this temperature. Attention is drawn to the legal
requirement (Public Health Act 1936, Paragraph 27) that the maximum
temperature of any liquid to be emptied into the public sewer or communicating
drain is 43°C. This may be interpreted as relating to the main building
connection to the sewer and not to the internal building drain.

6.33 Where a tank supplies water to a water-sealed vacuum pump or a water

pump used for an ejector vacuum system, the overflow discharge from the tank
should also include an air break.

Hazardous effluents

6.34 A sealed and vented drain is required for LTSF sterilizers, large EO
sterilizers (supplied from cylinders), EO gas disposal units and laboratory
sterilizers used to make-safe discard material. Small EO sterilizers (supplied from
cartridges) discharge gas only (see paragraph 6.62).

6.35 Chamber drains and vents should have a sealed independent discharge
which should be vented and trapped before it is connected to the drainage

34
system. Open tun-dishes should not be used. The vent should be not less than
30 mm in diameter and terminated above roof level, clear of ventilation air inlets
or windows. Steam should not issue from the vent. A “Hazardous Discharge”
warning notice should be fitted next to it. A similar arrangement should be
provided for any safety valves.

6.36 EO is considerably denser than air. For sterilizers with chamber volumes
greater than 300 litres there is a risk that the amount of gas discharged into the
drainage system could result in pockets of explosive mixtures of EO and air
accumulating at the bottom of the vent stack. Although there is no known case
of such an explosion in the UK, consideration should be given to installing a fan-
driven gas-capture system to draw gas from above the liquid effluent before the
liquid is discharged to the main drain. The gas should either be disposed of
chemically (see Chapter 13) or discharged at a high level. The vent should meet
the requirements of the local exhaust ventilation system (see paragraph 6.61).

6.37 In certain circumstances, such as special research activities involving high

concentrations or volumes of pathogens in Hazard Group 3, additional
safeguards may be required for laboratory sterilizers. The advice of HSE should
be sought in such cases.

6.38 Where a laboratory sterilizer is to be used to make-safe material

contaminated with Hazard Group 4 pathogens, further containment, filtration or
heat treatment will be necessary. Again, advice should be sought from HSE.

Ventilation

6.39 Ventilation of the area near the sterilizers is needed to remove both
excessive heat and odours, and also sterilant gases such as formaldehyde
and EO.

6.40 General room ventilation will be sufficient for most sterilizers, but
chamber exhaust ventilation will be required for certain small EO sterilizers and
local exhaust ventilation will be required to remove local concentrations of EO or
formaldehyde. The requirements are summarized in Table 10 and discussed
below.

6.41 Electrical systems used in ventilation systems should take account of the
explosion risk associated with ethylene oxide and comply with the requirements
of EN 61010: Part 2-042.

6.42 All ventilation systems should meet the ventilation requirements of the
Workplace (Health, Safety and Welfare) Regulations 1992.

6.43 Further guidance on ventilation systems may be found in HTM 2025,

‘Ventilation in healthcare premises’.

General room ventilation

6.44 The air change rate should be related to the heat and vapour emission
from the sterilizer and associated equipment and pipework so that working
conditions remain acceptable and control equipment is not adversely affected.
The ambient temperature in the plantroom with all plant running normally
should not be allowed to exceed 35°C at any time.

6.45 Current experience indicates that a 400-litre high-temperature steam

sterilizer with door closed will release by radiation and convection approximately
1.0 kW into the loading area and 4.0 kW into the plantroom. Sliding-door
machines installed behind a fascia panel with a separate door will release almost
all the heat into the plantroom. With the door open, additional heat into the
loading area might typically be 3.5 kW for a side-hinged door and 3.0 kW for a
sliding door. More specific figures should be obtained from the manufacturer of
the sterilizer (see Table 9).

6.46 In designing a ventilation system, account should also be taken of the

heat emitted from the sterilized load after it has been removed from the
chamber.

6.47 Ventilation air to the plantroom may be taken in either at low level from
the loading area or from an independent source and should be discharged to
the outside.

6.48 Where the plantroom does not have an outside wall, heat emissions will
need to be absorbed by a recirculating cooling unit with remote fan-cooled
condensers. The rating of the units should have sufficient reserve capacity to
reduce the temperature to 30°C in order to provide a safe and acceptable
working environment for staff during maintenance of the plant. Additional plant
space is required for the installation of the cooling units.

Room ventilation for LTSF and EO sterilizers

6.49 For LTSF, EO and laboratory sterilizers, the loading area should be
maintained at a lower pressure than the main corridor and at a higher pressure
than the plantroom. The discharge to the outside should not be sited where the
extracted air will be drawn into the building via windows or ventilation inlets.

6.50 Areas containing LTSF or EO sterilizers and aerators should have a

dedicated, non-recirculating room-ventilation system which ensures that air
movement is from the operator towards the sterilizer both during normal
operation and also when local exhaust ventilation (see paragraph 6.54) is
operative. During normal operation, exposure to formaldehyde and EO should
not be allowed to exceed the exposure limits given in Table 1.

6.51 Room ventilation for LTSF and EO sterilizers should be designed to permit
the extraction of the maximum possible leakage of gas within a reasonable time.
This requires at least ten air changes an hour. For example, Figure 1 shows the
relationship between the volume of a room and the number of air changes
required to reduce the concentration of EO to 5 ppm when a standard 134 g
cartridge is discharged into the room.

6.52 Sensing devices and interfaces should be provided to ensure that if the
room ventilation fails to maintain a rate of flow sufficient to ensure ten air
changes an hour:

a. a visual and audible alarm is given;

b. where the operating cycle has progressed beyond the point where sterilant
has been admitted into the chamber, it is not possible to open the door at
the end of the cycle until the room ventilation is restored to normal
operation;

C. it is not possible to start a new cycle until the room ventilation is restored
to normal operation.

6.53 Requirement 6.52(b) may be waived if the load can be transferred from
the sterilizer to an aeration facility without gas escaping into the atmosphere.
This would normally require a local exhaust ventilation system with a common
extractor hood covering both the door of the sterilizer and the door of the
aeration facility. If such a system is installed, it should be validated to
demonstrate that the specified rates of flow (see paragraph 6.54) can be
achieved when the room ventilation is not operating.

Local exhaust ventilation

6.54 In addition to the room ventilation, LTSF sterilizers, EO sterilizers and EO
aerating equipment should be fitted with an independent local exhaust
ventilation (LEV) system having a minimum flow of 0.3 m 3s-1 at each extractor
hood. The system should have hoods near any place where formaldehyde or EO
could be released into the atmosphere; for example, around the doors of
sterilizers and aeration cabinets and in the manifold room where cylinders are
connected to the EO supply manifold (see paragraph 6.74).

6.55 When activated, the LEV should operate for a preset period of up to
30 min.

6.56 Sensing devices and interfaces should be provided to ensure that the LEV
is activated on the following occasions:

a. when the door is ready to be released at the end of an operating cycle;

b. when sterilant cylinders are being changed;

c. on a pressurization failure of inflatable or pressure-activated door seals;

d. whenever the atmospheric concentration of sterilant gas exceeds a preset

safe level not greater than the short-term maximum exposure limit given in
Table 1.

6.57 Controls should be provided both within and outside the loading area to
activate the LEV manually.

6.58 Sensing devices and interfaces should be provided to ensure that if the
LEV, when activated, fails to attain or maintain a flow of at least 0.3 m3s-1:

a. an audible and visual alarm is given;

b. it is not possible to open the door at the end of the cycle until the LEV is
restored to normal operation;

C. it is not possible to start a new cycle until the LEV is restored to normal
operation.

6.59 Make-up air provision, preferably by indirect means, will be required.

6.60 Ducts designed to carry formaldehyde or EO gas should be maintained

under negative pressure, for example by locating the extractor fan at the
discharge end.

6.61 The discharge should be above roof level and away from windows, doors
and air intakes. This may be the same vent used to discharge gas from the
chamber. A “Hazardous Discharge” notice should be fitted next to the outlet. For
EO sterilizers supplied from cylinders, the discharge stack should be fitted with a
flame arrestor.

Chamber exhaust ventilation

6.62 Small EO sterilizers (supplied from cartridges) and EO aerators will require
a chamber exhaust ventilation (CEV) independent of the room and LEV systems.

6.63 The CEV for a sterilizer should extract gas from the sterilizer chamber
during the gas removal stage and throughout any aeration stage.
6.64 The CEV for an aerator should operate whenever an aeration cycle is in
operation. If an aeration room is used, the temperature and ventilation should
be controlled within adjustable ranges from ambient temperature to 55°C and
nominally zero to ten air changes an hour.

6.65 Interfaces should be provided so that in the event of a failure of the CEV:
a. an audible and visual alarm is given;

b. where the operating cycle has progressed beyond the point where EO has
been admitted to the chamber, it is not possible to open the door at the
end of the cycle until the CEV is restored to normal operation;
it is not possible to start a new cycle until the CEV is restored to normal
operation.

6.66 The discharge should be above roof level and away from windows, doors,
and air intakes. This may be the same vent used for the LEV. A “Hazardous
Discharge” notice should be fitted next to the outlet.

6.67 The CEV alarm circuit should be independent of the mains electricity
supply. It is recommended that the CEV system itself be connected to the
essential supplies circuit in the event of a mains power failure.

Ethylene oxide gas

6.68 Ethylene oxide gas may be supplied either from disposable cartridges
(pure EO) or from cylinders (pure EO or EO mixed with diluent gases). Both the
containers and the delivery system are subject to the Pressure Systems and
Transportable Gas Containers Regulations 1989.

Supply from cartridges

6.69 The number of cartridges kept within the plantroom should be limited to
those actually in use and those required for immediate stand-by. Cartridges
should be stored as described in Part 5 of this HTM. Cartridges for immediate
use may be held in the loading area.

Supply from cylinders

6.70 All pipework intended to carry EO should be in stainless steel. Flexible
hoses should be of stainless steel, preferably lined with PTFE or nitrile rubber.

6.71 Cylinders should be stored as described in Part 5 of this HTM.

6.72 Where EO is stored at a temperature below its normal boiling point

(10.7°C) it is essential to exclude air by pressurizing the cylinder with nitrogen or
other diluent gas. Even when nominally empty of liquid EO, cylinders should be
maintained at a minimum pressure of 2 bar. Nitrogen used for pressurising will
stay in the gaseous state and will not mix with the liquid EO.

6.73 Fittings to the cylinder, such as valves and pressure gauges, should be
protected against mechanical damage. Cylinders should be secured to prevent
them falling over or colliding during storage and transport.

6.74 Cylinders should be connected to the sterilizer supply line in a dedicated

manifold room separate from the plantroom. The room should not have direct
access from the loading area. The manifold room should meet the requirements
of HTM 2022. Local exhaust ventilation should be installed as described in
paragraph 6.54.
6.75 A duty and a reserve cylinder should each be connected to a common gas
manifold via a manual stop valve, at least one automatic stop valve, and a vent
with a stop valve (for use during cylinder change and inert gas purging). These
are in addition to the valve on the cylinder itself. The system should be designed
and constructed to allow only one cylinder at a time to supply gas to the
sterilizer. An indicator should show which cylinder is being used.

6.76 Each cylinder should be located on weighing scales with sufficient tare
capacity for the largest cylinder expected to be used. The scales should be
accurate enough to determine the mass of gas admitted to an accuracy of ± 1%
of the mass of gas required to fill the empty chamber to the preset operating
pressure. Recording scales are preferable, since the data obtained may be used
in the routine monitoring of the operating cycle.

6.77 An automatic change-over facility is recommended so that the reserve

cylinder can be brought on-line without interruption of the supply. An electrical
signal from the weighing scales may be used to determine when the duty
cylinder is nearly empty and to initiate the change-over automatically.

6.78 The temperature of the cylinders should not be allowed to exceed the
maximum stated by the supplier, and in any case not more than 45°C. The
temperature of the manifold and supply line should be kept above 11°C to
prevent EO condensing inside the pipework.

6.79 The number of cylinders kept within the manifold room should be limited
to those actually in use and those required for immediate stand-by.

6.80 Cylinders of an inert gas such as nitrogen should be available for purging
the pipework before maintenance and testing.
7.0 Steam supply

Introduction

7.1 A continuous supply of saturated steam is required for steam sterilization,

low-temperature steam and formaldehyde (LTSF) sterilization and for
humidification in certain ethylene oxide (EO) sterilizers and EO preconditioning
units.

7.2 The critical variables are the dryness of the steam (expressed as a dryness
value) and the level of non-condensable gases (expressed as a fraction by
volume). Before a newly installed or replaced sterilizer is handed over to the user,
the steam supply should be examined and tested by the methods described in
Part 3 of this HTM to ensure that it is satisfactory.

7.3 Users should note that where the steam is supplied from the mains, quality
can vary greatly during the course of a working day. In many hospitals, steam
demand is greatest early in the morning when sterile service departments (SSDs),
kitchens and laundries may start work at the same time. Care should be taken to
sample the steam at times throughout a typical working day to gauge the likely
range of steam quality.

7.4 Where a sterilizer is to be used in the aseptic production of medicinal

products, the steam should also be free of pyrogens. A discussion on the supply
of apyrogenic steam can be found in HTM 2031 - ‘Steam for use in sterilizers’
(in preparation).

7.5 European Standards supporting the EU Directives on medical devices (see

Chapter 1) place requirements on the quality of the environment in contact with
a medical device (EN 554) and specifically give guidance on the chemical quality
of steam (EN 285). Further guidance on steam quality will be published when
the effects of the Directives on the NHS become clear.

Engineering considerations

7.6 Except where the steam is generated within the chamber (such as in
transportable sterilizers), steam is generally obtained from the hospital mains and
the delivery of high-quality steam depends on careful engineering.

7.7 Occasionally, suitable steam may be available from the high-pressure hot-
water systems used in some hospitals. Steam from this source is not
recommended for porous-load sterilizers since the steam is generally too wet for
reliable sterilization, even with a recommended minimum return temperature
of 150°C.

Capacity
7.8 The steam service should be designed to meet the maximum steam
demand of the sterilizer for short periods, while keeping the fall in pressure
before the final pressure-reducing system to not more than 10%. Experience
shows that a single porous-load sterilizer of up to 600 litres requires a boiler of
at least 50 kW and storage to meet a peak demand of 125 kW for 15 min. The
effect on the steam supply of the demands of other sterilizers and equipment
should be carefully considered.
Pipework
7.9 Except for vertical rises between floors, steam pipework should be
designed so that any condensate flows by gravity in the same direction as the
steam. This general principle applies equally to steam mains, branch connections
and pipework on the sterilizer itself. Air vents and steam traps should be fitted
at each vertical rise. Care should be taken to trap, drain and return any
condensate which may be collected in pockets in the pipework. Dead-legs
should be avoided.

7.10 The accumulation of condensate in the periods when the sterilizer is not
in operation should be avoided, particularly in any part of the pipework and
fittings between the take-off from the manifold and the sterilizer chamber. This
can be achieved by the correct declination of each portion of pipework and by
adequate trapping throughout the steam distribution system.

7.11 Figure 2 shows a suggested layout for the steam service in the plantroom.
The supply main should terminate in an adequately vented and trapped
manifold, not less than 150 mm nominal bore, running the entire length of the
room (this provides for future expansion). A vent, with a cooling pot, should be
installed on the manifold upstream of the supply pipes to individual sterilizers.
A pressure gauge should be fitted to the manifold.

7.12 Where the supply pressure at the inlet to the sterilizer would exceed the
maximum value specified by the manufacturer, a pressure-reducing system and
separator should be fitted to the supply pipe at least 3 m from the sterilizer.
Heat loss from the section between the pressure-reducing system and the
sterilizer will help prevent superheating (paragraph 7.24).

7.13 If the sterilizer manufacturer has not already fitted them, an appropriate
and correctly installed separator and steam trap should be fitted upstream of the
sterilizer reducing valve.

7.14 Three suitable test connections should be provided on the supply pipe to
each sterilizer to permit the attachment of a needle valve, a pitot tube and a
temperature sensor as shown in Figure 2. (Details of the use of these items can
be found in Part 3 of this HTM.)

7.15 Careful attention should be paid to the location of all pressure relief
valves to ensure that the sterilizer is properly protected. Relief valves and their
discharge pipes should be large enough to prevent the pressure in the supply
pipe rising to more than 10% above the design pressure for the sterilizer. The
discharge pipe should terminate outside the building in a safe, visible position
not affected by frost. Any rising discharge pipe should be fitted with a drain at
the lowest point to prevent the accumulation of condensate. A tell-tale pipe of
narrow bore should be connected to the drain point and terminate inside the
plantroom.

Materials

7.16 Steel and copper piping have traditionally been used for steam supply,
but these materials will not be acceptable if compliance with the EU Directives
on medical devices is required. Suggested minimum standards for steam purity
are given in EN 285 (analytical methods for testing for these impurities, including
tests for pyrogens, will be included in HTM 2031), but these are unlikely to be
achieved with plant currently installed in the UK. Moreover, steam of such purity
would be severely corrosive to the steel and copper piping in the majority of
sterilizers in use in the NHS.
7.17 To meet the suggested purity standard for clinical sterilizers it will be
necessary for parts in contact with steam entering the chamber to be
constructed from low-carbon or stabilized stainless steel. However, in designing
a steam service purchasers should bear in mind that the steam service (and
indeed the sterilizer itself) may need to be upgraded within the life of the
sterilizer and that compliance for steam purity may be achieved at that stage.
Until the detailed implications of the Directives are known, it is recommended
that steel and copper piping continue to be used, but that space be reserved in
the plantroom for a mains steam conditioning unit. A space approximately 1.5 m
square by 2.0 m high will accommodate a unit capable of supplying two 600
litre porous-load sterilizers.

Dryness
7.18 The dryness of the steam is of vital importance to the performance of any
steam sterilizer. Excess moisture may cause damp loads in porous materials and
uneven temperature distributions in non-porous loads, particularly those
containing a large number of small items such as ampoules. When steam is
required to be in direct contact with the surface to be sterilized, such as in
porous-load sterilizers, sterilizing conditions may not be attained if the moisture
contained in the steam supply is insufficient to prevent the steam from
becoming superheated when expanding into the chamber.

7.19 Steam dryness is traditionally characterised by a “dryness fraction”, but

this is not appropriate for sterilizers because the method of measurement is
difficult and requires a constant flow of steam. The low-volume sampling
technique described in the steam dryness test (Part 3 of this HTM) cannot be
regarded as measuring a true dryness fraction because the sample is taken from
the centre of the steam supply pipe and condensate flowing along the pipe wall
is not collected. Consequently the term “dryness value” is used, where 1.0
represents dry, saturated steam. This method is used to determine whether
performance problems could occur during testing and routine production. It is
suitable for sterilizer installations because control valves and pipe services fitted
to the sterilizer considerably reduce the amount of condensate entering the
sterilizer chamber such that the sample has a similar amount of free condensate
to the steam in the chamber.

7.20 European Standards require that sterilizers be designed to operate with

steam having a dryness value of not less than 0.9 when measured in accordance
with the steam dryness test described in Part 3 of this HTM. For metal loads, the
dryness value should not be less than 0.95. In practice, problems are unlikely to
occur if the dryness value lies between 0.9 and 1.0, if it is reasonably constant
and if the pressure reduction through the final pressure-reducing system is of the
order two to one.

7.21 Although experience has shown that acceptable conditions are sometimes
achieved when optimum conditions do not prevail, significant deviations are
likely to cause the following problems:

a. wet loads, resulting from too low a dryness value;

b. superheating, resulting from either too high a dryness value before the
pressure-reducing system, or excessive pressure reduction through the
valve (superheating may be severe if both conditions are present
simultaneously);

c. difficulties with operation of the pressure-reducing system, resulting from

a low pressure-reduction ratio, water hammer, water logging, dirt and
other carry-over.
Excessive moisture

7.22 Excessive moisture, where droplets of water are present at the same
temperature as that of the steam, will cause wet loads in porous-load sterilizers,
low-temperature steam (LTS) disinfectors and LTSF sterilizers. It will reduce
formaldehyde concentration in LTSF sterilizers and impair the efficacy of the
process. Humidification may be impaired in EO sterilizers. Some causes of wet
loads are as follows:

a. steam pipes or manifolds may be incorrectly sloped and drained;

b. the sterilizer may be supplied from an inadequately drained and vented

“dead-leg” rather than a live steam main;

c. the pipework between the boiler and the sterilizer may be insufficiently
insulated, causing excessive condensation of the supply steam.

7.23 If wet steam continues to be a problem, “priming” may be occurring in

the boiler, causing water droplets to be delivered in the steam. Modern compact
and high rated boilers and steam generators are particularly sensitive to the
quality of feed-water treatment and are much more likely to prime than boilers
of traditional design. Priming or foaming (which results in carry-over of the
boiler water) may be caused by any of the following:

a. incorrect feed-water treatment;

b. boiler water level being set too high;

c. forcing a boiler which needs internal cleaning;
d. violent boiling under fluctuating load conditions;

e. a high level (typically 2000 ppm) of total dissolved solids

Superheating

7.24 Superheated steam is an unsuitable medium for moist heat sterilization

and can cause failure to sterilize, scorching of textiles and paper and rapid
deterioration of rubber. Superheat conditions within the load and chamber may
result from adiabatic expansion, exothermic reaction or both.

7.25 European Standards require that the superheat in free steam at

atmospheric pressure should not exceed 25°C when measured by the superheat
test described in Part 3 of this HTM.

7.26 Superheating caused by adiabatic expansion is usually the result of an

excessive reduction in pressure through a throttling device, such as a pressure-
reducing system or a partially closed main steam valve. It is unlikely to be of
significance in the circumstances normally encountered in hospital steam
distribution systems, but superheating may arise if the main steam supply is dry,
or the pressure is unusually high before the throttling device. This superheat can
sometimes be avoided by the measures described in paragraph 7.12, which will
reduce the dryness value of the steam at the inlet to the sterilizer pressure-
reducing system. The reduced pressure ratio will minimise the effect of the
expansion through it.

7.27 Superheating arising from exothermic reaction may occur during

sterilization as a result of rehydration of exceptionally dry hygroscopic material
Methods of avoiding this are described in Part 4 of this HTM.
Non-condensable gases

7.28 Non-condensable gases (NCGs) are defined as gases which cannot be

liquefied by compression under the range of conditions of temperature and
pressure used during the sterilization process. Low levels of NCGs contained in
steam supplied to sterilizers can markedly affect the performance of the sterilizer
and the efficacy of the process, cause chamber overheat and lead to
inconsistencies in the performance of air detectors and failure of the Bowie-Dick
test (see Part 3). The major NCGs are air and carbon dioxide.

7.29 British and European Standards require that sterilizers be designed to

operate with steam having a fraction of NCGs not exceeding 3.5% by volume
when measured by the method described in the non-condensable gas test (see
Part 3).

7.30 The main source of NCGs in the steam supply is the boiler feed-water and
the level will be greatly influenced by the water treatment employed. In some
cases a study by a water treatment specialist will be necessary. The study should
cover analysis of the water, venting and the blow-down regime required in order
to ensure protection of the boiler against corrosion whilst minimizing the
entrainment of NCGs in the steam supply.

7.31 If anti-foaming agents and oxygen-scavenging agents (such as sodium

sulphite) are used it is essential to ensure that the dosages are accurate.

7.32 Water-softening treatment is required to prevent the formation of scale.

Except in hard water areas, a simple base-exchange system may be adequate in
which bicarbonate ions are effectively converted into sludge-forming carbonates.
This releases carbon dioxide into the water. A properly managed blow-down
regime is essential to remove the accumulated sludge.

7.33 The most effective way of driving off dissolved air, carbon dioxide and
other NCGs is by degassing the boiler feed-water before use by heating in a
vented tank (a hot well). This will also break down bicarbonate ions, driving off
further carbon dioxide. For the degassing to be effective, it is important that the
temperature of the feed-water does not fall below 80°C at any time. The
following measures should be adopted:

a. pipework returning condensate to the hot well should be well lagged to

keep the condensate hot;

b. the amount of cold make-up water in the hot well should at no time
exceed 15% (the rest being returned condensate) since new water will
both lower the temperature and introduce further NCGs;
c. the water in the well should be kept well mixed; this may be achieved by
locating the feed-water inlet on the opposite side of the tank from the
outlet, and by arranging for the feed-water to be “sparged” from the inlet
through a number of small openings.

7.34 In very hard water areas the level of NCGs may still be high despite these
measures, and dealkalisation treatment of the feed-water may then be
necessary. In such cases the maintenance of high temperatures in the hot well is
even more critical. Treatment with filming amines should be avoided since this
method requires careful control and monitoring.

7.35 Users should note that, even with a well-designed system, the level of
NCGs can be affected by competing demands on the steam service. For
example, where a central steam boiler supplies both a sterilizer unit and a
laundry through the same distribution system, the level of NCGs in the steam at
the sterilizer may rise when the laundry demand is high. This is the result of an
influx of cold make-up water into the hot well. Paradoxically, in some
installations the NCG level may also rise when steam demand is low. In this case
NCGs which would normally be removed by the laundry are being carried
through to the sterilizer.

7.36 Some other causes of the presence of NCGs in the steam are as follows:

a. the boiler may be priming (paragraph 7.22f);

b. air may be being drawn into the system either through the boiler feed-
pump glands or through a leak in the steam pipework between the boiler
and the sterilizer;

c. steam pipework may be inadequately vented;

d. where NCGs are found in the sterilizer chamber during a production cycle:
(i) there may be an air leak into the chamber;
(ii) packaging materials, for example certain boxes, inks, adhesives,
labels or trays, may be liberating gases. See Part 4 for guidance on
packaging materials.
8.0 Porous-load sterilizers

Introduction

8.1 This chapter discusses specifications for clinical sterilizers designed to

process porous items such as towels, gowns and dressings; and medical and
surgical equipment, instruments and utensils that are packaged or wrapped in
porous materials such as paper or fabrics. Clinical sterilizers using high-
temperature steam to process porous loads are commonly known as “porous-
load sterilizers”.

8.2 The guidance given here assumes that the sterilizer is to be used to process
medical devices in compliance with the EU Directives discussed in Chapter 1.

8.3 Sterilization is achieved by direct contact of the load items with good-
quality saturated steam at a preferred sterilization temperature of 134°C (see
Table 4).

8.4 Porous-load sterilizers are distinguished from other high-temperature steam

sterilizers by the following features:

a. as porous loads trap both air and moisture, the sterilizer has a vacuum
system to ensure that sufficient air is removed from the chamber and load
before steam is admitted to the chamber. It also ensures that the pressure
during the drying stage is sufficiently reduced so that the load is sensibly
dry on completion of the cycle;

b. an air detector is fitted to the chamber to ensure that the plateau period
cannot start until sufficient air has been removed from the chamber and
load (see paragraph 8.7);

c. a heated jacket is generally used to prevent condensate from forming on

the chamber walls and to assist drying of the load.

Standard specifications

8.5 Porous-load sterilizers should conform to the specifications in EN 285 and

the safety specifications in EN 61010: Part 2-041. Until EN 285 is published,
sterilizers should conform to BS 3970: Parts 1 and 3.

Additional specifications

8.6 The following specifications are additional to those in EN 285 and

permitted as options.

Air detector

8.7 EN 285 requires means to be provided to ensure that the requirement for
steam penetration throughout the chamber and load is achieved for each cycle.
The most reliable way to do this is to specify an air detector to ensure that the
plateau period cannot commence if sufficient air and other non-condensable
gases have not been removed from the chamber. The correct functioning of the
air detector is crucial to the performance of the sterilizer.
8.8 Although an air detector is not required by EN 285, there is no other
proven means of assuring that air is not present during production cycles. (The
quantity of air sufficient to cause a failure of a sterilization cycle is small and for
this reason the comparison of pressure and temperature within the chamber is
by itself an unacceptable alternative.) An air detector is the most cost-effective
way of ensuring that the sterilization conditions established during validation
continue to apply.

8.9 If an air detector is not fitted, microbiological testing as described in

EN 285 will be required, along with more frequent periodic testing and more
demanding performance qualification. This option is expensive.

Port for air-flow metering device

8.10 A quarter-inch BSP port should be fitted on the side of the sterilizer,
preferably towards the lower front, for the attachment of an air-flow metering
device used for testing air-detector performance and chamber integrity (see
Part 3).

Absolute pressure indicator

8.11 For leak-testing purposes an absolute pressure indicator (0 to 160 mbar)

should be fitted, conforming to clause 6.2.2.2 of EN 285.

Bowie-Dick test cycle

8.12 Sterilizers for use in the NHS should be provided with a Bowie-Dick test
cycle.

Extended drying
8.13 An additional cycle with extended drying time should be provided to
process loads which are difficult to dry.
9.0 Fluid sterilizers

Introduction

9.1 This chapter discusses specifications for clinical sterilizers designed to

sterilize aqueous fluids in sealed containers (normally bottles) of either glass or
plastic. Such sterilizers are commonly known as “fluid sterilizers”.

9.2 The guidance given here assumes that the sterilizer is to be used to process
medicinal products in compliance with the GGMP and EU Directives discussed in
Chapter 1.

9.3 Sterilization is achieved by direct contact of the load items with a heating
medium, normally good-quality saturated steam, and then by heat transfer
through the container to increase and maintain the product at a preferred
sterilization temperature of 121°C (see Table 4).

9.4 Fluid sterilizers are distinguished from other high-temperature steam

sterilizers by the following features:
a. a thermal door lock is fitted to ensure that when glass containers are
being processed the door cannot be opened until the temperature inside
all the containers has fallen below 80°C: this prevents the containers
fracturing due to thermal stress;

b. operating cycles for plastic containers allow the door to be opened when
the temperature inside the containers has fallen below 90°C: this prevents
“blooming” of the containers;

c. cooling is usually by means of a water spray. The water may be either

derived from steam condensate collected in the chamber or sterile water
fed in from outside;
d. during all or parts of the cycle air may be introduced into the chamber to
prevent large pressure differences arising between the inside and outside
of containers; this is known as “pressure ballasting” (see paragraph 9.8).

Standard specifications

9.5 Fluid sterilizers intended for the sterilization of fluids in sealed rigid
containers (glass bottles) should conform to the specifications in BS3970: Parts 1
and 2 and the safety specifications in EN 61010: Part 2-041. See paragraph 9.8
for additional specifications for flexible (plastic) containers.

9.6 A European Standard for fluid sterilizers is being planned.

Additional specifications

9.7 The following specifications are in addition to those in BS3970: Parts 1

and 2.

Cycle for plastic containers

9.8 Where the sterilizer is to be used to process plastic containers, a modified

operating cycle may need to be specified. This is similar to the standard glass
cycle but with the following modifications:
 a. pressure ballasting should be used to prevent pressure differences arising
between the inside and the outside of containers sufficient to burst or
distort them;

b. the design pressure for the sterilizer chamber should be at least 10%
higher than the allowable pressure; the operating pressure will typically be
3.3 bar gauge for a sterilization temperature of 121°C;

c. the thermal door lock (9.4a) should be set so that the door cannot be
opened until the temperature of the fluid in all the containers has fallen
below 90°C.

9.9 If loads consisting solely of plastic containers are to be processed

infrequently, then it may be better to specify a single cycle suitable for both glass
and plastics (rarely used cycles may not be reliable). In that case the thermal
door lock should be set so that the door cannot be opened until the
temperature of the fluid in all the containers has fallen below 80°C.

Heat exchanger
9.10 The design of the coolant system should be such that, whenever a single
fault occurs in the coolant system, the quality of all water in contact with the
load complies with the requirements of the full-load test described in Part 3 of
this HTM. One example is a system whereby during any part of each operating
cycle the primary coolant pressure is known to be less than the pressure external
to each load container.

9.11 Connections for a pressure test gauge should be provided so that

measurements can be made of:

a. the pressure in the primary circuit;

b . the differential pressure between the primary and secondary circuits.

Monitoring and control by F O

9.12 Fo is a measure of the “lethality” delivered to a load throughout an

operating cycle, including the heating and cooling stages. It is expressed as a
time in minutes equivalent to a continuous period at 121°C. Guidance on the
use o f Fo is given in Part 4 of this HTM and an extensive discussion of the theory
and applications of Fo can be found in Part 5.

9.13 Fo may be used instead of the standard time - temperature relationships

given in Table 4 to determine whether sterilization conditions have been
achieved. Whe n Fo measured inside the load attains a certain value (normally 8
min or more) the load may be deemed to be sterile. It is particularly useful for
heat-sensitive loads that can withstand the heat received during the prescribed
holding time, but not the additional heat received during the heating and
cooling stages, or for loads which would not survive a second operating cycle.

9.14 Fo may be used either to monitor or to control an operating cycle:

a.where monitoring is required, a recorder displays the accumulated Fo

throughout the operating cycle. This facility may be useful in borderline
cases where the batch process record falls just outside the permitted
tolerances established during performance qualification. Quality control
procedures may then permit heat-sensitive products which would not
survive resterilization to be released provided that the required Fo has been
attained;

b. where control is required, the holding time continues until the required F o

is attained.
9.15 Sterilizers monitored by Fo should be equipped with a load temperature
probe to be inserted into the container of the load known to receive the lowest
Fo. The probe should be connected to a recorder displaying accumulated Fo
throughout the cycle.

9.16 Sterilizers controlled by Fo should have at least two load-temperature

probes to be inserted into two containers of the load known to receive the
lowest Fo . The probe showing the lowest accumulated Fo at any instant should
be used to control the cycle.

9.17 The recorder should display accumulated Fo computed from the following
equation:

where:
∆t = sampling interval;
Ti = temperature of sample i.

9.18 The sampling interval, ∆t, should be not greater than two seconds.

9.19 The precision and accuracy of the measuring and computing equipment
should be such that the performance requirements given in BS3970: Part 2 can
be met.

9.20 If an Fo system is to be specified, then the responsibility is on the user to

determine the nature of the bioburden in the load and also to determine that
the proposed cycle will ensure that the probability of survival of microorganisms
on any given load item does not exceed 10-6. Guidance on how to do this is
given in Part 4 of this HTM.

9.21 Whenever Fo is used either to control the operating cycle or to influence

product release, it should be part of a complete quality assurance system and
the validation and routine control subject to independent assessment by the
licensing authority.

9.22 The GGMP (see paragraph 1.9) requires validation and control of
equipment and processes. Any computer software used to determine the F o
delivered to the product should also be validated and any modifications
controlled.
10.0 Sterilizers for unwrapped
instruments and utensils

Introduction

10.1 This chapter discusses specifications for clinical sterilizers designed to

process unwrapped solid instruments and utensils intended for immediate use

10.2 The guidance given here assumes that the sterilizer is to be used to
process medical devices. However, these sterilizers do not meet the essential
requirements of the EU Directives discussed in Chapter 1, which do not permit
the supply of unpackaged sterile medical devices.

10.3 Sterilization is achieved by direct contact of the load items with good-
quality saturated steam at a preferred sterilization temperature of 134°C (see
Table 4).

10.4 Sterilizers for unwrapped instruments and utensils are distinguished from
other high-temperature steam sterilizers by the following features:

a. air is removed from the sterilizer by passive displacement, either

downward or upward depending whether the steam is supplied externally
or generated internally. These sterilizers should therefore not be used to
process either wrapped instruments and utensils or ‘unwrapped
instruments and utensils with narrow lumens which could inhibit the
removal of air and the penetration of steam. Such items should be
processed in a porous-load sterilizer (see Chapter 8);

b. except where vacuum is used to dry the load (normally in larger, fixed
sterilizers), the load is partially dried by natural evaporation after it has
been removed from the chamber;

c. since the sterilized items are exposed to the air on being removed from the
chamber, they are susceptible to rapid recontamination. These sterilizers
are therefore suitable for clinical use only within the immediate
environment in which the load items are to be used.

10.5 Where practicable, instruments and utensils should be wrapped and

processed in a porous-load sterilizer.

10.6 Sterilizers for unwrapped instruments and utensils may either be

transportable or fixed.

Transportable sterilizers

10.7 The majority of sterilizers are transportable (bench-top) models which are
electrically heated, requiring only a 13 A socket outlet and no piped services.
They are commonly used in theatre suites where there is no SSD service and in
primary health care units, such as GP and dental practices.

10.8 Steam is generated within the sterilizer chamber and a supply of distilled,
deionised or reverse-osmosis water is required. Tap water should not be used as
it may cause scaling and chlorine dissolved in the water may corrode the
chamber.

10.9 Certain machines, known as “flash” sterilizers, operate at 150°C with a

holding time of a few seconds. Although they are intended for rapid sterilization
of unwrapped instruments and utensils, the time saved in sterilization is lost in
waiting for the load to cool. They do not conform to BS3970 (see paragraph
10.11) and their use is not recommended.

Fixed sterilizers

10.10 Fixed sterilizers are generally discouraged, but may be installed in an

operating theatre to replace existing fixed sterilizers where supply from a porous-
load sterilizer is impracticable.

Standard specifications

10.11 Transportable sterilizers for unwrapped instruments and utensils should

conform with the specifications in BS3970: Parts 1 and 4 and the safety
specifications in EN 61010: Part 2-041. A European Standard on “small”
sterilizers (less than one module) is under development and will eventually
supersede the relevant clauses of BS3970.

10.12 At present there are no standards for fixed sterilizers, though these are
likely to be encompassed by the future European Standard. In the meantime,
fixed sterilizers should meet the performance requirements of BS3970: Parts 1
and 4.

Additional specifications

10.13 The following specifications are permitted as options to those in

BS3970: Parts 1 and 4.

Operating cycle
10.14 A transportable sterilizer should have a single operating cycle. Option A
of BS3970: Part 4 (134-138°C) is recommended for NHS use. Some sterilizers
may be equipped to provide other optional operating cycles, specified by the
purchaser, but the selection of the cycle should be by means of a key, code or
tool not available to the operator.

Temperature recorder
10.15 A temperature recorder is optional in BS3970: Part 4 but is
recommended where documented evidence of correct functioning is required.
11.0 Dry-heat sterilizers

Introduction

11.1 This chapter discusses specifications for clinical sterilizers designed to

sterilize load items by exposure to hot, dry air. Such sterilizers are correctly
known as “dry-heat sterilizers” and sometimes as “hot-air sterilizers” or
“sterilizing ovens”. They are intended to process materials such as oils, powders
and some ophthalmic instruments, which can withstand high temperatures but
are likely to be damaged or not sterilized by contact with steam.

11.2 The guidance given here assumes that the sterilizer is to be used to
process either medicinal products or medical devices in compliance with the EU
Directives discussed in Chapter 1.

11.3 Sterilization is achieved by direct contact of the load items with hot, dry
air at a preferred sterilization temperature of 160°C (see Table 4).

11.4 Purchasers should be aware that, owing to the low thermal conductivity
of air, it is difficult to obtain an even temperature distribution within the
chamber and heat transfer from the air to the load can be very slow. A complete
cycle, including assisted cooling to 80°C, takes approximately five hours for a full
test load as described in Part 3 of this HTM.

11.5 Dry-heat sterilizers are not suitable for use as drying cabinets (see BS2648
for specifications for drying cabinets).

Standard specifications

11.6 The only British Standard covering dry-heat sterilizers was BS3421: 1961,
which has long been inadequate and is now withdrawn. There are no immediate
plans for future British or European Standards covering dry-heat sterilizers. In the
absence of a current standard, dry-heat sterilizers should conform to Model
Engineering Specification C14 published by NHS Estates and to the safety
specifications in EN 61010: Part 2-043.

Additional specifications

11.7 The GGMP requires dry-heat sterilizers to have the following

characteristics:

a. air should be circulated within the chamber to promote a uniform

temperature distribution;

b. positive pressure should be maintained inside the chamber to prevent the

entry of non-sterile air;
c. any air admitted to the chamber should be passed through a bacteria-
retentive filter.
12.0 Low-temperature steam
disinfectors and low-
temperature steam and
formaldehyde sterilizers
Introduction

12.1 This chapter discusses specifications for clinical disinfectors and sterilizers
designed to process heat-sensitive items (wrapped or unwrapped) which will
withstand saturated steam at temperatures up to 80°C.

12.2 The guidance given here assumes that the sterilizer is to be used to
process medical devices in compliance with the EU Directives discussed in
Chapter 1. Low-temperature steam and formaldehyde (LTSF) is not listed in the
GGMP as a suitable method for sterilization of medicinal products.

12.3 Disinfection is achieved by the direct contact of the load items with good- In Scotland, LTSF sterilizers are
quality saturated steam at a disinfection temperature of 71°C at sub- considered to be disinfectors
atmospheric pressure (“LTS disinfectors”). Sterilization is achieved by contact with
both saturated steam and formaldehyde gas (“LTSF sterilizers”). Sterilizers
designed for LTSF will normally incorporate an LTS disinfection cycle.

12.4 Formaldehyde is a toxic gas. Exposure to formaldehyde is controlled by

the COSHH Regulations 1994 and subject to the maximum exposure limits
detailed in Table 1. Operational safety information is given in Part 4 of this HTM.

12.5 LTS disinfectors and LTSF sterilizers operate for the whole of the cycle with
the chamber pressure below atmospheric pressure. An air leak rate which is too
small to affect the efficacy of a porous-load process may in the case of LTS and
LTSF cause an unacceptable volume of air to enter the chamber. Air detectors
currently available cannot reliably detect at negative pressures, so as an
alternative manufacturers now include a vacuum leak monitor, set to fail the
cycle at a leak rate not exceeding 5.2 mbar min -1 (see the vacuum leak monitor
test in Part 3 of this HTM). A vacuum leak monitor is less effective than an air
detector.

12.6 Since the sterilization process is ultimately dependent on chemical action,

microbiological test methods are required to confirm that sterilization conditions
have been attained (see Part 3).

12.7 LTSF sterilizers require special precautions for ventilation and drainage (see
Chapter 6).

Standard specifications

12.8 LTS disinfectors (or LTSF sterilizers with an LTS cycle) should conform to
the specifications in BS3970: Parts 1 and 5. LTSF sterilizers should conform to the
specifications in BS3970: Parts 1, 5 and 6 and the safety specifications in
EN 61010: Part 2-042.

12.9 No European Standards are currently planned for LTS disinfectors or LTSF
sterilizers.
Additional specifications

12.10 The following specifications for LTSF sterilizers are in addition to those
given in BS3970: Parts 1 and 6.

Room ventilation

12.11 The sterilizer manufacturer should supply the appropriate interfaces to

enable the sterilizer to function with the room ventilation system as described in
Chapter 6.

Local exhaust ventilation

12.12 LTSF sterilizers should be connected to a local exhaust ventilation system

(LEV) to ensure that the emission of formaldehyde gas into the atmosphere does
not present a safety hazard. The sterilizer manufacturer should supply the
appropriate hoods and interfaces to enable the sterilizer to function with the LEV
system as described in Chapter 6.

Formalin supply

12.13 The formalin reservoir within LTSF sterilizers should be installed in a

sealed, recessed enclosure protected from mechanical damage. The means of
attachment of the reservoir should minimise the possibility of spillage. The top of
the reservoir should be no more than 1.5 m above floor level.

12.14 An indicator, visible from the front of the sterilizer, should show:

a. how much formalin has been used in the current cycle;

b. how much formalin remains in the reservoir.

Degassing facilities

12.15 A space or room should be allocated for the aeration and storage of
processed loads. Load items do not normally absorb formaldehyde and providing
the gas removal is satisfactory, the load may be placed in the downstream part
of the ventilation flow in a designated area of the finished goods store.

Gas monitoring system

12.16 Gas detectors should be placed wherever there is a risk of people being
exposed to formaldehyde. Such places would normally include both the loading
area and plantroom. The detectors should be placed close to the normal
working positions of personnel. The monitoring system should be set to sound a
visual and audible alarm when the atmospheric concentration of formaldehyde
exceeds a preset level no greater than the short-term maximum exposure limit
specified in Table 1.

12.17 Interfaces with the ventilation systems will also be required as discussed
in Chapter 6.
13.0 Ethylene oxide sterilizers

Introduction

13.1 This chapter discusses specifications for clinical sterilizers designed to

sterilize load items by exposure to ethylene oxide gas. Such sterilizers are
commonly known as “ethylene oxide sterilizers” or “EO sterilizers”.

13.2 The guidance given here assumes that the sterilizer is to be used to
process medical devices in compliance with the EU Directives discussed in
Chapter 1.

13.3 EO is a highly reactive liquid and gas which is toxic, flammable and
explosive. Exposure to EO is controlled by the COSHH Regulations 1994 (see
Chapter 1). The safe operation of EO sterilizers requires careful consideration of
all aspects of the installation and operation of equipment. Operational safety
information is given in Part 4 of this HTM.

13.4 EO sterilizers should be installed in dedicated areas which are not used for
any other working purposes.

13.5 An EO sterilization process may include preconditioning and degassing

procedures requiring additional equipment. Further information about
preconditioning is given in paragraph 13.21 and about degassing in
paragraph 13.35.

13.6 EO sterilizers have the potential to cause serious environmental pollution.

Large sterilizers will require additional plant to dispose safely of exhaust products
and this will add considerably to the cost. Such plant is described in paragraph
13.39. Precautions in ventilation and drainage systems are outlined in Chapter 6.

13.7 Since the sterilization process is ultimately dependent upon chemical

action, microbiological test methods are required to confirm that sterilization
conditions have been attained. These are described in Part 3 of this HTM.

13.8 Purchasers of an EO sterilizer should be aware of the following points:

a. the difficulty in validating and monitoring suitable cleaning processes for

loads before they are sterilized (see Part 4);

b. the difficulty in carrying out representative performance qualification tests

for the wide variety of loading conditions that may be used (see Part 3);

c. the difficulty in carrying out meaningful bioburden studies on small

numbers of widely differing devices to be sterilized (see Part 4);

d. the problems associated with determining the levels of residual EO and its
reaction products when small numbers of widely differing devices are
processed (see Part 3);

e. the need for specialist technical resources dedicated to the operation and
maintenance of the equipment (see Part 4).

13.9 EO installations can be expensive both to buy and to run. As there are
few items which need to be sterilized by EO, their provision cannot normally be
justified by individual hospitals. Where there is a clear need for EO sterilization,
the service should be run by a well-supported specialist unit where
microbiological testing, environmental controls, degassing procedures and
evaluation of residual EO in the sterilized product can be assured.

Types of sterilizer

13.10 Two types of EO sterilizer are suitable for NHS use

Low-pressure sterilizers

13.11 These are small sterilizers, of chamber volumes around 150 litres, where
the sterilant is pure EO at sub-atmospheric pressure. The gas is supplied from a
single-use, disposable cartridge contained within the chamber. The cartridge
limits the amount of EO in use at any one time and reduces the toxic and
explosive hazards. The chamber is designed to contain the effects of an
explosion of the contents of a single cartridge.

13.12 Low-pressure sterilizers are relatively cheap to install and to run,

requiring no piped EO service and no gas disposal plant. The low pressure in the
chamber allows pressure-sensitive equipment to be processed safely.

High-pressure sterilizers
13.13 These are large sterilizers, of chamber volume up to 500 litres, where
the sterilant is EO diluted with another gas, supplied from cylinders.

13.14 The mixtures are chosen to expose the load to an EO concentration of

around 500-1000 mg litre-1 while keeping the potential hazards to a minimum.
Two gas systems are in common use:

a. EO with chlorofluorocarbons (CFCs) at pressures up to 2 bar: CFCs have

traditionally been used as a diluent gas but are no longer acceptable for
environmental reasons;

b. EO with carbon dioxide at pressures up to 6 bar.

13.15 Because of their larger size, high-pressure sterilizers require gas disposal
plant to remove EO from the chamber exhaust (see paragraph 13.39).

Standard specifications

13.16 EO sterilizers should conform to the specifications in EN 1422 and the

safety specifications in EN 61010: Part 2-042. Two types of sterilizer are
specified:

a. type A sterilizers have operating cycles programmable by the user and

may have very large chamber volumes; they are intended primarily for use
in industry;

b. type B sterilizers have one or more preset operating cycles; the chamber
volume is no greater than 1000 litres.

13.17 EO sterilizers for use in the NHS should conform to Type B. They may be
either low-pressure or high-pressure systems (see paragraph 13.10).

Additional specifications

13.18 The following specifications for EO sterilizers are in addition to those

given in EN 1422.
Room ventilation

13.19 The sterilizer manufacturer should supply the appropriate interfaces to

enable the sterilizer to function with the room ventilation system as described in
Chapter 6.

Local exhaust ventilation

13.20 EO sterilizers should be connected to a local exhaust ventilation system
(LEV) to ensure that the emission of EO gas into the atmosphere does not
present a safety hazard. The sterilizer manufacturer should supply the
appropriate hoods and interfaces to enable the sterilizer to function with the LEV
system as described in Chapter 6.

Preconditioning facilities

13.21 For successful sterilization the load should be at a predetermined

temperature and humidity before the start of the operating cycle. This may be
achieved by exposing the load to the required conditions in an environmentally
controlled room or chamber. This preconditioning procedure is considered an
integral part of the sterilization process. See Part 4 for more information about
routine preconditioning.

13.22 Preconditioning requires either a chamber (designed to accommodate

one sterilizer load) or a room (two or more loads).

13.23 Humidification should be by direct injection of low-pressure steam and

should be controlled by direct measurement of relative humidity (RH) within the
chamber or room. Humidifiers which operate by dispersion of water into an
aerosol (such as spinning-disk humidifiers or nebulizers) are potent sources of
microbial contamination and should not be used.

13.24 Provision should be made for continuous monitoring and recording of

temperature and RH at locations determined as being representative of the
conditions prevailing throughout the chamber or room.

13.25 The temperature and RH at which the chamber or room is controlled

should be compatible with the conditions prevailing during the sterilizer
operating cycle. They should be selected so that the temperature and RH of the
load going into the sterilizer are neither so low that problems of long heat-up
and condensation occur, nor so high that temperature control of the cycle is
compromised. The uniformity of conditions should be established during
validation.

Preconditioning chamber
13.26 All internal surfaces should be smooth, impermeable, durable and easily
cleanable. Wherever possible internal corners should be rounded with a
minimum radius of 25 mm.

13.27 Chambers constructed of metal should be of stainless steel, mild steel

clad with stainless steel or nickel, or anodised aluminium. Alternatively, metal
surfaces may be treated to inhibit corrosion.

13.28 The chamber should have assisted air circulation designed to provide
effective airflow around all load items (whether partly or fully loaded) and to
maintain uniform temperature and humidity throughout the chamber. Air
entering the chamber should be filtered.
13.29 Door interlocks should be provided so that after the door has been
closed it cannot be opened until the preset preconditioning time has elapsed.

Preconditioning room

13.30 The room should be segregated from assembly and packaging areas but
located close to the sterilizer loading area to permit rapid transfer of the load.

13.31 Consideration should be given to cleanliness and ease of cleaning,

especially in the design and location of equipment. The room should have a
standard of finish similar to that of environmentally controlled areas. All internal
surfaces should be smooth and free from cracks. Surface finishes should be
impermeable, durable and easily cleanable. Ledges should be kept to a
minimum. Wherever possible, internal corners should be rounded with a
minimum radius of 25 mm. Any services required for cleaning should be
provided within the room.

13.32 Corrosion of metal components may be a problem in the high-humidity

conditions prevailing in the room. Uncoated metal surfaces should be either
stainless steel or anodised aluminium.

13.33 The room should have assisted air circulation designed to provide
effective airflow around all load items (whether the room is partly or fully
loaded) and to maintain uniform temperature and humidity throughout the
room. Air recirculation should incorporate a filtration system.

13.34 The door should be fitted with an audible and visual alarm set to
operate if the door is left open for more than the time for which the conditions
in the room can be maintained. This time should be established during validation
(see Part 3 of this HTM).

Degassing facilities

13.35 Most, if not all, materials subject to EO sterilization retain varying

amounts of EO gas. The residual EO in medical devices must be reduced to a
safe level, both for personnel handling the product and for the patient. The
general term for this procedure is aeration. Aeration within the operating cycle is
known as flushing. Aeration following the operating cycle is known as
degassing.

13.36 Other compounds may also be present as reaction products of EO, for
example ethylene chlorhydrin, and the concentration of these will also need to
be reduced. Reference in this HTM to reduction of EO concentration should be
read as applying equally to any other toxic reaction products which may be
present.

13.37 Reduction of residual EO occurs naturally as gas diffuses from the

product into the surrounding air. Under normal ambient conditions this process
may be very slow and significant amounts of EO may be released into the
environment. For these reasons degassing by storage under ambient conditions
is not recommended. Mechanical degassing should be used.

13.38 A degassing facility may be either a purpose-made aeration cabinet or a

room. Some sterilizers incorporate an additional flushing stage as part of the
operating cycle and this may be sufficient. Within the NHS the volume of
product and the number of cycles a week will be small; for most installations a
separate aeration cabinet is not normally necessary.
Disposal of EO

13.39 When an EO sterilizer is purchased consideration must be given to the

method to be used to dispose of gases exhausted from the chamber. For a low-
pressure sterilizer, chamber exhaust ventilation as described in Chapter 6 is
adequate. For high-pressure sterilizers, however, the quantity of EO is likely to be
too high to be disposed of safely without further processing.

13.40 Five basic methods are available: water scrubbing, incineration, catalytic
oxidation, reclamation and EO absorption and modification. Of these, catalytic
oxidation is recommended for use in the NHS.

13.41 Catalytic oxidation oxidizes EO to carbon dioxide and water by heating

the exhaust gases in the presence of a catalyst at a temperature of
approximately 300°C. Maximum efficiency is in excess of 99%.

13.42 Inlet gas streams must be diluted to contain less than 1% EO to prevent
significant heating of the catalyst bed. High EO concentrations may cause a
runaway reaction and under these conditions, in addition to the fire and
explosion hazard, any CFCs present in the gas may be degraded to give toxic
products such as phosgene.

13.43 The purchase and running costs are moderate to high. Little routine
maintenance is required other than periodic replacement of the catalyst bed.

13.44 Small units suitable for installation with small EO sterilizers are
commercially available and present few installation problems.

Gas monitoring system

13.45 Gas detectors should be placed wherever there is a risk of people being
exposed to EO. Such places would normally include the loading area, plantroom,
manifold room and degassing room. The detectors should be placed close to the
normal working positions of personnel. The monitoring system should be set to
sound a visual and audible alarm when the atmospheric concentration of EO
exceeds a preset level no greater than the short-term maximum exposure limit
specified in Table 1.

13.46 Interfaces with the ventilation systems will also be required as discussed
in Chapter 6.
14.0 Laboratory sterilizers

Introduction

14.1 This chapter discusses specifications for sterilizers (“laboratory sterilizers”)

used for the processing of materials and equipment to be used in clinical
laboratories.

14.2 These sterilizers are not intended for the processing of medical devices or
medicinal products. There is therefore no need for them to comply with the EU
Directives discussed in Chapter 1.

14.3 Guidance on validation and periodic testing of laboratory sterilizers is

given in Part 3 of this HTM. Guidance on operation is given in Part 4.

Provision of laboratory sterilizers

14.4 The HSE Advisory Committee on Dangerous Pathogens recommends that

laboratory sterilizers capable of making safe infected material be provided as
shown in Table 11.

Table 11 Provision of laboratory sterilizers

Containment
level Provision

1 No sterilizers are required

2 A sterilizer with a make-safe cycle must be readily accessible,
normally in the same building as the laboratory
3 A sterilizer with a make-safe cycle should be preferably situated
within the laboratory, but one must be readily accessible in the
laboratory suite
4 A double-ended sterilizer with interlocking doors with entry in
the laboratory and exit in a clean area must be provided

Source: ‘Categorisation of pathogens according to hazard and categories of containment’

(second edition), HSE 1990.

14.5 General information on the requirements for the four containment

categories can be found in the HSE document ‘Categorisation of pathogens
according to hazard and categories of containment’, published by HMSO.
Purchasers should note that the containment requirements have been
given statutory force by the Control of Substances Hazardous to Health
Regulations 1994.

14.6 Sufficient sterilizers should be installed to ensure that contaminated

material can continue to be made safe if any sterilizer is removed from service. A
cycle for the make-safe of small plastic discard (see paragraph 14.38 ) and a
cycle for the make-safe of contained fluid discard (see paragraph 14.42) should
be available at all times. The need for other cycles to be duplicated will depend
on the nature and volume of the work being done in the laboratory.
14.7 Where possible, at least one sterilizer should be designated solely for the
processing of discard material.

14.8 Laboratory sterilizers intended to process discard material should be sited

as close as possible to the area in which the discard is produced, to avoid
contaminated material being transported through rooms where it would not
normally be stored or handled. Laboratory sterilizers intended to process culture
media should be directly accessible from the media preparation area.

14.9 The preferred type of sterilizer is a front-loading unit, recessed into a

panel separating the loading area from the plantroom, as described in
Chapter 5. Such sterilizers are available with a wide range of chamber sizes and
operating cycles.

14.10 Sterilizers with a door at each end are essential for Containment Level 4
laboratories, though they present special problems of installation and access for
maintenance.

14.11 Free-standing machines, with chambers up to 500 litres, are also

available. They are either top-loading or front-loading. For top-loading sterilizers,
where there may be difficulties in load handling and lifting and a hazard from
hot surfaces, the practical limit is 250 litres. Multiple free-standing sterilizers are
not normally cost-effective when used in centralised sterilizing facilities.

14.12 Transportable sterilizers, which generate steam from an internal

reservoir, may be appropriate for small laboratories.

Design considerations

14.13 A laboratory sterilizer may provide one or more operating cycles, each
designed for processing a particular type of load. The number and nature of the
operating cycles which can be supported by any particular machine will depend
on details of its design and construction. It will depend in particular on the
methods used to remove air from the chamber and load, the methods used for
cooling and drying the load and the provision of thermal door locks. Purchasers
should carefully consider which operating cycles they are likely to need in the
future, so that the manufacturer can install the necessary hardware. Otherwise it
may not be possible to add a new operating cycle to a sterilizer without
expensive modification. It is not merely a matter of “reprogramming.”

14.14 The following three considerations are crucial. The cycles themselves are
described in paragraphs 14.36-14.55.

Air removal

14.15 Laboratory sterilizers commonly employ one of two principles for

removing air from the chamber, each of which can be implemented in several
ways:

a. passive: steam comes in at the top of the chamber and air is forced out at
the bottom (downward displacement). This is the simpler (and cheaper)
method, but only suitable for loads such as sealed bottles which do not
impede the removal of air from the chamber. (In certain machines, notably
transportables, passive air removal may be by upward displacement.)

b. active: the chamber is subjected to successive pressure changes to draw

air from the chamber. This is required for loads such as fabrics, glassware
and other equipment where trapped air cannot reliably be removed by
passive methods. The more difficult air is to remove, the more pressure
 pulses will be required. Active air removal is always faster than passive
methods.

Cooling and drying

14.16 Where necessary, one of four cooling methods may be used:

a. natural: the load is allowed to cool naturally in the chamber until it

reaches a safe temperature. This is the cheapest option and acceptable if
lengthy cycle times are tolerable and the load is not likely to be damaged
by remaining hot for long periods;

b. dry assisted: either cold water is circulated through the jacket or through
cooling coils, or air is circulated through the chamber (with or without
pressure pulsing) to accelerate the cooling process. This is faster than
natural cooling;

c. wet assisted: the load is sprayed or deluged with coolant water. This is
faster than dry assisted cooling, therefore the method of choice for
products which cannot withstand long periods at high temperature, but is
only acceptable for loads such as sealed bottles where the coolant cannot
come into contact with the contents. It is not suitable for loads contained
in discard boxes;
d . vacuum: the chamber is evacuated to permit the remaining heat in the
load to evaporate moisture, simultaneously cooling and drying the load.
This is suitable for loads which trap moisture (in general these are the
same as the loads which trap air).

Thermal door locks

14.17 Laboratory sterilizers constructed to BS2646 will have one or two door
locks designed to prevent the door from being opened until the load cools to a
preset temperature:

a. all sterilizers will have an interlock that prevents the door from being
opened until the temperature of any fluid in the chamber and load
(including condensate) has fallen below the boiling point of water at local
atmospheric pressure (100°C at sea level);

b. sterilizers designed to process discard and fluid loads (cycles for make-safe
of discard in large containers, sterilization of culture media, and free
steaming) will have an additional interlock (a “thermal door lock”) to
ensure that the door cannot be opened until the temperature of fluid in
sealed containers has fallen below 80°C (see paragraph 14.26 for
additional specifications). Note that this requirement will considerably
lengthen the cycle time.

Standard specifications

14.18 Specification of laboratory sterilizers is covered by the various parts of

BS2646, ‘Autoclaves for sterilization in laboratories’, which has been radically
revised in recent years:

Part 1: 1993 - ‘Specification for design, construction and performance’;

Part 2: 1990 - ‘Guide to planning and installation’;
Part 3: 1993 - ‘Guide to safe use and operation’;
Part 4: 1991 - ‘Guide to maintenance’;
Part 5: 1993 - ‘Methods of test for function and performance’.
14.19 While BS2646 is a sound basic specification for laboratory sterilizers, the
UK Health Departments recommend additional specifications which are detailed
in paragraphs 14.23-14.34.

14.20 Laboratory sterilizers constructed in accordance with BS2646 will not be

suitable for processing material infected with Hazard Group 4 pathogens unless
provision is made to contain and sterilize all chamber effluents before disposal.
Such a sterilizer should not be operated without a full fault-and-effect analysis to
ensure that the containment remains secure if a failure occurs. The advice of the
Public Health Laboratory Service or the NHS in Scotland Management Executive
should be sought before specifying a sterilizer for a Containment Level 4
laboratory.

14.21 BS2646 does not cover culture media preparators. A UK Health

Departments specification for these is discussed in paragraph 14.56.

14.22 A European Standard on laboratory sterilizers is in preparation but is

unlikely to be published in the near future.

Additional specifications

14.23 The following specifications are additional to those required by BS2646:

Part 1. Purchasers should ensure that they are agreed with the manufacturer
before any contract is made.

Instruments and controls

14.24 BS2646: Part 1: 1993 requires only that sterilizers be fitted with a
chamber temperature indicator and a chamber pressure indicator. Laboratory
sterilizers for use in the NHS must have a temperature recorder and a pressure
recorder, complying with the requirements of 853970: Part 1.

14.25 A cycle counter complying with 853970: Part 1 will also be required.

Thermal door-lock override

14.26 Where the sterilizer is provided with a thermal door lock designed to
prevent the door being opened until the temperature of fluids in sealed
containers has fallen to 80°C (14.17b), a means should be provided to override
the lock during the cooling stage of the operating cycle. The override is intended
for use by trained persons who wish to gain access at temperatures above 80°C
to loads which will not present an explosive hazard.

14.27 The override should meet the following specifications:

a . the override switch is accessible only by means of a key, code or tool

unique to the sterilizer;

b. it operates only during the cooling stage of the cycle and causes the
cooling stage to terminate;

c. there is a visual indication that the override has been operated;

d. the switch resets automatically when released;

e . at the end of the cycle the door cannot be opened except by means of a
key, code or tool.

14.28 Where the sterilizer is intended to be used exclusively for the make-safe
of discard in small containers, compliance with paragraphs 14.27d and 14.27e
may be waived with the agreement of the laboratory safety officer. In this case,
the switch should reset automatically whenever a different operating cycle is
selected or whenever the power supply is interrupted.

Load-temperature probe
14.29 Where the sterilizer is to be used with cycles other than the make-safe
of discard, a load-temperature probe should be provided within the chamber.
This is a temperature sensor attached to a flex and designed to be inserted into
load items (such as bottles) to monitor the temperature during an operating
cycle. The reading is displayed on a temperature recorder as described in
paragraph 14.24. Means should be provided to stow the probe in a safe position
within the chamber when it is not in use.

Steam generators
14.30 Where steam is supplied from a generator within the sterilizer (Types 2
and 3 of BS2646: Part 1: 1993), condensate from the steam which comes into
contact with any discard load should not be returned to the boiler.

14.31 Where the sterilizer chamber is used as a water reservoir (Type 4), the
water should enter the chamber after the start of the cycle and be drained
before the end of the cycle.

14.32 Reservoirs may accumulate solidified agar and should de designed so

that they can be cleaned easily.

Chamber drain

14.33 The chamber drain should be designed to minimise the risk of its
becoming blocked with solidified agar or similar material.

14.34 Where the temperature of the effluent is high, for example for free
steaming, means should be provided to prevent vapour being discharged into
the plantroom or the loading area. Further information on drainage may be
found in Chapter 6.

Top-loading sterilizers
14.35 Top-loading sterilizers are difficult to load safely without the use of
mechanical aids. Loading systems should be designed to protect the operator
from the risk of injury caused by lifting and hot surfaces and should comply with
the requirements of the Manual Handling Operations Regulations 1992 (see
Chapter 4 and Part 1 of this HTM).

Operating cycles

14.36 BS2646 recognises only three distinct operating cycles which it denotes
as make-safe, liquids sterilization, and equipment and glassware sterilization. The
range of operating cycles recommended for NHS use, and the materials they are
designed to process, are described below and specified in Table 12. Where the
table gives a choice of sterilization temperatures, the highest temperature should
normally be specified. The performance class listed for each cycle is explained in
Table 5. If heat-sensitive loads are likely to be processed, then additional lower-
temperature cycles may be required. The complete set of cycles to be provided
on each machine, including any non-standard cycles not shown here, should be
agreed with the manufacturer before the contract is placed.
Table 12 Operating cycles for laboratory sterilizers

Name of Thermal Air- Cooling Sterilization Typical

operating cycle door lock removal and drying temperature performance
(80°C) method method [°C]a class b

Make-safe of Yes Active None 134 5

small plastic 126 6
discard 121 6
Passive None 134 9
126 9
121 9
Make-safe of Yes Passive Natural 134 12
contained fluid 126 12
discard 121 12
Dry 134 9
assisted 126 9
121 9

Sterilization of Yes Passive Natural 121 12

culture media 115 12
(pre-set cycle)
Dry 121 8
assisted 115 9
Wet 121 5
assisted 115 6

Sterilization of Yes Passive Dry 102-134 10

culture media assisted
(variable cycle)
Disinfection of No Active None 134 3
fabrics 126 4
121 5

Sterilization of No Active Vacuum 134 3

glassware and 126 3
equipment 121 4
Passive None 134 4
126 5
121 6

Free steaming Yes Passive Dry 102-104 10

(variable cycle) assisted

These are the most common combinations for operating cycles. Others are
possible.
a
See Table 4 for full sterilization conditions.
b
See Table 5 for definitions of performance classes.

14.37 Operating cycles are normally automatic and preset and cannot be
adjusted by the operator. For some processes, however, such as the sterilization
of culture media and free steaming, it may be desirable to have a variable cycle
with controls for adjusting the sterilization temperature and holding time within
a preset range. This feature should normally be provided as a separate cycle.
Make-safe of small plastic discard

14.38 This cycle corresponds to the “make-safe” cycle specified in BS2646. It is

designed to sterilize infected material held in plastic containers not exceeding
50 ml. Examples of such containers include Petri dishes, specimen bottles and
other small plastic items intended either for disposal or for reuse.

14.39 Although the containers would normally be unsealed, the limits on

volume ensure that any fluid held in a sealed container does not present an
explosion hazard when the door is opened at the end of the cycle. Glass
containers and larger plastic containers should be processed with the make-safe
cycle for contained fluid discard (paragraph 14.42).

14.40 If the workload is heavy, an active air removal system (paragraph

14.15b) is recommended to shorten the cycle time.

14.41 Discard boxes as specified in paragraph 14.60 will be required.

Make-safe of contained fluid discard

14.42 This cycle is a variant of the “liquids sterilization” cycle specified in
BS2646. It is designed to make-safe infected material in sealed glass containers
of any size or sealed plastic containers of volume greater than 50 ml.

14.43 While essentially the same as the culture media cycle (paragraph 14.45),
a sterilization temperature of 126°C is normally used to protect the glass. Lower
sterilization temperatures should only be used if plastic containers are to be
processed.

14.44 Discard boxes as specified in paragraph 14.60 will be required.

Sterilization of culture media

14.45 This cycle is a variant of the “liquids sterilization” cycle specified in

BS2646. It is designed to sterilize culture media in open or sealed containers.

14.46 Since culture media are normally damaged by sterilization at 134°C the
maximum sterilization temperature is set at 121°C.

14.47 A variable cycle, in which combinations of sterilization temperature and

holding time can be set by the operator, may be desirable for certain products
and, if required, should be specified as a separate cycle.

14.48 The culture media cycle is also suitable for disinfecting unwrapped
equipment such as tubing sets.

Disinfection of fabrics

14.49 This cycle is a variant of the “glassware and equipment” cycle specified
in BS2646. It is designed to disinfect (but not sterilize) fabric materials such as
towels, clothing, wrapped animal bedding, and other porous materials.

14.50 If the fabrics are required to be sterile and dry at the end of the cycle, a
machine complying with the performance requirements for a clinical porous-load
sterilizer will be necessary (see Chapter 8).

14.51 The cycle differs from the glassware and equipment cycle (14.53) in that
more pressure pulses will be required to remove air from the load.
14.52 The fabrics cycle is also suitable for sterilizing empty glassware
without caps and for disinfecting wrapped tubing and wrapped filters (see
paragraph 14.54).

Sterilization of glassware and equipment

14.53 This cycle corresponds to the “glassware and equipment” cycle specified
in BS2646. It is designed to sterilize clean, empty glassware (without caps) and
equipment such as tubing and filters. Loads must not contain any fluids.

14.54 Some microbiological filter membranes may be damaged by the rapid

fluctuations in pressure used by an active air-removal system, and it may be
necessary to provide a separate filter cycle.

Free steaming
14.55 This cycle is not specified in BS2646. It is designed to melt solidified agar
by exposing it to steam near atmospheric pressure. It is normally a variable cycle.
If the workload is heavy, this will not be a cost-effective way of using a sterilizer
and a Koch steamer may be more suitable .

Culture media preparators

14.56 Many of the problems which relate to sterilizing culture media can be
solved by the use of small sterilizers in which the media constituents are placed
directly into the chamber, thus avoiding the use of glass containers and their
attendant hazards. Since these small machines have a unique function, their
design is specialised in comparison with other laboratory sterilizers and BS2646
is not applicable.

14.57 A culture media preparator consists of two or three modules

incorporated into a system designed to provide controlled preparation,
sterilization, cooling and dispensing of culture media with a minimum of
attention by the operator. The system may also include a module which
automatically stacks the completed culture plates.

14.58 The sterilizer module consists of a pressure vessel which contains the
medium, surrounded by a jacket (which may itself be a pressure vessel)
containing a heat transfer fluid (usually water) or separate heating elements and
coils. Throughout the preparation and sterilizing part of the process heat is
transmitted from the jacket to the culture medium to attain a controlled
temperature between 80°C and 130°C in order to dissolve the constituents and
sterilize the resultant culture medium. After a predetermined time at the
sterilization temperature the medium is rapidly cooled to a controlled dispensing
temperature between 40°C and 60°C. Cooling is usually achieved by circulating
cold water. Provision is also made for adding solutions to the sterilized cooled
medium before possible reheating, cooling and final dispensing.

14.59 The sterilizer module of these systems should conform with the UK
Health Departments’ specifications set out in ‘Performance and safety
specification for culture media sterilizers’ (STB 3A/85/12) with the following
modifications:

a . both inner and outer vessels must have a pressure relief valve; these must
be dedicated safety valves set to prevent the vessel being over-pressurised
and not have any other function. They must be positioned so that in the
event of the valves operating the discharge will not be expelled into the
immediate working area;
 b . port covers should be made of a material, such as stainless steel, which
will not distort under normal operating conditions.

Discard boxes
14.60 When a sterilizer intended for use with make-safe cycles is purchased,
suitable boxes will need to be specified for receiving discard material,
transporting it from the laboratory bench to the sterilizer, and containing the
load during the sterilization process. Enough boxes to load the chamber fully
should be provided.

14.61 The sterilizer manufacturer will have used a certain type of discard box
in determining the cycle time. If other types are used for routine production, the
cycle time may differ considerably.

14.62 The design of the box can greatly affect the overall cycle time, varying
between 45 minutes and two hours when the process incorporates an active air-
removal system, and between two and six hours for processes based on passive
displacement. Figure 3 illustrates a typical commercially available discard box.

14.63 The box should be designed to facilitate the removal of air from the load
and the penetration of steam into the load.

14.64 The box material should be impervious, conduct heat well, be robust,
resistant to puncturing, easily cleanable and able to withstand the sterilization
process without damage. Stainless steel, aluminium and plastic are the most
common materials:

a. stainless steel, preferably coated with polytetrafluoroethylene (PTFE), is the

material of choice. Its principal advantages are resistance to distortion at
sterilization temperatures, good heat transfer and “non-stick” properties;

b . aluminium is lighter than other metals but is prone to metal fatigue and
cracking, and so has a shorter life expectancy;

c . plastic boxes are cheaper than those made of metal but conduct heat
poorly, increasing energy consumption and lengthening cycle times. Where
inserts are used to segregate solid from liquid discard, a plastic box may
distort and prevent the discard or insert from being withdrawn.

14.65 Where small discard is to be made safe, the box should contain a trivet
to support the load before sterilization and allow any liquids to drain to the
bottom of the box during the cycle. This will make it easier to separate solid and
liquid residues for disposal.

14.66 Discard should be enclosed when the box is being moved. Loose-fitting
lids are satisfactory for transport within a laboratory. Alternatively, the discard
material may be placed in a discard bag (see paragraph 14.67) inside an open
box, providing the neck of the bag is closed. Whenever discard material is
transported outside the laboratory suite, a sealed and locked lid should be fitted.
Where the lid can affect the efficacy of the sterilization process, it should be
opened or removed before the cycle begins and sterilized along with the box.

14.67 Bags, usually plastic, are available with identification markings for
discard material. The bags are often manufactured in a material which will melt
at 134°C to assist air removal. Discard bags should always be contained in a
discard box and opened wide before sterilization.
Glossary

The following list of definitions has been adopted in HTM 2010 and used in Part 2. Certain pressure terms have been
modified to comply with the requirements of EN 764. Paragraph references indicate where further information may be
found in Part 2. Cross references to other terms are shown in bold type. References in parentheses at the end of
definitions are to this part of HTM 2010.

absolute pressure pressure for which the zero value is associated with absolute vacuum.

aeration a part of the sterilization process during which sterilant gas and/or its
reaction products desorb from the load until predetermined levels are reached.
See degassing and flushing.

air detector a device used to determine that sufficient air or other non-condensable gases
have been removed from the chamber (8.7).

allowable pressure of a pressure vessel, a limit to the operating pressure specified for safety
reasons. See design pressure.

automatic controller a device that, in response to predetermined cycle variables, operates the
sterilizer sequentially through the required stages of the operating cycle.

batch process record (BPR) a permanent record of one or more cycle variables recorded during a
complete operating cycle by instruments fitted permanently to the sterilizer.

cartridge in EO sterilizers, a portable, single-use, simple vessel containing sterilant gas

under pressure from which the gas is delivered by puncturing the cartridge
(13.11).

chamber the part of the sterilizer in which the load is placed.

chamber exhaust ventilation (CEV) a ventilation system designed to extract gas from the chamber of an EO
sterilizer supplied from a cartridge (6.62).

chamber furniture shelves, pallets, loading trolleys and other fixed or movable parts that support
the load within the chamber.

chamber temperature the lowest temperature prevailing in the chamber.

clinical sterilizer a sterilizer designed to process medical devices or medicinal products to be

used in the clinical care of patients (3.2).

commissioning the process of obtaining and documenting evidence that equipment has been
provided and installed in accordance with the equipment specifications and that
it functions within predetermined limits when operated in accordance with the
operational instructions.

conditioning in EO sterilizers, the treatment of a load within the operating cycle, but prior
to sterilization, to attain a predetermined temperature and humidity
throughout the load.

contained fluid discard discard material held in sealed glass containers or sealed plastic containers of
volume greater than 50 ml ( see small plastic discard ) (14.42).
cooling stage the period of the operating cycle, after the holding time has been completed,
during which the load remains in the chamber while the load cools to a safe
temperature.

culture media preparator a specialised laboratory sterilizer designed for the sterilization and
dispensing of culture media (14.56).

cycle complete recognition by the automatic controller that the preset values for the cycle
variables, necessary for a successful operating cycle, have been attained and
that the sterilized load is ready for removal from the chamber.

cycle variables the physical properties, for example time, temperature, pressure, humidity and
gas concentration, that influence the efficacy of the operating cycle (3.17).

dedicated steam supply a supply of steam produced by a generator for the exclusive use of a sterilizer
or group of sterilizers.

degassing 1. in LTSF and EO sterilizers, an aeration procedure in which sterilant gas

and its reaction products are desorbed from the load by defined treatment
outside the sterilizer after completion of the operating cycle (12.15, 13.35).
2. a pre-heating treatment of boiler feed-water to reduce the amount of non-
condensable gases in the steam supply (7.33).

design pressure of a pressure vessel, the pressure chosen for the design calculations. See
operating pressure, allowable pressure.

discard laboratory material which is, or may be, infected by micro-organisms and is to
be made safe before disposal.

discard bag a bag, usually of plastic, designed to receive solid discard material before being
placed in a discard box for processing by a make-safe cycle (14.67).

discard box a box designed to contain discard material for processing by a make-safe cycle
(14.60).

disinfection a process used to reduce the number of viable micro-organisms in a load but
which may not necessarily inactivate some viruses and bacterial spores.

disinfector an apparatus designed to achieve disinfection.

double-ended sterilizer a sterilizer in which there is a door at each end of the chamber (14.10).

dry-heat sterilizer a clinical sterilizer designed to sterilize loads by exposure to hot dry air near
atmospheric pressure (Chapter 11).

dryness value a dimensionless quantity, approximating to the dryness fraction, derived to

determine whether steam is of the correct dryness for sterilization purposes.
A dryness value of 1.0 represents dry saturated steam (7.19).

EO sterilizer a clinical sterilizer designed to sterilize loads by exposure to ethylene oxide

gas or EO gas mixtures (Chapter 13).

equilibration time the period which elapses between the attainment of the sterilization
temperature in the chamber and the attainment of the sterilization
temperature in all parts of the load (3.20).

ethylene oxide (EO) sterilant gas used to sterilize items that would be damaged by exposure to heat
or moisture. Chemical formula CH2CH2O.
F0 a quantity, measured in minutes, used to determine the efficacy of an operating
cycle and equivalent to a continuous period at a temperature of 121°C (9.12).

fail-safe an attribute of sterilizer design whereby failure of any component or its

associated services does not create a safety hazard.

fault the recognition by the automatic controller that the preset cycle variables for
the operating cycle have not been attained and that sterilization or
disinfection has been jeopardised.

flash sterilizer a device designed to achieve sterilization by exposing the load to a very high
temperature steam for a few seconds (10.9).

fluid sterilizer a clinical sterilizer designed to sterilize fluids in sealed containers by exposure
to high-temperature steam under pressure (Chapter 9).

flushing in LTSF and EO sterilizers, an aeration procedure by which remaining

sterilant gas is removed from the load within the chamber by the passage of
air or other inert gas.

formaldehyde sterilant gas used in combination with low-temperature steam to sterilize

items that would be damaged by exposure to high-temperature steam.
Chemical formula HCHO. Also known as methanal.

formalin formaldehyde Solution BP. A 38% aqueous solution of formaldehyde stabilised

with 10% w/v ethanol, commonly used as the primary material for generating
formaldehyde gas.

free steaming a process, used in laboratory sterilizers, in which the load is exposed to steam
near atmospheric pressure (14.55).

free-standing of a sterilizer, installed in a room which is not separated into a plantroom and
a loading area (5.1 1).

full load a specified load, used in thermometric tests, to represent the maximum size and
mass of load which the sterilizer is designed to process.

gas exposure time in EO sterilizers, the time for which the chamber is maintained at the specified
temperature, gas concentration, pressure and humidity.

gauge pressure pressure equal to the difference between the absolute pressure and local
atmospheric pressure.

high-temperature steam steam at a temperature above the boiling point of water at local atmospheric
pressure.

holding time the period during which the temperature in all parts of the chamber, load and
any coolant fluid is held within the sterilization temperature band. It follows
immediately after the equilibration time (3.18).

hot-air sterilizer see dry-heat sterilizer.

indicated an indicated value is that shown by a dial or other visual display fitted
permanently to the sterilizer (see recorded and measured).

installation checks a series of checks performed by the contractor to establish that the sterilizer
has been provided and installed correctly, is safe to operate, does not interfere
with nearby equipment and that all connected services are satisfactory and do
not restrict the attainment of conditions for sterilization.
installation tests a series of tests performed by the contractor after the installation checks to
demonstrate that the sterilizer is working satisfactorily.

integral steam supply a supply of steam produced in a sterilizer chamber or in a generator directly
connected to it. The pressure in the sterilizer chamber is equal to that in the
generator (4.44).

Koch steamer a laboratory apparatus designed to expose a load to steam near atmospheric
pressure and commonly used for melting solidified agar.

laboratory sterilizer a sterilizer designed to sterilize, disinfect or make-safe laboratory materials

and equipment (Chapter 14).

load collectively, all the goods, equipment and materials that are put into a sterilizer
or disinfector at any one time for the purpose of processing it by an operating
cycle.

load item one of several discrete containers, packs or other units that together constitute a
load.

load-temperature probe a movable temperature sensor fitted within the sterilizer chamber and
designed to record the temperature inside selected load items (14.29).

loading area the room or area in front of the sterilizer in which the operator works and from
which the sterilizer is loaded and unloaded. It is commonly separated by a fascia
panel from the plantroom (5.5).

loading condition a specified combination of the nature and number of load items, the items of
chamber furniture, and their distribution within the chamber.

loading factor the average fraction of the usable chamber space occupied by a load during
normal operation (3.34).

local exhaust ventilation (LEV) a ventilation system designed to extract small amounts EO or formaldehyde
vapour released during normal operation of a sterilizer and its ancillary
equipment (6.54).

low-temperature steam (LTS) steam at a temperature below the boiling point of water at local atmospheric
pressure.

LTS disinfector a clinical disinfector designed to disinfect loads by exposure to low-

temperature steam at sub-atmospheric pressure (Chapter 12).

LTSF sterilizer a clinical sterilizer designed to sterilize loads by exposure to low-

temperature steam and formaldehyde gas at sub-atmospheric pressure
(Chapter 12).

mains steam supply the supply of steam produced for distribution to a range of steam-consuming
equipment by an independent common boiler (Chapter 7).

make-safe a process, used in laboratory sterilizers, to reduce the microbial content of

contaminated material so that it can be handled and disposed of without
causing an infection hazard or environmental contamination (14.38, 14.42).

master process record (MPR) a batch process record obtained from a thermometric commissioning or
performance qualification test and annotated to show the permitted
tolerances for cycle variables during subsequent testing and routine
production.
measured a measured value is that shown on a test instrument, such as a thermometric
recorder or a test pressure gauge, attached to the sterilizer for test purposes
(see indicated and recorded).

medical device any instrument, apparatus, appliance, material or other article, whether used
alone or in combination, including the software necessary for its proper
application, intended by the manufacturer to be used on human beings for the
purpose of: diagnosis, prevention, monitoring, treatment or alleviation of
disease; diagnosis, monitoring, treatment, alleviation or compensation for an
injury or handicap; investigation, replacement or modification of the anatomy or
of a physiological process; control of conception; and which does not achieve its
principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by
such means. (Source: EU Council Directive 93/42/EEC.) (1.12)

medicinal product any substance or combination of substances presented for treating or preventing
disease in human beings or animals. Any substance or combination of
substances which may be administered to human beings or animals with a view
to making a medical diagnosis or to restoring, correcting or modifying
physiological functions in human beings or in animals is likewise considered a
medicinal product. (Source: EU Council Directive 65/65/EEC.) (1.8)

module a standard unit of chamber size being a rectangular box measuring 300 x 300 x
600 mm of volume 54 litres (3.30).

non-condensable gases (NCGs) gases which cannot be liquefied by compression under the range of conditions
of temperature and pressure used during the operating cycle (7.28).

noted a noted value is that written down by the operator, usually as the result of
observing an indicated, recorded or measured value.

operating cycle the set of stages of the sterilization or disinfection process carried out in
sequence and regulated by the automatic controller. It is synonymous with the
terms “sterilization cycle” for sterilizers and “disinfection cycle” for
disinfectors.

operating pressure the pressure in the chamber during the plateau period of an operating cycle.
See allowable pressure, design pressure.

override a system by which the progress of the operating cycle can be interrupted or
modified as necessary.

performance class an integer, from 1 to 20, related to the total cycle time for a sterilizer with a
full load (3.27).

performance qualification (PQ) the process of obtaining and documenting evidence that the equipment, as
commissioned, will produce acceptable product when operated in accordance
with the process specification.

performance requalification (PRQ) the process of confirming that the evidence obtained during performance
qualification remains valid.

periodic tests a series of tests carried out at daily, weekly, quarterly and yearly intervals.

plantroom the room or area to the rear of the sterilizer in which services are connected
and which provides access for maintenance. It is commonly separated by a fascia
panel from the loading area (5.3).

plateau period the equilibration time plus the holding time (3.21).
porous-load sterilizer a clinical sterilizer designed to process, by exposure to high-temperature
steam under pressure, porous items such as towels, gowns and dressings, and
also medical devices that are wrapped in porous materials such as paper or
fabrics (Chapter 8).

preconditioning treatment of a load to attain predetermined conditions, such as temperature

and humidity, before the start of an operating cycle (13.21).

pressure ballasting a technique used in fluid sterilizers by which the pressure in the chamber is
maintained at or near to the pressure inside the load containers during all or
part of the operating cycle (9.4).

pressure vessel a collective term describing the sterilizer chamber, jacket (if fitted), door(s) and
components that are in permanent open connection with the chamber.

priming of a steam generator, the delivery of steam containing water in suspension due
to violent boiling or frothing (7.23).

pyrogen a bacterial toxin that causes a rise in body temperature and which is not
destroyed by steam sterilization (7.4).

recommissioning a procedure to confirm that operational data established during commissioning

remain valid.

recorded a recorded value is that shown on the output of a recording instrument fitted
permanently to the sterilizer (see indicated and measured).

revalidation a procedure to confirm an established validation, consisting of

recommissioning followed by performance requalification.

safety hazard a potentially detrimental effect on persons or the surroundings arising directly
from either the sterilizer or its load.

saturated steam steam whose temperature, at any given pressure, corresponds to that of the
vaporisation curve of water.

small load a specified load, used in thermometric tests, to represent the minimum size and
mass of load which the sterilizer is designed to process.

small plastic discard discard material comprising or held in plastic containers not exceeding 50 ml in
volume (14.38).

sterilant an agent used to effect sterilization, such as steam, hot air or a sterilizing gas
(3.4).

sterile condition of a load item that is free from viable micro-organisms. See EN 556
for the requirements for a medical device to be labelled “sterile”.

sterilization a process undertaken to render a load sterile.

sterilization conditions the ranges of the cycle variables which may prevail throughout the chamber
and load during the holding time (3.16).

sterilization process the complete set of procedures required for sterilization of a load, including
the operating cycle and any treatment of the load before or after the operating
cycle.

sterilization temperature minimum acceptable temperature of the sterilization temperature band

(3.24).
sterilization temperature band the range of temperatures which may prevail throughout the load during the
holding time. These temperatures are expressed as a minimum acceptable (the
sterilization temperature) and a maximum allowable and are stated to the
nearest degree Celsius (3.24).

sterilizer an apparatus designed to achieve sterilization.

superheated steam steam whose temperature, at any given pressure, is higher than that indicated
by the vaporisation curve of water (7.24).

thermal door lock an interlock fitted to certain sterilizers to prevent the door from being opened
until the temperature in the chamber and load falls below a preset value.

transportable requiring no permanent connections or installation and capable of being moved

manually without mechanical assistance. Synonymous with “bench-top”.

type tests a series of tests conducted by the manufacturer to establish the working data
for a sterilizer type.

usable chamber space the space inside the chamber which is not restricted by chamber furniture and
which is consequently available to accept the load (3.29).

utilisation factor the fraction of the open hours for which a sterilizer is available to process loads
(3.34).

validation a documented procedure for obtaining, recording and interpreting data required
to show that a sterilization process will consistently comply with
predetermined specifications.

works tests a series of tests to establish the efficacy of each sterilizer at the manufacturer’s
works.
Abbreviations

BPR batch process record LTMEL long-term maximum exposure limit

BS British Standard LTS low-temperature steam

°C degree Celsius LTSF low-temperature steam and formaldehyde

CEN European Committee for Standardization µm micrometre (micron, 10-6 m)

(Comité Européen de Normalisation) m metre
CEV chamber exhaust ventilation mbar millibar (10-3 bar)
COSHH Control of Substances Hazardous to Health MCA Medicines Control Agency
(Regulations)
MDA Medical Devices Agency
dBA decibel, A-weighted
mg milligram (10-3 g)
EMC electromagnetic compatibility
min minute
EN European Standard (Europäische Norm)
ml millilitre (10-3 l )
EO ethylene oxide
mm millimetre (10-3 m)
EU European Union (formerly European Community)
mmol millimole (10-3 mole)
GGMP EU ‘Guide to good manufacturing practice for
medicinal products’ MPR master process record

h hour NCG non-condensable gas

HBN Health Building Note PES programmable electronic system

HDN Hospital Design Note ppm parts per million

HSC Health and Safety Commission PQ performance qualification

HSE Health and Safety Executive PRQ performance requalification

HTM Health Technical Memorandum RH relative humidity

ISO International Organisation for Standardisation s second

kW kilowatt SSD sterile services department

l litre STMEL short-term maximum exposure limit

LEV local exhaust ventilation UK United Kingdom

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Part 1:1993 Specification for design, constructron, safety and performance.
Part 2:1990 Guide to planning and installation.
Part 3:1993 Guide to safe use and operation.
Part 4:1991 Guide to maintenance.
Part 5:1993 Methods of test for function and performance.

BS2648:1955 Performance requirements for electrically-heated laboratory drying

ovens (PD 2517, 6/56)

BS3928:1969 Method for sodium flame test for air filters (other than for air
supply to I.C. engines and compressors)
BS3970 Sterilizing and disinfecting equipment for medicinal products.
Part 1:1990 Specification for general requirements.
Part 2:1991 Specification for steam sterilizers for aqueous fluids in sealed rigid
containers.
Part 3:1990 Specification for steam sterilizers for wrapped goods and porous
loads.
Part 4:1990 Specification for transportable steam sterilizers for unwrapped
instruments and utensils.
Part 5:1990 Specification for low-temperature steam disinfectors.
Part 6:1993 Specification for sterilizers using low temperature steam with
formaldehyde.

BS5304:1988 British standard code of practice for safety of machinery.

BS7671:1992 Requirements for electrical installations. IEE Wiring Regulations.

Sixteenth edition.

BS EN IS0 9001:1994 Quality systems. Model for quality assurance in design,

development, production, installation and servicing.

BS EN IS0 9002:1994 Quality systems. Model for quality assurance in

production, installation and servicing.

EN 285 (Draft 92158124) Sterilization, steam sterilizers, large sterilizers

(draft standard)

EN 550:1994 Sterilization of medical devices. Validation and routine control of

sterilization by ethylene oxide.

EN 554:1994 Sterilization of medical devices. Validation and routine control of

sterilization by moist heat,

EN 566:1995 Sterilization of medical devices. Requirements for terminally

sterilized medical devices to be labelled ‘STERILE’.

EN 764:1995 Pressure equipment. Terminology and symbols: pressure,

temperature, volume.

EN 837-l (Draft 92132342) Bourdon tube pressure gauges: dimensions,

metrology, requirements and testing.

EN 1422 (Draft 94/505596) Sterilizers for medical purposes - ethylene oxide

sterilizers - specification.

EN 46001:1993 Particular requirements for the application of EN 29001 for

medical devices.

EN 46002:1994 The application of EN 29002 (BS5750 Part 1) to the

manufacture of medical devices.

EN 50081 Electromagnetic compatibility. Generic emission standard.

EN 50081-1:1992 Residential, commercial and light industry.
EN 50081-2:1994 Industrial environment.

EN 50082 Electromagnetic compatibility. Generic immunity standard.

EN 50082-1:1992 Residential, commercial and light industry.
EN 50082-2 (Draft 91/21828) Industrial environment.
EN 61010 Safety requirements for electrical equipment for measurement,
control and laboratory use.
EN 61010-1:1993 General requirements.
EN 61010-2-041 (Draft) Particular requirements for autoclaves and sterilizers
using steam for the treatment of medical materials
and for laboratory processes.
EN 61010-2-042 (Draft) Particular requirements for autoclaves and sterilizers
using toxic gas for the treatment of medical
materials and for laboratory processes.
EN 61010-2-043 (Draft) Particular requirements for autoclaves and sterilizers
using either hot air or hot inert gas for the treatment
of medical materials and for laboratory processes.

IS0 554:1976 Standard atmospheres for conditions and/or testing.

Other publications

Fire safety: approved document B, The Building Regulations 1991,

Department of the Environment and the Welsh Office, 1991.

Lighting guide: hospitals and healthcare buildings, Chartered Institution of

Building Services Engineers, 1989.

Sterilization and disinfection of heat-labile equipment, Central Sterilizing

Club, 1986.
Appendix 1
Useful addresses

UK health agencies

NHS Estates, 1 Trevelyan Square, Boar Lane, Leeds LS1 6AE. Tel. 0113-254 7000.

Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.
Tel. 0171-273 3000.

Medical Devices Agency, 14 Russell Square, London WC1 B 5EP. Tel. 0171-972
2000.

NHS in Scotland Management Executive, St Andrew’s House, Edinburgh EH1

3DG. Tel. 0131-556 8400.

Welsh Office, Cathays Park, Cardiff CF1 3NQ. Tel. 01222-825111.

Estate and Property Division, Estate Services Directorate, HPSS Management

Executive, Stoney Road, Dundonald, Belfast BT16 0US. Tel. 01232-520025.

Public Health Laboratory Service, Central Public Health Laboratory, 61 Colindale

Avenue, London NW9 5HT. Tel. 0181-200 4400.

Health and safety

Health and Safety Executive, Broad Lane, Sheffield S3 7HQ. Tel. 0114-289 2345,
fax 0114-289 2333. Addresses of area HSE offices may be found in the local
telephone directory.

Standards organisations

British Standards Institution

Head office: 2 Park Street, London W1A 2BS.
Publications: Linford Wood, Milton Keynes MK14 6LE. Tel. 01908-221 166.

European Committee for Standardization, Rue de Stassart 36, B-1050 Brussels

Other organisations

Association of Consulting Engineers, Alliance House, 12 Caxton Street, London

SW1 H 0QL. Tel. 0171-222 6557.

Institute of Hospital Engineering, 2 Abingdon House, Cumberland Business

Centre, Northumber land Road, Portsmouth PO5 1 DS. Tel. 01705-823186.

lnstitution of Electrical Engineers, Publication Sales Department, PO Box 26,

Hitchin, Hertsfordshire SG5 1SA. Tel. 01438-742792.

Institution of Mechanical Engineers, Publication Sales Department, PO Box 24,

Northgate Avenue, Bury St Edmunds, Suffolk IP32 6BW. Tel. 01284-763277.
Appendix 2
Information to be supplied by the
manufacturer
A2.1 T h e following information should be supplied by the manufacturer of the
sterilizer at or before the time the sterilizer is delivered.

Standards

A2.2 Statements of compliance with relevant British and European Standards

and documentary evidence to demonstrate such compliance.

Instruction manual

A2.3 The manual should contain complete instructions including:

a. simplified operating instructions in a durable form suitable for fixing next

to the sterilizer;

b. guidance on the types of load that may be processed in the sterilizer and
their recommended packaging;

c. operational limits including design pressure, maximum permissible working

pressure and maximum permissible working temperature.

Instruments and controls

A2.4 The manual should include a description of each instrument and control
fitted to the sterilizer including:

a . the scale ranges of each and the limits of accuracy;

b. evidence that the calibration of each instrument has been verified and that
the instrument is reading correctly within its stated limits of accuracy.

A2.5 Where an air detector is fitted, the manual should give:

a. the setting of the sensitivity of the air detector;

b. the level of the signal from the airdetector which will trigger
automatic controller to abort the cycle and indicate a fault;

c . the vacuum leak rate that will cause this level to be exceeded.

Operating cycles

A2.6 The manual should give a description of each operating cycle available on
the sterilizer specifying:

a. the sterilization temperatures available;

b . graphical representation of cycle variables (temperature, pressure, etc.) as a
function of elapsed time for each sterilization temperature;

c. the maximum rate of change for each cycle variable;

d . the range of variation of any adjustable, preset cycle variables;

 e. the cycle time and performance class for the thermometric tests for a full
load described in Part 3 of this HTM;

f . copies of the cycle records obtained during any type tests or works tests.

Services

A2.7 The manual should give a description of all the engineering services
required by the sterilizer, specifying:

a values o f the fluctuating demands placed on each service during the

course of a normal operating cycle;
b. the maximum and minimum safe supply pressures,temperatures and
voltages.

Safety

A2.8 Safety information should include:

a. descriptions of any safety hazards that may arise in the normal operation
of the sterilizer and recommended precautions to avoid them;
b. descriptions of all safety devices including their recommended settings and
any means provided to override and reset them.

Chamber

A2.9 Information about the chamber should include the following:

a. the total volume of the chamber;

b. the dimensions of the usable chamber space and its capacity expressed
both in litres and as an integral number of sterilization modules;
c . sufficient information to enable the user to identify, for an empty
chamber:
(i) the parts of the usable chamber space that are the fastest and the
slowest to attain the sterilization temperature;
(ii) the parts of the usable chamber space that are the hottest and the
coolest during the sterilization holding time;
(iii) for sterilizers with a thermal door lock, the part of the usable
chamber space that is the slowest to cool to a preset safe
temperature (normally 80°C).

Maintenance manual

A2.10 Two copies should be provided. It should include:

a. a planned preventative maintenance programme consistent with the
principles outlined in Part 4 of this HTM together with detailed instructions
for the procedures contained within it;

b. a list of any special tools and equipment required for periodic maintenance
and testing;
c. diagrams of all electrical, steam, compressed air, water and gas systems;
d . a complete list of spare parts, indicating all parts which should be held in
stock and that may require replacement during the normal working life of
the sterilizer together with their likely usage rates;

e. guidance on tracing and rectifying likely causes of malfunction;

f . procedures for door safety control checks together with the sequence of
operation;

g. method of calibrating the pressure, temperature and humidity indicating

and recording systems.
Other publications in this series

(Given below are details of all Health Technical Component Data Base (HTMs 54 to 80)
Memoranda available from HMSO. HTMs marked (*) are
54.1 User manual, 1993.
currently being revised, those marked (†) are out of print.
55 Windows, 1989.
Some HTMs in preparation at the time of publication of
56 Partitions, 1989.
this HTM are also listed.)
57 Internal glazing, 1995.
1 Anti-static precautions: rubber, plastics and 58 Internal doorsets, 1989.
fabrics† 59 lronmongery†
2 Anti-static precautions: flooring in anaesthetising 60 Ceilings, 1989.
areas (and data processing rooms), 1977. 61 Flooring*
3 - 62 Demountable storage systems, 1989.
4 - 63 Fitted storage systems, 1989.
5 Steam boiler plant instrumentation† 64 Sanitary assemblies*
6 Protection of condensate systems: filming amines† 65 Health signs*
2007 Electrical services: supply and distribution, 1993. 66 Cubicle curtain track, 1989.
8 - 67 Laboratory fitting-out system, 1993.
2009 Pneumatic air tube transport systems, 1995. 68 Ducts and panel assemblies, 1993.
2011 Emergency electrical services, 1993. 69 Protection, 1993.
12 - 70 Fixings, 1993.
13 - 71 Materials management modular system*
2014 Abatement of electrical interference, 1993. 72 to 80 -
2015 Bedhead services, 1994, 1995.
16 -
Firecode
17 Health building engineering installations:
commissioning and associated activities, 1978. 81 Firecode: fire precautions in new hospitals*
18 Facsimile telegraphy: possible applications in 81 supp 1 1993.
DGHs† 82 Firecode: alarm and detection systems, 1989.
19 Facsimile telegraphy: the transmission of pathology 83 Fire safety in healthcare premises: general fire
reports within a hospital - a case study† precautions, 1994.
2020 Electrical safety code for low voltage systems, 85 Firecode: fire precautions in existing hospitals,
1993. 1994.
2021 Electrical safety code for high voltage systems, 86 Firecode: fire risk assessment in existing hospitals,
1993, 1994. 1994.
2022 Medical gas pipeline systems, 1994. 87 Firecode: textiles and furniture, 1993.
2023 Access and accommodation for engineering 88 Fire safety in health care premises: guide to fire
services* precautions in NHS housing in the community for
2025 Ventilation in healthcare premises, 1994. mentally handicapped/ill people, 1986.
26 Commissioning of oil, gas and dual fired boilers:
with notes on design, operation and maintenance† New HTMs in preparation
2027 Hot and cold water supply, storage and mains
2024 Lifts
services, 1995.
2030 Washers for sterile production
28 to39 -
2040 The control of legionellae in healthcare premises -
Health Technical Memoranda published by HMSO can be
a code of practice, 1993.
purchased from HMSO bookshops in London (post orders
41 to49 -
to PO Box 276, SW8 5DT), Edinburgh, Belfast, Manchester,
2050 Risk assessment in the NHS estate, 1994.
Birmingham and Bristol, or through good booksellers.
51 to 53 -
HMSO provide a copy service for publications which are
2 0 5 5 Telecommunications (telephone exchanges), 1994.
out of print; and a standing order service.

Enquiries about Health Technical Memoranda (but not

orders) should be addressed to: NHS Estates, Department
of Health, Marketing Unit, 1 Trevelyan Square, Boar Lane,
Leeds LS1 6AE.
About NHS Estates

NHS Estates is an Executive Agency of the Department of Firecode - for policy, technical guidance and specialist
Health and is involved with all aspects of health estate aspects of fire precautions. HMSO
management, development and maintenance. The Agency
has a dynamic fund of knowledge which it has acquired Health Facilities Notes - debate current and topical
during 30 years of working in the field. Using this issues of concern across all areas of healthcare provision.
knowledge NHS Estates has developed products which are HMSO
unique in range and depth. These are described below.
NHS Estates also makes its experience available to the field Capital Investment Manual Database - software
through its consultancy services. support for managing the capital programme. Compatible
with the Capital Investment Manual. NHS Estates
Enquiries about NHS Estates should be addressed to:
NHS Estates, Marketing Unit, Department of Health,
Model Engineering Specifications - comprehensive
1 Trevelyan Square, Boar Lane, Leeds LS1 6AE.
advice used in briefing consultants, contractors and
Telephone 0113 254 7000.
suppliers of healthcare engineering services to meet
Departmental policy and best practice guidance.
NHS Estates
Some other NHS Estates products
Quarterly Briefing - gives a regular overview on the
Activity DataBase - a computerised system for defining
construction industry and an outlook on how this may
the activities which have to be accommodated in spaces
affect building projects in the health sector, in particular
within health buildings. NHS Estates
the impact on business prices. Also provides information
on new and revised cost allowances for health buildings.
Design Guides - complementary to Health Building
Published four times a year; available on subscription direct
Notes, Design Guides provide advice for planners and
from NHS Estates. NHS Estates
designers about subjects not appropriate to the Health
Building Notes series. HMSO
Works Guidance Index - an annual, fully cross-
Estatecode - user manual for managing a health estate. referenced index listing all NHS Estates publications and
Includes a recommended methodology for property other documents related to the construction and
appraisal and provides a basis for integration of the estate equipping of health buildings. NHS Estates
into corporate business planning. HMS0
Items noted “HMSO” can be purchased from HMSO
Concode - outlines proven methods of selecting contracts Bookshops in London (post orders to PO Box 276,
and commissioning consultants. Reflects official policy on SW8 5DT), Edinburgh, Belfast, Manchester,
contract procedures. HMSO Birmingham and Bristol or through good booksellers.

Works Information Management System -

a computerised information system for estate
management tasks, enabling tangible assets to be put into NHS Estates consultancy service
the context of servicing requirements. NHS Estates
Designed to meet a range of needs, from advice on the
Health Building Notes - advice for project teams oversight of estates management functions to a much
procuring new buildings and adapting or extending fuller collaboration for particularly innovative or exemplary
existing buildings. HMSO projects.

Health Guidance Notes - an occasional series of

publications which respond to changes in Department of Enquiries should be addressed to: NHS Estates,
Health policy or reflect changing NHS operational Consultancy Service (address as above).
management. Each deals with a specific topic and is
complementary to a related HTM. HMSO

Printed in the United Kingdom for HMSO

Dd300372 3/95 Cl4 G559 10170
 Health Technical
Memorandum 2010
Part 3 (Including Amendment 1): Validation and
verification

Sterilization

London: HMSO

An Executive Agency of the Department of Health

© Crown copyright 1994. Published with permission of NHS Estates,
an Executive Agency of the Department of Health,
on behalf of the Controller of Her Majesty’s Stationery Office.

Applications for reproduction should be made in writing to

The Copyright Unit, Her Majesty’s Stationery Office,
St Clements House, 2–16 Colegate, Norwich NR3 1BQ.

First published 1994

Second impression 1995 (with amendments)
Reprinted 1998

ISBN 0-11-321746-3

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ii
About this publication

Health Technical Memoranda (HTMs) • Part 2 - Design considerations -

give comprehensive advice and guidance contains information relevant to the
on the design, installation and operation specification and installation of new
of specialised building and engineering sterilizing equipment. It discusses the
technology used in the delivery of requirements for each type of
healthcare. sterilizer and outlines the
specifications to be included in any
They are applicable to new and existing contract. Practical considerations for
sites, and are for use at various stages the installation of sterilizers are
during the inception, design, discussed, including siting, heat
construction, refurbishment and emission, ventilation, noise and
maintenance of a building. vibration, and mains services with an
emphasis on steam quality;

• Part 3 - Validation and

Health Technical Memorandum 2010 verification - covers all aspects of
HTM 2010 is being published in five validation and periodic testing of
parts: sterilizers. It includes detailed
schedules and procedures for tests
• Part 1 - Management policy - is a and checks to be carried out for
summary of the information required commissioning and performance
by non-technical personnel qualification, and for subsequent
responsible for the management of periodic testing;
sterilization services. It discusses the
various types of sterilizer, for both • Part 4 - Operational management
clinical and laboratory use, and also - covers all aspects of the routine
contains guidance on legal and operation and maintenance of
policy matters, and on the sterilizers, stressing the need for a
appointment and responsibilities of planned maintenance programme
personnel. It should be read by along with the type of records to be
anyone consulting this memorandum kept. Advice on the safe and efficient
for the first time; operation of sterilizers is given, as
 well as procedures for reporting b. the Health and Personal Social
defects and accidents; Services Management Executive in
Northern Ireland;
• Part 5 - Good practice guide -
provides advice on the fatigue life of C. the National Health Service in
pressure vessels, operational Scotland Management Executive.
procedures guidance on the control
of strategies, and use of the
References to legislation appearing in
supplementary publications (log
the main text of this guidance apply to
books etc). It also includes a
the United Kingdom as a whole, except
comprehensive bibliography.
where marginal notes indicate variations
for Scotland or Northern Ireland. Where
The contents of this HTM in terms of
appropriate, marginal notes are also
management policy and operational
used to amplify the text.
policy are endorsed by:

a. the Welsh Office for the NHS in

Wales;
Contents

About this publication 6. Test equipment page 33

6.1 Introduction
6.4 Calibration and sources of error
Preface page 3 6.8 Recorders
6.19 Temperature measurement
1. Introduction page 5 6.19 Temperature sensors
1.1 General 6.25 Use of sensors
1.4 European Standards 6.32 Verification of calibration
1.9 Personnel 6.40 Pressure measurement
1.26 Safety 6.41 Transducers
1.27 Infectious materials 6.42 Gauges
1.28 Gaseous sterilants 6.47 Humidity measurement
6.51 Other instruments
2. Testing of sterilizers page 9 6.51 Sound level meter
2.1 Introduction 6.52 Air flow metering device
2.7 Responsibilities for validation 6.53 Balance
2.8 Purchaser 6.54 Gas monitoring instrument
2.11 Manufacturer 6.58 Aerosol generator
2.12 Contractor 6.60 Photometer
2.14 The validation process
2.15 Commissioning 7. Testing methods page 43
2.17 Installation checks 7.1 Introduction
2.20 Installation tests 7.2 Terminology
2.23 Commissioning tests 7.3 Cycle variables
2.25 Performance qualification 7.8 Sterilization conditions
2.29 Documentation 7.15 Interpretation of thermometric measurements
2.30 Summary sheets 7.21 Chamber temperature profile
2.32 Validation report 7.27 Standard test pack
2.36 Periodic tests 7.36 Use of chemical indicators
2.39 Revalidation 7.43 Use of biological indicators
2.41 Repeat validation 7.48 Specifications
2.43 Types of test 7.51 Line-Pickerell helix
2.48 Procedure on failure of a test 7.54 Preparation of recovery medium
7.63 General procedure for microbiological
3. Schedule of installation checks page 16 tests
3.1 Introduction
3.5 Checks on ancillary equipment 8. Performance qualification page 54
3.6 Engineering services 8.1 Introduction
3.7 Additional checks for LTSF and EO 8.7 Loading conditions and reference loads
sterilizers 8.13 Thermometric test for performance qualification
3.11 Additional checks for EO sterilizers 8.29 Microbiological test for performance qualification
3.13 Checks on the sterilizer 8.37 Environmental gas test
3.14 Preliminary checks 8.46 Test for degassing time
3.16 Functional checks 8.47 Permitted tolerances
3.18 Response to external faults 8.54 PQ report
8.58 Preparation of a master process record
4. Schedule of validation tests page 20 8.64 Tests for performance requalification
4.1 Introduction
9. Steam quality tests page 65
5. Schedule of periodic tests page 26 9.1 Introduction
5.1 Introduction 9.4 Non-condensable gas test
5.7 Weekly safety checks 9.20 Superheat test
5.8 Yearly safety checks 9.30 Dryness test
10. Sound pressure test page 71 17. LTS disinfectors and LTSF sterilizers page 104
10.1 Introduction 17.1 Introduction
10.4 Test procedure 17.4 Chamber overheat cut-out test
17.10 Chamber wall temperature test
11. Chamber integrity tests page 74 17.15 Thermometric test for a small load
11.1 Introduction 17.23 Thermometric test for a full load
11.2 Vacuum leak test 17.32 Environmental formaldehyde vapour test
11.19 Vacuum leak monitor test 17.40 Microbiological test for basic performance
11.24 Pressure leak test 17.50 Microbiological test for performance qualification
11.37 Air detector tests 17.58 Routine microbiological test
11.45 Performance test for a small load
11.53 Performance test for a full load 18. Ethylene oxide sterilizers page 112
11.60 Function test 18.1 Introduction
18.4 Chamber overheat cut-out test
12. Automatic control test page 82 18.11 Chamber space temperature test
12.1 lntroduction 18.16 Chamber wall temperature test
12.3 Test procedure 18.20 Microbiological test for gas exposure time
18.30 Microbiological test for basic performance
13. Porous load sterilizers page 84 18.36 Thermometric test for performance qualification
13.1 Introduction 18.49 Microbiological test for performance qualification
13.3 Chamber wall temperature test 18.58 Routine microbiological test
13.7 Thermometric test for a small load
13.15 Thermometric test for a full load 19. Laboratory sterilizers page 121
13.25 Load dryness test 19.1 Introduction
13.37 Hospital load dryness check 19.4 Make-safe of small plastic discard
13.39 Bowie-Dick test for steam penetration 19.7 Thermometric test for a full load
13.41 Principle of the test 19.16 Thermometric test for a small load
13.45 Test procedure 19.20 Cycles for fluid loads
19.24 Thermometric test for a full load
14. Fluid sterilizers page 91 19.37 Thermometric test for a small load
14.1 Introduction 19.46 Simplified thermometric test for
14.4 Heat exchanger integrity test performance requalification
14.10 Thermometric test for a full load 19.51 Sterilization of glassware and equipment
14.21 Thermometric test for a small load 19.52 Thermometric test for a full load
14.27 Simplified thermometric test for performance 19.61 Thermometric test for a small load
requalification 19.64 Thermal door-lock override test
14.32 Coolant quality test 19.70 Culture media preparator
19.71 Thermometric test for a full load
15. Sterilizers for unwrapped instruments and 19.78 Reheat and dispensing test
utensils page 96
15.1 Introduction Glossary page 129
15.3 Chamber overheat cut-out test
15.7 Thermometric test for a small load Abbreviations page 135
15.13 Thermometric test for a full load
Bibliography page 136
16. Dry-heat sterilizers page 99
16.1 Introduction Appendix 1 - Useful addresses page 139
16.4 Automatic control test
16.8 Chamber overheat cut-out test Appendix 2 - Calculations page 141
16.13 Air filter integrity test
16.22 Thermometric test for performance qualification Appendix 3 - Summary sheets page 144
16.26 Simplified thermometric test for performance
requalification Other publications in this series page 180
16.33 Thermometric test for a full load
About NHS Estates page 181
 Preface

HTM 2010 gives guidance on the choice, specification, purchase, installation,

validation, periodic testing, operation and maintenance of the following types of
sterilizer in use in the National Health Service:

a. clinical sterilizers:
(i) high-temperature steam sterilizers used for processing porous loads
(including instruments and utensils wrapped in porous materials);
(ii) high-temperature steam sterilizers used for processing aqueous
fluids in sealed containers;
(iii) high-temperature steam sterilizers used for processing unwrapped
solid instruments and utensils;
(iv) dry-heat sterilizers (hot-air sterilizers);
In Scotland, LTSF sterilizers are (v) low-temperature steam (LTS) disinfectors and low-temperature
considered to be disinfectors. steam and formaldehyde (LTSF) sterilizers;
(vi) ethylene oxide (EO) sterilizers;
b. laboratory sterilizers:
(i) high-temperature steam sterilizers used with one or more
specialised operating cycles;
(ii) culture media preparators

Sterilization by irradiation is not covered.

This HTM is intended primarily as a guide for technical personnel, whether

specialists in sterilizers and sterilization procedures or those responsible for
maintenance and testing. It is also intended for those responsible for the day-to-
day running of sterilizers, and will also be of interest to supplies officers,
architects, estates managers and others in both the public and private sectors.

Scottish Health Planning Note 13, Detailed information on the planning and design of a sterile services
‘Sterile services department’, applies department, including the level of provision of sterilizers, is given in Health
in Scotland. Building Note 13 - ‘Sterile services department’. Guidance for laboratory
installations can be found in Health Building Note 15 - ‘Accommodation for
pathology services’.

Although this edition of HTM 2010 reflects established sterilizer technology, it is

recognized that considerable scope exists for the utilisation of emerging
technology in the management of sterilizers. This will be kept under review with
the aim of introducing recommendations for such technology at the earliest
opportunity so that the procedures essential for the efficient, safe and effective
operation of sterilizers can be optimised.

Most of the British Standards for sterilizers which were applicable at the time of
the last edition of this HTM, in 1980, have been either withdrawn or radically
revised. Some of them, in turn, are now being replaced by European Standards
which will be published during the currency of this edition of HTM 2010. Some
of these European Standards support new European Union (EU) Directives on
medical devices which will have a major impact on sterilization. Where
practicable the information in this HTM has been aligned with existing or
anticipated standards, and advice is offered where no standard has yet been
formulated.
The sterilizers described in this HTM may not be suitable, without modification, Information about Hazard Groups
for safely processing articles infected with Hazard Group 4 pathogens nor may be found in the HSC document
agents, such as those associated with transmissible spongiform ‘Categorisation of pathogens
encephalopathies, which are unusually resistant to sterilization. Design according to hazard and categories
considerations for sterilizers intended to process articles infected with such of containment’ (second edition,
organisms are discussed in Part 2. 1990) compiled by the Advisory
Committee on Dangerous
Pathogens.
1.0 Introduction

General

1.1 This part of HTM 2010 covers the validation and periodic testing of the
various sterilization processes used in hospitals, laboratories and other healthcare
facilities.

1.2 Terminology used in sterilization has long been inconsistent and

occasionally ambiguous. This HTM introduces a set of terms consistent with new
European Standards (see paragraph 1.4) which, it is hoped, will in time be
adopted by sterilization workers in the NHS. The Glossary contains definitions
referred to in this part. A fuller list of terms will be found in Part 5, ‘Good
practice guide’.

1.3 The Bibliography contains full references for all the documents referred to
in this part and for selected documents of which the reader should be aware.
A fuller list of references relevant to sterilization will be found in Part 5.

European Standards

1.4 Part 1 of this HTM discusses the three European Union Directives on the
manufacture and supply of medical devices, active implantable medical devices
and in-vitro diagnostic medical devices, which are being implemented in the UK
in stages from 1993 onwards. The Directives do not cover sterilization of
medicinal products, as this is governed by other legislation (see Part 1).

1.5 To support the Directives, the European Committee for Standardisation

(Comité Européen de Normalisation, CEN) has prepared draft European
Standards on operational procedures for different methods of sterilization of
medical devices. Compliance with the relevant standard is considered to be a
legal presumption of compliance with the sterilization requirements of the
Directive it supports. The standards require that persons responsible for
sterilization operate a quality system and that part of that system is validation
and routine testing of the process.

1.6 The following European Standards on the validation and routine control of
sterilization processes are relevant to this part of HTM 2010:

a. EN 550 covers ethylene oxide sterilization;

b. EN 554 covers all “moist heat” sterilization. This includes porous load and
fluid sterilizers (except where used for medicinal products), and sterilizers
for unwrapped instruments and utensils;

c. EN 556 sets out the requirements for medical devices to be labelled

“sterile”.

1.7 There are no European Standards, as yet, on the use of dry-heat sterilizers,
low-temperature steam disinfectors, low-temperature steam and formaldehyde
sterilizers or laboratory sterilizers. A complete list of European Standards specific
to sterilization is given in the Bibliography.

1.8 This edition of HTM 2010 has been written while the new standards are in
the course of development. While the guidance given here is designed to be
broadly consistent with the emerging standards, HTM 2010 should not be
regarded as a substitute for the standards themselves when ascertaining
compliance with EU Directives or the UK Regulations that implement them.

Personnel

1.9 The following personnel are referred to in this part of HTM 2010. Further
Information, including qualifications and areas of responsibility, can be found in
Part 1.

1.10 Management is defined as the owner, occupier, employer, general

manager, chief executive or other person of similar authority who is ultimately
accountable for the sole operation of the premises.

1.11 Depending on the nature of the organisation, this role may be filled by
the general manager, chief executive, laboratory director or other person of
similar authority. In small, autonomous installations the user may take on this
function.

1.12 The user is defined as the person designated by the executive manager
to be responsible for the management of the sterilizer.

1.13 In a hospital the user could be a sterile services department manager,

laboratory manager or theatre manager; in primary care he or she could be a
general practitioner, dentist, or other health professional. Where a sterilizer is
used to process medicinal products, the user is normally the production manager
(see paragraph 1.20) in charge of the entire manufacturing process.

1.14 The competent person (pressure vessels) is defined as a person or The Pressure Systems and
organisation designated by management to exercise certain legal responsibilities Transportable Gas Containers
with regard to the written scheme of examination of any pressure vessel Regulations (Northern Ireland) 1991
associated with a sterilizer described In the Pressure Systems and Transportable apply in Northern Ireland.
Gas Containers Regulations 1989 (see Part 1). The shorter term “competent
person” is used in this HTM.

1.15 The authorised person (sterilizers) is defined as a person designated by

management to provide independent auditing and advice on sterilizers and
sterilization and to review and witness documentation on validation. The shorter
term “authorised person” is used in this HTM.

1.16 A list of suitably qualified authorised persons (sterilizers) is maintained by

the Institution of Hospital Engineering (see Appendix 1).

1.17 The test person (sterilizers) is defined as a person designated by the

executive manager to carry out validation and periodic testing of sterilizers, The
shorter term “test person” is used in this HTM.

1.18 The maintenance person (sterilizers) is defined as a person designated

by the executive manager to carry out maintenance duties on sterilizers. The
shorter term “maintenance person” is used in this HTM.

1.19 The microbiologist (sterilizers) is defined as a person designated by the

executive manager to be responsible for advising the user on microbiological
aspects of the sterilization of non-medicinal products. The shorter term
“microbiologist” is used in this HTM.

1.20 The production manager IS defined as a person designated by the

executive manager to be responsible for the production of medicinal products.
 1.21 The quality controller is defined as a person designated by the executive
manager to be responsible for quality control of medicinal products with
authority to establish, verify and implement all quality control and quality
assurance procedures.

1.22 The laboratory safety officer is defined as a person designated by the

executive manager to be responsible for all aspects of laboratory safety including
equipment, personnel and training relating to safety Issues, and ensuring
compliance with safety legislation and guidelines.

1.23 An operator is defined as any person with the authority to operate a

sterilizer, including the noting of sterilizer instrument readings and simple
housekeeping duties.

1.24 The manufacturer is defined as a person or organisation responsible for

the manufacture of a sterilizer.

1.25 The contractor is defined as a person or organisation designated by the

executive manager to be responsible for the supply and installation of the
sterilizer, and for the conduct of the installation checks and tests. The contractor
is commonly the manufacturer of the sterilizer.

Safety

1.26 Extensive guidance on the safe operation of the various types of sterilizer
is given in Part 4, ‘Operational management’. As far as testing is concerned,
normal safety precautions are adequate except in the case of sterilizers used to
process infectious materials, and sterilizers using gaseous sterilants, as described
below. Users are recommended to operate a permit-to-work system to ensure
that such sterilizers are declared safe to work on, and that personnel working on
them have documented authority to do so.

Infectious materials

1.27 All sterilizers have the potential to process infectious materials, but
attention is drawn to certain laboratory sterilizers with cycles expressly designed
for the routine making-safe of discard material that is or may be contaminated
with pathogenic micro-organisms. Note also that laboratory sterilizers without a
make-safe cycle may be occasionally used to process infected material in the
event of the designated machine being out of service. The user should therefore
ensure that personnel working on laboratory sterilizers wear appropriate
protective clothing and are fully informed of any hazards that may be present.
Further guidance may be found in the HSC document ‘Safe working and the
prevention of infection in clinical laboratories: model rules for staff and visitors’,
compiled by the Health Services Advisory Committee.

Gaseous sterilants

The Control of Substances Hazardous 1.28 Low-temperature steam and formaldehyde (LTSF) sterilizers and ethylene
to Health Regulations (Northern oxide (EO) sterilizers both use toxic gases in the sterilization process.
Ireland) 1990 apply in Northern Occupational exposure to formaldehyde and EO is controlled by the Control of
Ireland. Substances Hazardous to Health (COSHH) Regulations (see Part 1). Maximum
exposure limits are set out in the annual Guidance Note EH40, ‘Occupational
exposure limits’, published by the Health and Safety Executive (HSE) (see
Bibliography). At the time of writing (1994) the limits are as shown in Table 1.
These limits are statutory maxima but should not be regarded as representing a
safe working exposure; employers have a legal obligation to ensure that the level
of exposure is reduced so far as is reasonably practicable and in any case below
the maximum exposure limit.
 Short-term exposure limit Long-term exposure limit
Gas [ppm] [mg m -3] [ppm] [mg m -3]

Formaldehyde 2 2.5 2 2.5

Ethylene oxide 15 30.0 5 10.0
The short-term exposure limit (STEL) IS the average exposure over any 15-minute period.
The long-term exposure limit (LTEL) is the exposure over any 24-hour period expressed as a
single uniform exposure over an 8-hour period.
COSHH does not specify a STEL for EO. In such cases the STEL is deemed to be three times
the LTEL in accordance with the recommendations of the Health and Safety Executive.

(Source: HSE Guidance Note EH40 (1994))

Table 1 Maximum exposure limits for atmospheric formaldehyde and ethylene oxide

1.29 Certain tests in this document require that the sterilant gases be replaced
with a suitable non-hazardous substitute:

a. for LTSF sterilizers, the primary material for generating formaldehyde

(usually formalin) should be replaced with water;

b. for EO sterilizers where the gas is supplied from cylinders, the sterilant gas
should be replaced with a suitable non-toxic, non-flammable gas or gas
mixture admitted to the chamber through the EO supply system (including
the vaporiser). Air may be used if the system is known to be free of
residual traces of EO sufficient to cause an explosive or fire hazard (see
paragraph 6.54 for a specification for a suitable monitoring instrument),
but nitrogen is recommended as being safe in all circumstances;

c. for EO sterilizers where the gas is supplied from cartridges contained

within the chamber, no substitute is normally necessary because of the
small amounts of EO present in the system. If a substitute is thought to be
desirable, nitrogen cartridges may be used.
2.0 Testing of sterilizers

Introduction

2.1 Sterilization is a process whose efficacy cannot be verified retrospectively

by inspection or testing of the product. For this reason sterilization processes
have to be validated before use, the performance of the process routinely
monitored, and the equipment maintained.

2.2 Means of assuring that a sterilizer is fit for its Intended purpose will include
tests and checks carried out during the various stages of manufacture, after
delivery, during validation and periodically thereafter. Tests will also be required
before a sterilizer is returned to service after modification.

2.3 The philosophy of testing and maintenance embodies three main principles
to ensure that required standards of performance and safety are attained and
sustained:
a. all sterilizers are subject to a planned programme of tests to monitor their
performance;

b. all sterilizers are subject to a planned programme of preventive

maintenance irrespective of whether or not a preventive maintenance
scheme is being operated on the premises generally;

c. expertise on all aspects of the testing of stenlrzers should be available at

two levels; these are represented by the authorised person (sterilizers) and
the test person.

2.4 The scheduled test programmes include simple procedures undertaken by

the user, as well as more complex tests undertaken by the test person to
demonstrate that the equipment is functioning satisfactorily.

2.5 Schedules for installation checks, validation tests and periodic tests are
presented in Chapters 3, 4 and 5, and discussed below. Where appropriate, the
schedules refer to detailed test procedures described in later chapters.

2.6 Maintenance of sterilizers is dealt with in Part 4 of this HTM

Responsibilities for validation

2.7 Sterilizers should be commissioned on site using the procedures described

in this HTM. The purchaser, manufacturer and contractor have distinct
responsibilities.

Purchaser

2.8 Management should nominate an authorised person (sterilizers) to provide

advice on validation.

2.9 The test person should witness the Installation checks and tests carried out
by the contractor, and arrange for test loads to be supplied as required.

2.10 The test person should carry out the commissioning tests and
performance qualification tests. (Some of the performance qualification tests on
LTSF and EO sterilizers are the responsibility of the user.)
 Manufacturer

2.11 The manufacturer should ensure that the sterilizer is designed,

manufactured and tested within a quality system such as that given in BS5750.
The extent of testing will depend on whether the manufacturer has obtained a
current certificate of compliance to a relevant British or European Standard by
means of a type test for the particular type and size of sterilizer:
a. where a certificate is available, the manufacturer may limit the works tests
to those which demonstrate compliance with the specification;
b. when a certificate is not available, such as for a one-off design, works
tests should (except for the sound pressure test) include those listed as
commissioning tests in Tables 2 and 3 (see Chapter 4). This option is
expensive.

Contractor
2.12 The contractor (who may also be the manufacturer) should complete the
installation checks and tests specified in Chapter 3 to the satisfaction of the test
person before the sterilizer can be accepted for use in accordance with the
contract.

2.13 The contractor should provide the test instruments and equipment (but
not the test loads, see paragraph 2.9) required for the installation checks and
tests, and should satisfy the authorised person that their accuracy, calibration
and condition meet the requirements for test instruments specified in Chapter 6,
and that the calibration of each instrument has been checked on site and is
satisfactory.

The validation process

2.14 Validation is defined as a documented procedure for obtaining, recording

and interpreting the results needed to show that a process will consistently yield
a product complying with predetermined specifications. Validation is considered
as a total process which consists of commissioning followed by performance
qualification (Figure 1).

Installation checks

Installation tests

Commissioning tests
VALIDATION

Thermometric tests

Microbiological tests

Residual gas tests

Figure 1 The validation process

Commissioning

2.15 Commissioning is defined as the process of obtaining and documenting

evidence that the equipment has been provided and installed in accordance with
its specifications, and that it functions within predetermined limits when
operated in accordance with operational instructions.
2.16 Commissioning consists of a series of installation checks and installation
tests (often identified as “installation qualification” and “equipment
qualification”) to be carried out by the contractor, and a series of commissioning
tests to be carried out by the test person.

Installation checks

2.17 On delivery of the sterilizer, the contractor should carry out the required
installation checks to establish that the sterilizer has been provided and installed
correctly, is safe to operate, does not interfere with nearby equipment and that
all connected services are satisfactory and do not restrict the attainment of
conditions for sterilization.

2.18 Ancillary equipment, such as service supplies and ventilation systems,

should be checked by the contractor responsible for their installation.

2.19 The schedule for installation checks is set out in Chapter 3.

Installation tests

2.20 When the installation checks have been completed, the contractor should
carry out the required installation tests to demonstrate that the sterilizer is
working satisfactorily. The contractor is not required to carry out any
thermometric tests unless previously specified in the contract. Any assistance
required from the department in which the sterilizer is installed should be agreed
between the contractor and the purchaser.

2.21 If any maintenance or modification work is carried out on the steam,

water or piped gas services after the installation tests have been completed, the
tests should be repeated by the test person before the commissioning tests
commence.

2.22 The schedule for installation tests is set out in Chapter 4.

Commissioning tests

2.23 When the sterilizer has been accepted, the test person should carry out a
sequence of commissioning tests to evaluate basic performance and safety.
Some of these commissioning tests are identical to those specified as installation
tests, and need not be repeated if commissioning follows within seven days of
the installation tests.

2.24 The schedule for commissioning tests is set out in Chapter 4.

Performance qualification

2.25 Performance qualification (PQ) is defined as the process of obtaining and

documenting evidence that the equipment as commissioned will produce an
acceptable product when operated according to process specification.

2.26 PQ consists of tests designed to show that sterilization conditions are

attained throughout a production load. A thermometric test is sufficient for
most sterilizers but an additional microbiological test is required for sterilizers
using gaseous sterilants, and may be necessary for any sterilizer where loading
conditions cannot be validated solely by thermometric methods.

2.27 In principle, a PQ test is required for each loading condition that the
sterilizer is intended to process. In practice, a test on a single “reference load”
may be valid for a range of less demanding loading conditions and in some
cases, notably porous loads, the tests specified for commissioning will often
provide sufficient evidence for performance qualification.

2.28 The schedule for performance qualification tests is set out with the
commissioning tests in Chapter 4. Further information and detailed procedures
for performance qualification are given in Chapter 8.

Documentation

2.29 Accurate and efficient keeping of records is an essential part of the

management of a sterilizer. A recommended system, based on a plant history file
and a sterilizer process log, is described in Part 4 of this HTM.

Summary sheets
2.30 On the completion of the validation process, and before leaving the
premises, the test person should prepare summary sheets for the user containing
the results of the commissioning and PQ tests, and essential working data.
At the request of the user the test person should also supply graphical
representations of cycle variables obtained from the thermometric tests. The
sheets should be signed by the test person and countersigned by the user to
certify that the sterilizer is fit for use. Summary sheets should be kept in the
sterilizer process log for ready reference by the user. A set of model summary
sheets is given in Appendix 3.

2.31 At the same time the test person should provide the user with copies of
any master process records (see paragraph 8.58) required for routine production.

Validation report

2.32 Within one month of the completion of the validation process the test
person should prepare a full validation report. It should include the following:

a. all the data, supplied by the contractor, collected during the installation
checks specified in Chapter 3 and the installation tests specified in
Chapter 4, with written confirmation from the contractor that they meet
the manufacturer's specifications;
b. written confirmation from the contractor that the calibration of all
instruments and gauges fitted to the sterilizer has been verified;
c. all the data collected during the commissioning tests specified in
Chapter 4, with written confirmation from the test person that they meet
the requirements of the tests;
d . data showing the correlation between the performance of the instruments
fitted on the sterilizer and the test instruments used for commissioning
and performance qualification;
e. all the data collected during the performance qualification tests in the
form of PQ reports (see paragraph 8.54), with written confirmation from
the test person and the user and (for medicinal products) the quality
controller of the loading conditions (see paragraph 8.7) which may be
satisfactorily processed in the sterilizer.

2.33 If any of the data is in the form of electronic data files, the report should
include copies of disks or tapes containing the data in a format agreed with the
user, and a print-out of each disk or tape directory showing clearly where the
data for each test are to be found.
2.34 The test person should certify that all tests and checks have been carried
out and that the results are satisfactory. The microbiologist should sign the
records of any microbiological tests. The complete validation report should be
examined and countersigned by the authorised person.

2.35 The validation report should be given to the user for the plant history file
and a copy retained by the test person. Copies should be sent to the authorised
person and, on request, to the quality controller and the microbiologist.

Periodic tests

2.36 After the validation process has been completed, and the sterilizer is
passed into service, it is subject to a schedule of periodic tests at daily, weekly,
quarterly and yearly intervals. These tests are the shared responsibility of the user
and the test person.

2.37 The yearly test schedule is essentially a revalidation schedule. It provides

for performance requalification (PRQ) tests to confirm that data collected during
performance qualification remain valid.

2.38 The schedule of periodic tests is set out in Chapter 5.

Revalidation

2.39 Revalidation is the process of confirming that the operational data

acquired during validation remain valid. It consists of recommissioning followed
by performance requalification. Revalidation is required on the following
occasions:
a. when modifications or engineering work are carried out which could
affect the performance of the sterilizer, for example:
(i) when a sterilizer is to be returned to service after the repair of a
serious defect (see Part 4);
(ii) when the inspection of a sterilizer pressure vessel by the competent
person requires the removal of components which could affect the
performance of the sterilizer (if the inspection immediately precedes
a yearly test, recommissioning is not necessary);
(iii) when the preset values of cycle variables have been modified;
(iv) when the software in a computer control system has been
upgraded or otherwise modified;
b. when the sterilizer is to be returned to service after investigation and
correction of unacceptable deviations from performance data established
during validation, for example:
(i) when the pattern of a batch process record is outside the limits
specified on the master process record;
(ii) when the sterilizer fails a periodic test;
c. when there is a demand for revalidation by an authorized inspectorate or
licensing authority;

d . whenever the user or authorised person advises that revalidation is

necessary.

2.40 The revalidation procedure is identical to that prescribed for the yearly
tests set out in Chapter 5.
Repeat validation

2 . 4 1 On occasions, usually rare, it will be necessary to repeat the validation

procedure to obtain a new set of commissioning and performance qualification
data to replace the set originally obtained during validation. Repeat validation is
required on the following occasions:

a. when the sterilizer is subject to modifications of such a nature that the

validation data must be presumed to be no longer valid, for example:
(i) when a sterilizer, other than a transportable, has been moved and
installed at a new site;
(ii) when a sterilizer has been dismantled or extensively overhauled or
modified;
(iii) when a new operating cycle has been introduced;
b. when revalidation or a yearly test fails to confirm the validity of the
original validation data and no obvious cause can be found;
c . whenever the authorised person advises that repeat validation is necessary;

d. when there is a demand for repeat validation by an authorised

inspectorate or licensing authority.

2.42 The authorised person should advise on which elements of the validation
process need be repeated. For example, it will not be necessary to repeat all of
the installation checks.

Types of test

2.43 Although many tests are listed in the schedules, they fall into a few basic
categories as follows.

2.44 Automatic control tests are designed to show that the operating cycle
functions correctly as evidenced by the values of the cycle variables indicated
and recorded by the instruments fitted permanently to the sterilizer.

2.45 Thermometric tests use accurate measuring equipment to monitor

temperatures and pressures independently of the instruments fitted to the
sterilizer. They provide the assurance that the temperature requirements for
sterilization are met:

a . thermometric tests for a small load are designed for two purposes. In
sterilizers with an active air removal system they demonstrate that the
sterilizer is capable of removing air from a small load in which air from a
near-empty chamber has been retained. In cycles for fluid loads they
demonstrate that sufficient condensate will be collected for cooling
purposes, and that the initial temperature overshoot is kept within
acceptable limits;

b. thermometric tests for a full load are designed to show that sterilization
conditions are present in a test load of specified maximum mass and of
sufficient size to fill the usable chamber space. In certain circumstances
they may also serve as PQ tests for loading conditions which present a
lesser challenge to the operating cycle than the specified full load (see
paragraph 8.7).

2.46 Microbiological tests are designed to show that sterilization conditions

are attained where thermometric methods are inadequate, that is, for LTSF and
EO sterilizers and for exceptional loading conditions in other sterilizers.
2.47 Other tests, specific to certain types of sterilizer, are designed to show
that the steam supply is suitable, the sterilizer does not produce too much noise,
the chamber is airtight, gaseous sterilants are not released into the environment,
and safety devices are functioning correctly.

Procedure on failure of a test

2.48 A correctly installed and maintained sterilizer should have no difficulty in

complying with either the validation tests or the periodic tests. As a rule, a
failure of a test implies that the sterilizer is not working to specification, and it
should be withdrawn from service and the failure investigated. In practice the
immediate action to be taken is a matter for judgement based on the nature of
the failure and experience gained in using the sterilizer. In some cases it may be
acceptable for the sterilizer to continue in service under restricted operating
conditions until the failure can be investigated. The authorised person and the
user should agree in advance on how to handle test failures.

2.49 It should be emphasised that the user has the ultimate

responsibility for certifying that the sterilizer is fit for use.
3.0 Schedule of installation checks

Introduction

3.1 On delivery of the sterilizer the contractor should carry out the Installation
checks set out in this chapter and included in the contract to establish that the
sterilizer has been provided and installed correctly, is safe to operate, does not
interfere with other equipment and that all connected services are satisfactory
and do not restrict the attainment of conditions for sterilization.

3.2 Installation checks on services and other ancillary equipment should be

carried out by the contractor responsible for their installation. These checks
should be completed satisfactorily before starting the checks on the sterilizer
itself.

3.3 Any checks specified here which are not included in the contract should be
completed by the test person before commissioning begins.

3.4 As a safety precaution, checks on LTSF sterilizers should be carried out on

the LTS cycle only. Checks on EO sterilizers should be carried out using a non-
hazardous substitute for the sterilant as described in Chapter 1.

Checks on ancillary equipment

3.5 Ancillary equipment should ideally be installed and commissioned before

the validation procedure for the sterilizer begins. Where the checks require the
sterilizer to be operating, the test person should carry them out in cooperation
with the sterilizer contractor. The sterilizer contractor is not responsible for the
correct functioning of services and other ancillary equipment unless agreed in
the contract.

Engineering services

3.6 Check that the following requirements are met:

a. the engineering services are installed correctly, they are adequate to meet
the demands of the sterilizer, and they do not leak;
b. drains remove effluent effectively when all plant in the vicinity, including
the sterilizer, is connected and operating;

c. the water economy system (if fitted) operates correctly;

d. for EO sterilizers supplied from cylinders, the system complies with the
requirements of Part 2, and all gas lines are free of leaks.

Additional checks for LTSF and EO sterilizers

3.7 LTSF and EO sterilizers require further checks to the ventilation and safety
systems because of the use of toxic gases.

3.8 For both LTSF and EO, check that the ventilation systems within the loading
area, plantroom and manifold room meet the requirements of Part 2. Pay
particular attention to the following:
 a. they meet the manufacturer s specification;

b. air flow is from the operator towards the sterilizer, and air does not flow
from the plantroom into the loading area;

c. exhaust systems are non-recirculating and their discharges comply with

safety regulations;

d. if the air flow is insufficient to cause a minimum of 10 air changes an

hour:
(i) a warning is given;
(ii) the door cannot be opened at the end of the operating cycle;
(iii) a new cycle cannot be started.

3.9 Check that the local exhaust ventilation system meets the requirements of
Part 2. Pay particular attention to the following:

a. air flow IS from the operator towards the sterilizer, and air does not flow
from the plantroom into the loading area;

b. the rate of flow complies with that specified in Part 2;

c. the exhaust discharge complies with safety regulations specified in Part 2.

3.10 Check that the drain from the sterilizer to the drainage system is trapped,
sealed and vented to a safe position, as described in Part 2.

Additional checks for EO sterilizers

3.11 Check that the local exhaust ventilation system meets the following
requirements in addition to those in paragraph 3.9:

a . manual control switches are located in prominent, easily accessible

positions, such as in the EO cylinder change area;

b . the system operates whenever any one of the manual switches is

operated;

c . it operates automatically at the end of an operating cycle and before the

door is opened;

d. it operates whenever any of the gas detectors sense that the atmospheric
concentration of EO exceeds the short-term exposure limit specified in
Table 1.

3.12 Check that EO safety installations meet the requirements of Part 2. Pay
particular attention to the following:
a. notices concerning emergency procedures, safety and restricted access are
displayed in prominent positions;

b. where gas is supplied from cylinders:

(i) environmental alarm and emergency systems are installed and
operate in accordance with the specification;
(ii) emergency protective equipment is provided and stored in
designated areas.

Checks on the sterilizer

3.13 The following checks presume that engineering services and other
ancillary equipment are functioning correctly.
Preliminary checks
3.14 After the sterilizer has been installed, check that the following
requirements are met:

a. the manufacturer has supplied all the documents specified in the contract;

b. the sterilizer has been supplied and installed in accordance with the
contract;

c. calibration verification certificates for the temperature and pressure

instruments and controllers are supplied;

d. no defects are apparent from a visual inspection of the sterilizer;

e. all supports, bases, and fixing are secure and without imposed strain from
service connections;
f. thermal insulation is in good condition and securely attached;

g. security and settings of door safety switches and door-locking components

are in compliance with data provided by the manufacturer;

h. keys, codes or tools required to operate locked controls are supplied and
operate satisfactorily. Each key, code or tool unlocks only the control for
which it is intended, and cannot unlock controls on other sterilizers in the
vicinity;

j. loading trolleys and other aids are effective and safe in use.

3.15 Check that the electrical equipment on the sterilizer is correctly connected
to the electrical service. Carry out the following electrical tests:

a. insulation resistance;
b. phase sequence (for three-phase installations);

c. polarity;

d. bonding and earth continuity;

e. emergency stop.

Functional checks

3.16 During an operating cycle with an empty chamber, check that the
following requirements are met (several cycles may be necessary to complete all
the checks):

a. the selection of automatic or manual control is by key, code or tool. When

the controller is in manual mode, the automatic control is inactivated.
When the controller is in automatic mode, the manual control is
inactivated;

b. under automatic control, steam, compressed air, formaldehyde or EO

cannot be admitted into the chamber, and the operating cycle cannot
start, until the door is locked and sealed. Under manual control, the
operator can advance the cycle only sequentially through each stage. Any
stages designed to remove formaldehyde or EO from the chamber and
load cannot be circumvented;

c. throughout the cycle, indicated and recorded steam, water, air and gas
pressures are within the limits specified by the manufacturer;

d. throughout the cycle, there are no leaks of steam, water, air, gas or
effluent;

e. there is no evidence of interference to or from other equipment connected

to the same services;
 f. there is no evidence of electromagnetic interference to or from other
equipment;
g. operation and readings of all instruments appear satisfactory, including
return to zero (this may not be achievable with combined pressure and
vacuum gauges);

h. the temperature of surfaces routinely handled by the operator does not

exceed that specified in Part 2;

j . the effluent temperature does not exceed that specified in Part 2.

3.17 At the end of a cycle check that the following requirements are met:
a. the door opening system cannot be operated until the chamber vent valve
is open, and the chamber pressure is within 200 mbar of atmospheric;

b. door retaining parts cannot be released until the seal between the door
and chamber has been broken, and the chamber is effectively vented to
atmospheric pressure;

c. the door interlock system is either fail-safe or is fitted with at least two
independent interlocks. Failure of one interlock, or any one service, does
not allow the door to be opened when conditions within the chamber
would cause a hazard, for example, pressure in excess of 200 mbar,
unacceptable level of sterilant gas, or temperature of fluid in sealed
containers above 80 C (glass) or 90 C (plastic);

d. for EO sterilizers, the operating cycle automatically returns to either the

gas removal stage or the flushing stage if the door has remained sealed for
more than 15 minutes after the admission of air;

e. the automatic controller has operated in accordance with the specification.

Response to external faults

3.18 It is necessary to check that the sterilizer reacts correctly and safely when
exposed to a number of external fault conditions, that is, a safety hazard is not
created and a false indication of cycle complete is not obtained. During each
stage of an operating cycle, check the response of the sterilizer to the following
simulated faults (where appropriate to the type of sterilizer):

a. operation of the emergency stop button;

b. power failure;

c. steam pressure too low;

d. steam pressure too high;

e. water pressure too low;

f. compressed air pressure too low;

g. failure of sterilant gas supply (LTSF and EO);

j. failure of room ventilation (LTSF and EO).
4.0 Schedule of validation tests

Introduction

4.1 Installation tests are carried out by the contractor to demonstrate

compliance with specifications, and may be repeated by the test person if
required. Commissioning and performance qualification tests are carried out by
the test person.

4.2 The schedules for the tests are set out for each type of clinical sterilizer in
Table 2 and for laboratory sterilizers in Table 3. Each test is cross-referenced to a
detailed description of the test procedure in a later chapter. The tests should be
carried out with the sterilizer at normal working temperature (a warming-up
cycle may be needed) and completed in the order shown.

4.3 The laboratory machine known as a Koch steamer is not listed here. Where
it is used primarily for melting agar, validation tests are not required. Where it is
to be used for the disinfection of a product, the thermometric tests prescribed in
Table 3b for the culture media cycle should be followed.

4.4 The calibration of thermometric test equipment should be checked before

and after the thermometric tests as described in paragraphs 6.32-39.

4.5 In principle, performance qualification tests should be carried out after the
commissioning tests have been completed. However, for sterilizers with an active
air removal system, thermometric PQ tests may be performed while the sensors
used in the commissioning tests are still in place and before any final vacuum
leak test. This is provided for in the schedules. Where tests on EO sterilizers
require EO gas to be in the chamber, however, sensors should either be removed
from the chamber or else disconnected from the recorder and the wires
grounded to the body of the sterilizer (see note (d) to Table 2f).

4.6 Chapter 8 describes general procedures for conducting performance

qualification tests and generating master process records.
Table 2 Schedule of validation tests for clinical sterilizers
Ref

Installation tests - contractor

1. Vacuum leak test 11.2
2. Verification of calibration of sterilizer instruments 6.32
3. Automatic control test 12.1

Commissioning tests - test person

1. Steam non-condensable gas test 9.4
2. Steam superheat test 9.20
3. Steam dryness test 9.30
4. Vacuum leak test 11.2
5. Vacuum leak test (temperature and pressure sensors connected) 11.2
6. Automatic control test 12.1
7. Verification of calibration of sterilizer instruments* 12.2
8. Chamber wall temperature test 13.3
9. Air detector performance test for a small load 11.45
10. Air detector performance test for a full load 11.53
11. Thermometric test for a full load 13.15
12. [Load dryness test]* 13.25
13. Thermometric test for a small load 13.7
14. [Load dryness test]* 13.25
15. Thermometric test for a small load (to check consistency with test 13.7
13)
Performance qualification tests (see below)
16. Vacuum leak test (sensors removed) 11.2
17. Air detector function test 11.60
18. Bowie-Dick test for steam penetration 13.3
19. [Sound pressure test] 10.1

Performance qualification tests - test person

1. Thermometric tests for performance qualification as required by 8.13
the usera
2. Hospital load dryness check 13.25

* May be done at the same time as the preceding test.

[ ] Optional test, to be done at the user s discretion.
a. Not normally required for loads processed in a sterile services department (SSD) (see
paragraph 8.7).

Table 2a Validation tests for porous load sterilizers

 Ref

Installation tests - contractor

1. Verification of calibration of sterilizer instruments 6.32
2. Heat exchanger integrity t e s t 14.4
3. Automatic control test 12.1
Commissioning tests - test person
1. Automatic control test 12.1
2. Verification of calibration of sterilizer instruments* 12.2
3. Chamber temperature profile 7.21
4. Thermometric test for a small load 14.21
5. Thermometric test for a full load 14.10
6. Coolant quality test 14.32
7. [Sound pressure test] 10.1
Performance qualification tests - test person
1. Thermometric tests for performance qualification as required by 8.13
the user and the quality controller (for medicinal products) or by
the user (other loads).

* May be done at the same time as the preceding test

[ ] Optional test, to be done at the user s discretion.

Table 2b Validation tests for fluid sterilizers

Ref
a
Installation tests - contractor
1.. Verification of calibration of sterilizer instruments 6.32
2. Automatic control test 12.1

Commissioning tests - test person

1. Automatic control test 12.1
2. Verification of calibration of sterilizer instruments* 12.2
3. Chamber temperature profile 7.21
b
4. Chamber overheat cut-out test 15.3
5. Thermometric test for a small load 15.7
6. Thermometric test for a full load 15.13
7. Thermometric test for a small load (to check consistency with 15.7
test 5)
8. [Sound pressure test]a 10.1
Performance qualification tests - test person
1. Thermometric tests for performance qualification as required by 8.13
the user

* May be done at the same time as the preceding test.

[] Optional test, to be done at the user s discretion.
a. Not required for transportable sterilizers.
b. Not required where steam is supplied from a source external to the chamber.

Table 2c Validation tests for sterilizers for unwrapped instruments and utensils
 Ref

Installation tests - contractor

1. Verification of calibration of sterilizer instruments 6.32
2. Automatic control test 16.4

Commissioning tests - test person

1. Automatic control test 16.4
2. Verification of calibration of sterilizer instruments* 12.2
3. Chamber temperature profile 7.21
4. Chamber overheat cut-out test 16.8
5. Air filter integrity test 16.13
Performance qualification tests (see below)
6. [Thermometric test for a full load] 16.33

Performance qualification tests - test person

1. Thermometric tests for performance qualification as required by 16.22
the user and quality controller (medicinal products) or by the user
(other loads)

* May be done at the same time as the preceding test.

[ ] Optional test, to be done at the user s discretion. The full-load test need be done only
if the sterilizer falls a PQ test.

Table 2d Validation tests for dry-heat sterilizers

 Ref

Installation tests - contractor

1. Vacuum leak test 11.2
2. Verification of calibration of sterilizer instruments 6.32
3. Automatic control test 12.1
4. Vacuum leak monitor test 11.19

Commissioning tests - test person

1. Steam non-condensable gas test 9.4
2. Steam superheat test 9.20
3. Steam dryness test 9.30
4. Vacuum leak test 11.2
5. Vacuum leak test (temperature and pressure sensors connected) 11.2
6. Automatic control test 12.1
7. Verification of calibration of sterilizer instruments* 12.2
8. Vacuum leak monitor test 11.19
9. Chamber temperature profile 7.21
10. Chamber overheat cut-out test 17.4
11. Chamber wall temperature test 17.10
12. Thermometric test for a small load 17.15
13. [Load dryness test]* 13.25
14. Thermometric test for a full load (LTS) 17.23
15. Thermometric test for a small load (to check consistency with 17.15
test 12)
16. Microbiological test for basic performance (LTSF) 17.40
17. Environmental formaldehyde vapour test (LTSF) 17.32
Performance qualification tests (see below)
18. Vacuum leak test (sensors removed) 11.2
19. [Sound pressure test] 10.1

Performance qualification tests - test person

1. Thermometric tests for performance qualification as required by 8.13
the user
2. Microbiological tests for performance qualification as required by 17.50
the user (LTSF)
3. Environmental gas tests (LTSF)* 8.37

Performance qualification tests - user

1. Tests for degassing time (LTSF) 8.46

* May be done at the same time as the preceding test

[ ] Optional test, to be done at the user s discretion.

Table 2e Validation tests for LTS disinfectors and LTSF sterilizers

 Ref

Installation tests - contractor

1. Verification of calibration of sterilizer instruments 6.32
2. Vacuum leak test 11.2
3. Pressure leak testa 11.24
4. Automatic control test 12.1

Commissioning tests - test person

1. Vacuum leak test 11.2
a
2. Pressure leak test 11.24
3. Vacuum leak test (temperature, pressure and RH sensors 11.2
connected)
4. Pressure leak testa 11.24
5. Automatic control test 12.1
6. Verification of calibration of sterilizer instruments* 12.2
7. vacuum leak monitor test 11.19
8. Chamber temperature profile 7.21
9. Chamber overheat cut-out test 18.4
10. Chamber space temperature test 18.11
11. Chamber wall temperature test 18.16
12. Gas circulation testb,d
13. Microbiological test for gas exposure timec,d 18.20
Performance qualification tests (see below)
14. Vacuum leak test (sensors removed) 11.2
15. Pressure leak test a
11.24
16. [Sound pressure test] 10.1

Performance qualification tests - test person

1. Thermometric tests for performance qualification as required by 18.36
the user
2. Microbiological tests for performance qualification as required by 18.49
the userd
3 . Environmental gas tests* 8.37

Performance qualification test - user

Tests for degassing time 8.46

* May be done at the same time as the preceding test.

[ ] Optional test, to be done at the user s discretion.
a. Required only where the sterilizer operates above atmospheric pressure.
b. Required only where a circulating fan is fitted. Instrumentation is used to demonstrate
that pressures and flows specified by the manufacturer are obtained.
c. May be omitted if test data are provided by the manufacturer.
d. To avoid risk of sparking, tests using EO gas should not be done while temperature
sensors are in the chamber. Providing safe operating procedures are not compromised, it
may be acceptable to disconnect the sensors from the recorder and ground the wires to
the body of the sterilizer.

Table 2f Validation tests for ethylene oxide sterilizers

Table 3 Schedule of validation tests for laboratory sterilizers

Ref

Installation tests - contractor

1 . V a c u u m l e a k t e s ta 11.2
2. Verification of calibration of sterilizer instruments 6.32
3. Automatic control test for each operating cycle 12.1
4. Thermal door-lock override test 19.64

Commissioning tests - test person

1. Vacuum leak test a 11.2
a
2 . Vacuum leak test (temperature and pressure sensors connected) 11.2
3. Automatic control test for each operating cycle 12.1
4 . Verification of calibration of sterilizer instruments* 12.2
5. Chamber temperature profile 7.21
6. Tests for make-safe of small plastic discard
(i) Thermometric test for a small load 19.16
(ii) Thermometric test for a full load 19.7
7 . Tests for make-safe of contained fluid discard
(i) Thermometric test for a small load 19.37
(ii) Thermometric test for a full load 19.24
8. Tests for sterilization of culture media
(i) Thermometric test for a small load 19.37
(ii) Thermometric test for a full load 19.24
9. Tests for disinfection of fabrics
(i) Thermometric test for a small load 13.7
10. Tests for sterilization of glassware and equipment
(i) Thermometric test for a small load 19.61
(ii) Thermometric test for a full load 19.52
11. Tests for free steaming
(i) Thermometric test for a full load 19.24
b
Performance qualification tests (see below)
12. Vacuum leak test (sensors removed)a 11.2
13. [Sound pressure test] 10.1
Performance qualification tests - test person
1. Thermometric tests for each operating cycle as required by the user 8.13

* May be done at the same time as the preceding test.

[] Optional test, to be done at the user s discretion.
a. For sterilizers with an active air removal system.
b. For sterilizers with an active air removal system, the PQ tests may be done at this point.

Table 3a Validation tests for high-temperature steam sterilizers

 Ref
a
Commissioning tests - test person
1. Automatic control test 12.1
2. Verification of calibration of sterilizer instruments* 12.2
3. Thermometric test for a full load 19.71
4. Reheat and dispensing test 19.78
* May be done at the same time as the preceding test.
a. The commissioning tests may be omitted if test data is supplied by the manufacturer.

Table 3b Validation tests for culture media preparators

5.0 Schedule of periodic tests

Introduction

5.1 Periodic tests are carried out at daily, weekly, quarterly and yearly intervals.
They are the shared responsibility of the test person and the user.

5.2 The yearly test schedule is identical to that carried out on revalidation (see
paragraph 2.39). It contains tests for both recommissioning and performance
requalification.

5.3 Tests should be performed on completion of planned maintenance tasks as

described in Part 4. The schedules for the tests are set out for each type of
clinical sterilizer in Table 4 and for laboratory sterilizers in Table 5. Each test is
cross-referenced to a detailed description of the test procedure in a later chapter.
The tests should be carried out with the sterilizer at normal working temperature
(a warming-up cycle may be needed) and completed in the order shown.

5.4 The calibration of thermometric test equipment should be checked before

and after the thermometric tests as described in Chapter 6.

5.5 Where tests on EO sterilizers require EO gas to be in the chamber, sensors

should either be removed from the chamber or else disconnected from the
recorder and the wires grounded to the body of the sterilizer (see note (d) to
Table 4f).

5.6 The results of the tests done by the test person should be kept in the plant
history file. The results of the tests done by the user should be kept in the
sterilizer process log. (See Part 4 for guidance on record-keeping.)

Weekly safety checks

5.7 The test person should make the following safety checks before starting
the sequence of weekly tests:

a. examine the door seal;

b. check the security and performance of door safety devices;

c. check that safety valves, or other pressure-limiting devices, are free to

operate;

d. make any other checks required by the competent person in connection

with the written scheme of examination for the pressure vessel.

Yearly safety checks

5.8 In order to ensure the safe functioning of the sterilizer, the test person
should conduct a sequence of safety checks before starting the yearly tests. The
installation checks (Chapter 3) should be used as a basis for these, but it will not
be necessary to repeat them all. In selecting which checks to include in the
yearly schedule, consideration should be given to conditions which affect safety
and to those which may have changed over the course of time. It will not be
necessary, for example, to check again that the sterilizer has been supplied in
accordance with specification, but it will be necessary to check that the
 5.0 Schedule of periodic tests

engineering services remain adequate and are connected safely. The

authorised person should advise on which checks will need to be included.

Table 4 Schedule of periodic tests for clinical sterilizers

Ref

Daily test – user

1. Bowie-Dick test for steam penetration 13.39

Weekly tests – test person

1. Weekly safety checks 5.7
2. Vacuum leak test 11.2
3. Air detector function test 11.60
4. Automatic control test 12.1
5. Bowie-Dick test for steam penetration* 13.39

Quarterly tests – test person

1. Weekly safety checks 5.7
2. Vacuum leak test 11.2
3. Vacuum leak test (temperature and pressure sensors connected) 11.2
4. Automatic control test 12.1
5. Verification of calibration of sterilizer instruments* 12.2
6. Thermometric test for a small load* 13.7
7. Vacuum leak test (sensors removed) 11.2
8. Air detector function test 11.60
9. Bowie-Dick test for steam penetration 13.39

Yearly and revalidation tests – test person

1. Yearly safety checks 5.8
2. Steam non-condensable gas test 9.4
3. Steam superheat test 9.20
4. Steam dryness test 9.30
5. Vacuum leak test 11.2
6. Vacuum leak test (temperature and pressure sensors connected) 11.2
7. Automatic control test 12.1
8. Verification of calibration of sterilizer instruments* 12.2
9. Air detector performance test for a small load 11.45
10. Air detector performance test for a full load 11.53
11. Thermometric test for a small load 13.7
12. Thermometric test for a full load 13.15
13. Test for performance requalification as required by the user 8.64
14. Vacuum leak test (sensors removed) 11.2
15. Air detector function test 11.60
16. Bowie-Dick test for steam penetration 13.39

* May be done at the same time as the preceding test

Table 4a Periodic tests for porous load sterilizers

29
5.0 Schedule of periodic tests

Ref

Weekly tests – test person

1. Weekly safety tests 5.7
2. Heat exchanger integrity test a,b 14.4
3. Automatic control test 12.1

Quarterly tests – test person

1. Weekly safety checks 5.7
2. Heat exchanger integrity test a 14.4
3. Automatic control test 12.1
4. Verification of calibration of sterilizer instruments* 12.2
5. Simplified thermometric test for performance requalification 14.27

Yearly and revalidation tests – test person

1. Yearly safety checks 5.8
2. Heat exchanger integrity test 14.4
3. Automatic control test 12.1
4. Verification of calibration of sterilizer instruments* 12.2
5. Tests for performance requalification as required by the user 8.64
and the quality controller (for medicinal products) or by the user
(other loads)
6. Coolant quality test 14.32

* May be done at the same time as the preceding test.

a. Not required where the heat exchanger is designed and constructed in a fail-safe
fashion so that coolant in the secondary circuit cannot become contaminated in any
circumstances.
b. Not required where the pressure in the secondary circuit exceeds the pressure in the
primary circuit throughout the operating cycle.

Table 4b Periodic tests for fluid sterilizers

Ref

Daily test c – user

1. Automatic control test – observe and note the reading on the 12.1
cycle counter, if visible to the user

Weekly tests – test person a

1. Weekly safety checks 5.7

2. Automatic control test 12.1

Quarterly tests – test person

1. Weekly safety checks 5.7
2. Automatic control test 12.1
3. Verification of calibration of sterilizer instruments* 12.2
4. Thermometric test for a small load 15.7

Yearly and revalidation tests – test person

1. Yearly safety checks 5.8
2. Automatic control test 12.1
3. Verification of calibration of sterilizer instruments* 12.2
4. Chamber overheat cut-out test b 15.3
5. Thermometric test for a small load 15.7
6. Thermometric test for a full load 15.13
7. Tests for performance requalification as required by the user 8.64

* May be done at the same time as the preceding test.

a. For transportable sterilizers, the weekly test may be done by the user by agreement
with the test person.
b. Not required where the steam is supplied from a source external to the chamber.
c. Not required if a recorder is fitted. Records to be examined weekly by the test person.

Table 4c Periodic tests for sterilizers for unwrapped instruments and

utensils
30
 Ref
Weekly tests - test person
1. Weekly safety checks 5.7
2. Automatic control testa 16.4

Quarterly tests - test person

1. Weekly safety checks 5.7
2. Automatic control test 16.4
3. Verification of calibration of sterilizer instruments* 12.2
4. Simplified thermometric test for performance requalification 16.26

Yearly and revalidation tests - test person

1. Yearly safety checks 5.8
2. Automatic control test 16.4
3. Verification of calibration of sterilizer instruments* 12.2
4. Chamber overheat cut-out test 16.8
5. Air filter integrity test 16.13
6. Tests for performance requalification as required by the user and 8.64
the quality controller (medicinal products) or by the user (other
loads)
* May be done at the same time as the preceding test.
a. Not required where the previous week s batch process records are Jointly reviewed by
the user and the test person and, within specified limits, are comparable with previous
records.

Table 4d Periodic tests for dry-heat sterilizers

Ref

Daily tests - user

1. Vacuum leak testa 11.2
2. During the holding time of the first production cycle of the day,
observe and note the reading on the cycle counter, chamber
temperature indicator and chamber pressure indicator
3. Routine microbiological test for each production cycle (LTSF) 17.58

Weekly tests - test person

1. Weekly safety checks 5.7
2. Vacuum leak test 11.2
3. Automatic control test 12.1

Quarterly tests - test person

1. Weekly safety checks 5.7
2. Vacuum leak test 11.2
3. Vacuum leak test (temperature and pressure sensors connected) 11.2
4. Automatic control test 12.1
5. Verification of calibration of sterilizer instruments* 12.2
6. Vacuum leak monitor test 11.19
7. Thermometric test for a small load 17.15
8. Vacuum leak test (sensors removed) 11.2
Yearly and revalidation tests - test person
1 . Yearly safety checks 5.8
2. Vacuum leak test 11.2
3. Vacuum leak test (temperature and pressure sensors connected) 11.2
Contd
 Ref
4. Automatic control test 12.1
5. Verification of calibration of sterilizer instruments* 2.2
6. Vacuum leak monitor test 11.19
7. Chamber overheat cut-out test 17.4
8. Chamber wall temperature test 17.10
9. Thermometric test for a small load 17.15
10. Thermometric test for a full load (LTS) 17.23
11. Microbiological test for basic performance (LTSF) 17.40
12. Environmental formaldehyde vapour test (LTSF) 17.32
13. Thermometric tests for performance requalification as required by 8.13
the user
14. Microbiological tests for performance requalification as required by 8.29
the user (LTSF)
15. Vacuum leak test (sensors removed) 11.2

Yearly and revalidation tests - user

1 . Tests for degassing time (LTSF, performance requalification) 8.46
* May be done at the same time as the preceding test.
a. Not required where a vacuum leak monitor is fitted.

Table 4e Periodic tests for LTS disinfectors and LTSF sterilizers

Ref
Daily tests - user
1 . Routine microbiological test for each production cycle 18.58
Weekly tests - test person
1. Weekly safety checks 5.7
2. Vacuum leak test 11.2
3. Pressure leak testa 11.24
4. Automatic control test b
12.1
Quarterly tests - test person
1. Weekly safety checks 5.7
2. Vacuum leak test 11.2
3. Pressure leak testa 11.24
4. Vacuum leak test (temperature and pressure sensors connected) 11.2
5. Pressure leak testa 11.24
6. Automatic control test 12.1
7. Verification of calibration of sterilizer Instruments* 12.2
8. Vacuum leak monitor test 11.19
9. Chamber space temperature test 18.11
10. Vacuum leak test (sensors removed) 11.2
a
11. Pressure leak test 11.24

Yearly and revalidation tests - test person

1. Yearly safety checks 5.8
2. Vacuum leak test 11.2
3. Pressure leak testa 11.24
4. Vacuum leak test (temperature, pressure and humidity sensors 11.2
connected)
Contd
 Ref

5. Pressure leak testa 11.24

6. Automatic control test 12.1
7. Verification of calibration of sterilizer instruments* 12.2
8. Vacuum leak monitor test 11.19
9. Chamber overheat cut-out test 18.4
10. Chamber wall temperature test 18.16
11. Chamber space temperature test 18.11
12. Gas circulation testc,d
13. Microbiological test for basic performanced 18.30
14. Thermometric tests for performance requalification as required by 18.36
the user
15. Microbiological tests for performance requalification as required by 18.49
the userb
16. Environmental gas tests*,d 8.37
17. Vacuum leak test (sensors removed) 11.2
18. Pressure leak test a
11.24

Yearly and revalidation tests - user

1. Tests for degassing time (performance requalification) 8.46

* May be done at the same time as the preceding test.

a. Required only where the sterilizer operates above atmospheric pressure.
b. Not required where the previous week s batch process records are jointly reviewed by
the user and the test person and, within specified limits, are comparable with previous
records.
c. Required only where a circulating fan is fitted. Instrumentation IS used to demonstrate
that pressures and flows specified by the manufacturer are obtained.
d. To avoid risk of sparking, tests using EO gas should not be done while temperature
sensors are in the chamber. Providing safe operating procedures are not compromised,
it may be acceptable to disconnect the sensors from the recorder and ground the wires
to the body of the sterilizer.

Table 4f Periodic tests for ethylene oxide sterilizers

Table 5 Schedule of periodic tests for laboratory sterilizers

Ref

Daily tests - user

1. During the holding time of the first production cycle of the day,
observe and note the reading on the cycle counter, chamber
temperature indicator and chamber pressure indicator

Weekly tests - test person

1. Weekly safety checks 5.7
2. Vacuum leak testa 11.2
3. Automatic control testb 12.1

Quarterly tests - test person

1. Weekly safety checks 5.7
a
2. Vacuum leak test 11.2
3. Vacuum leak test (temperature and pressure sensors connected)a 11.2
4. Automatic control test for each operating cycle 12.1
5. Verification of calibration of sterilizer instruments* 12.2
Contd
 Ref

6. Thermometric test for a small load (small plastic discard, or fabrics, 19.16,
or glassware and equipment)c 13.7,
19.61
7. Simplified thermometric test for performance requalification 19.46
(contained fluid discard, or culture media, or free steaming) c
8. Vacuum leak test (sensors removed)a 11.2
9. Thermal door-lock override test 19.64

Yearly and revalidation tests - test person

1. Yearly safety checks 5.8
a
2. Vacuum leak test 11.2
a
3. Vacuum leak test (temperature and pressure sensors connected) 11.2
4. Automatic control test for each operating cycle 12.1
5. Verification of calibration of sterilizer instruments* 12.2
6. Thermometric test for a small load (small plastic discard, or fabrics, 19.16,
or glassware and equipment)c 13.7,
19.61
7. Thermometric test for a full load (contained fluid discard, or 19.24
culture media, or free steaming)c
8. Tests for performance requalification as required by the user 8.64
a
9. Vacuum leak test (sensors removed) 11.2
10. Thermal door-lock override test 19.64
* May be done at the same time as the preceding test.
a. Required only for sterilizers with an active air removal system.
b. The cycle should be chosen on a rotating basis from the cycles in routine use.
c. Required only for the first cycle listed in brackets that is available on the sterilizer

Table 5a Periodic tests for high-temperature steam sterilizers

Ref

Weekly tests - user or test person

1. Weekly safety checks 5.7
2. Automatic control test 12.1
Yearly tests - test person
1. Yearly safety checks 5.8
2. Automatic control test 12.1
3. Verification of calibration of sterilizer instruments* 12.2
4 . Thermometric test for a full load 19.71
5. Reheat and dispensing test 19.78
* May be done at the same time as the preceding test.

Table 5b Periodic tests for culture media preparators

6.0 Test equipment

Introduction

6.1 This chapter discusses the portable test equipment required to carry out
the test procedures described in this document. Specifications for instruments
fitted permanently to sterilizers are given in the relevant British and European
Standards discussed in Part 2 of this HTM.

6.2 With the rapid advance in instrumentation technology, it is becoming

increasingly difficult (and undesirable) to set detailed specifications for the
equipment to be used in testing sterilizers. For example, a clear trend is for much
of the testing to be under the control of a computer which can automatically
take the desired measurements, check that they meet the requirements of the
tests in this HTM, and report the results. The object of this chapter is twofold.
First, to ensure that the traditional measurement methods are adequately
supported; and second, to make clear the essential requirements for test
equipment that apply for old and new technology alike. Where it is proposed to
use measurement and recording techniques that are not explicitly covered here,
the advice of the authorised person should be sought.

6.3 Access to standard laboratory equipment and supplies is assumed

Calibration and sources of error

6.4 The errors produced in temperature and pressure measurement will arise
from a number of factors. Some are inherent in the design, age and condition of
the measuring equipment, and others are due to loose terminals, imperfect plug
and socket connections, and the change of environmental temperature around
the instrument. Variations in thermocouple alloys, preparation of thermocouple
hot junctions, the method of introducing sensors into the chamber, and their
location within the load will add to the error in temperature measurement.
Temperature fluctuations within pressure-sensing elements will lead to errors in
pressure measurement.

6.5 Every effort should be made to eliminate or minimise these errors by

attention to detail, location of instruments, effective maintenance, and skill in
the application, handling and use of the instruments. Systematic errors can be
reduced by careful calibration.

6.6 Instruments should be maintained and calibrated as recommended by the

manufacturer as part of a planned maintenance programme. Each instrument
should be labelled with the calibration date and a reference to its certificate. The
calibration of all test instruments should be verified yearly by using reference
instruments with a valid certificate of calibration traceable to a national
standard. A history record should be kept for each instrument.

6.7 All electronic test instruments should be allowed a period of time to

stabilize within the test site environment. They should be located in a position
protected from draughts, and should not be subjected to rapid temperature
variations. The manufacturer s instructions should be followed.
Recorders
6.8 Test recorders are required to measure temperature and pressure in all
types of sterilizer, and humidity in EO sterilizers. They should be designed for use
with the appropriate sensors, independent of those fitted to the sterilizer, as
described later in this chapter. Most of the tests in this HTM may be conducted
with a single recorder combining temperature and pressure functions, preferably
showing both records on the same chart or print-out. For EO sterilizers, a third
function, for humidity, is desirable but not essential.

6.9 Twelve temperature channels are sufficient for all the tests on each type of
sterilizer in this HTM, though more may be convenient for determining chamber
temperature profiles (see paragraph 7.21). One pressure channel is required for
all sterilizers except fluid sterilizers which require up to three. The pressure
channel for a dry-heat sterilizer is required to measure the small differential
pressure (no more than 10 mbar) across the air filter. Two relative-humidity
channels are desirable for EO sterilizers.

6.10 Analogue recorders (conventional pen and chart recorders) should comply
with the display requirements of BS3693. If they use potentiometric techniques,
they should comply with BS5164.

6.11 Digital recorders (data loggers) are rapidly coming into use and have
many advantages over traditional pen recorders. They measure the variables
electronically and store the values in digital form suitable for computer
processing. Data may be presented graphically or as a numerical list, or as a
combination of both. Parts of the operating cycle, such as the plateau period,
can be expanded and replotted for closer examination. The record should
quantify all turning points in the data, and distinguish by colour, print format or
separate list, measurements which are within the sterilization temperature band
for the operating cycle under test. The recorder should have the facility for
downloading data onto tape or disk which can then be removed and kept
securely. Software used with digital recorders should be developed under a
quality system (such as BS5750) and validated before use.

6.12 The detailed specification for a test recorder will depend upon the range
of sterilizers with which it is to be used. In all cases the recorder and its sensors
should be capable of measuring cycle variables to considerably greater accuracy
than the instruments fitted to the sterilizer.

6.13 The accuracy with which a variable can be read from the recorder will be
affected not only by the sources of error discussed above (see paragraph 6.4),
but also by the precision of the calibration, the scale range selected, the
integration time, the sampling interval and the intrinsic accuracy of the recorder
itself. Digital recorders will invariably register measurements to a precision
greater than the accuracy of the system as a whole, and care should be taken in
interpreting such measurements.

6.14 The intrinsic accuracies quoted by recorder manufacturers are measured

under controlled reference conditions and do not include errors from
temperature, pressure or humidity sensors. Temperature measurement errors due
to ambient temperature changes should not exceed 0.04”C per ”C rise.

6.15 The scale ranges should include the expected maximum and minimum
values of the cycle variables throughout the operating cycle, with sufficient
leeway to accommodate any deviations resulting from a malfunctioning sterilizer.
(Note that in some sterilizers the temperature in the chamber free space will
considerably exceed the upper limit of the sterilization temperature band for a
short time at the start of the plateau period.)
6.16 The most critical stage of the operating cycle is the plateau period (the
equilibration time plus the holding time, see paragraph 7.11) during which the
load becomes exposed to the sterilization conditions. It is during this period that
the values of the cycle variables are at their most critical and the recorder should
be capable of measuring them to sufficient accuracy to confirm that the
sterilization conditions have been attained. The criteria are as follows:

a. for digital recorders, the sampling interval should be short enough for the
holding time to contain at least 180 independent measurements in each
recording channel. This corresponds to a sampling interval of one second
for the shortest holding time (3 minute, high-temperature steam sterilizers)
and 40 seconds for the longest (120 minute, dry-heat sterilizers). For pen
recorders, the chart speed should be fast enough to allow fluctuations on
that scale to be clearly resolved. The duration of the holding time should
be measurable to within 1%;

b. the integration time of the recorder (the response time) should be short
enough to enable the output to follow significant fluctuations in the cycle
variables and to ensure that successive measurements are independent of
each other, It should not be longer than the sampling interval;

c. the width of the sterilization temperature band (see paragraph 7.14) varies
from 3 º C (high-temperature steam sterilizers) to 10 º C (dry-heat sterilizers).
The recorder must be accurate enough to show clearly whether the
measured temperatures are within the band or not. For all the types of
sterilizer covered by this HTM, the repeatability of the recorder should be
± 0.25ºC or better, and the limit of error of the complete measurement
system (including sensors) should be no more than 0.5ºC;

d. for pressure measurement, the limit of error should be no more than 0.5%
of the absolute pressure during the plateau period;

e. for humidity measurement, the limiting factor is likely to be the

performance of the sensor (see paragraph 6.47).

6.17 A recorder chosen to meet these criteria for the plateau period will have
more than enough performance for the preceding and following stages of the
operating cycle.

6.18 If a fluid sterilizer is fitted with an F0 integrating system (see Part 4 for a
discussion of the use of F0 in controlling operating cycles), then the recorder
should be capable of computing and printing values of F0 for each channel with
integration times no greater than 2 s (see BS3970: Part 2).

Temperature measurement

Temperature sensors

6.19 Temperature sensors are required to sense the temperature in locations in

the chamber and load as specified in the tests. They may be either platinum
resistance elements or thermocouples.

6.20 Platinum resistance elements should comply with Class A of BS1904.

6.21 Thermocouples should conform to BS4937: Part 4 (nickel-chromium/

nickel-aluminium) or Part 5 (copper/constantan). The calibration accuracy should
be Tolerance Class 1 as specified in EN 60584: Part 2 (formerly BS4937: Part 20).
The tolerance on Part 4 thermocouples (± 1.5 º C) is high when compared with
that allowed for those in Part 5 (± 0.5 º C), and for this reason copper/constantan
thermocouples are usually preferred for the test recording system.
6.22 Thermocouple wire is available which is marked to show the limits of
variation of the reel from the figures given in the British Standard. The variation
will have been established by the manufacturer by testing samples from both
ends of the full reel. Selected rather than standard wire should be used. For
selected wire this variation is typically (for copper/constantan) of the order of
0.015 mV which is equivalent to 0.4 º C at 20 º C and 0.3 º C at 134 º C.

6.23 The wire should be single-strand, not exceeding 0.7 mm diameter over
the covering of one core of a twin cable. Twin-core cable is usually preferred
because it is easier to handle and more durable than single-core wire. The width
of the cable should not exceed 2 mm. If bulkier cable is used, the tracking of
steam along the outside of the cable may invalidate certain tests, such as those
which require temperatures to be measured in the centre of a standard test pack
(see paragraph 7.27).

6.24 Thermocouples may be argon arc-welded or micro-welded. However,

experience has shown that provided the wires are cleaned, they may be
satisfactorily twisted together to form the hot junction. Brazing, silver brazing
and welding with filler rods may be no more reliable in respect of accuracy than
freshly twisted wires. Particular attention should be given to the condition of
copper/constantan thermocouples when testing LTSF sterilizers. Thermocouples
should not be fitted with a heat sink.

Use of sensors

6.25 A typical method of introducing sensors into a sterilizer chamber is

illustrated in Figure 2. Methods which prevent the removal of individual sensors
are to be discouraged. In older machines having no dedicated entry port, entry
may be made via a tee which can usually be inserted into a service entry pipe to
the chamber (for example the steam supply pipe). Sensors should not be
introduced through the door seal. The test schedules for sterilizers employing
active air removal systems provide for a vacuum leak test to be done after
temperature sensors have been introduced into the chamber, and again after
they have been removed, to ensure that the chamber remains gas-tight.

6.26 Many of the tests require a temperature sensor to be placed in the active
chamber discharge of the sterilizer. This is a drain or vent which permits the
controlled flow of air and condensate (a drain) or of air alone (a vent), such that
the temperature within the discharge is the same as the chamber temperature.
The preferred locations are as follows:
a. in the drain, if it is active throughout the operating cycle;

b. otherwise in a vent, if it is active throughout the operating cycle;

c. otherwise in the coldest part of the usable chamber space.

6.27 The sensor should be placed in the drain or vent in steam phase boundary
conditions in a position where overheat cannot be detected. This will normally
require at least 10 mm insertion depth. The sensors connected to the sterilizer
temperature indicator and recorder, and to the automatic controller, are normally
in this position also. Care should be taken to ensure that the sensor does not
touch any metal parts. (Contact between the hot junction and metal surfaces
can cause induced electromotive forces (EMFs) leading to inaccurate readings.)

6.28 Figure 3 shows several methods for inserting sensors into glass or plastic
containers filled with fluid or powders. It is important that the sensor is firmly
supported and that the container does not leak. For rigid containers the sensor
should be located on the vertical axis and inserted to a depth of 85 ± 5% of the
height of the container. For flexible containers, such as plastic bags, the sensor
should be located as near as practicable to the centre of the fluid and supported
in this position throughout the operating cycle.
 6.0 Test equipment

NOTE: Where a handle

is used, the handle
must be removed

Body is castellated
to permit entry of
temperature sensor wire

A - Temperature sensor wire

B - Silicone rubber washer
C - Silicone rubber disc
D - Metal thrust washer
E - Metal body
F - Adaptor
G - Metal thrust spigot
H - O-ring

The illustration shows a fitting designed for a sterilizing chamber having a male
gland and an ‘O’ ring seal. When the gland is a female thread an adaptor will be
required (F). Other methods of introducing temperature sensors into a sterilizer
chamber and which guarantee a gas-tight seal are equally acceptable.

Figure 2 A method of introducing temperature sensors into a sterllizer chamber

6.29 When sensors are used in fluid containers, steam or fluid may be forced
along the wire between the core and the sheath. To prevent damage to the
recorder, the outer sheath should be either punctured a few centimetres from
the end or stripped back for a similar distance to ensure that droplets forming
where the sheath has been punctured or terminated fall clear of the recorder.

6.30 If the load item is a solid object, the sensor should be held securely in
good thermal contact with the object.

6.31 Where required, sensors may be attached to the chamber walls by means
of masking tape.

39
6.0 Test equipment

Container entry system

PVC containers
Polypropylene containers
and ampoules

Polypropylene container

DIN containers and A -Temperature sensor, wire 2mm O/D

others B - Needle tubing, 12 SWG, sealed at one end only
C - Silicone tubing, 4,5mm O/D x 1 mm I/D
D - No. 21 rubber stopper (852775) with
8mm diameter bore (used for DIN
containers)
E -Gland assembly (M8 x 25mm bolt with
5mm bore)
F - Silicone tubing (to suit container)

Examples

A - DIN standard glass

B - Glass ampoules
C - Rigid plastic container
D - Flexible plastic container

temperature sensor
tube in a central
position

Figure 3 Methods of inserting temperature sensors into load containers

40
Verification of calibration

6.32 The recorder should incorporate mechanical or electrical calibration

facilities. The manufacturer of the recorder will normally calibrate it without the
use of temperature sensors or transducers.

6.33 An independent temperature reference source (a hot source ) is

required, with a pocket to accommodate up to 12 temperature sensors. The
temperature gradient within the pocket should not exceed 0.2 º C and the control
accuracy should be within ±0.1 º C over the relevant sterilization temperature
band.

6.34 The temperature of the hot source should be measured either by a

mercury-in-glass laboratory thermometer conforming to BS593 or other
temperature measurement system of similar or greater accuracy. The supplier
should be asked to provide a certified calibration curve traceable to the national
primary standard. Note that all the thermometric measurements required by this
HTM will ultimately depend upon the accuracy of this calibration; an uncertified
laboratory thermometer will not be accurate enough to ensure that the sterilizer
is working correctly and may give dangerously misleading results. The following
types of mercury-in-glass thermometers are suitable:

a. F 75C/100 (24 º C to 78 º C) for EO sterilizers;

b. F 100C/100 (48 º C to 102 º C) for LTS disinfectors and LTSF sterilizers;

c. F 150C/100 (98 º C to 152 º C) for high-temperature steam sterilizers;

d. F 200C/100 (148 º C to 202 º C) for dry-heat sterilizers.

6.35 Mercury-in-glass thermometers should be used only in the hot source and
must never be placed inside a sterilizer chamber. Note that mercury-in-glass
thermometers are not permitted to be taken into pharmaceutical production
facilities.

6.36 Before a recorder is taken to site, verify the calibration of the system by
inserting the test sensors into the hot source at a temperature within the
sterilization temperature band. Adjust the recorder in accordance with the
manufacturer s instructions until the mean temperature measured by the sensors
is the same as the temperature indicated on the thermometer. The calibration is
satisfactory if the temperatures measured by individual sensors do not differ
from the mean by more than 0.5 º C. This test should be carried out at an
ambient temperature as close as practicable to that expected at site.

6.37 If the hot source is not to be taken to site, connect a millivolt source to
one channel of the recorder, and adjust it until the measured temperature is
within 2 º C of that obtained with the sensors connected. Note the measured
temperature and the voltage indicated on the millivolt source. Also note the
ambient air temperature near the source.

6.38 After arriving at site, and before starting any thermometric tests, check
the calibration using either the hot source or the millivolt source.

a. If the hot source is used, adjust the temperature to correspond with that
used off-site. Check that each sensor is measuring the same temperature
as before;

b. If the millivolt source is used, ensure that the ambient temperature is

similar to that measured off-site. Connect the millivolt source to the
recorder, apply the voltage obtained off-site and check that the same
temperature is measured. Bundle all the sensors together, place them in
the chamber and expose them to an operating cycle. Check that the
 temperatures measured during the holding time are consistent with those
obtained off-site with the hot source.

6.39 Repeat the check after the tests have been completed.

Pressure measurement

6.40 Pressures are required to be measured over a range from 20 mbar

absolute (in vacuum leak testing) to typically 3.8 bar absolute at the working
pressure of a high-temperature steam sterilizer and 7 bar absolute at the
working pressure of a sterilizer using EO gas diluted with carbon dioxide.

Transducers

6.41 Transducers for use with pressure recorders should conform with BS6447,
be suitable for the purpose, certified and no less accurate than the gauges
specified below. The natural frequency of the sensor and connected tubing
should not be less than 10 Hz, and the time constant for rising pressure
(0-63%) should not be greater than 0.04 s.

Gauges

6.42 Pressure gauges are required where the pressure recorder is unsuitable or
for calibrating pressure instruments fitted to the sterilizer. Four gauges will
normally be required to cover the whole pressure range for all sterilizers and
these are specified in Table 6.

Scale range Mark interval

[bar] [mbar] Calibration Application
0 to 0.160 (abs) 1 Gas Vacuum leak testing
-1 to 0 10 Gas LTS, LTSF + pure EO cycles
0 to 4 50 Liquid High-temp steam, EO + HFC
cycles
0 to 10 200 Gas EO + CO2 cycles
Table 6 Pressure gauges for test purposes

6.43 Pressure gauges should be temperature-compensated and, except for the

absolute gauge, be Bourdon-tube test gauges conforming to EN 837: Part 1 of
nominal size 150 mm and accuracy class 0.25 (that is, the error should not
exceed 0.25% of the maximum scale range). For pressure leak testing on EO
sterilizers, gauges should be of accuracy class 1 or, better, over a range within
10% of the gas exposure pressure.

6.44 Gauges not designed for direct connection to steam at 2.8 bar should be
connected via a syphon or similar device to ensure that the accuracy of the
gauge is maintained over the temperature range associated with changing
steam pressure. If the low-pressure gauge used for vacuum leak testing cannot
withstand the pressure in the chamber during sterilization an automatic valve
should be provided to protect it.

6.45 Gauges should be tested yearly by a recognised testing laboratory as

described in paragraph 5.2.1 of BS1780.

6.46 The very low differential pressure across the air filter in a dry-heat
sterilizer can be measured with a water manometer with a range of up to 10
mbar.
Humidity measurement

6.47 Humidity is a critical cycle variable in the control of EO processes. The

level of humidity in the chamber and load at the end of the conditioning stage is
ideally measured during validation by test instruments calibrated for relative
humidity (RH) at atmospheric pressure. The accuracy of measurement should not
be less than ± 10% RH over the range 30-80% RH.

6.48 In practice, the measurement of relative humidity within the chamber of

an EO sterilizer is difficult. Although the new European Standard on EO
sterilizers wiII require RH sensors to be fitted, such sensors are still rare in the UK
and the NHS has little experience in their use. If suitable test sensors are not
available, then the chamber humidity may be validated by calculation as
discussed in Appendix 2.

6.49 There is no British Standard for humidity sensors, but it is recommended

that test sensors should function at temperatures of 10-60 C and at pressures
from vacuum up to 7 bar absolute.

6.50 The sensitivity and accuracy of electrically operated humidity sensors is

often compromised by exposure to EO. The tests described in this HTM require
humidity to be measured only during cycles where an inert substitute for EO is
used. The measurement can then be extrapolated to production cycles provided
the other cycle variables are the same. If it becomes necessary to measure the
humidity during cycles using EO gas, sensors should normally be replaced,
degassed and recalibrated after each cycle.

Other instruments

Sound level meter

6.51 An integrating-averaging sound level meter is required for the sound

pressure test. It should comply with Type 2 of BS6698. Ten microphones are
required for a single sterilizer.

Air flow metering device

6.52 A metering device (such as a needle valve) is required to admit air into the
sterilizer chamber for the air detector tests, and vacuum and pressure leak tests.
The device should be capable of controlling the flow of air into an evacuated
chamber. It should be adjustable and have a range which includes a flow of
0-5 ml min-1 per litre volume of the sterilizer chamber. The error in repeatability
between 10% and 90% of the setting range should not exceed – 5%. The
device is connected to the chamber by a valved port provided by the sterilizer
manufacturer.

Balance

6.53 A laboratory balance is required for steam dryness tests, load dryness
tests and coolant quality tests. It should be capable of measuring the mass of
loads up to 2 kg to an accuracy of 0.1 g (dryness tests), and up to 100 g to an
accuracy of 0.1 mg (coolant quality test).

Gas monitoring instrument

6.54 A gas monitoring instrument, such as an infrared spectrophotometer, is

required for tests on LTSF and EO sterilizers.
6.55 The formaldehyde instrument should be suitable for measuring
formaldehyde concentration in air with an accuracy of ± 10% at 2 ppm.

6.56 The ethylene oxide instrument should be suitable for measuring ethylene
oxide concentration in air with an accuracy of ± 10% at 15 ppm.

6.57 The scale ranges should include the appropriate short-term exposure
limits specified in Table 1, and extend to at least ten times the exposure limit.
The two functions may be combined in one instrument.

Aerosol generator
6.58 An aerosol generator is required for tests on dry-heat sterilizers.

6.59 The device should be capable of generating a polydisperse aerosol with

particles having the size distribution shown in Table 7.

Particle size Fraction by mass

[ m u m] [%]
< 0.5 > 20
< 0.7 > 50
< 1.0 > 75

Source: BS5295: Part 1

Table 7 Particle size distribution for aerosol generator

Photometer
6.60 A photometer is required for tests on dry-heat sterilizers.

6.61 The device should be suitable for estimation or comparison of mass

concentration of airborne particles as defined in Table 7. It should have an
accuracy of better than ± 5% over the range of a five-expandable, six-decade
resolution (that is, 0.01% to 100% of the test cloud) as specified in Appendix C
of BS5295: Part 1.

6.62 The photometer should have a minimum threshold sensitivity of

0.0001 mu g l-1 and should be capable of measuring aerosol concentration in the
range 80-120 mu g. I -1

-1
6.63 The sample flow rate should be 0.40 ± 0.05 I s and sampling should be
via a suitable probe device.
7.0 Testing methods

Introduction

7.1 This chapter discusses general principles and methods that are used in the
thermometric and microbiological tests described in this HTM.

Terminology

7.2 For the purposes of this HTM the following definitions have been adopted.

Cycle variables

7.3 The cycle variables are the physical properties, such as time, temperature,
pressure, humidity and sterilant gas concentration, that influence the efficacy of
the sterilization process. Most of the tests described in this HTM require the
values of cycle variables to be determined experimentally and then compared
with standard values.

7.4 An indicated value is that shown by a dial or other visual display fitted
permanently to the sterilizer.

7.5 A recorded value is that shown on the output of a recording instrument

fitted permanently to the sterilizer.

7.6 A measured value is that shown on a test instrument, such as a

thermometric recorder or a test pressure gauge, attached to the sterilizer for test
purposes.

7.7 A noted value is that written down by the operator, usually as the result of
observing an indicated, recorded or measured value.

Sterilization conditions

7.8 Most operating cycles have a stage in which the load IS exposed to the
sterilization (or disinfection) conditions for a specified length of time. This period
is known as the holding time.

7.9 The sterilization conditions are the ranges of the cycle variables which
may prevail throughout the chamber and load during the holding time.

7.10 The holding time is preceded by a period in which the sterilization

conditions are present in the chamber but not yet present throughout the load.
This is known as the equilibration time.

7.11 Together, the equilibration time and the holding time constitute the
plateau period. While the plateau period can always be determined from the
recorded chamber temperature, the equilibration and holding times cannot be
distinguished unless the temperature in the part of the load that is slowest to
reach the sterilization temperature is also being recorded or measured.

7.12 Certain LTSF sterilizers may achieve sterilization by exposing the load to a
series of pulses of formaldehyde rather than a single holding time.
7.13 For EO sterilizers the plateau period is equivalent to the gas exposure
time. The holding time cannot be determined by thermometry and is therefore
of no practical interest.

7.14 For steam and dry-heat sterilizers, the sterilization conditions are specified
by a sterilization temperature band, defined by a minimum acceptable
temperature, known as the sterilization temperature, and a maximum
allowable temperature. A sterilization temperature band can also be quoted for
LTSF and EO sterilizers, but since these processes depend primarily upon
chemical action such a band is not a complete specification of the sterilization
conditions. Bands for the different types of sterilizer are listed in Table 8.

Ethylene
High-temperature steam Dry heat LTS LTSF oxide
a
Sterilization temperature [ º C] 115 121 126 134 160 170 180 71 b 71 30-56
c
Maximum allowable temperature [ º C] 118 124 129 137 170 180 190 80 80 T
Minimum holding time [min] 30 15 10 3 120 60 30 10 180d te
a. The temperature setting on the automatic controller will not generally be the sterilization temperature, but a higher temperature
within the sterilization temperature band.
b. Disinfection temperature.
c. For EO, the maximum allowable temperature will normally be 4 º C above the sterilization temperature.
d. For LTSF, the sterilization conditions may specify either a continuous holding time or the number of pulses of formaldehyde required
to achieve sterilization.
e. For EO, the gas exposure time IS determined for each sterilizer by microbiological methods during commissioning but IS typically
2-7 h depending upon sterilization temperature and gas concentration.

Table 8 Sterilization temperature bands

Interpretation of thermometric measurements

7.15 Figure 4 shows in schematic form the kind of data that are typically
obtained in a thermometric test using measuring equipment as described in
Chapter 6. In practice there may be more or fewer temperature traces
depending on the number of sensors used. The detailed behaviour before and
after the plateau period is dependent on the nature of the operating cycle and is
not shown here.

7.16 The equilibration time begins when the temperature in the coolest part of
the chamber (normally the active chamber discharge, see paragraph 6.26) first
attains the sterilization temperature. It ends when the holding time begins.

7.17 The holding time begins when the temperature in the part of the load
that is the slowest to heat up first attains the sterilization temperature. It ends at
the start of the cooling stage, when the temperature in the coolest part of the
chamber falls below the sterilization temperature.

7.18 The fluctuation in a trace over a given Interval is ±T C if the difference

between the maximum and minimum values is 2T.

7.19 The drift in a trace over a given interval is the change in the mean value
of the trace over that interval.

7.20 The difference between two traces is the difference in their values at a
given instant. A trace is said to be within T ºC of a given value or another trace
if the difference between them at any instant over a given interval is no more
than T.
 plateau period

The presentation of the

equilibration traces before and after
time holding time the plateau period is
schematic only, and will
depend upon the operating
cycle.

sterilization
temperature
free space
active discharge
fastest
slowest

drift over
2T
time, t

fluctuation is = T

Figure 4 Interpretation of thermometric recording

Chamber temperature profile

7.21 Many of the tests require temperature sensors (or biological or chemical
indicators) to be placed in the parts of the load known to be the most difficult
to sterilize. To make this assessment, it is necessary to know the hottest and
coolest parts of the chamber, and the parts that are the fastest and slowest to
attain the sterilization temperature.

7.22 This procedure is not required for porous load sterilizers since compliance
with the small-load, full-load and air detector tests ensures that the penetration
of steam is effectively instantaneous.

7.23 Place temperature sensors on a grid pattern throughout the usable

chamber space. The number of sensors should be at least as many as that
specified for the relevant full-load test. If the test recorder has too few channels
it will be necessary to run through more than one operating cycle to collect data
from a sufficient number of points. If so, at least two sensors should remain in
the same positions (including one in an active chamber discharge) to establish
the correlation between successive cycles.

7.24 If a choice of operating cycles is available, select the cycle with the
highest sterilization temperature. This will normally be 134 º C for high-
temperature steam sterilizers. Start the cycle.

7.25 At the end of the cycle, examine the measured temperatures and note
the following:

a. the parts of the usable chamber space that are the fastest and the slowest
to attain the sterilization temperature;

b. the parts of the usable chamber space that are the hottest and the coolest
during the sterilization holding time;
c. for sterilizers with a thermal door interlock, the part of the usable chamber
space that is the slowest to cool to 80 º C.

7.26 users should be aware that the temperature profile derived in this way is
valid only for an empty chamber. The presence of a load will disturb the profile,
although the positions determined in paragraph 7.25 will be accurate enough
for most practical purposes. However, where the sterilizer is to be used to
process medicinal products, the positions will need to be confirmed for each
loading condition as part of the performance qualification procedure (see
paragraph 8.17).

Standard test pack

7.27 In order to ensure that tests are carried out under repeatable conditions,
European Standards require the use of a standard test pack for all sterilizers
designed to process porous loads. As well as porous load sterilizers themselves,
the standard test pack is used for tests on LTS disinfectors, LTSF sterilizers and
laboratory sterilizers with a cycle for the disinfection of fabrics.

7.28 The standard test pack is used to check that, at the levels at which the
cycle variables are set, rapid and even penetration of steam into the pack is
attained. The pack is chosen to represent the maximum density of porous load
material which a sterilizer conforming to British and European Standards should
be able to process. It may be used with other materials to form a full load.

7.29 The test pack is composed of plain cotton sheets complying with BS5815:
Part 1, each bleached to a good white and having an approximate size of 90 cm
x 120 cm. The number of threads per centimetre in the warp should be 30 – 6
and in the weft 27 ± 5.

7.30 The sheets should be washed but not subjected to any conditioning
agent. (Conditioning agents may affect the characteristics of the fabric and may
contain volatile substances which will contribute to the non-condensable gases
in the chamber.)

7.31 The sheets should be dried and then aired for at least one hour at a
temperature of 15-25 C and a relative humidity of 30-70%. Failure to observe
this protocol can result in the test giving a pass result when it should have been
a failure. Sheets which have become excessively dehydrated may cause
superheating in the pack, which might also produce misleading results.

7.32 After airing, the sheets should be folded to approximately 22 cm x 30 cm

and stacked to a height of approximately 25 cm. After being compressed by
hand, the pack should be wrapped in similar fabric and then secured with tape
no more than 25 mm wide. The total weight of the pack should be 7.0 ± 0.7 kg.
The sheets will become compressed after the pack has been used. If the weight
of sheets needed to form a stack 25 cm high exceeds 7.7 kg, the sheets should
be discarded.

7.33 Packs which are not used within one hour of preparation may be stored,
providing the environmental conditions are maintained within those specified
above for airing.

7.34 Non-standard test packs made of different materials (including huckaback

towels TL5 or TL6 complying with BS1781) and of different sizes and weights
may be used, provided they comply with BS7720. These packs may also be
useful for small chambers (see paragraph 7.35).

7.35 The standard test pack should not be used where the usable chamber
space is less than five times the volume of the pack. In these cases a smaller
version of the pack may be constructed. This should be of cubic form with a
volume about one-fifth of the usable chamber space, and made of similar
materials to the standard test pack.

Use of chemical indicators

7.36 Chemical indicators are designed to show by a change of colour whether

specified sterilization conditions have been attained. They should, however,
always be regarded as supplementary to definitive thermometric, microbiological
or (for EO) hygrometric results. Whenever a cycle variable is outside its specified
limits an operating cycle should always be regarded as unsatisfactory, irrespective
of the results obtained from any chemical indicators.

7.37 Chemical indicators are manufactured for a range of sterilization

processes and cycle variables. They should not be used for any process other
than that specified by the manufacturer. The use of an inappropriate indicator
may give dangerously misleading results.

7.38 Specifications for chemical indicators for sterilization processes are given
in EN 867 which is currently in preparation (1994). Two classes are applicable to
the tests covered in HTM 2010.

7.39 Class A indicators ( process indicators ) are intended for use with
individual packs of product to demonstrate that the pack has been exposed to
the sterilization process. They have a defined end-point reaction, in which a
visible change occurs after exposure to the specified variables at a level equal to
or greater than that specified for the indicator. Class A indicators are used
alongside biological indicators in tests on LTSF and EO sterilizers to provide an
early visual indication of the efficacy of gas penetration. If a chemical indicator
shows a failure, then it is normal for the test to be abandoned and the cause
investigated. If all chemical indicators are satisfactory, then the biological
indicators should be incubated as described in the relevant test. Chemical
indicators by themselves are insufficient to demonstrate the efficacy of gaseous
sterilization processes. Class A indicators are specified in EN 867: Part 2.

7.40 Class B indicators are designed for use in the Bowie-Dick test for steam
penetration (see paragraph 13.37). They may have either a defined end-point or
a graduated response in which a progressive change occurs on exposure to one
or more process variables allowing assessment of the level achieved. Class B
indicators are specified in EN 867: Part 3.

7.41 Other classes of indicator are available but are not required for the tests
in this HTM.

7.42 The performance of chemical indicators may be affected by the

conditions of storage before use, the methods of use and the conditions of
storage after exposure to the process. For these reasons the recommendations of
the manufacturer for storage and use should be followed precisely. Indicators
should not be used beyond any expiry date stated by the manufacturer.

Use of biological indicators

7.43 Biological indicators are designed to show by the survival of test micro-
organisms whether specified sterilization conditions have been attained. The
absence of growth of a test micro-organism after exposure to a sterilization
process demonstrates that a specified level of microbiological inactivation has
been delivered. Survival of a test micro-organism subjected to a sterilization
process indicates that the process has failed. Biological indicators are required for
tests on LTSF and EO sterilizers to confirm that sterilization conditions have been
attained. On rare occasions they may be required for PQ tests on other types of
sterilizer (see paragraph 8.9).

7.44 Terminology adopted in this HTM conforms to that given in EN 866. An

inoculated carrier is defined as a piece of supporting material on which a
defined number of test organisms has been deposited. A biological indicator is
defined as an inoculated carrier contained within its primary pack ready for use.
The relationship between the components IS shown in Figure 5.

7.45 Biological indicators are manufactured for a range of sterilization

processes and cycle variables. They should not be used for any process other
than that specified by the manufacturer. The use of an inappropriate indicator
may give dangerously misleading results.

7.46 The performance of biological indicators may be affected by the

conditions of storage before use, the methods of use and the techniques
employed after exposure to the process. For these reasons the recommendations
of the manufacturer for storage and recovery conditions should be followed.
Biological indicators should be transferred to the specified recovery conditions as
soon as possible after exposure to the process and in any case within 2 hours of
the end of the cycle. lndicators must not be used beyond any expiry date stated
by the manufacturer.
 7.0 Testing methods

Figure 5 Components of a biological indicator

7.47 Control of biological indicators should be the responsibility of the

microbiologist. Incubation of indicators should be carried out by an accredited
laboratory registered with CPA (UK) Ltd (see Appendix 1) and/or an
independent testing laboratory working in accordance with the BS EN 45000
series of standards.

Specifications

7.48 Specifications for biological indicators for sterilization processes are

given in the several Parts of EN 866, which is currently in preparation (1994).
The standard draws a distinction between indicators designed for routine
monitoring and indicators designed for validation tests. For routine
monitoring, EN 866 specifies both the minimum number of organisms on the
carrier and also a minimum D-value. For validation, no such limits are set. As a
consequence, indicators manufactured in accordance with EN 866 for routine
monitoring will always be suitable for validation, but the reverse will not
necessarily be true.

7.49 The following organisms are recommended in EN 866 for the

microbiological tests specified in this HTM. Other strains or organisms may be
used provided they are demonstrated to be of equivalent performance.
Addresses for culture collections may be found in Appendix 1:

a. for LTSF sterilizers, Bacillus stearothermophilus as specified in EN 866:

Part 5. B. stearothermophilus strains NCIMB 8224 and NCTC 10003
have been found to be suitable;

b. for EO sterilizers, Bacillus subtilis var niger as specified in EN 866:

Part 2. B. subtilis var niger strains ATCC 9372, CIP 7718 and NCTC
10073 have been found to be suitable.

7.50 Although not normally required for the tests in this HTM, the following
organisms may be used where the need arises:

a. for high-temperature steam sterilizers, Bacillus stearothermophilus as

specified in EN 866: Part 3. B. stearothermophilus strains ATCC 7953,
ATCC 12980, CIP 5281 and NCTC 10003 have been found to be
suitable;

b. for dry-heat sterilizers, Bacillus subtilis as specified in EN 866: Part 6.

B. subtilis strains ATCC 9372 and CIP 7718 have been found to be
suitable.
51
7.0 Testing methods

Line-Pickerell helix

7.51 The Line-Pickerell helix (Line and Pickerell, 1973) is a process challenge
device used in microbiological tests on LTSF and EO sterilizers and designed to
simulate the worst-case penetration conditions for sterilization by gas. The
device is so constructed that an inoculated carrier can be placed within it in a
position most difficult for the gas to reach.

7.52 The device consists of stainless steel tubing with a gas-tight metal capsule
for the biological indicator at one end (Figure 6). The capsule is in two parts
which fit together against an O-ring seal and are secured by a knurled nut. The
capsule body is sealed to the stainless steel tube so that the only entry into the
assembled capsule is via the whole length of the tube. The nominal dimensions
of the tube are 4.55 m in length and 3.0 mm in internal diameter, presenting a
single-ended system with a length-to-bore ratio of approximately 1500:1. The
total internal volume of the assembly is approximately 32 ml, of which 0.85 ml
comprises the capsule. For compactness, the tube is formed into a helix of
nominal 115 mm diameter. The tail of the helix is turned out slightly for ease of
connection to air or water services for cleaning.

7.53 Before placing an inoculated carrier in the capsule, ensure that the helix is
clear by blowing oil-free compressed air through it. Check the seal for damage
or deterioration. Tighten the capsule and test it for leakage by submerging the
helix in water and pressurising it with oil-free air at approximately 0.15 bar.

internal diameter 6,0 mm

internal diameter
3,0mm ‘0’ ring seal

tube length
4550mm - Capsule
Stainless steel tubing
Test helix capsule

The test helix

3mm bore
Bore/length ratio =
4550mm long

The figure has been reproduced 1 -

=
from the Journal of Clinical Pathology. 1500

Figure 6 Line-Pickerell helix

52
 Preparation of recovery medium

7.54 The recovery medium should be tryptone soya broth demonstrated as

capable of recovering 10-100 viable spores of the test organism. Documentary
evidence of performance should be provided by the manufacturer for each batch
of dehydrated medium supplied.

7.55 The made-up medium should be prepared in accordance with the

producer s recommendation. If no recommendation is available, proceed as
follows.

7.56 Each batch should be dispensed in volumes of 15-20 ml in screw-capped

bottles of at least 25 ml capacity and sterilized at a sterilization temperature of
121 C. The bottles should be stored at 2-10 C and used within 12 months.

7.57 The microbiologist should test each batch for sterility at each of the
incubation temperatures at which it will be used. Select at least 2% of the
bottles at random and incubate them for seven days at 52-56 º C (for bottles
intended for use with B stearothermophilus) or 30-32 C (for bottles intended
for use with B subtilis). The batch should be considered satisfactory for use at
that incubation temperature if none of the bottles shows growth. If one or more
bottles does show growth, the entire batch should be regarded as not sterile.

7.58 The microbiologist should test each batch for its ability to promote
growth. Test organisms which are damaged but not killed in the sterilization
process may not outgrow if cultural conditions are not ideal. The following
method is recommended.

Ringer s solution (full strength) is 7.59 Remove the inoculated carriers from two biological indicators of the type
made from 9.0 g sodium chloride, to be used with the recovery medium. Place the carriers in 10 ml of quarter-
0.42 g potassium chloride, 0.48 g strength Ringer s solution. Agitate to release the test organisms from the carriers;
calcium chloride and 0.2 g sodium this may be done by ultrasonication, shaking with glass beads, or another
bicarbonate, in 1000 ml of distilled appropriate validated method.
water. Source: Bacteriological tests
for graded milk (Ministry of Health, 7.60 Dilute the solution to make a suspension with a count of 500 test
1937). organisms per ml.

7.61 Select 20 bottles at random from the sterilized batch of recovery medium.
Add 0.1 ml of the suspension to each bottle. Incubate the bottles for seven days
at 52-56 C (for B stearothermophilus) or 30-32 ºC (for B subtilis). Confirm the
recovery of the test organism by subculture as described in paragraph 7.71.

7.62 The batch of recovery medium should be considered satisfactory if all 20

bottles show growth. If one or more bottles does not show growth, the entire
batch should be discarded.

General procedure for microbiological tests

7.63 All biological indicators used in any one test should be taken from the
same batch.

7.64 Except where specified otherwise (in certain EO tests), all the
microbiological tests in this HTM require biological indicators to be used in the
form of unprotected inoculated carriers without their primary packs. They should
therefore be handled aseptically to avoid contamination.

7.65 Biological indicators should be positioned as described in the relevant test

procedure. If chemical indicators are to be used, they should be placed alongside
the biological indicators to form biological/chemical indicator pairs.
7.66 Indicators should be cultured in accordance with the manufacturer s
recommendations. The use of an inappropriate recovery system can give
dangerously misleading results. If no recommendation is available, proceed as
follows.

7.67 Within 2 hours of the end of the cycle, aseptically transfer each
inoculated carrier to a bottle of recovery medium at a temperature of 15-25 º C.
Fit the caps to the bottles loosely (for B stearothermophilus) or tightly (for
B subtilis) .

7.68 Prepare control bottles of recovery medium as follows:

a. at least three bottles (for validation tests) or at least one bottle (for
periodic tests), each containing an unexposed inoculated carrier, to
demonstrate that the indicators are viable;

b. at least three bottles containing recovery medium only, to demonstrate

that the medium is not contaminated.

7.69 Incubate the test bottles together with the controls under the conditions
shown in Table 9.

Organism B stearothermophilus B subtilis

Incubation temperature 52-56 º C 30-32 º C

Incubation time:
for validation tests 14 daysa 7 days
(commissioning and
performance qualification)
for routine tests (production 7 days 7 days
cycles)
a. For validation of LTSF cycles it is recommended that biological indicators are incubated
for 14 days to allow outgrowth of organisms which may have been damaged but not
inactivated by exposure to the process. Once the validation tests have been
successfully completed, incubation times of seven days are acceptable for subsequent
routine tests.

Table 9 Recommended incubation conditions for biological indicators

7.70 Inspect the bottles periodically for signs of growth. After inspection,
gently shake the bottles to aerate the medium. Control bottles should be
handled in the same way as test bottles.

7.71 As soon as one or more of the test bottles becomes turbid, confirm the
isolation of the test organism as follows. Take a sample from each turbid test
bottle and from each positive control bottle and streak them on to tryptone soya
agar on vented plates. B stearothermophilus should be incubated at 52-56 ºC in
an airtight container (such as a plastic bag) to prevent the agar drying out.
B subtilis should be incubated at 30-32 º C. If there is no growth on the test
plates after 18-24 hours, the cloudiness is not due to microbial growth. The
positive control plate should show characteristic colonies of the test organism as
described in A colour atlas of Bacillus species (Parry, Turnbull and Gibson, 1983).

7.72 The test should be considered satisfactory if the following requirements

are met:

a. chemical indicators show a uniform colour change at the end of the cycle;

b. all bottles containing an inoculated carrier exposed to the sterilization

process show no growth at the end of the incubation time;
 c. all control bottles containing an unexposed inoculated carrier show growth
of the test organism within 24 hours;

d. all control bottles without an inoculated carrier show no growth at the

end of the incubation time.

7.73 All culture results should be noted, whether satisfactory or not.

7.74 Where growth has resulted from an organism other than the test
organism, the test is inconclusive and should be repeated.

7.75 Note the following:

a. as a rough guide, the earlier the growth appears during the incubation
period, the less efficacious is the sterilization process;

b. consistent failures in one position in the chamber may indicate problems

of gas distribution (for example, stratification);

c. failure in a helix with no failures in the chamber free space may indicate
poor gas penetration possibly due to inadequate air removal, excessively
wet steam, or (for EO) low humidity;

d. for LTSF sterilizers, failure in the chamber with no failure in a helix may
indicate low humidity due to the chamber wall being too hot or the steam
being superheated.
8.0 Performance qualification

Introduction

8.1 Performance qualification (PQ) is defined as the process of obtaining and

documenting evidence that the sterilizer, as commissioned, will produce
acceptable goods when operated in accordance with the operational
instructions. PQ tests are performed as part of the initial validation procedure, as
part of any repeat validation procedure, and whenever the user judges that a
new loading condition calls for a new PQ test.

8.2 Performance qualification should not be attempted on any sterilizer that

falls to meet the requirements of the commissioning tests specified in Chapters 4
and 5.

8.3 Thermometric PQ is required for all sterilizers. Additional microbiological

PQ tests, and PQ tests for environmental gas and load degassing times, are
required for LTSF and EO sterilizers.

8.4 Information gathered from the PQ test is filed in a PQ report which

specifies the standard of performance expected with a particular operating cycle
and loading condition (see paragraph 8.7). The report includes a master process
record, employed by the user to validate routine production loads, together with
thermometric and (where required) microbiological data used for subsequent
performance requalification.

8.5 Performance requalification (PRQ) is the process of confirming that the

sterilizer continues to meet the performance standards established during
performance qualification, and that the working data collected during
performance qualification remain valid. It is carried out once a year as part of the
yearly test schedule, as part of any revalidation process, or whenever the user
requests such confirmation.

8.6 PQ and PRQ tests should normally be preceded by the basic performance
tests specified in the commissioning and yearly test schedules.

Loading conditions and reference loads

8.7 A loading condition is a specified combination of the nature and number

of load items, the items of chamber furniture, and their distribution within the
chamber. For example, a load placed on the top shelf of the chamber constitutes
a different loading condition from an identical load placed on the bottom shelf.
In principle, validation is not complete until a PQ test has been performed for
each loading condition that the sterilizer is expected to process. In practice,
loading conditions specified in the thermometric tests for small and full loads
carried out during commissioning are designed to be representative of the
nature of production loads, and to present a greater challenge to the process
than most production loads. In these cases PQ data may be taken from the
commissioning tests and PQ tests may not be necessary.

8.8 Guidance on the design of loading conditions to achieve efficient

sterilization can be found in Part 4 of this HTM.
8.9 PQ tests are indicated in the following circumstances:

a. where the loading condition presents a greater challenge to the process

than that presented by the commissioning tests. For example, while porous
load sterilizers rarely need PQ tests, such tests will be required if the
density of the porous material exceeds that of the standard test pack (see
paragraph 7.27) or if narrow lumens restrict air removal and steam
penetration;

b. where the nature of the load is not represented by the commissioning

tests. For example, certain loads may be damaged by exposure to the
normal sterilization temperature. In these cases, the settings of cycle
variables and their permitted tolerances should ensure not only that the
load is sterilized, but also that it is not unacceptably degraded by long
exposure to high temperatures.

8.10 Where PQ tests are required it is often possible to select a productron load
that is known to present a greater challenge to the process than any of the
others, This reference load can then serve as a worst case and allow one PQ
test to be valid for a range of less demanding loading conditions.

8.11 A microbiological PQ test is required for LTSF and EO sterilizers in addition

to the thermometric test. It may also be required for other sterilizers where air
removal and steam penetration are difficult, and a thermometric test does not
provide sufficient assurance that the sterilization conditions have been attained
throughout the load.

8.12 Responsibility for deciding which loading conditions require PQ tests is

exercised as follows (in doubtful cases advice should be sought from the
authorised person:

a. sterilizers to be used for medicinal products - jointly by the user, the

quality controller and the test person;

b. LTSF and EO sterilizers - jointly by the user, the microbiologist and the test
person;

c. all other sterilizers - jointly by the user and the test person.

Thermometric test for performance qualification

8.13 This test is suitable for all steam sterilizers, that is, porous loads, fluids,
unwrapped instruments and utensils, LTS, LTSF and laboratory sterilizers. (See
Chapter 16 for dry-heat sterilizers, and Chapter 18 for EO sterilizers.)

8.14 The production load under test will normally consist of discrete items such
as packs, bottles or other containers. Place temperature sensors in the following
positions:

a. one in each of three items known to be the slowest to attain the

sterilization temperature;

b. one in each of three items known to be the fastest to attain the

sterilization temperature;

C. if the sterilizer has a thermal door interlock, one in each of three items
known to be the slowest to cool to 80 º C.

8.15 If the load consists of less than six items, then place a sensor in each item.

8.16 The sensors should be in good thermal contact with the fluid or device
which they are monitoring, and placed, If possible, in or on the part of the item
slowest to heat up. (See Chapter 6 for guidance on the use of temperature
sensors.)

8.17 The fastest and slowest items should have been identified as part of the
design of the loading condition as described in Part 4. It may be desirable to
confirm that the correct items have been selected by placing additional sensors
in neighbouring items and running one or more preliminary operating cycles to
verify that the selected items are indeed the fastest and slowest.

8.18 Place a sensor either in an active chamber discharge (see paragraph 6.26)
or in the coolest part of the chamber. (This will normally be close to the sensor
connected to the sterilizer recording instrument.)

8.19 Insert any load temperature probes provided in the chamber into the
positions they will normally occupy in the load. If a probe is required to occupy
the same position as a sensor, then the sensor should be moved to a
neighbouring load item if they cannot both be accommodated in the same load
item.

8.20 Note the loading condition and the positrons of the sensors and probes in
sufficient detail for the test to be replicated on any future occasion.

8.21 If the sterilizer has a pressure instrument, connect a pressure recorder (or
test gauge) to the chamber.

8.22 Select the operating cycle that wiII be used for the productton load. Start
the cycle.

8.23 Ensure that a batch process record is made by the recording instrument
fitted to the sterilizer. This will serve as the basis for a master process record for
the loading condition under test (see paragraph 8.58). If the sterilizer does not
have a recorder (such as some machines for unwrapped instruments and
utensils), note the elapsed time, indicated chamber temperatures and pressures
at all significant points of the operating cycle, for example the beginning and
end of each stage or sub-stage.

8.24 At the approximate mid-point of the plateau period, note the elapsed
time and indicated chamber temperature and pressure.

8.25 For fluid loads, during the cooling stage wait for the temperature in the
containers to fall to 95 C (plastic containers) or 85 º C (glass). Wearing protective
visor and gloves, attempt to open the door. As soon as the cycle is complete, but
before opening the door, note the recorded temperature in the containers.

8.26 The test should be considered satisfactory if the following requirements

are met:

a. the requirements of the automatic control test (see paragraph 12.13) are
met;

b. the holding time, as determined from the measured temperatures, is not

less than that specified for the appropriate sterilization temperature band
in Table 8;

c. during the holding time:

(i) the measured temperatures are within the sterilization temperature
band specified for the operating cycle;
(ii) the indicated and recorded chamber temperatures are within 2 º C
of the temperature measured in the active chamber discharge;
 (iii) the temperature measured in each load item does not fluctuate
more than ± 1 º C, and does not differ from that in other load items
by more than 2 º C;
(iv) the indicated and recorded chamber pressures are within 0.05 bar
of the measured pressure;

d. at the end of the cycle:

(i) the temperature sensors have remained in position;
(ii) the items containing sensors are intact;
(iii) the temperature measured in any fluid containers is not greater
than 90 º C (plastic) or 80 º C (glass).

8.27 If the test is satisfactory, it should be performed two more times to check
for reproducibility and to establish permitted tolerances (see paragraph 8.47). A
master process record should then be made as described below (see paragraph
8.58).

8.28 If, having completed the commissioning tests, the sterilizer fails to meet
the above requirements then it is possible that the sterilizer is not capable of
processing the load. Advice should be sought from the authorised person.

Microbiological test for performance qualification

8.29 This test is designed to be used in exceptional circumstances as an

additional PQ test for steam and dry-heat sterilizers. (See Chapter 17 for LTSF
sterilizers, and Chapter 18 for EO sterilizers.)

8.30 The microbiological test should follow a satisfactory thermometric test,

and use the identical loading condition and operating cycle. (See Chapter 7 for
information on the use of biological and chemical indicators.)

8.31 Put a biological indicator and a chemical indicator together in each of the
six load items that carried temperature sensors in the thermometric test. Place
the items in as nearly as possible the same positions they occupied in the
thermometric test.

8.32 Select and start the operation cycle.

8.33 Ensure that a batch process record is made by the recording instrument
fitted to the sterilizer. If the sterilizer does not have a recorder (such as some
machines for unwrapped instruments and utensils), observe and note the
elapsed time, indicated chamber temperatures and pressures at all significant
points of the operating cycle, for example the beginning and end of each stage
or sub-stage.

8.34 At the approximate mid-point of the plateau period, note the elapsed
time and indicated chamber temperature and pressure.

8.35 At the end of the cycle, remove the indicators from the load items. Check
that the chemical indicators show a uniform colour change. If so, place each of
the inoculated carriers in a bottle of recovery medium and incubate them with
controls as described in the general procedure for microbiological tests (see
paragraphs 7.63-75).

8.36 The test should be considered satisfactory if the following requirements

are met:
 a. during the whole of the cycle the values of the cycle variables as shown on
the batch process record are within the permitted tolerances marked on
the master process record established during the thermometric PQ test;

b. the requirements for microbiological tests set out in paragraph 7.72 are
met.

Environmental gas test

8.37 This PQ test is designed to determine the concentration of formaldehyde

or EO gas discharged into the loading area from the chamber and load at the
end of a cycle. The concentration will vary with the type of load, wrapping
material and environmental ventilation and temperature.

8.38 This test should follow a satisfactory thermometric PQ test. The loading
condition, preconditioning process and operating cycle should be identical. The
test may be combined with the microbiological PQ test.

8.39 A gas monitoring instrument as described in Chapter 6 is required.

8.40 Load the chamber as for the microbiological test for performance
qualification.

8.41 Select the operating cycle used in the microbiological test. Start the cycle.

8.42 At the end of the cycle, measure the concentration of gas discharged
from the chamber into the air when the door starts to open. The sample should
be taken 80-120 mm in front of the gap at a height of 1.4-1.6 m. Continue to
monitor the gas concentration for the next 15 min.

8.43 Determine the average concentration of gas over the 15-min period.

8.44 The test should be considered satisfactory if the average concentration of

gas over the 15-min period does not exceed the short-term exposure limit
specified in Table 1.

8.45 The data from the test should be used to establish a permitted upper limit
for subsequent performance requalification. This should be as low as reasonably
practicable, and in any case lower than the short-term exposure limit (see
paragraph 1.28).

Test for degassing time

8.46 Loads from LTSF and EO sterilizers require a further PQ test to determine
the minimum degassing time required before a load may be released for clinical
use. It is the responsibility of the user to establish this period for the area in
which sterilized loads are stored. Procedures for determining the levels of
residual EO are described in EN 30993: Part 7; a standard for formaldehyde is
under development.

Permitted tolerances

8.47 It is the purpose of performance qualification to establish the standard of

performance expected with a particular operating cycle and loading condition,
so that subsequent productron cycles can be Judged by that standard. The
evidence for this performance is provided by the indicated, recorded and
measured cycle variables, and it is necessary to determine how much each
variable will be permitted to vary from cycle to cycle while still conforming to
that standard.

8.48 A starting point is the limits prescribed for the cycle variables in the
commissioning and PQ tests described in this HTM. Other than in exceptional
circumstances, these limits should be regarded as absolute, and a failure to meet
them implies a failure of the test and a gross failure of the sterilizer. These limits
originate from European and British Standards and from operational experience.
They are set to accommodate a wide range of sterilizer models and designs of
operating cycles. However, an individual sterilizer should be able to repeat a
cycle well within these limits, and the permitted tolerances for PQ purposes
should be correspondingly smaller.

8.49 It is important that the tolerances are set with careful consideration of the
likely range of variation from cycle to cycle. If set too tight, acceptable
production loads may be erroneously rejected as non-sterile, and automatic
control and PRQ tests may fail unnecessarily. However, it would be a mistake to
set an over-generous tolerance, since that may disguise variations signalling a
developing malfunction of the sterilizer. The following paragraphs give guidance
on determining the permitted tolerances. The authorised person should be
consulted in cases of doubt.

8.50 PQ tests (or commissioning tests providing PQ data) collect indicated,

recorded and measured data (see paragraph 7.2-7.20 for an explanation of
these terms). The three sets of data serve different purposes and may require
different tolerances:

a. indicated data are available to the user for production cycles on all types
of sterilizer, but cannot be regarded as definitive. Except for sterilizers
without a recorder, PQ tests require indicated values to be noted only
during the holding time to ensure that they comply with the sterilization
conditions;

b. recorded data are available to the user for production cycles on most
types of sterilizer and can be regarded as definitive for routine production
control. The permitted tolerances are normally marked on a master process
record (see paragraph 8.58). The user should be aware of any calibration
error in the recorder, but since production cycles are validated by direct
comparison of the batch process record (BPR) with the master process
record (MPR), such errors can be ignored in determining the permitted
tolerances;

c. measured data are not available for production cycles and so play no part
in routine monitoring. However, they are to be regarded as definitive for
the purposes of performance requalification. Measured variables are more
reliable than Indicated or recorded values, and the permitted tolerances
should reflect this.

8.51 A further consideration is the intended use of the PQ data:

a. PQ data valid for a single loading condition: where the PQ data are to
be used for one loading condition only, the variation between cycles is
essentially random (that is, due to uncontrolled variables or the intrinsic
performance limits of the sterilizer) and the permitted tolerances can be
tight. This is appropriate, as such cases are often used for loads which
would be damaged if the limits were broader. The tolerances should be set
by experience of the sterilizer and of the cycle. The three replicate
thermometric PQ tests (see paragraph 8.13) will give some indication of
what variation to expect;

b. PQ data valid for a range of loading conditions: where the PQ data

for a single loading condition is judged to be valid for a range of loading
 conditions, the variation between cycles will contain a systematic variation
related to the differing loading conditions and therefore the permitted
tolerances will be greater. The choice of loading conditions for which the
data is valid should take into account whether this greater tolerance is
acceptable;

c. PQ data obtained from commissioning tests: for many loads, especially

on porous load sterilizers, PQ tests are not normally necessary and data
from the thermometric commissioning tests are used to establish
performance standards for a wide range of loading conditions. In these
cases, data from the small-load and full-load tests can be used to establish
the limits of variation for production loads which fall between these two
extremes. The permitted tolerances will be broader than either (a) or (b).

8.52 Note that the permitted tolerances during the holding time of an
operating cycle will generally be tighter than those allowed during the preceding
and following stages. In no circumstances should these tolerances permit the
cycle variables to depart from the sterilization conditions specified in Table 8,
unless the operating cycle has been designed with that intention.

8.53 Tolerances are normally expressed as a permitted variation either side of a

central value, either in absolute terms or as a percentage. In some cases the
tolerances may be expressed as an upper or lower limit, with the variables
permitted to take any value on the safe side of the limit.

PQ report
8.54 All the data collected during PQ tests should be filed in a PQ report, a
copy of which should be kept with the plant history file. The report should
contain or refer to the complete specification for the sterilization process. The
specification should be detailed enough to allow the loading condition, the
operating cycle and the test itself to be replicated on any future occasion. The
report should include the following:
a. a specification of the loading condition, defined either by the nature and
number of load items, items of chamber furniture, and their distribution
within the chamber, or by a coded reference to a detailed specification
held elsewhere;

b. a specification of the operating cycle, defined either by the settings for the
cycle variables or by a coded reference to a detailed specification held
elsewhere;

c. a specification of any preconditioning, conditioning and degassing process

(this is essential for EO sterilizers);

d. all the indicated, recorded and measured data from the test, drawing
attention to the values and permitted tolerances of elapsed time and of
the indicated, recorded and measured cycle variables at all significant
points of the operating cycle, for example at the beginning and end of
each stage or sub-stage (the tolerances in recorded variables should also
be marked on the master process record);

e. for loads which require the removal of air before sterilization, the method
used to verify whether the minimum conditions of steam penetration into
the load are attained (for porous load sterilizers, this is by use of the air
detector);

f. the original of the master process record derived from the test.

8.55 EO sterilizers require extensive additional data for safety and quality
control purposes and these are listed in Table 11.
8.56 Immediately following the PQ tests, the test person should prepare PQ
summary sheets (see Appendix 3) and working copies of any necessary master
process records. These should be given to the user and kept with the sterilizer
process log.

8.57 If PQ tests are not required, the PQ summary sheet should contain data
from the thermometric test for a full load and be marked accordingly.

Preparation of a master process record

8.58 A master process record (MPR) is a record of the values and permitted
tolerances of cycle variables for a correctly functioning operating cycle against
which test and production cycles can be checked. (The term master
temperature record was used in previous editions of HTM 10.) It is derived
either from the batch process record (BPR) obtained during a thermometric PQ
test or, if no PQ test has been deemed necessary, from the BPR obtained from a
full-load thermometric test carried out during commissioning. (A further MPR
may be required to validate automatic control tests with an empty chamber.) It
may be a one-to-one transparent copy of the BPR, a template derived from
the BPR, or data stored in a computer control system and compared
automatically.

8.59 An MPR is primarily intended for production control on sterilizers used to

process medicinal products, but it is also used for test purposes on all types of
sterilizer.

8.60 When required for production purposes, a sufficient number and variety
of MPRs should be prepared so that there is a suitable MPR for each loading
condition or for the appropriate reference load (see paragraph 8.10).

8.61 To prepare an MPR, the appropriate thermometric test should be carried

out as described above (see paragraph 8.13). If all three cycles are satisfactory,
the BPR showing the shortest holding time should be used for producing the
MPR. It should be marked with the following information:

a. an MPR reference number and reference to the PQ report;

b. sufficient information to identify the sterilizer uniquely (by a unique

reference number; by the name of the manufacturer, the model of
sterilizer and the serial number; or by any sufficient combination of these);

c . a specification of the loading condition as in paragraph 8.54a and other

loading conditions for which the MPR is valid;

d. a specification of the operating cycle as in paragraph 8.54b;

e. the permitted tolerances for the cycle variables during each stage of the
operating cycle (these are best shown graphically);

f . for fluid loads, the point during the cycle at which the temperature of the
fluid in the hottest container falls to 80 º C (glass) or 90 º C (plastic);

g. date of test;

h. signatures of the test person and the user.

8.62 When the BPR has been annotated it may be endorsed master process
record and a transparency obtained. An example of an MPR is shown in Figure
7.

8.63 If the BPR is in the form of numerical data, the MPR should be presented
in a similar form to the BPR to permit ready comparison. As a minimum
8.0 Performance qualification

Reference
15-26-03-85

Site & Dept.

Western General
Pharmacy

P.Q. report reference

SDE/3/X

Make of sterilizer
& serial number
DAB - FC/378/93

Type of sterilizer
Fluid Mk4
RCF

Loading condition
reference
P/326

Location of load
temperature probe
Lower front centre

Operating cycle
reference
OC/31

Chart Speed
1 cm = 2 minutes

Test Person
J Stern
26 January 1993

User
T fear
26 January 1993

Figure 7 Example of Master Process Record (analogue)

64
 Reference - 15-26-03-85
Site and department - Western General/Pharmacy
PQ report reference - SDE/3/X
Make of sterilizer and serial number - DAB FC/378/93
Type of sterilizer - Fluid Mk4 RCF
Loading condition reference - P/326
Location of load temperature probe - Lower front centre
Operating cycle reference - oc/31
Sterilization temperature - 121 º C
Sterilization temperature band (F) - 3C
Sterilization pressure hand - 0.15 bar
Holding time - 15 Minutes

Stage Time Temperature ºC Pressure F (O)

min/sec Drain Load m bar min
Heating 0.00 22.2 20.0 996 0.0
(D) 5.15 110.0 80.1 1450 0.0
(C) 14.45 121.1 110.2 2060 0.0
Holding Time (B)
21.15 122.1 121.1 2155 5.6
22.00 122.1 121.2 2161 6.5
22.45 122.1 121.4 2165 7.2
23.30 122.1 121.5 2163 6.6
24.15 122.3 121.7 2163 8.9
25.00 122.1 121.7 2177 9.8
23.45 122.3 121.8 2147 10.6
26.30 122.3 121.9 2167 11.5
27.15 122.3 121.9 2187 12.4
28.00 122.3 122.1 2160 13.4
28.45 122.4 122.1 2171 14.2
29.30 122.3 122.0 2173 15.2
30.15 122.3 122.1 2182 16.2
31.00 122.4 122.1 2162 17.2
31.45 122.4 122.1 2151 18.0
32.30 122.4 122.1 2166 18.9
33.15 122.4 122.1 2166 19.8
34.00 122.4 122.2 2171 20.9
34.45 122.4 122.2 2151 21.8
35.30 122.4 122.2 2153 22.7
36.15 122.5 122.3 2156 23.7
(A) 37.00 115.6 121.0 2260 24.2
Cooling 37.45 113.6 120.1 2270 24.4

(E) 98.15 39.2 80.0 2271 24.8

101.00 35.4 76.3 2216 24.8
103.15 31.1 75.2 846 24.8

Venting 104.00 31.1 75.2 846 24.8

104.45 26.1 74.8 995 24.8
End

Test Person J Stem Date: 26 January 1993

User T Pear Date: 26 January1993

Figure 8 Example of Master Process Record (digital)

requirement, it should list the cycle variables at each turning point of the cycle
and contain a plot generated from the data. An example of a digital MPR is
shown in Figure 8.

Tests for performance requalification

8.64 PRQ tests are performed once a year to ensure that the sterilization
conditions are still met. They should follow the yearly schedule of checks and
tests listed in Chapter 5. For a given operating cycle it is normally necessary only
to perform the PRQ test for a reference load for which a PQ report exists. The
cycle can then be assumed to be effective for less demanding loads also. The
need for PRQ tests on other loads should be agreed between the user and the
test person.

8.65 The procedure for the PRQ test is similar to that for the PQ test. The
operating cycle and the loading condition should be identical to those used for
the original PQ test. The test should be considered satisfactory if the values of
the measured cycle variables are within the tolerances stated in the PQ report.

8.66 For dry-heat sterilizers, fluid sterilizers and certain fluid cycles on
laboratory sterilizers, a simplified PRQ test is required at quarterly intervals, and
this is provided for in the schedules (see Tables 4 and 5).

8.67 Results of PRQ tests should be appended to the relevant PQ report.

8.68 Providing the yearly test programme has been completed satisfactorily,
the sterilizer should pass the PRQ test. If the PRQ test is not satisfactory, the
advice of the authorised person should be sought.

Notes to Figures 7 and 8

Figure 7 shows a typical master process record (MPR) for a fluid sterilizer. This is
based on a batch process record made during a performance qualification test at
a sterilization temperature of 121 ºC.

X Temperature recorded in the active chamber discharge.

Y Temperature recorded in the load item slowest to attain the sterilization

temperature.

Z Chamber pressure.

A The end of the holding time is taken as the datum point from which
Intervals are measured.

B Start of the holding time, with permitted tolerance

C Start of the plateau period, with permitted tolerance.

D Temperature in the load item attains 80 º C.

E Temperature in the load item falls to 80 º C. The door may be opened at

this point.
F Sterilization temperature band.

G Sterilization pressure, with permitted tolerance.

The following deviations from the MPR are considered acceptable:

interval A-B, ± 10%;

interval A-C, ± 10%;

interval A-E, ± 20%;

interval B-D, ± 20%.

9.0 Steam quality tests

Introduction

9.1 A continuous supply of saturated steam is required for steam sterilization

and for humidification in certain EO sterilizers. Too high a level of non-
condensable gases will prevent the attainment of sterilizing conditions; too little
moisture carried in suspension may allow the steam to become superheated
during expansion into the chamber, while excess moisture may cause damp
loads.

9.2 For all these tests, the steam should be sampled from the steam service
pipe to each sterilizer. The measurements are taken during a period of maximum
steam demand, when steam is first admitted to the sterilizer chamber.

9.3 Silicone rubber tubing is porous to steam and should not be used to carry
steam in these tests.

Non-condensable gas test

9.4 This test is used to demonstrate that the level of non-condensable gases in
the steam will not prevent the attainment of sterilization conditions in any part
of the load. (Possible sources of non-condensable gases are discussed in Part 2
of this HTM.) The method described should be regarded not as measuring the
exact level of non-condensable gas, but a method by which the provision of
acceptable steam quality can be demonstrated.

9.5 The apparatus is shown and described in Figure 9. All sizes are nominal.

9.6 Connect the needle valve to the steam service pipe as shown in Figure 9.

9.7 Assemble the apparatus so that condensate will drain freely from the long
rubber tube into the sampling pipe. If the tube is too short, copper or stainless
steel tubing may also be used.

9.8 Fill the container with cold water until it overflows. Fill the burette and
funnel with cold water, invert them and place them in the container. Draw out
any air that has collected in the burette.

9.9 With the steam sampling pipe out of the container, open the needle valve
and allow steam to purge the air from the pipe. Place the pipe in the container,
locate the end within the funnel, and add more cold water until it flows through
the overflow pipe.

9.10 Place the empty measuring cylinder under the container overflow.

9.11 Adjust the needle valve to allow a continuous sample of steam into the
funnel sufficient to cause a small amount of steam hammer to be heard.
Ensure that all the steam is discharged into the funnel and does not bubble out
into the container. Note the setting of the needle valve. Close the valve.

9.12 Ensure that the container is topped up with cold water and that the
measuring cylinder is empty. Draw out any air present in the burette.
9.0 Steam quality tests

From steam service

b
d
a - 50ml burette with a minor mark of 1 ml
b - parallel-sided funnel with a nominal opening of 50mm
c - rubber tubing - size to suit funnel and burette
d - 2000ml container with overflow at 1500ml
e - steam sample delivery pipe - 6mm O/D with 75mm upturn
f - ¼ BSP needle valve
g - 250ml measuring cylinder with a minor mark of 10ml
h - burette stand
i - rubber tubing
j - thermometer 0-100% with a minor mark of 1°C
k - overflow pipe

Figure 9 Apparatus for non-condensable gas test

9.13 Ensure that the sterilizer chamber is empty except for the usual chamber
furniture. Select and start the operating cycle.

9.14 When the steam supply to the chamber first opens, open the needle valve
to the previously noted setting, allowing a continuous sample of steam into the
funnel sufficient to cause a small amount of steam hammer to be heard.

9.15 Allow the steam sample to condense in the funnel. Any non-condensable
gases will rise to the top of the burette. Overspill formed by the condensate and
the water displaced by the gases will collect in the measuring cylinder.

9.16 When the temperature of the water in the container reaches 70-75°C,
close the needle valve. Note the volume of gas collected in the burette and
the volume of water collected in the measuring cylinder (VC).

68
 9.0 Steam quality tests

9.17 Calculate the fraction of non-condensable gases as a percentage as

follows:

Fraction of non-condensable gases = 100 x

9.18 The test should be considered satisfactory if the fraction of non-

condensable gases does not exceed 3.5%.

9.19 The test should be done two more times to check consistency. If the
results of the three tests differ significantly, then the cause should be
investigated before proceeding further.

Superheat test

9.20 This test is used to demonstrate that the amount of moisture in

suspension with steam from the service supply is sufficient to prevent the steam
from becoming superheated during expansion into the chamber.

9.21 The method described here uses a low-volume sample, continuously

taken from the centre of the steam service pipe. The level of superheat
determined by this method cannot be regarded as indicative of the true dryness
of the steam in the pipe since condensate flowing along the inner surface is not
collected. However, devices designed to separate free condensate are
incorporated into the steam delivery system to the chamber and therefore the
level determined by this method is representative of steam conditions likely to
prevail within the chamber during the plateau period.

9.22 This test should normally follow a satisfactory test for non-condensable
gases.

9.23 This test, and the subsequent dryness value test, require a pitot tube as
shown in Figure 10. The rest of the apparatus is shown and described in Figure
11. All sizes are nominal.

9.24 Fit the pitot tube concentrically within the steam service pipe as shown in
Figure 11.

9.25 Fit the sensor entry gland to the steam service pipe. Insert one of the
sensors through the gland and position it on the axis of the pipe.

9.26 Insert the second sensor through the gland in the expansion tube and
position it on the axis of the pipe. Wrap lagging around the expansion tube.
Push the tube on to the pitot.

Steam
pressure Bore ‘A

bar mm 0,02

up to 3 0,8
Pitot tube up to 4 0,6
6mm O/D tubing up to 7 0,4

Silver solder

Figure 10 Pitot tube

69
9.0 Steam quality tests

Temperature sensor fitting

From steam service

To temperature measuring instrument

To sterilizer

Expansion tube

150 2

Nylon bush ‘A’ - Suitable fitting for

Push fit into locating a temperature
the tube sensor into the tube.
To minimise heat transfer
between the fitting and
temperature sensor,
insulation may be
required.

Figure 11 Apparatus for superheat test

9.27 Ensure that the sterilizer chamber is empty except for the usual chamber
furniture. Select and start the operating cycle.

9.28 From the measured temperatures, note the temperature in the steam
service pipe (for use in the dryness test) and in the expansion tube (Te) when the
steam supply to the chamber first opens. Calculate the superheat in °C from the
following equation:

Superheat = Te - TO

where TO is the boiling point of water at local atmospheric pressure.

9.29 The test should be considered satisfactory if the superheat measured in

the expansion tube does not exceed 25°C.

70
 9.0 Steam quality tests

Dryness test

9.30 The accurate measurement of the percentage of moisture content in the

steam is difficult, and the traditional methods where constant steam flow is
required are not suitable for sterilizers. This test should be regarded not as
measuring the true content of moisture in the steam, but as a method by which
the provision of acceptable steam quality can be demonstrated. Possible sources
of excess moisture are discussed in Part 2 of this HTM.

9.31 The test is conveniently carried out immediately after the superheat test.

9.32 This test requires a pitot tube as shown in Figure 10. The apparatus is
shown and described in Figure 12. All sizes are nominal. A laboratory balance is
also required, capable of weighing a load up to 2 kg with an accuracy of 0.1 g
or better.

9.33 If it is not already fitted, fit the pitot tube concentrically within the steam
service pipe as shown in Figure 12.

9.34 If it is not already fitted, fit the sensor entry gland to the steam service
pipe. Insert a temperature sensor through the gland and position it on the axis
of the pipe.

Rubber tubing of length 450 50mm

Pitot tube Must be self draining
From steam service

Temperature sensor
250mm (minimum) entry gland

To sterilizer

To temperature
measuring
instrument
Pipe for thermocouple
and vent

One-litre
vacuum
flask

Figure 12 Apparatus for dryness test

Rubber bung assembly
Glass pipes have 6mm outside diameter

71
9.35 Connect the rubber tube to the longer of the pipes in the stopper, place
the stopper in the neck of the vacuum flask, weigh the whole assembly and
note the mass (M1).

9.36 Remove the stopper and tube assembly and pour 650 – 50 ml of cold
water (below 27 ° C) into the flask. Replace the stopper and tube assembly, weigh
the flask and record the mass (M2).

9.37 Support the flask close to the pitot, and ensure that the rubber tube and
flask are protected from excess heat and draughts. Do not connect it to the pitot
tube yet.

9.38 Introduce the second temperature sensor through the shorter of the two
pipes in the stopper and into the water in the flask. Note the temperature of the
water in the flask (Ts).

9.39 Ensure that the sterilizer chamber is empty except for the usual chamber
furniture. Select and start the operating cycle.

9.40 When the steam supply to the chamber first opens, connect the rubber
tube to the pitot discharge and wrap lagging around it. Arrange the rubber tube
to permit condensate to drain freely into the flask. Note the temperature in the
steam service pipe (Ts).

9.41 When the temperature of the water in the flask is approximately 80 ° C,

disconnect the rubber tube from the pitot, agitate the flask so that the contents
are thoroughly mixed, and note the temperature of the water (T1).

9.42 Weigh the flask and stopper assembly and note the mass (M,

9.43 The initial mass of water in the flask is given by Mw = M2 - M1.

9.44 The mass of condensate collected is given by MC = M3 - M2.

9.45 Calculate the dryness value of the steam from the following equation:

T0 = initial temperature of the water in the flask ( ° C);

T1 = final temperature of the water and condensate in the flask ( ° C);
Ts = average temperature of the steam delivered to the sterilizer ( ° C);
Mw = initial mass of water in the flask (kg);
MC = mass of condensate collected (kg);
L = latent heat of dry saturated steam at temperature Ts (kJ kg-1).

9.46 A derivation of this equation, and a discussion of the assumptions implicit

within it, can be found in Appendix 2.

9.47 The test should be considered satisfactory if the following requirements

are met:

a. the dryness value is not less than 0.90 (if metal loads are to be processed,
the dryness value should not be less than 0.95);

b. throughout the operating cycle, the temperature measured in the steam

service pipe is within 3 ° C of that measured during the superheat test.
10.0 Sound pressure test

Introduction

10.1 British and European Standards require the manufacturer to carry out a
sound power test as a type test for the sterilizer. This test, which measures the
total radiated sound power from a sterilizer, must be performed in a suitably
equipped test room and it IS not necessary or practicable to repeat the test once
a sterilizer has been installed.

10.2 Of more practical concern is the perceived level of noise in the immediate
vicinity of the sterilizer. This quantity, the A-weighted sound pressure level,
depends not only upon the sound power, but also upon the acoustic properties
of the environment and other sources of noise. It must therefore be determined
on site with the sterilizer installed and working normally. It follows that a failure
of the sound pressure test need not imply that the sterilizer is faulty. It is possible
that the machine is installed in a room with insufficient sound insulation.
Information about sound-reducing measures may be found in Part 2 of this
HTM.

10.3 The sound pressure test described in this chapter should be carried out
according to the detailed Instructions in BS4196: Part 6 (referred to in this
chapter as BS4196). The additional information given here is by itself not
sufficient to permit the test to be completed by personnel unfamiliar with the
requirements of BS4196.

Test procedure

10.4 A precision sound-level meter is required as described in paragraph 6.51

The sound pressure levels are determined from a number of microphone
positions. Where the measuring Instrument has insufficient input channels,
additional instruments or repeated operating cycles willl be required.

10.5 The test determines the A-weighted sound pressure levels using a
rectangular measurement surface. For the purpose of this test, the reference
surface defined in BS4196 is to be drawn as follows:

a. for a single sterilizer, the reference surface IS the smallest rectangular box
that just encloses the sterilizer, with a width and depth measured from the
outside of the vessel lagging, and a height measured from the floor to the
top of the vessel lagging. The box does not Include pipes and valves used
to connect the sterilizer to its services;

b. for a group of sterilizers treated as a single source, the reference surface is

the smallest rectangular box that just encloses the reference surfaces of
the individual sterilizers.

10.6 Norse sources which contribute to the sound pressure level in the room in
which the sterilizer is installed (including sources in adjacent rooms) should be
operating during the test. In particular, all the building services in the area
surrounding the room containing the sterilizer should be working normally,
under their design conditions.

10.7 Sterilizers should be regarded as large sound sources as defined in

BS4197. The measurement distance, d, should be 1.0 ± 0.1 m or half the
10.0 Sound pressure test

distance from the sterilizer to an adjacent wall, whichever is less. It should not
be less than 150 mm. Microphones should be placed in the following positions:
a. where a single sterilizer is the only major noise source in the room, place
ten microphones as shown in Figure 13a. (If the sterilizer is recessed into a
wall or partition, three of these microphones will be in the loading area
and the remainder in the plantroom.) The microphone above the sterilizer
may be omitted for safety reasons or if preliminary measurements show
that its exclusion does not significantly affect the calculated value of the
mean sound pressure level;
b. where several sterilizers are installed, they should be treated as a single
large source and the reference surface drawn as described in paragraph
10.5b. Place ten microphones as shown in Figure 13b. If any dimension of
the reference surface exceeds 5.0 m, intermediate microphone positions
will be required as described in clause 7.4.3.2 of BS4196.

Figure 13a

Measurement
surface

(a) Single sterilizer

Figure 13b

Measurement
surface
i
(b) Multiple sterilizers

Microphone in Plant
position of room
greatest
sound pressure

Location of
microphones

Location of
additional
microphones

Reference
surface

Figure 13 Location of microphones for sound pressure test

74
10.8 Load the sterilizer with a full load as described in the appropriate chapter
of this HTM.

10.9 If there is a choice of operating cycle, select the cycle with the highest
sterilization temperature. Ensure that the pressure and flow from the steam and
water services are set to normal working levels. Start the operating cycle.

10.10 Integrate the sound pressure level throughout the operating cycle or, if
the cycle exceeds 30 minutes, over a 30-minute period known to contain the
loudest sounds.

10.11 Using the procedure described in clause 8.1 of BS4196, for both the
plantroom and the loading area, determine the following:

a. the mean A-weighted surface sound pressure level;

b. the peak A-weighted surface sound pressure level.

10.12 The test should be considered satisfactory if the following requirements

are met:

a. in the loading area, the mean A-weighted surface sound pressure level
does not exceed:
(i) 55 dBA for a sterilizer installed in an operating suite, pharmacy,
treatment room or other noise-sensitive area;
(ii) 70 dBA for a sterilizer installed in a sterile services department;
(iii) 85 dBA for a sterilizer installed in an area that is not noise-sensitive;
b. in the plantroom, the mean A-weighted surface sound pressure level does
not exceed 85 dBA;

c. in both the loading area and the plantroom, the peak A-weighted surface
sound pressure level does not exceed the mean A-weighted surface sound
pressure level by more than 15 dBA.
11.0 Chamber integrity tests

Introduction

11.1 These tests are designed to show that the steriliizer chamber does not leak
either under vacuum or under pressure, and that the devices used to monitor
leakage and the presence of air are functioning correctly.

Vacuum leak test

11.2 The vacuum leak test is applicable to any sterilizer which employs vacuum
to remove air from the load, that is, porous load sterilizers, LTS disinfectors, LTSF
sterilizers, EO sterilizers and some laboratory sterilizers.

11.3 Leakage of air into the chamber at a rate greater than that specified
below (see paragraph 11.15) is unacceptable for three reasons:

a. the presence of air inhibits penetration of the load by the sterilant (steam
or gas) and prevents sterilization;
b. air leaking into the chamber during the drying and air admission stages
will not have passed through the bacteria-retentive filter, and therefore
there is a risk of recontamination of the load;

c. the presence of air may cause an explosive hazard in EO sterilizers

11.4 A vacuum leak test is required to establish that permissible limits are not
exceeded.

11.5 The test is performed by measuring the change of vacuum in the

chamber when all valves leading to it have been closed and the vacuum source
isolated. If the test is conducted as part of a programme including thermometric
tests, it will be necessary to repeat it with the temperature sensors and any test
pressure gauge in place, and again when they have been removed, to ensure
that there is no leakage through the ports. These tests are specified in the
appropriate schedules in Chapters 4 and 5.

11.6 The test may either be part of the air removal stage or be performed at
the end of the drying stage. It is designed to be carried out either automatically
or semi-automatically, and in either case selected by a switch or data entry point
located on the front fascia. It should be performed with an empty chamber.

11.7 If the sterilizer is not fitted with a vacuum leak test instrument, connect a
0-160 mbar absolute pressure gauge (Table 6) to the chamber.

11.8 For the test to be accurate, the chamber temperature should be stable.
For example, in a closed vessel at 40 mbar absolute, the pressure changes by
approximately 1 mbar for each 10 ° C change in temperature over the range
20-140 ° C. At 70 mbar the change is approximately 2 mbar. The test could be
compromised if the temperature changes by more than 10 ° C during the period
in which the chamber pressure is monitored. Stabilise the temperature of the
chamber by one of the following methods:

a. If the vessel incorporates a heated jacket, carry out an operating cycle with
the chamber empty;
 b. if there is no heated jacket, ensure that the temperature of the chamber is
no greater than 20 C fro m ambient.

11.9 When the temperature has stabilised, start the vacuum leak test cycle. For
automatic systems the following steps are performed automatically, and the
vacuum leak rate is displayed as a pressure rise in mbar min-1. For semi-
automatic systems, the pressures should be read and noted by the operator.

11.10 When the pressure in the chamber drops below 50 mbar absolute (or
the maximum vacuum attained in an EO cycle), close all the valves connected to
the chamber and stop the vacuum pump. Note the time and the absolute
pressure (P1).

11.11 Wait for 5 minutes (± 10 s), and then note the pressure again (P2).

11.12 Wait for a further 10 minutes (± 10 s), and then note the pressure for a
third time (P3).

11.13 Restore the operating cycle, and allow it to proceed normally.

11.14 Calculate the vacuum leak rate for the 10-minute period from:

Vacuum leak rate = (P3 - P2)/10 mbar min-1

11.15 For chambers with a capacity of 250-600 I, the test should be

considered satisfactory if the following requirements are met:

a. the absolute pressure (P

2 ) at the start of the 10-minute period is:
(i) less than 70 mbar for porous load sterilizers, LTS disinfectors, LTSF
sterilizers and laboratory sterilizers;
(ii) as specified by the manufacturer for EO sterilizers;

b. the vacuum leak rate does not exceed:

(i) 1.3 mbar min-1 for porous load sterilizers and laboratory sterilizers;
(ii) 0.5 mbar min-1 for LTS disinfectors and LTSF sterilizers;
(iii) 1.0 mbar min-1 for EO sterilizers.

11.16 For chambers outside the range 250-600 I, the test should be
considered satisfactory if the pressure P2 and the vacuum leak rate are as
specified by the manufacturer.

11.17 Considerable care must be applied in the interpretation of the results of

leak tests. On a typical test on a porous load sterilizer the pressure may rise by
20 mbar or more (P2 - P1) in the first 5 minutes of the test due to the
evaporation of moisture remaining in the chamber and connecting pipework.
Such a result does not necessarily indicate a leak.

11.18 A machine which fails to meet the requirements of this test should not
be used until the fault has been rectified and the test satisfactorily completed.

Vacuum leak monitor test

11.19 For LTS disinfectors, and LTSF and EO sterilizers, the air removal stage is
followed by an automatic check on the leakage of air into the chamber. The
vacuum leak monitor test ensures that when the monitoring device is challenged
with a specified leak rate the operating cycle is aborted and a fault is indicated.

11.20 Connect an air flow metering device (see paragraph 6.52) to the
chamber.
11.21 Follow the procedure for the vacuum leak test, adjusting the metering
device to cause a leak rate over the 10-minute test period of:

a. 5.0 ± 0.2 mbar min-1 for LTS disinfectors and LTSF sterilizers;

b 3.0 ± 0.2 mbar min-1 for EO sterilizers.

11.22 For LTS disinfectors and LTSF sterilizers, place a standard test pack (see
paragraph 7.27) in the chamber. For EO sterilizers, leave the chamber empty.
Start the operating cycle.

11.23 The test should be considered satisfactory if the operating cycle is

aborted after the air removal stage and a fault is indicated at the end of the
cycle.

Pressure leak test

11.24 The pressure leak test is applicable to sterilizers which use EO or EO gas
mixtures to sterilize products in chambers pressurised above atmospheric
pressure.

11.25 Leakage of EO from the chamber at a rate greater than that specified
below (see paragraph 11.35) is unacceptable because the gas is toxic and
flammable. The maximum exposure limits are listed in Table 1. A pressure leak
test is required to establish that leakage from the sterilizer will not cause these
limits to be exceeded.

11.26 The test is performed by measuring the change of pressure in the

chamber when all valves leading to it have been closed and the pressurising
source has been Isolated. If the test is conducted as part of a programme which
includes thermometric tests, it will be necessary to repeat it with the
temperature sensors and any test pressure gauge in place, and again when they
have been removed, to ensure that there is no leakage through the ports. These
tests are specified in the appropriate schedules in Chapters 4 and 5.

11.27 The test is performed using an inert gas as described in paragraph 1.29
and the measurements taken during the gas exposure stage. The test is designed
to be carried out either automatically or semi-automatically, and in either case is
selected by a switch or data entry point located on the front fascia. It should be
performed with an empty chamber, immediately following a vacuum leak test.

11.28 If the sterilizer is not fitted with a pressure leak test instrument, connect
a test gauge to the chamber. Thus should have a accuracy of 1% or better over a
range of – 10% of the gas exposure pressure.

11.29 Start the pressure leak test cycle. This is similar to a normal operating
cycle except that an inert gas is used instead of EO. For automatic systems the
following steps are performed automatically and the pressure leak rate is
displayed as a pressure fall in mbar/min. For semi-automatic systems, the
pressures are noted by the operator.

11.30 When the working pressure is attained, the gas will continue to be
injected intermittently for a further 5 minutes to allow the pressure and
temperature in the chamber to stabilise.

11.31 Close the valves connected to the chamber, and stop the pressure
source. Observe and note the time and the pressure (P 1).

11.32 Wait for 60 ± 1 minutes and then observe and note the pressure again
(P2).
11.33 Restore the operating cycle, and allow it to proceed normally.

11.34 Calculate the pressure leak rate for the 60-minute period from:

Pressure leak rate = (P1 - P2)/60 mbar min-1.

11.35 The test should be considered satisfactory if the following requirements

are met:

a. for chambers with a capacity of 250-600 I, the pressure leak rate does not
exceed 1.0 mbar min-1;

b. for chambers outside the range 250-600 I, the pressure leak rate is as
specified by the manufacturer.

11.36 A machine which fails to meet the requirements of this test should not
be used until the fault has been rectified.

Air detector tests

11.37 An air detector is fitted to certain sterilizers which employ vacuum as a

means of removing air from the load before sterilization. It is currently required
for porous load sterilizers and may also be fitted to LTS disinfectors, LTSF
sterilizers and some laboratory sterilizers. It is used to determine whether any air
or non-condensable gas present in the chamber is sufficient to impair the
sterilizing process. The air detector should cause a fault to be indicated if the
amount of air or gas in the chamber at the start of the plateau period is
sufficient to depress the temperature in the centre of the load more than 2 ° C
below the temperature in the active chamber discharge.

11.38 A correctly adjusted air detector will contribute to product security but
should not be regarded as an alternative to effective maintenance.

11.39 The procedure for setting an air detector is lengthy and complex if prior
information is not available. The manufacturer will have established the correct
settings for the air detector and should supply the following information:

a. the setting of the sensitivity of the air detector;

b. the level of the signal from the air detector (the trigger point ), which will
trigger the automatic controller to abort the cycle and indicate a fault;

c. the vacuum leak rate that will cause this level to be exceeded.

11.40 The three air detector tests are designed to demonstrate compliance
with the manufacturer s specifications. Several operating cycles will be required
to complete the tests satisfactorily.

11.41 The three tests - for small load, full load and function - should be
performed in sequence after it has been established that the vacuum leak rate of
the sterilizer is acceptable.

11.42 Before starting the tests, connect an air-flow metering device (see
paragraph 6.52) to the chamber by means of the valved port provided by the
sterilizer manufacturer. It will normally be necessary to conduct a sequence of
vacuum leak tests to establish the relationship between the setting on the
metering device and the induced vacuum leak rate. The relationship should be
recorded in the plant history file for each sterilizer.

11.43 If the sterilizer is not fitted with a leak test instrument, connect a 0-160
mbar absolute pressure test gauge (Table 6) to the chamber.

79
11.44 The two air detector performance tests require temperatures to be
recorded by independent measuring equipment as described in Chapter 6.

Performance test for a small load

11.45 This test is designed to determine the setting for the air detector so that,
with a small load, it will respond to a leak rate sufficient to depress the
temperature in the test pack by no more than 2 ° C.

11.46 The procedure for the small-load test is set out in the flow chart in
Figure 14. If the air detector is correctly set, the test should proceed rapidly
down the left-hand branch and be complete in two cycles.

11.47 Select the operating cycle with the highest sterilization temperature and
standard drying time.

11.48 Place a standard test pack (see paragraph 7.27) in the chamber, with the
bottom of the pack supported 100-200 mm above the centre of the chamber
base, and two temperature sensors placed in the following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. one at the approximate centre of the test pack (the wire from the sensor
should be carefully arranged to prevent steam tracking along it).

11.49 A fresh test pack is required for each cycle. In practice, three test packs
will be enough, provided that two are unfolded and left to air while the other is
in the chamber.

11.50 At the start of the test ensure that the air detector sensitivity is set to
the value recommended by the manufacturer. The detector can be disabled by
adjusting the automatic controller so that it will not recognise a fault. This may
be done by setting the trigger point, in accordance with the manufacturer s
instructions, to a level that will not be attained during normal operation (see
paragraph 11.39(b)).

11.51 During the air removal stage, admit air into the chamber by means of
the metering device. From the measured temperatures, determine the
temperature depression at the start of the plateau period:
Depression, T = T c - T p

where:
T c = temperature measured in the active chamber discharge;
T p = temperature measured in the centre of the test pack.

11.52 When the small-load test is complete, proceed immediately to the full-
load test.

Performance test for a full load

11.53 This test is designed to show that an air detector set to respond correctly
during the small-load test will also respond correctly with a full load. It is
normally carried out immediately after a satisfactory completion of a small-load
test.

11.54 The procedure for the full-load test is set out in the flow chart in Figure
15. If the air detector has been correctly set, the test should proceed rapidly
down the left-hand branch and be complete in two cycles.

11.55 Select the operating cycle used for the small-load test.
 11.0 Chamber integrity tests

Start

Set leak
rate to
9,5 0.5

From full load test

Disable
air-detector

Standard test pack

in chamber

Set leak rate to

3,5 0,5

∆Τ 2,0°C

Fresh test pack Increase

in chamber

Fail

Consult
manufacturer

Record settings
Go to full
load test

Leak rates in millibars/minute

Temperatures, ∆Τ, in °C

Figure 14 Procedure for air detector small-load test

11.0 Chamber integrity tests

82
11.56 The load is a standard test pack placed in the chamber in a position
identified by the manufacturer as the most difficult to sterilize, with the
remaining usable chamber space filled with a full load appropriate to the type of
sterilizer under test (see the procedure for the relevant thermometric test for a
full load). Place temperature sensors as for the small-load test.

11.57 A fresh load is required for each cycle. In practice, three loads will be
enough provided that two are unfolded and left to air while the other is in the
chamber.

11.58 At the start of the test ensure that the air detector sensitivity and leak
rate settings are identical to those established in the small-load test.

11.59 If, during the test, it becomes necessary to readjust the air detector, the
procedure requires the small-load test to be repeated from the point indicated in
Figure 13.

Function test

11.60 This test is designed to confirm that the air detector is functioning
correctly during a normal operating cycle.

11.61 Set the air-flow metering device to the setting established during the
small-load test.

11.62 Place a standard test pack in the chamber, with the bottom of the pack
supported 100-200 mm above the centre of the chamber base.

11.63 Select and start the operating cycle.

11.64 The test should be considered satisfactory if the operating cycle is

aborted and a fault is indicated. If the cycle is not aborted, then the advice of
the manufacturer should be sought.

11.65 When the air detector tests are complete, the settings of the air detector
sensitivity, the automatic controller trigger point, and the air-flow metering
device and induced vacuum leak rate should be noted in the test report.
 12.0 Automatic control test

Introduction

12.1 The automatic control test is designed to show that the operating cycle
functions correctly as evidenced by the values of the cycle variables indicated
and recorded by the instruments fitted to the sterilizer. It is carried out once a
week on most sterilizers, and is the main test for ensuring that the sterilizer
continues to function correctly.

12.2 During the commissioning, yearly and quarterly test programmes the
temperature and pressure sensors for subsequent thermometric tests will be
connected to the chamber during this test. If one sensor is placed in the active
chamber discharge (see paragraph 6.26) the calibration of the sterilizer
instruments may conveniently be checked during the holding time of the
automatic control test.

Test procedure

12.3 For porous load sterilizers, LTS disinfectors and laboratory sterilizers
(fabrics cycle), place a standard test pack (see paragraph 7.27) in the chamber,
with the bottom of the pack supported 100-200 mm above the centre of the
chamber base.

12.4 For sterilizers for unwrapped instruments and utensils, leave the chamber
empty except for the usual chamber furniture.

12.5 For fluid, dry-heat, LTSF, EO and laboratory sterilizers:

a. for installation and commissioning tests, leave the chamber empty except
for the usual chamber furniture;

b. for periodic tests, load the chamber with a production load of a type for
which a record has been established during performance qualification. If
the test proves satisfactory, the sterilized load may be released for normal
use.

12.6 Sterilizers designed for fluid loads (fluid sterilizers, dry-heat sterilizers and
certain laboratory sterilizers) are equipped with one or two probes to record the
temperature of the load. If a production load is being processed, insert the
probes into the load in the positions they would normally occupy. Otherwise
stow the probes on the bracket provided in the chamber. Do not insert probes
into discard material to be processed in laboratory make-safe cycles.

12.7 If an LTSF or EO sterilizer is being tested with an empty chamber, ensure

that the sterilant is replaced with an inert substitute (see paragraph 1.29).

12.8 Select the sterilization temperature for the operating cycle to be tested.
As a rule, this should be the highest temperature compatible with the load. If a
production load is being used, select the temperature at which it would normally
be sterilized. Start the cycle.

12.9 Ensure that a batch process record is made by the recording instrument
fitted to the sterilizer. If the sterilizer does not have a recorder (such as some
machines for unwrapped instruments and utensils), observe and note the
elapsed time, indicated chamber temperatures and pressures at all significant
points of the operating cycle, for example the beginning and end of each stage
or sub-stage, and the maximum values during the holding time.

12.10 At the approximate mid-point of the plateau period, note the elapsed
time and indicated chamber temperature and pressure.

12.11 For fluid loads, during the cooling stage wait for the temperature in the
containers to fall to 95 C (plastic containers) or 85 ° C (glass). Wearing protective
visor and gloves, attempt to open the door.

12.12 For fluid loads, as soon as the cycle is complete, but before opening the
door, observe and note the recorded temperature in the containers.

12.13 The test should be considered satisfactory if the following requirements

are met:
a. a visual display of cycle complete is indicated;

b. during the whole of the cycle the values of the cycle variables as shown on
the batch process record are either within the limits established by the
manufacturer as giving satisfactory results, or, for production loads, within
the permitted tolerances marked on a master process record subsequently
established during performance qualification;

c. during the plateau period determined from the recorded chamber

temperature:
(i) the indicated and recorded chamber temperatures are within the
appropriate sterilization temperature band specified in Table 8;
(ii) the difference between the indicated and recorded chamber
temperature does not exceed 2 ° C;
(iii) the difference between the indicated and recorded chamber
pressure does not exceed 0.1 bar;

d. the holding time determined from any load temperature probes is not less
than that specified in Table 8;

e. during the holding time, any temperatures recorded in the load are within
the appropriate sterilization temperature band specified in Table 8;

f . the door cannot be opened until the cycle is complete;

g. for fluid loads, at the end of the cycle the temperature recorded in the
containers is not greater than 90 ° C (plastic) or 80 ° C (glass);

h. the person conducting the test does not observe any mechanical or other
anomaly.
13.0 Porous load sterilizers

Introduction
13.1 This chapter contains detailed procedures for tests specific to sterilizers
designed to process porous loads. Schedules prescribing which tests are to be
carried out and when are set out in Chapter 4 (for validation tests) and Chapter
5 (for periodic tests).

13.2 Unless specified otherwise, all the tests should be performed at each of
the sterilization temperatures available on the sterilizer.

Chamber wall temperature test

13.3 This test is designed to show that temperature variations across the
chamber walls do not exceed 2°C at the sterilization temperature. Temperatures
and pressures should be recorded by independent measuring equipment as
described in Chapter 6. The test is performed with an empty chamber.

13.4 Place 12 temperature sensors in the following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. five on each of the two chamber side walls (one at the approximate centre
and four adjacent to the corner positions of the usable chamber space);

c. one on the plane of the usable chamber space (not on the wall), at a point
nearest to the steam inlet port.

13.5 If a jacket is fitted, ensure that it is heated. Select and start the operating
cycle.

13.6 The test should be considered satisfactory if, at the start of the plateau
period, the measured temperatures are within 2°C of each other.

Thermometric test for a small load

13.7 This test is used to demonstrate that after the air removal stage of the
operating cycle, sterilizing conditions are obtained within the chamber and
standard test pack. The more air there is to remove, the more exacting will be
the test; that is why the pack is used by itself in an otherwise empty chamber.

13.8 Temperatures and pressures should be recorded by independent

measuring equipment as described in Chapter 6.

13.9 Place a standard test pack (see paragraph 7.27) in the chamber with the
bottom of the pack supported 100-200 mm above the centre of the chamber
base.

13.10 Place three temperature sensors in the following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. one at the approximate centre of the test pack (the wire from the sensor
should be carefully arranged to prevent steam tracking along it);

86
 13.0 Porous load sterilizers

c. one placed in the free space 50 ± 5 mm above the approximate centre

of the upper surface of the test pack.

13.11 Connect a pressure recorder (or test gauge) to the chamber.

13.12 Start the operating cycle, with standard drying time, and take readings
as described for the automatic control test (see paragraph 12.9).

13.13 If a test gauge is being used, measure the chamber pressure at the
approximate mid-point of the holding time.

13.14 The test should be considered satisfactory if the following requirements

are met:

a. the requirements of the automatic control test (see paragraph 12.13)

are met;

b. during the plateau period the temperature measured above the test
pack does not exceed the temperature measured in the active chamber
discharge by more than 5ºC for the first 60 s and 2ºC for the remaining
period;

c. the equilibration time determined from the measured temperatures

does not exceed 15 seconds for chambers up to 800 l and 30 seconds
for larger chambers;

d. the holding time determined from the measured temperatures is not

less than that specified in Table 8;

e. during the holding time the temperatures measured in the active

chamber discharge and in the centre of the test pack:
(i) are within the appropriate sterilization temperature band specified
in Table 8;
The second impression (1995) (ii) do not fluctuate by more than ±1ºC;
incorrectly indicated the limit in (iii) do not differ from one another by more than 2ºC;
paragraph 13.14(e)(ii) as ±0.5ºC
f. during the holding time:
(i) the indicated and recorded chamber temperatures are within 1ºC
of the temperature measured in the active chamber discharge;
(ii) the indicated and recorded chamber pressures are within 0.05 bar
of the measured pressure;

g. for sterilizers using vacuum as the sole method of drying:

(i) the duration of the drying stage is not less than 3 minutes;
(ii) the chamber pressure at the end of the stage does not exceed
40 mbar absolute;

h. at the end of the cycle the sheets are sensibly dry.

Thermometric test for a full load

13.15 The full-load test is designed to demonstrate that, at the levels at which
cycle variables are set, rapid and even penetration of steam into the centre of
a load occurs, and the sterilizing condition is achieved in a test load of
specified maximum mass and of sufficient size to fill the usable chamber
space.

13.16 Temperatures and pressures should be recorded by independent

measuring equipment as described in Chapter 6.

87
13.0 Porous load sterilizers

13.17 The load is made up of a standard test pack (see paragraph 7.27) and
additional folded sheets designed to represent the maximum mass of textiles
which may be processed in the sterilizer. Each sheet should contain at least 50%
m/m of cotton fibre and have a surface density of approximately 200 g m-2.
They should be washed and aired as for the standard test pack (see paragraphs
7.30-31). After airing, the sheets should be folded to approximately 25 cm x
50 cm and laid one on top of the other to form stacks of mass 7.5 0.5 kg.

13.18 Place the standard test pack within the chamber in a position identified
by the manufacturer as the most difficult to sterilize. This will normally be in the
approximate centre of the chamber.

13.19 Place three temperature sensors in the following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. one at the approximate centre of the test pack (the wire from the sensor
should be carefully arranged to prevent steam tracking along it);

c. one below the approximate centre of the top sheet of the test pack

13.20 Load the rest of the usable chamber space with stacks of sheets. (The
mass of fabric in the load should be equivalent to 7.5 0.5 kg for a unit volume
300 mm x 300 mm x 600 mm.)

13.21 Connect a pressure recorder (or test gauge) to the chamber.

13.22 Start the operating cycle, with standard drying time, and take readings
as described for the automatic control test (see paragraph 12.9).

13.23 If a test gauge is being used, measure the chamber pressure at the
approximate mid-point of the holding time.

13.24 The test should be considered satisfactory if the following requirements

are met:
a. the requirements of the automatic control test (see paragraph 12.13) are
met;
b. the equilibration time determined from the measured temperatures does
not exceed 15 s for chambers up to 800 I and 30 s for larger chambers;

c. the holding time determined from the measured temperatures is not less
than that specified in Table 8;

d. during the holding time:

(i) the measured temperatures are within the appropriate sterilization
temperature band specified in Table 8;
(ii) the measured temperatures do not fluctuate by more than 1 °C;
(iii) the measured temperatures do not differ from one another by
more than 2°C;
(iv) the indicated and recorded chamber temperatures are within 1 °C
of the temperature measured in the active chamber discharge;
(v) the indicated and recorded chamber pressures are within 0.05 bar
of the measured pressure;

e. the total cycle time is within the performance class stated by the
manufacturer;

f. at the end of the cycle the sheets are sensibly dry.

88
 13.0 Porous load sterilizers

Load dryness test

13.25 This test is used to demonstrate that the operating cycle, without
extended drying, will not cause an increase in moisture in a standard test pack
sufficient for there to be uncertainty about the dryness of loads routinely
processed.

13.26 Three polythene bags, at least 35 cm x 25 cm and of polythene at least

250 m thick, and a balance capable of weighing loads up to 2 kg with an
accuracy of 0.1 g or better, are required.

13.27 Allow the sheets which will comprise the standard test pack to air as
described in paragraph 7.31.

13.28 Mark three of the sheets and similarly mark each of the polythene bags
so that each sheet is identified with a bag.

13.29 Weigh each of the polythene bags and note the mass (M ).

13.30 Place each sheet in a polythene bag, weigh each bag with its enclosed
sheet and note the mass (M ).

13.31 Remove the sheets from the bags and assemble the standard test pack
with one of the sheets in the centre of the pack and one in the second position
from each end of the pack.

13.32 Place the test pack in the approximate centre of the sterilizer chamber
and start the operating cycle within one minute. (Extended drying should not be
used.)

13.33 Not more than one minute after the cycle has finished, remove the test
pack from the chamber. Remove the three sheets from the test pack and put
them quickly into their marked bags. Seal each bag by turning its open end over
several times. This operation should be completed as quickly as possible to
reduce evaporation of retained moisture and in any case within three minutes of
the end of the cycle.

13.34 Weigh each bag with its enclosed sheet and note the mass

13.35 Calculate the percentage gain in mass of each sheet from the formula.

percentage gain in mass = 100 x

13.36 The test should be considered satisfactory if the average gain in mass of
each of the three bagged sheets is not more than 1%.

Hospital load dryness check

13.37 Process a production load which is known to present the greatest

challenge to the operating cycle. Extended drying may be required.

13.38 The check should be considered satisfactory if a “cycle complete”

indication is obtained and the load is sensibly dry.

89
13.0 Porous load sterilizers

Bowie-Dick test for steam penetration

13.39 Sterilization is achieved by the rapid and even penetration of steam into
all parts of the load and the maintenance of these conditions for the specified
holding time. To ensure this, it is essential to remove air from the chamber and
load, and to provide a steam supply which contains a minimal volume of non-
condensable gases. Any residual air and non-condensable gases will become
concentrated as a bubble in the load and inhibit steam penetration.

13.40 The Bowie-Dick test shows whether or not steam penetration of the test
pack is even and rapid, and thus by implication that air or other non-
condensable gases are not present. It does not confirm that the sterilization
conditions in the load have been achieved.

Principle of the test

13.41 The test, as originally conceived and described in earlier editions of HTM
10 (Bowie, Kelsey and Thomson, 1963), is based on the use of a chemical
indicator in the form of an adhesive tape stuck to a piece of suitable paper to
form a St Andrew’s cross. This indicator paper is placed at the centre of a test
pack of folded huckaback towels and then subjected to an operating cycle. The
indicator tape shows a change of colour in response to a combination of time,
temperature and moisture.

13.42 If no air is present in the chamber, steam will penetrate rapidly and
completely, and the indicator will show a uniform colour change. If air is present,
it will collect within the pack as a bubble. The indicator in the region of the
bubble will be of a different colour than elsewhere on the paper, because of a
lower temperature, lower moisture level or both.

13.43 The modern Bowie-Dick test uses a Class B chemical indicator

conforming to EN 867: Part 3 (see paragraph 7.40) contained within a standard
test pack (see paragraph 7.27). The indicator is distributed over an A4 paper
sheet in the form of a geometric pattern.

13.44 When used in conjunction with a standard test pack, Class B indicators
are designed to show a failure either if, at the start of the holding time, the
temperature at the centre of the test pack is 2°C or more below the temperature
in the active chamber discharge; or if the indicator is exposed to insufficient
moisture. Both conditions are usually caused by the presence of air or other non-
condensable gases (see paragraph 13.56). Because of the tolerances necessary in
the manufacture of chemical indicators, users should be aware that in order to
detect a temperature difference of 2°C the indicator may show signs of failure
with a smaller temperature difference.

Test procedure
13.45 The Bowie-Dick test is normally preceded by a warm-up cycle. This cycle
is necessary because the effectiveness of air removal may depend on all parts of
the sterilizer being at working temperature. A satisfactory sterilizer may give a
fail result if this is not done.

13.46 Remove the wrapping from a standard test pack and place the indicator
paper in the sheet located nearest to the centre of the pack. Reassemble and
secure the pack and replace the wrapping.

13.47 Place the test pack in the chamber with the bottom of the pack
supported 100-200 mm above the centre of the chamber base.

90
 13.0 porous load sterilizers

13.48 Select the Bowie-Dick test cycle. Ensure that the holding time will not be
longer than that specified in Table 10. If this time is exceeded, the indicator may
change in such a way as to make it difficult to detect the variations that would
indicate a fail condition. Start the operating cycle.

Sterilization Holding time

temperature
minimum maximum
[°C] [min] [min]

134 3.3 3.5

126 10.8 11.0
121 16.8 17.0
Table 10 Holding times for the Bowie-Dick test cycle

13.49 During the holding time, note the reading on the cycle counter, the
chamber temperature indicator and the chamber pressure indicator.

13.50 When the cycle is complete, remove the indicator paper from the test
pack.

13.51 The test should be considered satisfactory if the following requirements

are met:

a. there is a uniform change throughout the indicator;

b. the automatic controller indicates that a Bowie-Dick test cycle has just
been completed.

13.52 It is important to compare the colour of the indicator at the corners of

the paper with that at the centre so that any difference can be clearly seen. If
there is any discernible difference the test should be recorded as failed, and the
paper marked accordingly. A large area of unchanged indicator points to a gross
failure.

13.53 The indicator paper should be marked with the result and kept for
reference for at least three months. The chemical reaction continues during this
time and the paper may be discarded when the indicator becomes unreadable.
The associated batch process record should be kept for at least 11 years.

13.54 An unsatisfactory test result indicates that the machine should not be
used until the fault has been rectified. It is important to realise that if a sterilizer
fails to pass the Bowie-Dick test it cannot be made safe simply by increasing the
holding time until a uniform colour change is produced. A failed sterilizer is in
urgent need of skilled attention.

13.55 Several factors may inhibit steam penetration and cause the test to fail
Common causes of failure include the following:

a. an inefficient air removal stage;

b. an air leak during the air removal stage;

c. the presence of non-condensable gases in the steam supply

13.56 A subsequent thermometric test for a small load (see paragraph 13.7)
will assist in diagnosing the cause of failure:
a. if the test reveals a temperature depression at the centre of the test pack,
the problem is likely to be inefficient air removal or an air leak into the

91
13.0 Porous load sterilizers

chamber. Air remaining in the centre of the test pack is inhibiting the
penetration of steam and the correct temperature is not being attained.
The sterilizer should not be returned to service until it has been subjected
to a vacuum leak test (see paragraph 11.2) and an air detector function
test (see paragraph 11.60);

b. if the test fails to reveal a temperature depression, the problem is almost

certainly air or other non-condensable gases in the steam supply. In this
case the correct temperature is being attained but the steam is diluted,
and insufficient moisture is present to change the indicator. The sterilizer
should not be returned to service until the steam supply has been tested
for the presence of non-condensable gases (see paragraph 9.4).

92
14.0 Fluid sterilizers
Introduction

1 4 . 1 This chapter contains detailed procedures for tests specific to sterilizers

to process aqueous fluids in sealed containers. Schedules prescribing
is are to be carried out and when are set out in Chapter 4 (for
tests) and Chapter 5 (for periodic tests).

14.2 Unless specified otherwise, all the tests should be performed at each of
the sterilization temperature available on the sterilizer.

14.3 For the thermometric tests the containers should be filled with the
volume of water. The volumes of the fluid in each container should not
differ from their mean by more than 5%. At the start of the cycle the
temperature of the fluid in each container should be 20 ± 5 C.

Heat exchanger integrity test

14.4 This test is designed to check the integrity of the heat exchanger used to
heat and cool the circulating coolant (air or water) in the sterilizer chamber. The
circuit which is directly heated is called the primary circuit. Water in the primary
circuit must be assumed to be non-sterile. The circuit which exposes coolant to
the load is called the secondary circuit. In recent models of fluid sterilizers the
secondary circuit is designed to operate at a higher pressure than the primary to
prevent leakage of contaminated water into the chamber.

14.5 Where the heat exchanger IS designed and constructed in a fall-safe

fashion so that the secondary coolant cannot become contaminated under any
circumstances, the test is required only for commissioning and yearly tests.

14.6 Attach a pressure recorder (or test qauqe) to the primary circuit. The
range should include the maximum pressure to which the circuit is to be
pressurised.

14.7 Charge the primary circuit with water and pressurise it to either 1.5 times
its maximum working pressure or twice the maximum pressure in the secondary
circuit, whichever is less. This should be done in accordance with the
manufacturer s instructions, and in some cases may require additional ports and
valves to be fitted.

14.8 Close the inlet and outlet valves, and allow the pressure to stabilise over a
period of 10 min. Observe and note the measured pressure. Wait for a further
10 min. Observe and note the pressure again.

14.9 The test should be considered satisfactory if the measured pressure has
not fallen over the 10-mm period.

Thermometric test for a full load

14.10 Temperatures and pressures should be recorded by independent
measuring equipment as described in Chapter 6.
14.11 Load the chamber with one-litre bottles (nominal capacity), each filled
with 1 I of water, at the minimum spacing recommended by the manufacturer.
The bottles and chamber furniture should fill the usable chamber space. If the
sterilizer is not designed to process one-litre bottles, the largest size
recommended by the sterilizer manufacturer should be used.

14.12 Place 10 or 11 temperature sensors in the following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. one in each of the three bottles that are the slowest to attain the
sterilization temperature;
c. one in each of the three bottles that are the fastest to attain t h e
sterilization temperature;

d. one in each of the three bottles that are the slowest to cool to 90 ° C
(plastic) or 80 C (glass);
e. one in the coolest part of the coolant spray system (if fitted).

14.13 Insert the load temperature probe into a bottle adjacent to the bottle
identified as the slowest to attain the sterilization temperature. If a second probe
is provided, insert it into a bottle adjacent to the bottle identified as the fastest
to attain the sterilization temperature.

14.14 Connect a pressure recorder (or test gauge) to the chamber and, for
sterilizers fitted with a spray pump, to the spray pump discharge. Where the
heat exchanger secondary circuit is designed to operate at a higher pressure
than the primary circuit, connect a third sensor to measure the differential
pressure between the circuits.

14.15 Select and start the operating cycle and take readings as described for
the automatic control test (see paragraph 12.9).

14.16 If a test gauge is being used, measure the chamber pressure at the
approximate mid-point of the holding time.

14.17 As soon as the cycle is complete, note the measured temperature in the
bottles before opening the door.

14.18 If required, collect a sample of coolant for a subsequent coolant quality

test (see paragraph 14.32).

14.19 If the coolant is derived from a water or steam service, and is intended
to come into contact with the load containers, the operating cycle must expose
the coolant to sufficient heat to ensure that it is free of microbial contamination
by the end of the holding time. This is checked by calculating an FO value (see
Part 4 for a discussion of the use of FO) that is equivalent to the time in minutes
at a sterilization temperature of 121 C. If the test recorder is not capable of
calculating FO (see paragraph 6.16), proceed as follows:
a. from the measured temperatures, identify the point during the heat-up
time at which the coolant temperature first reaches 108 C. Note the
temperature (T C) at subsequent one-minute intervals until the end of the
holding time;

b. for each measurement, calculate the incremental FO (D FO) from the

following equation:

minutes;

c. the FO value is the sum of all D F .

O
14.20 The test should be considered satisfactory if the following requirements
are met:

a. the requirements of the automatic control test (paragraph 12.13) are met;

b. the holding time is not less than that specified for the appropriate
sterilization temperature band in Table 8;

c. during the holding time:

( i ) the measured temperatures are within the appropriate sterilization
temperature band specified in Table 8;

(ii) The measured temperatures are within 1 ° C of each other;

(iii) the indicated and recorded chamber temperatures are within 1 °C
of the temperature measured in the active chamber discharge;
(iv) the indicated and recorded chamber pressures are within 0.05 bar
of the measured pressure;
(v) the recorded chamber pressure is within 0.05 bar of saturated
steam pressure or, if a partial pressure system is used, as specified
by the manufacturer;

d. at the end of the cycle:

(i) the temperature sensors have remained in position;
(ii) The bottles containing sensors have not leaked, burst or broken;
(iii) not more than one of the other bottles (or 1%, whichever is the
greater) has burst or broken;
(iv) the temperature measured in the bottles is not greater than 90 ° C
(plastic) or 80 ° C (glass);

e. throughout the cycle:

(i) the coolant spray pressure complies with the manufacturer s
specifications;
(ii) the pressure in the heat exchanger secondary circuit is greater than
that in the primary circuit (if appropriate);

f. F0, for the coolant is not less than 8 minutes;

g. the total cycle time is within the performance class stated by the
manufacturer.

Thermometric test for a small load

14.21 Temperatures and pressures should be recorded by independent
measuring equipment as described in Chapter 6.

14.22 Place 25 vials or ampoules of 5-ml nominal capacity, each containing

5 ml of water, in each of two wire baskets. Support one basket in the upper rear
half of the usable chamber space and the other in the lower front half. Use the
upper and lower shelves if provided. If the sterilizer is not designed to process
vials or ampoules of this size, the smallest size and number of containers
recommended by the sterilizer manufacturer should be used. Where the sterilizer
is to be used to process one size of container only, the test load may be a single
container of this size, filled with the nominal volume of water and supported in
a position known to be the slowest to attain the sterilization temperature.

14.23 Place temperature sensors and load temperature probes as described for
the full-load test.

14.24 Connect a pressure recorder (or test gauge) to the chamber and other
pressure sensors as described for the full-load test.
14.25 Follow the procedure for the full-load test.

14.26 The test should be considered satisfactory if, except for paragraph 14.20
(g), the requirements of the full-load test (see paragraph 14.20) are met.

Simplified thermometric test for performance

requalification

14.27 This test is not a substitute for a full PRQ test, but is used quarterly to
check that the sterilization conditions continue to be met. Temperatures and
pressures should be recorded by independent measuring equipment as described
in Chapter 6.

14.28 Prepare a production load known to present the greatest challenge to

the operating cycle and for which there is a PQ report. (This will normally be the
reference load used in the yearly PRQ tests.)

14.29 Place three or four temperature sensors in the following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. one in a container that is the slowest to attain the sterilization

temperature;

c. for chambers of capacity of 800 I and above, one in a container that is the
fastest to attain the sterilization temperature;

d. one in a container that is the slowest to cool to 80 ° C (glass) or 90 ° C

(plastic).

14.30 Place the load in the chamber as described in the PQ report. Select and
start the operating cycle.

14.31 The test should be considered satisfactory if the requirements listed in

the PQ report are met.

Coolant quality test

14.32 This test measures the concentration of particulates and dissolved solids
in the coolant. It is carried out after a satisfactory operating cycle, normally at
the end of a full-load, small-load or PQ test.

14.33 Rinse a one-litre bottle with purified water BP immediately before use
and discard the rinsings.

14.34 Use the bottle to collect a test sample of cooling water from the coolant
system immediately after an operating cycle but before the final discharge to
waste.

14.35 Take a dish or beaker, made of silica or borosilicate glass, of capacity at

least 150 ml. Dry the dish for 2 h in an oven at a temperature of 110 ± 2 C. Put
it in a desiccator and allow it to cool to ambient temperature. Weigh it to the
nearest 0.1 mg and note the mass (M,).

14.36 Ensuring that the test sample is well mixed, measure 100 ml of the test
sample into the dish and evaporate it over a boiling-water bath until apparently
dry.
14.37 Repeat with two further 100 ml of test sample transferred into the same
dish.

14.38 Put the dish into the oven and heat at a temperature of 110 ± 2 °C for
about 2 h. Put it in the desiccator and allow it to cool to ambient temperature.
Weigh it to the nearest 0.1 mg and note the mass (M 2).

14.39 Repeat paragraph 14.38 until the difference between two consecutive
weighings does not exceed 0.2 mg.

14.40 Calculate the concentration of residue in milligrams per litre of cooling

water.
( M2 - M1 )
Concentration of residue = m g l- 1
V
where:
M2 = mass of dry dish (mg);
M 2 = final mass of dish and residue (mg);
V = volume of sample water evaporated (normally 300 ml).

14.41 The test should be considered satisfactory if the concentration of residue

does not exceed 40 mg 1-1.

97
15.0 Sterilizers for unwrapped
instruments and utensils

Introduction

15.1 This chapter contains detailed procedures for tests specific to sterilizers
designed to process unwrapped solid instruments and utensils. Schedules,
prescribing which tests are to be carried out and when, are set out in Chapter 4
(for validation tests) and Chapter 5 (for periodic tests). Except where stated
otherwise, the tests in this chapter apply equally to fixed and transportable
sterilizers.

15.2 Unless specified otherwise, all the tests should be performed at each of
the sterilization temperatures available on the sterilizer.

Chamber overheat cut-out test

15.3 This test applies only to sterilizers where the steam is generated within
the chamber. The test is done with an empty chamber and with insufficient
water charge for a complete cycle. Temperatures should be recorded by
independent measuring equipment as described in Chapter 6.

15.4 Attach a temperature sensor to the chamber wall in a position identified

by the manufacturer as attaining the highest temperature.

15.5 Select the operating cycle with the highest sterilization temperature. (Only
one cycle is normally provided.) Start the cycle.

15.6 The test should be considered satisfactory if the following requirements

are met:

a . a boil-dry condition occurs before the end of the cycle;

b . the overheat cut-out operates, and the heaters are isolated from the
electricity supply;

c. the chamber wall temperature does not exceed the temperature specified
by the manufacturer.

Thermometric test for a small load

15.7 Temperatures and pressures should be recorded by independent

measuring equipment as described in Chapter 6.

15.8 Place a pair of forceps (for example 5-inch artery forceps) in the
approximate centre of the chamber.

15.9 Place three temperature sensors in the following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. one trapped between the jaws of the forceps;

c . where steam is supplied from outside the chamber, one in the upper third
of the free chamber space;
98
 d. where steam is generated within the chamber, one either in the reservoir
or, if water is retained in the chamber, in the water.

15.10 Connect a pressure recorder (or test gauge) to the chamber.

15.11 Select and start the operating cycle.

15.12 The test should be considered satisfactory if the following requirements

are met:
a. the requirements of the automatic control test (see paragraph 12.13) are
met;
b. during the first minute of the plateau period the temperature measured in
the chamber free space does not exceed the temperature measured in the
active chamber discharge by more than 5 ° C;

c. after the first minute of the plateau period:

(i) the temperature measured in the chamber free space does not
exceed the temperature measured in the active chamber discharge
by more than 2 ° C;
(ii) the temperature measured in the jaws of the forceps is within 1 ° C
of the temperature measured in the active chamber discharge;

d. the holding time determined from the measured temperatures is not less
than that specified in Table 8;

e. during the holding time:

(i) the measured temperatures are within the appropriate sterilization
temperature band specified in Table 8;
(iii) the indicated and recorded chamber temperatures are within 1 ° C
of the temperature measured in the active chamber discharge;
(v) the indicated and recorded chamber pressures are within 0.05 bar
of the measured chamber pressure;

f. at the end of the cycle the temperature of any water left in the chamber
or in the reservoir is less than the boiling point of water at local
atmospheric pressure.

Thermometric test for a full load

15.13 Temperatures and pressures should be recorded by independent

measuring equipment as described in Chapter 6.

15.14 Place a pair of forceps as for the small-load test in the approximate
centre of the chamber, and add further instruments and utensils up to the
maximum total mass which the sterilizer is designed to process.

15.15 Place four temperature sensors in the following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. one trapped between the jaws of the forceps;

c. where steam is supplied from outside the chamber, one in the free space
between the load items;

d. where steam is generated within the chamber, one either in the reservoir
or, if water is retained in the chamber, in the water.

15.16 Connect a pressure recorder (or test gauge) to the chamber.

15.17 Select and start the operating cycle.

15.18 The test should be considered satisfactory if the requirements for the
small-load test are met, and the total cycle time is within the performance class
stated by the manufacturer.
16.0 Dry-heat sterilizers

Introduction

16.1 This chapter contains detailed procedures for tests specific to dry-heat
sterilizers. Schedules, prescribing which tests are to be carried out and when, are
set out in Chapter 4 (for validation tests) and Chapter 5 (for periodic tests).

16.2 For these tests it is essential that load items are packaged and positioned
in a manner which will permit the circulation of air to all parts of the chamber
and pack surfaces.

16.3 Unless specified otherwise, all the tests should be performed at each of
the sterilization temperatures available on the sterilizer.

Automatic control test

16.4 Follow the general procedure for the automatic control test given in
Chapter 12 with the following amendments.

16.5 Where the chamber is pressurised during the cooling stage, note the
differential pressure across the air filter after the start of the cooling stage and
shortly before the end.

16.6 As soon as the cycle is complete, and before opening the door, note any
recorded temperatures in the load containers.

16.7 The test should be considered satisfactory if the following requirements

are met:

a. a visual indication of cycle complete is obtained;

b. during the whole of the cycle the values of the cycle variables as shown on
the batch process record are either within the limits established by the
manufacturer as giving satisfactory results, or within the permitted
tolerances marked on a master process record subsequently established
during performance qualification;
c. during the plateau period determined from the recorded chamber
temperature:
(i) the indicated and recorded chamber temperatures are within the
appropriate sterilization temperature band specified in Table 8;
(ii) the difference between the indicated and recorded chamber
temperature does not exceed 5 ° C;
(iii) the recorded chamber temperature does not drift by more than
2 ° C;

d. the holding time determined from any load temperature probes is not less
than that specified in Table 8;

e. during the holding time, the recorded temperature in the load containers
is within 5 ° C of the recorded chamber temperature;
f . during the cooling stage, the differential pressure indicated across the air
filter is in the range specified by the manufacturer;

g. the door cannot be opened until the cycle is complete;

 h. at the end of the cycle the temperature recorded in any load containers is
not greater than 90 ° C;

j. the person conducting the test does not observe any mechanical or other
anomaly.

Chamber overheat cut-out test

16.8 This test is designed to show that the thermal cut-out will prevent the
temperature in the chamber from exceeding 200 ° C. The test should be done
with an empty chamber. Temperatures should be recorded by independent
measuring equipment as described in Chapter 6.

16.9 Place a temperature sensor in the hottest part of the chamber free space.

16.10 Inactivate the chamber temperature control to allow the temperature to

rise. This should be done in accordance with the manufacturer s instructions.

16.11 Select and start the operating cycle

16.12 The test should be considered satisfactory if the measured chamber

temperature does not exceed 200 ° C during the cycle.

Air filter integrity test

16.13 This test is designed to show whether the high-efficiency particulate

filter fitted to a dry-heat sterilizer is intact and working correctly. It is based on
the test given in Appendix C of BS5295: Part 1.

16.14 A test aerosol generator and a photometer are required as described in

Chapter 6.

16.15 The sterilizer should be at room temperature with the chamber door
open. In accordance with the manufacturer s instructions, arrange for the
chamber pressurising fan to be drawing air through the filter at its normal rate

16.16 Set up the aerosol generator outside the chamber so that a uniform
concentration of particles is dispersed across the intake of the air filter and its
sealing frame. Ensure that this concentration is maintained throughout the test.

16.17 Using the photometer, measure the concentration of particles as close as

possible to the intake of the filter and ideally not more than 150 mm from the
filter face. Adjust the photometer (and the aerosol generator if necessary) to give
a stable reading of 100%.

16.18 Inside the chamber, use the photometer to scan all of the downstream
face of the filter Including the sealing device. Hold the sampling probe
approximately 25 mm away from the area being tested, and pass it over the
entire area in slightly overlapping strokes at a traverse rate of no more than
50 mm s-1. Make separate passes around the entire periphery of the filter, along
the bond between the filter pack and the frame, and around the seal between
the filter and retaining device.

16.19 Note the location of any steady, repeatable reading of the photometer.

16.20 The test should be considered satisfactory if any steady and repeatable
reading does not exceed 0.001%.
16.21 A filter that falls the test should be replaced. It is not possible to repair
the high-efficiency filters Installed in dry-heat sterilizers.

Thermometric test for performance qualification

16.22 Temperatures should be recorded by Independent measuring equipment.

16.23 Follow the procedure for the thermometric test for performance
qualification given in Chapter 8 (see paragraph 8.13), but instead of placing a
temperature sensor in an active chamber discharge place two sensors as follows:

a. one (sensor A) in thermal contact with the sensor connected to the

sterilizer temperature recorder;

b. one (sensor B) in thermal contact with the sensor connected to the

sterilizer temperature indicator.

16.24 Where the chamber is pressurised during the cooling stage, connect a
pressure recorder to measure the differential pressure across the air filter.
Measure the differential pressure during the cooling stage.

16.25 The test should be considered satisfactory if the following requirements

are met:

a. the requirements of the automatic control test (see paragraph 16.7) are
met;

b. the holding time, as determined from the measured temperatures, IS not

less than that specified in Table 8;

c. during the holding time:

(i) the measured temperatures are within the appropriate sterilization
temperature band specified in Table 8;
(ii) the indicated chamber temperature is within 1 ° C of the
temperature measured by sensor B;
(iii) the recorded chamber temperature is within 1 ° C of the
temperature measured by sensor A;
(iv) the tem peratures measured by each sensor in the load and by
sensor B are within 5 ° C of the temperature measured by sensor A;
(v) the temperature measured by sensor A does not drift more than
2 ° C;

d. during the cooling stage, the differential pressure measured across the air
filter is in the range specified by the manufacturer

e. at the end of the cycle:

(i) the temperature sensors have remained in position;
(ii) the items containing sensors are intact;
(iii) the temperature measured in any item is not greater than 90 ° C

Simplified thermometric test for performance

requalification

16.26 This test is not a substitute for a full PRQ test, but is used quarterly to
check that the sterilization conditions continue to be met. Temperatures should
be recorded by independent measuring equipment.
16.27 Prepare a productron load known to present the greatest challenge to
the operating cycle and for which there is a PQ report. (This will normally be the
reference load used in the yearly PRQ tests.)

16.28 Place the load in the chamber as described in the PQ report with
temperature sensors in the following positions:

a. one (sensor A) in thermal contact with the sensor connected to the

chamber temperature recorder;

b. one (sensor B) in thermal contact with the sensor connected to the

chamber temperature indicator;

one in the item of the load which is the slowest to attain the steriliza tion
temperature.

16.29 Where the chamber is pressurised during the cooling stage, connect a
pressure recorder to measure the differential pressure across the air filter.

16.30 Ensure that the operating cycle corresponds with that used for the
performance qualification test for the load. Start the cycle.

16.31 During the cooling stage, measure the differential pressure across the air
filter.

16.32 The test should be considered satisfactory if the requirements listed in

the PQ report are met.

Thermometric test for a full load

16.33 This test will have been carried out by the manufacturer as a type test. It
need be repeated only if the sterilizer fails to meet the requirements of the
thermometric test for performance qualification (see paragraph 16.22).

16.34 The test is adapted from the former BS3421 (now withdrawn).
Temperatures should be recorded by independent measuring equipment as
described in Chapter 6. For chambers with more than two shelves, two or more
cycles may be required to measure the temperature at all the required points.

16.35 The test load should comprise the largest number of open-topped glass
jars, nominally 12 cm high and 6 cm in diameter, which can be placed in the
usable chamber space subject to the following conditions:

a. the shelves should be of the type provided for use with the sterilizer. The
number of shelves should be the maximum that can be placed in the
chamber such that the distances between the top of each layer of jars and
the surface above (shelf or roof of chamber) is not less than 3 cm. For the
purposes of this test, it is permissible to arrange the shelves on temporary
supports;

b. on each shelf the number of jars should be the maximum that can be
placed in rows parallel to and at right angles to the front of the chamber
with at least 1 cm separating jars in adjacent rows.

16.36 Place 100 ml of a suitable heat-stable, non-volatile liquid in each of the

four jars at the corners of each shelf and in the jar nearest to the centre of each
shelf. The remaining jars should be empty. Suitable liquids for this purpose are
silicone oils which remain lrqurd under the conditions of the test. Alternative
liquids may be used providing they have a similar thermal behaviour.

16.37 Place temperature sensors in the following positions:

 a. one (sensor A) in thermal contact with the sensor connected to the
chamber temperature recorder;

b. one (sensor B) in thermal contact with the sensor connected to the

chamber temperature indicator;

c. one in the centre of the liquid in each of the jars.

16.38 Select a sterilization temperature of 160 ° C. Adjust the timer to give a

holding time of at least 2‰ h (this is longer than the recommended minimum).
Start the cycle.

16.39 At the end of the cycle, examine the recording of the chamber
temperature measured by sensor A:

a. determine the mean temperature during the first 30 min of the holding
time. If the temperature at any time before the start of the holding time is
higher than this mean, the difference between the maximum temperature
attained and this mean is the overheat;

b. determine the mean temperature during a 30-min period commencing

120 min after the start of the holding time. The difference between this
mean and the mean determined for the start of the holding time is the
temperature drift during a 2 h period.

16.40 The test should be considered satisfactory if the following requirements

are met:
a. the requirements of the automatic control test (see paragraph 16.7) are
met;
b. the temperature overheat does not exceed 2 C;

c. the holding time determined from the measured temperatures is not less
than that specified in Table 8;
d. during the holding time:
(i) the measured temperatures are within the appropriate sterilization
temperature band specified in Table 8;
(ii) the recorded chamber temperature is within 1 ° C of the
temperature measured by sensor A;
(iii) the indicated chamber temperature is within 1 ° C of the
temperature measured by sensor B;
(iv) the temperatures measured by each sensor in the load are within
5 ° C of the temperature measured by sensor A;
(v) the temperature measured by sensor A does not drift by more than
2 ° C over a 2-h period;
(vi) the temperature measured by sensor A does not fluctuate by more
than 1 ° C;

e. the total cycle time is within the performance class stated by the
manufacturer.
 17.0 LTS disinfectors and LTSF
sterilizers

Introduction

17.1 This chapter contains detailed procedures for tests specific to machines
designed to process loads by exposure to low-temperature steam (LTS
disinfectors) or low-temperature steam and formaldehyde (LTSF sterilizers).
Schedules, prescribing which tests are to be carried out and when, are set out in
Chapter 4 (for validation tests) and Chapter 5 (for periodic tests).

17.2 Machines are usually designed for both LTS and LTSF. These processes
have similar characteristics and a machine incapable of meeting the LTS
requirements will not normally meet the LTSF requirements. Note that some LTSF
machines expose the load to a series of pulses of sterilant rather than a
continuous holding time.

17.3 Attention is drawn to the safety Information presented in Chapter 1 and

the detailed safety precautions discussed in Part 4.

Chamber overheat cut-out test

17.4 This test is designed to show that the overheat cut-out mechanisms for
the chamber and jacket will prevent the temperature of the chamber walls and
free space from exceeding 80 C. Where two temperature control mechanisms
are fitted (for the jacket and the chamber) the test should be done twice, with
each mechanism Inactivated alternately.

17.5 Temperatures should be recorded by independent measuring equipment

as described in Chapter 6. If an LTSF sterilizer is being tested, the LTS cycle
should be selected. If an LTS cycle is not available, the primary material for
generating formaldehyde should be replaced with an inert substitute (see
paragraph 1.29). The chamber should be empty except for the usual chamber
furniture.

17.6 Place 12 temperature sensors in the following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. five on each of the two chamber side walls (one at the approximate centre
and four adjacent to the corner positrons of the usable chamber space);

c. one on the plane of the usable chamber space (not on the wall) at a point
nearest to the steam inlet port.

17.7 Inactivate the chamber or jacket temperature control in accordance with

the manufacturer s instructions.

17.8 Select and start the LTS operating cycle

17.9 The test should be considered satisfactory if the following requirements

are met:
a. the cut-out device operates and causes the heat source to be isolated from
the machine and the operating cycle to advance to the drying stage;

b. none of the measured temperatures exceeds 80 ° C;

 c . at the end of the cycle the door remains locked and a fault is indicated.

Chamber wall temperature test

17.10 This test is designed to show that the air removal stage will not start
until the chamber walls are heated to within 2 ° C of the selected operating
temperature. If an LTSF sterilizer is being tested, the LTS cycle should be selected
If an LTS cycle is not available, the primary material for generating formaldehyde
should be replaced with an inert substitute (see paragraph 1.29).

17.11 Temperatures should be recorded by independent measuring equipment

as described in Chapter 6. The chamber should be empty except for the usual
chamber furniture.

17.12 Place 12 temperature sensors in the positions described for the chamber
overheat cut-out test (see paragraph 17.6).

17.13 Select and start the LTS operating cycle.

17.14 The test should be considered satisfactory if the following requirements

are met:

a. the air removal stage of the operating cycle does not start until the
temperatures measured by the 10 sensors attached to the chamber side
walls are within 2 ° C of the selected operating temperature;

b. after the first 5 min of the holding time all the temperatures measured in
the chamber are within -0 ° C + 5 ° C of the temperature measured in the
active chamber discharge.

Thermometric test for a small load

17.15 If an LTV sterilizer is being tested, the LTS cycle should be selected. If an
LTS cycle is not available, the primary material for generating formaldehyde
should be replaced with an inert substitute (see paragraph 1.29).

17.16 Temperatures and pressures should be recorded by independent

measuring equipment as described in Chapter 6.

17.17 Place a standard test pack (see paragraph 7.27) in the chamber with the
bottom of the pack supported 100-200 mm above the centre of the chamber
base.

17.18 Place three temperature sensors in the following positrons:

a. one in an active chamber discharge (see paragraph 6.26);

b. one at the approximate centre of the test pack (the wire from the sensor
should be carefully arranged to prevent steam tracking along it);

c. one placed 50 ± 5 mm above the approximate centre of the upper surface

of the test pack.

17.19 Connect a pressure recorder (or test gauge) to the chamber.

17.20 Select the LTS cycle. Ensure that the process temperature is set to 73 ° C
(corresponding to a sterilization temperature of 71 ° C). Start the cycle.

17.21 If a test gauge is being used, measure and note the chamber pressure at
the approximate mid-point of the holding time.
17.0 LTS disinfectors and LTSF sterilizers

17.22 The test should be considered satisfactory if the following requirements

are met:

a. the requirements of the automatic control test (see paragraph 12.13)

are met;

b. the holding time, determined from the measured temperatures, is not

less than that specified in Table 8;

c. during the holding time:

(i) the measured temperatures are within the temperature band
specified in Table 8;
(ii) the temperature measured above the test pack is within 4ºC of the
temperature measured in the active chamber discharge;
(iii) the temperature measured in the centre of the test pack is not
more than 2ºC below the temperature measured in the active
chamber discharge;
(iv) the indicated and recorded chamber temperatures are within 1ºC
of the temperature measured in the active chamber discharge;
(v) the indicated and recorded chamber pressures are within 0.05 bar
of the measured pressure;

d. for sterilizers using vacuum as the sole method of drying:

(i) the duration of the drying stage is not less than 3 min;
(ii) the chamber pressure at the end of the stage does not exceed
50 mbar absolute;

e. at the end of the cycle the sheets are sensibly dry.

Thermometric test for a full load

17.23 This test applies to LTS disinfection cycles only. It is not required when
the machine is to be used solely with an LTSF sterilization cycle.

17.24 The load is made up of a standard test pack (see paragraph 7.27) and
additional folded sheets designed to represent the maximum mass of textiles
which may be processed in the machine, and is used to demonstrate that, at
the levels at which cycle variables are set, rapid and even penetration of steam
into the centre of a load occurs and disinfecting conditions are achieved.

17.25 Temperatures and pressures should be recorded by independent

measuring equipment as described in Chapter 6.

17.26 Place a standard test pack within the chamber in a position identified
by the manufacturer as the most difficult to disinfect. This will normally be in
the approximate centre of the chamber. Load the rest of the usable chamber
space with stacks of sheets as described for porous load sterilizers (see
paragraphs 13.17, 13.20).

17.27 Place three temperature sensors in the following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. one at the approximate centre of the test pack (the wire from the
sensor should be carefully arranged to prevent steam tracking along it);

c. one below the approximate centre of the top sheet of the test pack.

17.28 Connect a pressure recorder (or test gauge) to the chamber.

17.29 Ensure that the LTS operating cycle is set to an operating temperature
of 73ºC. Start the cycle.

108
17.30 If a test gauge is being used, measure and note the chamber pressure at
the approxrmate mid-point of the holding time.

17.31 The test should b e considered satisfactory if the following requirements

are met:

a. the requirements of the automatic control test (see paragraph 12.13) are
met;

b. during the holding time:

(i) the measured temperatures are within the temperature band
specified in Table 8;
(ii) the temperature measured in the centre of the test pack is within
2 ° C of the temperature measured in the active chamber discharge;

c. at the end of the test the sheets are sensibly dry;

d. the total cycle time is within the performance class stated by the
manufacturer.

Environmental formaldehyde vapour test

17.32 This test is designed to determine the concentration of formaldehyde

vapour discharged into the environment from the chamber and test load at the
end of an LTSF cycle. A gas monitoring instrument is required as specified in
paragraphs 6.54-56.

17.33 Line two modular cardboard Instrument trays (or similar), approximately
600 mm x 300 mm x 50 mm, with a 12-mm thickness of high-density, open-cell
polyurethane foam.

17.34 Place two stainless steel rods, each 400 ± 2 mm long by 10 ± 0.5 mm in
diameter, in each tray and fit the lids. If the trays are smaller than specified
above, the rods may be 250 mm long.

17.35 Place the trays side by side in the centre of the chamber.

17.36 Select the LTSF operating cycle. Ensure that the concentration of
formaldehyde used for the test is that to be used for the microbiological test for
basic performance. Start the cycle.

17.37 At the end of the cycle, measure the concentration of formaldehyde gas
discharged from the chamber when the door starts to open. The sample should
be taken 80-120 mm in front of the gap at a height of 1.4-1.6 m. Continue to
sample the gas for the next 15 min.

17.38 Determine the average concentration o-f gas over the 15-min period.

17.39 The test should be considered satisfactory if the atmospheric

concentratron of formaldehyde gas over the 15-min period does not exceed the
short-term exposure limit specified in Table 1.

Microbiological test for basic performance

17.40 Since the efficacy of LTSF sterilization cannot be assured by the

measurement of cycle variables, the only definitive performance test currently
available for LTSF sterilizers is microbiological. This test is designed to
demonstrate the distribution and penetration of formaldehyde gas within the
chamber. Chemical indicators are used to give an early Indication of the efficacy
of gas penetration but by themselves are not sufficient to validate the
sterilization process. See Chapter 7 for advice on the use of biological and
chemical indicators.

17.41 Place 27 inoculated carriers in the chamber arranged on fine thread to

the pattern shown in Figure 16. (If the usable chamber space is less than 200 I
fewer carriers may be used. The authorised person will advise on this.) Place a
chemical indicator alongside each of the inoculated carriers.

17.42 Place an inoculated carrier and a chemical indicator in each of four Line-
Pickerill helices (see paragraph 7.51). Double-wrap two of the helices in paper
bags (that is, bag in bag) conforming to 856257.

17.43 Place the wrapped helices in diametrically opposite corners of the

sterilizer chamber; one in the upper rear of the usable chamber space, and the
other in the lower front. Place one unwrapped helix in the front half of the
usable chamber space and one in the rear half. All these positions are shown in
Figure 16.

17.44 Ensure that the cycle variables are set to the values specified by the
manufacturer. The concentration of formaldehyde is normally 15 g m-3 of
chamber volume per pulse which can be achieved by the vaporisation of 40 ml
of formalin per cubic metre of chamber volume. Start the operating cycle.

17.45 At the end of the cycle, remove the inoculated carriers and chemical
indicators from the chamber and the helices. Check that the chemical indicators
show a uniform colour change. If so, place each of the inoculated carriers in a
bottle of recovery medium, and incubate them with controls as described in the
general procedure for microbiological tests (see paragraphs 7.63-75).

17.46 If the chemical Indicators do not show a uniform colour change, then
the test should be abandoned.

17.47 The test should be considered satisfactory if the requirements given in

paragraph 7.72 are met.

17.48 The test should be performed two more times to ensure that similar
results are obtained.

17.49 The test should be reported in the format shown in Figure 17

Microbiological test for performance qualification

17.50 This test is designed to follow a thermometric test for performance

qualification. The loading condition and operating cycle should be identical.
Chemical indicators are used to give an early indication of the efficacy of gas
penetration but by themselves are not sufficient to validate the sterilization
process. See Chapter 7 for advice on the use of biological and chemical
indicators.

17.51 Put an inoculated carrier and a chemical indicator together in each of

the SIX load items that carried temperature sensors in the thermometric test.
Place the items in as nearly as possible in the same positions they occupied in
the thermometric test. Put a biological indicator and a chemical indicator
together in a Line-Pickerell helix (see paragraph 7.51) and place the helix in a
position known to be the most difficult to sterilize (normally the coolest part of
the chamber).
 17.0 LTS disinfectors and LTSF sterilizers

Chamber

Plane of the front

limit of the usable
chamber space

chamber space
Helix

Helix-double wrapped

Inoculated carrier and

chemical indicator

Figure 16 Layout of Indicators for the microbiological test for basic performance (LTSF)

17.52 Select and start the operating cycle.

17.53 Ensure that a batch process record is made by the recording instrument
fitted to the sterilizer.

17.54 At the approximate mid-point of the plateau period, note the elapsed
time and indicated chamber temperature and pressure.

17.55 At the end of the cycle, remove the indicators from the load items and
the helix. Check that the chemical indicators show a uniform colour change. If
so, place each of the inoculated carriers in a bottle of recovery medium and
incubate them with controls as described in the general procedure for
microbiological tests (see paragraphs 7.63-75).

17.56 If the chemical indicators do not show a uniform colour change, then
the test should be abandoned.

17.57 The test should be considered satisfactory if the following requirements

are met:

a. during the whole of the cycle the values of the cycle variables as shown on
the batch process record are within the permitted tolerances marked on
the master process record established during the thermometric PQ test;
b. the requirements for microbiological tests set out in paragraph 7.72 are
met.

111
 LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZER
REPORT OF MICROBIOLOGICAL TEST FOR BASIC PERFORMANCE
Automatic controller settings for plateau period: Temperature C Time min s
Primary material for generating formaldehyde Batch no. Expiry date
Mass of primary material used in the cycle: Setting gram Measured gram
CHEMICAL INDICATORS: Manufacturer Batch no. Expiry date
BIOLOGICAL INDICATORS: Manufacturer Organism Strain
Manufacturer s declared number of recoverable spores on each indicator
Batch no. Expiry date
LOCATIONS OF CHEMICAL AND BIOLOGICAL INDICATORS
Location No Chemical Biological No Chemical Biological No Chemical Biological
Rear plane 1 PASS/FAIL PASS/FAIL 2 PASS/FAIL PASS/FAIL 3 PASS/FAIL PASS/FAIL
4 PASS/FAIL PASS/FAIL 5 PASS/FAIL PASS/FAIL 6 PASS/FAIL PASS/FAIL
7 PASS/FAIL PASS/FAIL 8 PASS/FAIL PASS/FAIL 9 PASS/FAIL PASS/FAIL
Centre plane 10 PASS/FAIL PASS/FAIL 11 PASS/FAIL PASS/FAIL 12 PASS/FAIL PASS/FAIL
13 PASS/FAIL PASS/FAIL 14 PASS/FAIL PASS/FAIL 15 PASS/FAIL PASS/FAIL
16 PASS/FAIL PASS/FAIL 17 PASS/FAIL PASS/FAIL 18 PASS/FAIL PASS/FAIL
Front plane 19 PASS/FAIL PASS/FAIL 20 PASS/FAIL PASS/FAIL 21 PASS/FAIL PASS/FAIL
22 PASS/FAIL PASS/FAIL 23 PASS/FAIL PASS/FAIL 24 PASS/FAIL PASS/FAIL
25 PASS/FAIL PASS/FAIL 26 PASS/FAIL PASS/FAIL 27 PASS/FAIL PASS/FAIL
Line-Pickerell helices: Wrapped 1 PASS/FAIL PASS/FAIL 2 PASS/FAIL PASS/FAIL
Unwrapped 3 PASS/FAIL PASS/FAIL 4 PASS/FAIL PASS/FAIL
BIOLOGICAL CONTROLS
Unexposed BI 1 GROWTH/NO GROWTH 2 GROWTH/NO GROWTH 3 GROWTH/NO GROWTH
No BI 4 GROWTH/NO GROWTH 5 GROWTH/NO GROWTH 6 GROWTH/NO GROWTH
Test person: Name Signature Date
Microbiologist: Name Signature Date
Figure 17 Report of microbiological test for basic performance (LTSF)

Routine microbiological test

17.58 A routine microbiological test is required for every productron load.

Chemical indicators are used to give an early indication of the efficacy of gas
penetration but by themselves are not sufficient to monitor the sterilization
process. See Chapter 7 for advice on the use of biological and chemical
indicators. Conditions under which the load may be released as sterile are
discussed in Part 4.

17.59 Place an inoculated carrier and a chemical indicator in a Line-Pickerill

helix (see paragraph 7.51). Double-wrap the helix in paper bags (that is, bag in
bag) conforming to BS6257. Put it in the chamber with the normal production
load.

17.60 Select and start the operating cycle.

17.61 At the end of the cycle, remove the inoculated carrier and chemical
indicator from the helix. Check that the chemical indicator shows a uniform
colour change. If so, place the inoculated carrier in a bottle of recovery medium
and incubate it with controls as described in the general procedure for
microbiological tests (see paragraphs 7.63-75).

17.62 If the chemical indicator does not show a uniform colour change, then
the test should be abandoned.

17.63 The test should be considered satisfactory if the requirements for

microbiological tests set out in paragraph 7.72 are met.
18.0 Ethylene oxide sterilizers

Introduction

18.1 This chapter contains detailed procedures for tests specific to sterilizers
designed to process loads by exposure to ethylene oxide gas (EO). Schedules,
prescribing which tests are to be carried out and when, are set out in Chapter 4
(for validation tests) and Chapter 5 (for periodic tests).

18.2 Attention is drawn to the safety information presented in Chapter 1 and

the detailed safety precautions discussed in Part 4.

18.3 Humidity is the most critical cycle variable in EO sterilization but also the
most difficult to measure and control. In several of these tests it is necessary to
determine the humidity in the sterilizer chamber during the conditioning stage.
The ideal method is to use humidity sensors calibrated for RH (see paragraphs
6.47-50), but if these are not available the RH should be calculated using the
method given in Appendix 2. Because of the large errors in both methods, and
the variation within the chamber, the new EN permits a relatively broad range of
40-85% RH and that is the value given here. Users should aim, however, to
attain an ideal true value of 50-60% RH to ensure that no part of the chamber
is allowed to reach the dangerous extremes of < 30% RH or > 95% RH.

Chamber overheat cut-out test

18.4 This test is designed to show that the overheat cut-out mechanisms for
the chamber and jacket will prevent the temperature of the chamber free space
from exceeding the gas exposure temperature by more than 6 C. Where cycles
with different gas exposure temperatures are available, the test should be done
for each cycle. Where two temperature control mechanisms are fitted (for the
jacket and the chamber) the test should be done with each mechanism
inactivated alternately.

18.5 The dimensions of the usable chamber space need to be known for this
test. The space is assumed to be a rectangular box. If the usable chamber space
is cylindrical, the planes referred to below are those of the smallest box that can
contain it (see Figure 18).

18.6 Temperatures should be recorded by independent measuring equipment

as described in Chapter 6. The chamber should be empty except for the usual
chamber furniture. EO gas should be replaced with an inert substitute (see
paragraph 1.29).

18.7 Place 12 temperature sensors in the following positrons:

a. one in thermal contact with the sensor connected to the temperature

recorder fitted to the sterilizer;

b . two on each of the planes of the usable chamber space, excluding doors
(one at the approximate centre of the plane and one in a position known
to be the hottest);

c . one on the plane of the usable chamber space at a point nearest to the
steam inlet port.
 18.0 Ethylene oxide sterilizers

Boundary of
Chamber wall usable
chamber
space

(a) Rectangular chamber

Chamber wall

Placement of
sensors in
these positions

(b) Cylindrical chamber

Figure 18 Location of sensors for EO chamber overheat cut-out and chamber space
temperature test

18.8 Inactivate the chamber or jacket temperature control in accordance with

the manufacturer’s instructions.

18.9 Select and start the operating cycle

18.10 The test should be considered satisfactory if the following requirements

are met:

a. the cut-out device operates and causes the heat source to be isolated from
the machine and the operating cycle to advance to the gas removal stage;
b. none of the measured temperatures exceeds the preset gas exposure
temperature by more than 6°C;
c. at the end of the cycle a fault is indicated

Chamber space temperature test

18.11 This test is designed to show that the temperature of the chamber free
space is within 2°C of the preset gas exposure temperature at the start of the
gas exposure stage.

115
18.12 Temperatures should be recorded by independent measuring equipment
as described in Chapter 6. The chamber should be empty except for the usual
chamber furniture. EO gas should be replaced by an inert substitute (see
paragraph 1.29).

18.13 Place 12 temperature sensors in the positions described for the chamber
overheat cut-out test (see paragraph 18.7).

18.14 Select and start the operating cycle.

18.15 The test should be considered satisfactory if the following requirements

are met:

a. at the start of the gas exposure stage the measured temperatures are
within 2 C of the preset gas exposure temperature;

b. after the first 5 min of the gas exposure stage the temperatures measured
in the chamber are within 2 C of the temperature measured by the sensor
adjacent to the temperature recorder sensor.

Chamber wall temperature test

18.16 Temperatures should be recorded by independent measuring equipment

as described in Chapter 6. The chamber should be empty except for the usual
chamber furniture. EO gas should be replaced by an inert substitute (see
paragraph 1.29).

18.17 Place 12 temperature sensors in the following positions:

a. one in thermal contact with the sensor connected to the temperature
recorder fitted to the sterilizer;
b. two on each of the chamber surfaces, excluding doors (one at the centre
of the surface and one in a position known to be the hottest);
c. one on the plane (not on the wall) of the usable chamber space at a point
nearest to the steam inlet port.

18.18 Select and start the operating cycle.

18.19 The test should be considered satisfactory if, after the first 5 min of the
gas exposure stage, the temperatures measured in the chamber are within 5 C
of the temperature measured by the sensor adjacent to the temperature
recorder sensor.

Microbiological test for gas exposure time

18.20 Since the efficacy of EO sterilization cannot be assured by the

measurement of cycle variables, the only definitive performance test currently
available for EO sterilizers is microbiological. This test is designed to demonstrate
the penetration of EO gas within the chamber and to determine the duration of
the gas exposure stage for routine production. Chemical indicators are used to
give an early indication of the efficacy of gas penetration but by themselves are
not sufficient to validate the sterilization process. See Chapter 7 for advice on
the use of biological and chemical indicators.

18.21 During the conditioning stage it will be necessary to determine the

relative humidity in the chamber. Humidity may be indicated or recorded by the
instrument fitted to the sterilizer, calculated (Appendix 2) or referenced to a test
in which an identical loading condition has been tested with an inert gas.
18.22 Place an inoculated carrier and a chemical indicator in each of four Line-
Pickerill helices (see paragraph 7.51). Triple-wrap the helices in paper bags (that
is, bag in bag in bag) conforming to BS6257. Seal the bags and allow them to
equilibrate in an environment of 20 – 5 C and 60 – 20% RH for at least one
hour.

18.23 Place two helices towards the front of the usable chamber space and
two towards the rear, in positions known to be the slowest to attain the gas
exposure temperature.

18.24 Select the operating cycle. The EO concentration in the chamber will
normally be 250-1000 mg l -1. The duration of the gas exposure stage should be
considerably less than one-third of that anticipated for routine production, and
insufficient to inactivate all the biological indicators. The authorised person will
advise on what this period should be. Start the cycle.

18.25 At the end of the cycle remove the inoculated carriers and chemical
indicators from the helices.

18.26 Repeat the cycle several times with fresh inoculated carriers and
chemical indicators and the gas exposure time increased in each cycle. The gas
exposure time for the final cycle should be sufficient to inactivate all the
inoculated carriers. The behaviour of the chemical indicators may be used to
estimate when this time is attained. The authorised person will advise on how
many cycles are required and the time increment for each one.

18.27 Place each of the inoculated carriers in a bottle of recovery medium and
incubate them with controls as described in the general procedure for
microbiological tests (see paragraphs 7.63-7.75).

18.28 The test should be considered satisfactory if the following requirements

are met;

a. at the end of the conditioning stage of each cycle the humidity in the
chamber is in the range 40-85% RH (see paragraph 18.3);
b. at the end of the incubation period:
(i) one or more of the bottles with inoculated carriers exposed to the
EO process shows growth for the shortest gas exposure time, but
none shows growth for the longest gas exposure time;
(ii) control bottles with no inoculated carrier show no growth;

c. control bottles with unexposed inoculated carriers show growth within

24 h.

18.29 Note the shortest gas exposure time for which no growth is observed.
Perform the test for a further two cycles at this exposure time. If all three cycles
are satisfactory, the gas exposure time determined by this procedure (the critical
gas exposure time) should be regarded as one-third of the minimum time
required for production loads representing less of a challenge than the load used
in this test.

Microbiological test for basic performance

18.30 This test is designed to demonstrate the penetration of EO gas within

the chamber and confirm the duration of the gas exposure stage for routine
production. Chemical indicators are used to give an early indication of the
efficacy of gas penetration, but by themselves are not sufficient to validate the
sterilization process. See Chapter 7 for advice on the use of biological and
chemical indicators.

18.31 Prepare and position four Line-Pickerell helices as described in the

microbiological test for gas exposure time (see paragraphs 18.22-18.23).

18.32 Select the operating cycle. Set the duration of the gas exposure stage to
the critical gas exposure time determined during commissioning (see paragraph
18.29). Start the cycle.

18.33 At the end of the cycle remove the inoculated carriers and chemical
indicators from the helices. Examine the chemical indicators and check whether
they show a uniform colour change. If so, place each inoculated carrier in a
bottle of recovery medium and incubate them with controls as described in the
general procedure for microbiological tests (see paragraphs 7.63-7.75).

18.34 If the chemical indicators do not show a uniform colour change, then
the test should be abandoned.

18.35 The test should be considered satisfactory if the following requirements

are met:

a. at the end of the conditioning stage the humidity in the chamber is in the
range 40-85% RH (see paragraph 18.3);

b. the requirements for microbiological tests set out in paragraph 7.72 are
met.

Thermometric test for performance qualification

18.36 The load used for this test should be one of the production loads
processed in the sterilizer. To serve as a reference load it should present to the
process the greatest challenge on the basis of moisture absorbency, gas
absorbency and the attainment of the gas exposure temperature throughout the
load. If the load presents a greater challenge than the test load used in the
microbiological test for basic performance, then that test will need to be
repeated with the new load in order to confirm the gas exposure time.

18.37 Table 11 Indicates the information that will need to be noted for the PQ
report. See Chapter 8 for general Information about PQ tests and reports.

18.38 Temperatures, pressures and humidities should be recorded by

independent measuring equipment as described in Chapter 6. If humidity
sensors are not available, humidity should be calculated as described in
Appendix 2. EO gas should be replaced with an inert substitute (see paragraph
1.29).

18.39 Package each item of the load in accordance with the procedure to be
used for routine production. Note the type of load and method of packaging.

18.40 Ensure that the preconditioning procedure is identical to that which will
be used for production. This should normally be for at least 1 h in an
environment having a temperature of 15-25 ° C and a humidity of 40-85% RH.

18.41 Place 12 temperature sensors in the following positions:

a. one in thermal contact with the sensor connected to the chamber

temperature recorder fitted to the sterilizer (sensor A);
b. one in the gas entry port to the chamber;
The PQ report for EO sterilizers should include the values and permitted
tolerances of the following variables:

1 . preconditioning (in separate area, if used):

a. time, temperature and humidity;
b. minimum temperature of product permitted to enter preconditioning;
C. maximum elapsed time between removal of the load from
preconditioning and the start of the conditioning stage of the operating
cycle;

2. conditioning (in sterilizer chamber):

a. temperature and humidity in the chamber and within the load at the
beginning and end of the conditioning stage;
b. if a humidity indicator or recorder is not fitted to the sterilizer, the
critical parameters necessary for the attainment of the specified
humidity of the load - the parameters chosen will depend on the
method used to humidify the load;

3. fertilization:
a. chamber pressure;
b. chamber temperature;
C. gas exposure time;
d. temperature of the load;
e. EO concentration, estimated from pressure change (see Appendix 2) or
(exceptionally) by direct analysis of chamber atmosphere;

4. flushing (in sterilizer chamber):

a. time, temperature and pressure changes;
b. rate of change of air or other gas;
c. temperature of the load;

5. degassing (in separate aeration cabinet and/or room):

Time, temperature and pressure changes;
b. Rate of change of air or other gas;
C. Temperature of the load.

Table 11 Performance qualification data for EO sterilizers

c. one in the primary heat source to the gas preheater (if fitted);
d. one in each of five load items known to be the slowest to attain the gas
exposure temperature and placed in the coolest part of the chamber;
e. one in a load item in the hottest part of the chamber;

f. one in the coolest part of the chamber free space;

g. one on the hottest part of the chamber surface;

h. one on the coolest part of the chamber surface.

18.42 If available, place two humidity sensors in the following positions:

a. one alongside the temperature sensor in the load item in the hottest part
of the chamber (see paragraph 18.41 (e));
b. one alongside the temperature sensor in the coolest part of the chamber
free space (see paragraph 18.41(f)).

18.43 Connect a pressure recorder (or test gauge) to the chamber.

18.44 Select the operating cycle that will be used for the production load. The
cycle variables should be set as determined in the microbiological test for gas
exposure time, although the duration of the flushing stage may need to be
adjusted to satisfy the requirements of the environmental gas test (see
paragraph 8.37) and the test for degassing time (see paragraph 8.46). Start the
cycle.

18.45 Ensure that a batch process record is made by the recording instrument
fitted to the sterilizer. This will serve as the basis for a master process record (see
paragraph 8.58) for the loading condition under test.

18.46 At the end of the conditioning stage, note the readings from the
humidity sensors, including the sterilizer humidity indicator (if fitted).

18.47 At the approximate mid-point of the gas exposure stage, note the
elapsed time and the indicated chamber temperature and pressure.

18.48 The test should be considered satisfactory if the following requirements

are met:

a. the requirements of the automatic control test (see paragraph 12.13) are
met;

b. after the first 5 min of the gas exposure time the temperatures measured
on the chamber walls are within 5 ° C of the temperature measured by
sensor A;

c. after the first 5 min of the gas exposure time, and until its end, all the
measured temperatures, except in the gas pre-heater and on the chamber
walls, are within 2 C of the temperature measured by sensor A;

d. at the end-of the conditioning stage:

(i) the humidity
I is in the range 40-85% RH (see paragraph 18.3);

(ii) the difference between the two RH measurements (if made) does
not exceed 20% RH;
(iii) the reading on the sterilizer humidity indicator (if fitted) is not less
than 40% RH;

e. after the first 15 min of the gas exposure time, and until its end, the peak-
to-peak variation in the measured chamber pressure does not exceed 20%
for cylinder systems and 25% for cartridge systems;

f. for cylinder systems, throughout the cycle the temperature measured in

the primary heat source to the gas pre-heaters does not exceed 70 C.

Microbiological test for performance qualification

18.49 This test is designed to follow a thermometric test for performance

qualification. The loading condition, preconditioning process and operating cycle
should be identical. Chemical indicators are used to give an early indication of
the efficacy of gas penetration but by themselves are not sufficient to validate
the sterilization process. See Chapter 7 for advice on the use of biological and
chemical indicators.

18.50 Assemble 20 biological indicators and 20 chemical indicators to form 20

biological-chemical indicator pairs. Place them in the following positions:

a. one pair in each of the six load items which carried temperature sensors in
the thermometric test (see paragraphs 19.41 (d), (e));

b. 14 pairs distributed throughout the remaining load items.

18.51 Select the operating cycle used in the thermometric test. The
concentration of EO used for the test should be the same as will be used for
production cycles. This is normally 250-1000 mg l -1. Start the cycle.

18.52 Ensure that a batch process record is made by the recording Instrument
fitted to the sterilizer.

18.53 At the end of the conditioning stage, note the indicated chamber
temperature, pressure and humidity. Where a humidity instrument is not
fitted, RH may be assumed to be the same as that determined during the
thermometric test provided that all the cycle variables are identical within the
permitted tolerances.

18.54 At the approximate mid-point of the gas exposure stage, note the
elapsed time and the indicated chamber temperature, pressure and humidity.

18.55 At the end of the cycle, remove the indicators from the load items.
Check whether the chemical indicators show a uniform colour change. If so,
place each of the inoculated carriers in a bottle of recovery medium and
incubate them with controls as described in the general procedure for
microbiological tests (see paragraphs 7.63-7.75).

18.56 If the chemical indicators do not show a uniform colour change, then
the test should be abandoned.

18.57 The test should be considered satisfactory if the following requirements

are met;

a. the requirements of the automatic control test (see paragraph 12.13) are
met;

b. the humidity values at the end of the conditioning stage, whether

indicated, measured or calculated, are consistent with those obtained
during the thermometric test;

c. the requirements for microbiological tests set out in paragraph 7.72 are
met.

Routine microbiological test

18.58 A routine mircrobiological test is required for every productron load.

Chemical indicators are used to give an early indication of the efficacy of gas
penetration but by themselves are not sufficient to monitor the sterilization
process. See Chapter 7 for advice on the use of biological and chemical
indicators. Conditions under which the load may be released as sterile are
discussed in Part 4.

18.59 Assemble ten biological indicators and ten chemical indicators to form
ten biological-chemical indicator pairs. Distribute the pairs evenly in the spaces
between the load items.

18.60 Select and start the operating cycle

18.61 At the end of the cycle, remove the indicators from the load. Check that
the chemical indicators show a uniform colour change. If so, place each of the
inoculated carriers in a bottle of recovery medium and incubate them with
controls as described in the general procedure for microbiological tests given in
Chapter 7.
18.62 If the chemical indicators do not show a uniform colour change, then
the test should be abandoned.

18.63 The test should be considered satisfactory if the requirements for

microbiological tests set out in paragraph 7.72 are met.
 19.0 Laboratory sterilizers

Introduction

19.1 This chapter contains detailed procedures for tests specific to laboratory
sterilizers, Schedules, prescribing which tests are to be carried out and when, are
set out in Chapter 4 (for validation tests) and Chapter 5 (for periodic tests). The
tests in this chapter apply to laboratory sterilizers equipped with one or more of
the following operating cycles:

a. make-safe of small plastic discard;

b. make-safe of contained fluid discard;

c. sterilization of culture media (preset or variable cycle);

d. disinfection of fabrics (see paragraph 13.7 for the small-load test);

e. sterilization of glassware and equipment;

f . free steaming;

g. culture media preparator.

19.2 Attention is drawn to the safety information presented in Chapter 1 and

the detailed safety precautions discussed in Part 4.

19.3 Unless specified otherwise, all the tests should be performed at each of
the sterilization temperatures available on the sterilizer.

Make-safe of small plastic discard

19.4 These tests apply to laboratory sterilizers with an operating cycle designed
to make-safe plastic discard material where no one item contains more than
50 ml of aqueous fluid.

19.5 If by agreement with the laboratory safety officer, the user authorises the
use of the sterilizer with the thermal door-lock override selected, then these tests
should be conducted both with and without the override selected.

Information about Hazard Groups 19.6 Containers should be held in the discard boxes recommended by the
may be found in the HSC document manufacturer. Discard boxes holding containers into which temperature sensors
Categorisation of pathogens are to be inserted should not contain infected material. Material infected with
according to hazard and categories Hazard Group 2 organisms may be used to make up other boxes in the test
of containment (second edition, load. At no time should any material known to contain Hazard Group 3 or 4
1990) compiled by the Advisory organisms be used.
Committee on Dangerous
Pathogens.
Thermometric test for a full load

19.7 Temperatures and pressures should be recorded by independent

measuring equipment as described in Chapter 6.

19.8 Prepare sufficient Petri dishes to fill two discard boxes when the dishes
are stacked vertically. Each dish should contain approximately 15 ml of agar gel.

19.9 Place one temperature sensor in the centre of each of six of the dishes.
Put three of these test dishes in each box: one in the centre of the box, one
one-third from the bottom and one one-third from the top, supported by the
remaining dishes. If only one box will fit in the chamber, put all six test dishes in
the box, two at each position.

19.10 Put the two test boxes in opposite corners of the chamber. Load the
remaining chamber space with boxes filled with discard material such that the
spacing between boxes is in accordance with the minimum recommended by
the manufacturer.

19.11 Place a further five temperature sensors in the following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. one in the chamber, alongside the sensing element of the load

temperature probe, if it is fitted (the probe should be stowed on its
bracket);

c. one in the centre of the free space between the bottom of each test box
and its trivet (if fitted). (If the box does not have a trivet, the sensor should
be placed in the free space between Petri dishes 15 mm above the centre
of the bottom of the box);

d. one in the chamber free space.

19.12 Connect a pressure recorder (or test gauge) to the chamber.

19.13 Select and start the operating cycle.

19.14 If a test gauge is being used, measure the chamber pressure at the
approximate mid-point of the holding time.

19.15 The test should be considered satisfactory if the requirements listed in

Table 12 are met, and the drain is not blocked with agar.

Thermometric test for a small load

19.16 This test is not required if the sterilizer is designed to accommodate only
one discard box. Temperatures and pressures should be recorded by independent
measuring equipment as described in Chapter 6.

19.17 Load the chamber with a single discard box filled with Petri dishes as
described in the full-load test, with three temperature sensors located in the
following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. one in the centre of a dish located one-third from the bottom of the box;

c. one in the centre of a dish located in the approximate centre of the box.

19.18 Follow the procedure for the full-load test.

19.19 The test should be considered satisfactory if all but the cycle time
condition of the requirements for the full-load test are met.

Cycles for fluid loads

19.20 These tests apply to laboratory sterilizers with cycles designed to process
fluid discard in glass containers and large plastic containers (> 50 ml), culture
media (preset or variable cycles) and for free steaming.
The test should be considered satisfactory if the following requirements are met:
a. the requirements of the automatic control test (paragraph 12.13) are met;
b. the holding time, as determined from the measured temperatures, is not
less than that specified for the appropriate sterilization temperature band
listed in Table 12;
c. during the holding time:
(i) the measured temperatures are within the appropriate sterilization
temperature band listed in Table 12;
(ii) except for discard cycles, the measured temperatures are within 1 ° C
of each other;
(iii) the indicated and recorded chamber temperatures are within 1 ° C of
the temperature measured in the active chamber discharge;
(iv) the indicated and recorded chamber pressures are within 0.05 bar of
the measured chamber pressure;
(v) the measured chamber pressure is within 0.05 bar of saturated steam
pressure or, if a partial pressure system is used, as specified by the
manufacturer;
d. at the end of the cycle:
(i) the temperature sensors have remained in position;
(ii) items holding sensors remain intact;
(iii) not more than one of the other items (or 1%, whichever is the
greater) has burst or broken;
(iv) the temperature measured in any fluid containers is not greater than
90 ° C (plastic) or 80 ° C (glass);
e. the total cycle time is within the performance class stated by the
manufacturer.

Table 12 General requirements for the full-load test (laboratory sterilizers)

19.21 Bottles into which temperature sensors are inserted should contain a
solution of 10 - 1 5 g of agar powder dissolved in 1000 ml of distilled water.
Other bottles in the loads should be filled with water or water-based culture
medium.

19.22 All bottles should be filled to 80% of their nominal capacity. The
volumes of the fluid in each bottle should not vary from their mean by more
than 5%. At the start of the cycle the temperature of the fluid in each bottle
should be 20 ± 5 ° C and the media preparation in the liquid form.

19.23 The bottles may be either all sealed or all unsealed, according to the
practice in the laboratory and the requirements of the schedules in Chapters 4
and 5. Sealed and unsealed bottles should not be mixed in the same load.

Thermometric test for a full load

19.24 Temperatures and pressures should be recorded by independent

measuring equipment as described in Chapter 6.

19.25 Fill nine one-litre bottles with the test liquid as described in paragraph
19.21. Insert a temperature sensor into each one, ensuring that the tops are
sealed or unsealed as required. Unsealed bottles should be capped loosely to
prevent coolant water entering the bottle.

19.26 If unsealed bottles are used, weigh each of them and note their masses
( M 1) to an accuracy of 1 g.
19.27 Place three of the bottles in positions known to be the slowest to attain
the sterilization temperature, three in positions known to be the fastest to attain
the sterilization temperature, and three in positions known to be the slowest to
cool to 80 C.

19.28 Load the remaining chamber space with one-litre bottles, filled either
with water or a water-based medium, at the minimum spacing recommended by
the manufacturer.

19.29 Place a further temperature sensor in an active chamber discharge (see

paragraph 6.26).

19.30 Connect a pressure recorder (or test gauge) to the chamber.

19.31 Select the operating cycle:

a. if a variable culture media cycle is being tested, set the sterilization

temperature to 121 C with a minimum holding time of 15 min;

b. if a free steaming cycle is being tested, set the load temperature to

95-98 C for a minimum of 15 min.

19.32 Start the cycle.

19.33 If a test gauge is being used, measure the chamber pressure at the
approximate mid-point of the holding time.

19.34 As soon as the cycle is complete, and before opening the door, observe
and note the measured temperatures in the bottles.

19.35 Within 5 min of the end of the cycle, weigh any unsealed test bottles
again and note their masses ( M 2). For each bottle, calculate the percentage loss
in mass from:

Percentage loss in mass = 100 x

19.36 The test should be considered satisfactory if the requirements listed in

Table 12 are met and the loss of fluid in any unsealed bottles does not exceed
2% by mass.

Thermometric test for a small load

19.37 Temperatures and pressures should be recorded by independent
measuring equipment as described in Chapter 6.

19.38 Fill nine 5-ml bijou bottles with 4 ml of test liquid as described in
paragraph 19.21. Insert a temperature sensor into each one, ensuring that the
tops are sealed.

19.39 Distribute them among two wire baskets, one supported in the upper
rear of the usable chamber space and the other in the lower front. Each should
contain a total of 25 bijou bottles, so that three test bottles are in positions
known to be the slowest to attain the sterilization temperature, three in
positions known to be the fastest to attain the sterilization temperature, and
three in positions known to be the slowest to cool to 80 C.

19.40 If the sterilizer is not designed to process bottles of this size, the smallest
size and number of containers recommended by the sterilizer manufacturer
should be used.
19.41 Where the sterilizer is to be used to process one size of container only,
the test load may be a single container of this size, filled with the nominal
volume of test liquid and supported in a position known to be the slowest to
attain the sterilization temperature.

19.42 Place a further temperature sensor in an active chamber discharge (see

paragraph 6.26).

19.43 Connect a pressure recorder (or test gauge) to the chamber.

19.44 Follow the procedure for the full-load test.

19.45 The test should be considered satisfactory if, except for the cycle time
condition, the requirements listed in Table 12 are met.

Simplified thermometric test for performance requalification

19.46 This test is not a substitute for a full PRQ test, but is used quarterly to
check that the sterilization conditions continue to be met. Temperatures and
pressures should be recorded by independent measuring equipment as described
in Chapter 6.

19.47 Prepare a production load known to present the greatest challenge to

the operating cycle and for which there is a PQ report. (This will normally be the
reference load used in the yearly PRQ tests.) Place temperature sensors in the
following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. one in a container known to be the slowest to attain the sterilization
temperature;

c. one in a container known to be slowest to cool to 80 ° C.

19.48 Place the load in the chamber as described in the PQ report

19.49 Select the operating cycle as specified in the PQ report. Start the cycle.

19.50 The test should be considered satisfactory if the requirements listed in

the PQ report are met.

Sterilization of glassware and equipment

19.51 These tests apply to laboratory sterilizers with a cycle designed to

sterilize empty glassware without caps and other non-porous equipment. If caps
are fitted, air will not be removed, and the glassware should be classed as
disinfected but not sterilized.

Thermometric test for a full load

19.52 Temperatures and pressures should be recorded by independent

measuring equipment as described in Chapter 6.

19.53 Fill four discard boxes with empty glass bijou bottles, without caps,
arranged randomly. Place two temperature sensors in each box, one inserted
into an inverted bottle in the centre of the box and one in an inverted bottle
one-third from the bottom.
19.54 Where the full load is less than four boxes, the maximum load which the
sterilizer is designed to process should be used. The eight temperature sensors
should be distributed within the load.

19.55 Put these test boxes in the chamber and load the remaining chamber
space with boxes of bijou bottles at the minimum spacing recommended by the
manufacturer.

19.56 Place three further temperature sensors in the following positions:

a. one in an active chamber discharge (see paragraph 6.26);

b. one in the chamber located alongside the load temperature probe (if
fitted);

c. one in the upper chamber free space.

19.57 Connect a test pressure recorder (or a test gauge) to the chamber.

19.58 Select and start the operating cycle.

19.59 If a test gauge is being used, measure the chamber pressure at the
approximate mid-point of the holding time.

19.60 The test should be considered satisfactory if the requirements listed in

Table 12 are met, and the load is visibly dry.

Thermometric test for a small load

19.61 Fill one discard box with bijou bottles with sensors placed as described
for the full-load test and put it in the chamber. Place a further sensor in an active
chamber discharge.

19.62 Follow the procedure for the full-load test.

19.63 The test should be considered satisfactory if, except for the cycle time
condition, the requirements listed for the full-load test are met.

Thermal door-lock override test

19.64 A thermal door-lock is fitted to certain laboratory sterilizers to prevent

the door from being opened until the temperature in the chamber and load falls
below 80 ° C. The override is intended for use by trained persons who wish to
gain access at temperatures above 80 ° C to loads which will not present an
explosive hazard.

19.65 For this test the sterilizer chamber should be empty.

19.66 Select and start the operating cycle to be tested.

19.67 Attempt to select the thermal door-lock override during the heat-up,
sterilization (holding time) and cooling stages.

19.68 The test should be considered satisfactory if the following requirements

are met:

a. the override operates only during the cooling stage of the cycle and causes
the cooling stage to terminate;

b. the override switch resets automatically when released;

 c. the thermal door-lock override indicator is Illuminated;

d. at the end of the cycle the door cannot be opened except by means of a
key, code or tool which is unique to the sterilizer.

19.69 Where the sterilizer is intended to be used exclusively for make-safe of

discard in small containers, compliance with (b) and (d) may be waived by
agreement with the laboratory safety officer. In this case, the switch should reset
automatically whenever a different operating cycle is selected or whenever the
power supply is interrupted.

Culture media preparator

19.70 For these tests, the sterilizer vessel should be filled with the test liquid
described in paragraph 19.21 to the nominal capacity specified by the
manufacturer.

Thermometric test for a full load

19.71 Temperatures and pressures should be recorded by independent

measuring equipment as described in Chapter 6.

19.72 Place two temperature sensors in the following positions:

a. one at the bottom of the chamber in the space occupied by the minimum
production volume stated by the manufacturer;

b. one in the approximate centre of the chamber.

19.73 Connect a pressure recorder (or test gauge) to the chamber.

19.74 Select and start the operating cycle.

19.75 If a test gauge is being used, measure the chamber pressure at the
beginning, middle and end of the holding time.

19.76 When the cycle is complete, wait for the temperature in the chamber to
fall to 85 ° C. Attempt to open the door safety hood. If the hood does not open,
wait for the temperature to fall below 80 ° C. Attempt to open the hood again.

19.77 The test should be considered satisfactory if the following requirements

are met:

a. the requirements of the automatic control test (see paragraph 12.13) are
met;
b. the holding time, as determined from the measured temperatures, is not
less than that specified for the appropriate sterilization temperature band
listed in Table 13;
c. during the holing time:
(i) the temperatures measured in the medium are both within ± 2 ° C of
the set temperature;
(ii) the indicated and recorded chamber temperatures are within 1 ° C
of the lower of the two temperatures measured in the medium;
(iv) the indicated and recorded chamber pressures are within 0.05 bar
of the measured chamber pressure;

d. the door safety hood cannot be opened until the higher of the two
temperatures measured in the medium falls below 80 ° C.
 Sterilization Maximum Minimum
temperature temperature holding time
Name of operating cycle [ ° C] [ ° C] [min]
Make-safe of small plastic discard 134 138 3
126 129 10
121 124 15
Make-safe of contained fluid discard 134 138 3
126 129 10
121 124 15
Sterilization of culture media (pre-set 121 124 15
cycle) 115 118 30
Sterilization of culture media 102-134 up to 60
(variable cycle) 121a 124 15
Disinfection of fabrics 134 138 3
126 129 10
121 124 15
Sterilization of glassware and 134 138 3
equipment 126 129 10
121 124 15
Free steaming (variable cycle) 102-104 up to 60
95a 98 15
Culture media preparator 121 124 15
115 118 30
a. Although the cycle is variable, this temperature band should be used for testing
purposes.
Table 13 Sterilization conditions for laboratory sterilizers

Reheat and dispensing test

19.78 This test follows immediately after the full-load test, using the same
load. Temperature and pressure sensors should be removed.

19.79 Set the sterilizer to reheat the batch to a nominal reheat temperature of
100 ° C.

19.80 Five minutes after the medium attains the reheat temperature, allow it
to cool to a nominal dispensing temperature of 55 ° C.

19.81 When the indicated chamber temperature reaches 55 ° C wait 10 min

and begin dispensing the medium.

19.82 Note the indicated chamber temperature and pressure at the beginning,
middle and end of the dispensing period.

19.83 The test should be considered satisfactory if the following requirements

are met:

a. during dispensing:
(i) he indicated chamber temperature is within ± 2 ° C of the set
dispensing temperature;
(ii) the indicated chamber pressure is zero;
(iii) the medium does not solidify;
b. the person conducting the test does not observe any mechanical or other
anomaly.
Glossary

The following list of definitions has been adopted in HTM 2010 and used in Part 3. Paragraph references indicate where
further information may be found in Part 3. Cross-references to other terms are shown in bold type.

absolute pressu re Pressure measured from absolute vacuum.

active chamber discharge The controlled flow of air, or of air and condensate, from the chamber, through
either a drain or a vent, such that the temperature of the discharge IS at the
temperature of the chamber (see paragraph 6.26).

aeration A part of the sterilization process during which sterilant gas and/or its reaction
products desorb from the load until predetermined levels are reached. See
degassing and flushing.

air detector A device used to determine that sufficient air or other non-condensable gases
have been removed from the chamber (see paragraph 11.37).

automatic controller A device that, in response to predetermined cycle variables, operates the
sterilizer sequentrally through the required stages of the operating cycle.

automatic control test A test designed to show that the operating cycle functions correctly as evidenced
by the values of the cycle variables indicated and recorded by the instruments
fitted to the sterilizer (Chapter 12).

A-weighted Of sound level measurements, weighted to the frequency response of the human
ear (see paragraph 10.2).

batch process record (BPR) A permanent record of one or more cycle variables recorded during a complete
operating cycle by instruments fitted permanently to the sterilizer.

biological indicator A device, consisting of an inoculated carrier contained within a primary pack,
designed to test the efficacy of an operating cycle (see paragraph 7.43).

cartridge In EO sterilizers, a portable, single-use, simple vessel containing sterilant gas

under pressure from which the gas is delivered by puncturing the cartridge.

chamber The part of the sterilizer in which the load is placed.

chamber furniture Shelves, pallets, loading trolleys and other fixed or movable parts that support the
load within the chamber.

chamber temperature The lowest temperature prevailing in the chamber.

chemical indicator A device designed to show, usually by a change of colour, whether specified values
of one or more cycle variables have been attained (see paragraph 7.36).

clinical sterilizer A sterilizer designed to process medical devices to be used in the clinical care of
patients.

commissioning The process of obtaining and documenting evidence that equipment has been
provided and installed in accordance with the equipment specifications and that it
functions within predetermined limits when operated in accordance with the
operational instructions (see paragraph 2.15).

conditioning In EO sterilizers, the treatment of a load within the operating cycle, but prior to
sterilization, to attain a predetermined temperature and humidity throughout the
load.

cooling stage The period of the operating cycle, after the holding time has been completed,
during which the load remains in the chamber while the load cools to a safe
temperature.
critical gas exposure time For EO sterilizers, the shortest gas exposure time, determined during
commissioning, for which all biological indicators are inactivated (see paragraph
18.20).

culture media preparator A specialised laboratory sterilizer designed for the sterilization and dispensing
of culture media.
cycle complete Recognition by the automatic controller that the pre-set values for the cycle
variables, necessary for a successful operating cycle, have been attained and that
the sterilized load is ready for removal from the chamber.

cycle variables The physical properties, for example time, temperature, pressure, humidity and gas
concentration, that influence the efficacy of the operating cycle (see paragraph
7.3).

degassing In LTSF and EO sterilizers, an aeration procedure in which sterilant gas and its
reaction products are desorbed from the load by defined treatment outside the
sterilizer after completion of the operating cycle.

disinfection A process used to reduce the number of viable micro-organisms in a load but
which may not necessarily inactivate some viruses and bacterial spores.
disinfector An apparatus designed to achieve disinfection

dry-heat sterilizer A clinical sterilizer designed to sterilize loads by exposure to hot dry air at near
atmospheric pressure.
dryness value A dimensionless quantity, approximating to the dryness fraction, derived to
determine whether steam is of the correct dryness for sterilization purposes. A
dryness value of 1.0 represents dry saturated steam (see paragraph 9.30).

D-value Decimal reduction value (for biological indicators). The time in minutes required
to secure inactivation of 90% of the test organisms under stated exposure
conditions.
EO sterilizer A clinical sterilizer designed to sterilize loads by exposure to EO gas or EO gas
mixtures.

equilibration time The period which elapses between the attainment of the sterilization
temperature in the chamber and the attainment of the sterilization temperature
in all parts of the load (see paragraph 7.10).

ethylene oxide (EO) Sterilant gas used to sterilize items that would be damaged by exposure to heat or
moisture. Chemical formula CH2CH2O.

FO A quantity, measured in minutes, used to determine the efficacy of an operating

cycle and equivalent to a continuous period at a temperature of 121 C (see
paragraph 14.19).

fail-safe An attribute of sterilizer design whereby failure of any component or its associated
services does not create a safety hazard.

fault The recognition by the automatic controller that the preset cycle variables for
the operating cycle have not been attained, and that sterilization or
disinfection has been jeopardised.

fluid sterilizer A clinical sterilizer designed to sterilize fluids in sealed containers by exposure to
high-temperature steam under pressure.
flushing In LTSF and EO sterilizers, an aeration procedure by which remaining sterilant
gas IS removed from the load within the chamber by the passage of air or other
inert gas.

formaldehyde Sterilant gas used in combination with low-temperature steam to sterilize items
that would be damaged by exposure to high-temperature steam. Chemical
formula HCHO.
formalin Formaldehyde solution BP. A 38% aqueous solution of formaldehyde stabilised
with 10% w/v ethanol, commonly used as the primary material for generating
formaldehyde gas.
free steaming A process, used in laboratory sterilizers, in which the load is exposed to steam
near atmospheric pressure.

full load A specified load, used in thermometric tests, to represent the maximum size and
mass of load which the sterilizer is designed to process (see paragraph 2.45).

gas exposure time In EO sterilizers, the time for which the chamber is maintained at the specified
temperature, gas concentration, pressure and humidity (see paragraph 18.20).

gauge pressure Pressure measured from atmospheric pressure.

high-temperature steam Steam at a temperature above the boiling point of water at local atmospheric
pressure.

holding time The period during which the temperature in all parts of the chamber, load and
any coolant fluid is held within the sterilization temperature band. It follows
immediately after the equilibration time (see paragraph 7.8).

hot-air sterilizer See dry-heat sterilizer.

hot source A temperature reference used to verify the calibration of a thermometric

measurement system (see paragraph 6.33).

indicated An indicated value is that shown by a dial or other visual display fitted permanently
to the sterilizer (see recorded and measured) (see paragraph 7.3).

inoculated carrier A component of a biological indicator, comprising a piece of supporting material

on which a defined number of test organisms are deposited (see paragraph 7.44).

installation checks A series of checks performed by the contractor to establish that the sterilizer has
been provided and Installed correctly, IS safe to operate, does not interfere with
nearby equipment and that all connected services are satisfactory and do not
restrict the attainment of conditions for sterilization (see paragraph 2.17).

installation tests A series of tests performed by the contractor after the installation checks to
demonstrate that the sterilizer is working satisfactorily (see paragraph 2.20).

K ch steamer A laboratory apparatus designed to expose a load to steam at near atmospheric

pressure and commonly used for melting solidified agar.

laboratory sterilizer A sterilizer designed to sterilize, disinfect or make-safe laboratory materials and
equipment.

Line-PickerelI helix A device containing an inoculated carrier, used in microbiological tests on LTSF
and EO sterilizers, and designed to simulate the worst-case conditions for
sterilization by gas (see paragraph 7.51).
load Collectively, all the goods, equipment and materials that are put into a sterilizer or
disinfector at any one time for the purpose of processing it by an operating
cycle.

load item One of several discrete containers, packs or other units that together constitute a
load.
load temperature probe A movable temperature sensor fitted within the sterilizer chamber and designed
to record the temperature inside selected load items.

loading area The room or area in front of the sterilizer in which the operator works and from
which the sterilizer is loaded and unloaded. It is commonly separated by a fascia
panel from the plantroom.

loading condition A specified combination of the nature and number of load items, the items of
chamber furniture, and their distribution within the chamber (see paragraph
8.7).
low-temperature steam (LTS) Steam at a temperature below the boiling point of water at local atmospheric
pressure.
LTS disinfector A clinical disinfector designed to disinfect loads by exposure to low-temperature
steam at sub-atmospheric pressure.
LTSF sterilizer A clinical sterilizer designed to sterilize loads by exposure to low-temperature
steam and formaldehyde gas at sub-atmospheric pressure.

make-safe A process, used in laboratory sterilizers, to reduce the microbial content of

contaminated material so that it can be handled and disposed of without causing
an infection hazard or environmental contamination.

master process record (MPR) A batch process record obtained from a thermometric commissioning or
performance qualification test and annotated to show the permitted
tolerances for cycle variables during subsequent testing and routine production
(see paragraph 8.58).

measured A measured value is that shown on a test instrument, such as a thermometric

recorder or a test pressure gauge, attached to the sterilizer for test purpose (see
indicated and recorded) (see paragraph 7.6).

medical device Any instrument, apparatus, appliance, material or other article, whether used alone
or in combination, including the software necessary for its proper application
intended by the manufacturer, to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis,
monitoring, treatment, alleviation of or compensation for an injury or handicap;
investigation, replacement or modification of the anatomy or of a physiological
process; and control of conception: and which does not achieve its principal
intended action in or on the human body by pharmacological, immunological or
metabolic means, but which may be assisted in its function by such means. (Source:
EU Council Directive 93/42/EEC)

medicinal product Any substance or combination of substances presented for treating or preventing
disease in human beings or animals. Any substance or combination of substances
which may be administered to human beings or animals with a view to making a
medical diagnosis or to restoring, correcting or modifying physiological functions in
human beings or in animals is likewise considered a medicinal product. (Source: EU
Council Directive 65/65/EEC)

non-condensable gases Gases which cannot be liquefied by compressron under the range of conditions of
temperature and pressure used during the operating cycle (see paragraph 9.4).

noted A noted value is that written down by the operator, usually as the result of
observing an indicated, recorded or measured value (see paragraph 7.7)

operating cycle The set of stages of the sterilization or disinfection process carried out in
sequence and regulated by the automatic controller. It is synonymous with the
terms sterilization cycle for sterilizers and disinfection cycle for disinfectors.

override A system by which the progress of the operating cycle can be interrupted or
modified as necessary.

performance class An integer, from 1 to 12, related to the total cycle time for a sterilizer with a full
load.
performance qualification (PQ) The process of obtaining and documenting evidence that the equipment, as
commissioned, will produce an acceptable product when operated in accordance
with the process specification (see paragraph 2.25).

performance requalification (PRQ) The process of confirming that the evidence obtained during performance
qualification remains valid (see paragraph 8.64).

periodic tests A series of tests carried out at daily, weekly, quarterly and yearly intervals (see
paragraph 2.36).

permitted tolerance A limit, determined during performance qualification, on how much a cycle
variable is permitted to vary from a nominal value (see paragraph 8.47).

plant history file A file containing validation, maintenance and other engineering records for each
sterilizer.
plantroom The room or area to the rear of the sterilizer in which services are connected and
which provides access for maintenance. It is commonly separated by a fascia panel
from the loading area.

plateau period The equilibration time plus the holding time (see paragraph 7.11).
porous load sterilizer A clinical sterilizer designed to process, by exposure to high-temperature steam
under pressure, porous items such as towels, gowns and dressings, and also
medical devices that are wrapped in porous materials such as paper or fabrics.

PQ report A report containing the data and results obtained from a performance
qualification test (see paragraph 8.54).

preconditioning Treatment of a load to attain predetermined conditions, such as temperature and

humidity, before the start of an operating cycle.

pressure vessel A collective term describing the sterilizer chamber, jacket (if fitted), door(s) and
components that are in permanent open connection with the chamber.

recommissioning A procedure to confirm that operational data established during commissioning

remain valid (see paragraph 2.39).

recorded A recorded value is that shown on the output of a recording instrument fitted
permanently to the sterilizer (see indicated and measured) (see paragraph 7.5).

reference load A specified load made up to represent the most difficult combination of items to
be sterilized (see paragraph 8.7).
repeat validation A procedure to obtain a new set of commissioning and performance
qualification data to replace the set originally obtained during validation (see
paragraph 2.41).
revalidation A procedure to confirm an established validation, consisting of recommissioning
followed by performance requalification (see paragraph 2.39).

safety hazard A potentrally detrimental effect on persons or the surroundings arising directly from
either the sterilizer or its load.
saturated steam Steam whose temperature, at any given pressure, corresponds to that of the
vaporisation curve of water.

small load A specified load, used in thermometric tests, to represent the minimum size and
mass of load which the sterilizer is designed to process (see paragraph 2.45(a)).

standard test pack A pack representing the maximum density of porous material which a porous load
sterilizer conforming to European Standards should be able to process (see
paragraph 7.27).

sterilant An agent used to effect sterilization, such as steam, hot air or a sterilizing gas
sterile Condition of a load item that is free from viable micro-organisms. See EN 556 for
the requirements for a medical device to be labelled sterile .
sterilization A process undertaken to render a load sterile

sterilization conditions The ranges of the cycle variables which may prevail throughout the chamber and
load during the holding time (see paragraph 7.8).
sterilization pressure band The range of pressures which may prevail in the chamber during the holding
time. For a steam sterilizer, the sterilization pressure band is directly related to the
sterilization temperature band.
sterilization process The complete set of procedures required for sterilization of a load, Including the
operating cycle and any treatment of the load before or after the operating cycle.
sterilization temperature Minimum acceptable temperature of the sterilization temperature band (see
paragraph 7.14).
sterilization temperature band The range of temperatures which may prevail throughout the load during the
holding time. These temperatures are expressed as a minimum acceptable (the
 sterilization temperature) and a maximum allowable, and are stated to the
nearest degree Celsius (see paragraph 7.14).
sterilizer An apparatus designed to achieve sterilization.
sterilizer process log A log, kept by the user, which contains records of each production cycle.

superheated steam Steam whose temperature, at any given pressure, is higher than that indicated by
the vaporisation curve of water.
thermal door-lock An interlock fitted to certain sterilizers to prevent the door from being opened
until the temperature in the chamber and load falls below a preset value (see
paragraph 19.64).

transportable Requiring no permanent connections or installation and capable of being moved

manually without mechanical assistance. Synonymous with bench-top .
type tests A series of tests conducted by the manu facturer to establish the working data for a
sterilizer type (see paragraph 2.11).

usable chamber space The space inside the chamber which is not restricted by chamber furniture and
which is consequently available to accept the load.

validation A documented procedure for obtaining, recording and interpreting data required to
show that a sterilization process will consistently comply with predetermined
specifications (see paragraph 2.14).
working pressure The pressure in the chamber during the plateau period of an operating cycle.

works tests A series of tests to establish the efficacy of each sterilizer at the manufacturer s
works (see paragraph 2.11).
Abbreviations

ATCC American Type Culture Collection

BPR batch process record
BS British Standard
CEN European Committee for Standardisation (ComitØ EuropØen
de Normalisation)
CIP Collection lnstitut Pasteur (France)
COSHH Control of Substances Hazardous to Health (Regulations)
dBA decibel, A-weighted
EMF electromotive force
EN European Standard (Europ ische Norm)
EO ethylene oxide
EU European Union (formerly European Community)
h hour(s)
HSC Health and Safety Commission
HSE Health and Safety Executive
HTM Health Technical Memorandum
l or l litre(s)
LTEL long-term exposure limit
LTS low-temperature steam
LTSF low-temperature steam and formaldehyde
m minute(s)
MPR master process record
NCIMB National Collections of Industrial and Marine Bacteria (UK)
NCTC National Collection of Type Cultures (US)
ppm parts per million
PQ performance qualification
PRQ performance requalification
RH relative humidity
s second(s)
SSD sterile services department
STEL short-term exposure limit
UK United Kingdom
Bibliography

Unless stated otherwise, all the publications listed below Health Services Advisory Committee Safe
, working and
are available from HMSO Books, 59 Nine Elms Lane, the prevention of infection in clinical laboratories
London SW8 5DR; tel 071 873 0011 (general enquiries), (HSC, 1991), ISBN 0 11 885446 1.
071 873 0022 (order enquiries), (0800) 282827 (free
information line); fax 071 873 8463. Health Services Advisory Committee Safe
, working and
the prevention of infection in clinical laboratories:
model rules for staff and visitors (HSC, 1991),
Legislation ISBN 0 11 885442 9.

The Active implantable Medical Devices Regulations Occupational Exposure Limits (EH40), HSE (published
1992 (SI 1992/3146), ISBN 0 11 025389 2. annually).

The Control of Substances Hazardous to Health

Regulations 1988 (SI 1988/1657), ISBN 0 11 0867657 1.
British Standards
The Pressure Systems and Transportable Gas
British Standards are available from the Sales Department,
Containers Regulations 1989 (SI 1989/2169),
British Standards Institution, Linford Wood, Milton Keynes
ISBN 0 11 098169 3.
MK14 6LE; tel (0908) 226888 (enquiries), (0908) 221166
(orders); fax (0908) 322484.
European Union Directives
BS593: 1989 Specification for laboratory
thermometers
( OJEC = Official Journal of the European Communities)
BS1780: 1985 (1992) Specification for bourdon tube
65/65/EEC - Council Directive of 26 January 1965 on the pressure and vacuum gauges (AMD 6124, Jul. 1989)
approximation of provisions laid down by law, regulation
or administrative action relating to proprietary medicinal BS1781: 1981 (1989), Specification for linen and linen
union textiles
products , OJEC, No 22, p 369 (9 Feb 1965).
BS1904: 1984, Specification for industrial platinum
90/385/EEC - Council Directive of 20 June 1990 on the resistance thermometer sensors (AMD 5671, Sep 1987;
approximation of the laws of the Member States relating AMD 7049, Jun 1992)
to active implantable medical devices OJEC,
, No L189,
BS2646: Autoclaves for sterilization in laboratories:
p 17 (20 Jul 1990).
Part 1: 1993, Specification for design, construction,
93/42/EEC - Council Directive of 14 June 1993 safety and performance
concerning medical devices OJEC,
, No L169, p 1 Part 2: 1990, Guide to planning and installation
(12 Jul 1993).
Part 3: 1993, Guide to safe use and operation
Part 4: 1991, Guide to maintenance
Health and safety publications Part 5: 1993, Methods of test for function and
performance
Health and Safety Commission (HSC) and Health and BS2775: 1987 (1992), Specification for rubber
Safety Executive (HSE) publications are available from HSE stoppers and tubing for general laboratory use
Books, PO Box 1999, Sudbury, Suffolk CO10 6FS. General
enquiries and requests for free leaflets should be addressed BS3693: 1992, Recommendations for design of scales
to the HSE Information Centre, Broad Lane, Sheffield S3 and indexes on analogue indicating instruments
7HQ; tel (0742) 892345 (general enquiries), (AMD 7448, Feb 1993)
(0742) 892346 (free leaflets); fax (0742) 892333. BS3970: Sterilizing and disinfecting equipment for
medical products:
Advisory Committee on Dangerous Pathogens,
Categorisation of pathogens according to hazard and Part 1: 1990, Specification for general requirements
categories of containment (second edition) (HSE, 1990), Part 2: 1991, Specification for steam sterilizers for
ISBN 0 11 885564 6. aqueous fluids in sealed rigid containers
 Bibliography

Part 3: 1990, Specification for steam sterilizers for EN 290:* Steam sterilizers – large sterilizers –
wrapped goods and porous loads terminology
Part 4: 1990, Specification for transportable steam EN 1422:* Sterilizers for medical purposes – ethylene
sterilizers for unwrapped instruments and utensils oxide sterilizers – specification
Part 5: 1990, Specification for low-temperature
EN ???:* Small steam sterilizers
steam disinfectors
Part 6: 1993, Specification for sterilizers using low- BS EN 550: 1994, Sterilization of medical devices.
temperature steam with formaldehyde Validation and routine control of ethylene oxide
sterilization
BS4196: Sound power levels of noise sources:
BS EN 554: 1994, Sterilization of medical devices.
Part 6: 1981 (1986), Survey method for
Validation and routine control of sterilization by
determination of sound power levels of noise
moist heat
sources
EN 556:* Sterilization of medical devices:
BS4937: International thermocouple reference tables:
requirements for medical devices to be labelled
Part 4: 1973 (1981), Nickel-chromium/nickel- “STERILE”
aluminium thermocouples, Type K (AMD 3986, Jun
1982) EN 837: Pressure gauges:

Part 5: 1974 (1981), Copper/copper-nickel Part 1:* Bourdon tube pressure gauges –
thermocouples, Type T (AMD 3987, Jun 1982) Dimensions, metrology, requirements and testing

BS5164: 1975 (1993), Specification for indirect acting EN 866: Biological systems for testing sterilizers:
electrical indicating amd recording instruments and Part 1:* General requirements
their accessories Part 2:* Systems for use in ethylene oxide
BS5295: Environmental cleanliness in enclosed sterilizers
spaces: Part 3:* Systems for use in steam sterilizers
Part 1: 1989, Specification for clean rooms and Part 5:* Systems for use in low-temperature steam
clean air devices (AMD 6602, Dec 1990) and formaldehyde sterilizers

BS EN 150 9000. Quality systems (several parts) Part 6:* Systems for use in dry-heat sterilizers

BS5815: Sheets, sheeting, pillowslips, towels, EN 867: Non-biological systems for use in sterilizers:
napkins, counterpanes and continental quilt Part 1:* General requirements
secondary covers for use in the public sector: Part 2:* Process indicators (Class A)
Part 1: 1989, Specification for sheeting, sheets and Part 3:* Specification for Class B indicators for use
pillowslips (AMD 6806, Dec 1991) in the Bowie and Dick test
BS6257: 1989, Specification for paper bags for steam EN 30993: Biological evaluation of medical devices:
sterilization for medical use
Part 7:* Ethylene oxide sterilization residuals
BS6447: 1984 (1992), Specification for absolute and
EN 45001: 1989, General criteria for the operation of
gauge pressure transmitters with electrical outputs
testing laboratories
(AMD 5223, Sep 1986)
EN 45002: 1989, General criteria for the assessment
BS EN 60804: 1994, Specification for integrating-
of testing laboratories
averaging sound level meters (AMD 8286, Jun 1994)
AMD 8237, Aug 1994 EN 45003: 1989, General criteria for laboratory
accreditation bodies
BS7720: 1994, Specification for non-biological
sterilization indicator systems equivalent to the EN 45011: 1989, General criteria for certification
Bowie and Dick test with alternative test loads bodies operating product certification

EN 45012: 1989, General criteria for certification

bodies operating quality system certification
European Standards
EN 45013: 1989, General criteria for certification
European Standards (issued in the UK with the prefix BS bodies operating certification of personnel
EN) are available from the British Standards Institution
EN 45014: 1989, General criteria for suppliers’
(address above). The titles of draft standards* may change
declaration of conformity
before publication.

EN 285:* Sterilization – steam sterilizers – large

??? – number not yet assigned
sterilizers

139
Bibliography

EN 45020: 1993, Glossary of terms for standardisation Health Building Notes

and related activities
Sterile services department (HBN 13) (NHS Estates,
EN 60584: Thermocouples:
1992), ISBN 0 11 321412 X
Part 2: 1993, Tolerances

EN 61010: Safety requirements for electrical Accommodation for pathology services (HBN 15)
equipment for measurement, control and laboratory (NHS Estates, 1991), ISBN 0 11 321401 4
use:
Part 1: 1993, General requirements
Part 2–041:* Particular requirements for Other references
autoclaves and sterilizers using steam for the
treatment of medical materials and for laboratory JH Bowie, JC Kelsey and GR Thomson, The Bowie and
processes Dick autoclave tape test, Lancet, 16, 586–587 (1963)
Part 2–042:* Particular requirements for
SJ Line and JK Pickerell, Testing a steam-formaldehyde
autoclaves and sterilizers using toxic gas for the
sterilizer for gas penetration efficiency, Journal of
treatment of medical materials and for laboratory
Clinical Pathology, 26, 716–720 (1973)
processes

JM Parry, PCB Turnbull and JR Gibson, A colour atlas of

bacillus species (Wolfe Medical Publications, 1983), ISBN
Department of Health publications 0 7234 0777 0 (hbk), 0 7234 1557 9 (pbk)

Department of Health publications are available from

The Stationery Office (details on back cover).

Bacteriological tests for graded milk (Memo 139/

Foods) (Ministry of Health, January 1937)

140
Appendix 1

Useful addresses

UK health agencies

NHS Estates, 1 Trevelyan Square, Boar Lane, Leeds LS1 6AE; tel. 0113 254 7000

Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ;
tel. 0171 273 3000

Medical Devices Agency, 14 Russell Square, London WC1B 5EP; tel. 0171 972
2000

NHS in Scotland Management Executive, St Andrew’s House, Edinburgh EH1 3DG;

tel. 0131 556 8400

Welsh Office, Cathays Park, Cardiff CF1 3NQ; tel. 01222 825111

Estate and Property Division, Estate Services Directorate, HPSS Management

Executive, Stoney Road, Dundonald, Belfast BT16 0US; tel. 01232 520025

Public Health Laboratory Service, Central Public Health Laboratory, 61 Colindale

Avenue, London NW9 5HT; tel. 0181 200 4400

Health and safety

Health and Safety Executive, Broad Lane, Sheffield S3 7HQ; tel. 0114 289 2345;
fax 0114 289 2333 (addresses of area HSE offices may be found in the local
telephone directory)

Standards organisations

British Standards Institution

Head office: 2 Park Street, London W1A 2BS

Publications: Linford Wood, Milton Keynes MK14 6LE; tel. 01908 221166

European Committee for Standardisation, rue de Stassart 36, B–1050 Brussels

Bacterial culture collections

American Type Culture Collection (ATCC), 12301 Park Lawn Drive, Rockville,
Maryland 20852–1776, USA; tel. +1 301 881 2600

Collection Institut Pasteur (CIP), Institut Pasteur, rue du Roux 25, F–75724 Paris
Cédex 15, France

National Collection of Type Cultures (NCTC), Central Public Health Laboratory,

61 Colindale Avenue, London NW9 5HT

141
Appendix 1

National Collections of Industrial and Marine Bacteria Ltd (NCIMB),

23 St Machar Drive, Aberdeen AB2 1RY

Other organisations

Clinical Pathology Accreditation (UK) Ltd, Pathology Block, The Children’s

Hospital, Western Bank, Sheffield S10 2TH; tel. (0114) 279 7472

Institution of Healthcare Engineering and Estate Management, 2 Abingdon

House, Cumberland Business Centre, Northumberland Road, Portsmouth PO5
1DS; tel. (01705) 823186

142
Appendix 2 Calculations

Derivation of the steam dryness value equation

A2.1 The equation given in Chapter 9 for the steam dryness value can be
derived as follows.

A2.2 Steam supplied from the main will contain dry steam with a small
amount of moisture carried as droplets in suspension at the same temperature.
The dryness fraction, D, is defined as:

(A2-1)

where a given mass Msteam of steam contains a mass Mdry of pure dry steam
and M wet of moisture. Dry saturated steam has a dryness fraction of 1.0.

A2.3 If dry saturated steam is allowed to condense in cold water, then the
temperature rise of the water is related to the amount of latent heat given up by
the condensing steam. If the steam contains moisture, then the latent heat (and
the temperature rise) will be less than for the same mass of pure dry saturated
steam. The dryness fraction may then be estimated (the estimate being known
as the dryness value) by equating the heat gained by the water to the heat lost
by the steam.

A2.4 At the start of the test the flask contains a mass Mwof water at a
temperature of T0. At the end of the test the temperature has risen to T1,

Heat gained by water = (T1 - T0)cM w (A2-2)

where c is the specific heat capacity of water at a representative temperature

between T0 and T1.

A2.5 The heat lost by the steam is equal to the latent heat of condensation
plus the heat lost from the condensate and moisture as they cool from Ts to T1.

Heat lost by Steam = LMdry + (Ts - T1)cMc, = DLMC, + (Ts - T1)cMC (A2-3)
where L is the specific latent heat of condensation of steam at temperature Ts,
and M C = Ms t e a m is the mass of condensate and moisture. Equating (A2-2) and
(A2-3) and solving for D gives:

(A2-4)

where the term A represents the effective heat capacity of the flask and other
apparatus. For the apparatus specified in Chapter 9, A can be taken as 0.24
kJ K -1 (see Table Al). If the apparatus being used differs significantly from Table
Al then the effective heat capacity should be recalculated.

A2.6 Example: In a dryness value test the temperature of the water in the flask
rises from T1 = 19 C to T2 = 81 C. The average steam temperature during this
time is Ts = 144 C. The initial mass of water in the flask is Mw = 632 g, and the
mass of condensate is Mc = 77 g. From tables c ≈ 4.18 kJ kg-1K-1, and L ≈
2130 kJ kg-1. Then:
 Mass [g] Heating Effective heat
Component factor b capacity [kJ K-1]

One-litre glass vacuum flask 355 0.5 0.119

Rubber bung 91 0.8 0.116
90-mm glass pipe 2.4 1.0 0.002
290-mm glass pipe 7.8 1.0 0.005
TOTAL 0.242

a. The rubber pipe is not Included as it is assumed to be at steam temperature at the

start of the test.
b. The heating factor is an estimate of the factor by which the component IS heated from
T1 to T2 during the test.

Table A1 Effective heat capacity for steam dryness apparatus

A2.7 It can be seen that the term for the heat capacity of the apparatus (0.24)
contributes approximately 10% to the total dryness value.

Relative humidity in EO sterilizers

A2.8 Due to the difficulty in measuring relative humidity in the chamber of an

EO sterilizer, it is usually better to calculate the RH from the measured or
recorded rise in pressure as humidifying steam is introduced.

A2.9 At the start of the conditioning stage the chamber contains a small
amount of air at pressure PO and temperature T. During the conditioning stage
steam is introduced into the chamber and the pressure rises to P1 while the
temperature remains at T. From the law of partial pressures we can identify the
pressure change, with the partial pressure of the water vapour, Pw.

A2.10 Relative humidity is defined as Pw/Ps where Ps is the saturated vapour

pressure of water at temperature T, which can be obtained from steam tables.
Hence,

(A2-5)

A2.11 Example: During a conditioning stage at a temperature of 55”C, the

chamber pressure rises from PO = 80 mbar to P1 = 168 mbar, a rise of
mbar (8.8 kPa). From the steam tables we find that at 55”C, Ps = 157 mbar. The
relative humidity is then 88/157 0.56 = 56%.

Concentration of ethylene oxide

A2.12 The concentration of ethylene oxide (EO) in a sterilizer chamber may be

calculated as follows.

A2.13 An ideal gas obeys the equation of state:

(A2-6)

where:
P = absolute pressure (Pa); = density (kg m-3);
v = molar volume (m3 mol -1); R = gas constant (8.3 14 J K-1 mol-1);
m = molecular weight (kg mol-1); T = absolute temperature (K).

A2.14 At the end of the conditioning stage, the chamber contains a mixture of
air and water vapour at a pressure P1 and temperature T. During the sterilant
gas injection stage the pressure rises to P2 while the temperature remains at T.
From the law of partial pressures the pressure change, can be
identified with the partial pressure of the EO mixture:
(A2-7)

where the subscript EO refers to ethylene oxide and DG to the diluent gas.
Rearranging for the EO density:

(A2-8)

A2.15 But from equation (A2.6):

(A2-9)

where is the mean molecular weight of the EO mixture and is the

proportion by mass of diluent gas such that

A2.16 Inserting equation (A2-9) in equation (A2-8) gives the EO

concentration:

(A2-10)

A2.17 The mean molecular weight of a mixture of two gases, 1 and 2, is

defined as:

(A2-11)

where n1 and n2 are the number of molecules of each gas. Hence, for an EO
mixture the mean molecular weight is given by:

(A2-12)

A2.18 Inserting equation (A2-12) in equation (A2-10) and rearranging, the

concentration of EO in the chamber is:

(A2-13)

A2.19 Example: A sterilizer uses a mixture of 12% EO (molecular weight: 44

g mol-1) and 88% dichlorodifluoromethane (molecular weight: 121 g mol-1).
From equation (A2-12), the mean molecular weight of the mixture is then:

A2.20 During the gas injection stage the pressure is observed to rise by 1.48
bar (1.48 x 105 Pa) while the temperature remains at 55 C (328 K). From
equation (A2-13) the concentration of EO in the chamber, in SI units, is then:

A2.21 Example: A sterilizer uses a mixture of 10% EO and 90% carbon dioxide
(molecular weight: 44 g mol-1), giving an effective molecular weight of 44 (since
both gases have the same molecular weight). During the gas injection stage the
pressure rises by 5.16 bar (5.16 x 105 Pa) while the temperature remains at 37 C
(310 K). From equation (A2-13) the concentration of EO in the chamber is then
0.881 kg m-3, or 0.88 g l-1.
Appendix 3

Summary sheets

A3.1 The following summary sheets for commissioning, performance

qualification and yearly or revalidation tests should be completed by the test
person and given to the user as described in paragraph 2.30.

A3.2 They cover porous load sterilizers, fluid sterilizers, sterilizers for
unwrapped instruments and utensils, dry-heat sterilizers, LTS disinfectors and
LTSF sterilizers, EO sterilizers and laboratory sterilizers.

A3.3 The lists of tests are to be regarded as a record of which tests have been
done, not a prescription for which tests ought to be done. Detailed schedules
are given in Chapters 4 and 5. Tests which do not apply to the sterilizer under
test should be marked N/A .

A3.4 Where fluid or dry-heat sterilizers are to be used for the sterilization of
medicinal products the sheets should be signed by the quality controller as
shown.

A3.5 Common sheets are used for LTS and LTSF machines since most of the
tests are identical. The signature of the microbiologist is required only for LTSF
sterilizers.

A3.6 The sheets for laboratory sterilizers are designed to be used with any of
the following operating cycles: make-safe of small plastic discard, make-safe of
contained fluid discard, sterilization of culture media (preset or variable cycle),
disinfection of fabrics, sterilization of glassware and equipment, free steaming.
They may also be used for a culture media preparator. For commissioning and
performance qualification, a separate sheet should be completed for each
operating cycle available on the machine, and the name of the cycle written
clearly in the space provided.
 Reference . . . . . . . . . . . . . . . . . . . ./SC Page 1 of 2

POROUS LOAD STERILIZER - SUMMARY OF COMMISSIONING TESTS

Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Department . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date(s) of tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

STERILIZER: Manufacturer ............................. Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Usable chamber space . . . . . . . . . . . . litres

Serial number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Plant reference number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

RESULT OF COMMISSIONING TESTS Data file reference . . . . . . . . . . . . . . . . . . . . . . . . . . .

Test (as specified in HTM 2010 Pass or Cycle Start time Results
* = optional) fail number h min s

Steam non-condensable gas ............... Concentration of NCG . . . . . . . . . . %

Steam superheat ............... ............... Superheat . . . . . °C

Steam dryness ............... ............... Dryness value . . . . . . . . . .

Automatic control .............. ............... .... .... . Sterilization temp (ST) selected . . . . . °C

Instrument calibration ............... ............... ... .... .... See below

Chamber wall temperature ............... ............... ... .... .... Max temp attained . . . . . °C

Air detector small load ............... ............... ... .... .... Leak rate . . . . . . . . . . . . . . . mbar/min

Air detector full load ............... ............... ... .... .... Leak rate . . . . . . . . . . . . . . . mbar/min

Thermometric full load ............... ............... ... .... .... ST selected . . . . . ° C Max temp . . . .° C
Load dryness* ............... ............... ... .... .... Average gain in mass . . . . . %

Thermometric small load ............... ............... ST selected . . . . . ° C Max temp . . . . .° C

Load dryness* ............... ............... .... .... .... Average gain in mass . . . . . %

Vacuum leak (final) ............... ............... Leak rate . . . . . . . . . . . . . . . mbar/min

Hospital load dryness ............... ...............

Air detector function ............... ............... Air detector setting . . . . . . . . . . mbar or °C

............... ............... Type of test pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

............... ............... Loading area: mean . . . . . dBA, peak . . . . . dBA

Plant room: mean . . . . . dBA, peak . . . . . dBA

Test equipment file references ..............................................................................................................................................................

STERILIZER INSTRUMENT CALIBRATION

Errors for instruments fitted to sterilizer as measured by test instruments during the holding time.

Sensor is measured reading - recorded/indicated error.

Measured Recorder error Indicator error

Chamber temperature .................................°C ...............................°C ...............................°C

Chamber pressure ................................. bar .................................. bar ................................. bar
 Reference . . . . . . . . . . . . . . . . . . . ./SC Page 2 of 2

POROUS LOAD STERILIZER - SUMMARY OF COMMISSIONING TESTS

SUMMARY OF THERMOMETRIC TESTS

Sterilization temperature (ST) selected . . . . . . . . . . . . . . . °C

Automatic controller settings for plateau period: Temperature . . . . . . . . . . . . . . .. . . . °C Time . . . . . . . . . min . . .. . . . . s

Temperature sensors
Event Elapsed time Chamber pressure Drain/ Test Free
min S bar vent °C pack°C space°C

SMALL LOAD TEST No ..... No........ No.........

Start of plateau period ........... ............. ................... .......... ............. .............
Start of holding time ........... ............. ................... .......... ............. .............
End of holding time ............. ............. ................... .......... ............. .............
Maximum values attained ................... .......... ............. .............
Equilibration time ............. .............
Holding time ............. .............
Total cycle time ............. .............

FULL LOAD TEST No ..... No.......... No...........

Start of plateau period ............. ............. ................... .......... ............. .............
Start of holding time ............. ............. ................... .......... ............. .............
End of holding time ............. ............. ................... .......... ............. .............
Maximum values attained .................. .......... ............. .............
Equilibration time ............. .............
Holding time ............. .............
Total cycle time ............. .............

DECLARATION OF TEST PERSON (STERILIZERS)

1. The installation checks and tests have been completed and show that the sterilizer has been provided and
installed in accordance with its specifications.
2. All test instruments have current calibration certificates.
3. Calibration of the temperature test instruments has been checked before and after the thermometric tests.
4. The commissioning tests have been completed and show that the sterilizer functions correctly when
operated in accordance with operational instructions.

Test Person: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . ...

DECLARATION OF USER
The sterilizer is fit for use. The first yearly tests are due no later than :

User: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . .

 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . . /SPQ Page 1 of 2

POROUS LOAD STERILIZER -SUMMARY OF PERFORMANCE QUALIFICATION TESTS

Hospital ............................................................. Department ..................................... Date(s) of tests ................................

STERILIZER: Manufacturer .............................. Model ............................................. Usable chamber space ............. litres

Serial number .................................................... Plant reference number.. ...........................................................................

Chamber shape ................................................. Width .................... mm Height .................... mm Depth ...................... m

OPERATING CYCLE REFERENCE ........................................................................... Sterilization temperature ............... °C

LOADING CONDITION REFERENCE ........................................................................ Batch reference ...............................

Nature of load ......................................................................................................................................................................

LOCATION OF SENSORS FOR THERMOMETRIC PQ TEST

Enter positions of temperature sensors within the chamber related to the bottom left-hand corner of a rectangular box
viewed from the loading end.

4 T

5 T

6 T

7 T

8 T

9 T

(T = Temperature P = Pressure)

Test equipment file references ...........................................................................................................................................................................................

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149
 Appendix 3

Reference ...................... /SPQ Page 2 of 2

POROUS LOAD STERlLlZER - SUMMARY OF PERFORMANCE QUALIFICATION TESTS

SUMMARY OF THERMOMETRIC PQ TEST

Sterilization temperature (ST) selected . . . . . . . . . °C

Automatic controller setting for plateau period: Temperature . . . . . . . . . . °C Time . . . . . . . . . . min .......... s

Identify sensors in the load which are the fastest and the slowest to attain the ST. Enter elapsed
times and measured chamber pressures and temperatures.

Equilibration time . . . . . min ..... s Holding time ..... min . . . . . s Total cycle time ..... min ..... s

Cycle number . . . . . . . . . . . . . . . . . . . . Master Process Record reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Is a microbiological PQ test required for this loading condition? . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Result of microbiological test PASS/FAIL PQ report reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DECLARATION OF TEST PERSON (STERILZERS)

1. This test has been preceded by a satisfactory sequence of commissioning/yearly tests.

Reference . . . . . . . . . . . . . . .
2. All test instruments have current calibration certificates.
3. Calibration of the thermometric test instruments has been verified before and after the thermometric tests.
4. The performance qualification tests show that the sterilizer produces acceptable product with the loading
condition identified above.

Test Person: Name ............................................... Signature ........................................... Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DECLARATION OF USER

The sterilizer is fit for use with the loading condition identified above. The first performance requalification test, due ............

User: Name ................................................. Signature .................................................. Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 Reference . . . . . . . . . . . . . . . . . . . ./SY Page 1 of 1

POROUS LOAD STERILIZER - SUMMARY OF YEARLY/REVALIDATION TESTS

Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Department . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date (s) of tests . . . . . . . . . . . . . . . . . . . . . . . . .......

STERILIZER: Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Usable chamber space . . . . . . . . . . . litres
Serial number ................................................... Plant reference number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . .

RESULTS OF YEARLY/REVALIDATION TESTS Data file reference .........................

Test (as specified in HTM 2010) Pass or Cycle Start time Results
fail number h min s

Yearly safety checks ..........

Automatic control .......... .......... .... .... .... Sterilization temp (ST) selected . . . . . °C
Instrument calibration .......... .......... .... .... .... See below
Air detector small load .......... .......... .... .... .... Leak rate . . . . . . . . . . . . . . . . . . . . mbar/min
Air detector full load .......... .......... .... .... .... Leak rate .................. mbar/min
Thermometric small load .......... .......... .... .... .... ST selected . . . . . ° C Max temp . . . . . °C
Vacuum leak (final) .......... .......... Leak rate ................... mbar/min

Air detector function .......... .......... Air detector setting . . . . . . . . . . . . . . . mbar or °C

Bowie-Dick .......... .......... Type of test pack .............................................

PERFORMANCE REQUALIFICATION (if required)

Thermometric Microbio. (optional)

PQ report Loading condition Operating ST Pass or Cycle Start time Pass or
reference ref cycle ref °C fail number h min s fail

............... .............................. ............... ............... .............. ............... .... . . . . . . . . ...............

............... .............................. ............... ............... ............... ............... .... ..... .... ...............

............... .............................. ............... ............... ............... ............... .... ..... .... ...............

Test equipment file references ...........................................................................................................................................................

DECLARATION OF TEST PERSON (STERILIZERS)

1. All test instruments have current calibration certificates.

2. Calibration of the temperature test instruments has been checked before and after the thermometric tests.
3. The yearly/revalidation checks and tests have been completed and confirm that the sterilizer is safe to use
and that commissioning and performance qualification data collected during validation remain valid.

Test Person: Name ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DECLARATION OF USER

The sterilizer is fit for use. The first yearly tests are due no later than :

User: Name ............................................ Signature .......... . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . . /SC Page 1 of 2

FLUID STERlLlZER - SUMMARY OF COMMISSIONING TESTS

Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Department . . . . . . . . . . . . . . . . . . . . . . . . . Dates(s) of tests . . . . . . . . . . . . . . . . . . . . . . . .

Sterilizer: Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Usable chamber space . . . . . . . . . . litres

Serial number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Plant reference number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

RESULTS OF COMMISSIONING TESTS Data file reference . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Automatic control Sterilization temp (ST) selected . . . . . . . °C

Instrument calibration

Chamber temp profile Max temperature attained . . . . . . . . . . °C

Thermometric small load ST selected . . . . . . . . . . °C Max temp . . . . . . . °C

Decontamination time ..... min ..... s

Thermometric full load ST selected ..... °C Max temp . . . . . s

Decontamination time ..... min ..... s

Concentration of residue . . . . . mg/litre

Loading area: mean ... dBA, peak . . . dBA

Test equipment file references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

STERILIZER INSTRUMENT CALIBRATION

Errors for instruments fitted to sterilizer as measured by test instruments during the holding time.
Sense is measured reading = recorded/indicated error

Load temperature (1)

Load temperature (2)

. . . . . . . . . . . . . . . . . . bar

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 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . . /SC Page 2 of 2

FLUID STERILIZER - SUMMARY OF COMMISSIONING TESTS

SUMMARY OF THERMOMETRIC TESTS

Sterilization temperature (ST) selected . . . . . . . . . . . . . . . °C

Automatic controller settings for plateau period: Temperature . . . . . . . . . . . . . . . °C Time . . . . . . . . . . min . . . . . . . . . . s
Door release temperature setting . . . . . . . . . . °C Fo setting . . . . . . . . . . min

Chamber Spray Temperature sensors

pressure pressure Drain/ Fast Slow
bar bar °C

SMALL LOAD TEST No . . . . . No . . . . . No. . . . .

Start of plateau period .......... .......... .......... I .......... ..........
Start of holding time .......... .......... .......... ..........
End of holding time .......... .......... .......... ..........
Maximum values attained ..........
Fo value at end ..... min ..... min . . . . . min
Equilibration time .......... ..........
Holding time .......... ..........
Total cycle time .......... ..........

Temperature of hottest container when cycle complete . . . . . . . . . . °C (sensor no. . . . . .)

FULL LOAD TEST I No . . . . . No . . . . . No . . . . .

Start of plateau period .......... .......... ............... ..........
Start of holding time .......... .......... ............... ........
End of holding time .......... .......... ............... ..........
Maximum values attained ........... ..........
Fo value at end ..... min ..... min ..... min
Equilibration time .......... ..........
Holding time .......... ..........
Total cycle time .......... ..........

Temperature of hottest container when cycle complete .......... °C (sensor no. .....)

DECLARATION OF TEST PERSON (STERILIZERS)

1. The installation checks and tests have been completed and show that the sterilizer has been provided and
installed in accordance with its specifications.
2. All test instruments have current calibration certificates.
3. Calibration of the temperature test instruments has been checked before and after the thermometric tests.
4. The commissioning tests have been completed and show that the sterilizer functions correctly when
operated in accordance with operational instructions.

Test Person: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature ......................................... Date

DECLARATION OF USER AND FOR MEDICINAL PRODUCTS QUALIFIED PERSON

The sterilizer is fit for use. The first yearly tests are due no later than :

User: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . .

Qualified Person: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . .

10.XLS Page 2 of 2

153
 Reference . . . . . . . . . . . . . . . . . . . . /SPQ Page 1 of 2

FLUID STERlLlZER - SUMMARY OF PERFORMANCE QUALIFICATION TESTS

Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Department . . . . . . . . . . . . . . . . . . . . . . Date(s) of tests . . . . . . . . . . . . . . . . . . . . . . . . . . . .

STERILIZER: Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Usable chamber space . . . . . . . . . . . . . litres

Serial number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P
. lant reference number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chamber shape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Width

. . . . . . . . . . . . . . . . . . . . .mm Height . . . . . . . . . . . . . . . . . . . . mm Depth . . . . . . . . . . . . . . . . . . . . . . m

OPERATING CYCLE REFERENCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Sterilization

.. temperature . . . . . . . . . . . . . . . °C

LOADING CONDITION REFERENCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Batch

.. reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Nature of load . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

LOCATION OF SENSORS FOR THERMOMETRIC PQ TEST

Enter positions of temperature sensors within the chamber related to the bottom left-hand corner of a rectangular box
viewed from the loading end.

(T = Temperature P = Pressure)

Test equipment file references ...............................................................................................................................................

11.XLS

154
 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . . /SPQ Page 2 of 2

FLUID STERlLlZER - SUMMARY OF PERFORMANCE QUALIFICATION TESTS

SUMMARY OF THERMOMETRIC PQ TEST

Sterilization temperature (ST) selected . . . . . . . . °C

Automatic controller setting for plateau period: Temperature . . . . . . . °C Time . . . . . . . . . . min . . . . . . s

Door release temperature setting ........... °C F. setting . . . . . . . . min

Identify sensors in the load which are the fastest and the slowest to attain the ST. Enter elapsed times and measured
chamber pressures and temperatures.

Equilibration time . . . . min . . . . s Holding time . . . . min . . . . s Total cycle time . . . . min . . . . s

Temp of hottest bottle at end .......... °C (sensor ..... ) Coolant decontamination time .... min ..... s

Cycle number .................... Master Process Record reference ..............................

Is a microbiological PQ test required for this loading condition? ...........................

Result of microbiological test PASS/FAIL PQ report reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DECLARATION OF TEST PERSON (STERILZERS)

1. This test has been preceded by a satisfactory sequence of commissioning/yearly tests.

Reference . . . . . . . . . . . . . . . . .
2. All test instruments have current calibration certificates.
3. Calibration of the thermometric test instruments has been verified before and after the thermometric tests.
4. The performance qualification tests show that the sterilizer produces acceptable product with the loading
condition identified above.

Test Person: Name ............................................. Signature ....................................... Date .............................

DECLARATION OF USER AND FOR MEDICINAL PRODUCTS QUALIFIED PERSON

The sterilizer is fit for use with the loading condition identified above. The first performance requalification test, due ..............

User: Name ............................................. Signature ....................................... Date .............................

Qualified Person: Name ............................................. Signature ....................................... Date .............................

11.XLS Page 2 of 2

155
 Reference .................... /SY Page 1 of 1

FLUID STERILIZER - SUMMARY OF YEARLY/REVALIDATION TESTS

Hospital ............................................................. Department .................................... Date (s) of tests ...............................

STERILIZER: Manufacturer ............................. Model ............................................. Usable chamber space ........... litres
Serial number .................................................... Plant reference number ............................................................................

RESULTS OF YEARLYIREVALIDATION TESTS Data file reference . . . . . . . . . . . . . . . . . . . . . . . . . . .

Test (as specified in HTM 2010) Pass or Cycle Start time Results
fail number h min s

Yearly safety checks

Heat exchanger integrity .......... .......... Test pressure .......... bar

Automatic control .......... .......... .... .... .... Sterilization temp (ST) selected .......... C
Instrument calibration .......... .......... .... .... .... See below
Coolant quality .......... .......... Concentration of residue .......... mg/litre

PERFORMANCE REQUALIFICATION

Thermometric Micro. (optional)

PQ report Loading condition Operating ST Pass or C y c l e Start time P a s s o r
reference r e f fail C fail number h m i n s f a i l
.. . . . . . . . . ................... .......... .......... .......... .......... .......... ..........
.......... .................... .......... . . .. . . . . . . .......... .......... .......... ..........
.......... .................... .......... . . .. . . . . . . .......... .......... .......... ..........
.......... .................... ......... . . .. . . . . . . .......... .......... .......... ..........
.......... .................... .......... .......... .......... .......... .......... ..........

Test equipment file references

DECLARATION OF TEST PERSON (STERILIZERS) AND USER

1. All test instruments have current calibration certificates.

2. Calibration of the temperature test instruments has been checked before and after the thermometric tests.
3. The yearly/revalidation checks and tests have been completed and confirm that the sterilizer is safe to use
and that commissioning and performance qualification data collected during validation remain valid.

Test Person: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature ................................... Date . . . . . . . . . . . . . . . . . . . . . . . . . .

DECLARATION OF USER AND FOR MEDICINAL PRODUCTS QUALIFIED PERSON

The sterilizer is fit for use. The first yearly tests are due no later than :

User:
Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . .. . . . . . .

Qualified Person: Name . . . . . . . . . . . . . . . . . .... . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . ...... . . . . . . . . . . . . . ..

12 XLS
Page 1 of 1
 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . . /SC Page 1 of 2

STERILIZER FOR UNWRAPPED INSTRUMENTS AND UTENSILS

SUMMARY OF COMMISSIONING TEST

Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D. epartment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dates(s) of tests . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sterilizer: Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Usable chamber space . . . . . . . litres

Serial number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Plant reference number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

RESULTS OF COMMISSIONING TESTS Data file reference . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Pass or Cycle
fail number

Automatic control

Instrument calibration

Chamber temp profile .... .... .... Max temp attained ........... °C

Chamber overheat cut-out .... .... .... Max temp attained .......... °C

Thermometric small load .... .... .... ST selected .......... °C Max temp .......... °C

Thermometric full load .... .... .... ST selected ........... °C Max temp .......... °C

Sound pressure* Loading area: mean ...... dBA, peak ...... dBA

mean ...... dBA, peak ...... dBA

Test equipment file references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

STERlLlZER INSTRUMENT CALIBRATION

Errors for instruments fitted to sterilizer as measured by test instruments during the holding time.
Sensor is measured reading - recorded/indicated error

.. ............. .. ....... ...................

Chamber pressure ......................... bar ......................... bar ......................... bar

13.XLS Page 1 of 2

157
 Appendix 3

Reference .................... /SC Page 2 of 2

STERlLlZER FOR UNWRAPPED INSTRUMENTS AND UTENSILS

SUMMARY OF COMMISSIONING TEST

SUMMARY OF THERMOMETRIC TESTS

Sterilization temperature (ST) selected . . . . . . . . . . . . . . . °C

Automatic controller settings for plateau period: Temperature . . . . . . . . . . . . . . . °C Time . . . . . . . . . . min . . . . . . . . . . s

Te erature se ors
Event Elapsed time Chamber pressure Drain/ Load Free
min S bar vent °C °C space °C

SMALL LOAD TEST No ..... No . . . . . No . . . . .

Start of plateau period .......... .......... ................................. .......... .......... ..........
Start of holding time .......... .......... ................................. .......... ..........
End of holding time .......... .......... ................................. .......... ..........
Maximum values attained ................................. .......... ..........
Equilibration time .......... ..........
Holding time .......... ..........
Total cycle time .......... ..........

FULL LOAD TEST No ..... No ..... No . . . . .

Start of plateau period .......... .......... ................................. .......... .......... ..........
Start of holding time .......... .......... ................................. .......... .......... ..........
End of holding time .......... .......... ................................. .......... .......... ..........
Maximum values attained ................................. .......... .......... ..........
Equilibration time .......... ..........
Holding time .......... ..........
Total cycle time .......... ..........

DECLARATION OF TEST PERSON (STERILIZERS)

1. The installation checks and tests have been completed and show that the sterilizer has been provided and
installed in accordance with its specifications.
2. All test instruments have current calibration certificates.
3. Calibration of the temperature test instruments has been checked before and after the thermometric tests.
4. The commissioning tests have been completed and show that the sterilizer functions correctly when
operated in accordance with operational instructions.

Test Person: Name .............................................. Signature ................................................. Date ...............................

DECLARATION OF USER
The sterilizer is fit for use. The first yearly tests are due no later than :

User: Name ................................................. Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13.XLS Page 2 of 2

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 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . . /SPQ Page 1 of 2

STERlLlZER FOR UNWRAPPED INSTRUMENTS AND UTENSILS

SUMMARY OF PERFORMANCE QUALIFICATION TESTS

Hospital ............................................................. Department ..................................... Date(s) of tests ................................

STERILIZER: Manufacturer .............................. Model ............................................. Usable chamber space ............. litres

Serial number .................................................... Plant reference number.. ...........................................................................

Chamber shape ................................................. Width .................... mm Height .................... mm Depth ...................... m

OPERATING CYCLE REFERENCE ............................................................................ Sterilization temperature . . . . . . . . . . . . . . . °C

LOADING CONDITION REFERENCE ........................................................................ Batch reference ...............................

Nature of load ......................................................................................................................................................................

LOCATION OF SENSORS FOR THERMOMETRIC PQ TEST

Enter positions of temperature sensors within the chamber related to the bottom left-hand corner of a rectangular box
viewed from the loading end.

(T = Temperature P = Pressure)

Test equipment file references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14.XLS Page 1 of 2

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 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . /SPQ Page 2 of 2

STERlLlZER FOR UNWRAPPED INSTRUMENTS AND UTENSILS

SUMMARY OF PERFORMANCE QUALIFICATION TESTS

SUMMARY OF THERMOMETRIC PQ TEST

Sterilization temperature (ST) selected . . . . . . . . . . °C

Automatic controller setting for plateau period: Temperature .......... °C Time .......... min ............. s

Identify sensors in the load which are the fastest and the slowest to attain the ST. Enter elapsed
times and measured chamber pressures and temperatures.

Equilibration time ..... min ..... s Holding time . . . . . min .... s Total cycle time ..... min ..... s

Cycle number . . . . . . . . . . . . . . Master Process Record reference . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Is a microbiological PQ test required for this loading condition? . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Result of microbiological test PASS/FAIL PQ report reference . . . . . . . . . . . . . . . . . . . . . . . . . .

DECLARATION OF TEST PERSON (STERILZERS)

1. This test has been preceded by a satisfactory sequence of commissioning/yearly tests.

Reference . . . . . . . . . . . . . . . . . . . . . . . .
2. All test instruments have current calibration certificates.
3. Calibration of the thermometric test instruments has been verified before and after the thermometric tests.
4. The performance qualification tests show that the sterilizer produces acceptable product with the loading
condition identified above.

Test Person: Name .................................................. Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DECLARATION OF USER

The sterilizer is fit for use with the loading condition identified above. The first performance requalification test, due ............

User: Name ............................................. Signature ....................................... Date .............................

I4.XLS Page 2 of 2

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 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . . /SY Page 1 of 1

STERILIZER FOR UNWRAPPED INSTRUMENTS AND UTENSILS

SUMMARY OF YEARLY/REVALlDATlON TESTS

Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Department . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date (s) of tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

STERILIZER: Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Usable chamber space . . . . . . . . . . . litres
Serial number . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Plant reference number ...............................................................................

RESULTS OF YEARLY/REVALlDATlON TESTS Data file reference . . . . . . . . . . . . . . . . . . . . . . . . . . .

(Specified in HTM 2010) Pass or Cycle Start time Results

fail number h min s

Yearly safety checks ..........

Automatic control .......... .......... .... . . . . . . . . Sterilization temp (ST) selected . . . . . °C

Instrument calibration .......... .......... .... . . . . ....

Chamber overheat cut-out .......... .......... .... . . . . . . . . Max temp attained °C

Thermometric small load .......... ........ .... . . . . . . . . ST selected °C Max temp . . . . . °C

Thermometric full load .......... .......... .... . . . . . . . . ST selected °C Max temp . . . . . °C

PERFORMANCE REQUALIFICATION (as required by user)

Thermometric Microbio. (optional)

PQ report Loading condition Operating ST Pass or Cycle Start time
reference ref cycle ref °C fail number h min s

........... .................. .......... .......... ........... .......... .... ..... .... .........
.......... .................. .......... .......... .......... .......... .... .... ....

.......... ................. ........... ........... ........... ........... .... .... .... .........

Test equipment file references ................................................................................................................................................

DECLARATION OF TEST PERSON (STERILIZERS) AND USER

1. All test instruments have current calibration certificates.

2. Calibration of the temperature test instruments has been checked before and after the thermometric tests.
3. The yearly/revalidation checks and tests have been completed and confirm that the sterilizer is safe to use
and that commissioning and performance qualification data collected during validation remain valid.

Test Person: Name .................................................. Signature .......................................... Date . . . . . . . . . . . . . . . . . . . . . .

DECLARATION OF USER

The sterilizer is fit for use. The first yearly tests are due no later than :

User: Name .................................................. Signature .......................................... Date ..............................

Page1 of 1

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161
 Appendix 3

Reference .................... /SC Page 1 of 1

DRY HEAT STERILIZER -SUMMARY OF COMMISSIONING TESTS

Hospital ............................................................. Department .................................... Dates(s) of tests ..............................

Sterilizer: Manufacturer ..................................... Model ............................................. Usable chamber space .......... litres
Serial number .................................................... Plant reference number ............................................................................

RESULTS OF COMMISSIONING TESTS Data file reference . . . . . . . . . . . . . . . . . . . . . . . . . . .

Test (as specified in HTM 2010 Pass or Cycle Start time Results
* = optional) fail number h min s

Automatic control ............... ............... .... . . . . .... Sterilization temp (ST) selected .......... °C
Instrument calibration ............... ............... .... .... . . . . See below
Chamber temp profile ............... ............... .... .... .... Max temperature.. ........ °C
Chamber overheat cut-out ............... ............... .... .... .... Max temperature.. ........ °C
Basic Performance* ............... ............... .... . . . . .... Heat-up time ....... min Drift .......... °C

Overshoot.. ........ °C Variation ....... degs C

Test equipment file references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

STERILIZER INSTRUMENT CALIBRATION

Errors for instruments fitted to sterilizer as measured by test instruments during the holding time.
Sensor is measured reading - recorded/indicated error

Measured Recorder error Indicator error

Chamber temperature . . . . . . . . . . . . . . . . . . . . . . . . . °C . . . . . . . . . . . . . . . . . . . °C . . . . . . . . . . . . . . . . . . . °C
Load Temperature (1) . . . . . . . . . . . . . . . . . . .. °C . . . . . . . . . . . . . . . . . . . °C

Load Temperature (2) . . . . . . . . . . . . . . . . . . . . . °C ............................ °C

DECLARATION OF TEST PERSON (STERILIZERS)

1 The installation checks and tests have been completed and show that the sterilizer has been provided and
installed in accordance with its specifications.
2. All test instruments have current calibration certificates.
3. Calibration of the temperature test instruments has been checked before and after the thermometric tests.
4. The commissioning tests have been completed and show that the sterilizer functions correctly when
operated in accordance with operational instructions.

Test Person: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DECLARATION OF USER AND FOR MEDICINAL PRODUCTS QUALIFIED PERSON

The sterilizer is fit for use. The first yearly tests are due no later than :

User: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . .

Qualified Person: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . . .

16.XLS

162 Page 1 of 1
 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . . /SPQ Page 1 of 2

DRY HEAT STERILIZER - SUMMARY OF PERFORMANCE QUALIFICATION TESTS

Hospital ............................................................. Department ..................................... Date(s) of tests ................................

STERILIZER: Manufacturer .............................. Model ............................................. Usable chamber space ............. litres

Serial number .................................................... Plant reference number.. ...........................................................................

Chamber shape ................................................. Width .................... mm Height .................... m Depth ...................... m

OPERATING CYCLE REFERENCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sterilization

.. temperature . . . . . . . . . . . . . . . °C

LOADING CONDITION REFERENCE ....................................................................... Batch reference ...............................

Nature of load ......................................................................................................................................................................

LOCATION OF SENSORS FOR THERMOMETRIC PQ TEST

Enter positions of temperature sensors within the chamber related to the bottom left-hand corner of a rectangular box
viewed from the loading end.

(T = Temperature P = Pressure)

Test equipment file references ..................................................................................................................................

17.XLS

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 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . . /SPQ Page 2 of 2

DRY HEAT STERILIZER -SUMMARY OF PERFORMANCE QUALIFICATION TESTS

SUMMARY OF THERMOMETRIC PQ TEST

Sterilization temperature (ST) selected . . . . . . . . . . °C

Automatic controller setting for plateau period: Temperature . . . . . . . . . . °C Time . . . . . . . . . . min . . . . . . . . . . s

Cooling temperature setting . . . . . . . . . . °C Fo setting* . . . . . . . . . . min

Identify sensors in the load which are the fastest and the slowest to attain the ST. Enter elapsed times and measured
chamber pressures and temperatures.

Equilibration time ..... min .... s Holding time ...... min ..... s Total cycle time ..... min ..... s

Cooling stage - minimum differential pressure across air filter: ....... millbars/pascals

Temp of hottest container at end ........... °C (sensor ...... )

Cycle number . . . . . . . . . . . . . . . . . . Master Process Record reference ............................

Is a microbiological PQ test required for this loading condition? ............................

Result of microbiological test PASS/FAIL PQ report reference ..............................

DECLARATION OF TEST PERSON (STERILIZERS)

1. This test has been preceded by a satisfactory sequence of commissioning/yearly tests.

Reference ............................
2. All test instruments have current calibration certificates.
3. Calibration of the thermometric test instruments has been verified before and after the thermometric tests.
4. The performance qualification tests show that the sterilizer produces acceptable product with the loading
condition identified above.

Test Person: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DECLARATION OF USER AND FOR MEDICAL PRODUCTS QUALIFIED PERSON

The sterilizer is fit for use with the loading condition identified above. The first performance requalification test, due
......................................

User: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S
. ignature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Qualified Person: . ignature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

17.XLS Page 2 of 2

164
 Reference . . . . . . . . . . . . . . . . . ./SY Page 1 of 1

DRY HEAT STERILIZER-SUMMARY OF YEARLY/REVALIDATION TESTS

Hospital . . . . . . . . . . . . . . . . . ........ . . . . . . . . . ....... . .............................. Department . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date (s) of tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

STERILIZER: Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Model . . . . . . ...... . . . . . . . . . . ......................... Usable chamber space . . . . . .. . . ... . litres

Serial number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Plant reference number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......

RESULTS OF YEARLY/REVALIDATION TESTS Data file reference . . . . . . . . . . . . . . . . . . . . . . . . . .

pecified in HTM 2010) Pass or Cycle Start time

Results
fail number h min s

Yearly safety checks ..........

Automatic control .......... .......... . . . . . . . . . . . . Sterilization temp (ST) selected . . . . . C

Instrument calibration .......... .... . . . ....

Chamber overheat cut-out .......... .......... . . . . . . . . . . . . Max temp attained . . . . . . . . . . C

PERFORMANCE REQUALIFICATION

Thermometric Microbio. (optional)

PQ report Loading condition Operating ST Pass or Cycle Start time Pass or
reference ref cycle ref C fail number h min s fail

............... .............................. ............... ............... ............... ............... .... ..... .... ...............

............... .............................. ............... ............... ............... ............... .... ..... .... ...............

............... .............................. ............... ............... ............... ............... .... ..... .... ...............

............... ............................................. ............... ............... ............... .... ..... .... ...............

............... .............................. ............... ............... ............... ............... .... ..... .... ...............

Test equipment file references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .....................

DECLARATION OF TEST PERSON (STERILIZERS)

1. All test instruments have current calibration certificates.

2. Calibration of the temperature test instruments has been checked before and after the thermometric tests.
3. The yearly/revalidation checks and tests have been completed and confirm that the sterilizer is safe to use
and that commissioning and performance qualification data collected during validation remain valid.

Test Person: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature ........................................ Date . . . ....................... .. . .. . . . .

DECLARATION OF USER AND FOR MEDICAL PRODUCTS QUALIFIED PERSON

The sterilizer s is fit for use. The first yearly tests are due no later than :

User: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . . . . . . , .

Qualified Person: Name . . .......................................... Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18.XLS Page 1 of 1
 Reference . . . . . . . . . . . . . . . . . . /SC Page 1 of 2

LOW-TEMPERATURE STEAM DISINFECTOR

LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERLIZER
SUMMARY OF COMMISSIONING TEST

Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Department . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dates(s) of tests . . . . . . . . . . . . . . . . . . . . . . . .....

Sterilizer: Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Usable chamber space . . . . . . . . . . litres

Serial number ........ ................................................ Plant reference number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

RESULTS OF COMMISSIONING TESTS Data file reference . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Pass or Cycle Start time Results

fail number h min s

Steam non-condensable gas ............... Concentration of NCG .......... %

Steam superheat ............... Superheat .......... C
Stem dryness ............... Dryness value ..........

Automatic control ............... ............... .... .... .... Sterilization temp (ST) selected .......... C
Instrument calibration ............... ............... .... .... .... See below
Vacuum leak monitor ............... .... .... ....

............... ............... .... .... .... Max temp attained .......... C

Chamber overheat cut-out ............... ............... .... .... .... Chamber cut-out: Max temp .......... C

............... ............... .... .... .... Jacket cut-out: Max temp .......... C
Chamber wall temperature ................. ............... .... .... .... Max temp attained .......... C
Thermometric small load ............... ............... .... .... .... ST selected .......... C Max temp .......... C
Load dryness* ............... ................ .... .... .... Average gain in mass .......... %
Thermometric full load ............... ............... .... .... .... ST selected .......... C Max temp .......... C
Load dryness* ............... ............... .... .... .... Average gain in mass .......... %
Basic performance ............... ............... .... .... .... Holding time ..... min ..... s
Environ formaldehyde ............... ............... .... .... .... Average gas concentration .......... ppm
Vacuum leak (final) ............... ............... Leak rate .................... mbar/min
Sound pressure* ............... ............... Loading area: mean ...... dBA, peak ...... dBA

Plant room: mean ...... dBA, peak ...... dBA

Test equipment file references ....................................................................................................................................

STERILIZER INSTRUMENT CALIBRATION

Errors for instruments fitted to sterilizer as measured by test instruments during the holding time.
Sense is measured reading = recorded/indicated error

Measured Recorder error Indicator error

Chamber temperature ......................... C ......................... C ............... C

Chamber pressure ................... bar ......................... C .......................... bar

Page 1of2
 Reference . . . ... . . . . . . . . . . . . . . ./SC Page 2 of 2

LOW-TEMPERATURE STEAM DISINFECTOR

LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERLIZER
SUMMARY OF COMMISSIONING TEST

SUMMARY OF THERMOMETRIC TESTS

Sterilization temperature (ST) selected . . . . . . . . . . . . . . . C

Automatic controller settings for plateau period: Temperature . . . . . . . . . . . . . . . C Time ................ min ............... s

Temperature sensors
Elapsed time Chamber pressure Drain/ Test Free
min s vent C pack C space C

SMALL LOAD TEST No . . . . . No ..... No . . . . .

Start of plateau period .......... .......... .................................. .......... .......... ..........
Start of holding time .......... .......... ........................... .......... .......... ..........
End of holding time .......... .......... .......................... .......... .......... ..........
Maximum values attained ................. .......... .......... ..........
Equilibration time .......... ..........
Holding time .......... ..........
Total cycle time .......... ..........

FULL LOAD TEST No ...... No ..... No . . . . .

Start of plateau period ............ ........... ...................... .......... .......... ..........
Start of holding time ........... ............ .......................... .......... .......... ..........
End of holding time .......... .......... .......................... .......... .......... . . . . . . ...
Maximum values attained ................ .......... .......... ..........
Equilibration time .......... ..........
Holding Time .......... ..........
Total cycle time .......... ..........

SUMMARY OF MICROBIOLOGICAL TEST FOR BASIC PERFORMANCE*

Automatic controller settings for plateau period: Temperature ............... C Time .......... min .......... s
Primary material .............................. Batch .............................. Expiry date ..............................
Primary material used in the cycle ........................ Setting .................... millilitres Measured .................... mg/litre

DECLARATION OF TEST PERSON (STERILIZERS)

1. The installation checks and tests have been completed and show that the sterilizer has been provided and
installed in accordance with its specifications.
2. All test instruments have current calibration certificates.
3. Calibration of the temperature test instruments has been checked before and after the thermometric tests.
4. The commissioning tests have been completed and show that the sterilizer functions correctly when
operated in accordance with operational instructions.

Test Person: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DECLARATION OF CONSULTANT MICROBIOLOGIST

The results of the microbiologist test for basic performance are satisfactory.

Microbiologist: Name .... ............ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . .. . . . . . . . . .... . .... Date . .. . . . . . . . . . . . . . . . . . . . . . . . .

DECLARATION OF USER

The sterilizer is fit for use.The first yearly tests are due no later than: 22-Feb-95

User: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

*not required for LTS

4.XLS
 Reference . . . . . . . . . . . . . . . . . . . . /SPQ Page 1 of 2

LOW-TEMPERATURE STEAM DISINFECTOR

LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZER
SUMMARY OF PERFORMANCE QUALIFICATION TESTS

Hospital .......................................................... Department .................................... Date(s) of tests ................................

STERILIZER: Manufacturer .............................. Model ............................................. Usable chamber space ............ .litres

Serial number .................................................... Plant reference number.............................................................................

Chamber shape ................................................. Width .................... mm Height .................... mm Depth ..................... m

OPERATING CYCLE REFERENCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sterilization

... temperature . . . . . . . . . . . . . . . C

LOADING CONDITION REFERENCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... . ................................. Batch reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Nature of load . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

LOCATION OF SENSORS FOR THERMOMETRIC PQ TEST

Enter positions of temperature sensors within the chamber related to the bottom left-hand corner of a rectangular box
viewed from the loading end.
Sensor Sensor Width (X) Height (Y) Depth (Z) Location of sensor
number Type mm m m mm

1 T Active chamber drain/vent

2 T

3 T

4 T

5 T

6 T

7 T

8 T
9 T

10 T

11 T

12 T
T Chamber pressure test port
13

(T = Temperature P = Pressure)

Test equipment file references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .....................

5.XLS Page- 1 of 2
 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . . /SPQ Page 2 of 2

LOW-TEMPERATURE STEAM DISINFECTOR

LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZER
SUMMARY OF PERFORMANCE QUALIFICATION TESTS

SUMMARY OF THERMOMETRIC PQ TEST

Sterilization temperature (ST) selected .......... oC

o
Automatic controller setting for plateau period: Temperature .......... C Time .......... min .......... s

Identify sensors in the load which are the fastest and the slowest to attain the ST. Enter elapsed
times and measured chamber pressures and temperatures.

Sensor Description Sensor first attains ST Sensor falls below ST Time Max temp
number Time Press Time Press above ST
o
min s bar min s bar min s C
.......... Drain/vent .......... .......... .......... .......... .......... ..........
.......... Fastest .......... .......... .......... .......... .......... ..........
.......... Slowest .......... .......... .......... .......... .......... ..........

Equilibration time ..... min ..... s Holding time ..... min ..... s Total cycle time ..... min ..... s

Cycle number .................... Master Process Record reference ..............................

*RESULT OF MICROBIOLOGICAL PQ TEST: PASS/FAIL Cycle no. ..........

*RESULT OF ENVIRONMENTAL GAS TEST: PASS/FAIL Cycle no ........... Average gas concentration ............ ppm

DECLARATION OF TEST PERSON (STERILIZERS)

This test has been preceded by a satisfactory sequence of commissioning/yearly tests.

Reference . . . . . . . . . . . . . . . . . . . . . . . . .
All test instruments have current calibration certificates.
Calibration of the thermometric test instruments has been verified before and after the thermometric tests.
The performance qualification tests show that the sterilizer produces acceptable product with the loading
condition identified above.

Test Person: Name ................................................ Signature ...........................................Date ...............................

DECLARATION OF CONSULTANT MICROBIOLOGIST

The results of the microbiological test for performance qualification are satisfactory.

Microbiologist: Name ................................................. Signature ........................................... Date ...............................

DECLARATION OF USER

The sterilizer is fit for use with the loading condition identified above. The first performance requalification test, due ..............

User: N a m e ............................................. Signature ....................................... Date .............................

* not required for LTS

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 Appendix 3

Reference . . . .. . . . . . . . . . . . . . . . /SY Page 1 of 1

LOW-TEMPERATURE STEAM DISINFECTOR

LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZER
SUMMARY OF YEARLY/REVALlDATlON TESTS

Hospital ..................................................................... Department ......................................... Date (s) of tests .....................................

STERILIZER: Manufacturer .................................. Model .................................................. U s a b l e c h a m b e r s p a c e l i t r e s
Serial number ........................................................... Plant reference number .......................................................................................

RESULTS OF YEARLY/REVALlDATlON TESTS Data file reference .....................

‘Test (as specified in HTM 2010) Pass or Cycle Start time Results
fail number h min s
Yearly safety checks ..........
o
Chamber overheat cut-out .......... .......... .... .... .... Max temp attained ...... C
Chamber wall temperature .......... .......... .... .... .... Max temp attained o C
Automatic control .......... .......... .... .... .... Sterilization temp (ST) selected ....... oC
Instrument calibration .......... .......... .... .... ....

Vacuum leak monitor .......... .......... .... .... ....

Thermometric small load .......... .......... .... .... .... ST selected ..... oC Max temp ....... oC
Thermometric full load .......... .......... .... .... .... ST selected ..... oC Max temp ....... oC
Basic performance .......... .......... .... .... ....

Environment formaldehyde .......... .......... .... .... .... Average gas concentration ......... ppm
Vacuum leak (final) .......... .......... .... .... .... Leak rate ...................... . mbar/min

PERFORMANCE REQUALIFICATION (if required)

Thermometric Microbio Env. gas

PQ report Loading condition Operating ST Pass or Cycle Start time Pass or Pass or
o
reference ref cycle ref C fail number h min s fail fail

Test equipment file references ....................................................................................................................................................................

DECLARATION OF TEST PERSON (STERILIZERS) AND USER

1. All test instruments have current calibration certificates.

2. Calibration of the temperature test instruments has been checked before and after the thermometric tests.
3. The yearly/revalidation checks and tests have been completed and confirm the sterilizer is safe to use and
the commissioning and performance qualification data collected during validation remain valid.

Test Person: Name .......................................... Signature ................................... Date ...........................

DECLARATION OF MICROBIOLOGIST
The results of the microbiological test are satisfactory.

Microbiologist: Name ................................................... Signature ............................................. Date ...............................

DECLARATION OF USER
The sterilizer is fit for use. The first yearly tests are due no later than :

User: Name ................................................... Signature ............................................ Date ................................

l not required for LTS

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170 Page 1 of 1
 1 OF 1
L O W -T E M P E R A T U R E S T E A M AND FORMALDEHYDE S TERILIZER
R EPORT OF MICROBIOLOGICAL AND CHEMLCAL INDICATOR TEST FOR BASIC PERFORMANCE

Automatic controller settings for pIateau period: Temperature oC Time____ min____Sec's

Primary materials for generating formaldehyde Batch No Expiry Date

Manufacture Reference Certificate No

Batch No Expiry Date Chemical Indicator Batch No Expiry Date

Mass of primary material use in cycle Setting ____gram Measured

Biological Indicators (BI) Organism Strain

Manufactures declared number of recoverable spores on each indicator Expiry date

Batch No ___.________ Process Cycle Number Date

TEST PERSON
Name .......................................... Signature .................................................................................. Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Location of Chemical and Biological Indicators

Biological Controls

Test performed by:- NAME .................................... Signature ...................................Date.............................

NAME .........................................Signature.................................... Date ..........................

NAME.. ........................................ Signature................................... Date. ..........................

DoH Sc5

171
 Reference........................ /SC page 1 of 2

ETHYLENE OXIDE STERILIZER - SUMMARY OF COMMISSIONING TESTS

Hospital ..................... ...................................... Department .................. Date(s) of tests .............................................................

STERILISER: Manufacturer ............................. Model .......................... Usable chamber space .......................... litres

Serial number ................... ............................... Plant reference number ............................. .....................................................

Composition of gas ........................................... Gas source .................. Preset gas exposure temperature............. o C

RESULTS OF COMMISSIONING TESTS Data file reference .............................................

Test equipment file references ............................................................................................................................

STERILIZER INSTRUMENT CALIBRATION

* If applicable
 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . . /SC Page 2 of 2

SUMMARY OF MICROBIOLOGICAL TEST FOR GAS EXPOSURE TIME (GET)

Jacket overheat cut-out setting .................... oC Vacuum leak monitor setting .................... mbar
Chamber overheat cut-out setting ................ oC Pressure leak monitor setting .................... mbar

Gas exposure time

Critical GET (shortest with no survivors)

h . . . . . . . min . . . . . . . . s

Recommended GET for production loads

. . . . . . . h . . . . . . min . . . . . . . . . . s

SET AND DETERMINE VALUES OF CYCLE VARIABLES FOR CRITICAL GAS EXPOSURE TIME

DECLARATION OF TEST PERSON (STERILIZERS)

1. The installation checks and tests have been completed and show that the sterilizer has been provided and
installed in accordance with its specifications.
2. All test instruments have current calibration certificates.
3. Calibration of the temperature test instruments has been checked before and after the thermometric tests.
4. The commissioning tests have been completed and show that the sterilizer functions correctly when
operated in accordance with operational instructions.

Test Person: Name .................................................. Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . ....................................

DECLARATION OF CONSULTANT MICROBIOLOGIST

The results of the microbiological test for gas exposure time are satisfactory.

Microbiologist: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date ........................

DECLARATION OF USER

The steriliser is fit for use. The first yearly tests are due no later than ....................................................................................................

User: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date ..........................

1.XLS Page - 2 of 2

173
 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . . /SPQ Page 1 of 2

ETHYLENE OXIDE STERlLlZER -SUMMARY OF PERFORMANCE QUALIFICATION TESTS

Hospital . . . . . . .......................................................................... Department . . . . . . . . . . . . Date(s) of tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

STERILIZER: Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . Model .......................... Usable chamber space . . . . . . . . . . . . . . . . . . . . . . . . . . litre
Serial number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Plant reference number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Composition of gas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Gas source . . . . . . . . . . . . . . . . . Preset gas exposure temperature . . . . . . . . . .. . . . oC

Chamber shape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Width . . . . . . . . . . .. . . . . . mm Height . . . . . . . . . . . . . . . mm Depth . . . . . . . . . . . . . . . . mm

OPERATING CYCLE: Mass of gas . . . . . . . . . . g Gas exposure time . . . . . h ..... min . . . . . s

LOADING CONDITION REFERENCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Batch reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Nature of load . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..............................................

LOCATION OF SENSORS FOR PARAMETRIC PQ TEST

Enter positions of sensors within the chamber related to the bottom left-hand corner of a rectangular box viewed from
the loading end.

(T = temperature RH = relative humidity P = pressure)

Test equipment file references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.XLS page - 1 of 2

174
 Appendix 3

Reference . . . . . . . . . . . . . . . . . . . . /SPQ Page 2 of 2

ETHYLENE OXIDE STERlLlZER - SUMMARY OF PERFORMANCE QUALIFICATION TESTS

SUMMARY OF PARAMETRIC PQ TEST

Sterilization temperature (ST) ..................... oC

o
Automatic controller settings for plateau period: Temperature . . . . . . . . . . . . . . C Time . . . . . . . . . . . . . . . min . . . . . . . . . . . . . . s

Identify sensors in the load which are the fastest and the slowest to attain the ST. Enter elapsed times and measured
chamber pressures and temperatures.

Humidity and temperature in chamber at the end of conditioning period . . . . . . . . . . . . . . . %RH . . . . . . . . . . . . . . . oC

o
Humidity and temperature in the load if in hottest part of chamber .......................%RH . . . . . . . . . . . . . C

Equilibration time ...... min .....s Holding time ...... min ......s Total cycle time . . . . . min ........s

Cycle number ............................. Master Process Record reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

RESULT OF MICROBIOLOGICAL PQ TEST PASS / FAIL

RESULT OF ENVIRONMENTAL GAS TEST PASS / FAIL Average gas concentration . . . . . . . . . . . ppm

DECLARATION OF TEST PERSON (STERILIZERS)

1. This test has been preceded by a satisfactory sequence of commissioning/yearly tests. Reference . . . . . . . . . . . . . . .
2. All test instruments have current calibration certificates.
3. Calibration of the thermometric test instruments has been verified before and after the thermometric tests.
4. The performance qualification tests show that the sterilizer produces acceptable product with the loading condition
identified above.

Test Person: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date .. ..................................... .

DECLARATION OF CONSULTANT MICROBIOLOGIST

The results of the microbiological test for performance qualification are satisfactory.

Microbiologist: Name .................................. Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . .......................................

DECLARATION OF USER

The sterilizer is fit for use with the loading condition identified above. The first performance requalification test, due ................

User: Name ....................................... Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date . . . . . . . . . . . . . . . . . . . . . .

l not required on cartridge systems

2.XLS Page - 2 of 2

175
 Reference ................../ S Y Page 1 of 1

ETHYLENE OXIDE STERILIZER - SUMMARY OF YEARLY/REVALIDATION TESTS

Hospital .................................................. Department ................. Dates(s) of tests ............................................

Sterilizer: Manufacturer .............................. Model ..................... Usable chamber space ............................. litre
Serial number ................................................ Plant reference number ........................................................
Composition of gas ................................... Gas source .................. Preset gas exposure temperature........... o C
RESULTS OF YEARLY/REVALlDATlON TESTS Data file reference ...................................

PERFORMANCE REQUALIFICATION

Testequipmentreference.......................................................................................................................................................

DECLARATION OF TEST PERSON (STERILIZERS)

1. All test instruments have current calibration certificates.

2. Calibration of the temperature test instruments has been checked before and after the thermometric tests.
3. The yearly/revalidation checks end tests have been completed and confirm that the sterilizer is safe to use
and that commissioning and performance qualification data collected during validation remain valid.

Test Person: Name .......................................... Signature ....................................... Date .......................

DECLARATION OF MICROBIOLOGIST
The results of the microbiological test are satisfactory

Microbiologist: Name......................................... Signature......................................... Date ........................

DECLARATION OF USER
The sterilizer is fit for use. The first yearly tests are due no later than :

User: Name.............................................. Signature......................................... Date..............................

*if applicable
 ETHYLENE OXIDE STERILIZER
REPORT OF MICROBIOLOGICAL TEST FOR BASlC PERFORMANCE
o
Automatic controller settings for plateau period: Temperature C Time ____ min ___ sec’s

Pre-set gas exposure Temperature

o
C Composition of gas Gas source

Manufacture Reference Certificate No

Batch No Expiry Date Chemical Indicator Batch No Expiry Date

Mass of primary material use in cycle Setting_____gram Measured gram

Biological Indicators (BI) Organism Strain

Manufactures declared number of recoverable spores on each indicator Expiry Date

Batch No Process Cycle Number Date

TEST PERSON
Name.......................................................Signature.....................................................................Date.........................................

Location of Chemical and Biological Indicators

Biological Controls

Test performed by:- NAME ............................... Signature ........................... Date .............................

NAME .............................. Signature ............................. Date ...........................

NAME ............................ Signature....................... Date ..............................

DoH 1c1
 Reference . . . . . . . . . . . . . / S C Page 1 of 2

LABORATORY STERILIZER - SUMMARY OF COMMISSIONING TESTS

NAME OF PROCESS CYCLE ...............................................................................................

Hospital ....................................................... Department ................................ Dates(s) of tests .............................

Sterilizer: Manufacturer ................................. M o d e .................................

l Usable chamber space ............. litres

Serial number ............................................ Plant reference number ......................................................................

RESULTS OF COMMISSIONING TESTS Data file references ...........................

Test equipment file references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

STERILIZER INSTRUMENT CALIBRATION

Errors for instruments fitted to sterilizer as measured by test instruments during the holding time,
Sense is measured reading = recorded/indicated error
 LABORATORY STERlLlZER - SUMMARY OF COMMISSIONING TESTS

NAME OF PROCESS CYCLE . . . . . . . . . . . . . . . . . . . . . . . . . .

SUMMARY OF THERMOMETRIC TESTS

Sterilization temperature (ST) selected . . . . . . . . . . . . . . . C
Automatic controller settings for plateau period: Temperature . . . . . . . . . . . . . . C Time . . . . . . . min . . . . . . . . s
Door release temperature setting . . . . . . . . . . C Fo Setting . . . . . . . . . . min*

Elapsed time Chamber pressure Temperature sensors

Event Drain/ Fast Slow
min s bar vent C C C

SMALL LOAD TEST No .......... No ......... No . . .

Start of plateau period ............. ......... .................... ............ ........... .........
Start of holding time ............... ........... ........................ ........... .......... ...........
End of holding time ............... ............ .................. .......... .......... .............
Maximum values attained ..................... .......... .......... ..............
Fo value at end* ...... min . . . min ...... min
Equilibration time ............ .............
Holding time .............. ............
Total cycle time ............... ............

Temperature of hottest load item when cycle complete . . . . . . . . C (sensor no. .......)

FULL LOAD TEST No ....... No . . . . . No ........

Start of plateau period .......... ......... ...................... .......... .......... ..........
Start of holding time .......... ........ .......................... .......... .......... ............
End of holding time .......... ......... .......................... .......... .......... ...........
Maximum values attained ........................ .......... ......... .........
Fo value at end* ..... min ..... min ...... min
Equilibration time .......... .........
Holding time .......... .........
Total cycle time .......... ........

Temperature of hottest load item when cycle complete ....................... 2 (sensor no. . . ...)

DECLARATION OF TEST PERSON (STERILIZERS)

1. The installation checks and tests have been completed and show that the sterilizer has been provided and
installed in accordance with its specifications.
2. All test instruments have current calibration certificates. Calibration of the temperature test instruments has
been checked before and after the thermometric tests.
3. The commisioning tests have been completed and show that the sterilizer functions correctly on this
process cycle when operated in accordance with operational instructions.

Test Person: Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature .............................. Date . . . . . . . . . . . . . . . . . . . . . .

DECLARATION OF USER
The sterilizer is fit for use. The first yearly tests are due no later than :

User: Name ............................................. Signature ....................................... Date ..............................

*if applicable
 LABORATORY STERILIZER - SUMMARY OF PERFORMANCE QUALIFICATION TESTS

NAME OF PROCESS CYCLE .................................... ...........................................................

Site .............................................................. Department ..................................... Date(s) of tests ................................

STERILIZER: Manufacturer ............................... Model .............................................. Usable chamber space ............ .litres

Serial number ..................................................... Plant reference number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chamber shape ........................................ Width .................... mm Height .................... mm Depth ...................... mm

Sterilization temperature .............................. C

OPERATING CYCLE REFERENCE

LOADING CONDITION REFERENCE ............................................................................

Nature of load . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

LOCATION OF SENSORS FOR THERMOMETRIC PQ TEST

Enter positions of temperature sensors within the chamber related to the bottom left-hand corner of a rectangular box
viewed from the loading end.

Sensor Sensor Width (X) Height (Y) Depth (Z) Location of sensor
number type mm mm mm

1 T Active chamber drain/vent

2 T

3 T

4 T

5 T

6 T

7 T

8 T

9 T

10 T

11 T

12 T

13 P Chamber pressure test port

14 P Spray pressure test port

(T = Temperature P = Pressure)

Test equipment file references ..................................................................................................................................................

 LABORATORY STERILIZER - SUMMARY OF PERFORMANCE QUALIFICATION TESTS

SUMMARY OF THERMOMETRIC PQ TEST

Sterilization temperature (ST) selected ............. C

Automatic controller setting for plateau period: Temperature ........... C Time ..................... min ................ s

Door release temperature setting ........... C F. setting .......... min

Identify sensors in the load which are the fastest and the slowest to attain the ST. Enter elapsed times and measured
chamber pressures and temperatures

Sensor Sensor first attains ST Sensor falls below ST Time Max temp Fo
number Description Time Press Time Press above ST
min s bar min s bar min s C min
.......... Drain/vent ...... ....... .......... ...... ....... . . . . . . . . . . . . ....... . . . . . .............. ..........
........... Fastest . . . . . ...... ........... ...... ...... . . . . . . . . . . . . ....... ...... ............. ..........
......... Slowest ...... ...... ........... ...... ..... . . . . . . . . . . . ....... ....... .............. ........

Equilibration time ....... min ....... s Holding time ......... min ........ s Total cycle time ............. min ............ s

Temp of hottest load item at end .............. C (sensor ........... )

Cycle number ........................ Master Process Record reference ..........................

Is a microbiological PQ test required for this loading condition? ...............

Result of microbiological test PASS/FAIL PQ report reference ....................

DECLARATION OF TEST PERSON (STERILIZERS)

1 This test has been preceded by a satIsfactory sequence of commIssIonIng/yearly tests

Reference .....................................
2 All test instruments have current calibration certificates.
3. Calibration of the thermometric test Instruments has been verified before and after the thermometric tests
4. The performance qualification tests show that the sterilizer produces acceptable product with the loading
condition identified above.

Test Person. N a m e . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature ......................................... Date .............................

DECLARATION OF USER

The sterilizer is fit for use with the loading condition identified above. The first performance requalification test, due .................................

User. Name .............................................. Signature ........................................... Date ................................

 References ....................../SY Page 1 of 2

LABORATORY STERlLlZER - SUMMARY OF YEARLY/REVALIDATION TESTS

Hospital .................................................................. Department ................................................... Date(s) of tests ...........................

STERILIZER: Manufacturer ................................. Model ................................................. Usable chamber space ............ litres
Serial number .......................................................... Plant reference number ........................................................................................
 References ...................../SY Page 2 of 2

LABORATORY STERILIZER YEARLY/REVALIDATION

PERFORMANCE REQUALlFICATION

DECLARATION OF TEST PERSON (STERILIZERS)

1.

2.

Test Person: N a m e ......................................... Signature ........................................... Date ...........................

DECLARATION OF USER

User: Name ........................................... Signature ................................... Date ............................

183
Other publications in this series

(Given below are details of all Health Technical Component Data Base (HTMs 54 to 80)
Memoranda available from The Stationery Office. HTMs 54.1 User manual, 1993.
marked (*) are currently being revised, those marked (†) 55 Windows, 1998.
are out of print. Some HTMs in preparation at the time of 56 Partitions, 1998.
publication of this HTM are also listed.) 57 Internal glazing, 1995.
58 Internal doorsets, 1998.
1 Anti-static precautions: rubber, plastics and fabrics† 59 Ironmongery, 1998.
2 Anti-static precautions: flooring in anaesthetising 60 Ceilings, 1989.
areas (and data processing rooms), 1977. 61 Flooring, 1995.
3–4 – 62 Demountable storage systems, 1989.
2005 Building management systems, 1996. 63 Fitted storage systems, 1989.
2007 Electrical services: supply and distribution, 1993. 64 Sanitary assemblies, 1995.
2009 Pneumatic air tube transport systems, 1995. 65 Health signs*
2010 Sterilization, 1994, 1995, 1997, 1998. 66 Cubicle curtain track, 1989.
2011 Emergency electrical services, 1993. 67 Laboratory fitting-out system, 1993.
2014 Abatement of electrical interference, 1993. 68 Ducts and panel assemblies, 1993.
2015 Bedhead services, 1994, 1995. 69 Protection, 1993.
2017 Health building engineering installations: 70 Fixings, 1993.
commissioning and associated activities.* 71 Materials management modular system, 1998.
2020 Electrical safety code for low voltage systems, 1998. 72 to 80 –
2021 Electrical safety code for high voltage systems, 1993,
1994.
Firecode
2022 Medical gas pipeline systems, 1994
Supp 1 Dental compressed air and vacuum systems,
81 Firecode: fire precautions in new hospitals, 1996.
1997
82 Firecode: alarm and detection systems, 1996.
Supp 2 Piped medical gases in ambulance vehicles,
83 Fire safety in healthcare premises: general fire
1997
precautions, 1994.
2023 Access and accommodation for engineering
84 Firecode: fire safety in residential care premises
services, 1995.
(applicable in Northern Ireland only), 1995.
2024 Lifts, 1995.
85 Firecode: fire precautions in existing hospitals, 1994.
2025 Ventilation in healthcare premises, 1994.
86 Firecode: fire risk assessment in hospitals, 1994.
2027 Hot and cold water supply, storage and mains
87 Firecode: textiles and furniture, 1993.
services, 1995.
88 Fire safety in healthcare premises: guide to fire
2030 Washer-disinfectors, 1997.
precautions in NHS housing in the community for
2031 Clean steam for sterilization, 1997.
mentally handicapped/ill people, 1986.
2035 Mains signalling, 1996.
2040 The control of legionellae in healthcare premises –
Health Technical Memoranda published by The Stationery
a code of practice, 1998.*
Office can be purchased from SO bookshops in London
2045 Acoustics, 1996.
(post orders to PO Box 276, SW8 5DT), Edinburgh, Belfast,
2050 Risk management in the NHS estate, 1994.
Cardiff, Manchester, Birmingham and Bristol, or through
2055 Telecommunications (telephone exchanges), 1994.
good booksellers. SO provide a copy service for
2060 Supply and treatment of water.*
publications which are out of print; and a standing order
2065 Waste guidance.*
service.
2070 Estates emergency and contingency planning, 1997.
2075 Clinical waste disposal: alternative technologies,
Enquiries about Health Technical Memoranda should be
1998.*
addressed to: NHS Estates, Department of Health,
Publications Unit, 1 Trevelyan Square, Boar Lane, Leeds
LS1 6AE.

184
About NHS Estates

NHS Estates is an Executive Agency of the Department of Encode – shows how to plan and implement a policy of
Health and is involved with all aspects of health estate energy efficiency in a building. SO
management, development and maintenance. The Agency
has a dynamic fund of knowledge which it has acquired Firecode – for policy, technical guidance and specialist
during over 35 years of working in the field. Using this aspects of fire precautions. SO
knowledge NHS Estates has developed products which are
unique in range and depth. These are described below. Capital Investment Manual Database – software
NHS Estates also makes its experience available to the field support for managing the capital programme. Compatible
through its consultancy services. with Capital Investment Manual. NHS Estates

Enquiries about NHS Estates should be addressed to: Model Engineering Specifications – comprehensive
NHS Estates, Publications Unit, Department of Health, advice used in briefing consultants, contractors and
1 Trevelyan Square, Boar Lane, Leeds LS1 6AE. suppliers of healthcare engineering services to meet
Telephone 0113 254 7000. Departmental policy and best practice guidance.
http://www.demon.co.uk/nhsestates/hpage.html/ NHS Estates

Quarterly Briefing – gives a regular overview on the

construction industry and an outlook on how this may
Some NHS Estates products affect building projects in the health sector, in particular
the impact on business prices. Also provides information
Activity DataBase – a computerised briefing and design
on new and revised cost allowances for health buildings.
system for use in health buildings, applicable to both new
Published four times a year; available on subscription
build and refurbishment schemes. NHS Estates
direct from NHS Estates. NHS Estates

Design Guides – complementary to Health Building

Works Guidance Index – an annual, fully cross-
Notes, Design Guides provide advice for planners and
referenced index listing all NHS Estates publications and
designers about subjects not appropriate to the Health
other documents related to the construction and
Building Notes series. SO
equipping of health buildings. NHS Estates

Estatecode – user manual for managing a health estate.

Items noted “SO” can be purchased from
Includes a recommended methodology for property
The Stationery Office Bookshops in London (post
appraisal and provides a basis for integration of the estate
orders to PO Box 276, SW8 5DT), Edinburgh, Belfast,
into corporate business planning. SO
Manchester, Birmingham and Bristol or through
good booksellers.
Concode – outlines proven methods of selecting contracts
and commissioning consultants. Reflects official policy on
contract procedures. SO
NHS Estates consultancy service
Health Building Notes – advice for project teams
procuring new buildings and adapting or extending Designed to meet a range of needs from advice on the
existing buildings. SO oversight of estates management functions to a much
fuller collaboration for particularly innovative or exemplary
Health Facilities Notes – debate current and topical projects.
issues of concern across all areas of healthcare provision.
SO Enquiries should be addressed to: NHS Estates Consultancy
Service (address as above).
Health Guidance Notes – an occasional series of
publications which respond to changes in Department of
Health policy or reflect changing NHS operational
management. Each deals with a specific topic and is
complementary to a related HTM. SO

185
 Sterilization
Part 4: Operational management
(New edition)
with
Part 6: Testing and validation
protocols
Health Technical Memorandum 2010

London: The Stationery Office

© Crown copyright 1997. Published with permission of NHS Estates,
an Executive Agency of the Department of Health,
on behalf of the Controller of Her Majesty’s Stationery Office.

Applications for reproduction should be made in writing to

The Copyright Unit, Her Majesty’s Stationery Office,
St Clements House, 2–16 Colegate, Norwich NR3 1BQ.

First published 1997

ISBN 0-11-322031-6

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About this publication

Health Technical Memoranda (HTMs) • Part 2 – Design considerations –

give comprehensive advice and contains information relevant to the
guidance on the design, installation and specification and installation of new
operation of specialised building and sterilizing equipment. It discusses
engineering technology used in the the requirements for each type of
delivery of healthcare. sterilizer and outlines the
specifications to be included in any
They are applicable to new and existing contract. Practical considerations for
sites, and are for use at various stages the installation of sterilizers are
during the inception, design, discussed, including siting, heat
construction, refurbishment and emission, ventilation, noise and
maintenance of a building. vibration, and mains services with
an emphasis on steam quality;
HTM 2010 is published in five volumes:
• Part 3 – Validation and
• Part 1 – Management policy – verification – covers all aspects of
is a summary of the information validation and periodic testing of
required by non-technical personnel sterilizers. It includes detailed
responsible for the management of schedules and procedures for tests
sterilization services. It discusses the and checks to be carried out for
various types of sterilizer, for both commissioning and performance
clinical and laboratory use, and also qualification and for subsequent
contains guidance on legal and periodic testing;
policy matters, and on the
appointment and responsibilities of • this volume includes Part 4 –
personnel. It should be read by Operational management –
anyone consulting this which covers all aspects of the
memorandum for the first time; routine operation and maintenance
of sterilizers, stressing the need for
a planned maintenance programme
 along with the type of records to be a. the Welsh Office for NHS Wales;
kept. Advice on the safe and
efficient operation of sterilizers is b. Health Estates for Northern
given, as well as procedures for Ireland;
reporting defects and accidents;
and Part 6 – Testing and c. the NHS in Scotland Estates
validation protocols – which Environment Forum.
provides step-by-step guidance on
testing and validation of processes; References to legislation appearing in
the main text of this guidance apply to
• Part 5 – Good practice guide – the United Kingdom as a whole, except
provides supplementary advice on a where marginal notes indicate variations
number of matters concerned with for Scotland or Northern Ireland. Where
the effective usage of sterilizers. appropriate, marginal notes are also
used to amplify the text.
The contents of this HTM in terms of
management policy and operational
policy are endorsed by:
 Executive summary

HTM 2010 gives guidance on the choice, specification, purchase, installation,

validation, periodic testing, operation and maintenance of the following types
of sterilizer in use in the National Health Service:

a. clinical sterilizers:
(i) high-temperature steam sterilizers used for processing porous
loads (including instruments and utensils wrapped in porous
materials);
(ii) high-temperature steam sterilizers used for processing aqueous
fluids in sealed containers;
(iii) high-temperature steam sterilizers used for processing unwrapped
solid instruments and utensils;
(iv) dry-heat sterilizers (hot-air sterilizers);
In Scotland LTSF sterilizers are (v) low-temperature steam (LTS) disinfectors and low-temperature
considered to be disinfectors steam and formaldehyde (LTSF) sterilizers;
(vi) ethylene oxide (EO) sterilizers;

b. laboratory sterilizers:
(i) high-temperature steam sterilizers used with one or more
specialised operating cycles;
(ii) culture media preparators.

Users who wish to employ processes not included here bear the responsibility
of ensuring that the validation procedures comply with the principles outlined
in Part 3 of this HTM and that the intended operating procedures will ensure
an efficacious process for the different types of load.

This HTM is intended primarily as a guide for technical personnel, whether

specialists in sterilizers and sterilization procedures or those responsible for
maintenance and testing. It is also intended for those responsible for the day-
to-day running of sterilizers, and will also be of interest to microbiologists,
infection control officers, supplies officers, architects, estates managers and
others in both the public and private sectors.

Scottish Health Planning Notes 13 – Detailed information on the planning and design of a sterile services
‘Sterile services department’, and 15 – department, including the level of provision of sterilizers, is given in
‘Accommodation for pathology HBN 13 – ‘Sterile services department’. Guidance for laboratory installations
services’, apply in Scotland can be found in HBN 15 – ‘Accommodation for pathology services’.

Although this edition of HTM 2010 reflects established sterilizer technology,

it is recognised that considerable scope exists for the utilisation of emerging
technology in the management of sterilizers. This will be kept under review
with the aim of introducing recommendations for such technology at the
earliest opportunity so that the procedures essential for the efficient, safe and
effective operation of sterilizers can be optimised.
Executive summary

Most of the British Standards for sterilizers which were applicable at the time
of HTM 10 ‘Sterilizers’ (1980), have been either withdrawn or radically revised.
Some of them, in turn, are being replaced by European Standards which will
be published during the currency of this edition of HTM 2010. Some of these
European Standards support new European Union Directives on medical
devices which are having a major impact on sterilization. Where practicable,
the information in this HTM has been aligned with existing or anticipated
standards and advice is offered where no standard has yet been formulated.

The sterilizers described in this HTM may not be suitable, without Information about Hazard Groups may
modification, for safely processing articles infected with Hazard Group 4 be found in the HSC document
pathogens. Design considerations for sterilizers intended to process articles ‘Categorisation of pathogens according
infected with such organisms are discussed in Part 2. to hazard and categories of
containment’ (second edition 1990)
compiled by the Advisory Committee
on Dangerous Pathogens

The agents associated with transmissible spongiform encephalopathies (TSEs) Information about TSEs may be found
are unusually resistant to sterilization and cannot be reliably inactivated by in the HSE document ‘Precautions for
the standard procedures described here. Advice on the sterilization of items work with human and animal
contaminated with TSE agents can be found in Appendix 2. Transmissible Spongiform
Encephalopathies’, compiled by the
This volume (Parts 4 and 6) substantially revises previous editions of Part 4 Advisory Committee on Dangerous
and includes guidance on testing and validation of sterilization processes. Pathogens
Contents

About this publication 4.21 Routine housekeeping

4.22 Maintenance of laboratory sterilizers
Preface 4.25 Features requiring special attention
4.26 Stainless steel chambers
PART 4 – OPERATIONAL MANAGEMENT 4.32 Air-tightness of the chamber
4.34 Door-locking mechanisms
1. General page 5 4.37 Air detector
1.1 Introduction 4.40 Instruments
1.4 Legal frameworks for sterilization 4.45 Ancillary equipment
1.8 Medicinal products 4.48 Returning a sterilizer to service
1.12 Medical devices
1.23 Quality systems 5. Operation of porous load sterilizers page 40
1.25 Personnel 5.1 Introduction
1.44 Safety 5.3 The process
5.6 Product compatibility
2. Operational management – 5.9 Items that should not be processed in a
an overview page 11 porous load sterilizer
2.1 Introduction 5.10 Design of the load
2.3 Maintenance 5.13 Air removal
2.5 Safety precautions 5.17 Handling of condensate
2.10 Hazards associated with sterilization 5.25 Packaging materials
2.12 Safety of pressure vessels 5.29 Performance qualification
2.13 Unloading 5.32 Selection of cycle variables
2.14 Personal protective equipment 5.33 Cycle monitoring and documentation
2.16 Compatibility of load and process 5.38 Product release
2.20 Process development 5.39 Troubleshooting
2.22 “Single-use” medical devices 5.39 Air detector fault
2.26 Cleaning 5.41 Wet loads
2.28 Packaging 5.47 Superheating
2.34 Performance qualification 5.51 Spontaneous combustion
2.42 Position of PQ sensors
2.43 Cycle variables 6. Operation of fluid sterilizers page 48
2.56 Cycle monitoring and documentation 6.1 Introduction
2.64 Process indicators 6.3 The process
2.66 Product release 6.6 Safety precautions
2.71 Master process record 6.10 Product compatibility
2.74 Rejected loads 6.11 Items that should not be processed in a
2.77 Storage fluid sterilizer
6.12 Design of the load
3. Record-keeping page 27 6.14 Bottles
3.1 Introduction 6.17 Plastic bags
3.9 Plant history file 6.18 Vials and ampoules
3.10 Sterilizer process log 6.20 Closure systems
6.26 Performance qualification
4. Maintenance page 31 6.29 Selection of cycle variables
4.1 Introduction 6.31 Cycle monitoring and documentation
4.5 Maintenance Person 6.35 Product release
4.9 Planned maintenance programme
4.10 Design of a PM programme 7. Operation of sterilizers for unwrapped
4.15 Review of the PM programme instruments and utensils page 55
4.17 Inspection of pressure vessels 7.1 Introduction
4.20 Modifications 7.3 The process

1
Contents

7.7 Water supply 10.58 Failure of the routine microbiological test

7.10 Safety precautions 10.59 Polymerisation of formaldehyde
7.12 Product compatibility
7.14 Items that should not be processed 11. Operation of ethylene oxide
7.15 Design of the load sterilizers page 77
7.18 Selection of cycle variables 11.1 Introduction
7.22 Cycle monitoring and documentation 11.4 The process
7.25 Product release 11.11 Safety precautions
11.12 Product compatibility
8. Operation of dry-heat sterilizers page 60 11.18 Items that should not be processed
8.1 Introduction by ethylene oxide
8.3 The process 11.19 Design of the load
8.5 Safety precautions 11.28 Performance qualification
8.7 Product compatibility 11.31 Preconditioning
8.9 Items that should not be processed 11.40 Selection of cycle variables
by dry heat 11.42 Cycle monitoring and documentation
8.11 Design of the load 11.45 Chamber humidity
8.14 Load preparation and packaging 11.47 EO concentration
8.22 Arrangement of load items 11.50 Product release
8.26 Performance qualification 11.52 Degassing
8.28 Selection of cycle variables 11.59 Troubleshooting
8.30 Cycle monitoring and documentation 11.59 Failure of the routine microbiological test
8.34 Product release
12. Operation of laboratory sterilizers page 86
9. Operation of LTS disinfectors page 65 12.1 Introduction
9.1 Introduction 12.3 Sterilization conditions
9.4 The process 12.7 Safety precautions
9.8 Safety precautions 12.9 Hazards
9.9 Product compatibility 12.13 Operating procedures
9.11 Items which should not be processed by LTS 12.16 Operating cycles
9.12 Design of the load 12.21 Make-safe of small plastic discard
9.13 Air removal 12.30 Make-safe of contained fluid discard
9.15 Handling of condensate 12.35 Sterilization of culture media (preset or
9.16 Packaging materials variable cycle)
9.17 Selection of cycle variables 12.44 Disinfection of fabrics
9.18 Cycle monitoring and documentation 12.48 Sterilization of glassware and equipment
9.20 Product release 12.50 Free steaming
12.51 Culture media preparator
10. Operation of LTSF sterilizers page 68 12.53 Performance qualification
10.1 Introduction 12.54 Product release
10.5 The process 12.59 Troubleshooting
10.9 Formaldehyde solution 12.59 Faults on make-safe cycles
10.12 Polymerisation
10.15 Safety precautions 13. Reporting of incidents page 94
10.17 Effects on health 13.1 Introduction
10.21 Replenishing the formalin supply 13.8 Department of Health reporting procedures
10.25 Product compatibility 13.14 Statutory reporting procedure
10.29 Items which should not be processed by LTSF
10.30 Design of the load Glossary page 97
10.31 Air removal
10.32 Handling of condensate Abbreviations page 103
10.38 Packaging materials
10.44 Performance qualification Bibliography page 105
10.45 Selection of cycle variables
10.47 Cycle monitoring and documentation Appendix 1 – Useful addresses page 112
10.51 Product release and storage
10.56 Troubleshooting
10.56 Cycle fault

2
 Contents

Appendix 2 – Sterilization of items contaminated

with TSE agents page 114
A2.1 Introduction
A2.7 Sterilization

Appendix 3 – Safety of EO sterilization page 116

A3.1 Introduction
A3.7 Fire and explosion hazards
A3.14Polymerisation
A3.16 Toxicity hazards
A3.16Vapour toxicity
A3.21Effects of liquid EO on skin and eyes
A3.23 Workplace monitoring and recording
A3.29Personal sampling
A3.32Environmental monitoring
A3.35 Personal protective equipment
A3.40Respiratory protective equipment
A3.48Protective clothing
A3.49 Emergency procedures
A3.53Leaking cylinder
A3.54Fire fighting advice
A3.57Spillage
A3.60First aid advice
A3.67 Control and handling of cylinders
A3.72 Information and training
A3.76 Maintenance

Appendix 4 – Guidance to management on the

appointment of an Authorised Person
page 126
A4.1 Introduction
A4.7 Contractual arrangements
A4.13 Core responsibilities
A4.14General advice
A4.15Validation programmes
A4.16Auditing of validation and yearly tests
A4.22Test and maintenance programmes
A4.23Operational procedures
A4.24 Additional services

PART 6 – TESTING AND VALIDATION PROTOCOLS

Appendix 5 – Sample log book for porous load

sterilizers page 132

Appendix 6 – Operational procedures page 157

About NHS Estates page 242

3
 1.0 General

Introduction

1.1 This Part of HTM 2010 covers the maintenance and operation of the
various types of sterilizer used in hospitals, laboratories and other healthcare
facilities.

1.2 Terminology used in sterilization has long been inconsistent and

occasionally ambiguous. This HTM introduces a set of terms consistent with
new European Standards (see paragraph 1.18) which, it is hoped, will in time
be adopted by sterilization workers in the NHS. The Glossary contains
definitions referred to in this Part.

1.3 The Bibliography contains full references for all the documents referred
to in this Part and for selected documents of which the reader should be
aware.

Legal frameworks for sterilization

1.4 There are now two legal frameworks governing the manufacture of
sterile products. The long-standing legislation on medicinal products has now
joined by new European Union (EU) Directives on medical devices.

1.5 Users should be clear as to whether the load items they intend to
process in a sterilizer are classified as medicinal products or medical devices.
Definitions for both may be found in the Glossary. While the practical
requirements have much in common, their implementation is very different.

1.6 For the guidance given in this HTM, the various types of sterilizer are
presumed to be used primarily as follows (though there are exceptions):

a. for medicinal products: fluid sterilizers, dry-heat sterilizers;

In Scotland, LTSF Sterilizers are b. for medical devices: porous load sterilizers, sterilizers for unwrapped
considered to be disinfectors instruments and utensils, dry-heat sterilizers, LTS disinfectors, LTSF
sterilizers, EO sterilizers.

1.7 Where a sterilizer is purchased with the intention of processing both

medicinal products and medical devices, Users should ensure that the
requirements for both types of product are met.

Medicinal products

1.8 The manufacture and supply of medicinal products are controlled by a

large body of legislation stemming from the EU Directives on medicinal
products and enacted by the UK Medicines Acts and numerous Regulations.
Further details can be found in Part 1 of this HTM.

5
1.0 General

1.9 The requirements for the manufacture of medicinal products are set out
in the ‘Guide to good manufacturing practice for medicinal products’
published in volume IV of ‘The rules governing medicinal products in the
European Community’. This document is referred to as the “GGMP” in this
HTM.

1.10 The GGMP contains an Annex on the ‘Manufacture of sterile medicinal

products’ which has considerable implications for the operation of sterilizers.
Users considering using a sterilizer for the processing of medicinal products
should consult the GGMP at an early stage.

1.11 Guidance on the application of medicines legislation to particular cases is

beyond the scope of this HTM and advice should be sought from the
Medicines Control Agency (MCA) whose address may be found in Appendix 1.

Medical devices

1.12 Part 1 of this HTM discusses the three EU Directives on the manufacture
and supply of medical devices, active implantable medical devices and in-vitro
diagnostic medical devices. The first two directives are implemented in the UK
by The Active Medical Devices Regulations 1992 and The Medical Devices
Regulations 1994. (The directive on in-vitro diagnostic medical devices is yet to
be published.) General guidance on these directives and regulations may be
found in MDA Directives Bulletin 8.

1.13 Annex I of the Medical Devices Directive lists a number of “essential

requirements”, among which the following are relevant to sterilization.

a. Section 7.2 requires that devices are “designed, manufactured and

packaged in such a way as to minimise the risk posed by contaminants
and residues to the persons involved in the transport, storage and use of
the devices and to the patients, taking account of the intended purpose
of the product.” This has implications for the quality of steam used in
sterilization processes, and for the efficacy of removal of gas residuals in
LTSF and EO sterilization.

b. Sections 8.3 and 8.4 require that devices delivered in a sterile state:
(i) “must be designed, manufactured and packed in a non-reusable
pack and/or according to appropriate procedures to ensure that
they are sterile when placed on the market and remain sterile,
under the storage and transport conditions laid down, until the
protective packaging is damaged or opened”;
(ii) “must have been manufactured and sterilized by an appropriate,
validated method.”

c. Section 8.7 requires that the “packaging and/or label of the device must
distinguish between identical or similar products sold in both sterile and
non-sterile condition.”

d. Section 13.3 sets out the requirements for the labelling of sterile packs.

e. Section 13.6 sets out requirements for the instructions for use which
must accompany each device, including instructions in the event of the
sterile pack being damaged.

1.14 Requirements for active implantable medical devices are similar, and
Users should consult the appropriate Directive and Regulations for details.

6
 1.0 General

1.15 It is likely that all or most products for clinical use that are not classified
as medicinal products will be classified as medical devices. Whether such
medical devices are subject to the Regulations is a complex issue turning on
the relationship between the producer and the end-user of the devices and is
discussed in MDA Directives Bulletin 18.

1.16 Certain sterilizers used in a “medical environment” are regarded as

“accessories” to medical devices, with the consequence that they are to be
treated as medical devices in their own right. These machines, which are often
(but not necessarily) transportable sterilizers designed for processing
unwrapped instruments and utensils, are intended by their manufacturer for
use with specific medical devices (such as surgical instruments or endoscopes)
in accordance with the manufacturer’s instructions for such devices.

1.17 The European Committee for Standardisation (Comité Européen de

Normalisation, CEN) has prepared a number of European Standards on the
manufacture of medical devices. These are known as “harmonised”
standards. Compliance with a harmonised standard is considered to bring
with it a legal presumption of compliance with the essential requirements of
the Directive it supports. Official notification of European Standards
supporting EU Directives is published in the Official Journal of the European
Communities and in the London, Edinburgh and Belfast Gazettes. European
Standards are published in the UK by the British Standards Institution with “BS
EN” prefixes.

1.18 Although compliance with a harmonised standard is not the only way of
complying with the directives, it is the simplest. Purchasers intending to
process sterile medical devices in compliance with the directives should
therefore ensure that their processes conform with one of the harmonised
standards. The following harmonised standards on the validation and control
of sterilization processes are discussed in this Part of this HTM:

a. EN 556 covering the requirements for a medical device to be labelled

“sterile”;

b. EN 554 covering sterilization by “moist heat” (i.e. steam);

c. EN 550 covering sterilization by ethylene oxide.

1.19 These standards are themselves supported by the following standards

for the specification of sterilizers which are discussed in Part 2 of this HTM:

a. EN 285 covering “large” porous load sterilizers;

b. EN 1422 covering ethylene oxide sterilizers.

1.20 There are no European Standards, as yet, for fluid sterilizers, sterilizers
for unwrapped instruments and utensils, dry-heat sterilizers, low-temperature
steam disinfectors, low-temperature steam and formaldehyde sterilizers or
laboratory sterilizers. CEN technical committee TC102 is developing standards
for “small” steam sterilizers which will cover certain porous load sterilizers and
also sterilizers for unwrapped instruments and utensils. A list of European
Standards specific to sterilization is given in the Bibliography.

1.21 This edition of HTM 2010 has been written while the new standards are
in the course of development. While the guidance given here is designed to
be broadly consistent with the emerging standards, HTM 2010 should not be
regarded as a substitute for the standards themselves when ascertaining
compliance with EU Directives and the UK Regulations that implement them.

7
1.0 General

1.22 Guidance on the application of medical devices legislation to particular

cases is beyond the scope of this HTM and advice should be sought from the
Medical Devices Agency (MDA) whose address may be found in Appendix 1.

Quality systems

1.23 The European Standards referred to in this HTM may be used alongside a
quality system for the supply of sterile medical devices based upon the EN ISO
9000 series:

a. EN ISO 9001 and 9002 (formerly EN 29001 and 29002) describe the
basic requirements for a quality system;

b. EN 46001 and 46002 describe particular requirements for the suppliers

of medical devices.

1.24 Appendix 6 contains written procedures for the procurement, validation

and management of sterilizers designed to support a quality system for the
production of sterile goods. Further guidance may be found in the ‘Guide to
good manufacturing practice for National Health Service sterile services
departments’ published by the Institute of Sterile Services Management and
issued to the NHS as EL89(P)136.

Personnel

1.25 The following personnel are referred to in this Part of HTM 2010. Further
information, including qualifications and areas of responsibility, can be found
in Part 1.

1.26 Management is defined as the person with ultimate management

responsibility, including allocation of resources and the appointment of
personnel, for the organisation in which the sterilizer is employed.

1.27 Depending on the nature of the organisation, this role may be filled by
the general manager, chief executive, laboratory director or other person of
similar authority. In small, autonomous installations the User may take on this
function.

1.28 The User is defined as the person designated by Management to be

responsible for the management of the sterilizer.

1.29 In a hospital the User could be a sterile services department manager,

laboratory manager or theatre manager; in primary care he or she could be a
general practitioner, dentist, or other health professional. Where a sterilizer is
used to process medicinal products, the User is normally the Production
Manager (see paragraph 1.37) in charge of the entire manufacturing process.

1.30 The Competent Person (Pressure Vessels) is defined as a person The Pressure Systems and
or organisation designated by Management to exercise certain legal Transportable Gas Containers
responsibilities with regard to the written scheme of examination of any Regulations (Northern Ireland) 1991
pressure vessel associated with a sterilizer described in the Pressure Systems apply in Northern Ireland
and Transportable Gas Containers Regulations 1989 (see Part 1). The shorter
term “Competent Person” is used in this HTM.

8
 1.0 General

1.31 The Authorised Person (Sterilizers) is defined as a person designated

by Management to provide independent auditing and advice on sterilizers and
sterilization and to review and witness documentation on validation. The
shorter term “Authorised Person” is used in this HTM.

1.32 The Institute of Healthcare Engineering and Estate Management

(formerly the Institute of Hospital Engineering) is the registration authority for
Authorised Persons. The address is given in Appendix 1.

1.33 Guidance on the appointment of an Authorised Person is given in

Appendix 4.

1.34 The Test Person (Sterilizers) is defined as a person designated by

Management to carry out validation and periodic testing of sterilizers. The
shorter term “Test Person” is used in this HTM.

1.35 The Maintenance Person (Sterilizers) is defined as a person

designated by Management to carry out maintenance duties on sterilizers. The
shorter term “Maintenance Person” is used in this HTM. See paragraphs 4.5 –
4.8 for more information.

1.36 The Microbiologist (Sterilizers) is defined as a person designated by

Management to be responsible for advising the User on microbiological
aspects of the sterilization of non-medicinal products. The shorter term
“Microbiologist” is used in this HTM.

1.37 The Production Manager is defined as a person designated by

Management to be responsible for the production of medicinal products.

1.38 The Quality Controller is defined as a person designated by

Management to be responsible for quality control of medicinal products with
authority to establish, verify and implement all quality control and quality
assurance procedures. (A similar role may be defined for the manufacture of
medical devices, but this is rarely the practice in hospitals.)

1.39 The Laboratory Safety Officer is defined as a person designated by

Management to be responsible for all aspects of laboratory safety including
equipment, personnel and training relating to safety issues, and ensuring
compliance with safety legislation and guidelines.

1.40 An operator is defined as any person with the authority to operate a

sterilizer, including the noting of sterilizer instrument readings and simple
housekeeping duties.

1.41 The manufacturer is defined as a person or organisation responsible

for the manufacture of a sterilizer.

1.42 The contractor is defined as a person or organisation designated by

Management to be responsible for the supply and installation of the sterilizer,
and for the conduct of the installation checks and tests. The contractor is
commonly the manufacturer of the sterilizer.

9
1.0 General

Safety

1.44 Guidance on the safe operation of the various types of sterilizer is given
in Chapters 5 to 12. Guidance on safe practices in the testing of sterilizers is
given in Part 3 of this HTM.

1.45 Low-temperature steam and formaldehyde (LTSF) sterilizers and ethylene

oxide (EO) sterilizers both use toxic gases in the sterilization process.
Occupational exposure to formaldehyde and EO is controlled by the Control of
Substances Hazardous to Health Regulations 1994. Maximum exposure limits
are set out in the annual Guidance Note EH40, ‘Occupational exposure limits’,
published by the Health and Safety Executive (see Bibliography). At the time of
writing (1996) the limits are as shown in Table 1. These limits are statutory
maxima but should not be regarded as representing a safe working exposure;
employers have a legal obligation to ensure that the level of exposure is
reduced so far as is reasonably practicable and in any case below the
maximum exposure limit.

Table 1 Maximum exposure limits for atmospheric formaldehyde

and ethylene oxide

Gas Short-term Long-term

maximum maximum
exposure limit exposure limit
[ppm] [mg m–3] [ppm] [mg m–3]

Formaldehyde 2 2.5 2 2.5

Ethylene oxide 15 30 5 10

The short-term maximum exposure limit (STMEL) is the average exposure over any 15-min period.

The long-term maximum exposure limit (LTMEL) is the exposure over any 24-h period expressed as a
single uniform exposure over an 8-h period.

COSHH does not specify a STMEL for EO. In the above table the STMEL is deemed to be three times
the LTMEL in accordance with the recommendations of the Health and Safety Executive.

Source: COSHH Regulations 1994, HSE Guidance Note EH40 (1995).

1.46 The COSHH Regulations 1994 also introduce new controls on biological
agents which are of relevance to Users of laboratory sterilizers.

10
 2.0 Operational management –
an overview

Introduction

2.1 Quality control and safety of a sterilization process are ultimately

dependent upon untiring vigilance. The type of process, and the details of the
operating cycle, should be selected with due regard to the nature of the
product. Items for sterilization should be properly cleaned, packaged and
assembled in accordance with procedures established during performance
qualification. Every production cycle should be monitored and carefully
documented. Products should not be released until predetermined conditions
have been met. The sterilizer itself should be subject to preventative
maintenance and periodic testing. In these areas vigilance will necessitate
skilful personnel, fully trained in the operation of sterilizers.

2.2 For assurance on these points, responsibility rests ultimately with the
User, supported by the Authorised Person, the Competent Person, the Test
Person, the Maintenance Person and the Microbiologist.

Maintenance

2.3 EN 554 (steam sterilization) and EN 550 (EO sterilization) make the
following requirements for the maintenance of sterilizers:

a. preventative maintenance shall be planned and performed in

accordance with documented procedures;

b. the procedure for each planned task and the frequency at which it is
carried out shall be specified and documented;

c. the sterilizer shall not be used to process medical devices until all
maintenance tasks have been satisfactorily completed and recorded;

d. records of maintenance shall be retained as specified in 4.16 of EN ISO

9001 or in 4.15 of EN ISO 9002;

e. the maintenance scheme, maintenance procedures and maintenance

records shall be reviewed periodically by persons designated by
management.

2.4 The guidance in Chapter 4 puts these requirements into practice.

Safety precautions

2.5 Part 1 of this HTM discusses the principal health and safety legislation
applying to sterilization.

2.6 HSE guidance note PM73, ‘Safety at autoclaves’, applies to steam

sterilizers and emphasises the guidance contained in this memorandum.

The Provision and Use of Work 2.7 Any equipment issued to operators should comply with the Provision and
Equipment Regulations (Northern Use of Work Equipment Regulations 1992. Guidance may be found in the
Ireland) 1993 apply in Northern HSE document ‘Work equipment’ (L22).
Ireland

11
2.0 Operational management – an overview

2.8 Users should note the requirements of The Manual Handling The Manual Handling Operations
Operations Regulations 1992 with regard to loading and unloading Regulations (Northern Ireland) 1992
sterilizers. Guidance may be found in the HSE document ‘Manual handling’ apply in Northern Ireland
(L23).

2.9 Access to sterilizer loading areas, plant rooms and equipment should
be restricted to those entitled to be there.

Hazards associated with sterilization

2.10 Attention is drawn to the following hazards which may be encountered

in the practice of sterilization:

a. the hazard of scalding from escaping steam;

b. the high temperatures (up to 200°C) at which sterilizers are operated;

c. the stored energy hazards associated with the operation of pressure

vessels contained within steam and EO sterilizers;

d. the stored energy hazards associated with the pressurised containers in

which EO gas is transported;

e. the explosive hazards associated with the sterilization of fluids in sealed

glass containers;

f. the toxic properties of formaldehyde gas used in LTSF sterilizers;

g. the toxic and explosive properties of ethylene oxide gas used in EO

sterilizers;

h. the infection hazard associated with pathogens that may be handled by

personnel using certain laboratory sterilizers;

j. the hazard of infection to patients and staff by the inadvertent release of

an unsterile load due to inadequate quality control;

k. the hazard to patients arising from residual ethylene oxide or

formaldehyde present in the product;

l. the hazards associated with the handling of heavy and hot loads while
loading and unloading sterilizers.

2.11 More detailed information about each process is given in Chapters 5

to 12.

Safety of pressure vessels

2.12 The majority of sterilizers discussed in this HTM contain pressure The Pressure Systems and
vessels that are subject to the Pressure Systems and Transportable Gas Transportable Gas Containers
Containers Regulations 1989. Users are reminded of the following safety Regulations (Northern Ireland) 1991
measures: apply in Northern Ireland
a. door interlocking safety devices are designed to prevent:
(i) the pressurisation of the chamber before the door is secured;
(ii) the uncontrolled release of chamber contents while the chamber is
under pressure;

b. any escape of steam should be reported immediately and appropriate

action taken;

c. arrangements for regular systematic inspection and maintenance must

be adhered to;

12
 2.0 Operational management – an overview

d. all operators must be adequately trained and supervised for their

allotted tasks;

e. documented operating procedures must be followed at all times.

Unloading

2.13 During the cooling stage the temperature of the load may be much
higher than that in the chamber. Containers of liquid could be pressurised and
may explode; liquids spilled on unloading may cause scalding. Users should
take note of the following safety measures:

a. thermal door-locks are fitted to sterilizers designed to process fluids, to

prevent the door mechanism being released while the temperature of
the fluid is too high;

b. a cooling timer may be used in addition to a thermal door-lock;

c. adequate training should ensure that the operator is aware of the

nature of the load and any hazards associated with it;

d. operators should wear appropriate personal protective equipment in

addition to their normal working clothes (see paragraph 2.14);

e. reaching into a hot sterilizer can be hazardous; consideration should be

given to the provision of a load transfer system such as sliding shelves
or a carriage and trolley.

Personal protective equipment

The Personal Protective Equipment at 2.14 Operators and maintenance personnel should be issued with appropriate
Work Regulations (Northern Ireland) personal protective equipment (PPE) complying with the Personal Protective
1993 apply in Northern Ireland Equipment at Work Regulations 1992 (see Part 1 of this HTM). The choice of
PPE should follow a suitable assessment of risk for each type of sterilizer.
Examples of PPE that may be required, in addition to normal working clothes,
include:

a. impervious apron to protect against liquid spills;

b. heat-resistant gloves for handling hot loads;

c. protective gloves for handling potentially infected material;

d. safety shoes for use when loading and unloading sterilizers;

e. eye and face protection for use when removing glass containers from a
sterilizer;

f. respiratory protective equipment and protective clothing for emergency

use with EO sterilizers (see paragraphs A3.35–A3.48).

2.15 PPE should always be regarded as a “last resort” to protect against risks
to health and safety; engineering controls and safe systems of work should
always be considered first. Guidance on the selection of PPE may be found in
‘Personal protective equipment: guidance on regulations’ (L25) published by
HSE.

Compatibility of load and process

2.16 The User should ensure that the load is suitable for the process to which
it is to be exposed.

13
2.0 Operational management – an overview

2.17 When selecting a process for a given item, the User should consider the
following questions in conjunction with the advice of the manufacturer of the
item.

a. Is sterilization required? In some cases, where the infection risk is

intermediate to low, disinfection or cleaning may be sufficient . The
guidance in Table 2 should be followed.

b. Will the item be damaged by exposure to the process? Several common

items cannot withstand the moisture of steam sterilization or the high
temperatures of dry-heat sterilization.

c. Will the item fail to be sterilized by exposure to the process? Even if an

item can withstand the process it may not be sterilized if, for example,
steam cannot penetrate narrow tubing.

d. Is the process excluded by health and safety considerations? Some

medical devices should not be exposed to formaldehyde or ethylene
oxide.

Table 2 Recommended processes for the decontamination of medical devices

according to risk of infection

Infection risk Application Recommendation

High Items in close contact with a Sterilization

break in the skin or mucous
membrane or introduced
into a sterile body area
Intermediate Items in contact with intact Sterilization or
skin, mucous membranes or disinfection. Cleaning
body fluids, particularly after may be acceptable in
use on infected patients or some agreed situations
prior to use on immuno-
compromised patients
Low Items in contact with healthy Cleaning
skin or mucous membranes
or not in contact with
patient

Adapted from: ‘Sterilization, disinfection and cleaning of medical equipment’, MDA 1993.

2.18 The flow-chart in Figure 1 will assist Users in selecting an appropriate

sterilization process. The Authorised Person should be consulted in cases of
doubt.

14
 2.0 Operational management – an overview

Figure 1 A guide for the selection of a sterilization process

15
2.0 Operational management – an overview

Notes to Figure 1

Figures refer to boxes on the flow chart.

1 Does the product consist of aqueous fluid?

If the product is a water solution, then it must be processed in a fluid sterilizer.
Bottles or other containers holding aqueous fluids must not be placed in any
other kind of sterilizer.

2 Does the product contain volatile liquid?

None of the processes discussed in this HTM are suitable for volatile liquids
other than water.

3 Can the product withstand contact with liquid water?

All steam sterilizers produce condensate on any surface which is in contact
with steam. Water will therefore condense inside hollow items, within
unsealed containers and inside porous packaging. Porous packaging is likely to
become saturated. Packaging designed for steam sterilizers will not be
damaged by such exposure.

4 Can it withstand temperatures in excess of 120ºC?

High-temperature steam sterilizers operate at sterilization temperatures of
121ºC, 126ºC or 134ºC, with the highest temperature preferred. Most items
of glass or metal will withstand such temperatures, but items with plastic
components may not. Some items constructed of two or more different metals
may distort at these temperatures and some medicinal products may be
damaged. In exceptional cases lower temperatures may be used provided the
bioburden and the required sterility assurance level are known.

5 Is the sterilized product for immediate use?

If the product is to be used in a controlled medical environment immediately
after the chamber door has been opened, then it need not be wrapped and a
sterilizer for unwrapped instruments and utensils is acceptable. Otherwise the
item should be wrapped and processed in a porous load sterilizer.

6 Is it likely to trap air and impede steam?

Items which are for immediate use may nevertheless require a porous-load
sterilizer if they are likely to trap air and impede the penetration of steam. See
paragraph 7.13 for further guidance.

7 Is exposure to formaldehyde permissible?

Certain items should not be processed by LTSF for reasons of health and
safety. See paragraph 10.29.

8 Can it withstand temperatures in excess of 160ºC?

Products that cannot withstand contact with liquid water may be processed in
a dry-heat sterilizer if they can withstand the high temperatures and prolonged
holding times.

9 Is exposure to ethylene oxide permissible?

Certain items should not be processed by EO for reasons of health and safety.
See paragraph 11.18.

2.19 Processes using toxic gases (LTSF and EO) are a last resort and should not
be used for items which could be sterilized or disinfected by another method.
Many heat-sensitive items are currently processed by LTSF or EO where LTS
disinfection would have been adequate and safer.

16
 2.0 Operational management – an overview

Process development

2.20 Once a basic process has been selected, Users should consider whether
the standard operating cycle needs to be modified to cope with specific load
items. For example, delicate items may not be able to withstand the rapid
pressure changes that take place in the chamber of a porous load sterilizer
and the rate of change of pressure may need to be reduced.

2.21 If the cycle variables are modified from the values used during
validation, revalidation (and possibly repeat validation) will be necessary (see
Part 3 of this HTM).

“Single-use” medical devices

2.22 Many medical devices are intended by their manufacturers to be used

once only and then discarded. However, it is not uncommon for hospitals to
clean, sterilize and reuse the more expensive of these devices (such as cardiac
catheters) where it is considered safe and economical to do so.

2.23 Users considering reprocessing single-use items should note the

following points:
a. the construction of many such devices, often with long and narrow
lumens, makes them difficult to clean with any degree of confidence;

b. if the efficacy of cleaning procedures cannot be assured then neither

can the sterilization process;

c. where devices have been sterilized by radiation, subsequent sterilization

by EO can lead to structural weakening of certain plastic components;

d. the User will have no redress from the manufacturer for any
subsequent failure of the device, whatever the cause.

2.24 The MDA gives the following advice on reprocessing.

An organisation that reprocesses a single-use device for reuse against

the instructions of the original manufacturer, and then supplies it to
other organisations, will be returning the device to the market and it is
likely to be regarded as a manufacturer in its own right, with all of the
obligations that entails. This is because the organisation is considered to
be placing a new device on the market under its own name and must
therefore meet the full obligations of the Medical Devices Directive.

If single-use devices are reprocessed for use solely within the

organisation, this would not be seen as placement upon the market.
Hence the requirements of the Directive, so far as they relate to
manufacture, would not apply.

2.25 Further information may be found in MDA Device Bulletin 9501.

Cleaning

2.26 Cleaning and drying of reusable load items before packaging and
sterilization are essential, since the efficacy of the process will be reduced if
soiling protects micro-organisms from exposure to the sterilant. All items
should therefore be scrupulously clean. Washer-disinfectors are suitable for
preparing many such items for sterilization and guidance may be found in
HTM 2030.

2.27 Discard items and materials should not be cleaned.

17
2.0 Operational management – an overview

Packaging

2.28 ENs 550 and 554 require the packaging specification to be part of the
definition and documentation of the of the sterilization process. The User
should therefore ensure that each load is packaged and assembled in
accordance with documented procedures validated during performance
qualification.

2.29 When handled in accordance with instructions the packaging should

protect the product from physical damage and maintain the sterility of the
product up to the point of use.

2.30 The packaging should not inhibit the efficacy of the process by, for
example, hindering the removal of air or the penetration of steam, impeding
the conduction of heat to the load, outgassing, altering the humidity in the
chamber, or absorbing chemical sterilants

2.31 The packaging should be able to withstand the sterilization process. It

may be necessary to carry out preliminary tests on the product and its
packaging in order to determine the levels and rates of change of temperature,
pressure and other cycle variables which start to cause unacceptable changes
in the performance qualities of the product or its packaging.

2.32 Packaging materials should be stored in the conditions recommended by

the manufacturer. Packaging material that has become dehydrated, for
example, may adversely affect the efficacy of an EO sterilization process.

2.33 Specifications for packaging materials may be found in EN 868. Extensive

guidance on packaging is given in Part 5 of this HTM, with a brief summary in
Chapters 5 to 12 of this Part.

Performance qualification

2.34 Performance qualification (PQ) is defined as the process of obtaining and

documenting evidence that the sterilizer, as commissioned, will produce
acceptable goods when operated in accordance with the process specification.

2.35 A loading condition is a specified combination of the nature and number

of load items, the items of chamber furniture, and their distribution within the
chamber. For example, a load placed on the top shelf of the chamber
constitutes a different loading condition from an identical load placed on the
bottom shelf. The specification is part of the PQ report for that loading
condition. Note that the specification may require load items to be arranged in
precise positions or permit them to be placed randomly in the chamber.

2.36 The extent of the PQ required will depend on the type of sterilizer and
the nature of the load. All Users should adopt the following procedure for
every sterilizer.

a. Establish a list of the distinct loading conditions to be processed in the

sterilizer. Each production load should correspond to one of the listed
loading conditions.

b. Determine whether each loading condition presents a greater or lesser

challenge to the process than the small and full loads used in the
thermometric tests carried out during commissioning (see Part 3 of this
HTM).

18
 2.0 Operational management – an overview

c. Where the loading condition is a lesser challenge than the

commissioning loads, the results of the commissioning tests may be
used as PQ data.

d. Where the loading condition is a greater challenge than the

commissioning loads, PQ tests will be required as specified in Part 3 of
this HTM.

2.37 The User is responsible for deciding which loading conditions require PQ
tests. The User is recommended to seek advice as follows:

a. sterilizers to be used for medicinal products – from the Quality

Controller and the Test Person;

b. LTSF and EO sterilizers – from the Microbiologist and the Test Person;

c. all other sterilizers – from the Test Person.

2.38 The flow chart in Figure 2 will assist Users in determining whether PQ
tests are required or whether data from the commissioning tests will be
sufficient. In cases of doubt, advice should be sought from the Authorised
Person.

2.39 PQ tests are normally performed as part of the initial validation

procedure, as part of any repeat validation procedure, and whenever the User
judges that a new loading condition calls for a new PQ test. Detailed
instructions for carrying out PQ tests are given in Part 3 of this HTM.

2.40 In some cases a new load may be adequately represented by one of the
existing loading conditions for which a PQ report exists. Further PQ tests will
not then be necessary. Where a new load is not covered by an existing PQ
report, full PQ tests as specified in Part 3 should be conducted.

2.41 When designing a new loading condition, it is important that the correct
packaging is selected and specified along with the load itself. The packaging
specification should not then be altered in subsequent production cycles
without repeating the PQ procedure unless the loading condition with new
packaging can be demonstrated to be equivalent to one covered by an
existing PQ report.

Position of PQ sensors

2.42 Temperature sensors should be placed as described in Chapter 8 of Part

3 of this HTM. In selecting which load items require sensors, the following
observations should be noted:

a. small load items will heat up and cool down faster than large items;

b. load items placed near the steam inlet port will heat up faster than
those placed further away.

Cycle variables

2.43 For the purposes of this HTM the following definitions have been
adopted.

2.44 The cycle variables are the physical properties, such as time,
temperature, pressure, humidity and sterilant gas concentration, that influence
the efficacy of the sterilization process.

19
2.0 Operational management – an overview

Figure 2 Performance qualification assessment guide

20
 2.0 Operational management – an overview

2.45 Most operating cycles have a stage in which the load is exposed to the
sterilization (or disinfection) conditions for a specified length of time. This
period is known as the holding time.

2.46 The sterilization conditions are the ranges of the cycle variables which
may prevail throughout the chamber and load during the holding time.

2.47 The holding time is preceded by a period in which the sterilization

conditions are present in the chamber but not yet present throughout the
load. This is known as the equilibration time.

2.48 Together, the equilibration time and the holding time constitute the
plateau period. While the duration of the plateau period can always be
determined from the recorded chamber temperature, the equilibration and
holding times cannot be distinguished unless the temperature in the part of
the load that is slowest to reach the sterilization temperature is also being
recorded or measured.

2.49 Certain LTSF sterilizers may achieve sterilization by exposing the load to
a series of pulses of formaldehyde rather than a continuous holding time.

2.50 For EO sterilizers the plateau period is equivalent to the gas exposure
time. The holding time cannot be determined by thermometry alone.

2.51 For steam and dry-heat sterilizers, the sterilization conditions are
specified by a sterilization temperature band, defined by a minimum
acceptable temperature, known as the sterilization temperature, and a
maximum allowable temperature. The higher the sterilization temperature the
shorter the holding time and the more rapidly the cycle is completed. A
sterilization temperature band can also be quoted for LTSF and EO sterilizers,
but since these processes depend primarily upon chemical action such a band
is only a partial specification of the sterilization conditions. Bands for the
different types of process are listed in Table 3. See Table 9 (Chapter 12) for
recommendations for laboratory sterilizers.

Table 3 Recommended sterilization temperature bands

High- Dry heat LTS LTSF Ethylene

temperature oxide
steam

Sterilization 121 126 134 160 170 180 71 71 30-56

temperature [°C] (a) (b) (c)

Maximum allowable 124 129 137 170 180 190 80 80 (e)

temperature [°C] (d)

Minimum holding 15 10 3 120 60 30 10 180 (g)

time [min] (f)

a. The temperature setting on the automatic controller will not generally be the sterilization
temperature, but a higher temperature within the sterilization temperature band.
b. Disinfection temperature.
c. This temperature is conventional but others may be used.
d. See paragraph 2.52.
e. For EO, the maximum allowable temperature will normally be 4°C above the sterilization
temperature.
f. For LTSF, the sterilization conditions may specify either a continuous holding time or the
number of pulses of formaldehyde required to achieve sterilization.
g. For EO, the “gas exposure time” is determined for each sterilizer by microbiological
methods during commissioning but is typically 2-7 hours depending upon sterilization
temperature and gas concentration.

21
2.0 Operational management – an overview

2.52 Whereas the bands for high-temperature steam are normally 3°C wide,
the 134°C band is anomalous in that the maximum allowable temperature
may be either 137°C or 138°C. In BS3970, 138°C is cited both for porous-load
sterilizers (Part 3) and transportable sterilizers for unwrapped instruments and
utensils (Part 4). At the time of writing these Parts are still current and existing
sterilizers are largely designed to operate with a maximum allowable
temperature of 138°C.

2.53 However, EN 285, which is to replace BS3970: Part 3, specifies that for
“large” porous-load sterilizers all bands should be 3°C wide, implying a
maximum allowable temperature of 137°C. This is the temperature adopted in
this HTM. Unfortunately, the proposed EN on “small” sterilizers (essentially
transportables) permits a width of 4°C for all bands where unwrapped
instruments and utensils are to be processed. The existing and proposed
requirements are summarised in Table 4. The recommendation of this HTM is
that a width of 3°C should be adopted for all sterilization bands.

2.54 The 143°C band listed in Table 4 has been rarely used in the NHS
because any time advantage offered by the short holding time is outweighed
by the longer heating and cooling times.

2.55 Settings for the automatic controller will be determined during

performance qualification. Generally these will consist of a chamber
temperature within the sterilization temperature band and a plateau period
designed to accommodate the equilibration time and the holding time.
Guidance on the setting of the cycle variables will be found in chapters 5 to
12.

Table 4 Sterilization temperature bands for high-temperature steam specified

by British and European Standards

Maximum allowable temperature

Fluids Porous loads Unwrapped

Sterilization BS3970: BS3970: EN 285 Proposed BS3970: Proposed Holding

temperature Part 2 Part 3 (“large”) type B* Part 4 type N* time [min]
[°C] (“small”) (“small”)

115 — — — 118 — 30
121 124 124 124 124 124 125 15
126 — 129 129 129 129 130 10
134 — 138 137 137 138 138 3
143 — — — 146 — 147 1

* Proposed European Standard under discussion by CEN

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 2.0 Operational management – an overview

Cycle monitoring and documentation

2.56 It is vital that every production cycle is monitored and documented and
that records are kept securely. Guidance on record-keeping is given in
Chapter 3.

2.57 Except for the simpler processes (specified in the relevant chapter)
documentation noted in the sterilizer process log for each sterilized load
should include:

a. sufficient information to identify the sterilizer uniquely (by a unique

reference number; by the name of the manufacturer, the model of
sterilizer and the serial number; or by any sufficient combination of
these);

b. a specification of the loading condition (defined either by the nature

and number of load items, items of chamber furniture, and their
distribution in the chamber, or by a coded reference to a detailed
specification held elsewhere);

c. a specification of the operating cycle (defined either by the settings for

the cycle variables or by a coded reference to a detailed specification
held elsewhere);

d. a reference to the result of any routine pre-production test, such as a

Bowie-Dick test;

e. the batch process record from the recorder fitted to the sterilizer
marked with the reference number of the master process record used
to validate it;

f. any deviations from the PQ specification in terms of loading condition

and settings of cycle variables whether or not these result in an
acceptable cycle;

g. the date and time of the start of the operating cycle;

h. the cycle number as indicated on the cycle counter;

j. the name or other identification of the operator;

k. any other records specified in Chapters 5 to 12.

2.58 The batch process record obtained from the sterilizer recorder should be
sufficiently detailed to confirm that the requirements for critical parts of the
operating cycle are met. This is best achieved by ensuring that a continuous
graph is plotted as the cycle progresses and, for a digital system, that the
values of all samples are retained for later inspection.

2.59 Biological indicators are not required for monitoring of steam or dry-
heat processes, though they may occasionally be necessary for performance
qualification of unusual loads (see Part 3 of this HTM). See Chapters 10 and
11 about the use of biological indicators in LTSF and EO sterilizers.

2.60 If in doubt as to which records are required, the User should consult the
Authorised Person. As a rule, it should be possible to trace any sterilized
goods from the point of use back through the supply chain to the specific
sterilizer and cycle in which they were processed and establish the precise
values of the cycle variables throughout the cycle. A bar code attached to
each load item is a practical way of keeping track of sterilized goods.

23
2.0 Operational management – an overview

2.61 Cycles abandoned for any reason should be noted in the sterilizer
process log along with any remedial action taken. Operators should be
encouraged to note and report any observations which suggest that the
sterilizer may not be working as it should be.

2.62 Where a load has been reprocessed following the failure of an earlier
cycle, records of the original cycle should be readily traceable from the
reprocessing records.

2.63 Further guidance on documentation is given in Chapters 5 to 12.

Process indicators

2.64 A foolproof system to differentiate between processed and unprocessed

load items should be used to prevent an unprocessed item being mistaken for
one that has been sterilized. A convenient method is to use chemical indicators
which change colour on exposure to the sterilization process. Such “process
indicators” are available in a variety of forms including adhesive tape, labels
and preprinted panels on sterilization packaging. Process indicators should
conform to the specifications for Class A indicators given in EN 867: Part 2.

2.65 Users should note that process indicators demonstrate only that the load
item has been exposed to an operating cycle. They offer no assurance that the
load item is sterile and can play no part in the validation and monitoring of the
process.

Product release

2.66 The User, in consultation with the Authorised Person, should establish
and document procedures to ensure that loads are not released for use until
the User is satisfied that the operating cycle has been reproduced within the
permitted tolerances established during performance qualification.

2.67 For medicinal products, the Quality Controller will establish the
procedures for product release.

2.68 The procedures should confirm the following:

a. that the load has been packaged and assembled in accordance with the
PQ specification;

b. that the settings for the operating cycle are in accordance with the PQ
specification;

c. that the batch process record for the cycle conforms with the relevant
master process record within the permitted tolerances (see paragraph
2.71);

d. that any indicated readings required to be noted during the cycle have
been noted and are in accordance with the PQ specification;

e. that the sterilized load shows no obvious anomalies, such as damaged

packaging or leaking containers, that may suggest a faulty cycle. (If any
degree of deterioration is acceptable this should be part of the PQ
specification.)

2.69 Loads processed in LTSF or EO sterilizers should not be released until the
results of the routine microbiological tests are known (see Chapters 10
and 11).

24
 2.0 Operational management – an overview

2.70 Regardless of the above procedure, whenever an operator has cause to

suspect that the load may not have been properly sterilized the load must not
be released. The User should be informed immediately.

Master process record

2.71 A master process record (MPR) is a record of the values and permitted
tolerances of cycle variables (normally time, temperature and pressure) for a
correctly functioning operating cycle against which production cycles can be
checked. (The term “master temperature record” was used in earlier editions
of HTM 10.) It is derived either from the batch process record (BPR) obtained
during a thermometric PQ test or, if no PQ test has been deemed necessary,
from the BPR obtained from a full-load thermometric test carried out during
commissioning. It may be a one-to-one transparent copy of the BPR, a
“template” derived from the BPR, or data stored in a computer control system
and compared automatically. See Part 3 of this HTM for further information
on MPRs.

2.72 Cycle variables recorded on the MPR may include chamber temperature,
chamber pressure and the temperature inside one or more load containers as
a function of time.

2.73 When a BPR from a production cycle is compared with the appropriate
MPR, the value of the cycle variables on the BPR should be contained within
the limits shown on the MPR for the entire cycle.

Rejected loads

2.74 Failure to meet any of the product release requirements should lead to
the load being placed in quarantine and the cause of the failure investigated.
The investigation should be documented and the handling of the product
should be in accordance with the procedures for control of non-conforming
product required by EN ISO 9001 or 9002.

In Scotland, the management of 2.75 Documented procedures for dealing with rejected loads should be
clinical waste and heat treatment agreed between the User and the Authorised Person. There are basically three
processes, published by the Scottish options:
Centre for Infection and
a. the load may be reprocessed; this should only be permitted if the
Environmental Health, Aug 1994,
nature of the load and its packaging is such that they will not be
ISBN 1 873772106, should be
unacceptably degraded by a second exposure to the sterilization
referred to
process;

b. the load may be “reworked”, i.e. dismantled, repackaged and then

reprocessed;

c. the load may be discarded; in this case, procedures should ensure that
load items are permanently marked as rejected, removed from the
supply chain and that there is no risk of them being mistaken for
correctly processed items.

2.76 Procedures for the disposal of a discarded load should ensure that no
hazard is caused either to personnel or to the environment.

25
2.0 Operational management – an overview

Storage

2.77 After sterilization and before product release, conditions for product
storage and handling should not compromise the qualities of the product.

2.78 Detailed guidance on storage and distribution of sterile goods can be

found in Part 5 of this HTM.

26
 3.0 Record-keeping

Introduction

3.1 The importance of maintaining careful records cannot be stressed too

highly. Complete and accurate records are an essential element in ensuring
the safe and efficient functioning of sterilizers and compliance with regulatory
requirements.

The collection, fractionation, quality 3.2 The following principles, based upon those issued by the World Health
control and uses of blood and blood Organisation for the processing of blood products, apply equally to quality
products, World Health Organisation control of sterilization processes. Records should:
1981
a. be original (not a transcription), indelible, legible and dated;

b. be made concurrently with the performance of each operation and test;

c. identify the person recording the data as well as the person checking
the data or authorising continuation of processing;

d. be detailed enough to allow a clear reconstruction and understanding

of all relevant procedures performed;

e. allow tracing of all successive steps and identify the inter-relationships

of dependent procedures, products and waste materials;

f. be maintained in an orderly fashion permitting the retrieval of data for

a period consistent with dating periods (shelf life) and legal
requirements;

g. indicate that processing and testing were carried out in accordance

with procedures established and approved by management;

h. if necessary, allow a prompt and complete recall of any particular

batch;

j. show the lot numbers of materials used for making up specified

batches of products.

3.3 The requirements for record-keeping in ENs 550 and 554 are the same
as ENs 46001 and 46002, namely that the supplier should retain the quality
records for a period of time at least equivalent to the lifetime of the medical
device defined by the supplier, but not less that two years from the date of
dispatch from the supplier. The supplier should establish a record for each
batch of medical devices that provides traceability and identifies the quantity
manufactured and quantity released for distribution. The batch record should
be verified and the load authorised for release by the User.

3.4 For medicinal products, the record-keeping principles outlined in the

GGMP should be followed.

3.5 The system recommended in this HTM requires two sets of records to be
kept for each sterilizer:

a. a plant history file;

b. a sterilizer process log.

27
3.0 Record-keeping

3.6 Both of these are the responsibility of the User. They should be made
available to any other personnel who need to use them. This will include the
Authorised Person, Test Person, Maintenance Person, Microbiologist,
Competent Person and operators.

3.7 In the case of sterilizers used for processing medicinal products, the form
of these records should be approved by both the Production Manager and the
Quality Controller.

3.8 Log books for recording data obtained from periodic tests are available In Scotland, log books are available
from NHS Estates. An example of a log book for a porous load sterilizer is from Scottish Healthcare Supplies
given in Appendix 5. The log book is regarded as part of the plant history
file.

Plant history file

3.9 The plant history file contains engineering records of the sterilizer
installation. It should be kept throughout the life of the sterilizer (see
paragraph 3.3). Examples of the information that should be kept in the plant
history file include:

• identification of the sterilizer;

• names, addresses and telephone numbers of the sterilizer manufacturer,

owner and key personnel (User, Authorised Person, Test Person,
Maintenance Person, Competent Person, Microbiologist);

• dates of installation and commissioning;

• validation procedures;

• validation reports (including PQ reports for each loading condition);

• copies of validation summary sheets;

• copy of any maintenance contract;

• planned maintenance programme including detailed procedures for all

maintenance tasks;.

• records of maintenance, both scheduled and unscheduled, sufficient to

show that all examinations, tests and checks have been carried out;

• manuals supplied by the manufacturer;

• documentation for any software used for control or instrumentation

(including the name of an agent where the source codes may be
obtained should the manufacturer cease trading);

• the written scheme of examination for any pressure vessel;

• reports by the Competent Person in respect of pressure vessels;

• data from periodic tests carried out by the Test Person or the
Maintenance Person;

• copies of data from the periodic tests carried out by the User (kept in the
sterilizer process log);

• records of any defects found on the sterilizer and corrective action

taken;

• records of any modification made to the sterilizer;

• references to the plant history files for the test instruments used in the
validation and periodic tests;

28
 3.0 Record-keeping

• specifications for the operating cycles.

Sterilizer process log

3.10 The sterilizer process log contains information required for routine
operation of the sterilizer and records relevant to each cycle. It should contain
the following information:

• identification of the sterilizer;

• names, addresses and telephone numbers of the sterilizer

manufacturer, owner and key personnel (User, Authorised Person, Test
Person, Maintenance Person, Competent Person, Microbiologist);

• names of authorised operators;

• written procedures for all duties to be carried out by the operators;

• full operating instructions;

• copies of validation summary sheets (see Part 3 of this HTM);

• data from the periodic tests carried out by the User;

• records of routine housekeeping carried out by the User (see paragraph

4.21);

• specifications for the operating cycles for which the sterilizer has been
validated, defined by the settings for the cycle variables;

• specifications for the loading conditions for which the sterilizer has
been validated, defined by the nature and number of load items, items
of chamber furniture, and their distribution within the chamber.

3.11 The following information should be noted for each batch processed by
the sterilizer:

• the name of the operator;

• the date and time of the start of the cycle;

• the cycle number;

• a reference to the loading condition;

• a reference to the operating cycle;

• a specification of any preconditioning, conditioning or degassing

process (this is essential for EO sterilizers);

• reference number of the master process record;

• values of cycle variables required to be observed and noted by the

operator during the cycle;

• a signature confirming whether or not the cycle was satisfactory;

• any notes or observations on the cycle.

3.12 The batch process record for each cycle should be filed in such a way
that it can be readily retrieved for inspection. Before filing it should be clearly
marked with the following:

• sterilizer identification;

• date;

• cycle number;

29
3.0 Record-keeping

• batch number;

• reference number of the master process record;

• a signature confirming whether or not the cycle was satisfactory.

3.13 Other requirements for entries in the sterilizer process log may be found
in Chapters 5 to 12.

30
4.0 Maintenance

Introduction

4.1 Sterilization is a process whose efficacy cannot be verified retrospectively

by inspection or testing of the product before use. For this reason sterilization
processes have to be validated, the performance of the process routinely
monitored, and the equipment maintained.

4.2 Means of assuring that a sterilizer is fit for its intended purpose will
include the validation and periodic testing programme specified in Part 3 of
this HTM, and also the programme of planned maintenance (PM) as described
in this chapter.

4.3 The philosophy of maintenance and testing embodies three main

principles to ensure that required standards of performance and safety are
attained and sustained:.

a. all sterilizers are subjected to a carefully planned programme of tests to

monitor their performance;

b. all sterilizers are subjected to a planned programme of preventative

maintenance irrespective of whether or not a preventative maintenance
scheme is being operated on the premises generally;

c. expertise on all aspects of the maintenance of sterilizers should be

available at two levels; these are represented by the Authorised Person
and the Maintenance Person.

4.4 Testing of sterilizers is dealt with in Part 3 of this HTM.

Maintenance Person

4.5 As discussed in Part 1 of this HTM, the Maintenance Person is defined as

a person designated by management to carry out maintenance duties on
sterilizers.

4.6 The Maintenance Person should be a fitter or an electrician with

documentary evidence to demonstrate competence in the maintenance of one
or more types of sterilizer. He or she should be in a position to deal with any
breakdown in an emergency and have the ability to diagnose faults and carry
out repairs or to arrange for repairs to be carried out by others. The
Maintenance Person is typically an employee of the organisation operating the
sterilizer, an employee of the sterilizer manufacturer, or an employee of an
independent contractor.

4.7 The principal responsibilities of the Maintenance Person are:

a. to carry out the maintenance tasks outlined in this chapter;

b. to carry out additional maintenance and repair work at the request of

the User.

31
4.0 Maintenance

4.8 A Maintenance Person who has a minimum of two years experience in

the maintenance of sterilizers and who has obtained a recognised qualification
in the testing of sterilizers may perform the duties of the Test Person for the
daily, weekly and quarterly tests described in Part 3.

Planned maintenance programme

4.9 The planned maintenance programme should be designed according to

the following principles:

a. all parts of the sterilizer which are vital to correct functioning or safety
should be tested at weekly intervals. This is interpreted as follows:
(i) there is no need to test components individually in those cases
where any malfunction will be revealed by the periodic tests
prescribed in Part 3 of this HTM for weekly or more frequent
intervals;
(ii) where the correct functioning of important components is not
necessarily verified by the periodic tests prescribed for the sterilizer,
those components should be individually tested each week and
reference to testing them should be included in the schedules of
maintenance tasks. This applies, for example, to door interlocks
which may only be required to perform their safety function when
presented with an abnormal condition;

b. the maintenance programme should include, at appropriate intervals,

those tasks such as lubrication and occasional dismantling of particular
components (such as pumps) the need for which is indicated by normal
good practice, manufacturer’s advice and experience. Apart from those
tasks, the maintenance programme should concentrate on verifying the
condition of the sterilizer and its components by means of testing and
examination without dismantling. Parts which are working correctly
should be left alone and not disturbed unnecessarily;

c. Maintenance should be carried out under a quality system such as EN

ISO 9000. Spares fitted to sterilizers constructed under a quality system
should be sourced from a similarly approved quality system.

Design of a PM programme

4.10 The PM programme supplied by the sterilizer manufacturer should be

used where it is available. If no manufacturer’s programme can be obtained, a
programme should be drawn up in consultation with the Authorised Person
and the Maintenance Person.

4.11 Although the sterilizer manufacturer may carry out certain inspection and
maintenance procedures under the terms of his guarantee, these may not
constitute a full PM programme. The User should therefore ensure that the
complete PM programme is carried out by the Maintenance Person (who may
be an employee of the manufacturer, see paragraph 4.6) during the guarantee
period. The User should also implement any reasonable instructions given by
the manufacturer during this period. Failure to carry out maintenance tasks
and periodic tests could affect safety. It could also allow a contractor to place
some, if not all of his liability on to the management. Where maintenance is
carried out under lump sum term contract (see Part 2) such failure is
tantamount to breach of contract and can give the contractor cause to
terminate the contract if he so wishes.

32
 4.0 Maintenance

4.12 A set of procedures should be developed for each sterilizer, containing

full instructions for each maintenance task.

4.13 The frequency at which any given task needs to be carried out will
depend on how heavily the sterilizer is used. Where there is a two-shift
system, for example, it will be necessary to adjust the programme so that
work is carried out more frequently than under a single-shift system. Where
sterilizers are used infrequently, however, less frequent maintenance is not
always acceptable. Infrequent use requires increased maintenance of certain
components because of failure of valves, seals, pumps, etc., due to sticking
through lack of use. Only when a component is subject to progressive wear in
use is the frequency of maintenance related to frequency of use.

4.14 It is important that maintenance is planned so that a sterilizer is out of

service for as little time as possible. Maintenance should, where practicable,
be scheduled to immediately precede the periodic tests as specified in Part 3.

Review of the PM programme

4.15 The PM programme, procedures and records should be reviewed at least

once a year by the User and the Maintenance Person in association with the
Authorised Person. To do this, it is necessary to keep systematic records of all
work done, so that judgement can be made in consultation with the
manufacturer on what changes, if any, to the PM programme would be
desirable.

4.16 The review should aim to identify:

a. any emerging defects;

b. any changes required to the maintenance scheme;

c. any changes to any maintenance procedure;

d. any additional training required by personnel concerned with

maintenance;

e. whether records have been completed satisfactorily, signed and dated.

Inspection of pressure vessels

The Pressure Systems and 4.17 Under the Pressure Systems and Transportable Gas Containers
Transportable Gas Containers Regulations 1989, all sterilizers containing pressure vessels are subject to a
Regulations (Northern Ireland) 1991 periodic inspection by a Competent Person (see Part 1 of this HTM). The
apply in Northern Ireland Regulations apply to all steam sterilizers, to EO sterilizers operating above 0.5
bar, to dedicated steam generators, to cartridges and cylinders used to supply
sterilant or purging gas to EO sterilizers, and to the steam and compressed air
services. Pressure vessels include doors and their closing systems. The
Authorised Person will advise on the application of the Regulations to any
particular installation.

4.18 The Competent Person has three principal duties under the Regulations:

a. advising on the scope of the written scheme of examination for each

pressure vessel;

b. drawing up the written scheme of examination or certifying the scheme

as being suitable;

c. carrying out examinations in accordance with the written scheme,

assessing the results and reviewing the written scheme for its suitability.

33
4.0 Maintenance

4.19 The User should cooperate closely with the Competent Person to ensure
that the written scheme of examination is accommodated within the
maintenance and testing programmes. The written scheme may require certain
examinations to be carried out more frequently than recommended by the
manufacturer. Each scheme should include detailed procedures and frequency
of examination and be regularly reviewed and updated.

Modifications

4.20 Occasionally, modifications to the sterilizer may be recommended by the

manufacturer or by the UK Health Departments for reasons of efficacy and
safety. The User should arrange for such modifications to be carried out within
a reasonable period, normally coinciding with a scheduled maintenance
session.

Routine housekeeping

4.21 Certain simple maintenance tasks may be carried out by the User (or by
an operator under the User’s supervision) and should be recorded in the
sterilizer process log. Examples of such tasks include the following:

a. steam sterilizers: daily, or more often if necessary, clean the strainer

fitted in the opening to the chamber discharge line;

b. all sterilizers: daily, wipe the door seal with a clean damp cloth and
inspect it for damage. This can normally be done by the operator if the
seal is completely exposed when the door is open;

c. all sterilizers: carry out any door safety checks required by the written
scheme of examination and which are within the technical competence
of the User. (Other door safety checks, normally weekly, will be carried
out by the Maintenance Person.)

Maintenance of laboratory sterilizers

4.22 Laboratory sterilizers differ from clinical sterilizers in that they may have
cycles expressly designed for the routine making-safe of discard material that is
or may be contaminated with pathogenic micro-organisms. Sterilizers without
a make-safe cycle may occasionally be used to process infected material if the
designated machine is out of service. The User should ensure that a
documented procedure is established for the decontamination of a sterilizer
before it is handed over to maintenance personnel. Such a procedure should
comply with the guidelines set out in HSG(93)26, ‘Decontamination of
equipment prior to inspection, service or repair.’

4.23 Since the contamination status of a sterilizer cannot be established by

inspection, all maintenance work should be conducted under a permit-to-work
system in which a certificate, signed by the User and the Laboratory Safety
Officer, is given to maintenance personnel to indicate that the sterilizer is safe.
Where it is not possible to guarantee that a sterilizer is free of contamination
(such as where a machine breaks down with a discard load in the chamber),
this should be made clear on the permit to work and detailed procedures for
safe working should be supplied. This latter option should only be resorted
to in exceptional cases and is not an acceptable alternative where
decontamination is practicable. A suggested format for the permit to work is
given in Figure 3.

34
 4.0 Maintenance

Figure 3 Suggested permit to work for laboratory sterilizers

PERMIT TO WORK
PERMIT-TO-WORK

This permit relates only to the hazards caused by the possible microbiological or chemical contamination of
the sterilizer. The sterilizer is not guaranteed safe against any other source of risk.

Location of sterilizer ___________________________________________________________________________

Manufacturer ______________________________________________ Serial no: _________________________

Model ____________________________________________________ Inv. no: __________________________

• I confirm that the above sterilizer has been decontaminated and cleaned as required to render it safe
for maintenance or repair (or)

• It is not possible to guarantee that the sterilizer is free of contamination. Guidance on safe working
practices is attached (delete as appropriate).

User: Name: _________________ Signature: _____________ Date __________ Time: __________

Safety Officer: Name: _________________ Signature: _____________ Date __________ Time: __________

RECEIPT (delete as appropriate)

• I accept responsibility for carrying out the work on the above sterilizer.

• I have received the guidance on safe working practices.

Name: _________________________ Signature: ________________ Date: ____________ Time: ___________

HAND-BACK (delete as appropriate)

• The work on the above sterilizer has been completed / suspended.

• The sterilizer may / may not be returned to service.

Name: _________________________ Signature: ________________ Date: ____________ Time: ___________

CANCELLATION

This permit-to-work is now cancelled.

User: Name: _________________ Signature: _____________ Date __________ Time: __________

35
4.0 Maintenance

4.24 Maintenance of laboratory sterilizers should conform with the guidance

given in BS2646: Part 4.

Features requiring special attention

4.25 The following sections provide background information to some of the

features requiring special attention in any PM programme.

Stainless steel chambers

4.26 Stainless steel, or mild steel clad with stainless steel, is used in the
manufacture of many sterilizer chambers. Over a wide variation in
specification, stainless steels, and to a much lesser extent stainless-clad mild
steel, are susceptible to cracking from crevice corrosion and stress corrosion
initiated by chemical attack. These phenomena occur when the material is
subjected to a combination of heat, stress and contact with chemicals, notably
chlorides or strong alkalis. The damage resulting from the combined effects
occurs at levels far below those which would be of significance if acting
separately. Heat and stress are present in all steam sterilizers.

4.27 Material in compression is less susceptible to crevice and stress corrosion

than material in stress. Some manufacturers use “shot blasting” (also known
as “shot peening”), to convert the tension stresses in the skin of the stainless
steel to compression stresses.

4.28 Chemical contact may occur in sterilizers under the following

circumstances:

a. in sterilizers processing certain fluids, such as saline solution, a spillage

will introduce chloride salts into the chamber;

b. if there is excessive carry-over of boiler water with the steam, this is

likely to include significant concentrations of both alkalis and chloride
salts;

c. in small electrically heated sterilizers, where steam is generated within

the chamber by an immersion heater, a build-up of alkalis and chloride
salts may occur if tap water is used to generate steam; this can result in
severe pitting corrosion leading to the perforation of the chamber.

4.29 Where cleaning with water is required, only water with a low chloride
level, such as distilled water or good quality condensate, should be used.

4.30 Vessels which have not been shot-blasted should be lightly polished by
hand. This should be done in accordance with the manufacturer’s instructions
and at quarterly intervals on sterilizers used to process fluids. Polishing should
only be done using iron-free materials. Household or domestic scouring and
polishing compounds should not be used since they often contain chlorine or
other corrosive agents which might cause, rather than prevent corrosion. After
polishing, the chamber should be thoroughly flushed out with water of low
chloride content.

4.31 During cleaning and polishing, precautions should be taken to prevent

damage to the door seal and the entry of foreign matter into the chamber
drain.

36
 4.0 Maintenance

Air-tightness of the chamber

4.32 Air-tightness of the chamber is of fundamental importance to the

correct functioning of sterilizers. The door seal is the major potential source of
leakage and should receive careful attention as advised by the manufacturer.
The working life of door seals varies widely and it is essential that all seals are
cleaned regularly. Door seals should be renewed with spares approved by the
manufacturer at recommended intervals, or when there is any evidence of
damage or deterioration.

4.33 Leaks may also occur in the following places:

a. joints in pipework;

b. connections to gauges;

c. blanked-off connections for test gauges;

d. entry points for temperature sensors (whether in use or blanked off);

e. glands and seats of valves;

f. bellows-operated door safety interlocks;

g. cracks in chamber welds or platework.

Door-locking mechanisms

4.34 There have been a number of incidents in which sterilizer door-locking

mechanisms have failed during operation.

4.35 Maintenance and inspection of door safety devices and door-locking

and chamber sealing systems must be carried out in accordance with the
manufacturer’s written instructions. Security and settings of door safety
switches and door-locking components must be checked weekly and the
settings must comply with those provided by the manufacturer.

4.36 Capstan-operated, hinged door-locking mechanisms should be

examined for excessive wear on the internal thread sections. Where these are
hard to see, thread profile gauges should be used. If there is evidence of
excessive wear, then the sterilizer should be removed from service until the
capstan wheel assembly can be replaced.

Air detector

4.37 Particular care should be taken when installing, removing or adjusting

any part of an air detector. It is preferable not to interfere with it except when
necessary. The sensitivity of the air detector should be adjusted in accordance
with the manufacturer’s instructions and the setting determined during
validation as detailed in Part 3 of this HTM.

4.38 Air detectors work by measuring either temperature or pressure. Certain

older temperature-operated air detectors may not fail safe if there is a leak
from the detector to the outside. It is crucial that air detectors are carefully
checked for air-tightness once a week. A leak too small to be detected by the
vacuum leak test given in Part 3 of this HTM could be large enough to permit
the expulsion by steam of any air present in the detector and cause it to
indicate falsely that all the air had been removed from the chamber.

4.39 If it has been necessary to adjust the air detector, the Test Person should
carry out recommissioning tests as described in Part 3 of this HTM.

37
4.0 Maintenance

Instruments

4.40 Instruments fitted to sterilizers should be maintained and calibrated in

accordance with the manufacturer’s instructions. Calibration should be verified
at the normal sterilization temperature and pressure and at stable ambient
temperatures. Any instrument found to read seriously in error or which is
inconsistent, i.e. will not repeat satisfactorily, should be discarded, or repaired
by the makers if practical and economical to do so. Instruments which do
repeat satisfactorily but read slightly in error should be checked for zero and
span and then adjusted to read correctly.

4.41 An instrument case should never be left open; broken glass should be
replaced promptly.

4.42 The recorder system is an essential monitor of the general functioning

and performance of a sterilizer. Temperature measuring systems are subject to
both inherent calibration errors and loss of calibration with use. As a
consequence temperatures read from a recorder should be regarded with
caution and interpreted from knowledge of the characteristics of the particular
recording system, the load and previous records.

4.43 Recording systems which are working correctly should not be interfered
with more than is absolutely necessary. Adjustments should be done strictly in
accordance with the manufacturer’s instructions.

4.44 Persons who change charts, print rolls and other consumables on
recording instruments should be trained, made fully aware of the delicate
nature of the instruments and authorised by the User.

Ancillary equipment

4.45 Ancillary equipment used in conjunction with the sterilizer should also be
subject to planned maintenance in accordance with manufacturers’
instructions.

4.46 Where the maintenance of ancillary equipment is not the responsibility of

the User, arrangements should be made to give the User reasonable notice of
all periods of maintenance (whether scheduled or not) and of impending
modifications to any part of the equipment. The User should also have access
to maintenance records.

4.47 Examples of ancillary equipment include:

a. all engineering services to the sterilizer, especially steam;

b. dedicated steam generators (see HTM 2031 for guidance);

c. room ventilation and local exhaust ventilation (see HTM 2025 and the
HSE document ‘The maintenance, examination and testing of local
exhaust ventilation’ (HS(G)54) for guidance); correct functioning is
essential to the safe operation of LTSF and EO sterilizers;

d. personal protective equipment;

e. equipment used to monitor, alarm or protect against exposure to

formaldehyde or ethylene oxide.

38
 4.0 Maintenance

Returning a sterilizer to service

4.48 The User, with the assistance of the Authorised Person, should prepare
an operational procedure for the return to service of a sterilizer after
maintenance or testing. The procedure should include safety checks and some
or all of.the recommissioning (yearly) tests specified in Part 3 of this HTM.

4.49 The Maintenance Person should certify that the work has been
completed and that the sterilizer is safe to use.

4.50 The User should ensure that a sterilizer is not used for production until
all required maintenance has been successfully completed.

39
5.0 Operation of porous load sterilizers

Introduction

5.1 This chapter gives guidance on the routine operation of clinical high-
temperature steam sterilizers designed to process wrapped goods and porous
loads.

5.2 The guidance given here assumes that the sterilizer is to be used to
process medical devices in compliance with the EU Directives discussed in
Chapter 1.

The process

5.3 Porous load sterilizers heat load items by direct contact with high-
temperature steam at a typical sterilization temperature of 134°C (see Table 5).

5.4 The operating cycle of a porous load sterilizer normally has five stages.

a. Air removal – Sufficient air is removed from the chamber and the load to
permit attainment of the sterilization conditions.

b. Steam admission – Steam is admitted to the chamber until the specified

sterilization temperature is attained throughout the chamber and load.

c. Holding time – The temperature throughout the chamber and load is

maintained within the sterilization temperature band for the appropriate
holding time.

d. Drying – Steam is removed from the chamber and the chamber pressure
is reduced to permit the evaporation of condensate from the load either
by prolonged evacuation or by the injection and extraction of hot air or
other gases.

e. Air admission – Air is admitted to the chamber until the chamber

pressure approaches atmospheric pressure.

5.5 The complete cycle time for a sterilization temperature of 134°C is

typically 35 minutes for a standard full load, but the drying stage may need to
be extended for up to a further 20 minutes for loads of high heat capacity,
such as trays of instruments, that take longer to dry.

Product compatibility

5.6 A porous load sterilizer is suitable for processing a very wide range of
goods and is the method of choice in most cases.

5.7 Items to be processed in a porous load sterilizer should have been

washed and dried by a validated cleaning process.

5.8 To reduce the possibility of superheating, load items consisting of textiles

should be allowed to air for a period of not less than fours hours after
laundering (see paragraph 5.50).

40
 5.0 Operation of porous load sterilizers

Items that should not be processed in a porous load sterilizer

5.9 The following items should not be processed in a porous load sterilizer:

a. items which would be damaged by exposure to moist heat at 121-

134°C;

b. items which would be damaged by rapid pressure changes (up to 10

bar min–1);

c. aqueous fluids (a fluid sterilizer is required);

d. non-aqueous fluids (a dry-heat sterilizer is required);

e. items in sealed containers (air will not be extracted).

Design of the load

5.10 Items processed in porous load sterilizers will either consist entirely of
porous materials (such as dressings) or else comprise wrapped goods, usually
of metal (such as surgical instruments).

5.11 The loading condition should be designed with two aims in mind:
a. to permit the rapid removal of air from the load items and the rapid
penetration of steam; and

b. to ensure that the condensate formed during the cycle does not result
in a wet load.

5.12 With some exceptions, porous load sterilizers may be loaded randomly.
It is not necessary to ensure that the loading condition is replicated in detail
for each cycle.

Air removal

5.13 The presence of air in the load can impede the penetration of steam
and thereby drastically reduce the effectiveness of the sterilization process.
Steam will not easily displace air contained in porous materials, such as a
paper bag containing an instrument. Any air remaining in the packages before
the start of the holding time will occur in random locations and in different
volumes. During the holding time it may unpredictably delay or prevent
saturated steam from contacting the surfaces over which this air is present.
Levels of air will depend on the theoretical dilution rate, the method used for
air removal and the air leakage into the chamber.

5.14 Porous load sterilizers have an active air removal system in which air is
replaced with steam by a series of vacuum and pressure changes. Provided it
is validated according to the schedule set out in Part 3 of this HTM, a sterilizer
complying with EN 285 will be capable of removing sufficient air from
packages randomly placed in the chamber and which contain porous material
not exceeding the density of the standard test pack.

5.15 Where the density of porous material exceeds that of the standard test
pack, or the load consists of components into which steam penetration is not
instantaneous, e.g. filters and flasks with small orifices, a thermometric
performance qualification test is required (see Part 3 of this HTM).

41
5.0 Operation of porous load sterilizers

5.16 As well as air retained in the load, steam penetration may be inhibited if
non-condensable gases are liberated from the load as it is heated. This may
happen with certain packaging materials, inks, adhesives, labels, etc. Packaging
materials should conform to one of standards listed in paragraph 5.27. As a
precaution, new non-metallic boxes or trays should be processed in a non-
production cycle before being used with production loads.

Handling of condensate

5.17 As in all steam sterilizers, the energy which heats the load is derived
almost entirely from the latent heat given up as the steam condenses on the
load items. (It is not a simple conduction of heat from hot steam to the cool
load.) The more latent heat is given up, the more condensate will be formed.
This condensate (hot water) is an essential and unavoidable consequence of
steam sterilization.

5.18 The amount of condensate formed will depend on the latent heat
required to raise the load to the sterilization temperature. This depends on the
heat capacity of the load, which in turn depends on the mass and specific heat
capacity of each item. Loads containing metal items have a higher heat
capacity than a load of purely porous materials and therefore will produce
more condensate. Essentially all of the condensate will be formed before the
start of the holding time.

5.19 The process is substantially reversible, however, and by subjecting the

chamber to a vacuum during the drying stage, the lowered boiling point of
water associated with the reduced pressure enables the heat energy stored in
the load item to re-evaporate the condensate and as a consequence the item is
both cooled and dried. The re-evaporation process will not occur if the
condensate becomes separated from the load items.

5.20 In order to ensure that porous loads are dry at the end of the cycle, it is
therefore necessary either to drain the condensate completely clear of the
load, or to retain it close to the hot load items where it can be evaporated.
With wrapped loads, the latter solution is preferred. No special measures are
needed for purely porous loads, but metal items are likely to produce sufficient
condensate to saturate their wrapping. The condensate may then spread to
other parts of the load from which it may not be evaporated. This migration of
condensate may be avoided by including absorbent padding (in addition to the
wrapping) suitably positioned inside each pack.

5.21 The optimum amount and arrangement of this extra padding can only be
determined by experiment. As a rule, metal items should be well spaced and
separated by padding. With preset instrument trays, for example, the
instruments should be spaced out across the tray. Unusually heavy items, such
as orthopaedic hammers, should be placed away from other instruments and
well padded. Loads containing large amounts of metal may require
performance qualification tests.

5.22 Holloware, such as bowls and tubes, should be arranged in such a way
that condensate will not collect inside them. It may not be practical to ensure
that wrapped holloware is always processed inverted and in this case the
drainage problem may be overcome by placing absorbent materials inside the
holloware.

5.23 Drip deflectors between tiers of instrument trays will ensure that
condensate does not drain from one tray to another.

42
 5.0 Operation of porous load sterilizers

5.24 If a mixed load of porous and wrapped metal items is to be processed,

the porous items should be placed above the metal items to ensure that
condensate does not drip on to them.

Packaging materials

5.25 Items to be sterilized should use packaging materials which are

permeable to air and steam but have an effective maximum pore size which is
small enough to exclude microbial contamination under the specified storage
and transport conditions.

5.26 Goods are normally double-wrapped; at least one of the layers will
usually be a sheet of paper, a paper bag or a plastic pouch. The inner lining
may be chosen primarily for its absorbency in order to retain condensate as
described above.

5.27 Load items should be wrapped in materials complying with one of the
following parts of EN 868: Packaging materials for sterilization of wrapped
goods:

a. Part 1: General requirements and requirements for the validation of

packaging of terminally-sterilized devices;.

b. Part 2: Sterilization wrap – requirements and tests;

c. Part 3: Paper for use in the manufacture of paper bags and in the
manufacture of pouches and reels;

d. Part 4: Paper bags – requirements and tests;

e. Part 5: Heat-sealable pouches and reel material of paper and plastic

film construction – requirements and tests;

f. Part 8: Reusable sterilization containers – requirements and tests.

5.28 Extensive guidance on packaging materials and methods is given in Part

5 of this HTM.

Performance qualification

5.29 PQ tests are not normally required for the majority of loading conditions
processed in a porous load sterilizer since they are less of a challenge to the
cycle than the full-load and small-load tests carried out during validation.

5.30 PQ tests are required where:

a. the density of any porous load item exceeds the density of the standard
test pack (see Part 3 of this HTM);

b. the mass of any single metal item exceeds 1 kg;

c. the construction of any load item is such that sufficient air may not be
removed to ensure the rapid penetration of steam;

d. any cycle variable has been modified from the setting used in
validation.

5.31 Two categories of product require special consideration:

43
5.0 Operation of porous load sterilizers

a. minimally invasive surgical instruments (such as laparoscopic biopsy

forceps) which present particular problems of air removal and steam
penetration;

b. barrier fabrics (such as Gore-tex) which have such low porosity to both
air and steam that normal air removal stages may be inadequate.

Selection of cycle variables

5.32 The preferred sterilization temperature is 134°C. However, any of the

lower sterilization temperature bands in Table 5 may be used where load items
would be damaged at 134°C.

Table 5 Sterilization conditions for porous load sterilizers

Sterilization Maximum Minimum holding

temperature allowable time
temperature
[°C] [°C] [min]

134 137 3

126 129 10

121 124 15

See paragraphs 2.52-2.53 for comment on maximum allowable temperatures.

Cycle monitoring and documentation

5.33 Users are reminded that a Bowie-Dick test should be carried out at the
start of each day as described in Part 3 of this HTM. Production should not
begin until the test has been shown to be satisfactory. Some departments may
also require a daily vacuum leak test.

5.34 Documentation as listed in paragraph 2.57 should be recorded. Each

cycle should be noted in the sterilizer process log (see paragraph 3.11).

5.35 A batch process record should be generated for each production cycle.
The batch process record will contain the following:

a. the temperature (chamber temperature) recorded by a sensor in the

active chamber discharge;

b. the pressure (chamber pressure) recorded by a sensor in the chamber.

5.36 It is not necessary to monitor the temperature inside the load.

5.37 In addition to the above information, any cycle aborted due to a fault
sensed by the air detector should be noted along with the remedial action
taken.

44
 5.0 Operation of porous load sterilizers

Product release

5.38 The load may be released for use provided that:

a. during the whole of the cycle the values of the cycle variables as shown
on the batch process record are within the permitted tolerances marked
on the master process record established during performance
qualification;

b. the packaging is undamaged;

c. the load items are visibly dry.

Troubleshooting

Air detector fault

5.39 The air detector is designed to register a fault when the level of air and
gas sampled from the chamber is high enough to affect the even and rapid
penetration of steam into the load. Possible causes of an air detector fault
include:
a. an inefficient air removal stage;

b. an air leak during the air removal stage;

c. non-condensable gases evolved from the packaging;

d. non-condensable gases in the steam supply;

e. a defective air detector.

5.40 When a cycle has been aborted due to an air detector fault the sterilizer
should be taken out of service. If there is no obvious cause for suspicion, such
as a change in the loading condition, the sterilizer should be subjected to the
weekly tests as described in Part 3 of this HTM. These will include an air
detector function test.

Wet loads

5.41 Any item with wet outer packaging should be rejected since the
moisture compromises the protective qualities of the wrapping.

5.42 Wet spots or patches on the packaging show that liquid water has been
drawn into the chamber. There are several possible explanations, including:

a. poorly draining steam traps between the sterilizer and boiler (a sudden
demand for steam can draw water out of a full trap);

b. severe pressure fluctuations in the main;

c. priming of the boiler leading to carry-over of water in the steam.

5.43 Occasionally, load items with dry outer packaging may be found to be
wet inside. While the sterility of the product may be satisfactory, there
remains the possibility that the load was wet throughout at some stage and
therefore sterility cannot be assured. Since they are invariably discovered by
the end-user at the point of need, such wet items do not promote confidence
in the sterile supply service.

45
5.0 Operation of porous load sterilizers

5.44 Packages that are damp inside are often the result of inadequate
packaging and loading (see paragraphs 5.17–5.24), especially when metal
objects have been processed. If the precautions outlined above have been
followed, however, the cause may be a wet steam supply. This can be
confirmed by the steam dryness test described in Part 3 of this HTM. Users
should note that this test will not reliably detect wetness due to sporadic carry-
over of water.

5.45 Part 2 of this HTM describes the engineering requirements for a steam
supply of the correct dryness for sterilization. The sudden appearance of wet
loads from a loading condition and operating cycle that have been used
successfully for a long time may indicate a change in the steam service. For
example, there may be a fault somewhere in the system or there may have
been engineering modifications to the steam service; new or modified boilers,
extensions to the steam main and new equipment installed elsewhere may all
affect the dryness of the steam supplied to the sterilizer.

5.46 Another possibility is that operating practice in the boiler room may have
changed. For example, it is common in hospitals to shut down all but one
boiler for the summer months. When demand increases again in the autumn,
the boiler may start to prime (carry over water) before the other boilers are
returned to service.

Superheating

5.47 Superheating, arising from steam that is too dry, can cause a failure to
sterilize. It is uncommon and can be difficult to identify. A failed process
indicator is one sign; charring of wrapping materials is another.

5.48 One possible cause of superheating is an excessive reduction in pressure

through a throttling device, such as a pressure reducing system or a partially
closed main steam valve. In this case superheating arises from adiabatic
expansion. Engineering solutions to this problem are described in Part 2 of this
HTM.

5.49 Superheat can also arise if the steam is admitted into the chamber with
excessive velocity. This problem is usually detected and overcome during
commissioning, by fitting a throttling device in or over the steam inlet port
with some modifications to the baffle plate assembly.

5.50 Another possibility is superheating from exothermic reaction. This may

occur during sterilization as a result of rehydration of exceptionally dry
hygroscopic material. In these circumstances the superheating may persist for
the entire holding time with consequential risk of a failure to sterilize. This
phenomenon is usually associated with certain textiles, particularly those
incorporating cellulosic materials (such as cotton), which have become
excessively dry before sterilization. It may occur during periods of very cold, dry
weather especially where the materials to be sterilized are kept in rooms which
are heated and mechanically ventilated without humidification.

Spontaneous combustion

5.51 There have been reports of textile loads bursting into flame within the
sterilizer chamber. Invariably this is because the load has been allowed to
become excessively dry and hot. There are two circumstances in which this
may occur:

46
 5.0 Operation of porous load sterilizers

a. the load is placed in a heated chamber and left for a considerable time
before the cycle is started; ignition is believed to occur when the load
becomes rehydrated on the introduction of steam to the chamber;

b. the load is left inside the chamber for a long time after the end of the
operating cycle; ignition occurs when the door is opened and the load
exposed to air. This is most likely to happen where the operating cycle
has aborted due to a fault condition and the load is not removed
promptly.

5.52 Users should be mindful of this risk and establish operating procedures
to ensure that loads are not left in heated chambers for longer than
necessary.

47
6.0 Operation of fluid sterilizers

Introduction

6.1 This chapter gives guidance on the routine operation of clinical high-
temperature steam sterilizers designed to process aqueous fluids in sealed
containers.

6.2 The guidance given here assumes that the sterilizer is to be used to
process medicinal products in compliance with the EU Directives discussed in
Chapter 1. Users should be aware, however, that products in which medicinal
products are contained within a delivery system, such as certain irrigations and
ophthalmic preparations, may be classified as medical devices as well as
medicinal products.

The process

6.3 Fluid sterilizers heat load items by direct contact with high-temperature
steam at a typical sterilization temperature of 121°C. Although steam does not
penetrate to the product inside the sealed containers, sterilization is effected
by the water molecules in the product itself. That is why these sterilizers
cannot be used to process non-aqueous fluids.

6.4 A fluid sterilizer will normally have the following operating cycle.

a. Heat-up. Steam is admitted to the chamber, heating the load.

b. The plateau period starts when the chamber temperature, recorded by a

sensor located in the active chamber discharge, reaches the sterilization
temperature, which is typically 121°C (see Table 6).
(i) In the first part of this period, the equilibration time, all parts of
the load attain the sterilization temperature. This time depends on
the nature and amount of the product, and the material, size and
shape of the container.
(ii) The moment when the temperature in all parts of the load finally
attains the sterilization temperature marks the end of the
equilibration time and the start of the holding time.

c. Cooling. The load is cooled, either by spraying with sterile water (usually
chamber condensate) or the circulation of cooled air, until the
temperature in the hottest part of the load has fallen below 80°C.

6.5 Heat transfer to the contents is predominantly by conduction through

the walls of the containers and by internal convection. A small radiant heat
transfer component is also present. During the heat-up phase of the operating
cycle, the outside temperature of the load containers quickly approaches that
of the chamber space, with a corresponding increase in the temperature of
condensate in the active chamber discharge.

48
 6.0 Operation of fluid sterilizers

Safety precautions

6.6 The main hazard with fluid sterilizers is the high pressure attained inside
glass bottles at the sterilization temperature. This pressure may cause weak or
damaged containers to burst during sterilization and such explosions may
damage other containers in the load.

6.7 A hazard to the operator may result if bottles are removed from the
sterilizer before they have cooled to a safe temperature. At a sterilization
temperature of 121°C the absolute pressure inside a bottle having a nominal
fill of fluid is in the region of 3.6 bar (see Figure 4). If the door were to be
opened at this temperature, and the load subject to cold draughts or
unintentional impact, the stresses arising in the glass would be sufficient to
crack the bottle and cause an explosive breakage. Fluid sterilizers are fitted
with a thermal door-lock to ensure that when glass bottles are being
processed the door cannot be opened until the temperature inside all the
containers has fallen below a safe maximum of 80°C. (Even at this
temperature the pressure inside a bottle is approximately 1.8 bar.) Failure to
observe this requirement has led to serious accidents resulting from the
explosion of glass bottles.

6.8 Operators should be aware that some bottles may break before the end
of the cycle and broken glass may need to be removed before the next cycle
can begin.

6.9 Operating cycles for plastic containers have the following modifications:

a. pressure ballasting with air is used to prevent pressure differences

arising between the inside and the outside of containers sufficient to
burst or distort them;

b. the door may be opened when the temperature inside the containers
falls below 90°C. This prevents “blooming” of the containers. On no
account should these cycles be used with glass containers unless the
thermal door lock has been reset to 80°C.

Product compatibility

6.10 Fluid sterilizers may be used to process a wide range of medicinal

products in the form of aqueous solutions in sealed containers of either glass
or plastic .

Items that should not be processed in a fluid sterilizer

6.11 The following items should not be processed in a fluid sterilizer:

a. fluids in unsealed bottles (the product may be modified by the

evaporation of water and the entry of steam and condensate, and will
not remain sterile after removal from the chamber);
b. non-aqueous fluids (they will not be sterilized);

c. contaminated fluids intended for discard (discard material should not

be processed in clinical sterilizers).

49
6.0 Operation of fluid sterilizers

Design of the load

6.12 Items processed in fluid sterilizers will normally consist of large numbers
of identical containers such as bottles, bags, ampoules or vials. While the
containers are usually made of glass, plastic containers may also be processed.
All containers should be sealed to prevent the escape of the contents and the
entry of steam or condensate.

6.13 The loading condition should be designed with the aim of permitting the
free circulation of steam and coolant over the surfaces of the containers.

Bottles

6.14 Bottles in a load should preferably all be of the same size. Where mixed
sizes are unavoidable, the PQ tests should ensure that the largest bottles are
monitored to ensure that they attain the required sterilization conditions.

6.15 It is important that steam is allowed to pass freely around the surfaces of
bottles. They should be placed in crates or on trays designed to locate each
bottle so that it cannot touch its neighbours. Chamber furniture should also
allow the free passage of steam and condensate.

6.16 Plastic bottles, particularly those made of polymers which undergo a

reduction in tensile strength at the temperatures used for steam sterilization,
are often only suitable for use in sterilizers which include air or gas ballasting
to increase the pressure throughout the cycle and thus restrain the bottle from
bursting.

Plastic bags

6.17 Plastic bags should not be stacked on top of each other. Steam should
be allowed to circulate freely around them. Bags may be hung from racks
within the chamber or placed on shallow shelves.

Vials and ampoules

6.18 Loads consisting of small containers, such as vials and ampoules, have a
large surface-area-to-volume ratio and therefore will cause steam to condense
rapidly during the heat-up stage. Where steam is admitted to the chamber
through a single inlet, it will first condense on the ampoules nearest to the
inlet and these will consequently heat up faster than those further from the
inlet. This will produce a large difference in temperature across the chamber
and an extended equilibration time. This is acceptable provided that the
product can withstand the extended heating experienced by the ampoules
near the steam inlet and the ampoules slowest to heat up are correctly
identified for the thermometric PQ test.

6.19 Where the product cannot withstand this extended heating, the size of
the load should be reduced so that it can be placed further from the steam
inlet. A sterilizer with multiple inlets is the preferred solution.

Closure systems

6.20 Containers should have gas-tight seals to prevent evaporation of water

from the contents and the entry of steam or condensate. Glass bottles for
sterile fluids are commonly sealed with compound closures comprising an

50
 6.0 Operation of fluid sterilizers

elastomeric disc or plug which is secured to the neck of the bottle by means
of an aluminium screw cap, an aluminium crimped-on (or turned-on) cap, a
cap made of plastic material or a retaining closure embodying both plastic and
aluminium parts.

6.21 It is essential that the elastomer is held in tight contact with the neck of
the bottle in order to prevent the entry of micro-organisms or other materials
which might contaminate the product. It is a characteristic of such containers
that when they are charged with the specified volume of the product there
remains a substantial air space (sometimes referred to as ullage) above the
liquid. The proportion of the total internal volume of a bottle filled with liquid
may vary with the design of the bottle but is commonly 80-90 percent, so the
ullage may be about 10-20 percent of the internal volume. Such a space is
necessary for thermal expansion of the liquid during sterilization.

6.22 When a sealed bottle is sterilized, the pressure inside exceeds that in the
sterilizer chamber by a substantial margin. The pressure within the bottle is
due to the partial pressures of the air and steam at the sterilization
temperature plus an additional factor due to the compression of the air and
steam mixture in the ullage by thermal expansion of the liquid in the bottle.
Thus at any single temperature the pressure within a bottle under sterilizing
conditions will be determined largely by the proportion of the total internal
volume filled with liquid since, as this increases, the effect of thermal
expansion on the air and steam mixture also increases. Figure 4 shows the
internal absolute pressure in a rigid container of water at 121°C as a function
of filling factor. This diagram is equally applicable to all sizes of container.

6.23 This high internal pressure imposes a stress on the closures which may
be distorted or even ruptured as a result. Distortion of closures, especially of
aluminium parts, may allow the elastomeric seal to lift or loosen in the bottle
neck and allow the escape of some air from the ullage. Should this occur, the
bottle on cooling tends to develop a partial internal vacuum. This itself is no
danger to the product but may allow the entry into the bottle of spray cooling
fluid which will dilute the product and may carry in chemical or microbial
contamination. An attempt is made to reduce the risk of product
contamination by using retained condensate in the sterilizer (or in some cases
filtered gas) as the cooling agent. But since the failure of the seal may not be
apparent by visual inspection, an acceptable product requires that the closure
of the bottle remains an effective seal throughout the sterilization process.

6.24 Since the above problems arise as a result of the inevitable excess
pressure generated within bottles, the security of bottle closures is the
responsibility of the User. Thus the User is required to ensure that the closures
and containers are suitably designed to withstand the proposed sterilizing
conditions. This is best achieved by ensuring that containers and closures
comply with a recognised standard. Where containers are reused, the User
has to institute a rigid system of inspection after washing to ensure that all
bottles with signs of damage, especially of the neck area, are discarded. It is
imperative that a bottle is not charged with a volume of fluid greater than the
stated nominal volume of the bottle.

51
6.0 Operation of fluid sterilizers

Figure 4 Internal pressure against filling factor for aqueous fluids at 121°C

7.0
Internal absolute pressure [bar]
Internal absolute pressure (bar)

6.0

5.0

4.0

3.0
0.80 0.85 0.90 0.95 1.00
Filling factor

Note: Pressures are calculated assuming that the product is pure water bottled
at 15°C.

6.25 Users are recommended to establish a quality system to ensure that the
probability of failure of a closure is low enough that the sterility of the product
is not jeopardised. This will generally require the User to identify the
parameters of the container and closure system which could lead to a failure
and to set limits of acceptance which have been validated to demonstrate
closure integrity. Production cycles may require the introduction of a dye into
the chamber to identify failed closures. Electronic monitoring systems are also
available. Within the NHS it may not be practicable to determine the
probability of failure statistically, and in such cases sufficient assurance of
sterility may be achieved by ensuring that the steam supplied to the sterilizer,
and any coolant water in contact with the load, complies with the “clean
steam” purity specification described in HTM 2031. See also Part 2 of this HTM
for a discussion on the fail-safe design of heat exchangers.

Performance qualification

6.26 PQ tests are not required for loading conditions presenting less of a
challenge to the cycle than the full-load and small-load tests carried out during
commissioning. Decisions on which loading conditions require PQ tests should
be made by the User, in consultation with the Quality Controller and Test
Person.

6.27 PQ tests are required where:

a. the nominal capacity of any container exceeds 1 litre;

b. the product cannot withstand the equilibration time associated with the
commissioning tests (see Part 3 of this HTM);

52
 6.0 Operation of fluid sterilizers

c. any cycle variable has been modified from the setting used in
validation.

6.28 Users should consider the economic benefits of conducting PQ tests

even for stable products, since the heating and cooling times will be generally
shorter than that required for the commissioning tests

Selection of cycle variables

6.29 The sterilizer should be preset to operate in the standard sterilization

temperature band shown in Table 6. Other combinations of sterilization
temperature and holding time may be used provided that they have been
satisfactorily demonstrated to deliver an adequate level of lethality when
operated routinely within established tolerances.

Table 6 Sterilization conditions for fluid sterilizers

Sterilization Maximum Minimum holding

temperature allowable time
temperature
[°C] [°C] [min]

121 124 15

6.30 The automatic controller should be preset to a plateau period,

established during performance qualification, sufficient to include both the
minimum holding time and the equilibration time.

Cycle monitoring and documentation

6.31 Documentation as listed in paragraph 2.57 should be recorded. Each

cycle should be noted in the sterilizer process log (see paragraph 3.11).

6.32 Where the temperature of the load is to be monitored, the load

temperature probe should be inserted into a load item known to be the
slowest to attain the sterilization temperature. Where two probes are provided
(normally in sterilizers over 600 litres) the second probe should be inserted
into the load item known to be the fastest to attain the sterilization
temperature. The probe should be located along the geometric axis of the
container and inserted to a depth of 85% of the container height.

6.33 A batch process record should be generated for each production cycle.
The batch process record will contain the following:

a. the temperature (“chamber temperature”) recorded by a sensor in the

active chamber discharge;

b. the pressure (“chamber pressure”) recorded by a sensor in the

chamber;

c. the temperature (“load temperature”) recorded by the load

temperature probe.

53
6.0 Operation of fluid sterilizers

6.34 In certain applications the operating cycle may be controlled by

measuring the lethality (F0) delivered to the load as the cycle progresses. An
extensive discussion on the applications of the F0 principle may be found in
Part 5 of this HTM.

Product release

6.35 Documented procedures for release of medicinal products should be

established by the Quality Controller.

6.36 The load may be released for use provided that:

a. during the whole of the cycle the values of the cycle variables as shown
on the batch process record are within the permitted tolerances marked
on the master process record established during performance
qualification;

b. not more than one container (or 1%, whichever is the greater) has burst
or broken.

6.37 If the batch process record is unacceptable the load should be rejected.
A decision on reprocessing should be based upon a validated procedure which
takes account of the chemical and physical stability of the product.

6.38 The load should be examined for damaged containers. The occasional
broken bottle or bag may be acceptable provided intact containers have not
also been damaged.

6.39 Blooming of plastic containers is a surface effect which normally clears

and does not harm the container or the contents. The User and Quality
Controller should decide whether blooming is acceptable.

54
7.0 Operation of sterilizers for
unwrapped instruments and
utensils

Introduction

7.1 This chapter gives guidance on the routine operation of clinical sterilizers
designed to process unwrapped solid instruments and utensils by exposure to
high-temperature steam.

7.2 The guidance given here assumes that the sterilizer is to be used to
process medical devices However, these sterilizers do not meet the essential
requirements of the EU Directives discussed in Chapter 1, which do not permit
the supply of unpackaged sterile medical devices.

The process

7.3 This type of sterilizer is used to process unwrapped surgical instruments

and utensils intended for immediate use in a controlled medical environment.
Heating is by the direct contact of the product with saturated steam.

7.4 Air is normally removed from the sterilizer by passive displacement,

either downward or upward depending on whether steam is supplied
externally or generated internally. Active air removal systems of the type
found in a porous load sterilizer are rare.

7.5 A few models have a drying stage in which the load is dried by passing
filtered air through the chamber, but it is more usual for the load to be
partially dried by evaporation after it has been removed from the machine.

7.6 A sterilizer conforming to BS3970 will have the following operating

cycle:

a. Heating. The water is heated and steam generated in order to vent the
air from the chamber until the sterilization temperature is attained.

b. The plateau period starts when the chamber temperature, recorded by

a sensor located in the active chamber discharge, reaches the
sterilization temperature.
(i) In the first part of this period, the equilibration time, all parts of
the load attain the sterilization temperature.
(ii) The moment when the temperature in all parts of the load finally
attains the sterilization temperature marks the end of the
equilibration time and the start of the holding time.

c. Cooling. The load is allowed to cool naturally in the chamber.

Water supply

7.7 In transportable sterilizers steam is generated by the heating of

feedwater within the chamber. The recommendations contained in HTM 2031
should be followed.

55
7.0 Operation of sterilizers for unwrapped instruments and utensils

7.8 Users should note that the recommendation for feedwater is designed to
facilitate effective sterilization and avoid damage to the machine. Where the
steam quality in the chamber is required to meet the specification for pyrogen-
free “clean steam” (set out in HTM 2031), only water complying with
Sterilized Water for Injections BP is acceptable.

7.9 A sufficient supply of suitable water should be kept at hand. Operating

procedures should ensure that the water level in the sterilizer is checked before
every cycle and the reservoir replenished at specified intervals. This is
particularly critical for clean steam (see HTM 2031).

Safety precautions

7.10 As there is no thermal door-lock on the sterilizer, the load may still be
very hot (up to 100°C) when it is removed from the chamber. Operators
should therefore be issued with heat-resistant gloves.

7.11 Care should be taken not to contaminate load items with the gloves
when removing the load from the chamber.

Product compatibility

7.12 These sterilizers are designed to process unwrapped instruments and

utensils for immediate use in a controlled medical environment, such as an
operating theatre. They should not be used to process items that are wrapped
or items intended to be stored or transported before use.

7.13 Because these sterilizers have no active means of extracting air from load
items, they should not be used with instruments and utensils whose
construction could impede the passive removal of air and the subsequent
penetration of steam. In practice, this means that hollow or porous items
should not be processed in this type of sterilizer. A sterilizer with an active air
removal system, such as a porous load sterilizer, is required in such cases. Draft
European standards in preparation at the time of writing (1996) regard an item
as hollow, and therefore unsuitable, if the item possesses a cavity of depth
greater than the width of its orifice, or a double-ended hole of length greater
than twice its width. This is a conservative criterion, and many borderline items
may be safely processed if they are placed correctly in the chamber (see 7.17).
However, the risk of incomplete sterilization is a real one, and Users should
carefully examine each type of item to be processed to ensure that air removal
and steam penetration will be effective. Failure to observe this requirement has
led to serious incidents in which patients have become infected by unsterile
surgical instruments. The Authorised Person should be consulted in cases of
doubt.

56
 7.0 Operation of sterilizers for unwrapped instruments and utensils

Items that should not be processed

7.14 The following items should not be processed in a sterilizer for

unwrapped instruments and utensils:

a. medical devices intended to be supplied in compliance with the EU

Directives discussed in Chapter 1 (unpackaged devices are not
acceptable);

b. medicinal products;

c. wrapped items and other items likely to trap air and impede the
penetration of steam (see paragraph 7.13);

d. aqueous fluids (a fluid sterilizer is required);

e. items not for immediate use.

Design of the load

7.15 Load items should be arranged on shelves or trays that permit the free
circulation of steam and draining of condensate. Items should not be allowed
to rest on the bottom of the chamber.

7.16 Trays or baskets should be constructed of open mesh or with sufficient

ventilation holes to ensure that they present no barrier to air removal and
steam penetration. BS3970: Part 4 specifies that any such load containers
used in these sterilizers should be perforated such that the total area of the
perforations is at least 10% of the surface area of the container. The
perforations should be uniformly distributed and each of area 20 mm2 or
more. Draft European standards make the same requirement.

7.17 As far as possible, load items should be arranged to ease the removal of
air and the penetration of steam and allow condensate to run directly to the
drain, away from the individual objects. Items of the load which could retain
air and condensate, such as bowls, should be places on their sides so that air
will be displaced and condensate will drain out.

Selection of cycle variables

7.18 Sterilizers conforming to the standards discussed in Part 2 of this HTM

will have a single operating cycle, normally with a sterilization temperature of
134°C and a holding time of at least 3 min. If other cycles are provided (see
Table 7), the highest sterilization temperature compatible with the load should
be chosen.

7.19 It is recognised that Users of transportable sterilizers in primary health

care units, such as GP and dental practices, where close supervision of the
sterilizer is not practicable may wish to operate their machines with a wider
margin of safety than would be the case in a hospital SSD staffed by full-time
specialist personnel. In such cases the machine’s plateau period may be preset
to the extended plateau period given in Table 7.

57
7.0 Operation of sterilizers for unwrapped instruments and utensils

Table 7 Sterilization conditions for sterilizers for unwrapped instruments

and utensils

Sterilization Maximum Minimum holding Extended plateau

temperature allowable time period (b)
temperature
[°C] [°C] (a) [min] [min]

134 137 3 4

126 129 10 15

121 124 15 20

115 (c) 118 30 —

a. See paragraphs 2.52-2.53 for comment on maximum allowable temperatures.

b. See paragraph 7.19.

c. Permitted by BS3970: Part 4 but not recommended for NHS use.

7.20 Users should note that the “plateau period” here is regarded as
beginning when the chamber temperature attains its preset value as signalled
by the indicator light. The conventional plateau period (see paragraph 2.48),
which starts when the chamber temperature attains the sterilization
temperature, cannot normally be defined on these small sterilizers which have
no means of detecting when that temperature has been reached.

7.21 The need for regular testing, as specified in Part 3 of this HTM, is re-
emphasised.

Cycle monitoring and documentation

7.22 Each cycle should be noted in the sterilizer process log (see paragraph
3.11).

7.23 Where a recorder is fitted to the sterilizer (as recommended in Part 2 of

this HTM), a batch process record should be generated for each production
cycle. The batch process record will contain the following:

a. the temperature (“chamber temperature”) recorded by a sensor in the

coolest part of the chamber (normally the active chamber discharge);

b. the pressure (“chamber pressure”) recorded by a sensor in the chamber.

7.24 Where a recorder is not fitted, the following records should be made:

a. once a day, note the duration of the plateau period, and the indicated
chamber temperatures and pressures at the beginning, middle and end
of the plateau period, for a selected production cycle;

b. where practicable, note the indicated chamber temperature and pressure

at the approximate mid-point of the plateau period for each production
cycle.

58
 7.0 Operation of sterilizers for unwrapped instruments and utensils

Product release

7.25 The load may be released for use provided that:

a. either, during the whole of the cycle the values of the cycle variables as
shown on the batch process record are within the permitted tolerances
marked on the master process record established during performance
qualification;

b. or, during the plateau period:

(i) the values of the plateau period and the indicated chamber
temperature and pressures as described in paragraph 7.24a are
within the permitted tolerances established during performance
qualification;
(ii) the values of the indicated chamber temperature and pressures as
described in paragraph 7.24b are also within the permitted
tolerances established during performance qualification.

7.26 As load items are not wrapped, they are exposed to the air at the end
of the cycle and subject to rapid recontamination. They should therefore be
used without delay.

59
8.0 Operation of dry-heat sterilizers

Introduction

8.1 This chapter gives guidance on the routine operation of clinical sterilizers
designed to sterilize load items by exposure to hot, dry air. Such sterilizers are
correctly known as “dry-heat sterilizers” and sometimes as “hot-air sterilizers”
or “sterilizing ovens”.

8.2 The guidance given here assumes that the sterilizer is to be used to
process either medicinal products or medical devices in compliance with the EU
Directives discussed in Chapter 1.

The process

8.3 Dry heat sterilizers expose the load to hot, dry gas (normally hot air) at a
temperature of 160 ºC or greater (see Table 8). The load is heated by
conduction from the hot air to the load items. The process is slow and cycle
times are several hours.

8.4 A dry-heat sterilizer will typically have the following operating cycle.

a. Heating-up. Hot air is heated electrically and circulated through the

chamber.

b. The plateau period starts when the chamber temperature, recorded by a

sensor located in the part of the chamber known to be the slowest to
heat up, reaches the sterilization temperature.
(i) In the first part of this period, the equilibration time, all parts of
the load attain the sterilization temperature.
(ii) The moment when the temperature in all parts of the load finally
attains the sterilization temperature marks the end of the
equilibration time and the start of the holding time.

c. Cooling. The load is cooled by circulating cold, filtered air through the
chamber or through a jacket.

Safety precautions

8.5 The main hazard associated with dry-heat sterilizers is the high
temperatures at which they operate. The highest sterilization temperature
permits the temperature of the load to rise to 190 ºC (see Table 8). In the
event of a control failure, the chamber temperature may rise to 200 ºC before
the thermal cut-out shuts off the heaters.

8.6 In normal operation, a thermal door-lock prevents the door being

opened until the temperature in all parts of the load has fallen to 80 ºC.
Nonetheless, operators should take great care in both unloading hot load
items from the chamber and reloading a chamber that remains hot from a
previous cycle.

60
 8.0 Operation of dry-heat sterilizers

Product compatibility

8.7 Dry heat may be used to process a variety of items and materials which
would either be damaged by exposure to high-temperature steam or LTSF or
would not be sterilized.

8.8 Suitable items include solids, heat-stable powders, waxes, greases,

ointments, non-stainless metals, hollow needles, glass syringes and items in
sealed containers. Dry heat may also be used for non-aqueous fluids such as
white soft paraffin, paraffin gauze dressings, eye ointment bases, oily
injections, silicone lubricant and pure glycerol.

Items that should not be processed by dry heat

8.9 The following items should not be processed by dry heat:

a. items that would be damaged by exposure to hot air at 160°C, such as

glycerol/water mixtures, rubber, certain plastic or electrical items;

b. aqueous fluids (a fluid sterilizer is required).

8.10 As cycle times can be several hours, items must be able to withstand not
only the holding time, but also the relatively slow heating and cooling stages.

Design of the load

8.11 The loading condition should be designed with two aims in mind:

a. to permit air to circulate freely within the chamber and around each
item of the load;

b. to allow heat to be transmitted to and within each item of the load.

8.12 The time required for an individual load item to attain the sterilization
temperature will depend upon its size, shape and thermal conductivity, and
can vary widely. Powders and oils, in particular, take a long time to heat up.
Loads should therefore be designed to contain items of similar size and
nature.

8.13 If a mixed load cannot be avoided, then great care must be taken
during performance qualification to identify the load items that are the
slowest to heat up. The duration of the plateau period should be selected to
ensure that these items are exposed to the sterilization temperature for the
correct time.

Load preparation and packaging

8.14 All items must be clean and dry before sterilization.

8.15 Glass or metal syringes should be assembled and hinged instruments

should be closed.

8.16 Delicate instruments, such as eye instruments, should be supported to

guard against physical damage.

61
8.0 Operation of dry-heat sterilizers

8.17 Good thermal contact between load items and their containers is
essential. In the case of a heavy instrument, heat conduction can be improved
by supporting the instrument in a metal cradle within its container. Smaller
items may be wrapped in heavy or light gauge metal foil or contained in
aluminium cans or tubes each of which may be sealed with push-on caps,
screw caps, or crimp-on foil caps. Crimp-on foil caps with a pre-printed
chemical indicator are also available.

8.18 The packaging does not need to be porous since the heat transfer
normally takes place by conduction. However, in sealed packaging the
contents of the pack when heated can exert a considerable pressure which
may be sufficient to rupture the packaging material or seals. Vented packaging
systems that allow pressure equilibration may be suitable for use in sterilizers
which operate with a chamber atmosphere which has been filtered through a
bacteria-retentive filter. This is particularly important during the cooling stage.

8.19 For items such as laboratory glassware, foil may be used to close the
open end of the product to prevent contamination when the load is removed
from the sterilizer.

8.20 Kraft paper bags or a simple layer of wrapping material can be used to
pack individual items. Plastic bags of the sort sold for roasting meat in
domestic ovens may also be suitable.

8.21 An extensive discussion on packaging materials and methods may be

found in Part 5 of this HTM.

Arrangement of load items

8.22 Random loading is not acceptable.

8.23 Load items should be placed in the chamber in such a way that air can
circulate freely around them. This requires a space of at least 10 mm between
adjacent items. They should therefore not be stacked and should not be
allowed to touch each other.

8.24 Shelves and trays should be either perforated or made of wire mesh.

8.25 Because of the importance of air circulation, even minor variations in the
loading pattern may seriously affect heat distribution and prevent complete
sterilization of the load. Purpose-made shelving or spacers should be used to
ensure accurate and repeatable positioning of load items.

Performance qualification

8.26 Because of the need for careful design of the load, performance
qualification is required for each loading condition to be processed. The full-
load test used during commissioning is not an acceptable substitute. The
number of different loading conditions should be rationalised by careful design
to minimise the number of PQ tests required.

8.27 Decisions on which loading conditions require PQ tests should be made

by the User in consultation with the Test Person.

62
 8.0 Operation of dry-heat sterilizers

Selection of cycle variables

8.28 The cycle variables should be selected to expose the load to one of the
three combinations of sterilization temperature and holding time given in
Table 8. The highest sterilization temperature compatible with the load should
be chosen.

Table 8 Sterilization conditions for dry-heat sterilizers

Sterilization Maximum Minimum holding

temperature temperature time

[°C] [°C] [min]

160 170 120

170 180 60

180 190 30

8.29 A few heat-sensitive products may require lower temperatures and

consequently prolonged holding times. The advice of the Authorised Person
should be sought in such cases.

Cycle monitoring and documentation

8.30 The integrity of the air filter should be checked daily or, in the case of
medicinal products, during each cycle. This will normally be done by
measuring the differential pressure across the filter during the cooling stage
and ensuring that the measured value is within the limits specified by the
manufacturer. Note that this check is not the same as the air filter integrity
test described in Part 3 of this HTM.

8.31 Where the temperature of the load is to be monitored, the load

temperature probe should be inserted into a load item known to be the
slowest to attain the sterilization temperature. Where two probes are provided
(normally in sterilizers over 600 litres) the second probe should be inserted
into the load item known to be the fastest to attain the sterilization
temperature. Sensors sealed into load containers should be located along the
geometric axis and inserted to an approximate depth of 50% of the container
height.

8.32 Documentation as listed in paragraph 2.57 should be recorded. Each

cycle should be noted in the sterilizer process log (see paragraph 3.11).

8.33 The batch process record will contain the following:

a. the temperature (“chamber temperature”) recorded by a sensor in the

coolest part of the chamber;

b. for medicinal products, the temperature (“load temperature”) recorded

by load temperature probes placed:
(i) in the load item known to be the slowest to reach the sterilization
temperature;
(ii) for larger sterilizers, also in the load item known to be the fastest
to reach the sterilization temperature.

63
8.0 Operation of dry-heat sterilizers

Product release

8.34 The load may be released for use provided that:

a. during the whole of the cycle the values of the cycle variables as shown
on the batch process record are within the permitted tolerances marked
on the master process record established during performance
qualification;

b. the packaging is undamaged.

64
9.0 Operation of LTS disinfectors

Introduction

9.1 This chapter gives guidance on the routine operation of clinical

disinfectors designed to disinfect load items by exposure to low-temperature
steam (LTS). See Chapter 10 for guidance on the operation of low-
temperature steam and formaldehyde (LTSF) sterilizers.

9.2 The guidance given here assumes that the disinfector is to be used to
process medical devices. However, the LTS process does not meet the
sterilization requirements of the EU Directives discussed in Chapter 1. LTS
should not be used for processing medicinal products.

9.3 LTS disinfectors are occasionally used to decontaminate soiled surgical

components to make them safe to handle before they are washed and
sterilized (see also paragraph 9.8). In such cases the machine used for initial
decontamination should be reserved for that purpose and not be used also for
the terminal disinfection of medical devices.

The process

9.4 Disinfection is achieved by direct contact with low-temperature

saturated steam at sub-atmospheric pressure at a nominal temperature of
73°C (and not exceeding 80°C) for a minimum holding time of 10 minutes.

9.5 The LTS process kills most vegetative micro-organisms and some heat-
sensitive viruses. It disinfects but does not sterilize.

9.6 LTS is free of toxic residues that may occur with chemical disinfection.

9.7 Part 2 of this HTM specifies that new LTS disinfectors should conform to
the requirements of BS3970. Such a machine will have the following
operating cycle.

a. Preheating. The walls of the chamber are heated to the preset

operating temperature between 71°C and 78°C. This reduces
condensation on the walls of the chamber (the door is not normally
heated).

b. Air removal. Sufficient air is withdrawn from the chamber to permit the
attainment of the disinfection conditions. This normally requires an
absolute pressure of less than 50 mbar.

c. Air ingress monitoring. The chamber is automatically subject to a

vacuum leak test before the cycle proceeds any further. If the leak rate
is higher than a preset value (normally 5.0 ± 0.2 mbar min–1) the cycle
is aborted.

d. Steam admission. Steam is admitted to the chamber until the

temperature attained throughout the load is 73 ± 2°C.

e. Disinfection. The temperature throughout the chamber and load is

maintained at or above the disinfection temperature (71°C) for a
holding time of not less than 10 min.

65
9.0 Operation of LTS disinfectors

f. Drying. Steam is extracted from the chamber and the chamber pressure
is reduced sufficiently to permit the evaporation of condensate from the
load, either by prolonged evacuation of the chamber or by the injection
and subsequent extraction of heated air or other gases within the
chamber.

g. Air admission. Air is admitted to the chamber through a filter until the
chamber pressure is within 100 mbar of atmospheric pressure.

Safety precautions

9.8 Where LTS disinfectors are used to decontaminate soiled items before
cleaning, operators should be aware that the steam may not have penetrated
below the surface of the soil and that decontamination may therefore not be
complete. Care is required in the subsequent handling of the item before it is
cleaned.

Product compatibility

9.9 LTS disinfection is suitable for a wide range of heat-sensitive items

capable of withstanding a moist process.

9.10 The process is particularly suitable for the disinfection of respiratory and
anaesthetic equipment, external pacemakers and for rigid endoscopes not
requiring a sterilization process.

Items which should not be processed by LTS

9.11 The following items should not be processed by LTS:

a. items requiring sterilization;

b. items which may be damaged by the conditions of heat, moisture and

pressure during the cycle;

c. items in sealed containers (the steam will not reach them);

d. oily or greasy items (oil or grease will impede the penetration of steam);

e. items likely to be contaminated with bacterial spores or other agents of

similar resistance to the disinfection process.

Design of the load

9.12 The loading condition should be designed with two aims in mind:

a. to permit the rapid removal of air from the load items and the rapid
penetration of steam; and

b. to ensure that the condensate formed during the cycle does not result in
a wet load.

Air removal

9.13 The presence of air in the load can impede the penetration of steam and
thereby drastically reduce the effectiveness of the disinfection process.

66
 9.0 Operation of LTS disinfectors

9.14 The principles of ensuring effective air removal for LTS disinfectors are
the same as those for porous load sterilizers (see paragraphs 5.13-5.16).

Handling of condensate

9.15 The principles of ensuring that condensate does not result in wet loads
are the same as those for porous load sterilizers (see paragraphs 5.17-5.24).

Packaging materials

9.16 Packaging materials for LTS sterilizers should meet the same
requirements as those for porous load sterilizers (see paragraphs 5.25-5.28).
Any process indicators in the form of printed panels designed for high-
temperature steam processes will not, however, reliably respond to the LTS
process. Until specific LTS indicators are available, plain bags should be used.

Selection of cycle variables

9.17 The LTS operating cycle is preset by the manufacturer and usually no
adjustment is possible.

Cycle monitoring and documentation

9.18 Documentation as listed in paragraph 2.57 should be recorded. Each

cycle should be noted in the sterilizer process log (see paragraph 3.11).

9.19 A batch process record should be generated for each production cycle.
The batch process record will contain the following:
a. the temperature (“chamber temperature”) recorded by a sensor in the
active chamber discharge;

b. the pressure (“chamber pressure”) recorded by a sensor in the

chamber.

Product release

9.20 The load may be released for use provided that :

a. during the whole of the cycle the values of the cycle variables as shown
on the batch process record are within the permitted tolerances marked
on the master process record established during performance
qualification;

b. the packaging is undamaged;

c. the load items are visibly dry.

67
10.0 Operation of LTSF sterilizers

Introduction

10.1 This chapter gives guidance on the routine operation of clinical In Scotland LTSF sterilizers are
sterilizers designed to sterilize load items by exposure to low-temperature considered to be disinfectors
steam and formaldehyde (LTSF). See Chapter 9 for guidance on the
operation of low-temperature steam (LTS) disinfectors.

10.2 The guidance given here assumes that the sterilizer is to be used to
process medical devices in compliance with the EU Directives discussed in
Chapter 1. Due to its toxicity, LTSF should not be used for sterilization of
medicinal products.

10.3 LTSF sterilizers are occasionally used to decontaminate soiled surgical

components to make them safe to handle before they are washed and
sterilized. In such cases the sterilizer used for initial decontamination should be
reserved for that purpose and not be used also for the terminal sterilization of
medical devices.

10.4 The User should seek advice from the Authorised Person, the
Microbiologist or the manufacturer if in any doubt about the operation of LTSF
sterilizers.

The process

10.5 Sterilization is achieved by direct contact with a mixture of low-

temperature saturated steam and formaldehyde gas at sub-atmospheric
pressure at a typical operating temperature of 73°C and not exceeding 80°C.

10.6 LTSF has a broad-spectrum action against vegetative bacteria, bacterial

spores, fungi and most viruses .

10.7 Many operating cycles are in use, in which there are variations in the
pattern of injection of steam and formaldehyde injection, the depth of
vacuum, length of holding stages and the amount of formaldehyde employed.
Part 2 of this HTM specifies that new LTSF sterilizers should conform to the
requirements of BS3970. Such a sterilizer will have the following operating
cycle.

a. Preheating. The walls of the chamber are heated to the preset operating
temperature (typically 73°C, but the standard does not specify this). This
reduces condensation on the walls of the chamber (the door is not
normally heated).

b. Air removal. Sufficient air is withdrawn from the chamber to permit the
attainment of the sterilization conditions. This normally requires an
absolute pressure of less than 50 mbar.

c. Air ingress monitoring. The chamber is automatically subjected to a

vacuum leak test before the cycle proceeds any further. If the leak rate is
higher than a preset value (normally 5.0 ± 0.2 mbar min–1) the cycle is
aborted.

68
 10.0 Operation of LTSF sterilizers

d. Sterilization.
(i) Phase 1. The required steam and formaldehyde conditions within
the chamber and load are attained.
(ii) Phase 2. The temperature, humidity and formaldehyde
concentration are maintained within specified limits for the
holding time.

e. Gas removal. Formaldehyde and steam are removed from the chamber
and load.

f. Drying. Steam is extracted from the chamber and the chamber pressure
is reduced sufficiently to permit the evaporation of condensate from
the load, either by prolonged evacuation of the chamber or by the
injection and subsequent extraction of heated air or other gases within
the chamber.

g. Air admission. Air is admitted to the chamber through a filter until the
chamber pressure is within 100 mbar of atmospheric pressure.

10.8 Since the sterilization process is ultimately dependent on chemical

action, a routine microbiological test is required for each production load to
confirm that sterilization conditions have been attained (see paragraph 10.48).

Formaldehyde solution

10.9 Formaldehyde (CH2O), also known as methanal, is a colourless, toxic

gas with a strong, characteristic odour. It is normally produced within the
sterilizer by the evaporation of Formaldehyde Solution BP, also known as
formalin, containing 34-38% w/w formaldehyde stabilised with methanol.

10.10 Analytical reagent grade formaldehyde solution, also specified in the

British Pharmacopoeia, is unstabilised and is not suitable for use in sterilizers.

10.11 BS3970 permits other “primary materials” to be used for the

generation of formaldehyde, though formalin is by far the most common. If
other materials are used, the User should ensure that adequate information
on safety and usage is supplied by the manufacturer of the product.

Polymerisation

10.12 When formalin is allowed to stand or evaporate, white flocculent

masses of paraformaldehyde are precipitated. Paraformaldehyde is a mixture
of polymethylene glycols (of the general form (CH2O)n,xH2O, where n is 6-50)
formed by the reaction of formaldehyde with water. It is readily converted
back to formaldehyde gas by heating.

10.13 Paraformaldehyde may be formed in LTSF sterilizers where the

formaldehyde gas is allowed to condense on a cold, wet surface. As the
reaction removes formaldehyde from the chamber atmosphere it can lead to a
failure of the sterilization process. Paraformaldehyde deposits may also block
pipework in the heat exchanger and so reduce the efficiency of vaporisation
of the formalin. Polymerisation is controlled mainly by careful handling of
condensate (see paragraphs 10.32–10.37). Heated doors, provided on some
models, are also helpful.

69
10.0 Operation of LTSF sterilizers

10.14 Experience has shown that on larger LTSF machines an occasional

flushing cycle, in which the formalin supply is replaced with water and a cycle
run with an empty chamber, is beneficial in reducing polymerisation problems.
Flushing cycles may conveniently be run overnight.

Safety precautions

10.15 Where LTSF sterilizers are used to decontaminate soiled items before
cleaning, operators should be aware that the sterilant may not have
penetrated below the surface of the soil and that decontamination may
therefore not be complete. Care is required in the subsequent handling of the
item before it is cleaned.

10.16 Formalin is a toxic liquid which requires careful handling and secure
storage.

Effects on health

10.17 Formaldehyde gas has a pungent odour which is very irritating to

the eyes and respiratory tract, with a threshold of detection by smell at
around 0.8 ppm, though the threshold for irritation may be lower. The
threshold for eye irritation may be as low as 0.01 ppm; 4 ppm usually causes
the eyes to water. Mild effects on the throat may occur at 0.5 ppm; 10 ppm
causes severe irritation to the eyes, nose and throat. Formaldehyde is
assigned a maximum exposure limit of 2 ppm (both short-term and long-
term limits) under the COSHH Regulations 1994 (see Schedule 1). The Refer also to EH40 ‘Occupational
presence of formaldehyde in the air can therefore be sensed by personnel at exposure limits’, Table 1
levels below the maximum exposure limit; in this respect, LTSF sterilization is
safer than EO sterilization.

10.18 Workers regularly exposed to formaldehyde may become acclimatised

to the effects at low concentrations. There is no evidence to suggest that
exposure to formaldehyde leads to chronic impairment of lung function. There
have been only a few case reports of occupational asthma associated with
formaldehyde exposure, despite its widespread use in industry. However, skin
contact has been shown to cause allergic contact dermatitis.

10.19 Although there is no epidemiological evidence that formaldehyde is

associated with cancer in humans, HSE advises that it should be regarded as a
potential carcinogen.

10.20 Formalin liquid can cause irreparable damage if splashed in the eyes.
Eye-washing facilities should be provided. Hazard labels should be displayed
prominently in all areas in which formalin is handled and used.

Replenishing the formalin supply

10.21 In normal operation of LTSF sterilizers, the greatest risk of exposure

occurs when the formalin supply in the sterilizer is replenished. A written
procedure for the filling and the connection of formalin tanks should be
devised, based on a risk assessment complying with the COSHH Regulations.
Care should be taken that the exposure limits given in Schedule 1 are not
exceeded. All staff whose duties include replenishing the formalin supply
should receive instruction.

70
 10.0 Operation of LTSF sterilizers

10.22 Formalin should be stored in a closed container in a locked cabinet at

a temperature of 15-25ºC. Vessels required for handling the formalin, such as
jugs and funnels, should also be kept in the cabinet.

10.23 On certain older sterilizers replenishment of the formalin supply is a

matter of removing the empty tank from the sterilizer and installing a full one
in its place. On newer sterilizers, formalin is decanted into the tank from a
storage container.

10.24 The decanting operation should be done in a well-ventilated room

where an accidental spillage will not endanger staff or patients. A safety
cabinet or fume cupboard is desirable. The following precautions should be
observed when decanting is necessary.

a. Dress in appropriate personal protective equipment (PPE), i.e. apron,

facemask and gloves (see paragraphs 2.14-2.15.).

b. Remove the formalin tank from the sterilizer and take it to a bench or
worktop near a sink or hand-basin where plenty of running water is
available.

c. Take the formalin bottle from the storage cupboard.

(i) Check the expiry date. If the date has passed, the solution should
not be used.
(ii) Examine the solution to ensure that polymerisation and separation
have not taken place. The solution should be clear, with no sign of
white particles or sediment. If there are any signs of
polymerisation, the solution is not suitable for sterilization and
should not be used.

d. Check the quantity of formalin to be decanted into the tank.

e. Decant the solution slowly into the tank. Do not lift the storage bottle
above chest height.

f. When the decanting is complete, wash any jugs or funnels used in the
process with ample clean, cold water.

g. Return the tank to the sterilizer and install it in accordance with the
manufacturer’s instructions.
h. Return the formalin storage bottle and filling vessels to the cabinet and
lock the door.

j. Remove the PPE, discard or clean as appropriate, and return it to its

storage location.

Product compatibility

10.25 LTSF is a suitable process for a wide variety of items which are
unsuitable for sterilization by high-temperature steam or dry heat. This
includes many materials and items of equipment with integral plastic parts
which could be damaged by heat. Complex items, such as certain
electromedical equipment, may be sterilized by this process.

10.26 For example, LTSF can be used for sterilizing ophthalmic and
cardiology items such as retinal and cataract detachment probes, cardiac
catheters and pacing electrodes. It is also useful for elastic bougies, artificial
joints, foetal scalp electrodes, amniotic membrane perforators and similar
heat-labile items.

71
10.0 Operation of LTSF sterilizers

10.27 The reversible adsorption of formaldehyde by some materials must be

considered. The high surface area of fabrics can adsorb large quantities of
formaldehyde (effectively absorption) and these may remain for long periods
unsuitable for patient use.

10.28 Because of the hazards associated with LTSF, it should not be used Sterilization and disinfection of heat-
to sterilize items which could be processed by other means. A survey by the labile equipment, Central Sterilising
Central Sterilising Club showed that many items processed in hospital LTSF Club 1986
sterilizers carry only an intermediate infection risk (see Table 2 in Chapter 2)
and LTS disinfection would have been more appropriate. Examples include
face masks, ventilator tubing, nebulisers, airways, mattresses, sheepskins,
breast milk expressors and toys.

Items which should not be processed by LTSF

10.29 The following items should not be processed by LTSF:

a. items which may be damaged by the conditions of temperature,

pressure, moisture and chemical environment prevailing during the cycle;

b. items in sealed containers (the sterilant will not reach them);

c. oily or greasy items (oil or grease will impede the penetration of the
sterilant);

d. items contaminated with body fluids (hardened, fixed protein deposits

will be produced); e.g. “dirty returns” from operating theatres, clinics,
etc.;

e. electrical or other items requiring a dry process, e.g. fully assembled air
drills, dental hand pieces and infant ventilators;

f. certain flexible fibre-optic endoscopes (differential expansion will crack

the sealants and let moisture penetrate the optics);

g. items which may absorb and retain unacceptable quantities of

formaldehyde.

Design of the load

10.30 The loading condition should be designed with two aims in mind:

a. to permit the rapid removal of air from the load items and the rapid
penetration of steam and formaldehyde; and
b. to ensure that the condensate formed during the cycle is quickly drained
clear of the load.

Air removal

10.31 The presence of air in the load can impede the penetration of steam
and formaldehyde and thereby drastically reduce the effectiveness of the
sterilization process. The principles of ensuring effective air removal for LTSF
sterilizers are the same as those for porous load sterilizers (see paragraphs
5.13-5.16).

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 10.0 Operation of LTSF sterilizers

Handling of condensate

10.32 As in all steam sterilizers, water condenses during the heating stages
of the LTSF cycle. This problem is particularly acute when sterilizing metal
items.

10.33 In contrast to porous load sterilizers (see paragraphs 5.17-5.24),

where it is preferable to retain condensate close to the load items to permit
re-evaporation, condensate formed in LTSF sterilizers should be drained clear
of the load as quickly as possible. This is for two reasons:

a. excessive moisture may impede the penetration of formaldehyde gas

into the load (especially where items have narrow lumens);

b. condensate allowed to remain on the load will promote the formation

of paraformaldehyde (see paragraph 10.13).

10.34 Chamber furniture should therefore be made from materials of high

thermal conductivity (such as aluminium) to reduce heat-up time and so avoid
cool surfaces. Open mesh supports should be used to allow drainage as well
as gas penetration.

10.35 Packs should be arranged in a manner which will permit the free
drainage of condensate.

10.36 To retain heat and reduce condensate formation, the door should
remain closed whenever the machine is not in use.

10.37 LTSF sterilizers should always be preheated prior to use. This may be
either from a previous LTSF cycle, or from an LTS cycle used specifically for
preheating.

Packaging materials

10.38 The basic considerations for packaging are similar to those for
porous load sterilizers (see paragraphs 5.25-5.28), except for the following:.

a. the extent to which packaging materials will retain both moisture and
formaldehyde residuals may affect the efficacy of the process;

b. materials which are slow to attain the sterilization temperature may

promote polymerisation;

c. materials of high heat capacity promote the formation of excessive

amounts of condensate.

10.39 It is therefore recommended that packaging should be kept to a

minimum.

10.40 Packaging may consist of paper, used as plain or creped wraps, or in

the form of bags or, in combination with plastic film, as pouches. Light
cardboard boxes, or corrugated polypropylene boxes, adequately vented and
overwrapped with paper or other material as a bacterial barrier, are also
suitable. When particularly delicate instruments are to be processed, the use
of open-cell foam for support and protection is acceptable.

10.41 To assist in the detection of paraformaldehyde deposits, packaging

materials should preferably be of dark colour (such as green) rather than
white.

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10.0 Operation of LTSF sterilizers

10.42 If packaging designed for porous-load sterilizers is used, Users should

note that any process indicators in the form of printed panels will not reliably
respond to the LTSF process. If specific LTSF indicators are not available (they
should conform to EN 867: Part 2) plain bags should be used.

10.43 Extensive guidance on packaging may be found in Part 5 of this HTM.

Performance qualification

10.44 Decisions on which loading conditions require PQ tests should be

made by the User in consultation with the Microbiologist and Test Person.

Selection of cycle variables

10.45 The concentration of formaldehyde in the chamber during the

holding time will have been determined during performance qualification and
is typically around 15 g m–3 for an operating temperature of 73°C. This is
equivalent to the evaporation of 40 ml of formalin per cubic metre of the
chamber volume (this is the volume of the pressure vessel, not the usable
chamber space).

10.46 Other cycle variables are preset by the manufacturer.

Cycle monitoring and documentation

10.47 Documentation as listed in paragraph 2.57 should be recorded. Each

cycle should be noted in the sterilizer process log (see paragraph 3.11).

10.48 A routine microbiological test should be carried out with every

production load as described in Part 3 of this HTM. Note that the full result of
the test will not be known until the biological indicator has been cultured for 7
days.

10.49 A batch process record should be generated for each production

cycle. The batch process record will contain the following:

a. the temperature (“chamber temperature”) recorded by a sensor in the

active chamber discharge;

b. the pressure (“chamber pressure”) recorded by a sensor in the chamber.

10.50 The operator should note the indicated amount of formalin

consumed during the cycle and check that the gas removal stage has been
completed satisfactorily before opening the door.

Product release and storage

10.51 The load may be released for degassing provided that:

a. during the whole of the cycle the values of the cycle variables as shown
on the batch process record are within the permitted tolerances marked
on the master process record established during performance
qualification;

74
 10.0 Operation of LTSF sterilizers

b. the correct amount of formalin has been taken from the tank;

c. the chemical indicator used in the routine microbiological test shows a

uniform colour change;

d. there is no visual evidence of polymerisation (see paragraph 10.59);

e. the packaging is undamaged;

f. the load items are visibly dry.

10.52 The load may subsequently be released as sterile provided that the
microbial culture results of the routine microbiological test described in Part 3
of this HTM are satisfactory.

10.53 It is common practice in some units to release loads on the strength

of the batch process record and not wait until the result of the microbiological
test is known. The rationale for this is that the BPR confirms that the load has
been exposed to a high-grade LTS disinfection process and is therefore safe
for use. A subsequent failure of the microbiological test would lead to the
sterilizer being withdrawn from service for investigation but would not
normally lead to the recall of the released goods.

10.54 While such practices have been justified on the grounds of economy,
they would not be acceptable under the EU Directives on medical devices. If
the microbiological test shows a failure, the machine is, by definition, not
working to the specifications established during validation and the process is
therefore not adequately controlled (see paragraph 10.58).

10.55 A degassing time for each load will have been established during
performance qualification. This will typically be no more than one hour. An
active degassing system is not necessary. Goods processed in an LTSF sterilizer
should be stored in such a way that air from the ventilation system cannot
carry traces of formaldehyde over goods from other types of sterilizer.

Troubleshooting

Cycle fault

10.56 The automatic controller may indicate a fault for a number of

reasons, including:

a. a vacuum leak greater than a preset value (normally 5.0 ± 0.2 mbar
min–1);

b. failure to attain the sterilization temperature;

c. insufficient formalin for a complete cycle.

10.57 Should a fault develop, the risk of exposure to formaldehyde is much

greater than in normal operation. The Maintenance Person should be notified
immediately. The batch process record should be carefully compared with the
master process record to establish the precise point the cycle has reached. If it
is suspected that formaldehyde has not been withdrawn from the chamber,
the door of the sterilizer should not be opened until the loading area has
been evacuated. Both the room ventilation and local exhaust ventilation
should be operating. Provided the chamber has reached atmospheric pressure,
the door can then be cranked partially open by an operator wearing a
respirator. The chamber and load should be left overnight with the ventilation
systems running during which time the formaldehyde will safely disperse.

75
10.0 Operation of LTSF sterilizers

Failure of the routine microbiological test

10.58 Failure of the microbiological test shows that the prescribed

sterilization conditions have not been attained. If the batch process record
shows that the physical cycle variables were satisfactory, then suspicion should
fall on the formaldehyde component of the process.

a. The concentration of formaldehyde in the chamber was too low. There

are several reasons why this might be.
(i) Insufficient formalin was consumed. This would normally lead to a
fault indication and would have been revealed by inspection of the
formalin level indicator.
(ii) Some of the formaldehyde was polymerised (see paragraph 10.59);
(iii) Some of the formaldehyde was dissolved in condensate. Check
that there are no places in the load or chamber where standing
water could collect (this could happen if chamber furniture or
loading trolleys become dented).
(iv) Some of the formaldehyde was absorbed into the load. This is
improbable if performance qualification tests have been conducted
and previous loads have been processed satisfactorily.

b. The loading condition is too great a challenge to the penetration of

formaldehyde. Again, this is unlikely if performance qualification has
been satisfactory.

Polymerisation of formaldehyde

10.59 The scientific background to formaldehyde polymerisation is discussed

in paragraph 10.12. Evidence that polymerisation has occurred during a cycle is
normally in the form of patchy white deposits of paraformaldehyde in the
chamber and on the load items. There are three main causes to be considered.

a. Too much water was present in the chamber. Principles for avoiding
wetness are discussed in paragraphs 10.32–10.37. If the loading
condition has been processed many times before without difficulty, then
the problem may lie in the steam supply which should be tested for
dryness as described in Part 3 of this HTM.

b. Too much formalin was used in the cycle. This is unlikely if the formalin
indicator is working correctly and has been read correctly.

c. Failure (or partial failure) of the heat exchanger. If white streaks are
visible in and around the steam entry port, it is likely that liquid formalin
has entered the chamber. This implies that the temperature in the heat
exchanger was too low for complete vaporisation.

76
11.0 Operation of ethylene oxide
sterilizers

Introduction

11.1 This chapter gives guidance on the routine operation of clinical sterilizers
designed to sterilize load items by exposure to ethylene oxide gas (EO).

11.2 The guidance given here assumes that the sterilizer is to be used to
process medical devices in compliance with the EU Directives discussed in
Chapter 1. Due to its toxicity, EO should not be used for sterilization of
medicinal products.

11.3 Sterilization by EO should be regarded as a last resort, only to be used

when other forms of sterilization are not possible. The wide variety of items
processed in hospital SSDs will increase the difficulty in validating the process
to achieve consistently low levels of residual EO. Items sterilized by EO may
therefore contain higher levels of residuals than are desirable.

The process

11.4 EO is a highly penetrative, non-corrosive agent which has a broad-

spectrum action against viruses, vegetative bacteria, bacterial spores, fungi,
and other living cells under optimal conditions of concentration, relative
humidity, temperature and exposure time. It may be used at temperatures and
pressures which minimise damage to sensitive equipment. Typical operating
temperatures are in the range 20-60°C.

11.5 Two types of EO sterilizer are employed in the NHS.

11.6 In low-pressure sterilizers, of chamber volumes around 150 litres, the

sterilant is pure EO at sub-atmospheric pressure. The gas is supplied from a
single-use, disposable cartridge contained within the chamber. The cartridge
limits the amount of EO in use at any one time and so reduces the toxic and
explosive hazards. The chamber is designed to contain the effects of an
explosion of the contents of a single cartridge. Compared with high-pressure
sterilizers (see paragraph 11.7), low-pressure machines are relatively cheap to
install and to run, requiring no piped EO service and no gas disposal plant.
The low pressure in the chamber allows pressure-sensitive equipment to be
processed safely.

11.7 In high-pressure sterilizers, of chamber volume up to 500 litres, the

sterilant is EO diluted with another gas, supplied from cylinders. The mixtures
are chosen to expose the load to an EO concentration of around 500-1000
mg litre–1 while keeping the potential hazards to a minimum Two gas systems
are in common use:

a. EO with chlorofluorocarbons (CFCs) or hydrochlorofluorocarbons

(HCFCs) at pressures up to 2 bar: CFCs have traditionally been used as
a diluent gas but are no longer acceptable for environmental reasons;
HCFCs require even more critical control of humidity than other systems
and are themselves due to be phased out;

b. EO with carbon dioxide at pressures up to 6 bar.

77
11.0 Operation of ethylene oxide sterilizers

11.8 The operating cycle of an EO sterilizer constructed to EN 1422 will have

the following stages, though the order may be varied slightly.

a. Chamber preheating. With the load in place, the chamber is heated to a

preset working temperature.

b. Air removal. Sufficient air is removed from the chamber and load to
permit the subsequent attainment of the sterilization conditions and to
ensure that the admission of EO will not result in a flammable or
explosive mixture.

c. Automatic leak test. A vacuum leak test is carried out to ensure that air
does not leak into the chamber. For sterilizers operating at pressures
higher than 1.05 bar, a pressure leak test is also carried out to ensure
that EO does not leak out of the chamber.

d. Conditioning. The load is heated and humidified to a preset sterilization

temperature and humidity (at least 40% RH). The length of this stage
will depend on the extent of any preconditioning.

e. Gas injection. Gas is admitted to the chamber until the operating

pressure has been attained.

f. Gas exposure. The temperature and gas pressure (or concentration) are
maintained within limits throughout the chamber and load for a preset
holding time.

g. Gas removal. Gas is removed from the chamber to reduce the

concentration below the flammable limit when air is admitted at the end
of the stage. Some gas will still be left in the load.

h. Flushing. Sufficient gas is removed from the load so that there is no

longer a safety hazard to the operator when the sterilizer is unloaded.
The flushing agent is normally filtered air or an inert gas.

j. Air admission. Air is admitted to the chamber until the pressure

approaches atmospheric pressure.

k. End of cycle. If the door remains unopened for more than 15 min after
the end of the air admission stage, the gas removal and/or flushing
stages are automatically repeated to prevent an accumulation of gas in
the chamber.

11.9 Typical process times, including degassing after the cycle is complete, can
range from 12 to 24 hours depending on the sterilization temperature, gas
concentration and the nature of the load.

11.10 Since the sterilization process is ultimately dependent on chemical

action, a routine microbiological test is required for each production load to
confirm that sterilization conditions have been attained (see paragraph 11.43).

Safety precautions

11.11 EO presents hazards not found in conventional sterilizers. The gas is Management Executive Letter
toxic, flammable and explosive. Extensive guidance on safety precautions to MEL(1995)48 modifies HBN 13
be followed in handling EO can be found in Appendix 3. See also ‘Ethylene Supplement 1 for use in Scotland
oxide sterilization section’ (HBN 13 Supplement 1) published by NHS Estates.

78
 11.0 Operation of ethylene oxide sterilizers

Product compatibility

11.12 EO sterilizers can be used to process heat-sensitive materials which

cannot withstand low-temperature steam. They should not be used to process
products which can be sterilized by alternative methods; that is by
high-temperature steam, dry heat or LTSF.

Sterilization and disinfection of heat- 11.13 A survey by the Central Sterilising Club showed that many items
labile equipment, Central Sterilising processed in hospital EO sterilizers carry only an intermediate infection risk
Club 1986 (see Table 2 in Chapter 2) and LTS disinfection would have been safer and
more appropriate. Examples include face masks, ventilator tubing, airways,
breast milk expressors, plastic vaginal speculae, amniotic membrane
perforators and eye patches. None of these items requires EO sterilization and
some may be designated by the manufacturer as single-use only.

11.14 It is common practice to use EO to resterilize items such as cardiac

catheters that are intended by the manufacturer to be used only once. While
this may be justified on economic grounds, attention is drawn in paragraphs
2.22-2.25 to the difficulties in validating cleaning procedures for such items
and the possible legal implications of reusing them. Users also should bear in
mind that some medical devices designed for single-use may have been
originally sterilized by radiation. In certain circumstances these may be
weakened by subsequent exposure to EO and should therefore not be
resterilized.

11.15 Low-pressure EO is suitable for items such as certain flexible

endoscopes and electronic equipment which would be damaged by exposure
to an LTSF process.

11.16 Certain types of EO sterilizer, notably those employing EO diluted

with carbon dioxide, operate at pressures up to 6 bar. Users should ensure
that load items would not be damaged by exposure to such pressures.

11.17 Care should be taken that materials submitted for sterilization do not
undergo undesirable reactions with EO. If doubt exists about this, it is
advisable to contact the supplier of the gas.

Items that should not be processed by ethylene oxide

11.18 The following items should not be processed by EO:

a. items that could be sterilized by another process;

b. items which may be damaged by the conditions of temperature,

pressure and chemical environment prevailing during the cycle;

c. medicinal products;

d. ventilatory and respiratory equipment;

e. soiled items;

f. plastic items previously sterilized by radiation;

g. items which may absorb and retain unacceptable quantities of EO

residuals.

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11.0 Operation of ethylene oxide sterilizers

Design of the load

11.19 Packaging materials and methods should be selected which are

compatible with the EO sterilization process and which maintain sterility and
the quality of the contained product. Packaging should be designed to allow
removal of air and penetration of both steam and EO.

11.20 Because a wide variety of EO processes are in use, packaging suitable

for one EO sterilizer may not be suitable for another. For example, package
seals may be weakened and possibly fail in a cycle with relatively high humidity
and several large and rapid changes in pressure, where seals of the same type
would have been satisfactory for a cycle employing less extreme conditions.

11.21 The extent to which packaging absorbs or adsorbs EO and its

permeability to EO may have a major influence on the efficacy of the cycle and
the subsequent aeration process. Cartons (shelf packs, transit cartons) may be
convenient but they may increase the humidification time, the gas exposure
time and subsequent level of EO residuals.

11.22 Because of the need to control humidity, the extent to which

packaging absorbs moisture may have a major influence on the efficacy of the
process and must be considered before a satisfactory humidification stage can
be demonstrated.

11.23 Process control is also a concern since packaging material that has
become dehydrated may absorb excessive moisture during the conditioning
phase; if this possibility were not recognised during validation the achieved
cycle lethality may be adversely affected.

11.24 In practice, many of the packaging materials routinely used for steam
sterilization in hospitals are equally suitable for EO. However, Users should be
aware that because of the lower temperatures employed in the EO process a
wider range of materials is available.

11.25 Paper bags or plastic/paper pouches are usually found to be the most
convenient for small items. Polythene bags with gas exchange ports of Tyvek
are also suitable.

11.26 Large procedure trays containing endoscopes or other heat-sensitive

equipment may be wrapped in sheets of plain or crepe paper, or textiles.
Moulded foam inserts may be used to provide mechanical protection.

11.27 Biological indicators should be placed in the load before

preconditioning (see 11.43).

Performance qualification

11.28 PQ tests are required for loading conditions representing every

production load. Decisions on which loading conditions require PQ tests should
be made by the User in consultation with the Microbiologist and Test Person.

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 11.0 Operation of ethylene oxide sterilizers

11.29 Because of the wide variety of items processed by EO, it is not always
practicable to conduct PQ tests for every possible loading condition. Users are
advised to categorise load items by the degree to which they can absorb and
retain moisture and EO, and then ensure that loads are made up of items in
the same category. For example, rubber absorbs EO readily, while electronic
devices do not.

11.30 The amount of microbial contamination (the bioburden) after

cleaning may need to be determined as part of the performance qualification
process, though this is not normally required in hospitals where a wide range
of items are to be sterilized and gas exposure times are calculated to be more
than sufficient to deal with the maximum anticipated bioburden. Where such
determinations are required they should comply with EN 1174.

Preconditioning

11.31 If EO sterilization is to be effective, it is essential that the humidity

within any part of the load should not be less than 30% RH, and that there
should be no free water within the chamber.

11.32 To ensure that these extremes of humidity are not exceeded when
sterilizing different types and sizes of load which have been stored in
unknown ambient temperatures and humidity, it may be necessary to subject
the load to a preconditioning treatment in a known environment.
Preconditioning may be done within the sterilizer chamber before the start of
the operating cycle, or in a purpose-built room or cabinet. Specifications for
preconditioning rooms or cabinets can be found in Part 2 of this HTM.

11.33 Preconditioning may not be necessary where workloads are small. In

such cases the conditioning stage of the operating cycle may be satisfactory
(see paragraph 11.8d). However, Users should note that the humidity
instruments attached to the sterilizer may not be as reliable as those provided
for a purpose-built preconditioning room or cabinet. For this reason,
preconditioning is always recommended.

11.34 Within limits, the humidity within the chamber can be determined
from the mass of steam injected, the pressure change within the chamber, the
moisture absorbent characteristics of the load and the temperature and
humidity of the load before it is placed in the sterilizer chamber. However,
whenever preconditioning is to be done in the sterilizer chamber, the humidity
should be by direct measurement (but see paragraph 11.46a) and within limits
its value should be known for each cycle.

11.35 All packaged product within the preconditioning area should be

identified. For each batch processed, the levels of the physical values achieved
during preconditioning should be recorded. These should include the
following.

a. the ambient temperature of the packaged product entering the

preconditioning room;

b. the time when the packaged product enters the preconditioning room;

c. the time when the packaged product leaves the preconditioning room;

d. the temperature record for the period the packaged product is in the
preconditioning room;

81
11.0 Operation of ethylene oxide sterilizers

e. the humidity (RH) record for the period the packaged product is in the
preconditioning room.

11.36 The temperature and humidity within the preconditioning area should
be set to the same values that will prevail during the gas exposure time. The
temperature within the load at the end of the preconditioning period should
not deviate by more than ± 5°C from the nominal conditions within the area
and the RH should not deviate by more than ± 15% RH from the nominal
conditions in the area. The time taken to achieve these conditions during
validation should be noted and used as the minimum specified for routine
operations.

11.37 The preconditioning area should be subject to performance

qualification. PQ should be performed with the preconditioning area in both
fully loaded and typical partly loaded states and carried out with the loading
patterns and pallet spacings specified in documented procedures.

11.38 The reference position for monitoring temperature and RH during

preconditioning should be that at which it is most difficult to achieve the
desired conditions. Data for this routine monitoring should be reviewed before
the load is released for sterilization.

11.39 The ambient temperature of items entering the preconditioning area

should be at or above the minimum temperature specified during validation. It
is not generally necessary to routinely determine the temperature of load items
before preconditioning where the conditions of storage are known.

Selection of cycle variables

11.40 The EO concentration prevailing during the gas exposure stage will
have been established during performance qualification. A concentration of at
least 300 mg litre–1 is commonly used. Concentrations greater than
1200 mg litre–1 do not result in a substantial increase in the effectiveness of
the sterilization process.

11.41 Apart from adjustment of flushing times, other cycle variables are
preset and cannot be modified by the User.

Cycle monitoring and documentation

11.42 Each cycle should be noted in the sterilizer process log (see paragraph
3.11). The following information should be recorded for each load processed:

a. for preconditioning (if used), the temperature and humidity monitored

and recorded from a position which can be related to that at which it is
most difficult to achieve the specified conditions;

b. time of commencement and removal of load from preconditioning (if

used) of each load;

c. time of commencement of the operating cycle;

d. chamber temperature and pressure during the operating cycle measured

from a representative position within the chamber;

e. evidence that the gaseous sterilant has been admitted to the chamber;

f. a measure of the quantity of EO used or the concentration of EO in the

chamber;

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 11.0 Operation of ethylene oxide sterilizers

g. duration of the gas exposure time;

h. time, temperature, pressure changes (if any) and/or the operation of

the air supply (if used) during aeration;

j. the results of the routine microbiological test.

11.43 A routine microbiological test should be carried out with every

production load as described in Part 3 of this HTM. Note that the full result of
the test will not be known until the biological indicators have been cultured
for 7 days.

11.44 A batch process record should be generated for each production

cycle. The batch process record will contain the following:

a. the temperature (“chamber temperature”) recorded by a sensor in the

coolest part of the chamber;

b. the pressure (“chamber pressure”) recorded by a sensor in the

chamber.

Chamber humidity

11.45 A load which has been preconditioned may lose moisture during the
air removal stage of the operating cycle and steam may be injected during the
conditioning stage (before gas injection) to maintain the moisture content at
the specified level.

11.46 The humidity within the chamber should be monitored in one of two
ways:

a. by direct measurement of RH. Many RH sensors are poisoned by

absorption of EO and provision should be made either to isolate the
sensor from the chamber atmosphere before EO is admitted, or to
remove the sensor for degassing after the sterilization cycle is complete.
Note that the RH as perceived by a sensor at a low pressure may be
different from that measured at a higher pressure;

b. by monitoring the rise in temperature and pressure as steam is

admitted; care should be taken to ensure that the measured values
truly relate to RH and are reproducible. Details of the calculation are
given in Part 3: Appendix 2.

EO concentration

11.47 The pressure rise at gas injection provides the primary, though
indirect, measure of the EO concentration in the chamber. The measuring
equipment should have sufficient sensitivity to allow recordings of small
quantities of gas which may be admitted throughout both the gas injection
and gas exposure stages. Details of the calculation are given in Part 3:
Appendix 2.

11.48 Since the EO concentration is critical to the efficacy of the cycle, a

second, independent system is required to confirm that the pressure rise is
due to EO. Either of the following may be used:

a. monitoring the change in mass of the gas supply cylinder or cartridge;

b. metering the volume of gas delivered to the chamber.

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11.0 Operation of ethylene oxide sterilizers

11.49 Where a sterilizer is supplied from a disposable cartridge, it can be

assumed that the entire contents of the cartridge are released into the
chamber. However, it should not be assumed that the mass of the contents
corresponds precisely to the manufacturer’s stated value. As a matter of
routine, the cartridge should be weighed immediately before it is placed in the
sterilizer and after it has been removed to establish the mass of gas consumed,
and the results noted in the sterilizer process log.

Product release

11.50 The load may be released for degassing (see paragraph 11.52)
provided that:

a. the preconditioning records are satisfactory;

b. during the whole of the cycle the values of the cycle variables as shown
on the batch process record are within the permitted tolerances marked
on the master process record established during performance
qualification;

c. the correct amount of EO has been injected into the chamber;

d. the chemical indicators used in the routine microbiological test show a

uniform colour change;

e. the packaging is undamaged;

f. load items are visibly dry.

11.51 The load may subsequently be released as sterile provided that the
microbial culture results of the routine microbiological test described in Part 3
of this HTM are satisfactory and approved by the Microbiologist.

Degassing

11.52 Most, if not all, materials retain varying amounts of EO following

sterilization. The residual EO in items for medical use should be reduced to a
safe level, both for personnel handling the items and for the patient. Other
compounds may also be present as reaction products of EO, such as ethylene
chlorohydrin, and the concentration of these may also need to be reduced.
Reference in this HTM to reduction of residual EO should be read as applying
equally to any other toxic reaction products which may be present.

11.53 Certain materials, such as polyvinyl chloride, silicone and rubber, are
particularly absorbent and require longer degassing times. If not removed,
residual EO will give rise to burning sensations and other irritant or toxic
effects when the sterilized item is implanted or in contact with body tissue.

11.54 Permitted levels of EO residuals, and methods for their determination,

are given in EN 30993: Part 7.

11.55 Reduction of residual EO occurs naturally as gas diffuses from the

product into the surrounding air down the concentration gradient. Under
normal ambient conditions this process may be very slow and significant
amounts of EO may be present in the environment. For these reasons
degassing by storage under ambient conditions is not recommended;
mechanical degassing should be used.

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 11.0 Operation of ethylene oxide sterilizers

11.56 The time required for degassing depends on a number of factors:

a. the composition, form and mass of the items in the load;

b. the concentration of residual EO when the load is removed from the

sterilizer (this will in part depend on the EO concentration and gas
exposure time, but more importantly on the extent and nature of the
flushing stage in the sterilizer);

c. the temperature at which degassing takes place;

d. the concentration of residual EO which is acceptable for the intended

use of the product.

11.57 The time required under the prevailing conditions should be

determined for each type of product as part of performance qualification.
Where this is impracticable, such as where a sterilizer is used for low numbers
of a great variety of items, the degassing process should be determined for
the item which has the longest degassing time. This is likely to be the largest
and most complex item made from polyvinyl chloride.

11.58 A validated and monitored degassing procedure should be followed.

Degassing can be performed within the sterilizer or in a separate chamber or
area (see Part 2 of this HTM). The temperature profile and air flow rate during
degassing should be monitored and recorded.

Troubleshooting

Failure of the routine microbiological test

11.59 Failure of the microbiological test shows that the prescribed

sterilization conditions have not been attained. If the test itself appears to
have been carried out correctly (the biological indicators should be checked to
make sure the correct type has been used) and the batch process record is
satisfactory, then the following possibilities should be considered.

a. The concentration of EO in the chamber was too low. There are several
reasons why this might be.
(i) Insufficient EO was admitted. This would normally lead to a fault
indication and would be revealed by inspection of the chamber
pressure record and the secondary method (mass or volume, see
paragraph 11.48).
(ii) Some of the EO was polymerised. Green streaks on the chamber
walls near the inlet port suggest that liquid EO entered the
chamber. The preheater should be checked.
(iii) Some of the EO was absorbed into the load. This is improbable if
performance qualification tests have been conducted and previous
loads have been processed satisfactorily.

b. The humidity in the chamber was either too high or too low. Humidity
is critical to the operation of EO sterilizers and even small deviations
from the ideal level can have large effects on the efficacy of the cycle.
Incorrect humidity is the single most common cause of failure. If the
preconditioning records are satisfactory, suspicion should fall on the
sterilizer humidifying system.

c. The loading condition is too great a challenge to the penetration of EO.

This is unlikely if performance qualification has been satisfactory.

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12.0 Operation of laboratory sterilizers

Introduction

12.1 This chapter gives guidance on the routine operation of high-

temperature steam sterilizers (“laboratory sterilizers”) designed to process
materials and equipment for use in clinical laboratories.

12.2 These sterilizers are not suitable for processing either medical devices or
medicinal products and are therefore not subject to the EU Directives discussed
in Chapter 1.

Sterilization conditions

12.3 European Standards for medical devices and medicinal products require
that for a product to be labelled “sterile”, no more than one micro-organism
should survive in 106 load items (see EN 556). There is no universally accepted
probability of survival for laboratory purposes. In laboratory practice for make-
safe loads, the high initial concentration of micro-organisms is considered to
be balanced by a higher acceptable probability of survival than in items
intended to be used on patients. This has allowed the standard sterilization
conditions adopted for medicinal products and medical devices (see paragraphs
2.43-2.55) to be used for laboratory make-safe loads.

12.4 The same standards are also used for sterilizing culture media, fabrics
and equipment and glassware; for these loads (but not for make-safe loads)
times and temperatures may be reduced if necessary to minimise deterioration
of the product. Account should also be taken of the contributory effect of high
temperatures during the heat-up and cooling stages on the degradation of
culture media constituents.

12.5 Examples of recommended sterilization conditions are shown in Table 9.

12.6 The effect of the initial cell population (bioburden) on the number of
survivors after heating reinforces the need to reduce numbers by cleaning
equipment and glassware before sterilization. In microbiology laboratories it is
possible, with good laboratory practice and by using dehydrated culture media
from reputable manufacturers, to ensure that there are minimal numbers of
contaminating micro-organisms in media prepared for sterilization. However, in
discard boxes to be subjected to a make-safe process, the numbers of micro-
organisms present are inevitably several orders of magnitude greater and no
pre-treatment is possible to reduce the concentration of what may be very
heat-resistant spores.

Safety precautions

12.7 Users should ensure that operational procedures are in accord with the
safety guidelines set out in the HSC document ‘Safe working and the
prevention of infection in clinical laboratories’ and the accompanying ‘Model
rules for staff and visitors.’

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 12.0 Operation of laboratory sterilizers

Table 9 Recommended sterilization conditions for laboratory sterilizers

Name of operating cycle Sterilization Maximum Minimum

temperature temperature holding time
[°C] [ºC] [min]

Make-safe of small plastic 134 138 3

discard (a) 126 130 10
121 125 15

Make-safe of contained 134 138 3

fluid discard (a) 126 130 10
121 125 15

Sterilization of culture 121 124 15

media (pre-set cycle) 115 118 30

Sterilization of culture 102-134 up to 60

media (variable cycle) 121 (b) 124 15

Disinfection of fabrics 134 138 3

126 129 10
121 124 15

Sterilization of glassware 134 138 3

and equipment 126 129 10
121 124 15

Free steaming (variable 102-104 up to 60

cycle) 95 (b) 98 15

Culture media preparator 121 124 30

115 118 15

a. All bands for make-safe are 4 degrees wide to conform with BS2646: Part 3.

b. Although the cycle is variable, this temperature band should be used for testing purposes.

12.8 The COSHH Regulations 1994 introduce new controls on biological

agents which are of relevance to Users of laboratory sterilizers.

Hazards

12.9 Due to the wide variety of loads processed in laboratory sterilizers, the
range of potential hazards is wider than for a typical clinical sterilizer (see
paragraph 2.10). Additional hazards may include:

a. spillage of biohazardous material;

b. spillage of hot material;

c. spillage of corrosive substances;

d. vapour from volatile chemicals.

12.10 Access to the loading area should be limited to personnel aware of

the hazards from potentially infective material. The loading position should
not be obstructed.

12.11 All materials awaiting sterilization should be placed so they cannot

be overturned, spilled or damaged.

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12.0 Operation of laboratory sterilizers

12.12 Loading and unloading procedures should be designed to avoid

health hazards and also injuries to personnel by the elimination of awkward
lifting positions and excessively heavy load containers (see paragraph 2.8).
Heavy loads should not be lifted into or out of vertically mounted chambers by
personnel of unsuitable build or strength. Consideration should be given to the
provision of mechanical assistance.

Operating procedures

12.13 A written standard operating procedure based on the manufacturer’s

instructions and local conditions of use should be adopted and should include
the following:

a. a statement specifying the safe operating limits of the sterilizer including

the maximum pressures and temperatures for safe operation;

b. a statement that operators should be instructed to note and report any

defects or unusual or out-of-range conditions to their supervisor;

c. training requirements for the operators of the sterilizer and a statement

that those unfamiliar with the equipment are forbidden to operate it
unless supervised, or until they are considered competent in its use;

d. maintenance requirements: the scope of User maintenance should be

defined and restricted to cleaning, functional checks and any User safety
checks recommended in the instruction manual.

12.14 Operating instructions should always be readily accessible and Users

should ensure that they are followed.

12.15 Certain laboratory sterilizers are provided with a switch to override

the thermal door-lock during the cooling stage of the cycle (see Part 2 of this
HTM). The switch is protected by a key, code or tool which is not available to
the operator. The responsibility for the operation of the thermal door-lock
override should be assigned to the User or other senior member of the
laboratory staff. The override should only be used if all the implications of such
action are documented and understood.

Operating cycles

12.16 Operating cycles recommended in this HTM are as follows:

a. make-safe of small plastic discard;

b. make-safe of contained fluid discard;

c. sterilization of culture media (preset or variable cycle);

d. disinfection of fabrics;

e. sterilization of glassware and equipment;

f. free steaming.

12.17 The specialised sterilizer known as a culture media preparator is also

discussed.

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 12.0 Operation of laboratory sterilizers

12.18 Sterilizer loads should be carefully segregated to ensure that the

appropriate cycle is selected for each type of load. Particular care should be
taken to ensure that culture media, discard, glass containers with caps fitted,
and contained fluid are processed in sterilizers fitted with a thermal door-lock,
demonstrated to be effective on these cycles (see Part 2 of this HTM).

12.19 Materials processed in laboratory sterilizers can be either “clean” or

“dirty”. Clean work is material which will be used within the laboratory, such
as culture media, tubing and filters. Dirty work is discard material which is to
be made safe. In larger laboratories, separate sterilizers are often designated
for clean and dirty work.

12.20 The discovery of non-sporing infective agents with an increased

resistance to chemical and heat treatment (“slow viruses”, “prions”, “TSE
agents”) has led to the need for increased temperatures and holding times for
treatment of material from a suspected case of infection by these agents.
None of the standard cycles described here is effective in inactivating such
agents. Advice can be found in Appendix 2.

Make-safe of small plastic discard

12.21 This cycle corresponds to the “make-safe” cycle specified in BS2646.

It is designed to sterilize infected material held in plastic containers not
exceeding 50 ml in volume. Examples of such containers include Petri dishes,
specimen bottles and other small plastic items intended for disposal.

12.22 Although the containers would normally be unsealed, the limits on

volume ensure that any fluid held in a sealed container does not present an
explosion hazard when the door is opened at the end of the cycle. Glass
containers and larger plastic containers should be processed with the
make-safe cycle for contained fluid discard (see paragraph 12.30). Items of
unknown content should likewise be treated as contained fluid discard.

12.23 Items made from polystyrene, such as plastic Petri dishes, start to
soften at around 70°C. Any air remaining in the chamber at that point may
become trapped as bubbles within the melting plastic and prevent complete
sterilization. The hardened plastic mass removed at the end of the cycle may
then contain pockets of viable micro-organisms that may cause a health
hazard if the plastic is subsequently broken. Users should therefore ensure
that the air-removal stage of the cycle is substantially complete before the
load temperature attains 70°C. That is why plastic Petri dishes are specified for
the small-load and full-load thermometric tests described in Part 3 of this
HTM.

12.24 Items for making-safe should be placed in a discard box as specified

in Part 2 of this HTM. It is important that the box is of the type used for
performance qualification, otherwise the specified sterilization conditions may
not be achieved.

12.25 Discard should be stored in the box at the work station for later
sterilization. Once in the box, items should not be handled until after they
have been made safe. They should not be transferred from one box to
another. The box and contents should be sterilized together.

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12.0 Operation of laboratory sterilizers

12.26 Discard should be enclosed when the box is moved. Loose-fitting lids
are satisfactory for transport within a laboratory. Alternatively, the discard
material may be placed in a discard bag (see paragraph 12.27) inside an open
box, providing the neck of the bag is closed before the box is moved.
Whenever discard material is transported outside the laboratory suite a sealed
and locked lid should be fitted. The lid should be opened or removed before
the cycle begins and sterilized along with the box.

12.27 Discard bags, if used, should always be contained in a discard box

and opened widely before sterilization to permit the removal of air and the
penetration of steam. The open mouth of the bag should not be folded back
over the rim of the box, since this would impede the removal of air from the
space between the bag and the box. Bags with identification markings for
discard material are available which are designed to melt at 134°C to assist air
removal .

12.28 Discard boxes awaiting sterilization should not be stored in the

loading area.

12.29 Load temperature probes should not be inserted into discard loads.
Any probes provided in the chamber should be stowed in a safe, fixed
position, usually on a bracket provided for this purpose.

Make-safe of contained fluid discard

12.30 This cycle is a variant of the “liquids sterilization” cycle specified in

BS2646. It is designed to make-safe infected material in sealed glass containers
of any size or sealed plastic containers of volume greater than 50 ml.

12.31 While essentially the same as the culture media cycle (paragraph
12.35), higher sterilization temperatures are preferable. Lower sterilization
temperatures should only be used if plastic containers are to be processed.

12.32 Fluid containers should be placed in discard boxes to prevent

contamination of the chamber if a bottle breaks during the cycle (see
paragraph 6.7 about pressure inside bottles).

12.33 A risk assessment should be made before corrosive chemicals or

materials and chemicals (including disinfectants) likely to produce harmful
vapour are processed. Such materials should be enclosed in a sealed,
unbreakable container, preferably of metal.

12.34 Load temperature probes should not be inserted into discard loads.
Any probes provided in the chamber should be stowed in a safe, fixed
position, usually on a bracket provided for this purpose.

Sterilization of culture media (preset or variable cycle)

12.35 This cycle is a variant of the “liquids sterilization” cycle specified in

BS2646. It is designed to sterilize culture media in open or sealed containers.

12.36 Since culture media are normally damaged by sterilization at 134°C

the maximum sterilization temperature is set at 121°C.

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 12.0 Operation of laboratory sterilizers

12.37 A variable cycle, in which combinations of sterilization temperature

and holding time can be set by the operator, is necessary for some heat-labile
products. It is normally provided in addition to the preset culture media cycle.

12.38 The culture media cycle is also suitable for disinfecting unwrapped
equipment, such as tubing sets, where a glassware and equipment cycle is not
available (see paragraph 12.48).

12.39 Culture media are particularly sensitive to heat, the degree of

deterioration being related to the time the medium is maintained above the
sterilization temperature. The heating and cooling stages also contribute
significantly to this deterioration, so heating and cooling times should be as
short as possible. Large volumes of fluids will heat up and cool down slowly,
therefore volumes of fluid should be kept small; a maximum container volume
of 500 ml is recommended.

12.40 Agar-based media take longer to heat up than water-based media;

this differential is greater the larger the volume. When media are to be
sterilized in volumes of over 100 ml, agar-based and water-based products
should be processed separately.

12.41 Loads should be designed to process containers of similar size. For

example:

a. up to 100 ml;
b. 101 to 1000 ml;

c. 1001 ml to 3 litre.

12.42 Containers should be loosely capped unless they are specifically

designed to be sealed. However, sealing bottles can increase the likelihood of
an explosion during sterilization (see paragraph 6.6 about pressure inside
bottles) and extends the cooling time.

12.43 A fault may result in contaminated or over-heated culture media.

After a fault, a careful assessment should be made before the batch is
reprocessed or discarded.

Disinfection of fabrics

12.44 This cycle is a variant of the “glassware and equipment” cycle

specified in BS2646. It is designed to disinfect (but not sterilize) fabric
materials such as towels, clothing, wrapped animal bedding, and other porous
materials.

12.45 If the fabrics are required to be sterile and dry at the end of the
cycle, a machine complying with the performance requirements for a clinical
porous load sterilizer should be specified. This will require validation and
periodic testing in accordance with the schedule for porous load sterilizers in
Part 3 of this HTM.

12.46 The cycle differs from the glassware and equipment cycle (see
paragraph 12.48) in that more pressure pulses will be required to remove air
from the load.

12.47 The fabrics cycle is also suitable for sterilizing empty glassware
without caps and for disinfecting wrapped tubing and wrapped filters (but see
paragraph 12.49).

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12.0 Operation of laboratory sterilizers

Sterilization of glassware and equipment

12.48 This cycle corresponds to the “glassware and equipment” cycle

specified in BS2646. It is designed to sterilize clean, empty glassware (without
caps) and equipment such as tubing and filters. Loads must not contain any
fluids.

12.49 Some microbiological filter membranes may be damaged by the rapid

fluctuations in pressure used by an active air removal system, and it may be
necessary to provide a separate filter cycle.

Free steaming

12.50 This cycle is not specified in BS2646. It is designed to melt solidified

agar by exposing it to steam near atmospheric pressure. It is normally a
variable cycle. If the workload is heavy, this will not be a cost-effective way of
using a sterilizer and a Koch steamer may be more suitable .

Culture media preparator

12.51 Many of the problems which relate to sterilizing culture media can be
solved by the use of small sterilizers in which the media constituents are placed
directly into the chamber thus avoiding the use of glass containers and their
attendant hazards. Since these small machines have a unique function, their
design is specialised in comparison with other laboratory sterilizers and BS2646
is not applicable (see Part 2 of this HTM).

12.52 The manufacturer’s recommendations on operation should be

followed.

Performance qualification

12.53 Some loads processed in clinical laboratories may not be represented

by the reference loads used in the commissioning tests described in Part 3 of
this HTM. In these cases, thermometric PQ tests should be undertaken to
establish master process records for these loads.

Product release

12.54 The load may be released for use provided that:

a. during the whole of the cycle the values of the cycle variables as shown
on the batch process record are within the permitted tolerances marked
on the master process record established during performance
qualification;

b. not more than one container (or 1%, whichever is the greater) has burst
or broken.

12.55 The load should be examined for damaged containers. The occasional
broken bottle or bag may be acceptable provided intact containers have not
also been damaged.

12.56 Discard for disposal outside the laboratory must be safe to handle.

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 12.0 Operation of laboratory sterilizers

12.57 Other materials processed in the sterilizer will be used in the

laboratory. “Fit for use” should be defined by the User.

12.58 Blooming of plastic containers is a surface effect that does not harm
the container or the contents. The User should decide whether blooming is
acceptable.

Troubleshooting

Faults on make-safe cycles

12.59 A written procedure based on a risk assessment should be

established for dealing with a fault on a make-safe cycle, taking into account
the nature of the load. The usual practice is to decontaminate the sterilizer by
flushing the chamber with steam. Where this is not possible, the User should
proceed on the advice of the Laboratory Safety Officer. The guidelines given in
HSG(93)26, ‘Decontamination of equipment prior to inspection, service or
repair’, should be followed.

12.60 When considering the appropriate course of action, Users should

note the following:

a. the Laboratory Safety Officer should be notified before any attempt is

made to open the sterilizer;

b chamber condensate should be considered to be contaminated with

viable micro-organisms;

c. disinfection of the chamber and/or pipework should not involve

prolonged contact with disinfectants corrosive to metal;

d. a contaminated sterilizer should never be removed from the laboratory

for repair.

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13.0 Reporting of incidents

Introduction

13.1 The general framework for the reporting of adverse incidents and Reporting procedures are set out in
defective equipment in the NHS in England is set out in MDA SN 9701 MEL(1995)74 for Scotland, PEL(93)36
published by the Medical Devices Agency (MDA) for the NHS Management for Northern Ireland and WHC(89)26
Executive and in EPL(95)16. Arrangements for Scotland, Northern Ireland for Wales
and Wales are different. The rest of this chapter applies to England only.

13.2 Management should designate, for each sterilizer, a responsible person

to act as liaison officer for the reporting of incidents. For the purposes of this
HTM, the User is assumed to fill this role.

13.3 The User should be familiar with the reporting procedures established by
NHS Estates and the MDA and with statutory reporting requirements. Training
may be required.

13.4 Operators and others concerned with the operation of sterilizers should
know what action to take in the event of an incident or failure.

13.5 The User should ensure that a sufficient supply of the correct reporting
forms is available at all times.

13.6 The Authorised Person should advise, for each type of sterilizer, which
types of defects are to be considered as serious. The list should include all
defects which may result in failure to sterilize or danger to personnel or
damage to the product.

13.7 If a serious defect occurs, the sterilizer should be withdrawn from service
and should not be used until any necessary repairs have been made and a
repeat validation has been carried out (see Part 3 of this HTM). If the defect
involves a pressure vessel, an inspection by the Competent Person (Pressure
Systems) is required.

Department of Health reporting procedures

13.8 Certain types of defects should be reported to the Department of Health.

Reportable defects are those where some central action may be helpful in
bringing about necessary improvements in the standards of safety, design,
construction, performance reliability or economics. Examples of reportable
defects include the following:

a. accidents involving sterilizers;

b. failures of the integrity of the pressure vessel, i.e. failures of door

mechanisms, explosions and bursting or cracking of parts of the
chamber, door, jacket or structural members;

c. incipient or potential defects likely to lead to such failures;

d. failures of the basic safety devices connected with closing or opening of

the door and pressurisation of the chamber;

e. failures of electrical safety;

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 13.0 Reporting of incidents

f. any constructional features which do not comply with safety codes or

with accepted good practice or are hazardous in some way;

g. any unusual circumstances which may jeopardise safety or proper

functioning, e.g. if safety devices or the automatic process controls can
be defeated under certain conditions;

h. inability of a properly maintained and operated machine to meet the

performance standards specified for it;

j. unreliability, persistent malfunction, frequent failures of particular

components or any other feature which generates excessive or
abnormally expensive maintenance or operational requirements, having
regard to the intensity of use and operating conditions;

k. electromagnetic interference to or from other equipment and

particularly to computer control systems.

13.9 Adverse incidents should be reported either to NHS Estates or to the

MDA.

13.10 All adverse incidents involving transportable (benchtop) sterilizers

should be reported to the MDA. The reporting procedure is set out in Safety
Notice MDA SN 9701, ‘Reporting adverse incidents relating to medical
devices’. The address and telephone numbers can be found in Appendix 1.

13.11 Adverse incidents involving permanently installed sterilizers

should be reported to NHS Estates. The reporting procedure is set out in the
NHSE document, ‘Reporting defects and failures relating to non-medical
equipment, engineering plant, installed services, buildings and building
fabrics’. The address and telephone numbers can be found in Appendix 1.

13.12 The User is recommended to display a notice on or near each

sterilizer setting out the appropriate reporting procedure.

Statutory reporting procedure

The Reporting of Injuries, Diseases 13.13 The Reporting of Injuries, Diseases and Dangerous Occurrences
and Dangerous Occurrences Regulations 1995 place responsibilities on employers to report certain
Regulations (Northern Ireland) 1986 incidents and dangerous occurrences to the local office of the Health and
apply in Northern Ireland Safety Executive (HSE). The action to be taken following any incident with a
sterilizer will need to be detailed in hospital procedures to ensure compliance
with this legal requirement.

13.14 The User must notify HSE immediately, normally by telephone, if any
of the following should occur:

a. any fatal injuries to employees or other people in an accident

connected with the operation of the sterilizer;

b. any major injuries to employees or other people in an accident

connected with the operation of the sterilizer;

c. any of the dangerous occurrences listed in the Regulations.

13.15 The User must send a written report to HSE within seven days of any
incident including:

a. any of the notifiable incidents listed above;

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13.0 Reporting of incidents

b. any other injury to an employee which results in their absence from

work or being unable to do their normal work for more than three days;

c. any of the cases of ill health listed in the Regulations.

13.16 A record must be kept of any injury, occurrence or case of disease

requiring a report. This should include the date, time and place, personal
details of those involved and a brief description of the nature of the event.

13.17 Examples of dangerous occurrences applicable to sterilizers include:

a. the explosion, collapse or bursting of any closed vessel;

b. electrical short circuit or overload causing fire or explosion;

c. any explosion or fire resulting in the suspension of normal work for more
than 24 hours;

d. an uncontrolled or accidental release or escape of any pathogens or

substance from any apparatus or equipment;

e. any incident where breathing apparatus malfunctions in such a way as

to deprive the wearer of oxygen.

13.18 Examples of reportable diseases applicable to sterilizers include:

a. poisoning by ethylene oxide;

b. any illness caused by a pathogen.

13.19 Full details may be found in ‘A guide to the Reporting of Injuries,

Diseases and Dangerous Occurrences Regulations 1985’, HS(R)23, published by
HSE.

13.20 Incidents and dangerous occurrences which are reported to HSE

should also be reported either to the MDA or to NHS Estates, as appropriate,
by telephone during the first working day after the incident and then followed
by a written report.

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Glossary

The following list of definitions has been adopted in HTM 2010 and used in Part 4. Paragraph and chapter references
indicate where further information may be found in this Part. Cross references to other terms are shown in bold type.

aeration A part of the sterilization process during which sterilant gas and/or its
reaction products desorb from the load until predetermined levels are reached.
See degassing and flushing.

air detector A device used to determine that sufficient air or other non-condensable
gases have been removed from the chamber (4.37, 5.39).

automatic controller A device that, in response to predetermined cycle variables, operates the
sterilizer sequentially through the required stages of the operating cycle.

batch process record (BPR) A permanent record of one or more cycle variables recorded during a
complete operating cycle by instruments fitted permanently to the sterilizer
(2.58, 3.12).

biological indicator A device, consisting of an inoculated carrier contained within a primary pack,
designed to test the efficacy of an operating cycle (2.59).

Bowie-Dick test A test, used mainly with porous load sterilizers, to show whether or not steam
penetration into a standard test pack is even and rapid (5.33).

cartridge In EO sterilizers, a portable, single-use, simple vessel containing sterilant gas

under pressure from which the gas is delivered by puncturing the cartridge
(11.6).

chamber The part of the sterilizer in which the load is placed.

chamber furniture Shelves, pallets, loading trolleys and other fixed or movable parts that support
the load within the chamber.

chamber temperature The lowest temperature prevailing in the chamber.

chemical indicator A device designed to show, usually by a change of colour, whether specified
values of one or more cycle variables have been attained (2.64).

clinical sterilizer A sterilizer designed to process medical devices or medicinal products to

be used in the clinical care of patients.

commissioning The process of obtaining and documenting evidence that equipment has been
provided and installed in accordance with the equipment specifications and
that it functions within predetermined limits when operated in accordance
with the operational instructions.

conditioning In EO sterilizers, the treatment of a load within the operating cycle, but
prior to sterilization, to attain a predetermined temperature and humidity
throughout the load (11.8d).

contained fluid discard Discard material held in sealed glass containers or sealed plastic containers of
volume greater than 50 ml (see small plastic discard) (12.30).

97
Glossary

cooling stage The period of the operating cycle, after the holding time has been
completed, during which the load remains in the chamber while the load
cools to a safe temperature.

culture media preparator A specialised laboratory sterilizer designed for the sterilization and
dispensing of culture media (12.51).

cycle variables The physical properties. e.g. time, temperature, pressure, humidity and gas
concentration, that influence the efficacy of the operating cycle (2.43-2.55).

degassing 1. In LTSF and EO sterilizers, an aeration procedure in which sterilant gas

and its reaction products are desorbed from the load by defined treatment
outside the sterilizer after completion of the operating cycle (10.55, 11.52).

2. A pre-heating treatment of boiler feed-water to reduce the amount of non-

condensable gases in the steam supply.

discard Laboratory material which is, or may be, infected by micro-organisms and is to
be made safe before disposal.

discard bag A bag, usually of plastic, designed to receive solid discard material before
being placed in a discard box for processing by a make-safe cycle (12.27).

discard box A box designed to contain discard material for processing by a make-safe
cycle (12.24).

disinfection A process used to reduce the number of viable micro-organisms in a load but
which may not necessarily inactivate some viruses and bacterial spores.

disinfector An apparatus designed to achieve disinfection.

dry-heat sterilizer A clinical sterilizer designed to sterilize loads by exposure to hot dry air near
atmospheric pressure (Chapter 8).

EO sterilizer A clinical sterilizer designed to sterilize loads by exposure to ethylene oxide

gas or EO gas mixtures (Chapter 11).

equilibration time The period which elapses between the attainment of the sterilization
temperature in the chamber and the attainment of the sterilization
temperature in all parts of the load (2.47).

ethylene oxide (EO) Sterilant gas used to sterilize items that would be damaged by exposure to
heat or moisture. Chemical formula CH2CH2O (Chapter 11).

F0 A quantity, measured in minutes, used to determine the efficacy of an

operating cycle and equivalent to a continuous period at a temperature of
121°C (6.34).

fault The recognition by the automatic controller that the preset cycle variables
for the operating cycle have not been attained and that sterilization or
disinfection has been jeopardised.

fluid sterilizer A clinical sterilizer designed to sterilize fluids in sealed containers by exposure
to high-temperature steam under pressure (Chapter 6).

flushing In EO sterilizers, an aeration procedure by which remaining sterilant gas is

removed from the load within the chamber by the passage of air or other
inert gas (11.8h).

98
 Glossary

formaldehyde Sterilant gas used in combination with low-temperature steam to sterilize

items that would be damaged by exposure to high-temperature steam.
Chemical formula HCHO. Also known as methanal (10.9).

formalin Formaldehyde Solution BP. A 38% aqueous solution of formaldehyde

stabilised with 10% w/v ethanol, commonly used as the primary material for
generating formaldehyde gas (10.9).

free steaming A process, used in laboratory sterilizers, in which the load is exposed to
steam near atmospheric pressure (12.50).

full load A specified load, used in thermometric tests, to represent the maximum size
and mass of load which the sterilizer is designed to process.

gas exposure time In EO sterilizers, the time for which the chamber is maintained at the
specified temperature, gas concentration, pressure and humidity (2.50).

high-temperature steam Steam at a temperature above the boiling point of water at local atmospheric
pressure.

holding time The period during which the temperature in all parts of the chamber, load
and any coolant fluid is held within the sterilization temperature band. It
follows immediately after the equilibration time (2.45).

hot-air sterilizer See dry-heat sterilizer.

indicated An indicated value is that shown by a dial or other visual display fitted
permanently to the sterilizer (see recorded and measured).

Koch steamer A laboratory apparatus designed to expose a load to steam near atmospheric
pressure and commonly used for melting solidified agar (12.50).

laboratory sterilizer A sterilizer designed to sterilize, disinfect or make-safe laboratory materials

and equipment (Chapter 12).

load Collectively, all the goods, equipment and materials that are put into a
sterilizer or disinfector at any one time for the purpose of processing it by an
operating cycle.

load item One of several discrete containers, packs or other units that together constitute
a load.

load temperature probe A movable temperature sensor fitted within the sterilizer chamber and
designed to record the temperature inside selected load items (6.32, 8.31).

loading area The room or area in front of the sterilizer in which the operator works and
from which the sterilizer is loaded and unloaded. It is commonly separated by
a fascia panel from the plant room.

loading condition A specified combination of the nature and number of load items, the items of
chamber furniture, and their distribution within the chamber (2.35).

local exhaust ventilation (LEV) A ventilation system designed to extract small amounts EO or formaldehyde
vapour released during normal operation of a sterilizer and its ancillary
equipment (4.47c).

low-temperature steam (LTS) Steam at a temperature below the boiling point of water at local atmospheric
pressure.

99
Glossary

LTS disinfector A clinical disinfector designed to disinfect loads by exposure to low-

temperature steam at sub-atmospheric pressure (Chapter 9).

LTSF sterilizer A clinical sterilizer designed to sterilize loads by exposure to low-

temperature steam and formaldehyde gas at sub-atmospheric pressure
(Chapter 10).

make-safe A process, used in laboratory sterilizers, to reduce the microbial content of

contaminated material so that it can be handled and disposed of without
causing an infection hazard or environmental contamination (12.21, 12.30).

master process record (MPR) A batch process record obtained from a thermometric commissioning or
performance qualification test and annotated to show the permitted
tolerances for cycle variables during subsequent testing and routine
production (2.71).

measured A measured value is that shown on a test instrument, such as a thermometric

recorder or a test pressure gauge, attached to the sterilizer for test purposes
(see indicated and recorded).

medical device Any instrument, apparatus, appliance, material or other article, whether used
alone or in combination, including the software necessary for its proper
application, intended by the manufacturer to be used for human beings for
the purpose of diagnosis, prevention, monitoring, treatment or alleviation of
disease; diagnosis, monitoring, treatment, alleviation of or compensation for
an injury or handicap; investigation, replacement or modification of the
anatomy or of a physiological process; control of conception; and which does
not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be
assisted in its function by such means (source: EU Council Directive 93/42/EEC)
(1.12).

medicinal product Any substance or combination of substances presented for treating or

preventing disease in human beings or animals. Any substance or combination
of substances which may be administered to human beings or animals with a
view to making a medical diagnosis or to restoring, correcting, or modifying
physiological functions in human beings or in animals is likewise considered a
medicinal product (source: EU Council Directive 65/65/EEC) (1.8).

non-condensable gases (NCGs) Gases which cannot be liquefied by compression under the range of conditions
of temperature and pressure used during the operating cycle.

noted A noted value is that written down by the operator, usually as the result of
observing an indicated, recorded or measured value.

operating cycle The set of stages of the sterilization or disinfection process carried out in
sequence and regulated by the automatic controller. It is synonymous with
the terms “sterilization cycle” for sterilizers and “disinfection cycle” for
disinfectors.

override A system by which the progress of the operating cycle can be interrupted or
modified as necessary.

paraformaldehyde A mixture of polymethylene glycols formed by the reaction of formaldehyde

with water (10.12).

100
 Glossary

performance qualification (PQ) The process of obtaining and documenting evidence that the equipment, as
commissioned, will produce acceptable product when operated in accordance
with the process specification (2.34).

performance requalification (PRQ) The process of confirming that the evidence obtained during performance
qualification remains valid.

periodic tests A series of tests carried out at daily, weekly, quarterly and yearly intervals.

personal protective equipment (PPE) Equipment, including clothing, which is intended to be worn or held by a
person at work and which protects against one or more risks to his or her
health and safety (2.14).

plant history file A file containing validation, maintenance and other engineering records for
each sterilizer (3.9).

plant room The room or area to the rear of the sterilizer in which services are connected
and which provides access for maintenance. It is commonly separated by a
fascia panel from the loading area.

plateau period The equilibration time plus the holding time (2.48).

porous load sterilizer A clinical sterilizer designed to process, by exposure to high-temperature

steam under pressure, porous items such as towels, gowns and dressings, and
also medical devices that are wrapped in porous materials such as paper or
fabrics (Chapter 5).

preconditioning Treatment of a load to attain predetermined conditions, such as temperature

and humidity, before the start of an operating cycle (11.31).

pressure ballasting A technique used in fluid sterilizers by which the pressure in the chamber is
maintained at or near to the pressure inside the load containers during all or
part of the operating cycle (6.9, 6.16).

pressure vessel A collective term describing the sterilizer chamber, jacket (if fitted), door(s)
and components that are in permanent open connection with the chamber
(4.17).

priming Of a steam generator, the delivery of steam containing water in suspension

due to violent boiling or frothing (5.42).

process indicator A chemical indicator used to distinguish between processed and unprocessed
load items (2.64).

recommissioning A procedure to confirm that operational data established during

commissioning remain valid.

recorded A recorded value is that shown on the output of a recording instrument fitted
permanently to the sterilizer (see indicated and measured).

revalidation A procedure to confirm an established validation, consisting of

recommissioning followed by performance requalification.

safety hazard A potentially detrimental effect on persons or the surroundings arising directly
from either the sterilizer or its load.

saturated steam Steam whose temperature, at any given pressure, corresponds to that of the
vaporisation curve of water.

101
Glossary

small load A specified load, used in thermometric tests, to represent the minimum size
and mass of load which the sterilizer is designed to process.

small plastic discard Discard material comprising or held in plastic containers not exceeding 50 ml
in volume (12.21).

sterilant An agent used to effect sterilization, such as steam, hot air, or a sterilizing
gas.

sterile Condition of a load item that is free from viable micro-organisms. See EN 556
for the requirements for a medical device to be labelled “sterile”.

sterilization A process undertaken to render a load sterile.

sterilization conditions The ranges of the cycle variables which may prevail throughout the chamber
and load during the holding time (2.46).

sterilization process The complete set of procedures required for sterilization of a load, including
the operating cycle and any treatment of the load before or after the
operating cycle.

sterilization temperature Minimum acceptable temperature of the sterilization temperature band

(2.51).

sterilization temperature band The range of temperatures which may prevail throughout the load during the
holding time. These temperatures are expressed as a minimum acceptable
(the sterilization temperature) and a maximum allowable and are stated to
the nearest degree Celsius (2.51).

sterilizer An apparatus designed to achieve sterilization.

sterilizer process log A log, kept by the User, which contains records for each production cycle
(3.10).

superheated steam Steam whose temperature, at any given pressure, is higher than that indicated
by the vaporisation curve of water (5.47).

thermal door-lock An interlock fitted to certain sterilizers to prevent the door from being
opened until the temperature in the chamber and load falls below a preset
value (12.15).

transportable Requiring no permanent connections or installation and capable of being

moved manually without mechanical assistance. Synonymous with “bench-
top”.

usable chamber space The space inside the chamber which is not restricted by chamber furniture
and which is consequently available to accept the load.

validation A documented procedure for obtaining, recording and interpreting data

required to show that a sterilization process will consistently comply with
predetermined specifications.

102
Abbreviations

BP British Pharmacopoeia

BPR batch process record

BS British Standard

°C degree Celsius

CEN European Committee for Standardisation (Comité Européen de Normalisation)

CFCs chlorofluorocarbons

COSHH Control of Substances Hazardous to Health (Regulations)

EN European Standard (Europäische Norm)

EO ethylene oxide

EU European Union (formerly European Community)

GGMP EU ‘Guide to good manufacturing practice for medicinal products’

HBN Health Building Note

HCFCs hydrochlorofluorocarbons

HSC Health and Safety Commission

HSE Health and Safety Executive

HTM Health Technical Memorandum

ISO International Organisation for Standardisation

kg kilogram

LTMEL long-term maximum exposure limit

LTS low-temperature steam

LTSF low-temperature steam and formaldehyde

m metre

mbar millibar

MCA Medicines Control Agency

MDA Medical Devices Agency

min minute

103
Abbreviations

ml millilitre

MPR master process record

mS millisiemens

NHS National Health Service

NHSE NHS Estates

PM planned maintenance

PPE personal protective equipment

ppm parts per million

PQ performance qualification

PRQ performance requalification

PVC polyvinyl chloride

RH relative humidity

SSD sterile services department

STMEL short-term maximum exposure limit

TSE transmissible spongiform encephalopathy

UK United Kingdom

104
Bibliography

Legislation

The Active Implantable Medical Devices Regulations 1992 (SI

1992/3146).

The Control of Substances Hazardous to Health Regulations 1994 (SI

1994/3246).

The Manual Handling Operations Regulations 1992 (SI 1992/2793).

The Manual Handling Operations Regulations (Northern Ireland) 1992

(SR 1992/535).

The Medical Devices Regulations 1994 (SI 1994/3017).

The Personal Protective Equipment at Work Regulations 1992 (SI

1992/2966).

The Personal Protective Equipment at Work Regulations (Northern

Ireland) 1993 (SR 1993/20).

The Pressure Systems and Transportable Gas Containers Regulations

1989 (SI 1989/2169).

The Pressure Systems and Transportable Gas Containers Regulations

(Northern Ireland) 1991 (SR 1991/471).

The Provision and Use of Work Equipment Regulations 1992 (SI

1992/2932).

The Provision and Use of Work Equipment Regulations (Northern

Ireland) 1993 (SR 1993/19).

The Reporting of Injuries, Diseases and Dangerous Occurrences

Regulations 1985 (SI 1985/2023).

The Reporting of Injuries, Diseases and Dangerous Occurrences

Regulations (Northern Ireland) 1986 (SI 1986/247).

European Union Directives

65/65/EEC – Council Directive of 26 January 1965 on the approximation

of provisions laid down by law, regulation or administrative action
relating to proprietary medicinal products. OJEC No 22, p 369 (9 Feb
1965).

90/385/EEC – Council Directive of 20 June 1990 on the approximation

of the laws of the Member States relating to active implantable
medical devices. OJEC No L189, p 17 (20 Jul 1990).

105
Bibliography

93/42/EEC – Council Directive of 14 June 1993 concerning medical

devices. OJEC No L169, p 1 (12 Jul 1993).

Health and safety publications

Health and Safety Commission (HSC) and Health and Safety Executive (HSE)
publications are available from HMSO bookshops or HSE Books, PO Box 1999,
Sudbury, Suffolk CO10 6FS. General enquiries and requests for free leaflets
should be addressed to the HSE Information Centre, Broad Lane, Sheffield S3
7HQ. Tel. (0742) 892345 (general enquiries), (0742) 892346 (free leaflets). Fax
(0742) 892333.

Advisory Committee on Dangerous Pathogens, Categorisation of

pathogens according to hazard and categories of containment (second
edition), HSE 1990.

Advisory Committee on Dangerous Pathogens, Precautions for work

with human and animal Transmissible Spongiform Encephalopathies,
HSE 1994.

Health Services Advisory Committee, Guidance on the manual handling

of loads in the health services, HSE 1992.

Health Services Advisory Committee, Guidance on the recording of

accidents and incidents in the health services, HSC 1986.

Health Services Advisory Committee, Safe working and the prevention

of infection in clinical laboratories, HSC 1991.

Health Services Advisory Committee, Safe working and the prevention

of infection in clinical laboratories: model rules for staff and visitors,
HSC 1991.

A guide to the Reporting of Injuries, Diseases and Dangerous

Occurrences Regulations 1985 (HS(R)23)

The maintenance, examination and testing of local exhaust ventilation

(HS(G)54), HSE 1990.

Manual handling (L23), Manual Handling Operations Regulations 1992:

Guidance on Regulations. HSE 1992.

Occupational Exposure Limits (EH40), HSE (published annually).

Personal protective equipment at work (L25), Personal Protective

Equipment at Work Regulations 1992: Guidance on Regulations.
HSE 1992.

Safety at autoclaves (PM73), HSE 1990.

Work equipment (L22), Provision and Use of Work Equipment

Regulations 1992: Guidance on Regulations. HSE 1992.

106
 Bibliography

British Standards

British Standards are available from the Sales Department, British Standards
Institution, Linford Wood, Milton Keynes MK14 6LE. Tel. (01908) 226888
(enquiries), (01908) 221166 (orders). Fax (01908) 322484.

BS2646: Autoclaves for sterilization in laboratories

Part 1: 1993 Specification for design, construction, safety and

performance

Part 2: 1990 Guide to planning and installation

Part 3: 1993 Guide to safe use and operation

Part 4: 1991 Guide to maintenance

Part 5: 1993 Methods of test for function and performance

BS3970: Sterilizing and disinfecting equipment for medical products

Part 1: 1990 Specification for general requirements

Part 2: 1991 Specification for steam sterilizers for aqueous fluids in sealed
rigid containers

Part 3: 1990 Specification for steam sterilizers for wrapped goods and
porous loads

Part 4: 1990 Specification for transportable steam sterilizers for

unwrapped instruments and utensils

Part 5: 1990 Specification for low-temperature steam disinfectors

Part 6: 1993 Specification for sterilizers using low temperature steam with
formaldehyde

BS4275: 1974 Recommendations for the selection, use and

maintenance of respiratory protective equipment.

European Standards

European Standards (issued in the UK with the prefix BS EN) are available
from the British Standards Institution. The titles of draft standards may change
before publication.

EN 285: draft Sterilization – steam sterilizers – large sterilizers

EN 550: 1994 Sterilization of medical devices – Validation and routine

control of ethylene oxide sterilization

EN 554: 1994 Sterilization of medical devices – Validation and routine

control of sterilization by moist heat

EN 556: 1994 Sterilization of medical devices: requirements for

terminally sterilized medical devices to be labelled ‘STERILE’

EN 866: Biological systems for testing sterilizers

Part 1: draft General requirements

Part 2: draft Systems for use in ethylene oxide sterilizers

Part 3: draft Systems for use in steam sterilizers

107
Bibliography

Part 5: draft Systems for use in low temperature steam and formaldehyde
sterilizers

Part 6: draft Systems for use in dry heat sterilizers

EN 867: Non-biological indicators for use in sterilizers

Part 1: draft General requirements

Part 2: draft Process indicators (Class A)

Part 3: draft Specification for Class B indicators for use in the Bowie and
Dick test

EN 868: Packaging materials for sterilization of wrapped goods

Part 1: draft General requirements and requirements for the validation of

packaging for terminally sterilized devices

Part 2: draft Sterilization wrap – requirements and tests

Part 3: draft Paper for use in the manufacture of paper bags and in the
manufacture of pouches and reels – requirements and tests

Part 4: draft Paper bags – requirements and tests

Part 5: draft Heat sealable pouches and reel material of paper and plastic
film construction – requirements and tests

Part 6: draft Paper for the manufacture of packs for medical use for
sterilization by ethylene oxide or irradiation – requirements and tests

Part 7: draft Adhesive coated paper for the manufacture of packs for
medical use for sterilization by ethylene oxide or irradiation –
requirements and tests

Part 8: draft Reusable sterilization containers – requirements and tests

Part 9: draft Non-woven uncoated materials of high density polyethylene

fibres (non-woven HDPE) for use in the manufacture of pouches, reels,
etc. – requirements and tests

Part 10: draft Non-woven adhesive coated materials of high density

polyethylene fibres (non-woven HDPE) for use in the manufacture of
pouches, reels, etc. – requirements and tests

Part 11: draft Heat-sealable pouches and reel materials of non-woven high
density polyethylene fibres (non-woven HDPE) and plastic film
construction – requirements and tests

EN 1174 Sterilization of medical devices – Estimation of the population

of micro-organisms on product

Part 1: draft Requirements

Part 2: draft Guidance

Part 3: draft Guide to the methods for validation of microbiological

techniques

EN 1422: draft Sterilizers for medical purposes – ethylene oxide

sterilizers – specification

EN ISO 9001: 1994 Quality systems – Model for quality assurance in

design/development, production, installation and servicing

108
 Bibliography

EN ISO 9002: 1994 Quality systems – Model for quality assurance in

production, installation and servicing

EN 30993 Biological evaluation of medical devices

Part 7: draft Ethylene oxide sterilization residuals

EN 46001: 1993 Quality systems – Medical devices – Particular

requirements for the application of EN 29001 [now EN ISO 9001]

EN 46002: 1993 Quality systems – Medical devices – Particular requirements

for the application of EN 29002 [now EN ISO 9002]

EN 61010 Safety requirements for electrical equipment for measurement,

control and laboratory use

Part 1: 1993 General requirements

Part 2-041: draft Particular requirements for autoclaves and sterilizers

using steam for the treatment of medical materials and for laboratory
processes

Part 2-042: draft Particular requirements for autoclaves and sterilizers

using toxic gas for the treatment of medical materials and for
laboratory processes

Part 2-043: draft Particular requirements for dry heat sterilizers using either
hot air or hot inert gas for the treatment of medical materials and for
laboratory processes

International Standards

ISO 11737 Sterilization of medical devices – Microbiological methods

Part 1: draft Estimation of population of microorganisms on products

Part 2: draft Tests of sterility performed in the validation of a sterilization

process

Department of Health publications

Advisory Committee on Dangerous Pathogens: Guidance on

precautions for work with human and animal transmissible spongiform
encephalopathies (TSEs) (PL(94)CO/5), Department of Health, 24
September 1994.

Decontamination of equipment prior to inspection, service or repair

(HSG(93)26), NHS Management Executive, 17 June 1993.

Guide to good manufacturing practice for National Health Service

sterile services departments (EL89(P)136), 1989.

Scotland

Accommodation for pathology services (Scottish Health Planning Note

15)

109
Bibliography

Reporting of adverse incidents and defective equipment (MEL(1995)74),

NHS in Scotland Management Executive, 23 November 1995.

Sterile services department (Scottish Health Planning Note 13)

Health Building Note 13 Supplement 1: Ethylene oxide sterilization

section (MEL (1995)48), NHS in Scotland Management Executive, 24 July
1995.

Decontamination of health care equipment prior to inspection, service

or repair (DGM(87)66). Scottish Office, Department of Health, 1987.

Wales

Reporting accidents with and defects in medicinal products; buildings

and plant; and other medical and non-medical equipment and supplies
(WHC(89)26), Welsh Office, 21 August 1989.

Reporting adverse incidents relating to medical devices (WO

SAB(96)08), Welsh Office, February 1996.

Decontamination of health care equipment prior to inspection, service

or repair with addendum (WHC(87)41). Welsh Office, 1987.

Northern Ireland

Reporting adverse incidents and reactions and defective products

relating to medical and non-medical equipment and supplies, food,
buildings and plant and medicinal products (PEL(93)36)

Decontamination of equipment prior to inspection, service or repair

(PEL(94)34). Management Executive Estates Services Directorate Northern
Ireland, 1994.

NHS Estates publications

HBN 13 – Sterile services department, NHS Estates 1992.

HBN 13 Supplement 1 – Ethylene oxide sterilization section, NHS Estates

1994.

HBN 15 – Accommodation for pathology services, NHS Estates 1991.

HTM 10 – Sterilizers, DHSS 1980 (out of print).

HTM 83 – Firecode: Fire safety in healthcare premises: general fire

precautions. NHS Estates, 1994.

HTM 2010 – Sterilization, NHS Estates 1994/5/6 (5 volumes).

HTM 2025 – Ventilation in healthcare premises, NHS Estates 1994

(4 volumes).

HTM 2030 – Washer-disinfectors (in preparation).

HTM 2031 – Clean steam for sterilization (in preparation).

110
 Bibliography

Reporting defects and failures relating to non-medical equipment,

engineering plant, installed services, and building fabric (EPL(95)16).
NHS Estates.

Medical Devices Agency publications

Activities of healthcare establishments (in-house manufacture) in the

UK (Directives Bulletin 18), Medical Devices Agency, June 1995.

Decontamination of equipment prior to inspection, service or repair

(HSG(93)26), NHS Management Executive, 17 June 1993.

Information about the EC Medical Devices Directives (Directives

Bulletin 8), Medical Devices Directorate, April 1993.

Reporting adverse incidents and reactions, and defective products

relating to medical and non-medical equipment and supplies, food,
buildings and plant, and medicinal products (HSG(93)13), NHS
Management Executive, 1993.

Reporting adverse incidents relating to medical devices (MDA SN

9701), Medical Devices Agency, 1997.

The reuse of medical devices supplied for single use only (MDA
Bulletin 9501), Medical Devices Agency – [DATE UNKNOWN]

Sterilization, disinfection and cleaning of medical equipment: guidance

on decontamination from the Microbiology Committee to Department
of Health Medical Devices Directorate, Medical Devices Directorate, 1993.

Other references

Code and rules of conduct and disciplinary regulations for registered

Authorised Persons (Sterilizers), Institute of Healthcare Engineering and
Estate Management (First draft, undated).

Guidelines for the safe operation of ethylene oxide sterilization plant,

ICI plc (undated).

Information relevant to the installation of, and ancillary equipment

for, ethylene oxide sterilizers (CEN TC 102 WG6 N67+), CEN
(unpublished).

Product safety data: ethylene oxide, ICI Chemicals & Polymers Ltd 1995.

The rules governing medicinal products in the European Community.

Volume IV: Good manufacturing practice for medicinal products
(CO-71-91-760-EN-C), Office for Official Publications of the European
Communities 1992.

Sterilization and disinfection of heat-labile equipment, Central Sterilising

Club 1986.

The collection, fractionation, quality control and uses of blood and

blood products, World Health Organisation 1981.

111
Appendix 1 – Useful addresses

UK health agencies

NHS Estates, 1 Trevelyan Square, Boar Lane, Leeds LS1 6AE

Switchboard: Tel. 0113-254 7000.
Defect and failure reports: Tel: 0113-254 7052.

Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London SW8
5NQ, Tel. 0171-273 3000.

Medical Devices Agency, Hannibal House, Elephant and Castle, London SE1
6TQ. Switchboard: Tel. 0171-972 8000, Adverse Incidents Centre: Tel: 0171-
972 8080, Fax: 0171-972 8109. Internet: mda_mail@mda.win-uk.net

Public Health Laboratory Service, Central Public Health Laboratory, 61

Colindale Avenue, London NW9 5HT, Tel. 0181-200 4400.

Scotland

Healthcare Engineering and Environment Unit, University of Strathclyde, Room

8:51 Graham Hills Building, 50 George Street, Glasgow G1 1QE
Tel. 0141-552 4400, extension 3446.

Incident Reporting and Investigation Centre, Scottish Healthcare Supplies,

Trinity Park House, South Trinity Road, Edinburgh EH5 3SH
Daytime help and report line: 0131-551 8333,.emergency: 0131-552 6380,
fax 0131-552 6535.

The Scottish Centre for Infection and Environmental Health, Ruchill Hospital,
Glasgow G20 9NB. Tel. 0141-946 7120.

Scottish Healthcare Supplies, Trinity Park House, South Trinity Road, Edinburgh
EH5 3SH. Tel. 0131-552 6255.

Estates Environment Forum, c/o Healthcare Engineering and Environment Unit,

University of Strathclyde, Room 8.51, Graham Hills Building, 50 George Street,
Glasgow G1 1QE. Tel. 0141-548 3446.

Wales

Welsh Office, Cathays Park, Cardiff CF1 3NQ, Tel. (01222) 825111.

Northern Ireland

Estate Policy, Health Estates, Stoney Road, Dundonald, Belfast BT16 0US
Tel. (01232) 520025, fax (01232) 523900
Defect centre: (01232) 523714.

112
 Appendix 1 – useful addresses

Health and safety

Health and Safety Executive, Broad Lane, Sheffield S3 7HQ. Tel. 0114-289
2345, fax 0114-289 2333. Addresses of area HSE offices may be found in the
local telephone directory.

Standards organisations

British Standards Institution, Head office: 2 Park Street, London W1A 2BS,
Publications: Linford Wood, Milton Keynes MK14 6LE. Tel. (01908) 221166.

European Committee for Standardisation, Rue de Stassart 36, B-1050 Brussels.

Other organisations

Central Sterilising Club, c/o A.C. Viant (Secretary), 2 Crown Court, Bradford-
on-Avon BA15 1BG. Tel. (01225) 865042, fax (01225) 868416.

Institute of Healthcare Engineering and Estate Management, 2 Abingdon

House, Cumberland Business Centre, Northumberland Road, Portsmouth PO5
1DS. Tel. (01705) 823186.

Institute of Sterile Services Management, (Chairman) Mrs Ishbel Ingram, Sterile

Services Manager, Hope Hospital, Salford Royal Hospitals NHS Trust, Stott
Lane, Salford M6 8HD. Tel. (0161) 787 5098, fax (0161) 787 5096.

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Appendix 2 – Sterilization of items
contaminated with TSE agents

Introduction

A2.1 The following information is extracted from the HSE document

‘Precautions for work with human and animal Transmissible Spongiform
Encephalopathies’, compiled by the Advisory Committee on Dangerous
Pathogens and issued to the NHS under Department of Health circular
PL(94)CO/5.

A2.2 The term transmissible spongiform encephalopathy (TSE) describes a rare

and fatal degenerative condition of the central nervous system occurring in
man and in certain animal species. The three TSEs that are recognised in man
are:

a. Creutzfeld-Jakob disease (CJD);

b. Gerstmann-Straussler-Scheinker syndrome (GSS);

c. kuru.

A2.3 The two chief TSEs in animals include:

a. scrapie (in sheep);

b. bovine spongiform encephalopathy (BSE).

A2.4 Similar diseases include transmissible mink encephalopathy (TME),

chronic wasting disease (CWD) in Rocky Mountain elk and captive mule deer,
and TSEs in small numbers of exotic ungulates and cats.

A2.5 Although these diseases appear to be caused by transmissible agents, the

nature of these agents remains uncertain.

A2.6 Animal TSEs are classified as Hazard Group 1. Human TSEs are now
classified as Hazard Group 3 (formerly Hazard Group 2) as required by the
COSHH Regulations 1994, although full Containment Level 3 precautions are
not always required.

Sterilization

A2.7 All agents of TSE exhibit an unusual resistance to conventional

decontamination methods used in clinical and laboratory practice. They are not
significantly affected by a number of standard chemical agents such as
formalin and ethylene oxide, and infectivity persists after autoclaving at
conventional times and temperatures (such as 121°C for 15 min). In addition,
only extremely high doses of ionising and UV irradiation have been successful
in reducing infectivity.

A2.8 The Advisory Committee on Dangerous Pathogens recommends porous

load sterilization as the method of choice in most situations. Two processes are
recommended:

a. a single cycle at 134-138°C for a minimum holding time of 18 min; or

b. six cycles at 134-138°C for a minimum holding time of 3 min.

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 Appendix 2 – Sterilization of items contaminated with TSE agents

A2.9 The latter represents the standard operating cycle for a porous load
sterilizer (run six times) and may be used if the single, longer cycle is not
available.

A2.10 Although no practical problems appear to have arisen with this time
and temperature combination, recent preliminary studies of a scrapie agent
under rigorous experimental conditions have shown some residual infectivity.
This may be due to the use of relatively high-titred and more thermostable
strains. Further work is planned to confirm the appropriate lower temperature
limit.

A2.11 Users should consult Annex 2 of the HSE document for specialised
advice on:

a. the effectiveness of other sterilization processes;

b. treatment of work surfaces and non-heat-stable equipment;

c. decontamination and disposal of liquids;

d. decontamination of microbiological safety cabinets;

e. fixation for histology;

f. disposal of tissue.

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Appendix 3 – Safety of EO sterilization

Introduction

A3.1 Ethylene oxide presents hazards not found in conventional sterilizers. The Reporting of Injuries, Diseases and
The vapour is extremely flammable and irritates both the eyes and the Dangerous Occurrences Regulations
respiratory system. Poisoning by ethylene oxide is a reportable disease listed (Northern Ireland) 1986 apply in
in Schedule 2 of The Reporting of Injuries, Diseases and Dangerous Northern Ireland
Occurrences Regulations 1985.

A3.2 Much of the guidance in this appendix is drawn, with permission, from
‘Guidelines for the safe operation of ethylene oxide sterilization plant’
published by ICI plc but no longer available.

A3.3 The advice is primarily aimed at Users of large sterilizers supplied from
cylinders. Many of the precautions described here will not be necessary for
Users of small sterilizers supplied from disposable cartridges. However, all Users
of EO sterilizers are strongly advised to make a risk assessment of the worst
case accident that could occur. The amount of EO that could be involved is of
prime consideration; the small amount contained in a cartridge is unlikely, for
example, to lead to spillages of liquid.

A3.4 Personnel exposure to ethylene oxide should not exceed the maximum
exposure limits given in Table 1.

A3.5 Persons employed on plant handling EO should be adequately trained

and provided with detailed operating instructions.

A3.6 A selection of physical and chemical properties of EO is listed in Table

A1.

Table A1 Selected properties of ethylene oxide

Relative molecular mass 44.05

Form Liquefied gas
Colour Colourless
Odour Ethereal
Odour threshold 450 – 700 ppm
Boiling point 10.5°C
Flash point (open cup) –17.8°C

Flammable limits in air (v/v) 3 – 100%

Auto ignition temperature 429°C
Vapour pressure 139 kPa (20°C), 349 kPa (50°C)
Density of liquid at 4°C 890 kg m–3
Solubility Miscible in water
Vapour density (air = 1) 1.5

Sources: ‘Product safety data’, ICI Chemicals & Polymers Ltd, 1995; ‘Information relevant to the
installation of, and ancillary equipment for, ethylene oxide sterilizers’, CEN TC 102 WG6 N67+, CEN
(unpublished).

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 Appendix 3 – Safety of EO sterilization

Fire and explosion hazards

Further guidance is contained in A3.7 EO is highly flammable and forms explosive mixtures with air at all
HTM 83 – ‘Fire safety in healthcare concentrations above 3% (v/v). There is no upper explosive limit as normally
premises: general fire precautions’ expected for hydrocarbons; exothermic reaction replaces combustion at higher
concentrations up to 100%. The auto-ignition temperature in air at
atmospheric pressure is 429°C, and the decomposition temperature in the
absence of air is 560°C.

A3.8 Because of its flammability and low boiling point, EO is akin to liquefied
petroleum gas (LPG). An essential difference is that it is fully miscible with
water. At concentrations in water below 1% w/w the vapours are not
flammable at air ambient temperature, so a leakage of liquid EO can be
rendered non-flammable by diluting it 100-fold with water. In the open air
appreciably less dilution (24-fold) can extinguish burning EO.

A3.9 Fire risks in general and electrical classifications are covered by

conforming to typical codes related to the storage of LPG or liquefied natural
gas (LNG) products and to the selection of electrical installations for use in
flammable atmospheres. Additional precautions are called for because of the
thermal instability of EO.

A3.10 Accumulation of electrostatic charge does not take place in EO

because of its high electrical conductivity (> 3 mS m–1). There is thus no
reason to limit flow velocities in pipework.

A3.11 The aim should be to handle EO in closed equipment and to deal

promptly with any leaks or spillages whenever these occur.

A3.12 For detecting leaks, gas detectors with automatic alarms located at
strategic points (e.g. near the sterilizer door) are recommended.

A3.13 The prime defence against escaped EO is the use of water in very
large quantities to dilute the EO and render it non-flammable. Insufficient
amounts of water, on the other hand, may promote the vaporisation of EO
from large spillages.

Polymerisation

A3.14 Liquid EO is very susceptible to polymerisation initiated at ambient

temperature by acids, bases or catalysts, such as anhydrous chlorides of iron,
aluminium, tin and metal oxides. Iron rust is a moderate initiator for this
reaction and therefore it should be substantially removed from any equipment
containing EO. Purely thermal initiation starts at around 100°C and once
started, iron is a promoter. The polymerisation is highly exothermic and if the
temperature is not controlled the polymerisation is self-accelerating, leading to
vaporisation of unreacted EO and possibly to explosive decomposition of the
vapour.

A3.15 Slow polymerisation can occur, producing solid polymer, which is

thermally stable. Solid polymer is soluble in the monomer. The polymer may
also contain considerable amounts of dissolved monomer which during
dispersal, may be released into the atmosphere.

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Appendix 3 – Safety of EO sterilization

Toxicity hazards

Vapour toxicity

A3.16 EO boils at 10.5°C and vaporises at normal atmospheric temperature

and pressure so that exposure of personnel to vapour, rather than liquid
contact, is the more likely hazard. High concentrations of the gas in contact
with the skin may produce serious burns if not removed immediately. It has
been reported that concentrations of 2000 ppm retained in rubber gloves have
caused skin irritation.

A3.17 Exposure to EO vapour causes irritation of the eyes and respiratory

system accompanied by headache. The vapour has anaesthetic properties.
Signs and symptoms may include nausea, vomiting, coughing, irritation to the
nose, loss of smell and, progressively, dizziness, stupor and coma. These effects
are noticeable at concentrations greater than 50 ppm. Acute symptoms are
normally delayed except in the case of serious exposure. Fluid build-up in the
lungs (pulmonary oedema) may occur up to 48 hours after exposure and could
prove fatal. The effects of low concentrations of EO are not thought to be
cumulative, though the evidence is equivocal and the subject of continuing
research.

A3.18 The sweetish smell of pure EO is not apparent until the concentration
reaches several hundred ppm (figures between 400 and 700 ppm have been
quoted), far above the level at which harm is caused. Personnel concerned
with the operation of EO sterilizers cannot rely on smell to protect themselves
against exposure. It is essential that EO environmental tests are carried out at
least once a year and that there is an effective system for personal monitoring.

A3.19 Adverse reproductive effects (reduced fertility and embryotoxicity)

have been reported in rats exposed to high concentrations for prolonged
periods. Epidemiological studies on human reproductive effects have so far
been inconclusive although spontaneous abortions and an excess of foetal
deaths have been reported among women exposed to EO. The exposure levels
are not known.

A3.20 EO is mutagenic in a wide variety of in vitro and in vivo biological test

systems. It has been shown to cause cancer in animals and HSE advises that it
should be regarded as a potential human carcinogen.

Effects of liquid EO on skin and eyes

A3.21 Liquid EO can persist under open conditions, particularly at low

temperatures. Serious freeze burns can result from contact from liquid splashes
or spray. Solutions of EO in water cause more rapid burning than the dry
material. Delayed inflammation of the skin may also result.

A3.22 The eyes are particularly susceptible to serious permanent damage

from splashes, even of dilute solutions. The onset of effects may be delayed for
several hours.

Workplace monitoring and recording

A3.23 Atmospheric concentrations of EO should be monitored in the

appropriate working area and any abnormalities should be reported,
investigated and corrected.

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 Appendix 3 – Safety of EO sterilization

A3.24 While background atmospheric monitoring of the sterilization and

quarantine areas is recommended, regular personal monitoring of operators
working in these areas is regarded as essential in assessing exposure.

A3.25 All assessment of operator exposure should be based on personal

monitoring unless this can be obtained from workplace air sampling by
showing the necessary correlation. Monitoring should be based on an 8-hour
exposure unless it has been shown that exposure occurs only at specific times;
in such cases the shift exposure may be calculated from measurements made
at these times. Additionally, spot measurements should be made at times of
peak exposures with a view to reducing these levels.

A3.26 Plant monitoring may be useful for the early detection of leaks but
considerable thought should be given to the siting of sample points and the
frequency of sampling.

A3.27 Records should be established of the names and job classification of

operators who work in areas where exposure to EO may occur. All personal
monitoring results should be recorded. Records should be kept of all cases of
acute exposure to EO. All of these records should be kept for at least 30
years.

A3.28 Users setting up monitoring systems are strongly recommended to

obtain advice both from gas manufacturers or suppliers and also from
properly qualified occupational health consultants.

Personal sampling

A3.29 Personal sampling should be undertaken to evaluate the level of

exposure of individuals. It is the only technique recognised by HSE as
producing results for judging compliance with the established exposure limits.

A3.30 A number of methods based on collection of atmospheric EO on a

solid adsorbent, such as charcoal, are available. There are principally two
types;

a. active sampling using a small pump;

b. passive diffusion.

A3.31 Both systems require the subsequent desorption and estimation of

EO.

Environmental monitoring

A3.32 Systems which are currently in use for environmental monitoring are
based on several analytical techniques including infrared spectroscopy, flame
ionisation, photoionisation, mass spectrometry and gas chromatography. It
should be borne in mind that each suffers from limitations dependent upon
interference from other compounds which may be present concurrently with
EO. The system to be established should be considered in relation to the
particular installation for which it is intended.

A3.33 Newer and simpler techniques are continuously being developed and
the current state-of-the-art should be considered before commitment to any
particular system is made.

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Appendix 3 – Safety of EO sterilization

A3.34 The principal systems available are as follows.

a. Colour-changes indicator system (1 – 30 ppm). This system is for spot

monitoring and cannot give accurate time-weighted average reading of
exposure. The MEL for EO is at the low end of the detection range,
hence accuracy is poor. The system does not pinpoint the source of
emissions.

b. Direct-reading infrared analysers (0.2 – 1000 ppm). This equipment can

be portable for single-point monitoring. More elaborate static units are
available for continuous cycle and multipoint monitoring. These systems
can give accurate time-weighted average figures for specific points and
extremely good historical perspective, but give no indication of
concentrations in the air breathed by personnel.

c. Gas chromatography. As with infrared there are both portable and static
units providing a sensitivity of 0.1 ppm, depending upon sample size and
analytical system. All gas chromatography applications for time-weighted
average readings require charcoal tubes for adsorption and desorption.

Personal protective equipment

A3.35 Personal protective equipment (PPE) guarding against the effects of

EO should not need to be used as a matter of routine, since the sterilizer
design, ventilation systems and operating procedures should preclude the
presence of harmful concentrations of EO.

A3.36 Where work in contact with EO is unavoidable, the following items of

PPE should be available:

a. for exposure to EO vapour – respiratory protective equipment and eye

protection;

b. for exposure to EO liquid – air breathing hood, protective suit, gloves

and rubber boots.

A3.37 There should be training programmes to ensure that the relevant

people are able to use PPE correctly and quickly. Training should be carried out
by a suitably qualified instructor.

A3.38 Suitable arrangements should be made for periodic maintenance of

the equipment.

A3.39 Records should be kept of both training and maintenance.

Respiratory protective equipment

A3.40 Where atmospheric concentrations of EO are, or could reasonably be

expected to be, above the Maximum Exposure Limit (see Table 1), suitable
respiratory protective equipment should be worn. This may be self-contained
breathing apparatus, compressed air line breathing apparatus or a suitable
canister respirator, the type of equipment being selected according to the
levels of EO which may be present.

A3.41 The equipment should comply with all relevant British or European
Standards. In selecting suitable equipment, reference should be made to
BS4275, ‘Recommendations for the selection, use and maintenance of
respiratory protective equipment’.

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 Appendix 3 – Safety of EO sterilization

A3.42 The system chosen should be adequate for the protection of the
wearer under all foreseeable circumstances. Factors to be taken into
consideration are:

a. the highest possible exposure level;

b. the longest possible excursion time;

c. the nominal protection factor of the equipment; this will indicate the
efficiency of the equipment (the best nominal protection factor is
conferred by positive-pressure breathing apparatus);

d. the goodness of fit of face masks.

Breathing apparatus

A3.43 Full, positive-pressure breathing apparatus provides a totally enclosed

respiratory environment for the wearer. Because of the design, there is a 30-
min usage limit.

A3.44 Two sets of breathing apparatus for rescue work should be kept
outside the EO working area.

Chest-mounted canister respirator

A3.45 Canister respirators should only be used when the atmospheric

concentrations of EO are known to be within the levels for which the canister
is designed and the duration of use should be within the life of the canister.
These devices rely on a good seal between the respirator and the face of the
wearer; if this seal is lessened by facial hair, spectacles, etc., a very much
lower degree of protection will be achieved.

A3.46 The canister filters the air to a full face mask. It should not be used in
atmospheres where the exposure level is likely to be in excess of 0.2% by
volume. There is a specified time limit for usage. HSE recommends that
canisters be discarded after each use unless tests against EO can show that
desorption does not occur on re-use. Canisters should be degassed before
disposal.

Cartridge respirator

A3.47 The cartridge fits directly into an ori-nasal mask. It should not be
used in atmospheres where the EO level is likely to exceed 1000 ppm. The
useful life of the cartridge is 30 min for exposure to maximum concentration.
It is essential to adhere closely to the manufacturer’s or supplier’s instructions.
Cartridges should be degassed before disposal.

Protective clothing

A3.48 In emergency situations when handling liquid EO and when

atmospheric concentrations are high, full protective clothing should be worn.
This should provide complete protection to the skin and eyes. Particular note
should be taken of the construction of the clothing, such as the sealing of
seams, and of the ability of the material to limit the permeation of EO on to
the skin. If any clothing becomes contaminated with liquid EO it should be
destroyed.

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Appendix 3 – Safety of EO sterilization

Emergency procedures

A3.49 Comprehensive written procedures should be prepared covering shut-

down, evacuation and rescue. This should involve an assessment of the worst
possible consequences of an incident. The procedures thus described should be
tested and audited at regular intervals.

A3.50 A fire certificate issued by the Home Office may be required. In Scotland, procedures should be
Guidance from the local fire brigade should be sought. Emergency prepared in accordance with Firecode
procedures should be agreed with the fire officers and displayed in a in Scotland and the appropriate HTMs
permanent form in a prominent position.

A3.51 Liaison with the local accident and emergency department is

recommended, particularly to ensure that the specific hazards associated with
exposure to EO are known and that the remedial treatment is available.

A3.52 First aid procedures relevant to the nature of the sterilization

operation should be drawn up and agreed. Sterilizer operators and first aiders
on the site should be trained in these procedures.

Leaking cylinder

A3.53 If the cylinder is in an enclosed area, evacuate the area. Wear suitable
protection. Check that the cylinder valve is closed. Move the cylinder to a fume
room or open space downwind and away from persons and buildings. Post
warning notices and seal off the area. The suppliers should be contacted in the
event of difficulty.

Fire fighting advice

A3.54 In the event of a leakage of gas becoming ignited, the fire brigade
should be called immediately. The fire should be extinguished only by closing
the valve. No attempt should be made to put out the flame in any other way
but, provided it is safe to do so, the cylinder should be cooled by copious
spraying with water. The person directing the spray should take up a position
where he or she will be protected should a cylinder explode. If flame from the
burning leak impinges on cylinders, the building should be evacuated
immediately and no fire-fighting attempted.

A3.55 Cylinders which have not become heated should be moved to a safe
place in the open as quickly as possible, making sure any valves are turned off
first. If this is not possible, such cylinders should be kept cool by spraying with
water from a safe position.

A3.56 On arrival at the premises, the fire brigade should be informed of the
position of all cylinders, even those that are not directly threatened by the fire.

Spillage

A3.57 In any area where the spillage of liquid EO can occur a piped water
supply should be provided. Escaped EO should be diluted with copious
quantities of water sufficient to dilute the EO to less than 4%. At this
concentration the vapours are not flammable. Restricted amounts of water
may only serve to increase the vaporisation of EO.

A3.58 In the event of spillage, the area should be evacuated immediately.

Re-entry should only be by personnel wearing full protective clothing - i.e.

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 Appendix 3 – Safety of EO sterilization

rubber boots, non-absorbent overalls, gloves and breathing apparatus. The

supply source should be isolated, if possible. Spillages should be cleared by
drenching with sufficient water to dilute the EO at least 100-fold and never by
mopping up. It should be remembered that EO is heavier than air so higher
concentrations will tend to accumulate at ground level.

A3.59 EO is a persistent contaminant, and particular attention should be

paid to the cleansing of contaminated clothing and equipment. Where
decontamination is not possible (such as on leather items), the article should
be destroyed.

First aid advice

A3.60 In the event of an accident personnel should take steps to protect

themselves and isolate any sources of escaping EO. If someone is exposed to
EO, medical attention should be sought immediately.

A3.61 In all cases of severe or suspected exposure to EO the person should

be immediately removed from the contaminated area to a well ventilated area
by trained personnel wearing the necessary protective equipment. The
following action should be taken.

A3.62 If the skin has been affected:

a. remove all contaminated clothing;

b. if liquid EO is on the skin, allow it to evaporate;

c. wash skin copiously with water for 15 minutes. Exposed skin should be
treated with high-pressure water such as a hose or strong shower –
gentle washing is not sufficient.

A3.63 If EO has been inhaled:

a. lay the casualty flat and keep him warm and still;

b. if breathing has stopped, given artificial respiration with a Brooks

airway; do not attempt mouth-to-mouth or mouth-to-nose
resuscitation. If oxygen is available it should be administered by a
suitably qualified person.

A3.64 If the eyes have been affected, flush copiously with water for 15
minutes.

A3.65 If EO has been swallowed, activated charcoal may be used to adsorb

unreacted EO. It should be administered as an aqueous slurry of 240 ml of
water to 30 g charcoal. The usual dose is 30-100 g in adults. EO is irritating
and usually serves as its own cathartic.

A3.66 The possibility of delayed effects following exposure should not be

overlooked.

Control and handling of cylinders

A3.67 The gas should be supplied to an agreed specification guaranteed by

the supplier. The specification should include:

a. details of the composition and pressure of the gas or gas mixture;

b. a technical description of the construction and fittings of the cylinders;

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Appendix 3 – Safety of EO sterilization

c. individual cylinder identification to allow the rotation of stock.

A3.68 A procedure should be defined for the acceptance of deliveries of gas

cylinders from the supplier. The procedure should include the following details:

a. confirmation of the identity of the gas by reference to the

manufacturer’s product identification; a copy of the code and procedure
should be prominently displayed in the goods received and in the gas
storage areas;

b. the leak testing of each cylinder using a suitable leak detection device or
soapy water. Leak tests should be carried out:
(i) on the joint between the cylinder neck and the discharge valve;
(ii) around the valve control handle stem;
(iii) around and inside the valve discharge orifice.

A3.69 Any cylinders found to be leaking or otherwise not conforming to the

specification should not be accepted and will remain the responsibility of the
supplier, who should be informed immediately.

A3.70 The manufacturer’s recommendation regarding the maintenance of

residual pressure or weight in nominally empty cylinders for return should be
followed.

A3.71 Cylinders should be stored in a cool, well-ventilated, secure area (see

Part 5 of this HTM for guidance). EO should be stored away from fire risk and
sources of heat. A suitable cylinder handling trolley should be provided.

Information and training

A3.72 All personnel employed in the operation of EO sterilizers, including

maintenance personnel and operators, should receive adequate, documented
training. Personnel should not commence their duties until this training has
been completed and detailed operating instructions have been provided.
Maintenance personnel should be trained and certified by the manufacturer of
the sterilizer.

A3.73 As a minimum, training should include:

a. operational policies;

b. safety provisions;
c. connection and disconnection of gas cylinders;

d. first aid;

e. emergency procedures;

f. use of respiratory equipment;

g. duties to be performed;

h. actions in the event of a fire.

A3.74 On completion of training, employees should be assessed to ensure

that the training programme has been understood. No person should be
permitted to work with EO until he or she has attained an adequate level of
proficiency.

A3.75 All personnel coming into contact with EO should be informed of the
hazards and provided with a hazard data sheet.

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 Appendix 3 – Safety of EO sterilization

Maintenance

A3.76 Maintenance should only be performed by suitably trained and

qualified personnel. Before working on equipment known to contain EO, the
equipment should be drained, isolated, washed out with water and
demonstrated to be clear of flammable vapour (by gas analysis, for example).

A3.77 Systems which have carried EO but which are thought to be free of
any residue should nevertheless be thoroughly purged with nitrogen before
work commences.

A3.78 Planned, regular maintenance of all elements of the gas supply

system is essential to safe operation.

A3.79 A list of spares vital for safe operation should be compiled and a
stock maintained.

A3.80 Before any work is carried out on equipment known to contain EO,
or that has carried EO, or is thought to be free of EO, the local exhaust
ventilation should be known to be effective. If work is to be carried out on
the supply line from the manifold (cylinder supply) or pipe systems that have
carried EO, they should first be purged with a non-flammable gas such as
nitrogen before work commences.

A3.81 A procedure should be defined for the maintenance of lines and

fittings which have contained EO and for subsequent pressure and vacuum
testing. The following details should be included:

a. compulsory wearing of face shields, respiratory protection (where

appropriate) and gloves;

b. disconnection and isolation of the source of EO;

c. the source of purging gas, together with any entrained material, shall
be vented to a safe location (provision should be made for the handling
and disposal of polymerised EO which may contain EO monomer);

d. on completion of the maintenance schedule, pressure testing at an

appropriate pressure, with leak testing as required;

e. vacuum testing as appropriate;

f. checking that all valves and other control settings are correct before
putting the sterilizer back into service.

A3.82 Where potentially flammable EO mixtures are present, sources of

ignition should be prohibited. For example:

a. smoking and the use of naked flames should be strictly prohibited and
matches or other means of ignition should not be carried into the work
area;

b. tools made from spark-producing metals should also be prohibited;

only tools and equipment which do not induce sparks should be issued;

c. garments containing synthetic fibres likely to induce static discharge

should not be worn; conductive footwear should be used.

125
Appendix 4 – Guidance to management
on the appointment of an Authorised
Person (Sterilizers)

Introduction

A4.1 The Authorised Person (Sterilizers) is defined as a person designated by

management to provide independent auditing and advice on sterilisers and
sterilization and to review and witness documentation on validation. The
shorter term “Authorised Person” is used in this HTM.

A4.2 The specific requirements for the services of an Authorised Person should
be based upon the core responsibilities outlined in Part 1 of this HTM, namely:

a. to provide general and impartial advice on all matters concerned with

sterilization;

b. to advise on programmes of validation;

c. to audit reports on validation, revalidation and yearly tests prepared by

the Test Person;

d. to advise on programmes of periodic tests and periodic maintenance;

e. to advise on operational procedures for routine production.

A4.3 The Institute of Healthcare Engineering and Estate Management

(formerly the Institute of Hospital Engineering) is the registration authority for
Authorised Persons. The address is given in Appendix 1.

A4.4 In appointing an Authorised Person, management should ensure that

there is no conflict of interest that would compromise his or her impartiality in
carrying out the assigned duties. Candidates should be required to declare any
such interest at an early stage. Management should carefully assess whether
such declared interests are likely to affect the ability of the candidate to carry
out the duties defined above or any proposed extension to them. A candidate
employed by a sterilizer manufacturer, for example, may be able to discharge
all the core duties satisfactorily but be considered unsuitable to offer advice on
procurement of new equipment. See also paragraph A4.7.

A4.5 Management should ensure that the selected candidate has the
appropriate qualifications and experience for the sterilizers for which he or she
will be responsible. Not all Authorised Persons will be qualified to advise on all
types of sterilization process. It may be necessary to appoint one or more
Authorised Persons specialised in different processes; namely steam, dry heat,
LTSF or EO. In such cases, there should be a clear definition of each
appointee’s sphere of responsibility.

A4.6 In normal circumstances an Authorised Person should have exclusive

responsibility for each machine in his or her charge. It is not good practice for
more than one Authorised Person to be contracted to share continuing
responsibility for a particular machine. This does not prevent Users seeking a
second opinion where the need arises, though such action should be the
exception rather than the norm.

126
Appendix 4 – Guidance to management on the appointment of an Authorised Person (sterilizers)

Contractual arrangements

A4.7 Authorised Persons are required to comply with the ‘Code and rules of
conduct and disciplinary regulations for registered Authorised Persons
(Sterilizers)’ issued by the Institute of Healthcare Engineering and Estate
Management. Management should ensure that no part of the contract, nor
any subsequent instructions, conflict with the code and rules of conduct.

A4.8 A term of contract is suitable for the procurement of the services of an

Authorised Person. The minimum term should be one year, although a five-
year term has the advantage of greater continuity, enabling the appointee to
become familiar with each of the sterilizers for which he or she is responsible.
Casual appointments on a one-off basis are unlikely to foster the mutual
confidence necessary for a consistent quality of service.

A4.9 The contract should specify the core responsibilities outlined above and
further explained below (see paragraph A4.13). Provision should be made for
extensions to the contract to include, for example, the duties associated with
the validation of a new sterilizer or the introduction of a new product.

A4.10 Management may also require the Authorised Person to undertake

additional duties outside the range of the core responsibilities. To enable this
assistance to be given when needed, the contract should include the terms of
payment for such additional work. Examples of additional services are given in
paragraph A4.24.

A4.11 Formal lines of accountability should be made clear in the contract.

The Authorised Person should normally report in the first instance to the User,
who bears the day-to-day responsibility for the operation of the sterilizer.

A4.12 On appointment, the Authorised Person should be notified in writing

of the names, addresses and telephone numbers of key personnel defined in
Part 1 of this HTM; namely, the Executive Manager of the contracting
organisation, the User, the Competent Person, the Test Person, the
Maintenance Person and the Microbiologist; and for medicinal products, the
Production Manager and Quality Controller. The Authorised Person should be
notified promptly in writing of any changes to this information.

Core responsibilities

A4.13 The following are the core responsibilities that should be written into
the contract.

General advice

A4.14 The Authorised Person is required to provide general and impartial

advice on all matters concerned with sterilization. This will usually be provided
in response to enquiries by telephone, post, fax or electronic mail, as
appropriate. In some cases site visits may be required.

Validation programmes

A4.15 The Authorised Person is required to advise on programmes of

validation for the processes for which he or she is qualified. These
programmes should be based on the guidance given in Part 3 of this HTM and
any other regulatory requirements that may be specified.

127
Appendix 4 – Guidance to management on the appointment of an Authorised Person (sterilizers)

Auditing of validation and yearly tests

A4.16 The Authorised Person is required to audit reports on validation,

revalidation and yearly tests prepared by the Test Person.

A4.17 The Authorised Person should be given reasonable notice of the date
of commencement any validation, revalidation or yearly tests which he or she is
required to audit.

A4.18 Whether audits require a visit to the sterilizer is a matter of

professional judgement dependent on the type of sterilizer, its operational
history, the experience of the Test Person and the complexity of the
performance qualification procedures. As a rule, site visits are recommended.
However, since an Authorised Person cannot effectively audit a machine that
he or she has not seen, site visits are essential on at least the following
occasions:

a. for each sterilizer, before or during the first audit following appointment;

b. during the initial validation of a newly installed sterilizer.

A4.19 In order to perform this work effectively, the Authorised Person

should have access to the sterilizer itself, the plant history file, the sterilizer
process log and any other documentation bearing on the functioning of the
sterilizer. He or she should also have reasonable access to the User, Test Person
and other key personnel, and sterilizer operators. During site visits the
Authorised Person should be provided with a quiet room in which to examine
documentation.

A4.20 Within an agreed period following completion of the tests as notified

in paragraph A4.17, the Authorised Person should provide a report of the
audit. The report should include the following information:

a. names of the User, Executive Manager and the Authorised Person;

b. details of the Test Person who carried out the work, including:
(i) name;
(ii) relevant qualifications;
(iii) name of employer;

d. information for each sterilizer tested including:

(i) identification of the sterilizer (including manufacturer, model and
serial number and any inventory number);
(ii) type of process;
(iii) dates of manufacture, installation and validation;
(iv) date of the audit;
(v) a list of the tests carried out (validation, revalidation or yearly, as
appropriate) and a statement as to whether each was satisfactory;
(vi) a summary of the evidence that the test equipment used in the
tests was properly calibrated;
(vii) detailed comments on the outcome of the audit, especially if there
is any evidence of deterioration in performance, with
recommendations;
(viii) a signed and dated recommendation as to whether the sterilizer
should be considered fit for use.

128
Appendix 4 – Guidance to management on the appointment of an Authorised Person (sterilizers)

A4.21 Where the Authorised Person has reason to recommend that the
sterilizer is not fit for use, this information should be conveyed to the User
before leaving the site, both in writing and (if possible) verbally, in advance of
the full report.

Test and maintenance programmes

A4.22 The Authorised Person is required to advise on programmes of

periodic tests and periodic maintenance. Advice should cover the following:

a. programmes of daily, weekly, quarterly and yearly tests, based on the

schedules in Part 3 of this HTM;

b. maintenance schedules, based on the guidelines in Part 4 of this HTM;

c. implementation of written schemes of examination for pressure vessels

issued by the Competent Person (Pressure Vessels).

Operational procedures

A4.23 The Authorised Person is required to advise on operational

procedures for routine production. Examples where advice may be needed
include:

a. load design;

b. packaging;

c. product compatibility;

d. product release;

e. documentation;

f. safety;

g. training requirements;

h. compliance with legislation and standards.

Additional services

A4.24 Examples of services which would not be included in the core

responsibilities may include:

a. advice on the planning, operation and quality control of whole

departments;

b. delivery of training;
c. auditing of periodic tests at more frequent intervals (quarterly or
weekly);

d. technical consultancy for tendering, equipment and services;

e. preparing procurement specifications for sterilizers and washer

disinfectors;

f. risk assessments for health and safety purposes.

129
 Health Technical
Memorandum 2010
Part 5: Good practice guide

Sterilization

London: HMSO
© Crown copyright 1995
Applications for reproduction should be made to HMSO
Copyright Unit
First Published 1995

ISBN 0 11 322188 6

HMSO
Standing order service

Placing a standing order with HMSO BOOKS enables a

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About this publication

Health Technical Memoranda (HTMs) • Part 2 - Design considerations

give comprehensive advice and - contains information relevant
guidance on the design, installation and to the specification and
operation of specialised building and installation of new sterilizing
engineering technology used in the equipment. It discusses the
delivery of healthcare. requirements for each type of
sterilizer and outlines the
They are applicable to new and existing specifications to be included in
sites, and are for use at various stages any contract. Practical
during the inception, design, considerations for the installation
construction, refurbishment and of sterilizers are discussed,
maintenance of a building. including siting, heat emission,
ventilation, noise and vibration,
Health Technical Memorandum 2010 and mains services with an
HTM 2010 is being published in five emphasis on steam quality;
parts:
• Part 3 - Validation and
• Part 1 - Management policy - verification - covers all aspects
is a summary of the information of validation and periodic testing
required by non-technical of sterilizers. It includes detailed
personnel responsible for the schedules and procedures for
management of sterilization tests and checks to be carried
services. It discusses the various out for commissioning and
types of sterilizer, for both clinical performance qualification, and
and laboratory use, and also for subsequent periodic testing;
contains guidance on legal and
policy matters, and on the • Part 4 - Operational
appointment and responsibilities management - covers all
of personnel. It should be read aspects of the routine operation
by anyone consulting this and maintenance of sterilizers,
memorandum for the first time; stressing the need for a planned
 maintenance programme along The contents of this HTM in terms of
with the type of records to be management policy and operational
kept. Advice on the safe and policy are endorsed by:
efficient operation of sterilizers is
a. the Welsh Office for the NHS in
given, as well as procedures for
Wales;
reporting defects and accidents;
b. the Health and Personal Social
• Part 5 - Good practice guide - Services Management Executive
provides advice on the fatigue in Northern Ireland;
life of pressure vessels, the
c. the National Health Service in
lethality of heat sterilization
Scotland Management
processes, steam, contracts for
Executive.
testing, and accommodation for
gas cylinders and canisters. It also
References to legislation appearing in
includes a comprehensive
the main text of this guidance apply to
bibliography.
the United Kingdom as a whole, except
where marginal notes indicate variations
for Scotland and Northern Ireland.
Where appropriate, marginal notes are
also used to amplify the text.
 Preface

HTM 2010 gives guidance on the choice, specification, purchase, installation,

validation, periodic testing, operation and maintenance of the following types
of sterilizer in use in the National Health Service:

a. clinical sterilizers:

(i) high-temperature steam sterilizers used for processing porous loads

(including instruments and utensils wrapped in porous materials);
(ii) high-temperature steam sterilizers used for processing aqueous
fluids in sealed containers;
(iii) high-temperature steam sterilizers used for processing unwrapped
solid instruments and utensils;
(iv) dry-heat sterilizers (hot-air sterilizers);
(v) low-temperature steam (LTS) disinfectors and low-temperature
In Scotland LTSF sterilizers are steam and formaldehyde (LTSF) sterilizers;
considered to be disinfectors. (vi) ethylene oxide (EO) sterilizers;

b. laboratory sterilizers:

( i ) high-temperature steam sterilizers used with one or more

specialised operating cycles;
(ii) culture media preparators.

No guidance is given on sterilization by irradiation, hydrogen peroxide, gas

plasma or filtration. Users who wish to employ these processes bear the
responsibility of ensuring that the validation procedures comply with the
principles outlined in Part 3 of this HTM and that the intended operating
procedures will ensure an efficacious process for the different types of load.

This HTM is intended primarily as a guide for technical personnel, whether

specialists in sterilizers and sterilization procedures or those responsible for
maintenance and testing. It is also intended for those responsible for the day-
to-day running of sterilizers, and will also be of interest to supplies officers,
architects, estates managers and others in both the public and private sectors.

Detailed information on the planning and design of a sterile services

department, including the level of provision of sterilizers, is given in Health
Scottish Health Planning Note 13, Building Note 13, ‘Sterile services department’. Guidance for laboratory
‘Sterile services department’, applies installations can be found in Health Building Note 15, ‘Accommodation for
in Scotland. pathology services’.

Although this edition of HTM 2010 reflects established sterilizer technology, it is

recognised that considerable scope exists for the utilisation of emerging
technology in the management of sterilizers. This will be kept under review
with the aim of introducing recommendations for such technology at the
earliest opportunity so that the procedures essential for the efficient, safe and
effective operation of sterilizers can be optimised.

Most of the British Standards for sterilizers which were applicable at the time of
the last edition of this HTM, in 1980, have been either withdrawn or radically
revised. Some of them, in turn, are now being replaced by European Standards
which will be published during the currency of this edition of HTM 2010. Some
of these European Standards support new European Union Directives on
medical devices which will have a major impact on sterilization. Where
practicable the information in this HTM has been aligned with existing or
anticipated standards and advice is offered where no standard has yet been
formulated.

The sterilizers described in this HTM may not be suitable, without modification,
for safely processing articles infected with Hazard Group 4 pathogens nor InformatIon about Hazard Groups
agents, such as those associated with transmissable spongiform may be found in the HSC document
encephalopathies, which are unusually resistant to sterilization. Design ‘Ca tegorisation of pathogens
considerations for sterilizers intended to process articles infected with such according to hazard and categories of
organisms are discussed in Part 2. containment’ (second edition 1990)
compiled by the Advisory Committee
This part of HTM 2010 contains detailed supplementary information that on Dangerous Pathogens.
expands upon the guidance given in Parts 1 to 4 and should be read in
conjunction with them.
Contents

About this publication

Preface

A The lethality of heat sterilization processes - the

F0 concept page 3

B Methods for determining the fatigue life of

rectangular pressure vessels page 33

C Packaging for terminallysterilized

products page 51

D A contract for the annual testing of

sterilizers page 127

E Procedures for determining thesound power

generated by a sterilizer page 171

F Accommodation for ethylene oxide gas cylinders,

manifolds and canisters page 179

References and bibliography page 185

Other publications in this series page 189

About NHS Estates page 190

Section A

Lethality of heat sterilization processes;

the FO concept
Contents

A1 Introduction page 7

A2 Fundamental concepts page 9

A2.2 How microbes die: the logarithmic order of death
A2.10 Conditions resulting in a non-logarithmic order of
death
A2.11 Factors influencing the nature of the survivor
curve
A2.12 Factors influencing the heat resistance of spores
A2.16 Treatment of sterilization process microbial
survival data
A2.19 Decimal reduction value
A2.25 The temperature dependence of resistance
A2.29 Z value
A2.35 Lethal rates
A2.38 F value

A3 Sterility page 19
A3.2 Sterility assurance
A3.9 Calculation of F0 values

A4 Applications of the F 0 concept page 22

A4.1 General
A4.2 Control of sterile cooling fluid
A4.3 F 0 controlled sterilizers
A4.11 Monitoring operating cycles
A4.15 Validation of operating cycles
A4.17 Container cool point
A4.23 Load cool point
A4.27 Microbial challenge studies
A4.34 Product degradation and stability v cycle lethality
A4.45 Product stability
A4.49 Cycle development studies

A5 Test methods page 28

Glossary page 30

Bibliography page 31
A1.0 Introduction

A1.1 There are several, well established, time temperature relationships for
thermal sterilization methods which are regarded as equally acceptable (see Part
3 of this HTM, Table 8, page 41). Clearly temperatures other than those shown,
when maintained for an appropriate time, will also be capable of producing a
sterile product.

A1.2 For a moist heat sterilization process, we can expect a particular time at
a particular temperature to have a predictable lethal effect against a
standardised population of organisms. If we choose particularly resistant
organisms and assume they are present in numbers in excess of that likely to be
encountered in real product we can define standard exposure conditions which
will always yield a sterile product in a correctly operated sterilizer. Actual
exposures can then be related to these standard exposure conditions.

For example, in the laboratory it is possible to produce conditions where the

time to attain a pre-selected sterilization temperature, and the time to cool to
ambient temperature after sterilization, is so short that it may be disregarded: a
so-called “square wave exposure” system. This will enable very accurate
determinations of the thermal resistance of micro-organisms under well defined
conditions, and from several such determinations at different temperatures an
accurate determination of the change in thermal resistance with temperature to
be made.

Operational sterilizer cycles do not produce this rapid heating and cooling but
have relatively slow temperature changes. The product is thus exposed to
temperatures somewhat below the chosen sterilizing temperatures for
considerable periods. It is apparent that there will be some lethal effect on
micro-organisms during the heating and cooling phases of any particular
sterilization cycle since microbial death occurs over a wide range of
temperatures, albeit at different rates.

The F0 concept recognises this and allows us to take account of the lethality
obtained during the heating and cooling phases.

A1.3 For heat sensitive products it is desirable to minimise the heat treatment
given to the product and reduce the energy input to a level which, while
providing adequate assurance of sterility, will minimise the degradation of the
product. Because the F0 concept allows us to take account of the inactivation
of micro-organisms throughout the cycle, not just during the sterilization hold
period, we can thus obtain a cycle with the required lethality but with
minimum thermal degradation.

A1.4 In summary, optimisation of thermal sterilization processes may be

achieved by means of the F method which uses a knowledge of the lethality of
the particular process at different temperatures to assess the overall lethality of
the cycle and express this as the equivalent exposure time at a specified
temperature.

A1.5 F is defined as the equivalent time in minutes at 121.1°C to produce a

given sterilization effect.

A1.6 Where the specified temperature is 121.1°C (250°F) and the Z value is
10°C the term F0 is used.
The F0 value of a saturated steam sterilization process is the lethality expressed
in terms of the equivalent time in minutes at a temperature of 121ºC delivered
by that process to the product in its final container with reference to micro-
organisms possessing a Z value of 10.

The total F0 value of a process takes account of the heating up and cooling
down phases of the cycle and can be calculated by integration of lethal rates
with respect to time at discrete intervals.

A1.7 The F0 method may be used for assessment, or control, of processes

where difference in temperature is the only factor influencing the efficacy of
the cycle. For example, it may be applied to the steam sterilization of aqueous
fluids in sealed containers but it is not applicable to steam sterilization of
porous loads where air removal is also a key factor and failure to achieve direct
contact with Dry Saturated Steam can lead to failure, regardless of whether the
required temperature was achieved within the load.

A1.8 Similar concepts are also used for dry heat sterilization processes and for
depyrogenation by exposure to dry heat.

A1.9 There are a number of pre-requisites which it is necessary to consider

before the use of the F0 method is appropriate. These include:

• the efficacy of the sterilization process under consideration IS dependent

only on temperature eg air removal is not critical. Thus in a porous-load
steam sterilizer where impaired air removal can allow air to persist in
random locations throughout the load, and where it may be present in
sufficient quantity to impair sterilization, the use of the F 0 method for
cycle control or monitoring IS inappropriate;

• the sterilizer to be used has cycle control which is adequate to ensure

that production cycles consistently reproduce the conditions established
during validation. F 0 monitoring of a process may not be used to justify
the use of a sterilizer which demonstrates excessive temperature variation
within the load or poor reproducibility from cycle to cycle etc;

• temperature profile studies/validation studies have been conducted to

establish the uniformity of conditions throughout load and to identify the
location of those parts of the load which are slowest to heat up and
fastest to cool down;

• the loading composition and pattern of production cycles is controlled

within the limits established during validation to ensure that the results
obtained remain valid;

• production controls and bioburden studies are adequate to maintain a

known, low level, of microbial contamination and the thermal resistance
and temperature dependence (D and Z values respectively) of the most
resistant contaminant(s) are known or the assumed values are in
accordance with the Pharmacopoeial recommendations.
A2.0 Fundamental concepts

A2.1 In order to use the F 0 concept correctly it is important to understand the

facts, definitions and assumptions on which the model is based. It has become
common place to use certain functions and terms in the analysis and
interpretation of data on the effect of physical or chemical stress on microbial
survival. These terms are discussed below.

How microbes die: the logarithmic order of death

A2.2 Organisms which die as a result of an imposed stress die in an orderly,

and predictable, manner. This can be represented as survivor curve, showing
the number of organisms still living at various times after the beginning of
exposure to the stress condition.

A2.3 The order of death is, in principle, the same for all multicellular
organisms. The survivor curve remains constant for as long as individuals can
recover from that length of exposure; then as the first individuals die, the
frequency of death rapidly Increases until only a few very resistant organisms
remain, and they succumb shortly after the majority of the population (see
Figure A1). In a unicellular organism the individual is dead when a single cell
dies, whereas in multicellular organisms the death of one cell is not likely to kill
the Individual. The multicellular organism will survive until enough cells have
been killed to cause death.

Figure A1 Arithmetic survivor curve for multicellular organisms

A2.4 Whichever multicellular organisms are tested, for example insects or

plants, and whatever the lethal stress, the survivor curve remains essentially the
same. This was accepted as universally true for all organisms until the early
1900s when workers such as Harriet Chick [see Chick (1908)] showed that in
an homogeneous culture of a single strain of bacteria the cells died at a
constant rate when exposed to a particular lethal stress.
A2.5 It was apparent that these bacteria were dying in a manner which was
somewhat unexpected. This may be illustrated by taking as an example the
survival of microbial spores subjected to heat stress. An experiment may be
devised in which all factors other than the heating time are held as constant as
possible. If a number of biological indicators, each bearing a known number of
bacterial spores, are subjected to a thermal sterilization process, at a
predetermined temperature for various increments of exposure time, and then
the survivors on each indicator enumerated, the data obtained shows the
number of colony forming units remaining viable after each exposure time.

A2.6 A survivor graph can be prepared showing the number of survivors as a

function of the length of heating time. Both the number of survivors and the
time may be plotted on an arithmetic scale (see Figure A2).

Unicellular bacteria

Figure A2 Arithmetic survivor curve for unicellular bacteria

A2.7 Alternatively the number of survivors may be plotted on a logarithmic

scale as a function of time on the arithmetic scale, which is referred to as a
semi-log survivor curve (see Figures A3 and A4). While both the arithmetic and
semi-log survivor curves accurately represent the death of bacteria the latter is
more useful in sterilization studies where interest is concentrated on the rate of
destruction as the number of survivors approaches zero.

Multicellular organisms

Figure A3 Semi-log survivor curve for multicellular organisms

A2.8 It is usual to use the latter approach since in sterilization studies we are
interested in the rate of destruction as the number of surviving micro-organisms
approaches zero, which is best shown using a logarithmic plot.

Unicellular bacteria

Figure A4 Semi-log survivor curve for unicellular bacteria

A2.9 Experience has shown that the semi-log survivor curve for heat stress
often approximates to a straight line for part or all of the survivor curve.
However there are many recorded instances where deviations from the “ideal”
straight line condition occur (see Figure A5).

Figure A5 Microbial survivor curves showing typical deviations from the linear model;
curve a is a theoretical linear survivor curve; curve b shows an initial “shoulder”
followed by a linear survivor curve; curve c shows an initial increase in count,
“activation”, followed by a linear survivor curve; curve d shows an initial linear
survivor curve followed by a decreasing rate of kill, “tailing”; curve e shows the
sigmoidal survivor curve often encountered in experimental determinations.
Conditions resulting in a non-logarithmic order of
death
A2.10 Typical survivor curves for bacterial spores exposed to moist heat
sterilization processes are shown in Figure A5 in which the logarithm of the
number of surviving organisms is plotted against time and various types of
response are illustrated:

• Curve a - exponential - constant fraction of the population is inactivated

per unit time;

• Curve b - shows an increasing death rate after an initial period where

there was little or no inactivation - a “shoulder”;
• Curve c - initial activation (increase in population) followed by a constant
death rate;
• Curve d - decreasing death rate with a low number of highly resistant
organisms surviving for a prolonged period - "tailing";

• Curve e - a sigmoidal survivor curve of the type frequently encountered in

experimental determinations of resistance. This type of survivor curve may
be regarded as a composite of elements of the survivor curves described
above.

Factors influencing the nature of the survivor curve

A2.11 There are a number of factors which have a significant effect on the
nature of the survivor curve. Workers such as Moats et al (1971) have discussed
these factors in detail. Some of the key factors can be summarised as follows:

• Growth index. During recovery there are many instances when not all
viable spores will germinate and outgrow within a short time period. The
percentage of those present which do germinate and grow immediately
on incubation is referred to as the growth index. The growth index varies
both with the species of bacterial spore and the cultural conditions in
which it was grown and is to be recovered. It may be as high as 100%,
for example for Bacillus subtilis, but may be as low as <1%, for example
for Bacillus stearothermophilus. Sublethal heating may increase (activate)
or decrease (deactivate) the growth index and give rise to non-linear
survivor curves. [see Favero (1967), Finley and Fields (1967)] The
interaction of activation and inactivation on the thermal treatment of
heat resistant dormant spores of B stearothermophilus can be described
mathematically. [see Shull et al. (1963)]

• Cell clusters. The usual method of counting the number of surviving

bacteria is by the plate count method which gives the number of colonies
developed from a known volume of suspension inoculated onto the
surface of solid growth medium. The number of colonies is equal to the
number of bacteria present only when each colony arises from a single
cell.

When the cells are in clusters, for example Staphylococcus spp., or in

chains, for example Streptococcus spp., one colony may represent a large
number of cells. All the time there are one or more surviving cells within
the aggregation a colony will be formed and death therefore becomes
evident only when the last cell is dead. Such clusters “die” like
multicellular organisms and show convex survivor curves (see Figures A3
and A5, curve b).
 l Cell age. It has been demonstrated that young cells, that is, the
exponential growth phase of a culture, are more susceptible to both
chemical and physical stress than old cells from the stationary phase of a
culture. Furthermore if old cells are transferred to a new environment
they do not all begin to grow at the same time and a culture develops in
which both old and young cells coexist leading to heterogeneous
resistance and concave survivor curves (see Figure A5, curve d).
l Mixed populations. Where more than one strain or species is present,
with different resistances to the lethal stress being imposed, a non-linear
survivor curve, typically of concave form, will arise (see Figure A5,
curve d).

Factors influencing the heat resistance of spores

A2.12 Any assessment of thermal resistance of micro-organisms must involve

consideration of those factors which may affect the thermal resistance.

A2.13 These factors include the species and strain of organisms to be

considered; its physiological state, which will in part depend on its immediate
cultural history, the manner in which it is presented to the sterilization process,
for example the suspending menstruum; and the recovery conditions which are
used in an attempt to grow the organism after exposure to the process; as well
as the exposure conditions used, for example whether dry heat or moist heat
(direct contact with dry saturated steam or being in an aqueous solution) was
used, and the exposure temperature. [see Russell (1971)]

A2.14 The nature of the product also affects the thermal resistance of
contaminating organisms; the protective effects of various salts and
carbohydrates in solution are well documented in the literature.

A2.15 The influence of changes in the manufacturing environment and/or

process on the nature and extent of contaminating micro-organisms must also
be considered.

Treatment of sterilization-process microbial survival

data

A2.16 A mathematical approach to the resistance of bacteria to thermal

death is required to allow calculation of equivalent lethality. Two factors need
to be considered; the thermal resistance of the micro-organism at a particular
temperature and the change in that resistance which occurs with changes in
temperature.

These two factors are analogous to the rate constant and temperature
coefficient of a chemical reaction, respectively.

A2.17 Spore inactivation in moist heat may be considered as a

monomolecular first order reaction, that is where the rate of reaction is
governed by the concentration of the reactant, in this case the bacterial spores.
This may be expressed as

where t = time,
Ca = spore concentration
k = a reaction rate constant at constant temperature

0
Then (log C a 0 - log C a ) = k ( t - t )

where the superscript 0 indicates initial conditions

A2.18 A semi-logarithmic plot of concentration versus time will yield a

straight line of slope k. k has dimensions of time-1. The negative reciprocal of
the rate constant k is equivalent to the number of minutes required to
inactivate 90% of the organisms present, that is a 1 log reduction. This value is
referred to as the D value and, as stated, mathematically it is inversely
proportional to the inactivation rate constant k

D = 2.303/k.

Decimal reduction value (D value)

A2.19 The D value is used as a measure of the resistance of a defined micro-

organism to a defined sterilization process. It is a convenient way to describe
the slope of a linear semi-log survivor curve.

A2.20 More particularly it may be defined as the extent of exposure, under

stated conditions, necessary to produce a 90%, or 1 log, reduction in the
bacterial population (see Figure A6). It is usually stated in minutes, except for
sterilization processes using ionising irradiation where it is given in kiloGreys
(units of absorbed radiation dose).

Figure A6 Decimal reduction value

A2.21 For moist heat sterilization processes it is often given a subscript to
indicate the temperature at which it was determined, for example D121 .
Although this in itself is insufficient definition of the conditions under which
the determination was made to allow valid comparison.

A2.22 The D value is highly specific to the experimental conditions under

which it was determined. Even apparently minor changes in experimental
procedure, for example incubation temperature, recovery medium can have a
dramatic effect on the apparent D value.

A2.23 The D value is only relevant to the survivor curve when the survivor
curve is truly a straight line over the range of population values of interest,
including the “probability” zone.

A2.24 It is not necessary to construct a survivor curve to determine D value

The determination may be done by a replicate unit method involving fractional-
unit-negative (FN) data. A number of replicates are heated for a certain time
and the number viable and the number sterile are determined. [see Pflug and
Schmidt (1968)]

Then where r = total number,

p = growth,
q = sterile,
U = time in min,
N0 = initial population per replicate unit
NU = population per replicate unit after time U,
then
N U = logn(r/q) = 2.303 log (r/q)
and
duration of treatment (min) .
D =
log initial no - log final no of spores

U .
=
lo g N 0 - lo g N U

The temperature dependence of resistance

A2.25 A common measure of the temperature dependence of a chemical

reaction is the Q10 value. This is defined as the change in reaction rate constant
k for a 10°C change in temperature:

A2.26 For most chemical reactions Q 10 has a value of about 2, but for spore
inactivation in moist heat Q10 ≈ 10 to 18 and for spore inactivation in dry heat
Q10 ≈ 2.2 to 4.6.

A2.27 Other measures of temperature dependence include the Arrhenius

equation;

k = A ex p ( - E A ( RT) - 1 )

where k = the reaction rate constant;

A = the frequency factor;
E A = the activation energy;
R = the universal gas constant;
T = the absolute temperature.
A2.28 However, the temperature dependence of reaction rates for spores is
generally expressed as a Z value,

where

or

Z value

A2.29 The Z value is a measure of the change of inactivation rate with

temperature. It is the slope of a plot of D value on a logarithmic scale against
temperature on an arithmetic scale (see Figure A7).

A2.30 The Z value allows comparison of the lethal effect of heating at

different temperatures. [see Bigelow (1921)]

A2.31 As originally defined Z is numerically equal to the number of degrees

Fahrenheit change in temperature required to reduce the D value by 90%, or 1
log. Considerable confusion, and error, can be caused where the temperature
scale used is not specified. Although values are now usually given in °C care
must be taken when using published data, for example from the official
compendia, to note whether the D value is quoted in °F or °C.

A2.32 The mathematical relationship with the D value can be expressed as:

A2.33 It should be noted that, the greater the Z value, the greater the
increase in temperature which is required to give a tenfold decrease in D value.
Hence the assumption of a Z value higher than in fact exists will give an
additional margin of safety. The Z value assumed for most thermophiles, such
as Bacillus stearothermophilus, is 10°C.
A2.34 The straight-line relationship holds good only over a limited
temperature range for an homogenous culture of a single strain of micro-
organisms. Mixed cultures give a non-linear relationship, but in practice one
sub-population, either by virtue of its resistance or its prevalence, will be
controlling with regard to attainment of sterility.

Lethal rates

A2.35 The usefulness of the temperature dependent model lies in being able
to calculate the lethality over a range of temperatures, which will include those
experienced during heating-up and cooling-down of a load in a steam sterilizer.

A2.36 The relative lethality at a temperature T,exp , compared to the known

lethality at a particular reference temperature Tref, , is dependent on the Z value.

Thus, the lethality L is given by the equation

Lethality factors for any temperature deviation from the

r reference temperature
and for any Z value can be calculated using this formula (see Table A1).

A2.37 A new variable F, the thermal death time can be defined. The change
in F with temperature is analogous to the change in thermal resistance (D
value) with temperature and both are dependent on the Z value. Plots of log D
versus temperature and log F versus temperature both have slope Z:

F value
A2.38 The F value expresses heat treatment in terms of the equivalent effect
of a stated time at some stated temperature for a particular Z value, that is to
say that the F value is the equivalent time in minutes at 121.1°C (250°F) for an
organism of specified Z value.

A2.39 F0 is the F value when Z is 18°F (10°C):

where t is the chosen time interval, and T is the temperature in the container.

Note For dry heat F values, F is equal to the time in minutes at 176°C (350°F).
Table A1 Lethality factors for a Z value of 10°C

Temperature Lethality Temperature Lethality

difference factor difference f a c t o r
°C minutes* °C minutes*

-20.0 0.0100 +20.0 100.000

-19.0 0.0126 +19.0 83.180

-18.0 0.0159 +18.0 66.070
-17.0 0.0200 +17.0 52.480
-16.0 0.0251 +16.0 41.690
-15.0 0.0316 +15.0 31.620

-14.0 0.0398 +14.0 25.120

-13.0 0.0501 +13.0 19.950
-12.0 0.0631 +12.0 15.850
-11.0 0.0794 +11.01 12.590
-10.0 0.1000 +10.0 10.000

- 9.0 0.1259 + 9.0 8.318

- 8.0 0.1585 + 8.0 6.607
- 7.0 0.1995 + 7.0 5.248
- 6.0 0.2512 + 6.0 4.169
- 5.0 0.3162 + 5.0 3.162
- 4.5 0.3548
- 4.0 0.3981 + 4.0 2.512
- 3.5 0.4467

- 3.0 0.5012 + 3.0 1.995

+ 2.8 1.905
- 2.5 0.5623 + 2.6 1.820
+ 2.4 1.738
+ 2.2 1.660

- 2.0 0.6310 + 2.0 1.585

+ 1.8 1.514
- 1.5 0.7079 + 1.6 1.445
+ 1.4 1.380
+ 1.2 1.318

- 1.0 0.7943 + 1.0 1.259

+ 0.8 1.202
- 0.5 0.8913 + 0.6 1.148
+ 0.4 1.096
+ 0.2 1.047
0.0 1.000 0.0 1.000

Lethality L is given by

* Lethality factor is given in minutes equivalent at the reference temperature

A3.0 Sterility

A3.1 In order to utilise the F0 method it is first necessary to decide on the

extent of treatment which will be necessary to provide the required level of
assurance that the product is sterile. Several different definitions are in common
use.

Sterility assurance

A3.2 If the survivor curve is extrapolated beyond log100, that is one surviving
organism, we reach a region of “probability” of finding a single surviving
organism. For example at log10[-1] we expect to find, not 0.1 organisms
surviving in every sample but, one in every ten samples with a surviving micro-
organism.

We can thus determine from the survivor curve a theoretical probability of any
one unit of product being non-sterile.

A3.3 The European standard, EN556, in common with a definition in the

European Pharmacopoeia, states that a product may be regarded as sterile
when the theoretical level of not more than one micro-organism is present in
1 x 10 6 sterilized units of the final product.

A3.4 This calculation may be based on data, obtained by investigation, on

the extent and resistance of microbial contamination immediately prior to
sterilization (the Bioburden) or on a theoretical contamination of 106 micro-
organisms per unit of product presumed to be of a type having known high
resistance to the process, for example bacterial spores. In the latter case the
cycle is often referred to as a “12D” or “overkill” cycle and was first proposed
by Esty and Meyer (1922) for processing low-acid canned food products.

A3.5 The British Pharmacopoeia in Appendix XVIII 'Methods of Sterilization'

states: “For aqueous preparations sterilized by heating in an autoclave the
preferred combination of temperature and time is a minimum of 121ºC
maintained throughout the load during a holding period of 15 minutes.”
However, it goes on to say: “Other combinations of time and temperature may
be used provided that the process chosen delivers an adequate level of lethality
when operated routinely within the established tolerances.”

A3.6 In Annex 2, 'Guidance on application of the F 0 concept to aqueous

preparations.’ the British Pharmacopoeia sugggests that "In general for aqueous
preparations a microbiologically validated steam sterilization process that
delivers, in total, an F 0 value of not less than 8 to every container in the load is
considered satisfactory.”

A3.7 In certain circumstances, however, use of a steam sterilization process

that delivers, in total, an F0 of less than 8 may be considered justifiable, for
example where the product is especially heat sensitive. The nature of processes
delivering an F 0 of less than 8 is such that great care must be taken in order to
ensure that adequate assurance of sterility is consistently achieved. It is
necessary not only to validate the process microbiologically but also to perform
continuous, rigorous microbiological monitoring during routine production to
demonstrate that the microbiological parameters are within established
tolerances so as to give a theoretical level of not more than one living micro-
organism per 106 containers in the final product.

A3.8 The European Pharmacopoeia also states that the recommended method
for parenteral products is moist heat sterilization at a minimum of 121°C
maintained throughout the load for a minimum of 15 minutes. Other time
temperatures can be used but the crucial requirement is delivery of an
adequate level of “lethality” to the product. The use of F0 is recognised with an
F0 of 8 being the usually acceptable minimum. It is emphasised that this
requires a low pre-sterilization bioburden and the absence of heat resistant
spores.

Calculation of F0 values

A3.9 Reliabl e F0 value calculations are simply achieved with modern

microprocessor based control and monitoring systems. However F0 values can
be calculated manually, and many of the available computer programs employ
essentially similar methods:

a. Graphical method. In the graphical method F reference paper is used on

which the lethal rate per minute, at particular temperature, is represented
by length on the vertical axis. The horizontal axis has a corresponding
arithmetic scale for time such that the area of a rectangle delineated by
the ordinate 121.1°C and a length corresponding to one minute on the
abscissa is equal, by definition to an F0 of one. The cumulative area under
the curve as the cycle progresses represents the cumulative lethality of the
process (see Figure A8). In practice the temperature profile is plotted and
the area under the curve determined using a planimeter. The area
measured is then converted to an F0 value using the scale of the F
reference paper.

b. Summation method. In the summation method the lethal rate at each

specific temperature is calculated or read from a table (see Table A1) and
multiplied by the time for which that temperature persisted. The values
obtained for each temperature are summed to give the overall F0 value
for the cycle.

A3.10 The accuracy of the integration is affected by a number of factors.

These include:

· the choice of time interval between successive temperature

measurements. BS 3970 Part 2 specifies a maximum interval of two
seconds;

· whether the minimum, maximum or average temperature during the

chosen time interval is used. (Since the method is an approximation based
on summing discrete data to represent continuous data there will always
be some error, which may be positive or negative; each may be correct
for different purposes);

· the location of the sensor(s) from which the temperature is read and the
adequacy of the validation of sensor location;

· should be used only over the temperature range for which Z has been
determined. The Z value for any micro-organism does not remain
constant over all possible temperatures. Therefore any particular lower
temperature limits for the integration need not be set since, for a Z value
of 10 , F0 values below 105°C make so little contribution. For example, 40
minutes exposure at 105°C is equivalent to one minute at 121°C.
Figure A8 Graphical determination of F 0 values. The ordinate scale (temperature) of
F-reference paper is proportional to the lethal rate so that the area beneath
the curve is a measure of the F value. The cumulative values during the
cooling stage are not used for sterilizer control but may be used in monitoring
to provide an accurate assessment of the overall lethality delivered by the
sterilization cycle. Within each box the figures in italics indicate the F 0 value
calculated for that time-temperature rectangle. The lower figures indicate
the cumulative F0 value through the cycle. The F0 controller, set to provide an
F0 value of 9, initiates the cooling stage at point A. The total monitored F0
value of the cycle is 11.99.
A4.0 Applications of the F0 concept

General

A4.1 Part 3 of this HTM states that if a fluid sterilizer is fitted with an F0
integrating system, then the recorder should be capable of computing and
printing values of F0 for each channel with integration times no greater than
2 s. This is also a requirement of BS 3970: Part 2.

Control of sterile cooling fluid (in a steam sterilizer

for fluids in sealed containers)

A4.2 It is a requirement that if the coolant is derived from a water or steam

service and is intended to come into contact with the load containers, the
operating cycle must expose the coolant to sufficient heat to ensure that it is
free of microbial contamination by the end of the holding time. This is checked
by calculating an F0 value for the heat treatment received by the coolant. If the
test recorder is not capable of calculating F0 both BS 3970 and Part 3 of this
HTM recommend the following procedure:

a. from the measured temperatures, identify the point during the heat-up
time at which the coolant temperature first reaches 108°C. Note the
temperature (T°C) at subsequent one minute intervals until the end of the
holding time;
b. for each measurement, calculate the incremental F 0 (∆ F 0 ) from the
following equation:

where T is the lowest temperature of the coolant water for each one
minute time interval

c. the F 0 value is the sum of all ∆ F0.

The test should be considered satisfactory if the F0 for the coolant is not less
than 8 minutes.

F0 controlled sterilizers - Control of operating cycles

in steam sterilizers for fluids in sealed containers

A4.3 The operating cycle for steam sterilizers used to process aqueous fluids
in sealed containers may be divided into several stages.

1. heat up (and, where necessary, air removal) - the chamber atmosphere

attains the required temperature;

2. equilibration time - all parts of the load attain or exceed the minimum
temperature of the sterilization temperature band;
 3. holding time - all parts of the load are maintained at a temperature
within the sterilization temperature band;

4. cooling stage - the load is cooled to a temperature at which it will be

safe to handle.

A4.4 Stages 2 and 3 may be controlled by one of the following:

a. adjustable timers of an automatic controller in conjunction with

temperature sensors within the active chamber discharge and within
containers of the load;

b. a simulator control system;

c. an F0 system.

A4.5 Provision for adjustment of the equilibration time (stage 2) is necessary

and may be achieved by one of the following:

a. an operator adjustable timer on the instrument panel;

b. a simulator control system;

c. an F0 integrating system.

A4.6 When an F0 control system is fitted, the control function should be

limited to the Initiation of the cooling stage (stage 4) once a selected F 0 value
has been attained.

A4.7 In addition to the minimum requirement of two temperature sensors

(see 13.1.4 of BS 3970 Part 1) two further temperature sensors shall be
provided for use in two load containers.

A4.8 The control system shall be designed to integrate from the temperatures
sensed within containers of the load at selected locations at time intervals not
exceeding 2 seconds.

A4.9 The range of F0 values selectable shall include 1 to 30.

Table A2 Permitted ranges for F0 values A4.10 When tested in accordance with Test method 1, the Individual values
of F0 determined using the reference instrument shall be within the ranges
F0 value Permitted range stated in Table A2 for each of the F 0 values indicated by the sterilizer under
indicated by for F0 values test.
sterilizer determination
under by the reference
test instrument* Monitoring operating cycles in steam sterilizers for

1 1 to 105
fluids in sealed containers
15 15 to 15.7 A4.11 For aqueous products in sealed containers temperatures are measured
30 30 to 31.5 (with thermocouples or RTDs) throughout the heating and cooling stages as
well as during the sterilization hold period. The slowest container to heat and
* The reference instrument is described in the fastest container to cool may be used to determine the minimum lethality
Test method 2. received by the load. these locations are often found in different locations.

A4.12 Determination of the maximum temperatures in the load may also be

necessary for thermolabile products where deterioration may be a problem.
A4.13 It is essential that during commissioning and validation it is established
that the position of containers which need to be monitored remains consistent
from cycle to cycle. A sterilizer where the slowest part of the load to reach
temperature is found in different parts of the load on successive cycles is not
suitable for control or monitoring by F0 values and is in urgent need of skilled
attention. For air-ballasted sterilizers this may involve additional requirements
on monitoring the circulation of the chamber atmosphere to ensure that the
location of the cool point remains constant.

A4.14 Calculation of the F0 value delivered by a process may be estimated

from the lowest temperature-time curve registered from the containers in the
load. The process is satisfactory if the registered F0 value is within the minimum
and maximum limits established during validation.

Validatio n of operating cycles in steam sterilizers for

fluids in sealed containers

A4.15 The use of F0 control or monitoring systems places additional

requirements on the validation process.

A4.16 As described in Part 3 of this HTM, paragraph 8.4 'Sterilizer function

using a full load' '... the temperature of all sites monitored within the load ......
shall be within 1°C of each other throughout stage 3'. This requirement applies
regardless of whether an F0 system is used.

Container cool point

A4.17 Container mapping is necessary to determine the container cool point.

Container mapping studies should be conducted prior to conducting loaded
chamber heat penetration studies in order to determine the position within the
liquid-filled container which is slowest to attain temperature.

A4.18 Small volume containers and those of cylindrical form where the
length:diameter ratio is large are the least likely to demonstrate a detectable
cold spot.

The number of thermocouples within the container should be sufficient to

monitor the upper, middle and lower layers of the central region of the
container. Using an excessive number of temperature probes may introduce
significant errors in the determination.

A4.19 The profile point requiring the longest exposure time to equilibrate
with the chamber temperature should then be used in subsequent F0 studies
and monitoring (but see later for degradation/product stability considerations).

A4.20 Suitable container entry systems for the insertion of temperature

probes into sealed containers are described in part 3 of this HTM (Figure 3,
p 40)

A4.21 Independent measuring equipment should be to the standard

described in part 3 of this HTM, Chapter 6.
A4.22 The test should be carried out as described in part 3 of this HTM for a
thermometric test for a full load (see paragraph 14.10) except that the load
should be containers of the type and number to be used in practice and filled
with the product to be sterilized or a suitable substitute with similar thermal
characteristics, (see paragraph A4.31 below).

Load cool point

A4.23 It is necessary to determine the coolest point within a specified load

type and configuration of load. Cool points arise because of varied rate of heat
transfer throughout the load and studies are needed to ensure that the cool
points are identified so that they may be exposed to sufficient heat lethality.

A4.24 The study is carried out in the same manner as the performance
qualification described in part 3 of this HTM (see paragraphs 8.13 to 8.28
performance qualification, pp 57 to 59)

A4.25 Similar studies may be used to identify those containers which attain
temperature maxima or most prolonged exposure to the equilibrium
temperature for product degradation and/or stability studies.

A4.26 The F0 value for the process may then be determined by integrating
the lethal rates throughout the heating process using one of the methods
previously described.

Microbial challenge studies

(See also part 3 of this HTM paragraphs 8.29 to 8.36, pp 59 - 60)

A4.27 Biological challenges may be used during validation studies in order to

demonstrate the process lethality provided by the sterilization cycle. Calibrated
biological indicators used for this purpose act as bioburden models and can be
used in obtaining data to calculate F0 values delivered by the cycle or to
supplement physical temperature measurement, for example from
thermocouples.

A4.28 The number of spores to be used in the BI can be calculated from the
following formula

A4.29 Designated liquid-filled containers are inoculated with the indicator

organism by injecting an aliquot of a calibrated spore suspension into the
suspending menstruum to provide the calculated concentration of spores. The
containers chosen should be those previously established by temperature
measurement as having the lowest delivered lethality.

A4.30 The suspending menstruum should be the product to be sterilized

unless this contains preservatives, antimicrobials or other substances which
inhibit the growth of the indicator micro-organisms.
A4.31 If it is necessary to use a product substitute it should be selected to
have similar physical characteristics to the product this should include heat
capacity (specific heat), density, viscosity, thermal conductivity.

A4.32 Great care needed when using inoculated product to minimise the
possibility of contaminating the production environment.

A4.33 Microbial challenge studies should be conducted concurrently with

heat penetration studies.

Product degradation and stability versus cycle

lethality

A4.34 When heat-sensitive thermolabile products are to be sterilized it is

important that adequate assurance of sterility is not obtained at the expense of
product degradation or stability.

A4.35 For sterilization the temperature dependence of the process is

described by the Z value, that is the change in temperature required to give a
tenfold change in the rate of microbial kill. Increasing or decreasing the
temperature of the process requires a corresponding decrease or increase in
exposure time to maintain the same cycle lethality or F0 value.

A4.36 For any given temperature, microbial death and chemical degradation
take place at different rates. The relationship between time and temperature
which exists for microbial lethality cannot be extrapolated to the product
degradation reaction.

A4.37 If the degradation reaction is not altered significantly by the change in

temperature the extent of degradation will increase as process (exposure) time
is extended. Conversely, if the degradation reaction is highly temperature
dependent (high activation energy) a decrease in temperature may more than
compensate for the increase in time, resulting in less degradation.

A4.38 The key variable is the activation energy, EA. If the activation energy
for the chemical degradation reaction is lower than that of the microbial death
curve, that is it is less temperature dependent, then it can be assumed that a
decrease in sterilization temperature will result in greater product degradation.

A4.39 Furthermore it cannot be assumed that sterilization cycles of

equivalent lethality, but which differ with regard to time and temperature, will
yield product of equal quality.

A4.40 The assumption that degradation reactions follow first-order reaction

kinetics is probably a good approximation in most cases where a single active
drug product is contained in the solution.

A4.41 Experience has shown that a decrease in sterilization temperature can

have a marked deleterious effect on product and its long term stability.

A4.42 Sterilization of glucose solutions in plastic containers may require a

sterilization temperature in the range 115-118°C in order to protect the
thermolabile container. The increased time required for sterilization compared
with a traditional cycle at 121°C used for similar solutions in glass bottles
results in a noticeable increase in caramelization.
A4.43 The activation energy of the lethal reaction for bacterial spores with a
Z value of 10°C is high (typically around 60 kcaI/moIe) compared to most first-
order liquid-phase decompositions. Thus products that degrade with heat are
more affected by an increase in time than an increase in temperature. For
example, expressed as a Z value the temperature effect of the degradation of
glucose would have a Z value of about 33°C.

A4.44 The use of F values based on the Z value of the most resistant
contaminating organism found during bioburden studies rather than an
assumed Z value of 10°C may be necessary for particularly thermolabile
products. Great care is needed in the application of this technique because of
the inherent variability of microbial contamination and the rigorous process
control and monitoring needed to minimise this.

Product stability

A4.45 Product stability may also be related to degradation during

sterilization. Chemical reaction kinetic studies on many products indicate that
product stability over the desired shelf life can be extrapolated from the extent
of degradation measured just after sterilization. In some cases a degradation
product formed during sterilization triggers subsequent deterioration and the
specific factors affecting the formation of the degradation product would need
to be investigated.

A4.46 Both microbial lethality and degradation are cumulative with respect to
time and temperature, so variations in the heating and cooling phases of the
cycle will affect the extent of degradation, and thus product stability, as well as
lethality.

A4.47 Degradation and stability studies should consider the entire cycle and
not just the dwell time. These effects are more pronounced for products where
the degradation reaction has a lower activation energy.

A4.48 F0 values are generally calculated from the coolest part of the load. For
degradation and stability purposes the hottest part of the load is of more
consequence. The entire range of temperature and time experienced
throughout the load must be recorded in order to substantiate degradation and
stability claims.

Cycle development studies

A4.49 Determination of F 0 values is often of value in the development of

appropriate operating cycles for steam sterilization of both fluids in sealed
containers and wrapped goods and porous loads. However, since temperature
measurement alone cannot reliably detect failure to obtain direct contact with
dry saturated steam, it is not practicable to use F0 values for monitoring or
controlling porous load cycles.

The use of F 0 values for porous load cycles should be limited to determining
suitable sublethal cycles for biological challenge studies.
A5.0 Test methods

Test for F0 control compliance

Apparatus

A5.1 Glass bottle, of nominal capacity 1 litre, complying with DIN 58363.

A5.2 Independent F0 reference instrument, as described in section F.

Procedure
A5.3 Install the reference instrument.

A5.4 Place 1 litre of cold water in the bottle. Insert the two temperature
sensors of the F0 control system and the sensor of the reference instrument so
that the sensing points of all three are at about 85% of the bottle depth and
over the approximate centre of the bottom of the bottle. Seal the bottle.

A5.5 Select the required F0 value on the control panel and perform a cycle in
which automatic control is terminated manually immediately at the beginning
of stage 4. Note the value of F0 shown by the reference instrument.

A5.6 Repeat the procedure described in paragraph A5.5 twice.

A5.7 This test procedure shall be carried out for F0 values of 1, 15 and 30.

A5.8 Calculate the mean of the three replicate values for each setting of F0
control and check for compliance with the values given in Table A2.

Test for performance of reference instrument

Apparatus
A5.9 Temperature regulated heat source capable of being controlled at a
given temperature within 0.10°C in the range 115°C to 126°C.

A5.10 Thermometer traceable to national standards to include the range

100°C to 130°C complying with BS 593 and graduated at intervals of 0.1ºC.

A5.11 Temperature logging device computing F0 values of the sensor(s) with

integration at least every 2 s and means of print out, together with suitable
temperature sensor(s).

A5.12 Stopwatch.

Procedure
A5.13 Install the sensor(s) into the temperature regulated heat source.

A5.14 Adjust the heat source so that it maintains a temperature of

121±0.1°C.
A5.15 Allow the equipment to integrate F0 for 15 minutes timed with the
stopwatch. Note the indicated F0 value.

A5.16 Repeat with the temperature source maintained at 115±0.1°C for 30

min.

A5.17 Repeat with the temperature source maintained at 126±0.1°C for 10

min.

A5.18 The replicate F0 values obtained at 121°C shall lie within the range
14.66 to 15.34.

A5.19 The replicate F0 values obtained at 115°C shall lie within the range
7.36 to 7.71.

A5.20 The replicate F0 values obtained at 126°C shall lie within the range
30.90 to 33.36.
Glossary

D value The D value (or Decimal Reduction Value) is a measure of the resistance of a micro-organism to a
particular type of sterilization process. It is the value of the appropriate parameter of the process
(duration or absorbed dose) required to reduce the number of viable micro-organisms to 10% of
the original number.

In connection with sterilization by heating in an autoclave the D value is expressed by the time in
minutes at a defined temperature (the temperature is often shown as a subscript, for example
D 1 2 1 ).

Z value In connection with sterilization by heating in an autoclave the Z value relates the heat resistance of
a micro-organism to changes in temperature. The Z value is the change in temperature required to
alter the D value by a factor of 10.

F0 A quantity, measured in minutes, used to determine the efficacy of an operating cycle and
equivalent to a continuous period at a temperature of 121.1°C for an organism with a Z value of
10°C.
Bibliography

Laboratory Manual for Food Canners and Processors. 1968, Vol 1 Microbiology
and Processing, National Food Processors Association Research Laboratories,
Westport, Connecticut. AVI Publishing Company.

Tucker G S and Clark P. 1989, Computer Modeling for the Control of

Sterilization Processes. Technical memorandum No 529. Campden Food and
Drink Research Association.

Pflug I. 1982 Textbook for an Introductory Course in the Microbiology and

Engineering of Sterilization Processes. Minneapolis. Environmental Sterilization
Laboratories.

Hersom and Holland 1980 Canned Foods: Thermal Processing and

Microbiology. 7th Edition. London. Churchill Livingstone.

Stumbo C R 1973 Thermobacteriology in Food Processing. 2nd Edition. New

York. Academic Press.

Validation of steam sterilization cycles. Technical Monograph No 1. 1978,

Philadelphia, Parenteral Drug Association.
Section B
Methods for determining the fatigue life of
rectangular pressure vessels

(This section has been withdrawn pending clarification

of copyright.

Please refer to BS 3970 Appendix C.)

Previous page
is blank

33
Section C

Packaging for terminally sterilized products

Contents

C1 Introduction page 55 C4 Packaging materials and

C1.3 Sterilization process systems page 78
C1.6 Product applications C4.5 Sterilization compatibility
C1.11 Responsibility C4.5 Steam sterilization
C1.14 General performance requirements C4.5 Wrapped goods and
C1.16 Packaging operations porous loads
C1.17 Quality control C4.7 Fluids in sealed containers
C4.8 Dry heat
C2 Regulatory requirements and C4.11 LTSF
standards page 58 C4.14 Irradiation
C2.2 Safety C4.15 Ethylene oxide
C2.4 Medicinal products C4.19 Bacterial barrier properties
C2.6 Guide to Good Manufacturing C4.27 Materials used in packaging
Practice C4.29 Textiles
C2.7 Consumer protection C4.35 Papers and non-wovens
C2.8 Active Implantable Medical Devices Regulations C4.45 Synthetic materials and laminates
1992 C4.51 Polyethylene (polythene)
C2.9 Medical Devices Regulations C4.58 Polyester
C2.12 General requirements C4.60 Polyvinyl chloride (PVC)
C2.14 Requirements regarding design and C4.63 Polypropylene and polycarbonate
construction C4.68 Nylon
C2.31 Glass containers EEC Directive 75/107 C4.69 Glass containers
C2.32 British and European standards C4.73 Metals
C4.76 Single-use packaging
C3 Design considerations page 65 C4.78 Paper or textile wraps
C3.9 Compatibility with sterilization process C4.93 Paper bags, paper/plastic pouches
C3.11 Moist-heat/steam processors C4.93 Folding
C3.12 Sterilizers for wrapped goods and C4.98 Self-seal
porous loads C4.100 Heat seal
C3.21 Sterilizers for unwrapped instruments C4.114 Glass containers
and utensils C4.117 Ampoules - fusion seal
C3.24 Aqueous products in sealed C4.128 Vials and bottles
containers C4.129 Screw caps
C3.32 Low-temperature steam and C4.133 Crimp caps
formaldehyde C4.136 Re-usable packaging
C3.36 Ethylene oxide C4.136 Textiles
C3.49 Hot-air sterilizers C4.142 Containers for solid goods
C3.53 Irradiation C4.142 Impermeable or unvented
C3.62 Compatibility with labelling system containers
C3.68 Compatibility with requirements for aseptic C4.143 Open-topped trays and
opening perforated containers
C3.92 Compatibility with the contents C4.146 Instrument orientation trays
C3.92 Medical devices C4.148 Dressings drums
C3.95 Medicinal products C4.150 Re-usable rigid containers
C3.97 Laboratory products C4.187 Glass containers
C3.98 Toxicity C4.190 Vials and bottles
C3.101 Biocompatibility C4.190 Cleaning
C3.103 Preservation of sterility C4.192 Inspection
C3.108 Storage and transport of sterile packs C4.196 Screw caps
C3.110 Number of layers of packaging material C4.201 Crimp caps
C3.120 Primary and secondary packaging
C3.121 Secondary packaging

Previous page
is blank
C5 Purchase, quality control and C9 Storage and distribution page 120
storage page 101 C9.1 Shelf life
C5.2 Purchase C9.8 Distribution of sterilized supplies
C5.8 Specification C9.10 Storage of sterile supplies
C5.9 Quality control C9.25 Handling sterile packs
C5.17 Storage C9.28 Transport and distribution
C9.36 Storage in clinical areas
C6 Validation of packaging systems page 104 C9.42 Packaging for return of used items for
re-processing
C7 Facilities and environmental control for
packaging operations page 107 Glossary of terms page 124
C7.1 Packaging operations
C7.3 General requirements
C7.11 Facilities for packaging operations
C7.11 Cleaning
C7.16 Cleaners’ room
C7.20 Sterile Services Department
- SSD
C7.24 Linen room
C7.31 Packing room
C7.42 Sterilizer loading area
C7.44 Post-sterilization area
C7.48 Processed goods store
C7.54 Materials store
C7.60 Packaging equipment
C7.60 Heat sealers
C7.65 Overseal crimpers
C7.70 Screw cappers - controlled torque
C7.72 Ampoule sealers
C7.72 Manual sealing

C8 Packaging operations page 114

C8.1 Routine operation, control and monitoring
C8.3 Documentation
C8.5 Packaging instructions
C8.6 Batch packaging records
C8.10 Packaging records for single packs
C8.11 Batch numbering
C8.14 Labelling
C8.20 Control of the packaging operation
C8.27 Heat-sealing equipment
C8.32 Glass containers
C8.36 QC tests
C8.39 Pin holes
C8.43 Inspection of seals
C8.46 Packaging for sterile medicinal
products
C8.49 Process indicators
C8.53 Sterile product release
C8.58 Operator training
C1.0 Introduction

C1.1 This section discusses the factors which should be considered in the
selection and use of packaging for terminally sterilized products, that is, those
materials which are sterilized in their packaging.

Packaging for medical equipment which has been cleaned,

decontaminated/disinfected and serviced ready for return to use is not included
in this guidance.

C1.2 It does not consider those products which are sterilized and then
aseptically packed in sterilized packaging materials nor does it cover packaging
of terminally sterilized components to be used in aseptic manufacturing.

Sterilization processes

C1.3 Because the product is sterilized in its packaging it is necessary that the
packaging maternal is compatible with the sterilization process to be used.

C1.4 The sterilization processes included are those which are generally
available for use either directly or through a sub-contractor. It does not include
requirements for new processes which are currently under development or at
an early stage of their introduction for practical use. This would include, for
example, those systems employing gaseous or plasma phase peracetic acid
and/or hydrogen peroxide.

C1.5 Sterilization processes included are:

a. Steam - for clinical use (see HTM 2010 Part 1, paragraph 2.1 (a)):
(i) for wrapped goods and porous loads;
(ii) for aqueous fluids
- in rigid containers;
- in flexible containers;
(iii) for unwrapped instruments and utensils
- externally supplied steam;
- internally generated steam;

b. Steam - for laboratory use (see HTM 2010 Part 1, paragraph 2.1 (b)):
c. Low-temperature steam and formaldehyde. Note. The packaging
materials, systems and procedures described are also suitable for use with
disinfection processes intended for use with wrapped goods, for example
Low Temperature Steam Disinfectors (LTS);

d. Ethylene oxide

e. Dry heat (hot air)

f . Ionising irradiation (gamma and beta)
Product applications

C1.6 The sterile products for which packaging is considered include:

• medical devices and surgical Instruments:

- primarily those products, including re-usable instruments, utensils and

textiles, which are processed by Sterile Service Departments, including
units directly serving operating theatres (although the same principles
apply to other manufacturing systems which have a wide range of
product specifications produced singly or in small numbers. Only
passing reference is made to high speed automated packaging
systems.);
- re-usable instruments processed in clinics and general practices (dental
and medical);

• pharmaceutical manufacturing of sterile products;

• laboratory product manufacturing, for example culture media for

microbiology;

• discard (or make-safe) prior to disposal of potentially infective material.

C1.7 Consideration is given to materials and systems for both single-use and
re-usable packaging.

C1.8 Single-use packaging includes, for example, ampoules, single-trip

bottles, paper bags, paper/plastic pouches & reels, paper wraps, vacuum
formed trays, etc.

C1.9 Re-usable packaging includes, for example, multiple-trip bottles,

procedure trays, sterilization containers, textile wraps, etc.

C1.10 This guidance section also makes reference to labelling, storage and
distribution giving both guidance and particular requirements necessary to
ensure compliance with extant regulations.

Responsibility

C1.11 Part 1 of HTM 2010 (paragraph 1.15 (h)) Identifies the procedures for
production, quality control and safety as a major responsibility of management.

C1.12 The provisions of this section should be reviewed by those responsible

for the management of sterile production and adapted to local circumstances
(for example taking into consideration the nature of the product, the volume of
production, the sterilization process(es) available etc).

C1.13 It should be used as the basis for the development of written policies,
specifications and procedures to be used in the control of sterile production.

General performance requirements

C1.14 The purposes for which packaging is used are:

• to contain the product;

• to permit sterilization of the packaged product;

• to protect the product from deterioration and damage;

 • to maintain the sterility of the product through distribution and storage
to the point of use;

• to prevent contamination of the product.

C1.15 In addition the packaging must:

• permit identification of the number and type of product contained, the

lot number, the manufacturer and the expiry date (by labelling);

• include specification of storage conditions which the packaging is

designed to withstand;

• provide any necessary instructions for the correct use of the product (by
labelling and/or instruction sheets);

• present th e product in a manner which allows it to be removed aseptically

immediately before use.

Packaging operations

C1.16 The procedures and controls implemented for packaging operations

must be designed to ensure that:

• each product produced is in the correct type of pack;

• each pack is correctly and effectively sealed;
• each pack is correctly labelled with all the necessary information.

Quality control
C1.17 The nature of packaging for terminally sterilized products is such that:

• it is not possible to test the packaging on finished product in a manner

which permits its subsequent distribution for use;

• it is not possible to test any one sample for all necessary characteristics;
• it is not possible to test each pack immediately before use to ensure that
the packaging has performed correctly throughout sterilization,
distribution and storage.

C1.18 Adequate control of the quality of packaging can only be obtained

through a comprehensive programme including:

• design, and design verification;

• specification of packaging procedures;
• validation of packaging procedures;

• control of purchased material;

• control and monitoring of the packaging process;

• training for all who produce, handle or use sterile packs.

C1.19 Labelling is an essential part of packaging and procedures are required

to ensure that particular care is taken to avoid labelling errors.

C1.20 The importance of proper control over all aspects of the packaging
process cannot be over-emphasised. When products such as medical devices or
medicinal products are presented wrongly labelled, contaminated, or damaged
their use can cause serious adverse effect and may, in extreme cases, be lethal.
C2.0 Regulatory requirements and
standards

C2.1 So far as requirements for packaging, including labelling, are concerned,

the chief areas of legislation with which managers should be familiar are those
concerned with safety, consumer protection, medicinal products, medical
devices, active implantable medical devices and in vitro diagnostics.

The legislation relevant to sterilizers is also discussed in HTM 2010 Part 1,

Chapter 3, to which reference should be made.

Safety

C2.2 Manufacturers have two specific obligations under the Health and
Safety at Work etc. Act 1974:

a. to take all reasonably practicable steps to ensure that their products have
been designed and manufactured so as to be safe when used for the
intended purpose;

b. to ensure that persons who use their product in further manufacturing

and retailing operations have adequate information and advice about
how the products should be used to ensure safety.

C2.3 There is also a more general requirement under common law to protect
all persons involved with the use of the product.

Medicinal products

C2.4 Where a packaging material or system is used to contain a medicinal

product the licensing provisions of the Medicines Act 1968 apply.

Further information may be found in ‘Guidance to the NHS on the licensing

requirements of the Medicines Act 1968’ published by the Medicines Control
Agency.

C2.5 The Medicines (Standard Provisions of Licences and Certificates)

Amendment Regulations 1992 (Sl 1992/2846) give statutory force to the
European Commission document ‘The rules governing medicinal products in
the European Community Volume IV Guide to Good Manufacturing Practice for
medicinal products.’

Guide to Good Manufacturing Practice for medicinal products

C2.6 T h e principles and detailed guidelines of good manufacturing practice

deal with a number of aspects of packaging including:

• Documentation, which should include:

- a formal, written specification for packaging materials;
- formally authorised packaging instructions for each product, pack size
and type;
- a record kept for each batch or part batch processed.
 • Purchase, handling and control should be treated in the same manner as
starting materials with particular attention paid to printed material;

• Packaging operations should be designed to minimise the risk of mix-ups

by the inclusion of a line clearance procedure and special care should be
exercised to avoid mislabelling.

The packaging should be verified as being of the correct type, clean and in the
correct quantity and there should be suitable on-line control and monitoring to
verify the adequacy of the packaging operation.

Consumer protection

C2.7 Part 1 of the Consumer Protection Act 1987 implements Directive

85/374/EEC (the Product Liability Directive) and provides for compensation to
be paid to persons suffering injury from a defective product. The implications of
this legislation are discussed in HTM 2010 Part 1 (paragraphs 3.26 to 3.28
inclusive).

Active Implantable Medical Device Regulations 1992

C2.8 The Active Implantable Medical Devices Regulations 1992

(Sl/1992/3146) implements Council Directive 90/385/EEC. Schedule 2,
paragraph 7 of these regulations requires active implantable medical devices to
be designed, manufactured and packed in a non-reusable packaging according
to procedures which are sufficient to procedures which are sufficient to ensure
that:

a. the device is sterile when placed on the market;

b. if handled in accordance with conditions as to storage laid down by the

manufacturer, the device remains sterile until the packaging is removed
and the device is implanted.

Medical Devices Regulations

C2.9 The Medical Devices Regulations 1994 (Sl/1994/3017) implements

Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices and
came into effect on 1 January 1995.

C2.10 Regulation 11 concerns the procedure for systems and procedure

packs and requires, inter alia, that any person who puts devices bearing the CE
marking together, within their intended purpose and within the limits of use
specified by their manufacturers, in order to place them on the market as a
system or procedure pack, shall draw up a declaration by which he states that
he has packaged the system or procedure pack and supplied relevant
information to users incorporating relevant instructions from the manufacturers,
and that the whole activity is subjected to appropriate methods of internal
control and inspection.

C2.11 The Essential Requirements described in Annex 1 (of the Directive)

include a number of specific requirements for packaging and labelling which
are summarised below.
General requirements
C2.12 The devices must be designed, manufactured and packaged in such a
way that they are suitable for the functions specified by the manufacturer.

C2.13 The devices must be designed, manufactured and packed in such a

way that their characteristics and performances during their intended use will
not be adversely affected during transport and storage taking account of the
instructions and information supplied by the manufacturer.

Requirements regarding design and construction

C2.14 The devices be designed, manufactured and packed in such a way as

to minimise the risk posed by contaminants and residues to the persons
involved in the transport, storage and use of the devices and to the patients
taking into account the intended purpose of the product.

C2.15 The devices and manufacturing processes must be designed in such a

way as to eliminate or reduce as far as possible the risk of infection to the
patient, user and third parties.

C2.16 Devices delivered in a sterile state must be designed, manufactured

and packed in a non-reusable pack and/or according to appropriate procedures
to ensure that they are sterile when placed on the market and remain sterile
under the storage and transport conditions laid down, until the protective
packaging is damaged or opened.

C2.17 Packaging systems for non-sterile devices must keep the product
without deterioration at the level of cleanliness stipulated and, if the devices
are to be sterilized prior to use, minimise the risk of microbial contamination;
the packaging system must be suitable taking account of the method of
sterilization specified by the manufacturer.

C2.18 The packaging and/or label of the device must distinguish between
identical or similar products sold in both sterile and non-sterile condition.

C2.19 Each device must be accompanied by the information needed to use it

safely and to identify the manufacturer, taking into account the training and
knowledge of the users.

C2.20 This information comprises the data on the label and the data in the
instructions for use.

C2.21 As far as practicable and appropriate, the information needed to use

the device safely must be set out on the device itself and/or on the packaging
for each unit or, where appropriate, on the sales packaging.

C2.22 If individual packaging of each unit is not practicable the information

must be set out in the leaflet supplied with one or more devices.

C2.23 Instructions for use must be included in the packaging for every device.
By way of exception, no such instructions for use are needed for devices
classified in Class I or IIa if they can be used safely without any such
instructions. The majority of, but not all, products produced in hospital based
sterilization units would fall into this category, for example re-usable surgical
instruments which are in Class I. Exceptions include implants, and may include
devices intended for use on skin wounds that have breached the dermis. In
case of doubt reference should be made to the classification criteria given in
Annex IX of the directive or advice sought from the competent authority
(Medical Devices Agency, DoH).

C2.24 Where appropriate is information should take the form of symbols.

Any symbol or identification colour used must conform to the harmonised
standards. In areas for which no standards exist, the symbols and colours must
be described in the documentation supplied with the device.

C2.25 The label must bear the following particulars:

a. the name and trade address of the manufacturer;

b. the details strictly necessary for the user to identify the device and the
contents of the packaging;
c. where appropriate, the word STERILE;

d. where appropriate, the batch code, preceded by the word LOT, or the
serial number;
e. where appropriate, an indication of the date by which the device should
be used, in safety, expressed as the year and month;

f. where appropriate, an indication that the device is for single use;

g. if the device is custom made, the words “custom made device”;
h. if the device is intended for clinical investigations, the words "exclusively
for clinical investigations";

i. any special storage and/or handling conditions;

j. any special operating instructions;

k. any warnings and/or precautions to take;
l. year of manufacture for active devices other than those covered by e. This
indication may be included in the batch or serial number;

m. where applicable, method of sterilization.

C2.26 If the intended purpose of the device is not obvious to the user the
manufacturer must clearly state it on the label and in the instructions for use.

C2.27 Wherever reasonable and practicable, the devices and detachable

components must be Identified, where appropriate in terms of batches, to
allow all appropriate action to detect any potential risk posed by the devices
and detachable components.

C2.28 Where appropriate the instructions for use must contain the following
particulars:

a. information to avoid certain risks in connection with implantation of the

device;

b. the necessary instructions in the event of damage to the sterile packaging

and where appropriate details of appropriate methods of re-sterilization;

c. if the device is reusable, information on the appropriate processes to

allow re-use, including cleaning, disinfection, packaging and, where
appropriate, the method of sterilization of the device to be re-sterilized,
and any restriction on the number of re-uses.
C2.29 Where devices are supplied with the intention that they be sterilized
before use, the instructions for cleaning and sterilization must be such that if
correctly followed the device will still comply with the general requirements
specified in Section I, Annex I of the directive.

C2.30 The instructions for use must also include details allowing the medical
staff to brief the patient on any contra-indications and any precautions to be
taken.

Glass containers EEC Directive 75/107

C2.31 Capacity tolerances for bottles specified as measuring containers were Table C1 Capacity tolerances for bottles
defined in the Directive and are summarised in Table C1. as measuring containers

Nominal Capacity tolerances

Two methods of capacity verification were specified, the Standard deviation capacity as %
method and the Mean range method. of C in ml
C (ml)

50 - 100 - ±3
British and European standards 100 - 200 ±3 -

C2.32 The rapid development in European Standards, which are required to 200 - 300 - ±6
be adopted as national standards by all European members of the European 300 - 500 ±2 -
Committee for Standardisation (CEN), is largely due to the role that such
standards have in demonstrating compliance with legislation implementing 500 - 1000 - ±10
European Directives. 1000 - 5000 ±1 -

CEN is recognised by the European Union as a competent body for the

adoption of harmonised standards.

C2.33 For the purpose of the European Directives on Medical Devices and
Active Implantable Medical Devices a harmonised standard is a technical
specification (European standard or harmonisation, document) adopted, on a
mandate from the European Commission, by CEN.

C2.34 There is a presumption of compliance to the essential requirements of

the Directive for devices which are in conformity with the relevant harmonised
standards the references of which have been published in the Official Journal of
the European Communities.

C2.35 A number of standards are in preparation which are relevant to

packaging and labelling of terminally sterilized products.

The following list is not exhaustive. The standards discussed are in various
stages of preparation, those marked * are finalised and published. All EN
standards are available in the UK as British Standards; there is now a dual
numbering system so that EN *** will be numbered as BS EN ***.

C2.36 EN 1041 Terminology symbols and information provided with medical

devices - Information supplied by the manufacturer with medical devices

This standard specifies the information to be supplied by the manufacturer of

medical devices necessary to comply with the requirements of the Directive.

C2.37 EN 980 Terminology symbols and information provided with medical

devices - Graphical symbols for the labelling of medical devices
This standard defines a number of symbols to be used in labelling medical
devices. The use of these symbols will both facilitate provision of all the
essential information on small packs and minimise the need for multi-lingual
labelling.

C2.38 EN 868 series Packaging materials for sterilization of wrapped goods

This standard is presented in a series of separate parts. The first part specifies
the general requirements for packaging materials to be used for medical
devices which are to be terminally sterilized and provides requirements,
guidance and test methods for the validation of packaging materials and
systems.

The subsequent parts of the standard specify requirements for a variety of

packaging materials and systems. Conformity with the specified requirements in
these parts of the standard may be used as one means of demonstrating
compliance with some, or all, of the requirements of Part 1.

C2.39 EN 867 series Non-biological systems for testing sterilizers

This series of standards specifies the requirements for chemical indicators used
in testing sterilizers. Part 2 of the standard specifically addresses the
performance requirements for process indicators, whether used independently
of, or printed on, labels or packaging materials. Detailed specifications are
given for performance criteria relevant to all the sterilization processes
considered in this Section (see paragraph C1.5).

C2.40 EN 724 Guidance on the application of EN 29001 and EN 46001 and

of EN 29002 and EN 46002 for non-active medical devices

This standard provides guidance on suitable methods and procedures, including

aspects of packaging, for the manufacture of medical devices in conformity
with the requirements of the Quality System standards which may be used to
demonstrate compliance with the requirements of the Directive.

C2.41 EN 550* Sterilization of medical devices - Validation and routine

control of ethylene oxide sterilization

This standard specifies requirements for the development, validation, process

control and monitoring of the sterilization of medical devices using ethylene
oxide and gives guidance on means by which these requirements may be met.
The importance of packaging in the correct functioning of an ethylene oxide
sterilization process is recognised.

C2.42 EN 552* Sterilization of medical devices - Validation and routine

control of sterilization by irradiation

This standard specifies requirements for the development, validation, process

control and monitoring of the sterilization of medical devices using ionising
radiation and gives guidance on means by which these requirements may be
met. The importance of specifying and controlling packaging from validation
through to routine batch control is emphasised.

C2.43 EN 554* Sterilization of medical devices - Validation and routine

control of sterilization by moist heat

This standard specifies requirements for the development, validation, process

control and monitoring of the sterilization of medical devices using moist heat.
The methods used are based on monitoring physical factors and control of the
packaging is an essential part of the system.

C2.44 EN 1174 series Sterilization of medical devices - estimation of the

population of micro-organisms on product

This standard describes methods for determining the extent of microbial

contamination on products, including packaging, prior to sterilization.
C3.0 Design considerations

C3.1 The manufacturer of the sterile product is responsible for adopting a

design for the pack which is suitable for its intended purpose.

C3.2 However, in many cases the design of the packaging material and/or
system may be controlled by the manufacturer of the packaging material
and/or packaging system and sold as suitable for a particular range of
applications.

C3.3 The choice of such a pre-designed, commercially available packaging

system does not absolve the sterile product manufacturer from the
responsibility for ensuring that:

• the design of the packaging system, including the selection of materials,

is suitable in all respects for the intended application (see Chapter C6)

• the packaging system as received from the supplier is in conformity with

the specification against which the choice was made (see Chapter C5)
• the production facilities, including the skills of production personnel, are
compatible with the packaging system chosen and have the
demonstrated capability to fill, seal and sterilize the packaging in
accordance with the instructions provided by the manufacturer of the
packaging system, (see Chapters C7 - C9).

C3.4 The packaging is required to fulfil a number of functions. These may be

summarised as: “to minimise the safety hazard to the manufacturer, user or
patient arising from interaction of the product with its environment under the
conditions of sterilization, transport, storage and use as specified by the
producer of the packaging system and/or sterile product.”

C3.5 The design should include consideration of at least the following:

• the compatibility of the packaging with the sterilization process;

• the compatibility of the packaging with the labelling system;

• the compatibility of the packaging with the users’ requirements at the

point of use, for example aseptic opening;

• the sensitivity of the pack contents to particular risks, for example

irradiation, moisture, mechanical shock, static discharge.
• the compatibility of the packaging with the contents, for example the
medical device or medicinal substance, in order that the packaging has
no adverse effect on the medical device or vice versa;

• the protection provided by the packaging against adverse environmental

influences which may reasonably be anticipated, for example mechanical
shock, vibration, chemical or microbial contamination;

C3.6 The emphasis to be given to each of these considerations will be

different for each of the various sterile products manufactured but,
compatibility with the sterilization process and the subsequent protection
against microbial contamination are paramount in providing the user with a
sterile product.
C3.7 In many cases historical data may be used to provide satisfactory
evidence that the packaging is suitable for its intended purpose where
packaging to the same specification has previously been used satisfactorily for a
particular product, or one that is similar in all essential respects.

C3.8 The design documentation should include details of the product to be

packaged, the sterilization process to be used, the storage and transport
conditions as well as the specification of the packaging materials and processes
to be used.

Compatibility with the sterilization process

C3.9 There are two important aspects to sterilization compatibility:

a. the ability of the packaging material to permit the attainment of the
required conditions for sterilization in the process with which it is
intended to be used;

b. the ability of the packaging material to withstand the sterilization process

without deterioration which adversely affects its protective performance.

C3.10 Both attributes should be demonstrated.

Moist-heat/steam sterilization processes

C3.11 For effective sterilization by moist heat all parts of the load should be
in contact with water or saturated steam at the required temperature for the
required time.

Sterilizers for wrapped goods and porous loads

C3.12 Items to be sterilized, other than aqueous products in sealed

containers, should be packaged in a pack which allows removal of air and
penetration of steam but which prevents recontamination after sterilization

C3.13 This is normally achieved by the use of materials which are permeable
to air and steam but have an effective maximum pore size which is small
enough to exclude microbial contamination under the specified storage and
transport conditions.

C3.14 This includes wrapping in porous materials, the use of rigid containers
which are fitted with filters or valves, or a combination of these methods.

C3.15 Effective sterilization requires complete permeation of the porous

materials with the moisture and heat of the steam. This may occur rapidly or
slowly and depends, inter alia, on the size and density of the pack, the method
of air removal, the nature of the porous material etc.

C3.16 With packaged solid, hollow or fibrous products air may become
trapped, randomly, in the sterilizer chamber and load. The microbial lethality of
elevated temperatures under dry and moist conditions are vastly different. The
presence of air can cause an unacceptable impairment of the sterilization
process.

C3.17 Unpredictable air retention is of particular concern with porous

wrapping materials. Hence for effective sterilization of wrapped goods and
porous loads it is important to employ a sterilization process which incorporates
forced air removal prior to the sterilization stage.
C3.18 Preliminary tests on the product and its packaging in order to
determine the levels and rates of change of pressure, temperature and vacuum
which start to cause unacceptable changes in the performance qualities of the
medical device and/or its packaging may be necessary.

C3.19 Performance qualification should be performed on the introduction of

new or modified packaging unless equivalence either to a validated reference
load or to previously validated packaging has been demonstrated.

C3.20 Materials used for packaging should be compatible with the

sterilization process not only in permitting passage of steam and air as required
by the process but also in not contributing any other inhibitory factors. For
example they should not generate gases which could mimic the presence of
retained air and restrict the penetration of steam.

Sterilizers for unwrapped instruments and utensils

C3.21 Sterilizers not intended for use with wrapped goods, for example bowl
and instrument sterilizers, and small transportable electrically heated sterilizers
rely on steam flow to remove air. Although the air may eventually be displaced
from wrapped loads the process is slower and less predictable than when
forced air removal is used.

C3.22 The only packaging suitable for unwrapped instrument and utensils
sterilizers are “instrument orientation” trays which are constructed of open
mesh or with sufficient ventilation holes to ensure that they present no barrier
to air removal and steam penetration.

C3.23 BS 3970 Part 4 requires that load containers for transportable sterilizers
should be designed to permit free draining of condensate and penetration of
steam by perforation of appropriate surfaces. The perforated surfaces should
have not less than 10% of their area as uniformly distributed perforations, each
perforation being at least 20 mm2.

Aqueous products in sealed containers

C3.24 Sealed glass or plastics containers containing aqueous solutions permit

moist heat sterilization of the contents by virtue of the moisture present in the
product.

C3.25 The container must have a gas-tight seal if the composition of the
contents is not to be modified by evaporation of water from the contents or
the ingress and condensation of steam from the sterilizer chamber.

C3.26 The container must be able to withstand the considerable internal

pressures which will be generated during the sterilization process. This increase
in pressure arises from the volumetric expansion of the container being
insufficient to compensate for the volumetric expansion of the liquid, the
increased vapour pressure of the liquid and the increased pressure of the
heated air in the vacuity.

C3.27 The pressure generated in a correctly filled 1 litre bottle when it is

heated to 121°C may exceed 8 bar.

C3.28 Plastic containers, -particularly those made of polymers which undergo

a reduction in tensile strength at the temperatures used for steam sterilization,
are often only suitable for use in sterilizers which include air or gas ballasting to
increase the pressure throughout the cycle and thus restrain the container from
bursting. A similar approach may be used to sterilized devices used as packaging.
for example pre-filled syringes.

C3.29 The safety of operators will be at serious risk from the violent failure of
containers and dispersal of their contents if the containers are removed from
the sterilizer at too high a temperature (see HTM 2010 Part 3 paragraph
14.20 d).

C3.30 The use of unsealed containers to avoid this problem is unacceptable.

Not only is the composition of the contents subject to unpredictable changes,
but liquids such as molten agar might still be boiling violently. Splashes from
hot liquids of high thermal capacity can cause serious burns.

C3.31 Containers which are “unsealed” but plugged with porous material, or
have the cap in place but left loose, that is not screwed tightly closed, may also
become unsafe at elevated temperature. The evaporation of water from
residues of the contents which boiled over during the early stages of the
cooling process can effectively seal the container” It is important to emphasise
that these are not theoretical considerations but represent a real hazard which
has, in the past, caused injury to a number of personnel.

Low-temperature steam and formaldehyde

C3.32 The basic considerations for packaging for this process are similar to
those for steam sterilizers for porous loads and wrapped goods.

C3.33 However, the thermal characteristics (both the thermal capacity and
thermal conductivity) of the packaging can be of importance:

a . Materials which are slow to attain the required temperature may promote
the polymerisation of the formaldehyde gas.

b. Materials of high thermal capacity promote the formation of excessive

quantities of condensate which also may adversely affect the sterilization
process.

C3.34 In addition, the extent to which the packaging material will absorb and
adsorb both moisture and formaldehyde gas may affect the efficacy of the
process.

C3.35 In general packaging should be kept to the minimum compatible with

adequate protection for the product and the maintenance of sterility.

Ethylene oxide

C3.36 The packaging should be designed to allow removal of air and

penetration of both steam and ethylene oxide and it should be demonstrated
that the specified sterilization process does not affect adversely the functioning
of the packaging.

C3.37 Impervious packaging materials are unsuitable for ethylene oxide

sterilization.

C3.38 There are a considerable number of different ethylene oxide

sterilization processes ranging from those employing pure ethylene oxide at
sub-atmospheric pressures to those which use a mixture of ethylene oxide and
carbon dioxide at pressures of several bar.
C3.39 The nature of the process, including the rate of air removal and the
nature of the humidification stages used, will influence the suitability of
packaging to be used in the process.

C3.40 A sterilization process that employs a high moisture content and

several large and rapid changes in pressure may affect the strength of package
seals, with a consequent loss of integrity, whereas. package seals of the same
type would have been perfectly satisfactory for a process employing less
extreme conditions.

C3.41 The extent to which the packaging absorbs moisture may have a major
influence on the efficacy of the process and must be considered before a
satisfactory humidification stage can be demonstrated.

C3.42 The extent to which the packaging absorbs or adsorbs ethylene oxide,
and its permeability to ethylene oxide may have a major influence on the
efficacy of the process and the subsequent aeration process used to remove the
potentially toxic residuals.

C3.43 Process control is also a concern since packaging material that has
become dehydrated may absorb excessive moisture during the conditioning
phase; if this possibility was not recognised during validation the achieved cycle
lethality may be adversely affected.

C3.44 The use of cartons (shelf packs, transit cartons) may be convenient for
handling product but increase the post-sterilization level of ethylene oxide
residuals, the necessary humidification time and the length of the gas exposure
stage of the cycle (by inhibiting gas penetration). All the packaging which is
intended to go into the sterilizer must be compatible with the process.

C3.45 The standard on validation of ethylene oxide sterilization processes (see

EN 550) includes the requirement that the packaging specification be part of
the definition and documentation of the sterilization process. The validation
report should include or reference details of product sterilized, including
packaging specification and load patterns in the sterilizer.

C3.46 It is therefore necessary that product used for physical and

microbiological performance qualification studies should be packaged in an
identical manner to that to be used routinely when they are presented for
sterilization.

C3.47 The introduction of a new, or altered, packaging material or system

requires validation. Physical and microbiological performance qualification
studies should be performed on the introduction of new or modified
packaging, although demonstration of equivalence to a previously validated
package would satisfy this requirement.

C3.48 Many of the packaging materials for hospital use are the same as
those for use in steam sterilizers because of similar permeability requirements;
however, the lower temperatures involved in the process permit a wider range
of materials to be used.

Hot-air sterilizers

C3.49 The thermal conductivity, specific heat and ability to withstand

temperatures of 165°C, 175°C or 185°C (depending on the process used) for
extended periods, without deterioration which impairs the utility of the
packaging, are obvious considerations.
C3.50 The packaging does not need to be porous since the heat transfer
normally takes place by conduction.

C3.51 However, in sealed packaging the contents of the pack when heated
can exert a considerable pressure and may be sufficient to rupture the
packaging material or its seals.

C3.52 Vented packaging systems that allow pressure equilibration may be

suitable for use in hot air sterilizers which operate with a chamber atmosphere
which has been filtered through a bacteria retentive filter. This is particularly
important during the during the post-sterilization cooling stage.

Irradiation
C3.53 The standard for validation of radiation sterilization processes (EN 552)
requires that the process specification should include descriptions of the
dimensions, density and orientation of the product within the packaging, as
well as the pattern for the loading of product within the container to be used
to transport the packs through the irradiator. This should be established and
documented before commencing performance qualification studies.

C3.54 The orientation of the product during irradiation is one of the factors
ensuring uniformity of dose and the ability of the packaging to maintain
consistent orientation of the product must be considered.

C3.55 The density of the packaging, and hence its “transparency” to the
radiation to be used may be an important consideration, particularly in the case
of electron beam irradiation.

C3.56 Although radiation sterilization is a low-temperature process there IS

nevertheless some increase in temperature above normal ambient temperatures
and this should be considered.

C3.57 There is no requirement for the packaging to be gas permeable. If the

packaging is gas tight it may reasonably be assumed to be a satisfactory barrier
to microbial contamination.

C3.58 Many materials are structurally altered by the radiation process; they
may become hardened and embrittled, or discoloured, for example.

C3.59 These radiation induced changes may be beneficial or disadvantageous

to the subsequent performance of the packaging or they may simply be
aesthetically unacceptable, for example the yellowing which occurs with some
PVC materials.

C3.60 Many polymers are now available specifically formulated with

stabilisers which make them suitable for use in irradiation processes. The
adhesives used to seal packages must also be considered for potentially adverse
effects of the radiation.

C3.61 For most hospital users, with only small numbers of items to be
irradiated, the advice of the sub-contractor providing the irradiation sterilization
service should be sought. Based on their experience of radiation sterilization of
similar products they will often be able to suggest appropriate packaging which
can be validated by comparison with previously validated products.
Compatibility with the labelling system

C3.62 The importance as labelling as an integral element of the product

packaging has been stressed (see paragraphs C1.15 and C2.19 to C2.30).

C3.63 Labelling may take a number of forms, including:

• labelling printed directly on the packaging;

• printed labels attached to the surface of the packaging by adhesive, etc.

C3.64 Whether labels are printed directly on the packaging or onto discrete
labels which are subsequently attached to the pack, the labelling system
should:

a. not adversely affect the compatibility of the packaging with the

sterilization process to be used, for example by excessively restricting the
porous area available for gas exchange;
b. not be rendered illegible by the sterilization process to be used;
c . not employ ink of a type which may
(i) transfer to the pack contents;
(ii) react with the packaging to impair its utility;
(iii) change colour and render the label Illegible;
(iv) interfere with the sterilization process by, for example, evolution of
volatile components.

C3.65 Labels fixed to the surface of the packaging must be able to withstand
exposure to the sterilization process and the defined storage and transport
conditions without becoming detached.

C3.66 Given the low cost of computerised label printing systems there can be
little justification for using hand-written labels with the inevitable variation in
legibility that this causes.

C3.67 Writing on the packaging also presents an unacceptably high risk of

causing damage to, for example, paper packaging, which may not be readily
visible but is sufficient to breach the microbial barrier properties of the material.
Furthermore, some pens, such as ‘felt-tip’ pens and ‘marker’ pens, have inks
which may release volatile components in sufficient quantities to interfere with
the correct functioning of a steam sterilizer.

Compatibility with requirements for aseptic opening

C3.68 Failure to consider adequately how a pack is to be opened and the

contents removed may significantly increase the chance of contamination
occurring. With inadequate provision for aseptic opening a 10-3 probability of
contamination is easily possible which compares unfavourably with a 10-6
probability of sterility required as a minimum standard before labelling a
product as sterile (EN 556).

C3.69 The means of sealing or closing the pack should be tamper evident in
order that the user may rely upon the integrity of the contents.

C3.70 For sterile products the other major consideration at the point of use
must be the ability to remove the product from the packaging without it
becoming contaminated with micro-organisms, in other words the aseptic
removal of the product.
C3.71 The provision of aseptic removal may be influenced by a number of
elements in the design of the packaged product Including:

• the type of product;

• the packaging system chosen;

• the method of closure or sealing;

• the number of layers of packaging material;

• the arrangement of the contents of the pack;

• the use of special equipment to remove the contents.

C3.72 Sterile medicinal products include both parenteral and topical

preparations. The former are predominantly aqueous solutions whereas the
latter may be aqueous solutions, oils, emulsions (ointments or creams), or dry
powders.

C3.73 The packaging system employed for sterile medicinal products will
normally consist of a closed rigid or flexible container as the primary pack. This
may be closed by being hermetically sealed or by being sealed with a
penetrable (or removable) elastomeric closure (such as a bung, stopper or disk)
held in place with a screwed cap or crimped overseal.

C3.74 Sterile medicinal products are usually best presented in single-use form.
Where a multi-use presentation is employed there will be a requirement for a
suitable preservative to be included in the product formulation.

C3.75 The primary pack may need to be overwrapped if it is necessary to

provide for aseptic handling of the primary pack.

C3.76 Sterile medical devices may be presented as single items such as

individual instruments, dressings, etc or, as a single pack containing multiple
items; the composition of which is designed so that contents comprise the
items required for one (or more) particular procedure(s).

C3.77 These are commonly described in a variety of terms such as:

• Basic packs (dressing packs which may or may not contain instruments);

• Composite packs (instruments, dressings and other equipment/utensils);

• Supplementary packs (which include instruments, utensils, dressings for

use with basic packs and composite packs);

• Procedure packs (which contain all the instruments, drapes, dressings and
utensils required for a particular procedure);

• Linen packs packs (which contain all the drapes required for a particular
procedure);

• Gown packs, dressing packs, etc.

C3.78 The packaging system employed for sterile medical devices may consist
of flexible or rigid packaging, or the two types used in combination; and may
be intended for single use, or be re-usable or a be combination of single use
and re-usable.

C3.79 These may be closed by heat-seal, adhesive, compression gaskets, or

tortuous path closures. A common format used in hospital SSDs is a pack
formed from a rigid tray wrapped in a flexible packaging material. The tray may
be re-usable metal or plastic, such as polypropylene, or single use, such as
metal foil, moulded pulp, folded cardboard.
C3.80 For medical devices the arrangement of the pack contents will be of
importance. The contents generally are arranged so that when the pack is
opened they are available in an order convenient to the user for the intended
purpose and suitable for aseptic removal.

C3.81 The method of opening the sealed or closed pack and/or removing the
contents affects the aseptic removal capability. The various sealing and closing
methods may involve particular risks with regard to transfer of contamination
from the outside surface of the pack, or to transfer of fragments of the
packaging.

C3.82 Tortuous path seals formed by the folding of flexible packaging

material may be constructed so that they may be opened without touching the
inner surfaces.

C3.83 Pealable seals are used on heat sealed, and some adhesive-sealed,
flexible packs and on many commercially produced packs, for example lidded
blister packs. The construction of the seal should allow the opposing surfaces
to be grasped easily and the seal on separating should not cause fibre shedding
by, say, the splitting or tearing of either surface.

C3.84 Both flexible and rigid packaging systems are used which are intended
to be broken, cut or torn open, for example ampoules, paper bags and
pouches. It is important that this can be done without introducing
contamination into the pack contents either from fragments of the packaging
(for example glass particles from an ampoule), or from instruments used in the
opening procedure, such as scissors for cutting open paper bags.

C3.85 Rigid re-usable containers for dry goods should have a tamper evident
seal which must be broken before the container can be unlatched and the lid
opened.

C3.86 Both single-use and re-usable containers for liquids, particularly those
intended for topical administration or laboratory use, may have a seal which is
formed from a compressible gasket (for example a rubber wad or stopper) held
in place by, or as an integral part of, a screw capped lid. Aseptic removal of the
contents will depend not only on the ease with which the cap and gasket can
be removed but also on the method used subsequently to dispense the
contents, for example pipetting, pouring.

C3.87 Both single-use and re-usable containers for liquids, particularly those
intended for parenteral administration, may have a seal which must be
punctured and penetrated by a suitable device to remove the contents, for
example using a hypodermic needle and syringe to remove the contents of a
vial.

C3.88 The potential risk of introduction of contamination from surface of seal

should be considered. The external surface of the seal may need protection
(overseal) which can be removed immediately before use, or the instructions for
use may require pre-treatment of the seal surface, for example by swapping
with a 70% m/v aqueous solution of spore-free isopropanol.

C3.89 For re-usable systems the ability of the closure to re-seal after each
penetration will be an important consideration in the maintenance of sterility.

C3.90 The seal for either single-use or re-usable systems must be of a

material which will not be damaged by the penetrating needle to the extent
that fragments of the closure will contaminate the contents of the container.
C3.91 Sealed packs should always be carefully inspected for seal integrity, or
adventitious contamination, before being opened and this requirement should
be drawn to the users’ attention both in the labelling of the pack and on any
instructions for use or training programme which may be given.

Compatibility with the contents

Medical devices

C3.92 The suitability of the packaging for use with the particular medical
device should be established. This should include limiting values for physical
characteristics of both the medical device as well as the stresses which will be
imposed during sterilization and subsequent transport and storage.

C3.93 Factors to be considered include, but are not limited to:

• the mass and configuration of the medical device to be packed;

• the presence of sharp edges or protrusions;

• the need for mechanical and other protection;

• interactions with the packaging materials.

C3.94 Consideration of product interaction should also include physical

contamination with the packaging material. Small particles introduced into the
body during, for example, surgical procedures are widely reported to cause
clinical problems including inducing adhesions, granulomata and foreign body
reactions in tissues.

Medicinal products

C3.95 Factors to be considered include:

• interactions with the packaging materials, including adsorption,

absorption and chemical reactions with components of the packaging
materials, for a period not less than the specified storage life under the
specified storage conditions;

• adverse effects on the contents due to gas or water vapour permeability,

such as permitting loss of water from a formulation, or permitting the
ingress of oxygen and subsequent oxidation of one or more components
of the formulation.

C3.96 Materials used for packaging should be compatible with the contained
product, For example packaging intended for use with parenteral fluids should
not shed particulate material to an extent which could compromise the quality
of the parenteral being administered.

Laboratory products

C3.97 Factors to be considered include all those noted in the two previous
sections for medical devices and medicinal products.
Toxicity

C3.98 Packaging materials and/or systems should not release material known
to be toxic in sufficient quantity to cause a health hazard either before, during
or after sterilization under the specified conditions of use.

C3.99 Evidence that the packaging material and/or system does not either
contain material known to be toxic, or contain material which may react during
the sterilization process to form a substance known to be toxic, in sufficient
quantity to cause a health hazard is normally sufficient to meet this
requirement.

C3.100 Manufacturers of packaging are aware of this requirement and

should be able to provide evidence that the formulation of the packaging has
been reviewed by a competent toxicologist and found to meet this
requirement.

Biocompatibility

C3.101 The biocompatibility of the packaging should be assessed with regard

to the intended use of the pack contents. If particular requirements for the
product to be sterilized, for example freedom from particulate matter, cannot
be established from the material specification for the packaging under
consideration expert advice should be sought. In the first instance this advice
should come from the manufacturer of the device, who has a legal obligation
to specify any particular requirements for the safe sterilization of the product.

C3.102 Test methods for bio-compatibility are described in EN 30933-1; they

require the services of a specialist laboratory.

Preservation of sterility

C3.103 The packaging materials and/or systems assembled in the form in

which it will be presented to the sterilizers, when assembled, stored,
transported and used in accordance with the producer’s instruction, should
preserve the sterility of the contents from the time at which they are rendered
sterile to the expiry date specified by the manufacturer and/or the point of use.

C3.104 Preservation of sterility is achieved by preventing the ingress of micro-

organisms. Many factors affect the probability of such ingress occurring. These
include, but are not limited to:

• the concentration of micro-organism in the environment;

• the size of particle on which the micro-organisms occur;
• environmental conditions of temperature, humidity and pressure;

• the rate of change of these environmental conditions;

• flow rates through the layers of packaging material;

• pore size and other filtration parameters of the packaging material.

C3.105 There is no universally applicable, single test method which can be

used to establish the microbial barrier properties of a pack.

For particular types or sizes of pack there are tests which may be of value as an
overall monitor of microbial barrier properties.
C3.106 For most practical purposes it is necessary to infer satisfactory
microbial barrier performance from a combination of tests designed to test
attributes of the packaging which are related to microbial barrier properties, for
example to test the gas tightness of seals.

C3.107 The time for which any packaging system will maintain the sterility of
the pack contents is event related not time related. It is therefore necessary to
define, and control, the conditions for both storage and transport, within
which the pack will maintain the sterility of the contents.

Storage and transport of sterile packs

C3.108 It is necessary to ensure that the packaging is able to provide the

protection necessary to maintain the performance characteristics of:

• the packaging during storage and transport under the specified

conditions;

• the contents during storage and transport under the specified conditions.

C3.109 When handled according to instructions, the packaging should

protect the product from physical damage and maintain the sterility of the
medical device up to the point of use.

Number of layers of packaging material

C3.110 Products may be packaged in a single layer of packaging material, or

in multiple layers. Multiple layers of packaging may be used to reduce the
likelihood of contamination during storage and when the pack is opened.

C3.111 When two layers of packaging are used to facilitate aseptic removal
of the contents:

• the outer wrap is sealed and acts as a barrier to microbial penetration to

the product from the environment,

• the inner wrap may, or may not, be sealed and may, or may not, be
intended to be a barrier to environmental microbial contamination. It acts
as a protective cover during removal of the product.

C3.112 When the inner wrap is a microbial barrier it may serve to provide
additional assurance of the maintenance of sterility.

C3.113 This inner wrap, having been maintained in a sterile state by the
presence of the outer wrap, may be handled by persons, wearing sterile gloves
and about to undertake an aseptic procedure.

C3.114 Moulded plastic shields covering hypodermic needles, plastic end-caps

on intravenous administration sets are two examples of inner wraps found on
commercially sterilized products. They may also serve additional functions
unrelated to the sterile nature of the product, such as mechanical protection,
protection of operators from hazards associated with the product etc.

C3.115 Double wrapping is essential for equipment that will be used in an

aseptic environment such as an operating room or a protective Isolation unit.

C3.116 In particular instances, triple-wrapped product may be necessary to

permit the adoption of procedures with a high level of assurance that there will
be no contamination, for example transfer of laboratory products into a sterility
test containment facility or transfer of equipment and components into an
aseptic manufacturing environment.

C3.117 Single wrapping may be more economical and appropriate when the
product, although sterile, will not be used in an aseptic environment and will
not be used parenterally or to penetrate tissue, for example Ryles tubes,
oesophageal and suction tubes, urine bags, rectal examination sets etc.

C3.118 The various layers of packaging may be used to provide for different
functional requirements, for example many surgical instrument and dressings
packs are wrapped with an inner layer of paper or cloth which is used to
provide a sterile field when opened onto a table, trolley or tray at the point of
use.

C3.119 Two or more layers of packaging may be used together to provide a

functional requirement which neither alone could meet, for example a single
layer of textile may not be an adequate barrier to microbial penetration but
two layers in combination may provide satisfactory performance.

Primary and secondary packaging

C3.120 If two layers used together are needed to meet a basic performance
requirement then layers both together constitute the primary pack.

Secondary packaging
C3.121 Several individual units, each wrapped in its own primary packaging,
may be packed together in a “shelf pack” which may consist of a carton,
plastic film wrap, film-wrapped carton or similar.

C3.122 For distribution, multiples of individual units or shelf packs may be

packed in transit containers.

C3.123 These may be intended as single-use, for example fibreboard cartons

or re-usable, for example plastic or aluminium boxes. Their primary function is
to withstand the predictable risks arising during transport and distribution.

C3.124 Some or all of the secondary packaging may be applied before

sterilization, especially in commercial sterilization. When this is the case the
packaging, in its entirety as presented to the sterilization process, must meet
the requirements for sterilization compatibility.

C3.125 When re-usable transport containers are employed, a documented

and monitored procedure for maintaining them in a clean, hygienic condition
and a good state of repair is necessary.
C4.0 Packaging materials and
systems

C4.1 The following section summarises various packaging systems and

materials that are available, including methods of effecting suitable seals or
closures, their suitability for use with sterilization processes which may be
employed by hospital users, and equipment necessary for their effective use.

C4.2 The summary is wide ranging and comprehensive, but not exhaustive.
The absence of a particular system or material should not be taken as implying
that it is unsatisfactory for use, nor should the inclusion of a particular system
or material been seen as an endorsement of its use.

C4.3 The choice of suitable packaging systems and materials will b ebase d on
a number of factors .These include, but are not limited to:

• compatibility with available sterilization processes and other factors (see

paragraph C3.5);

• particular requirements of the user;

• availability and cost of suitable automatic equipment for filling, sealing,

labelling;

• availability and cost of suitable re-processing facilities for re-usable

packaging;

• availability and cost of suitable disposal methods for used single-use

packaging;
• standardisation of packaging systems within a single production unit.

C4.4 There is no one packaging system that is “correct” for all applications;
and for any particular application there may be several systems available none
of which is perfect. It may then be necessary to prioritise the requirements to
be met by the packaging and select the system which most nearly meets these
requirements (Table C2). The two characteristics which are afforded the highest
priority most often are compatibility with the sterilization process and
maintenance of sterility in storage and distribution.

Sterilization compatibility

Steam sterilization

Wrapped goods and porous loads

C4.5 Goods are normally double wrapped; at least one of the layers will
usually be a sheet of paper, paper bag or paper/plastic pouch.

C4.6 The inner lining may be chosen primarily for its absorbency in order to
retain condensate in a position from which it will be successfully evaporated
during the drying stage of the sterilization cycle.
Table C2 Selection of packaging materials by sterilization process

Sterilization Re-usable Single-use

process packaging packaging

Steam sterilization
for wrapped goods Containers (valve or filter) Papers
and porous loads* Textiles (cotton and/or Plastic/paper pouches
synthetic) Cellulose/synthetic wraps
Spun-bonded polyolefins
up to 121°C

for instruments and Free-draining “instrument

utensils orientation” trays

for aqueous fluids Glass bottles Glass bottles

Glass vials Glass vials/ampoules
Plastic bottles Plastic bottles
Plastic pouches

Ethylene oxide Containers (valve or filter) Papers

Plastic/paper pouches
Spun-bonded polyolefins
(eg Tyvek)
Polypropylene boxes Plastic/paper pouches
Open cell foam (for Papers
instrument protection)

Dry heat Metal (eg aluminium) Metal foils

canisters Plastic films
Glass containers

Radiation Treated paper

Polyethylene
Polypropylene
Metal foils
Various laminates
Cardboard
(PVC)

* The same packaging materials are also suitable for use with LTS disinfectors

Fluids in sealed containers

C4.7 Glass or plastic bottles, vials or ampoules are used for rigid containers
and plastic pouches, usually a laminated construction to optimise the
performance characteristics, are suitable for flexible containers.

Dry heat

C4.8 Aluminium cans or tubes, glass tubes or jars, each of which may be
sealed with push on caps, screw caps or crimp-on foil caps, are suitable for dry
heat sterilization. Crimp-on foil caps with a pre-printed colour change indicator
are also available.

C4.9 Items may be wrapped in heavy or light gauge metal foil or, for items
such as laboratory glassware the foil may be used simply to seal the open end
of the product.

C4.10 Plastic bags of the sort sold for roasting meat in domestic ovens may
also be suitable.
LTSF

C4.11 Packaging may consist of paper, used as plain or creped wraps, or in

the form of bags or, in combination with plastic film as pouches.

C4.12 Light cardboard boxes, or corrugated polypropylene boxes, adequately

vented and overwrapped with paper or other material as a bacterial barrier are
also suitable. When particularly delicate instruments are to be processed the
use of an open cell foam for support and protection is acceptable.

C4.13 The quantity of packaging should be kept to the minimum possible.

Irradiation

C4.14 Polythene/polyester/nylon or metal foil may be used. The material may

be non-porous and gas impermeable which gives good microbial barrier
properties. Paper, spun-bonded polymers and non-wovens can also be used but
lose the advantage of a process that can deal with impermeable packaging.

Ethylene oxide

C4.15 For ethylene oxide sterilization a high permeability to air, steam and
ethylene oxide is essential.

C4.16 Paper bags or plastic/paper pouches are usually found to be most

convenient for small articles. Wrapping in sheets of plain or crepe paper, or
textiles, may be required for large procedure trays containing endoscopes or
other thermolabile equipment.

C4.17 Moulded foam inserts may also be used to provide protection for
sensitive equipment such as endoscopes.

C4.18 Polythene bags with gas exchange ports of Tyvek are also suitable.

Bacterial barrier properties

C4.19 The basic requirement is for a material which will not allow the
product within the pack to be contaminated by the ingress of microbes in the
environment from the time that it is removed from the sterilizer, during
transport and storage up to the point of use.

C4.20 With a non-porous material, where gas flow through the material can
only occur through diffusion, the material itself will be an absolute barrier to
microbial contamination. The microbial barrier properties of the pack will then
depend on the adequacy of the seal or closure. For example, an ampoule, if
correctly sealed by fusion, and having no cracks or other flaws, will be an
absolute barrier to microbial contamination.

C4.21 When a porous material is used the barrier to microbial penetration

will not be absolute; there will be always a finite possibility of a micro-organism
penetrating the barrier and potentially contaminating the pack.
C4.22 The probability of a micro-organism penetrating the barrier will depend
on many factors, including, but not limited to:

• the rate of air flow through the web, which may be influenced by the
rate and extent of environmental changes in pressure and temperature;

• the relative humidity, which can affect both the pore size and surface
charge of natural fibrous materials (paper, linen etc);
• the type and number of micro-organisms in the environment;

• the form in which they are presented, for example as single organisms or,
as they are more usually found, on relatively large particles such as skin
squames;

• the nature of the product, which may influence whether contaminating

organisms can survive or multiply.

C4.23 The effect of these various factors is not the same for all materials. For
example some porous materials are better at excluding particles of a given size
at very low flow rates while other materials perform best at higher flow rates.

C4.24 It is apparent that the storage conditions will also be a controlling

factor in the maintenance of sterility. Dirty, damp conditions can give rise to
high microbial counts in the environment; large and rapid changes of
temperature, and changes of pressure (including the slamming shut, or violent
opening, of doors) will lead to an exchange of air between the contaminated
air of the environment and the interior of the pack.

C4.25 The ability to maintain sterility is primarily “event related” rather than
“time related”, although even under controlled conditions there is a greater
probability of an adverse event having occurred after prolonged storage.

C4.26 The most sensitive time for contamination through porous wrapping
material is when steam sterilized product has been removed from the sterilizer
and is cooling down. During this process air will be taken into the warm and
humid environment in the pack.

Materials used in packaging

C4.27 The materials of which the packaging is made will necessarily limit the
sterilization processes with which it is compatible as well as affecting its ability
to meet other performance requirements.

C4.28 Performance requirements for packaging materials include:

• permeability to air, steam and gaseous sterilants, (although this does not
apply to materials intended for use with aqueous fluids in sealed
containers, dry-heat sterilization by hot air or sterilization by ionising
irradiation);

• resistance to penetration by micro-organisms from the surrounding

environment;

• resistance to punctures, tears and other mechanical damage which would

breach the barrier to microbial penetration;

• freedom from loose fibres and particles;

• freedom from toxic ingredients and non-fast dyes;

 • compatibility with the contents under the proposed sterilizing conditions;
• compatibility with the sterilization process to be used, that is, not
degraded by it.

Textiles

C4.29 Textile fabrics are used for packaging; traditionally these are woven
cotton materials but may also be cotton/polyester blends.

C4.30 Specialist fabrics are also available which may are intended to be water
repellent while at the same time being gas permeable. This may be achieved by
several means, for example a particularly tight weave of polyester fibres, or a
laminated construction with a middle lamella of a suitable polymer film. Care
needs to be exercised in using these fabrics that the flow rate of both air and
steam through the fabric is adequate for the sterilization process.

C4.31 Textiles are often used as a wrapping material for heavy packs,
especially of theatre instruments, which are to be sterilized in a porous-load
steam sterilizer.

C4.32 Textiles are stronger than paper, and stronger than many non-wovens,
and will resist tearing and rupture.

C4.33 However, textiles are generally a less efficient bacterial barrier than
sterilization grade wrapping paper and should always be used in two or more
layers. The second layer may be a textile wrap also or a suitable sterilization
grade wrapping paper. Alternatively, a sterilization grade paper bag may be
used to enclose the textile-wrapped pack.

C4.34 Textile wraps are re-usable.

Papers and non-wovens

C4.35 Both papers, which are made from cellulose fibres, and non-wovens,
made from a combination of cellulosic and synthetic fibres, may be used. Both
types are suitable for porous-load steam sterilization and most gas processes
because they are permeable to air, steam and other gases.

C4.36 The original papers used for steam sterilization wrappers were kraft
papers produced for general purposes. Purpose made papers with better
controlled porosity and microbial barrier properties, and with enhanced wet
strength and water repellency are now used. These are available as plain sheets,
creped sheets which give better drape characteristics, as bags and in
combination with a plastic film as pouches (or reel material from which
pouches can be made).

C4.37 Good drape and handle characteristics are also provided by crepe
paper (BS 6254 1989).

C4.38 Plain papers may be used as wraps or preformed into bags or pouches.
The bags and pouches may be plain sided or may be gussetted to
accommodate bulky items.

C4.39 Wet strength and water repellency are specifically improved over
“normal” papers by the impregnation of the paper with high wet-strength
resins.
C4.40 The water content of the paper may be maintained at a relatively high
level, thus improving the feel and drape of the paper and minimising
superheating due to exothermal rehydration, by the addition of humectants
such as sorbitol.

C4.41 Over many years experience the various forms of paper packaging have
been demonstrated to provide an effective microbial barrier.

C4.42 Non-wovens are generally less effective as a microbial barrier and may
need to be used in, or as one of, two layers; they are however generally softer
with better handling and drape characteristics.

C4.43 British Standards exist for all the paper packaging materials and should
be used as the basis for purchasing specifications. (These standards will be
replaced in due course with European Standards currently in preparation; the
draft standards cover the same range of requirements as the existing
standards.)

C4.44 Non-woven materials, made from a combination of natural and

synthetic fibres are also widely used. These are often used where otherwise re-
usable textiles would be used. They are generally of greater porosity than paper
wraps and for this reason may not be as effective as a microbial barrier. They
have higher tear and puncture resistance and are softer with better drape
qualities. They may also show extremely good water repellency.

Synthetic materials and laminates

C4.45 Polymeric materials, or plastics, may be used in the manufacture of

rigid, semi-rigid, or flexible packaging systems.

C4.46 They may be in the form of sheet or film, which is non-porous, or be

produced as a spun-bonded or non-woven sheet which is porous.

C4.47 Plastic materials are also used in the manufacture of moulded

containers, for dry products or for liquids.

C4.48 Film or sheet material may be an absolute barrier to microbes if it is

free from pinholes. Although it may be non-porous that does not necessarily
mean that it will be impermeable. Most polymers have some permeability to
gas, air, and water vapour. The extent of the permeability varies with
temperature, concentration gradient of the diffusing substance etc and
although generally low may be important, for example in the long term storage
and stability of a pharmaceutical product.

C4.49 Plastic materials are generally robust and resistant to tearing. The
extent to which they show puncture resistance depends much more on the
polymer and film thickness used. There have been in the past major problems
with thin-film moulded polyethylene commercially produced packs being
breached by the sharp edges of the product within.

C4.50 Plastic materials can usually be heat-sealed to give a high-integrity

barrier.

Polyethylene (polythene)
C4.51 Polyethylene is effectively impermeable to air and water and is not
suitable therefore for general use in ethylene oxide sterilization processes
without special precautions. However very thin films (up to 0.076 mm) thick
allow the passage of ethylene oxide (by dissolving in the thin film and then
evaporating from the inner surface). Paper laminated with a thin polythene film
may thus be used to provide a heat sealable paper for use in ethylene oxide
sterilization.

C4.52 High-density polyethylene is produced as a spun-bonded, non-woven

(known commercially as Tyvek) paper-like material. It is very tough, and
although it is porous like paper it is water repellent.

C4.53 In commercial use it has been found to provide a satisfactory bacterial

barrier. It is frequently used in packs which are to be ethylene oxide sterilized
and may be used with a clear film in the form of a pouch, as venting panels in
impermeable bags made of, for example polythene, or as a sealing lid on blister
packs.

C4.54 It has also been found suitable for use in steam sterilizers operating at
sterilization temperatures up to 121°C.

C4.55 It has some disadvantages in that it may attract dust and fibres owing
to its electrostatic character, it can be difficult to print on and also it may be
difficult to seal, although these latter difficulties largely can be overcome by
using non-oil based inks and lacquering with a suitable heat-seal lacquer,
respectively. It is also expensive compared with paper.

C4.56 At temperatures above 125°C even high-density polythene has

softened too much to be used on its own as an effective packaging material
and it is therefore unsuitable for steam sterilization at 126°C or 134°C of for
hot-air sterilization.

C4.57 Polythene can be sterilized by ionising radiation.

Polyester

C4.58 Polyester, in the form known as oriented or crystallised polyester, is

used as a laminate with polythene in the construction of paper/plastic pouches
and reel material.

C4.59 The polythene forms the inner surface which is heat sealed to the
paper. The outer layer of the plastic laminate is polyester which gives the
required mechanical strength at elevated temperature as well as a good
printing surface.

Polyvinyl chloride (PVC)

C4.60 PVC generally has a very low stability to both heat and ionising
radiation.

C4.61 PVC will absorb ethylene oxide in large amounts. This is exacerbated
by the ethylene oxide combining with the phthalate plasticiser, from which it is
aerated only very slowly under ambient conditions.

C4.62 Some grades of PVC are used for the moulded bases of commercially
available blister packs.

Polypropylene and polycarbonate

C4.63 Both polypropylene and polycarbonate are relatively heat stable
materials.

C4.64 Polypropylene has a very low permeability to air, moisture and ethylene
oxide. It has been used extensively, either separately or in combination with
other polymer laminates, as flexible, semi-rigid or rigid containers for heat
sterilization of water and aqueous fluids.

C4.65 Polypropylene has been laminated with aluminium foil for use as
packaging for wet or oily materials such as skin swabs, alcohol wipes.

C4.66 Polycarbonate has been used extensively for th e manufact ure of

autoclavable laboratory bottles (at 121°C).

C4.67 Certain grades of polypropylene, specifically formulated for the

purpose, can be radiation sterilized.

Nylon
C4.68 Nylon is heat stable, and is also steam permeable but it is impermeable
to air. Packaging constructed entirely from nylon film is unsuitable for steam
sterilization because the air retained in the package may interfere with effective
sterilization. It may however be used effectively in combination with a porous
material, such as paper, to form a steam-sterilizable pouch.

Glass containers

C4.69 Glass containers, are usually in the form of ampoules, vials, jars or
bottles and come in a variety of capacities and shapes, with several different
closure systems.

C4.70 Three different grades of glass are available.

a. Soda glass is normally the cheapest (also referred to as Grade I). It is

subject to hydrolytic attack particularly when autoclaved containing
aqueous solutions. Solutions sterilized in bottles made of soda glass may
become contaminated with reactive silicates and show an increased pH.
Such bottles are rarely intended for more than a single use.

b. Sulphated soda glass, also referred to as Grade II, is soda glass which is
protected against hydrolytic attack by a surface coating of sulphate. The
coating is normally applied by sublimation of ammonium sulphate onto
the surface of the hot glass concurrently with annealing during the
manufacturing process. Bottles made of sulphated soda glass are rarely
intended for more than a single use and, if re-used, the sulphate coating
is eventually lost and the glass is once again subject to hydrolytic attack.

c. Borosilicate glass, also referred to as Grade III, is much more resistant to

hydrolytic attack than Grade I or II glass and is generally the preferred
material for containers which are to be used for autoclaving aqueous
solutions. Providing there is a suitable cleaning process compatible with
the intended end-use, bottles made of borosilicate glass may be re-used a
number of times.

C4.71 Borosilicate glass also has better thermal shock resistance

characteristics than soda glass when used in a similar container.

C4.72 Glass containers may also be used for dry heat sterilization, and can
withstand radiation sterilization. However, irradiation causes a darkening of the
glass which may be aesthetically unacceptable.
Metals

C4.73 Metals are used in the fabrication of sterilization containers for use in
both steam and hot-air sterilization processes, and to a lesser extent in gas
processes such as LTSF or ethylene oxide. Since the material is neither porous
nor permeable it must be constructed with a suitable venting system for use in
sterilization processes other than dry heat or radiation.

C4.74 The choice of metal should be based on consideration of both its

corrosion resistance to the sterilization process, for example in a steam
atmosphere, and on its thermal characteristics. The ideal material would have a
high thermal conductivity and a low heat capacity and would attain the
required temperature quickly, uniformly and without the formation of excessive
amounts of condensate.

C4.75 In practice, the choice is usually between aluminium, anodised or

otherwise surface treated to give it suitable corrosion resistance, and a suitable
grade of stainless steel.

Single-use packaging

C4.76 Both flexible and rigid packaging systems are available which are
intended for single use.

C4.77 The recently enacted medical device regulations (see Chapter C2)
include a requirement that sterile medical devices be designed, manufactured
and packed in a non-reusable pack and/or according to appropriate procedures
to ensure that they are sterile when placed on the market. There is thus a
clearly stated preference for single-use packaging as the primary packaging for
sterile medical devices.

Paper or textile wraps

C4.78 For wrapping materials two different folding methods have been
adopted, both of which, when correctly executed, provide a suitable tortuous
path to prevent the ingress of contamination.

C4.79 For large packs the parcel fold is the preferred method (see Figure C1).

C4.80 The pack contents are placed on the wrap, approximately in the centre
of the wrap. The long edge of the contents should be aligned parallel to the
long edge of the wrap.

C4.81 One of the long edges of the wrap is folded over the pack contents to
overlap the centre line, and the edge of the wrap is turned back on itself. The
fold made by the turning back of the wrap should overlap the centre line of
the contents.

C4.82 The opposite side of the wrap is then folded over pack contents to
overlap the centre line (and the side already folded over the pack contents),
and the edge is turned back on itself.

C4.83 The ends beyond the short side of the contents are then folded to a
point and each is then folded over the contents.

C4.84 The same procedure may then be repeated for an outer wrap(s).
C4.85 The wrap is secured in position using pressure-sensitive adhesive tape
(high-temperature masking tape or autoclave indicator tape) or by tying with
tape or cords.

C4.86 For smaller packs the envelope fold is preferred (see Figure C2).

C4.87 In the envelope fold method the contents are placed on the wrap
diagonally and slightly off the centre line.

C4.88 The section of the wrap with the shorter corner-to-pack length is
folded over the contents by bringing the corner to the centre.

C4.89 This is repeated with the corners to the right and left of the first folded
corner.

C4.90 In each case the corner is turned back to provide a flap for opening.

C4.91 Finally the larger fold is brought over the top and tucked in under the
earlier folds with a corner protruding, to facilitate aseptic opening.

C4.92 The envelope fold if properly executed is quite secure without further
attention but if preferred may be secured also with tape or by tying.

Paper bags, paper/plastic pouches

Folding
C4.93 Folding is the simplest method to obtain a satisfactory closure for both
pouches and bags, although it may not be convenient for high volume
production (see Figure C3).

C4.94 The corners at the open end of the bag or pouch are folded diagonally
to give mitred corners.

C4.95 The top of the bag or pouch is then folded over three times in
succession and secured in place with a piece of high-temperature masking
tape, or autoclave indicator tape.

C4.96 The folded top should always be secured with tape; staples should
never be used because of the holes that are then made in the package.

C4.97 The folded top may be opened by cutting through the bag or pouch
with a pair of sterile scissors. For non-critical applications it may be torn open;
it should not be opened by removing the tape and unfolding the closure.

Self-seal
C4.98 Self-seal bags and pouches are closed by folding as described for plain
top bags and pouches, above. However the bag or pouch is manufactured with
an impact adhesive coating in a small area of the paper, which is protected
before use by a piece of “release paper”.

C4.99 When the bag has been filled the top is folded over as previously
described, the release paper is removed and the adhesive patch is pressed onto
the surface of the bag to secure the folded top in place.

Heat seal
C4.100 Paper bags and paper/plastic pouches and reel material are available
in forms suitable for heat sealing.
C4.101 The melting point of the heat-seal will effectively limit the maximum
temperature at which the pack can be used. Heat-seal packaging should not be
used at temperatures above those specified by the packaging manufacturer.

C4.102 Heat sealing is performed by compressing the opposing sides of

packaging, coated on one or both inner surfaces with a lacquer, adhesive or
polymer film, between heated plates.

C4.103 Packaging intended for heat sealing may be film coated, grid
lacquered, or have an adhesive band.

C4.104 Film-coated heat-seal packaging has a thin film of a suitable polymer,

such as polythene, laminated to the inner surface. When heated this melts
sufficiently to fuse with the opposing surface and form a seal. The heat-seal
polymer may be laminated to another plastic or to paper. The polymer film, if
applied to the paper element, may limit the porosity of the pack.

C4.105 Grid-lacquered heat-seal packaging has one side, usually the paper,
printed with a heat-seal adhesive in a repeating diamond pattern all over the
inner surface. Care needs to be taken that the width of the heat-seal is
sufficient to ensure that there is a continuous seal across the width of the
packaging.

C4.106 Adhesive-coated heat-seal packaging has a band of heat-seal

adhesive printed on the inner surface of the packaging in the area where the
heat-seal is to be made. The adhesive is coloured, usually blue, to aid
identification of the heat-seal area.

C4.107 The seals need to be peelable. They should peel without splitting,
tearing or shedding paper fibres since fibres can cause adverse reactions if
introduced into open wounds.

C4.108 Peelability is a compromise between seal strength and the peel

characteristics required which can only be achieved by use of the correct heat-
sealing conditions.

C4.109 The heat-seal may be a single line, in which case it should be not less
than 5 mm deep and extend across the width of the pack, or a series of lines
each about 1 mm wide and 1 mm apart to give a seal width of about 9 mm,
with each line extending across the full width of the pack.

C4.110 The heat-sealing process must be undertaken with care. Creases in

the packaging material can result in inadequate or uneven seals.

C4.111 A weak point in the heat-seal of paper bags may often be found in
the corners where the paper is folded back on itself and in gusseted packs
where four thicknesses of material become two. This latter problem can be
minimised by reverse folding the gusset in the area to be heat sealed, before
sealing.

C4.112 The effect of the sterilization process on heat seals must be

considered. The elevated temperatures involved in steam sterilization can
weaken the seals. Ethylene oxide gas leaves many seals unaffected but can
cause embrittlement of others.

C4.113 Heat sealing is not only used for flexible packaging. It may be used
also on rigid packaging when lids are sealed onto moulded plastic bases. The
base tray may be moulded in-line just before filling or may be pre-formed. The
lid may be of paper, Tyvek or other porous material for use in steam or gas
sterilization processes or of impermeable film for use with radiation sterilization.

Glass containers

C4.114 Bottles and vials are extensively used for aqueous solutions for use as
topical and parenteral medicines, microbiology media, laboratory reagents, in
vitro diagnostics, disinfectants, etc which are to be sterilized by moist heat.

C4.115 Glass containers may also be used for hot air sterilization of non-
aqueous liquids, such as oils.

C4.116 Containers should never be filled with a volume greater than the
manufacturer’s recommended maximum.

Ampoules - fusion seal

C4.117 Two forms of glass ampoule are available; one form intended only for
automatic (or semi-automatic) filling and sealing and one which is suitable for
manual sealing.

C4.118 Ampoules intended for automatic filling and sealing may be supplied,
internally clean, sterile and apyrogenic, with the neck closed by a “bubble” of
glass. During the automatic filling process this “bubble” is melted by a flame
directed vertically downwards to open the ampoule immediately prior to filling.
This normally takes place in an environment controlled to be free from
contamination. This type of ampoule is not suitable for manual filling and
sealing operations.

C4.119 The relevant DIN standards may be used as suitable specifications.

C4.120 Ampoules are sealed by fusion. After filling, the neck of the ampoule
is heated, almost invariably in a gas flame, until the glass softens and the walls
of the neck coalesce, surplus unmelted glass in the neck above the point of
melting is drawn away and the fused end of the neck is allowed to cool.

C4.121 For any given design of ampoule, the temperature of the flame, the
duration of heating and the time and speed at which the surplus neck material
is drawn off all affect the quality of the seal. When correctly performed the seal
is as strong, or stronger than other parts of the ampoule.

C4.122 Ampoules for use in freeze driers are similarly sealed by fusion.

C4.123 Ampoules are opened by breaking off the neck. This may be
facilitated by the inclusion of a deliberate weak point, in the form of a break
ring, at the base of the neck during manufacture. Other methods which are
available include notching the neck of the ampoule with a glass file, creating a
fracture line by the application of a hot wire or rod and several commercially
available devices.

C4.124 Whichever method is to be employed, users should be given

appropriate instructions and training and should always take precautions to
protect their hands from injury due to broken glass.

C4.125 Ampoules are produced to a high level of consistency and faults in

sealing are likely to be due to poor setting up or control of the sealing method
and rarely, if ever, due to variations in the ampoules.
C4.126 After the ampoules have cooled, careful visual examination,
preferably using a magnifier and a polarised light source, should be used to
inspect the seal and any showing cracks, thinning or “blowing” of the seal and
sharp protrusions or “tails” of glass, should be rejected.

C4.127 A vertical drop of 10-15 cm, for example inside a tube of suitable
diameter so that the sealed end impacts onto a solid surface, such as a plastic
laminate, may also be used to test the ampoule seal. A satisfactory seal will
survive, whereas a weak seal will break.

Vials and bottles

C4.128 As manufactured, glass bottles are generally clean, sterile and
apyrogenic. Nevertheless they should be washed before use since they may
have become contaminated during packaging and distribution, unless special
precautions were taken to avoid this happening.

Screw caps
C4.129 Screw caps may be made of metal or plastic. They may be used to
used to retain in place a separate elastomeric seal, such as a stopper or a wad,
or they may incorporate a seal within the cap. In either case the seal is formed
by compression of a deformable sealing material between the cap and the glass
container. The compressive force applied is a key factor in creating a leak-tight
seal.

C4.130 Metal caps may “back-off” during autoclaving. The differential

thermal expansion of the metal of the cap and the glass of the bottle combine
to make the cap unscrew slightly during processing. This rarely happens with
plastic screwcaps.

C4. 131 The problem can be minimised for metal caps by careful control over
the extent to which the cap is tightened before sterilization.

C4.132 Devices to control the force used to tighten the cap (torque) should
be used both to ensure reliable sealing and to minimise the risk of
overtightening which can damage the cap or make it difficult to remove

Crimp caps
C4.133 Crimp caps are metal, or sometimes plastic, capsules used to retain
an elastomeric seal, usually in the form of a stopper, in position in the neck of
the container.

C4.134 During the application of the crimp seal, pressure is applied to

compress the stopper slightly against the top surface of the neck finish of the
bottle. The skirt of the overseal is bent under the base of the retaining rim on
the bottle neck by the crimping device. This retains the stopper in place and
maintains it under slight compression to provide a good seal.

C4.135 During steam sterilization of the sealed container the pressure applied
by the crimp may be released to some extent by the thermal expansion of the
metal capsule. This, and the high internal pressure generated within the
container, may cause the seal to leak. It should not be assumed that a seal
which is demonstrably leak tight at room temperature will remain so
throughout the various stages of steam sterilization.
Re-usable packaging

Textiles
C4.136 Textiles are used in combination with aluminium trays for packs of
theatre instruments.

C4.137 The textile wraps should be laundered before each re-use.

C4.138 Control should be exercised over the laundry process to ensure that
fabric softeners and fresheners are not used since many of these contain
volatile components which will evolve gas during steam sterilization and
compromise the efficacy of the sterilization process.

C4.139 The importance of thorough inspection before re-use cannot be over-

emphasised. A light table should be used, and wraps with pinholes, clearly
visible as points of light, should not be used.

C4.140 The location of the defect should be clearly marked and the item sent
for repair by means of a heat-seal patch. Sewn patches are not acceptable
because of the needle holes created around the patch.

C4.141 Worn textile wraps are readily discernible since the light will shine
through the more open weave that occurs as the fabric wears. These should no
longer be used as a sterile packaging wrap.

Containers for solid goods

Impermeable or unvented containers

C4.142 Aluminium tubes with crimped foil caps and larger canisters (made
from aluminium, copper or stainless steel) with slide or screw-fit caps may be
used satisfactorily for hot-air sterilization. Containers of this sort are used
frequently for pipettes or glassware in the laboratory.

Open-topped trays and perforated containers

C4.143 Trays for containing sets of theatre instruments, or similar, are often
constructed in aluminium. Plastics such as polypropylene may also be used. The
trays may have solid bases and sides or be equipped with drainage ports to
allow condensate formed during steam sterilization to run off.

C4.144 When condensate drainage is provided it is necessary to ensure that

the condensate is not discharged onto other parts of the sterilizer load, which
will then emerge form the sterilizer wet.

C4.145 Trays may be overwrapped in textiles, single-use wraps or bags, or a

combination of these materials to achieve the required protection, absorbency
and microbial barrier properties.

Instrument orientation trays

C4.146 These trays, usually constructed in metal, are fitted with retaining
clips designed to hold a particular set of instruments in position. They are often
found in dental practice and also for use with sets of orthopaedic instruments
and rigid endoscopic instruments.

C4.147 They are almost invariably fully vented, or unlidded, and in this
condition may be suitable for use in a steam sterilizer intended for unwrapped
instruments and utensils (see paragraph 3.23).
Dressings drums

C4.148 Perforated metal containers, fitted with a filter material and closable
louvres were specified in BS 3281, 1960, for use as “dressings drums”. These
were intended to contain dressings and porous goods sufficient for a number
of clinical procedures.The product has been regarded as obsolete except for its
use, until recently, as a convenient container for towels for the Bowie and Dick
test. Even this use has now been discontinued.

C4.149 There is, however, a new generation of re-usable rigid containers

intended for use as a packaging system in steam (and in some cases, gas)
sterilization processes. These are intended to contain instruments and/or porous
goods which will be used in a single clinical procedure. They are thus more akin
to the trays described in paragraphs C4.143 to C4.145 than to the obsolete
dressings drums.

Re-usable rigid containers

C4.150 A European standard specifying performance requirements for rigid

re-usable containers is in preparation. When adopted it will be published as BS
EN 868 – 8.

C4.151 Container systems are constructed in a variety of materials and those

from various manufacturers differ greatly in design, construction and mode of
operation.

C4.152 The containers are constructed from impermeable materials. The joint
between the lid and the base is sealed by means of a suitable gasket, which
should be accessible for inspection and cleaning between uses.

C4.153 In order to permit the flow of gases (air and steam and, where
applicable, sterilant gas) in and out of the container that is required by the
sterilization process the containers are fitted with one or more sterilant ports.

C4.154 Two different operating principles are used for the sterilant ports,
although both may be used in combination. The exchange of gases may be
through a porous filter material or through a valve system.

C4.155 The filter system is little different in principle from the porous
packaging systems considered previously. Its compatibility with the sterilization
process depends on its porosity and on being able to provide the necessary
flow rate through the filter to permit attainment of the sterilizing conditions
within the container.

C4.156 The ability to maintain sterility depends on the filter efficacy and
whether it is able to exclude particles of a size which may contain viable
organisms. The small area of surface available compared with the volume of
the pack produces relatively high flow rates across the filter material and this
influences the materials which can be used effectively.

C4.157 If a re-usable filter is used then great care is needed to ensure that:
• it has not become partially blocked, thus impairing the flow of gases and
compromising the sterilization process;
• it has not been damaged, thus allowing the passage of unfiltered gases
which would compromise the maintenance of sterility.
C4.158 Both re-usable and single-use filters need to be installed correctly so
that the filter is effectively sealed in the holder and there is no passage of
unfiltered gases around the filter.

C4.159 The alternative system for sterilant ports is the valve system.

C4.160 Outside the sterilizer the valve is normally closed and, if the seals on
the valves are effective, presents an impermeable barrier to external
contamination.

C4.161 The valve system has to be arranged to open automatically in the

sterilizer to permit the exchange of gases between the container and the
environment.

C4.162 A number of systems are used by the various manufacturers but most
depend on valves which open in response to a pressure difference between the
container and its surroundings. A diagram of the operation of such a system is
shown in Figure C4.

C4.163 It is apparent that a finite pressure difference must exist across the
valve before it will open. The magnitude of the pressure difference will depend
on the force exerted by the springs keeping the valve closed.

C4.164 If the pressure difference required to open the valve is too great, the
contents of the container will not be exposed to the sterilizing conditions in the
sterilizer chamber. The correct functioning of the container is closely related to
the pressure change characteristics of the sterilization cycle.

C4.165 If the required pressure difference is too small the valve will open
outside the sterilizer due to changes in ambient pressure and temperature, thus
allowing the inflow of unfiltered air from the environment.

C4.166 Some container systems are also fitted with a valve in the base of the
container which is used to allow condensate to drain away, to assist in drying
the contents of the container.

C4.167 The condensate drain valve may be fitted with a thermostatic device
to open the valve when it is above a specified temperature, say 80°C, or it may
operate on pressure differential as previously described for valved sterilant
ports.

C4.168 After repeated use, the springs controlling a valved system will age
and the force exerted by them will change. It is essential that the
manufacturer’s instructions for maintenance, testing and replacement of key
components such as seals, sterilant ports and drainage valves are followed
rigorously.

C4.169 The performance of either type of container may be seriously affected

both by the nature of the sterilization cycle (particularly the characteristics of
the air removal phase and the drying stage) and by variations in the quality of
services supplied to the sterilizer (for example the dryness fraction of the
steam). These variables are sterilizer and site specific respectively.

C4.170 It is necessary, therefore, to establish, by appropriate on-site testing,

that any particular design which it is intended to use functions correctly in the
specific sterilization cycle with which it is to be processed, in the sterilizers
which will be used in practice.
C4.171 Re-usable containers have a number of apparent advantages. They
offer excellent mechanical protection to the contents and a convenient,
modular system for storage and distribution.

C4.172 The use of a solid-walled container gives the impression of providing

good protection against microbial and other environmental contamination. In
practice the barrier properties are dependent on the adequacy of gaskets and
seals and the sterilant ports described above.

C4.173 The condition and function of filters, valves, sealing gaskets and
locking systems needs to be verified on each container before each use.

C4.174 Between uses containers should be disassembled and cleaned

following the manufacturer’s recommendations. These usually suggest cleaning
by washing with a mild detergent, either manually or in a washer/disinfector.

C4.175 The choice of detergent should accord strictly with the manufacturers
recommendations since a number of cleaning agents in common use can cause
corrosion or surface cracking on the metal or plastic surface of containers.

C4.176 These containers are often used to return used and soiled
instruments, which are potentially contaminated. Whenever practicable they
should be decontaminated and cleaned in a washer/disinfector.

C4.177 Most containers are fitted with interior baskets or mesh trays used to
hold the instruments. These may be suitable to contain returned instruments as
they are processed through a washer disinfector.

C4.178 In use the containers need to be properly loaded if they are to be

used successfully. The manufacturers recommendations concerning the
maximum weight, the proportion or density of metal ware or rubber goods and
the presence and location of absorptive materials in the load should be
followed.

C4.179 Some containers are intended to be used in conjunction with porous

packaging materials, either as an inner or outer layer of packaging, whereas
others are intended to be used, and will only function correctly, without any
other packaging being present during sterilization. It is important that the
manufacturer’s instructions are followed.

C4.180 Containers which are not intended for use with a second layer of
packaging, that is those which can only function as a single packaging layer,
are not suitable for use in an aseptic environment (see paragraphs C3.109ff).

C4.181 Containers manufactured to the proposed European Standard will be

sized in relation to the standard loading module for large steam sterilizers (see
EN 285). High packing densities within the sterilizer chamber can be achieved
and it is important to ensure that the maximum permitted load for the sterilizer
is not exceeded.

C4.182 To avoid problems with moisture retention within the container it may
be necessary to increase the time allowed for the drying stage of the
sterilization cycle.

C4.183 Each container should be fitted with a tamper evident closure system
which should provide a clear indication when the integrity of the closure has
been compromised.
C4.184 The containers are designed to stack for storage purposes. Containers
from any one manufacturer should stack securely but containers of different
provenance may not.

C4.185 When purchasing this type of packaging system all the containers
should be from the same manufacturer to ensure compatibility.

C4.186 Re-usable containers are often promoted on the basis that they are
more cost effective than single-use packaging. A decision based on cost
grounds requires careful evaluation of the initial capital cost, cleaning and
maintenance costs (including all equipment, components, consumables and
labour required), the working life (the number of re-uses) which the
manufacturer is prepared to guarantee, the likelihood of damage or loss and
the cost of eventual disposal.

Glass containers
C4.187 Bottles intended for single use should not be re-used. Bottles
intended for multiple use are available for most applications.

C4.188 Re-usable containers should not be used for solutions intended for
parenteral administration.

C4.189 The information given for single-use screw cap and crimp-on closures
is equally applicable to re-usable containers, with the following additional
requirements.

Vials and bottles

Cleaning
C4.190 Before bottles can be satisfactorily re-used a cleaning procedure is
required which has a demonstrated capability to remove any dirt or
contamination, as well as any residues from the previous use. It is also
important that the cleaning process is well controlled and ensures that there
are no residues of cleaning agents.

C4.191 Cross-contamination can be most easily controlled by ensuring that

whenever possible re-usable containers are only refilled with the same product,
for example by reserving a set of bottles only for sterile water and another set
only for sterile isotonic saline and so on.

Inspection
C4.192 Inspection of the bottles after cleaning and prior to re-use should
include a careful visual examination of the neck finish. A chipped or cracked
neck finish could prevent an adequate seal or lead to the failure of the seal
during transport or storage. Bottles that have been damaged in this way should
be scrapped.

C4.193 Inspection of the outer surface of the bottle should also be made.
Bottles being sterilized are subjected to considerable stress both from the high
internal pressures generated and from thermal shock. Scratches or other
mechanical damage on the outer surface of the bottle weaken it and
significantly reduce the pressure and the thermal shock which can be tolerated
without breakage.
C4.194 One bottle breaking in a sterilizer load may provide sufficient force to
cause others to break also. Re-usable bottles with surface damage should be
rejected and either used for applications which do not require steam
sterilization or be scrapped.

C4.195 The inspection of the neck finish should also consider any damage to
the screw threads or the retaining shoulder on the outside of the neck of
bottles which are closed with screw caps or crimped seals respectively.

Screw caps

C4.196 Screw caps, and the elastomer wads, stoppers or bungs used in
conjunction with them, are often regarded as re-usable, and many of them may
be satisfactorily re-used a number of times.

C4.197 The screw cap should be separated from any sealing wad and both
should be thoroughly cleaned and inspected for damage before re-use.

C4.198 Metal caps that have been dented, or are showing visible signs of
wear on the threads, should be scrapped.

C4.199 Rubber wads and rubber stoppers should also be carefully inspected
for surface damage and any showing cuts, abrasions, staining or permanent
deformation should be scrapped.

C4.200 Plastic screw caps with a built-in seal are also commonly used. These
should be inspected very carefully for damage to the thin sealing gasket which
is moulded into the inner surface of the cap. Any damage to this area will
almost certainly cause the cap to leak.

Crimp caps
C4.201 Crimp caps are not themselves re-usable but the bottles on which
they may be used can be. A special tool and some care is needed to remove
crimped seals without risk of injury.

C4.202 The old seal should be discarded. The seals are usually fabricated
from aluminium and the metal can therefore be reclaimed.

C4.203 The elastomer seal should also be scrapped.

C5.0 Purchase, quality control and
storage

C5.1 The purchase, handling and control of packaging materials should be

given similar attention to that given to components and other materials
incorporated directly into the product.

Purchase

C5.2 All packaging materials should be purchased, whenever possible, to a

British Standard or other suitable specification from approved suppliers.

C5.3 Packaging material should be purchased only to an agreed, written

specification. When it is intended to purchase a catalogue item, the
specification for that item should be obtained from the supplier and used as
the basis of that purchase, and all subsequent purchases of the material. This
should ensure that the user is informed of any changes in specification
subsequently made by the supplier.

C5.4 The purchase order should be based on not more than the quantity
which can reasonably, be expected to be used within the manufacturer’s stated
shelf life for the product.

C5.5 Although paper products, and other packaging materials, have a

prolonged shelf life the manufacturer’s expiry date may relate to other
properties of the product such as a process indicator or an heat-seal adhesive
whose performance may deteriorate on storage.

C5.6 The specification and purchase order should require that the material be
delivered in unopened containers, using covered vehicles, suitably protected
from water damage or soiling and that it is handled with care to prevent
mechanical damage.

C5.7 The packaging materials should be supplied suitably wrapped to provide

the required protection when it is stored under the specified conditions.

Specification

C5.8 For medical devices and medicinal products, and generally for laboratory
products also, the specification should include:

• a description of the materials including:

- the designated name and any code or reference;
- the size;

- the quantity in each unit pack delivered;

- the reference, if any, to a pharmacopoeia1 monograph, British Standard

or other published specification;
- the approved suppliers, and if possible, the original producer of the
material;
- a specimen of printed materials;
 • directions for sampling and testing, or reference to written procedures;

• qualitative and quantitative requirements with acceptance limits;

• storage conditions and precautions including the maximum period of

storage.

Quality control

C5.9 In many cases users of packaging materials will lack the facilities
necessary to carry out a comprehensive independent assessment of delivered
materials for conformity to their purchase specification.

C5.10 Nevertheless every reasonable step should be taken to establish

conformity. This requires that each delivery should be examined to ensure that:

• there is no visible damage to the shipment;

• the delivery note, the label description and the purchase order are in
agreement concerning the quality, size and number of the material;

• that each consignment has clearly identifiable lot numbers;

• that each lot delivered is accompanied by a Certificate of Analysis or

Certificate of Conformity, or if the delivery is a further supply from a lot
previously received that the appropriate certificate is on record.

C5.11 When, due to the nature of the packaging or the product, it is

necessary to carry out tests, other than a careful visual appraisal, on incoming
packaging materials a random sample should be taken and submitted for
analysis.

C5.12 There should be a formal sampling plan which should take account of:

• the quantity received;

• the quality required;

• the nature of the material, and the risk involved if the material is not to
specification, for example if the product makes contact with the
packaging material;

• the established reliability of the packaging manufacturer.

C5.13 The number of samples taken should be specified statistically, in

accordance with a recognised standard, such as BS 6000 or BS 6001.

C5.14 In confirming that the material supplied is identical in every respect

with the material ordered particular attention should be paid to printed labels
and packaging materials.

C5.15 A system for segregating delivery of packaging materials which have

not been examined from those which have been found suitable for use should
be implemented.

C5.16 Provision should be made for the temporary secure storage, prior to
disposal or return to the supplier, of material which was delivered but, on
examination was found not to conform to the specified requirements.
Storage

C5.17 Packaging materials should be stored under conditions which are

maintained within those specified by the manufacturer of the packaging. This is
best achieved by environmental control of the storage area.

C5.18 The temperature, and where necessary the humidity, of the storage
environment should be monitored with a maximum-minimum thermometer
and hygrometer, even if the store is not environmentally controlled.

C5.19 Paper and other moisture sensitive packaging materials should not be
stored adjacent to:

• external walls or other surfaces which may be at a lower temperature

than the ambient temperature of the store;
• sources of heat which could cause dehydration of the packaging
material.

C5.20 Sheet materials should be stored flat, not on edge.

C5.21 Packaging materials should be stored on shelves, clear of the floor.

C5.22 Pre-printed labels and other printed packaging materials should be

stored in secure conditions which exclude unauthorised access and should be
transported in separate containers in order to avoid mix-ups.

C5.23 Packaging materials should be issued for use only by authorised

personnel following an approved and documented procedure.

C5.24 Outdated or obsolete packaging material, especially printed material,

should be destroyed and this disposal recorded.
C6.0 Validation of packaging
systems

C6.1 All materials and procedures for packaging should be specified in

documented form.

C6.2 Before a particular packaging system is adopted for a product, or group

of similar products, it should be evaluated to establish its suitability.

C6.3 This evaluation should be documented.

C6.4 Specific testing may not be necessary when appropriate data are
available, historically from similar use (whether by the same or different sterile
product manufacturers), from the manufacturers of the packaging system or
from an independent third party.

C6.5 The factors that need to be considered for evaluation include, as a

minimum, those listed in paragraph C3.5.

C6.6 The compatibility of the packaging with the sterilization process can be
established for many packaging systems by demonstrating conformity of the
packaging and the sterilization process with published standards, for example
sterilization-grade paper bags manufactured in conformity to BS 6257 for use
in a sterilizer conforming to BS 3970 Part 3 and operated in accordance with
the guidance given in this HTM may be presumed to be compatible.

C6.7 Re-usable containers should be subjected to thermometric performance

tests before they are adopted as a packaging system. This may be accomplished
using a container modified to provide a gas-tight thermocouple entry port and
carrying out tests essentially similar to the small load and full load tests
described in HTM 2010 Part 3 paragraphs 13.7 to 13.14 and 13.15 to 13.24
respectively.

C6.8 The tests should be carried out with a container fully loaded with items
of the type which it is intended to process. If both instruments and textiles are
to be processed the container should be tested under both fully loaded
conditions. The full load test should be carried out with the sterilizer fully
loaded with fully loaded containers.

C6.9 The temperature profile obtained should not show any delay in the
contents of the container equilibrating with the sterilization temperature in the
chamber, when compared to the results obtained using a small-load test pack.

C6.10 Load dryness should be verified using either the hospital load test
described in HTM 2010 Part 3 paragraph 13.37 or, when quantitative results
are necessary, by a modification of the method described in HTM 2010 Part 3
paragraphs 13.25 to 13.36.

C6.11 The compatibility of the packaging with the labelling system will
usually be established by using the labelled pack for such tests as may be
necessary.
C6.12 The compatibility of the packaging with the user’s requirements at the
point of use, for example aseptic opening, should be verified by consultation
with the user. Testing is rarely required.

C6.13 The sensitivity of the pack contents to particular risks, such as

irradiation, moisture, mechanical shock, static discharge and the compatibility
of the packaging with the contents, for example the medical device or
medicinal substance, in other words, that the packaging has no adverse effect
on the medical device or vice versa, will usually be apparent from historical
data. When new products are to be packaged and sterilized, the instructions
which the device manufacturer is required to provide should be followed.

C6.14 The protection provided by the packaging against adverse

environmental influences which may reasonably be anticipated, such as
mechanical shock, vibration, chemical or microbial contamination, may be
considered in two stages:

a. First, the extent to which the environment to be encountered during

transport and storage may be controlled. Secondly, the protection
provided by the packaging.
b. Adequate performance of the packaging should be demonstrated under
the anticipated conditions of use by simulating the abuses a pack may
encounter during routine methods of transit and storage.

C6.15 Guidance on the methods to be adopted is given in BS 6082: ‘Guide

to compilation of performance test schedule for complete, filled transport
packages’ Part 1 ‘General principles’ and BS 4826: ‘Testing of complete filled
transport packages’ Parts 1-14.

C6.16 The protection provided by the packaging against microbial

contamination should also be evaluated.

C6.17 Tests for bacterial penetration of packaging are beyond the experience
and competence of most hospital users and could only be carried out by
specialist subcontractors. There is no agreement on suitable test methods, or
performance standards, for the microbial barrier properties of sterile packs.

C6.18 The microbial barrier properties of a sterile pack are dependent on

both the materials of which the packaging is made and the construction of the
package.

C6.19 Materials that are impermeable to gases may reasonably be assumed

to present an absolute barrier to microbial contamination. When such materials
are used in the construction of a pack which is hermetically sealed (for example
glass ampoules) the barrier may also be assumed to be absolute.

C6.20 Package testing may be avoided by the compilation of evidence that

the materials of construction are themselves an adequate barrier together with
evidence that all seals and closures are adequate barriers.

C6.21 Two different approaches have been adopted to testing porous

materials for their ability to exclude microbial contamination; tests based on
physical particulate retention (for example the methylene blue test specified in
British Standards for sterilization packaging) and tests based on the use of
micro-organisms (for example the tests specified in German standards for
sterilization packaging).

C6.22 For many materials a standard specification has been adopted which
specifies the physical and/or chemical characteristics of the material which have
been shown to provide satisfactory performance against a standard penetration
test. Whenever possible materials in compliance with one of these standards
should be adopted so that purchases are to an agreed specification which will
give the required level of assurance.

C6.23 The methods available for verification of the adequacy of the seal or
closure depend on the method chosen. Seals formed in impermeable packaging
materials can be tested by one of several leak test methods but these are not
generally applicable to seals formed in porous materials, nor to closures which
rely upon a tortuous path to exclude microbial contamination.

C6.24 Heat seals are also dependent for their success on the performance of
the heat sealer used. Several methods for testing heat seals are available but
visual examination of the quality and uniformity of the seal from samples of
packaging taken before and after sterilization and before and after storage and
Journey trials may be sufficient.

C6.25 Closures which rely on a tortuous path formed by folding are very
dependent for their success on the skill of the operator forming the closure.
There is good published evidence, from a number of studies carried out over
many years, that the closures described in paragraphs C4.78 to C4.97 are
satisfactory.

C6.26 For packaging materials to be used in gas or irradiation sterilization

processes it may be necessary to determine the extent and nature of microbial
contamination on the packaging before sterilization. This should not be
necessary for steam sterilization processes operating at 134°C for not less than
three minutes.

C6.27 When knowledge of the packaging bioburden is required this

information should be sought from the packaging manufacturer or it should be
determined in accordance with EN 11174 by an appropriately experienced
laboratory.

C6.28 When re-usable packaging systems are being evaluated it is important

that the cleaning, inspection and maintenance procedures and methods are
also evaluated for their ability to consistently restore the packaging system to
the required condition for re-use.

C6.29 Before any performance testing is undertaken a test protocol should be

prepared. This should document:

• the tests to be performed, including full details of the equipment and

methods to be used, personnel etc.;
• the purpose of the tests;

• the sequence in which the tests are to be carried out;

• the format in which the results are to be documented;
• the pass fail criteria for each attribute being evaluated.

C6.30 The test protocol and the written report of the results should form part
of the validation documentation.
C7.0 Facilities and environmental
control for packaging
operations
Packaging operations

C7.1 In SSDs the assembly of components, placing them in primary

packaging and sealing or closing the packaging usually is referred to as a
“packaging operation”. Thus is in contrast to pharmaceutical and laboratory
practice where the same operation is described usually as a “filling operation”
and the term “packaging operation” is reserved for the subsequent, often
post-sterilization, application of secondary packaging. In the following section
“packaging operation” refers to the application of primary packaging and any
secondary packaging which is included in the sterilization process.

C7.2 Detailed guidance on suitable facilities is given in Health Building Note

13 - ‘Sterile services department’ HMSO 1992 and Health Building Note 29 -
‘Accommodation for pharmaceutical services’ HMSO 1988.

General requirements
C7.3 All areas used for the reception, inspection, storage, filling, and sealing
of packaging require a high standard of finish and cleanliness.

C7.4 Areas where clean, unpacked product is to be handled for, say, assembly
and packaging, need a controlled environment to minimise the potential for
recontamination of product by, for example mechanical ventilation or gowning
procedures.

C7.5 All exposed surfaces should be smooth, water resistant and sufficiently
durable to withstand frequent cleaning. The construction and any fitments
should be designed to be free from crevices and sharp internal corners, which
can trap dirt.

C7.6 Areas where product, ready for incorporation into primary packaging,
and primary packaging materials are exposed to the environment for significant
periods should be controlled to defined standards of environmental cleanliness.

C7.7 For SSDs there should be a dedicated room where the production of
packs, trays etc takes place. This should be a controlled environment. HBN 13
recommends that packaging facilities for SSDs should be controlled to BS 5295
Class L and a detailed summary of the environmental needs of the various areas
is provided in HBN 13, Appendix 5.

C7.8 The GMP Guide for Pharmaceuticals recommends that parenteral

solutions should be filled under a laminar flow work station (Grade A) within a
cleanroom controlled to Grade C.

C7.9 The provision of controlled, clean environments has additional

implications for staff hygiene, gowning and entry procedures and the behaviour
of personnel within the facility. These requirements are fully described in the
relevant GMP guides.

C7.10 Doorways throughout the facility should be wide enough, and free
from damaged or rough edges, to eliminate the danger of packs of product on
trolleys being damaged as they are wheeled through.
Facilities for packaging operations

Cleaning
C7.11 All operational areas of a sterile-product manufacturing facility need to
be maintained to a high standard of cleanliness.

C7.12 Detailed cleaning procedures and schedules should be documented

and their implementation monitored.

C7.13 For guidance on suitable procedures and schedules see ISSM Guide to
Good Manufacturing Practice for NHS Sterile Services Departments and The
DoH MRS Guide to Water and Environmental Cleaning.

C7.14 Surface finishes and cleaning methods must be compatible. Appendix

6 of HBN 13 suggests appropriate finishes.

C7.15 Cleaning equipment and facilities for the storage and preparation of
cleaning materials and equipment should be provided separately for areas
between which cross-contamination could be problematic.

Cleaners’ room

C7.16 HBN 13 recommends the provision of a dedicated cleaning facility for

the packing room, and a separate, dedicated, cleaning facility for the linen
preparation area (if one is used).

C7.17 The cleaning facility provides storage for cleaning equipment and
materials, a sink or sluice with hot and cold water of the appropriate quality
and other facilities needed for the cleaning and preparation of the cleaning
equipment. In addition, it usually accommodates consumable items for
operational areas which are normally replaced by the cleaner. This would
include plastic waste bags, liquid or leaf soap refills for dispensers in changing
rooms etc.

C7.18 Hand washing and drying facilities should also be available in the
cleaning facility.

C7.19 Whether or not separate facilities are provided, it is necessary to ensure

that separate cleaning equipment is used for the assembly/packing area and
other areas within the unit.

Sterile services departments - SSD

C7.20 The packing room receives single-use materials from materials’store
and reusable goods after the completion of appropriate decontamination
procedures.

C7.21 The decontaminated re-usable goods will include components to be

incorporated into packs and may include re-usable packaging, such as textiles,
instrument trays, re-usable containers.

C7.22 Within each of the areas supplying the packing room, or at the
interface between these areas and the packing room there is usually provision
of inspection/verification facilities to ensure that all product transferred into the
packing room is the correct item and in a suitable condition for use.

C7.23 In the packing room these goods are then assembled into the
combinations specified to form the pre-set trays and procedure packs which are
required. These are then packed in preparation for sterilization (see HBN 13
paragraph 2.44).
Linen room

C7.24 Cleaning facility - dedicated required same as packing room. Textiles

for incorporation into packs may be product items, such as surgical drapes,
towels or gowns, or they may be wrapping materials.

C7.25 Textiles for wrapping purposes may be received in the SSD as

laundered linen which has already been checked and folded to an agreed
pattern or in bulk form, unchecked and unfolded.

C7.26 The SSD has an obligation to ensure that the laundry process is defined
and controlled and the quality checks on the textiles to be used are rigorously
applied to ensure that the pre-determined standard is maintained, even if the
laundry has the devolved responsibility for inspecting the packaging textiles (see
paragraphs C4.136 to C4.141).

C7.27 When unchecked linen IS provided from the laundry, the SSD will
require suitable inspection facilities within a linen preparation room.

C7.28 When textiles are to be used as the primary wrap for sterile packs they
have to be inspected to a defined standard, which should include freedom
from all tears, cuts and visible holes. A light table is essential for inspection to
this standard.

C7.29 When the textiles are used only as an inner wrap and it is Intended
that the necessary bacterial barrier properties will be provided by an outer wrap
of another material, such as a sterilization grade paper wrap or bag, a less
rigorous inspection standard may be accepted for the textiles. A large flat
surface where the wrap can be fully unfolded and a good standard of ambient
lighting are still necessary.

C7.30 The linting of fabrics can be a major problem. Lint is a respiratory

hazard and a fire or explosion hazard and together with other dust may
contribute to an insanitary environment by providing a vehicle for the transfer
of micro-organisms.

Packing room
C7.31 The activities undertaken in the packing area may be summarised as to:

• receive QC released single use, re-usable and consumable items. Note

that in some units the QC Inspection on cleaned and decontaminated
items is carried out within the packing area. When this system is used,
and particularly when inspection is done at the same time as assembly,
great care is needed to ensure proper segregation of rejected items;

• assemble items into pre-set trays and procedure packs;

• verify that the contents match the specification;

• pack;
• close and/or seal the packaging system;
• label;

• verify the accuracy of the label;

• transfer to sterilizer.

C7.32 The packing room should be mechanically ventilated to ensure that the
particulate count and pressure differentials meet the requirements of BS 5295
Class L in the “unmanned condition”.
C7.33 Although it may be possible to demonstrate that areas lacking
mechanical ventilation can meet the required particulate standard when tested,
this is not a satisfactory substitute. Mechanical ventilation is required to ensure
that the particulate standard can be met consistently and also to ensure that
there is a positive pressure relative to surrounding areas to minimise the ingress
of contamination.

C7.34 HBN 13 recommends that the air supply filters should have a minimum
resistance of 85% when tested in accordance with BS 6540 Part 1 (EU6).

C7.35 Humidification may also be required to avoid dehydration and

subsequent problems.

C7.36 When plastic materials are being used for packaging excessively dry
atmospheres can promote a build up of static electricity which causes problems,
such as attraction of particulate material.

C7.37 Dry atmospheres may lead also to excessively dry absorbent materials,
such as paper or cotton textiles. When steam sterilized the exothermal
rehydration of these materials can lead to local superheating and impairment of
the sterilization process.

C7.38 Ethylene oxide sterilization requires goods to be sterilized which have

been humidified to provide an optimum moisture content. This can be greatly
facilitated by the maintenance of appropriate ambient humidity during
assembly and packaging.

C7.39 The layout of the packing room should allow an orderly flow of work
and should provide sufficient separation between activities to preclude the
possibility of mix-ups, mis-labelling etc.

C7.40 Work surfaces should be of sufficient size to allow the largest

wrapping materials which will be used to be fully opened without draping over
the edges of the work surface.

C7.41 In-line labelling and label printing may be used to advantage, but
printers are often noisy. Their location should be considered carefully to
minimise the adverse effect of this noise. In addition, when it is necessary for
staff to read information displayed on VDU screens it is essential that the
ambient lighting is suitable.

Sterilizer loading area

C7.42 When single-ended sterilizers are used it is important to ensure

adequate segregation of unprocessed goods from processed goods. Chemical
process indicators in conformity to EN 867-2 may be of value.

C7.43 Adequate space must be available for the number and type of trolleys
to be used.

Post-sterilization area

C7.44 This area provides the interface between the sterilizers and the
processed goods store and should provide adequate space and facilities to
allow product removed from the sterilizer to be inspected and to be
quarantined until verification that the cycle was satisfactory.

C7.45 The area should provide space where packs may be allowed to cool to
room temperature before they are handled.
C7.46 Each pack should then be inspected to verify that the packaging is not
wet or damaged and that the seal or closure is intact.

C7.47 For gas sterilization processes an additional facility to provide the

controlled removal of residual sterilant gas may be required. After verification
that the sterilization cycle was satisfactory and inspection of the sterilized packs
they may be transferred to the processed goods store or sent directly to
despatch for immediate distribution.

Processed goods store

C7.48 The area should provide facilities where sterile packs may be stored
away from excessively humid, hot or cold locations, strong light sources and
electrical power supplies. Adverse conditions can cause deterioration of plastics,
rubber and cellulosic materials found in the packaging or the contents, giving
rise to embrittlement, loss of tensile strength, and so on (see SIB(7)3 ‘Storage
of sterile medical devices and surgical products’, DHSS 1982).

C7.49 The storage area needs to be clean, dry and well ventilated but free
from draughts. Ideally the environment in the store should be maintained at
18-22°C with RH 35-75%.

C7.50 Storage may be on open shelves or in closed cupboards. When shelves

are used they may be solid or of wire mesh construction. The lowest shelf
should be solid and should be 25-30 cm above floor level. The top of shelving
stack should be a solid shelf 25-30 cm below ceiling level to allow room for
cleaning, but should not be used for storage.

C7.51 Shelves should be located away from outside walls which can suffer
from condensation problems, and from other sources of water such as sinks,
and sprinklers.

C7.52 There should be no unlagged cold water pipes or other similar services
which may cause condensation to form and drip onto packs.

C7.53 A high standard of cleanliness is required in this area. When facilities

are less than ideal the inadequate conditions may be ameliorated by wrapping
the sterile packs in a protective dust cover such as a polythene bag during
storage. This may then be removed immediately prior to despatch. Note that, if
packs are to be wrapped in dust covers, they must be allowed to cool to room
temperature first.

Materials storage

C7.54 HBN 13 Appendix 4 provides guidance on determining the space

required.

C7.55 A materials store is required for the storage of incoming supplies,

including single use items, consumables, and new re-usable items as well as
packaging materials.

C7.56 The same store may also be used for incoming supplies of
commercially produced supplies items (for example commercially produced
sterile packs).

C7.57 The passageway between shelves or racking should be wide enough to

permit proper use of handling equipment without causing damage to stored
materials.
C7.58 Secure separate storage needs to be provided for the segregation of
defective or non-conforming materials products.

C7.59 Facilities are required for the reception of purchased goods and
subsequent inspection and confirmation that they are supplied in accordance
with the purchase specification.

Packaging equipment

Heat sealers

C7.60 Several patterns of heat sealer are in common use:

a. Hand-operated heat sealers with scissor action jaws; many of these were
designed for sealing light gauge polythene bags for food use and are
rarely satisfactory for sterilization packaging.

b. Parallel-jaw sealers, which may be hand or foot operated, have one of the
jaws heated and this presses against the opposing unheated jaw. Heat-
seal packaging placed between the jaws is heated and compressed.

c. Heat-seal conveyors work in a similar manner, but items to be sealed are

moved between heated elements of the conveyor.

C7.61 The seal integrity and strength is affected by the temperature, pressure
and dwell time of the heat-sealing equipment.

C7.62 In order to ensure reproducible satisfactory sealing all three variables

should be validated, controlled and monitored.

C7.63 Many of these heat sealers are available without a built-in timer, with
no reproducible control over sealing pressure and with no indication of the
operating temperature. The design of many heat sealers makes effective
monitoring, calibration and adjustment of the operating conditions difficult.

C7.64 Any heat sealer which is to be used for sealing packs for sterilization
should be monitored regularly for the controlling variable of temperature,
pressure and dwell time. Machines which cannot be independently tested
should not be used.

Overseal crimpers

C7.65 Crimping devices for the application of crimp-on overseals may be

manual or automatic.

C7.66 The manual crimpers are available as hand-held devices or as bench-

mounted, lever-operated machines.

C7.67 Most, if not all, of the manually operated crimping equipment available
is pre-set for overseals of a particular size, or has sets of change parts to
accommodate other sizes. The compressive force applied is not adjustable.

C7.68 It is essential that the crimper is only used with overseals, stoppers and
containers of the pattern for which it is intended.

C7.69 Crimpers for applying foil caps to aluminium tubes for use in hot air
sterilizers are also available. These are usually hydraulically operated.
Screw cappers - controlled torque

C7.70 Capping machines with a built-in, adjustable, torque limiter are

available. The torque setting to be used varies with the size and type of cap
and the stopper or other seal being used. The settings recommended by the
manufacturer of the closure should be used.

C7.71 The calibration of the torque limiting device should be verified at

regular intervals.

Ampoule sealers

Manual sealing
C7.72 Although it is possible to effectively seal an ampoule without a
purpose-built ampoule sealer, it is difficult to get the correct temperature,
sufficiently localised and in the required time.

C7.73 Commercially available ampoule sealers use a natural gas/compressed

air (low pressure of the order of 2-3 psig) or gas/oxygen flame, in burners set
either side of the ampoule.

C7.74 The ampoule stands on a support platform which is vertically

adjustable to position the flames at the required position on the ampoule neck.

C7.75 The flames are positioned and adjusted so that the glass wall of t h e
ampoule neck is just by the points of the blue cones within the flames.

C7.76 The filled ampoule is rotated in the flame.

C7.77 When the glass in the heated region of the neck melts and starts to
fuse the top of the ampoule is grasped with pliers or forceps and pulled
upwards in a smooth but fairly rapid movement.

C7.78 This detaches the unwanted portion of the neck leaving a fused end
which should be smooth and round without any sharp pointed protrusion or a
long tail of glass.

C7.79 To produce consistently successful seals requires some skill, which is

only achieved through practice and experience.

C7.80 Semi-automatic and automatic ampoule sealers reproduce the same

sequence of events but the whole process is automatic.

C7.81 The flame temperature, the position of the flame, the dwell time, and
the timing and rate of detachment of the neck extremity all affect the quality
of the seal.
C8.0 Packaging operations

Routine operation, control and monitoring

C8.1 The materials, systems, equipment and procedures used should have
been evaluated for their suitability before implementation for routine use (see
Chapter C6).

C8.2 The following guidance is based on the assumption that high-speed

packaging machinery capable of handling large batches will not be used. When
large batches are to be processed on such equipment the guidance and
requirements in the Regulations and Standards applicable to commercial
manufacturers should be adopted.

Documentation

C8.3 There should be written specifications for all packs giving details of both
the contents and the packaging requirements.

C8.4 The order in which the contents of composite packs should be placed,
to facilitate their aseptic removal from the pack, should be documented in the
pack specification and the associated packing procedure.

Packaging instructions

C8.5 There should be formally authorised packaging instructions for each

product, pack size and type. These should normally include or make reference
to the following:

a . the name of the product;

b. either a description of its pharmaceutical form and strength,where
applicable, or a list of the contents of the pack;
c . the pack size expressed as the weight or volume of the product in the
final container, where applicable;

d. a complete list of all the packaging materials required including

quantities, sizes and types, with the code or reference number relating to
the specifications of each packaging material;
e. where appropriate, an example or reproduction of the relevant printed
packaging materials, and specimens indicating where to apply any batch
number, references and shelf life of the product;
f. any special precautions to be observed, including the order in which
components should be assembled to facilitate aseptic removal;

g . a description of the packaging operation,including any significant

subsidiary operations, and equipment, to be used;

h . details of in-process controls with instructions for sampling and

acceptance limits, where applicable.
Batch packaging records

C8.6 When products are prepared in batches a batch packaging record

should be kept for each batch or part batch processed.

C8.7 The record should carry the batch number and the quantity of bulk
product to be packed as well as the batch number and the planned quantity of
finished product that will be obtained.

C8.8 Before any batch packaging operation begins, there should be recorded
checks that the equipment and work station are clear of previous products
documents or materials not required for the planned packaging operations and
that the equipment is clean and suitable for use.

C8.9 The information should be entered at the time each action is taken and,
after completion, the record should be dated and signed.

Packaging records for single packs

C8.10 The records kept should have a sequential batch code enabling
finished pack to the manufacturing's lot number for any single,
including packaging, used in the composition of the pack.

Batch numbering

C8.11 All packs produced should have a sequential batch code enabling
traceability and, when necessary, the recall of defective product.

C8.12 The batch code used should indicate the date of sterilization, the
machine used and the process log/cycle number.

C8.13 Batch numbering with sterilizer and cycle may conveniently be done
after sterilization when inspecting each pack to ensure that it has not become
wet or sustained any damage.

Labelling

C8.14 Each sterile pack should be clearly labelled with a description of the
pack contents and the description “sterile”.

C8.15 Normally filling and sealing should be followed as quickly as possible

by labelling to ensure that no mix-ups or mislabelling can occur.

C8.16 The correct performance of any printing operation (for example, code
numbers, expiry dates), whether done separately or in the course of the
packaging operation, should be checked and recorded.

C8.17 The accuracy of labelling should be checked. Special care should be

taken when using individual pre-printed labels and when over-printing is carried
out off-line. Roll feed labels are normally preferable to cut labels, in helping to
avoid mix-ups.

C8.18 When large batches of single product are being processed the correct
number of bags may be labelled for each batch. On completion of the
packaging operation for each batch the number of labelled bags should be
reconciled with the number of products packed and any surplus bags destroyed
before commencement of a different product. Any pre-stamping or labelling of
bags should be controlled by documented procedures.
C8.19 Checks should be made to ensure that any electronic code readers,
label counters or similar devices are operating correctly.

Control of the packaging operation

C8.20 When setting up a programme for the packaging operations particular

attention should be given to minimising the risk of cross-contamination, mix-
ups, substitutions, or mis-labelling.

C8.21 Before packaging operations begin, steps should be taken to ensure

that the work area and packaging equipment are clean and free from any
products, materials or documents previously used, if these are not required for
the current operation.

C8.22 All products and packaging materials to be used should be checked on

delivery to the packaging department for quantity, identity and conformity with
the packaging instructions.

C8.23 Containers and packaging for filling should be clean before filling;
particular attention should be given to avoiding and removing any
contaminants such as glass fragments and metal particles.

C8.24 Control of the product during packaging should include at least

checking the following:
• general appearance of the packages;
• whether the packages are complete;

• whether the correct products and packaging materials are used;

• whether the labelling, including any over-printing, is correct;

• the correct functioning of packaging equipment, for example the
temperature gauge reading on heat sealing equipment.

C8.25 All wrapping material used should be inspected for flaws, holes, tears,
dirt, stains and other defects at the time of packaging by the operator using it.

C8.26 Any of these defects should be cause for rejection of the material,
which should be scrapped.

Heat-sealing equipment

C8.27 Closing and sealing machines must be in good condition, properly set
and maintained to the manufacturer’s specification, and closing and sealing
operations should be under constant supervision.

C8.28 For heat-sealing operations the critical variables of temperature,

temperature uniformity, pressure, pressure uniformity, dwell time, and the
characteristics of the packaging materials, for example the type, thickness and
uniformity of the heat-seal adhesive, should, ideally, be verified at frequent
regular intervals.

C8.29 If the available equipment does not provide the facility for routine
monitoring of the physical operating variables then routine monitoring of
process efficacy by checking the quality of the output should be adopted.

C8.30 The efficacy of the seals should be tested and proved on a regular
basis, not less than daily for each heat sealer.
C8.31 As a minimum daily heat-sealing records should be kept and these
should be reviewed quarterly; there should also be a quarterly check on the
temperature control of each heat sealer.

Glass containers

C8.32 Because of the hazards associated with glass contamination it is

essential that, if packing in glass takes place, suitable precautions are described
in formal documented procedures to deal with any glass breakages which may
occur.

C8.33 Equipment for handling and processing glass containers should be

adequately screened to ensure that any broken glass is contained. In particular,
cleaning and filling equipment must be suitably screened and it is good practice
to fully enclose all conveyors between cleaning and closing.

C8.34 Conveyors for glass should not pass over areas where exposed product
or components may be held.

C8.35 Suitable lidded containers to be used only for the disposal of broken
glass should be provided.

QC tests

C8.36 Quantitative testing of the adequacy of packaging seals and closures

requires the use of laboratory facilities and equipment not available in most
hospitals.

C8.37 However, there are qualitative procedures that can be carried out
which are sufficient to demonstrate a satisfactory seal, although they may be of
less value in any investigation as to the cause of an unsatisfactory seal.

C8.38 These procedures are based on visual examination which can be

carried out either by the operator during the various stages of the packing
operation or by a QC inspector given that specific task.

Pinholes

C8.39 The performance of both porous and impermeable materials as a

bacterial barrier depends on them being free from pinholes and other similar
defects.

C8.40 Laboratory tests for pinholes are based on detecting the passage of a
dye solution.

C8.41 However, visual examination of opaque or translucent material against

a bright light is a sensitive method of detection, which may be applied in the
packing room.

C8.42 The method is unsatisfactory for transparent film. However the plastic
film used in pouch and reel material is typically a laminate of two films. There is
a very low probability of a pinhole occurring in the same spot in both films.

Inspection of seals

C8.43 A subjective assessment may be carried out by examining and opening

a number of sample packs taken from production.
C8.44 Where one of the webs being sealed is transparent the uniformity of
the seal can be examined without opening the pack. In other cases it will be
necessary to peel open the seal.

C8.45 In carrying out the examination the following factors should be

considered:

• the appearance of the seal; it should be uniform across the entire sealed
surface and should be free from creases, striations or unsealed areas;

• the seal strength; the seal should be peeled apart and attention paid to
whether the force required remains constant or whether there are
apparent weak spots; with practice and experience it is also possible to
recognise overall increased or decreased seal strength;

• the seal characteristics; when the seal is peeled apart there should be
visible evidence of the seal on both of the webs, but there should be no
spitting, tearing, delamination or fibre shedding;

• the condition of the packaging, particularly in the area of the seal;

excessive pressure during heat sealing may cause damage or distortion;
high temperatures or prolonged dwell times may cause scorching of the
paper web.

Packaging for sterile medicinal products

C8.46 Filled containers of parenteral products should be inspected

individually. When inspection is done visually this should be done under suitable
and controlled conditions of illumination and background.

C8.47 Operators doing the inspection should pass regular eye-sight checks,
with spectacles if worn, and be allowed frequent breaks from inspection.

C8.48 When other methods of inspection are used the process should be
validated and the performance of the equipment checked at intervals.

Process indicators

C8.49 Asystem to differentiate between processed and unprocessed items

should be used.

C8.50 Single-use packaging materials may be obtained pre-printed with

process indicators suitable for one or more sterilization processes.

C8.51 For other packaging materials suitable process indicators may be

purchased printed onto adhesive packaging tape, adhesive patches or onto
labels.

C8.52 Whichever system is chosen the process indicator should conform to

the requirements of the relevant European standards (BS EN 867-l and BS EN
867-2).

Sterile product release

C8.53 Post-sterilization it is necessary to verify that the sterilization cycle was

satisfactory and check that each pack is either

• labelled with a reference to the number of the sterilizer cycle through

which it was processed, or
 • reconciled with the load manifest for the cycle, for packs which were
labelled before sterilization with a reference intended to be traceable to
the cycle number.

C8.54 Packaged sterile product should be inspected after sterilization and

before release to ensure that the seal or closure remains intact, and that the
pack is undamaged.

C8.55 The nature of the inspection will depend upon the nature of the
packaging system used.

C8.56 For example, glass ampoules may be inspected for cracks and flaws
visually, by means of a dye penetration test or by means of a corona discharge
crack detector.

C8.57 Whenever the integrity of the packaging is in doubt the sterilized

product, or in extreme cases the sterilizer load, should be regarded as non-
sterile and not released for distribution.

Operator training

C8.58 All operators should receive training in the documented procedures

that they will be expected to carry out.

C8.59 Particular emphasis should be placed on operator dependent

techniques such as the correct folding and closure of wraps.

C8.60 Training should Include instruction on the correct use of equipment,

inspection techniques and test methods and on the intended use of the
product.

C8.61 Training should be documented and recorded and should be reviewed

periodically.
C9.0 Storage and distribution

Shelf life

C9.1 Time-related expiry dates for the maintenance of sterility are widely
recognised as being of little value since under artificially created worst-case
storage conditions packs such as textile wrapped packs could be shown to have
become contaminated within 18-30 days.

C9.2 When the products were overwrapped with a dust sheet this was
extended to at least nine months, and in paper/plastic pouches was found to
be at least a year.

C9.3 Maintenance of sterility depends to a great extent on the storage

conditions including such factors as:

• the microbial contamination of the storage environment;

• movements of air;

• movements and behavioural standard of personnel;

• environmental temperature, relative humidity;

• moisture, such as condensation;
• location in the store, etc.

C9.4 The barrier properties of the packaging material are also a contributory
factor. The general concept is that the combination of the packaging and the
control exerted over storage and distribution conditions should guarantee that
the contents remain sterile until opened for use.

C9.5 Some form of date coding may still form a convenient inventory control
system, means of assessing the frequency of usage and for deciding whether
unused packs are of a type which no longer need to be produced.

C9.6 The use of arbitrary expiry dating on packs should be replaced with
batch numbering and/or manufacturing date codes which can be used to
facilitate good stock rotation, based on a first-in-first-out system.

C9.7 Maintenance of sterility cannot be guaranteed once the packaging has

been breached and the labelling should warn the user to verify the condition of
the packaging before opening the pack for use. A warning such as “sterile
unless packaging opened or damaged” is usually sufficient.

Distribution of sterilized supplies

C9.8 Trolleys used for distribution within the hospital should be covered or
closed with a solid bottom shelf.

C9.9 Each article to be loaded onto a trolley or into a transit container should
be inspected and handled with care; packs should not be crushed together.
Cramming additional packs into too small a space will invariably result in
damage.
Storage of sterile supplies

C9.10 The function of this storage area may be limited to the storage of
packs produced in the SSD or may also accommodate commercially produced
packs and sterile devices purchased from commercial suppliers.

C9.11 Medical equipment that has been decontaminated, disinfected,

cleaned, serviced, repaired and readyfor re-issue may also be stored here.

C9.12 Sufficient space is required for loading trolleys and containers for
distribution on site and for loading containers for delivery off site.

C9.13 Entry to the area should be restricted to authorised and trained

personnel.

C9.14 Staff should wash their hands before entering; where no convenient
washing facility is available, it may be acceptable to substitute treating clean
hands with an alcohol-based hand rub for washing.

C9.15 Movement of personnel within the area should be kept to the

minimum necessary.

C9.16 The floor should be cleaned regularly by damp mopping and/or

vacuuming; sweeping, brushing or the use of rotary scrubbing and polishing
machines should be avoided since these may disperse contamination from the
floor as an aerosol.

C9.17 Shelves, trolleys, delivery carts and transit containers should be subject
to regular cleaning in accordance with a documented procedure and schedule.

C9.18 Packs should be spaced on shelves with sufficient room to avoid

friction or the jarring of adjacent products when one is removed.

C9.19 Rigid re-usable transit containers may be used with advantage to

contain smaller packs; these containers should also be on the cleaning
schedule.

C9.20 Packs dropped on the floor should be discarded or sent for re-
processing, as applicable, unless they were protected by an outer dust cover,
such as a polythene bag, show no visible damage to the packaging and do not
contain items which could be damaged by impact.

C9.21 Storage arrangements should be orderly to facilitate efficient rotation

of stocks, batch differentiation and ease of cleaning.

C9.22 Sterilized packs should be issued in rotation based on the First-ln–

First-Out (FIFO) principle in accordance with a documented procedure.

C9.23 Sterilized packs should be handled as little as possible.

C9.24 After sterilization it is important that packs are stored safely in a

manner which will assist in preserving the sterility of the contents.

Handling sterile packs

C9.25 It is important that all personnel who will be required to handle sterile
packs (porters, drivers, SSD assistants, phlebotomists, nurses, clinicians, etc)
receive appropriate training in the correct handling procedures and why they
are necessary.

C9.26 Many sterile packs wiII contain expensive and delicate Instruments and
require careful handling. All sterile packs need to be handled in a manner
which wiII not compromise their sterile condition.

C9.27 As a minimum the following rules should apply:

a. The hands of personnel who will handle sterile packs need to be clean
and dry;

b. The sterile packs need to be kept dry and must not be torn, punctured or
otherwise damaged;

c. Any packs that are visibly damaged, stained or wet should be returned to
the SSD for disposal or re-processing, as appropriate;

d. It should be possible to verify that the pack has been processed; this may
be by means of a process indicator, or by appropriate labelling such as a
sterilizer cycle number. Note that process Indicators do not indicate the
sterility of the pack contents, only that the pack was processed through a
sterilizer;

Containers, distribution trolleys and any surfaces on which the packs will
be placed must be clean and dry;

Transport and distribution

C9.28 There should be documented procedures for delivery and for the
packaging, collection and return of used goods

C9.29 Containers and trolleys should be easy to clean, properly maintained

and should adequately isolate the goods in transit from environmental hazards

C9.30 The cleaning procedure for bulk containers and trolleys should be
documented and records should be kept of cleaning carried out

C9.31 In transit the contents of containers should be adequately identified by

means, such as labels, which will not be erased in transit.

C9.32 Used goods being returned must be segregated from clean and sterile
goods being delivered.

C9.33 Vehicles reserved for the delivery of clean and sterile goods should be
used whenever possible. If dedicated vehicles are not used then each vehicle
used must be cleaned after use for the return of used goods and before use for
the transport of sterile goods.

C9.34 The cleaning procedure for the vehicle interior should be documented
and records should be kept of cleaning carried out.

C9.35 As an alternative the use of sealed leakproof containers may be used

for transport in either or both directions.

Storage in clinical areas

C9.36 The same principles apply as were discussed for the processed goods
store
C9.37 The storage facility should be secure, easy to clean and organised to
aid stock rotation (for example a double-sided cupboard filled from the back
but where goods are removed from the front).

C9.38 The quantity of goods stored should be limited to those actually

needed within a reasonable time period.

C9.39 The place and method of storage varies, but it should be separate
accommodation, not a general store with bedpans, urinals etc.

C9.40 Storage should be segregated or, if it has to be shared, it should be

with other clean and/or sterile equipment.

C9.41 A high standard of cleanliness is required and packs must be kept well
away from sinks and other sites of possible contamination.

Packaging for return of used items for re-processing

C9.42 A local policy for the handling of potentially contaminated and

hazardous items, and practices for safe containment during transport back to
the SSD need to be established.

C9.43 All returned items should be regarded as potentially contaminated and

thus infective.

C9.44 Containers for returning goods should be leak proof, securely closeable
and safe to handle. The container design should Include the facility for clear
labelling to indicate the nature of the contents.
Glossary of terms

Bioburden Population of viable micro-organisms on an item.

Capacity (for glass containers) The internal volume at 20°C.

Closure Means used to close a package where no seal is formed, for example by repeated
folding to construct a tortuous path.

Closure integrity The quality of the closure which ensures that it presents a microbial barrier

Final pack The pack in which a medical device is sterilized. In addition to the primary pack a
secondary and/or transport pack may be included.

Internal pressure resistance The internal hydraulic pressure which a glass container at 20°C can withstand
without breaking

Microbial barrier The ability to prevent the ingress of micro-organisms.

Multi-trip container A glass container which has strength characteristics sufficient for it to withstand a
number of filling/use operations.

Packaging compatibility The ability of the packaging material and/or system to achieve the required
performance without detrimental effect on the medical device.

Packaging material Any material used in the fabrication or sealing of a packaging system or primary
pack.

Packaging system One or more packaging materials assembled into a single unit intended as part or all
of a primary pack.

Primary pack The sealed or closed packaging system forming a microbial barrier enclosing the
medical device, and (usually) in contact with the medical device.

Seal The result of joining of layers, for example by use of adhesives or thermal fusion.

Seal integrity The quality of the seal which ensures that it presents a microbial barrier.

Secondary pack The pack containing one or more medical devices, each in its primary pack.

Shelf pack see Secondary pack.

Shipper pack see Transport pack.

Single-trip container A glass container designed and manufactured to be sufficiently strong to withstand
only one filling/use operation.

Terminally sterilized Descriptor for medical devices which are sterilized after being completely sealed or
enclosed in at least the primary pack.

Thermal shock resistance The ability of a glass container to withstand a sudden temperature change without
breaking.

Transport pack The pack containing one or more primary and/or secondary packs intended to
provide the necessary protection during transport and storage
Ullage That part of the contents of a container which wants for filling. Expressed in units of
volume or as a percentage of the total container volume.

Unit pack see Primary pack.

Vacuity The free space left above the contents in a sealed container expressed as a
percentage of the nominal volume of the contents.

Validation Documented procedure for obtaining, recording and interpreting the data required
to show that a process will comply with predetermined specifications.
Section D

A contract for the annual testing of sterilizers

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 21
Small power
Contents

Invitation to tender page 131 Appendix A - Sterilizer inventory and unit

costs page 156
Price schedule page 133
Appendix B - Testing philosophy and
Value Added Tax estimation form page 134 procedures page 158

Schedule of information to be Appendix C - Annual performance tests page 160

supplied by the tenderer page 135
Appendix D - Reports page 162
Abstract of particulars page 136
Appendix E - Retest request form page 168
General conditions of contract page 137
Definitions
Period of contract and determination
Procedure
Contract rates and prices
Accounts
Assignment transfer or sub-letting of the
contract
Determination of the contract due to default or
failure
Injury to persons: loss of property
Insurance against injury to persons and loss of
property
Data Protection Act
Admission to the site(s)
Arbitration
Value Added Tax
Local health building requirements
Racial discrimination
Mental Health Act

Particular specification page 151

Regulations
Compliance with British Standards
Obligations of the employer
Access to site
Health and safety
Fire precautions
Security and public health precautions
Facilities on site
Workmanship and materials
Requisitioning of works
Documentation
Description of the work

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Previous page
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GENERAL CONDITIONS OF CONTRACT

FOR ANNUAL TESTING OF STERILIZERS

GENERAL CONDITIONS OF CONTRACT

1. DEFINITIONS

1.01 ‘The Contract’ means all documents forming the tender and acceptance thereof,
together with the documents referred to therein, including these Conditions (except
as set out in the Abstract of Particulars) and the Appendix. All these documents
taken together shall be deemed to form one Contract.

1.02 In the case of a discrepancy between these conditions and the Annexes forming part
of the Contract Document, the Provisions of these Conditions shall prevail.

1.03 In the Contract the following expressions shall, unless the context otherwise
requires, have the meanings hereby respectively assigned to them;

1.04 ‘The Schedule(s)‘ means the Price Schedule(s) listed in the Abstract of
Particulars.

1.05 ‘The Employer’ means the NHS Trust/Employer so designated in the Abstract of
Particulars.

1.06 ‘The Contractor’ means the person or persons whose tender is accepted by the
Employer and his or their legal personal representatives or permitted Sub-
Contractors and assigns.

1.07 ‘The Contract Administrator’ is the person nominated by the NHS Trust/Employer
to act for the NHS Trust/Employer in Managing the Contract or any person for the
time being acting for him/her for the purpose of the Contract. Nominated
representatives are listed in the Abstract of Particulars.

1.08 ‘The Authorised User’ means the person responsible for the Management of the
Hospital Department in which the Sterilizer is installed.

1.09 ‘The Work’ means the work for the performance of which the Contract provides.

1.10 ‘Unscheduled Work’ means the work carried out by the Contractor at the request
of the Contract Administrator which does not form part of the Work.

1.11 ‘The Site(s) means the grounds, buildings and/or installations within or without the
buildings in or at which the work is to be performed under the Contract (See
Inventory - Appendix A).

1.12 ‘The Contract Period’ means the period commencing on the date indicated in the
invitation to Tender and continuing until a date 5 years thereafter or until such
earlier date at which the Contract may have been determined by either party in
accordance with Condition 2 and 7 hereof or by the Employer in accordance with
Condition 10 hereof.
1. DEFINITIONS (Continued)

1.13 The proper law of the Contract shall be English Law.

1.14 Any decision to be made by the Employer under the Contract may be made by any
persons authorised to act for them for that purpose and may be made in such
manner and on such evidence or information as such person or persons shall think
fit.

1.15 The headings to the Conditions shall not affect the interpretation thereof.

1.16 Any notice required to be given under this Contract shall be in writing and shall
be delivered or posted by recorded delivery to the last known place or abode or
business of the Contractor or, if the Contractor is a Company, to the registered
office of the Company, in which case the notice shall be deemed to have been duly
served at the time it is delivered.

2. PERIOD OF CONTRACT AND DETERMINATION

2.01 The Contract shall remain in force for a minimum period of 1 year and a
maximum period of 5 years from the date for the commencement of the Contract
as stated in the Invitation to Tender, subject to the due performance by the
Contractor of his obligations under the Contract and without prejudice to the
specific rights of the parties of determination thereunder.

2.02 The Contract may be determined (without prejudice to the Contractor’s or

Employer’s rights under Conditions 7 and the Employer’s rights under Condition
10 hereof) at the end of the 1 year minimum period or at any time thereafter
provided 13 weeks notice to that effect shall have previously been given by either
party.

3. PROCEDURE

3.01 Subject to the provision of the Contract, the Contractor shall carry out the Work
required in accordance with the Contract and to the satisfaction of the Contract
Administrator at the times set out in the Schedule or at such other times as the
Employer may from time to time direct and, so as not to interfere with the normal
carrying out of business of the Employer’s staff in occupation of premises in
which the Work is being carried out.

3.02 The Employer may from time to time by notice in writing subject to the agreement
of the Contractor (which shall not unreasonably be withheld) vary the Contract by:
3. PROCEDURE (Continued)

A. The deletion from the Inventory of the name and particulars of any site and
the price payable for the work in respect thereof. If the Contract price for
that item is an annual price, the amount to be paid to the Contractor in
respect of the work satisfactorily performed up to that date specified in such
notice shall be calculated pro-rata to the annual price.

B. The addition to or the reduction in the items of work, plan and/or equipment
at any of the site(s) referred to in the said Inventory and in the event of such
variation a fair and reasonable adjustment of the price payable for such items
of work at that site shall be agreed with the Contractor.

4. CONTRACT RATES AND PRICES

NB Conditions 4.01 and 4.02 applicable as stated in the Abstract of Particulars.

4.01 The Contract Rates and Prices quoted in the Schedule and agreed by the Employer
shall be subject to adjustment on each successive anniversary of the date of
commencement of the Contract Period in accordance with the formula set out
below:

For this purpose, the reference in this Condition to an Index refers to the
appropriate Index indicated in the Health Services Price Index for
Engineering Maintenance Contracts issued by the Department of Health,
Richmond House, 79 Whitehall, London, SW 1A 2NS, and ‘index numbers’
means the index numbers contained therein.

FORMULA

X = Y a
b

Where:

X = The required adjusted Contract Rate or Price

Y = The Contract Rate or Price that is required to be adjusted
a= The index indicated for the month during which commenced the first day
of the second or subsequent years for which the revised Contract Rate or
price is to be calculated.
b = The Base Index for the month during which the Contract Period
commenced.
4. CONTRACT RATES AND PRICES (Continued)

4.02 The Contract Rates and Prices quoted in the Schedule shall apply to all the work
which is required to be carried out under the Contract in accordance with
Conditions 3.01 hereof, but either party may give notice under Condition 2.02
hereof to terminate the period within which the Contract Rates and Prices are
applicable with a view to negotiating a revision in the said Rates and Prices. The
Employer will not, however, be obliged to consider an increase in the Contract
Rates and Prices to take effect in respect of the work which is required to be
carried out before the end of the first year of the Contract period, or to negotiate a
subsequent increase in the Contract Rates and Prices to take effect in respect of the
work which is required to be carried out within a period of 12 months following a
previous increase, save in circumstances, accepted by the Employer as being
exceptional.

5. ACCOUNT

5.01 Invoices shall be rendered monthly within 14 days after the end of the month to the
Contract Administrator.

5.02 Payment of fixed charges for ordinary testing will be made as soon as the invoices
for the month can be examined and approved by the Employer. They will only be
considered for payment, however, after receipt of the test results of those
Sterilizers that have been satisfactorily tested and invoiced.

5.03 Accounts for retesting or Unscheduled Work ordered by the Contract

Administrator will be paid as soon as possible after examination of test results
and invoices and certification by the Contract Administrator.

6. ASSIGNMENT, TRANSFER OR SUB-LETTING OF THE CONTRACT

6.01 The Contractor shall not, without the written consent of the Employer whose
consent shall not unreasonably be withheld, assign or purport to assign his
obligations hereunder or enter into any Sub-Contract in respect of any portion of
the work.

6.02 The Contractor shall be responsible for any Sub-Contractor employed by him in
connection with the Work.

6.03 The Contractor shall make good any loss suffered or expense incurred by the
Employer by reason of any default of failure, whether total or partial on the part
of any Sub-Contractor.
7. DETERMINATION OF THE CONTRACT DUE TO DEFAULT OR FAILURE
OR CORRUPTION

7.01 If materials and workmanship of the quality and standards specified have been
used in carrying out the work or any part thereof is otherwise not in accordance
with the Contract and if the Contractor, having been given by the Employer a
notice in writing to rectify, reconstruct or replace any defective work or a notice
in writing that the work is being performed in an inefficient manner, shall omit to
comply with the requirements of such notices for a period of 7 days thereafter, or,
if the Contractor shall fail to carry out the work during any period stated in the
Schedule or otherwise as the Employer shall have directed or required, the
Employer shall have the right to;

A. i. Have such unsatisfactory materials or workmanship or uncompleted

work replaced, rectified or completed by persons other than the Contractor
and to recover from the Contractor any cost incurred thereby in excess of
the amount which would have been payable under the Contract for such
work, or

ii. Determine the Contract immediately and any costs or expenses incurred
thereby, from the day of such determination until the first day thereafter
upon which the Contractor, but for such determination, could have
determined the Contract under Condition 2.02 hereof, shall, so far as they
exceed the sums which would have been payable under the Contract for
that period, be chargeable to and recoverable from the Contractor by the
Employer.

B. i. If the Contractor makes a composition or arrangement with his creditors, or

becomes bankrupt, or being a company makes a proposal for a voluntary
arrangement for a composition of debts or scheme or arrangement to be
approved in accordance with the Companies Act 1985 or the Insolvency Act
1986 as the case may be or any amendment or re-enactment thereof, or

has a provisional liquidator appointed, or

has a winding-up order made, or

passes a resolution for voluntary winding-up (except for the purposes of

amalgamation or reconstruction), or

under the Insolvency Act 1866 or any amendment or re-enactment thereof

has an administrator or an administrative receiver appointed.

142
7. DETERMINATION OF THE CONTRACT DUE TO DEFAULT OR
FAILURE OR CORRUPTION (Continued)

offer or give or agree to give to any person any gift or consideration of any
kind as an inducement or reward for doing or forbearing to do or for having
done or forborne to do any action in relation to the obtaining or execution of
this or any other contract with the Employer, or for showing or forbearing to
show favour or disfavour to any person in relation to this or any other
contract with the Employer, or if the like acts shall have been done by any
person employed by the Contractor or acting on his behalf (whether with or
without the knowledge of the Contractor), or if in relation to this or any
other contract with the Employer the Contractor or any person employed by
him or acting on his behalf shall have committed an offence under the
Prevention of Corruption Acts to 1916.

7.02 The Contractor may without prejudice to any other rights and remedies that he may
possess, by notice in writing determine the Contract if the Employer has not paid
within 28 days of receipt of an invoice from the Contractor any amount properly
payable to the Contractor by the Employer, and having been given notice by the
Contractor shall fail to comply with such notice within seven days from the service
thereof.

7.03 Any dispute or different of opinion arising in respect of either the interpretation or
effect of 7.02 or of the amount recoverable hereunder the Employer from the
Contractor shall be decided by the Employer, whose decision on that matter shall
be final and conclusive.

8. INJURY TO PERSONS : LOSS OF PROPERTY

8.01 This condition applies to any personal injury or loss of property which arises out
of or in any way in connection with the execution or purported execution of the
Contract.

8.02 Subject to the following provisions of the Condition, the Contractor shall:

A. Be responsible for and reinstate and make good to the satisfaction of the
Employer, or make compensation for, any loss of property suffered by the
Employer to which this Condition applies;

B. Indemnify the Employer and servants of the Employer against all claims and
proceedings made or brought against the Employer or servants of the
Employer in respect of any personal injury or loss of property to which this
Condition applies and against all costs and expense reasonably incurred in
connection therewith;
8. INJURY TO PERSONS: LOSS OF PROPERTY (Continued)
C. Indemnify the Employer against any payment by the Employer in order to
indemnify in whole or in part a servant of the Employer against any such
claim, proceedings, costs of expenses; and
D. Indemnify the Employer against any payment by the Employer to a servant
of the Employer in respect of loss of property to which this Condition
applies suffered by that servant of the Employer and against any payment
made under any Government provision in connection with any personal
injury to which this Condition applies suffered by any servant of the
Employer.
8.03 If the Contractor shows that any personal injury or loss of property to which this
Condition applies was not caused nor contributed to by his neglect or default or by
that of his servants, agents or Sub-Contractors, or by any circumstances within his
of their control he shall be under no liability under this Condition, and if he shows
that the neglect of default of any person (not being his servant, agent or Sub-
Contractor) was in part responsible for any personal injury or loss of property to
which this Condition applies, the Contractor’s liability under this Condition shall
not extend to the share in the responsibility attributable to the neglect or default of
that person.
8.04 A. The Employer shall notify the Contractor of any claim or proceeding made
or brought in respect of any personal injury or loss or property to which this
Condition applies.
B. If the Contractor admits that he is liable wholly to indemnify the Employer
in respect of any such claim or proceeding, and the claim or proceeding is
not an excepted claim, he, or, if he so desires and it is agreed with the
Employer his insurers, shall be responsible (subject to the condition imposed
by the following sub-paragraph) for dealing with or settling that claim or
proceeding.
C. If in connection with any such claim or proceeding with which the
Contractor or his insurers are dealing, any matter or issue shall arise which
involves or may involve any privilege or special right of the Employer
(including any privilege or right in relation to the discovery or production of
documents) the Contractor or his insurers shall before taking any action
thereon, consult the legal adviser or the Employer and act in relation thereto
as may be required by the Employer, and if either the Contractor or his
insurers fail to comply with this sub-paragraph, sub-paragraph B. above shall
cease to apply.

D. For the purpose of this paragraph ‘an excepted claim’ means a claim or
proceeding in respect of a matter failing to be dealt with under a
Government provision, or a claim or proceeding made or brought by or
against a servant of the Employer.
8. INJURY TO PERSONS: LOSS OF PROPERTY (Continued)

8.05 Where any such claim or proceeding as is mentioned in paragraph B. or C. of this

Condition is settled otherwise than by the Contractor or his insurers, he shall not
be required to pay by way of indemnity any sum greater than that which would be
reasonably payable in settlement having regard to the circumstances of the case and
in particular to the damage which might be recoverable at law.

8.0 6 In this Condition;

A. The expression ‘loss of property’ includes damage to property, loss of

profits and loss of use;

B. The expression ‘personal injury’ includes sickness and death;

C. The expressions ‘servant of the Employer’ and ‘servants of the Employer’

include persons who are servants of the Employer at the time when a
personal injury or loss of property to which this Condition applies occurs,
notwithstanding that they cease to be such before any payment in respect of
the personal injury or loss of property is made, and, where they have ceased
to be such by reason of their deaths, include their personal representatives:
and

D. The expression ‘Government provision’ means any statue, warrant order,

scheme, regulations or conditions of service applicable to a servant of the
Employer making provision for continuance of pay or for payment of sick
pay, or any allowance to - or for the benefit of servants of the Employer,
or their families, or dependants during or in respect of sickness, injury or
disablement suffered by such servants.

9. INSURANCE AGAINST INJURY TO PERSONS AND LOSS OF PROPERTY

9.01 Without prejudice to his liability to indemnify the Employer under Condition 8 the
Contractor shall, throughout the Contract Period, maintain and shall cause any
Sub-Contractor to maintain such insurances as are necessary to cover the liability
of the Contractor or, as the case may be, of such Sub-Contractor, in respect of the
matters specified in Condition 8. The insurance in respect of claims for personal
injury, sickness or death of any person under a Contract of service or
apprenticeship with the Contractor or the Sub-Contractor, as the case may be, and
arising out of had in the course of such person’s employment, shall comply with
the Employer’s Liability (Compulsory Insurance) Act 1969 and any statutory
orders made thereunder or any amendment or re-enactment thereof For all. other
claims to which this Condition applies the insurance cover shall be &5,000,000 (or
such greater sum as the Contractor may choose) for any one occurrence or series
of occurrences arising out of one event.
9. INSURANCE AGAINST INJURY TO PERSONS AND LOSS OF
PROPERTY (Continued)
9.02 The Contractor shall, at the request of the Employer, produce and shall cause any
Sub-Contractor to produce, for inspection by the Employer, documentary evidence
that the insurances required by Condition 9.01 are properly maintained.
9.03 Should the Contractor or any Sub-Contractor make default in maintaining
insurances as provided in Condition 9.01 the Employer may itself insure against
any risk in respect of which the default has occurred and may charge the cost of
such insurance to the Contractor.
10. DATA PROTECTION ACT
10.01 Indemnity to Employer
If during the subsistence of this Contract the Contractor or any sub-contractor, or
any employee servant or agent of them, is furnished by the Employer with, or
otherwise obtains (with or without the knowledge or consent of the Employer),
access to confidential or personal or commercial data owned or held by the
Employer upon any medium either in relation to the Employer’s own affairs or
those of others, and at any time either directly or indirectly discloses or copies or
makes improper use of any such data to a third party or allows a third party
unauthorised access to them or if the Contractor or any sub-contractor, or any
employee, servant or agent of them, is responsible for or causes the loss, damage
or destruction of all or any such data, the Contractor shall be liable in damages for
any loss or damage suffered by the Employer and shall indemnify the Employer
against all or any claims, proceedings, costs or expenses to which the Employer
may be or become liable at the suit of any third party in respect thereof.
11. ADMISSION TO THE SITE(S)
11.0l The Employer may give to the Contractor notice that such persons as it may
identify whether by name, description or employment or otherwise are not to be
admitted to the Site(s).
11.02 The Contractor shall take all reasonable steps to ensure that such persons are not
admitted to Site(s).

11.03 Subject to the provisions of sub-paragraphs 11.0l and 11.02 above and if and
when directed by the Contractor shall furnish a list of names and addresses of all
persons who are or may be at any time concerned with the Work or any part
thereof, specifying the capacities in which they are so concerned, and giving such
other particulars as the Contract Administrator may reasonably require.
11.04 The decision of the Employer as to whether any person is to be admitted to the
Site(s), and as to whether the Contractor has furnished the information or taken the
steps required of him by this Condition shall be final and conclusive.
12. ARBITRATION

12.0 1 All disputes, differences or questions between the parties to the Contract with
respect to any matter or thing arising out of or relating to the Contract, other than
a matter or thing as to which the decision or report to the Employer or of any
other person is by the Contract expressed to be final and conclusive shall after
written notice by either party to the Contract to the other of them be referred to a
single Arbitrator agreed for the purpose, or in default of such agreement to be
appointed at the request of the Employer by the President of such one of the
following the Employer may decide:

A. The Law Society

B. The Institution of Civil Engineers

C. The Institution of Mechanical Engineers

D. The Institution of Electrical Engineers

E. The Royal Institution of Chartered Surveyors

* (Delete as applicable)

Unless the parties otherwise agree, such reference shall not take place until
after the termination of determination of the Contract, or abandonment of
the Works.

12.0 2 Such reference shall in the case of the Contract being subject to English Law be
deemed to be a submission to arbitration under the Arbitration Acts 1950 and
1979, or any statutory modification or re-enactment thereof.

13. VALUE ADDED TAX

13.0 1 The Contractor shall determine whether Value Added Tax is chargeable on any or
all of the goods, and services to be supplied under this Contract, and shall add the
properly calculated amount of Value Added Tax to the tax invoice or other
document submitted for the supplies made, in accordance with the conditions
published by HM Customs and Excise.

14. LOCAL HEALTH BUILDING REQUIREMENTS

14.0 1 The Contractor and his employees shall comply with all relevant local
requirements for working conditions in each Health Building within the Contract
Area.
15. RACIAL DISCRIMINATION

15.01 The Contractor shall not unlawfully discriminate within the meaning and scope of
the provisions of the Race Relations Act 1976 or any statuary modification or re-
enactment thereof relating to discrimination in employment.

15.02. The Contractor shall take all reasonable steps to ensure the observance of the
preceding paragraph by all servants, employees or agents of the Contractor and all
sub-contractors.

16. MENTAL HEALTH ACT

16.01 The Contractor shall take all reasonable steps to ensure the observance of the Mental
Health Act 1959 as repealed by the Mental Health Act 1983 or any statutory
modification or re-enactment thereof by all servants, employees or agents of the
Contractor and all Sub-Contractors, e.g. 16.02 to 16.05.

16.02 Patients within these Hospitals, however they may appear and behave may be
receiving treatment for mental disorder under the terms of the Mental Health Act
1983. The following regulations therefore apply to everyone working on the
Hospital premises - whether engaged on the staff of the Health Employer, or by
contractors working within the Hospital.

16.03 Ill treatment of patients (Section 127, Mental Health Act 1983).
“It shall be an offence for any person who is an officer on the staff of, or otherwise
employed in, or who is one of the Managers or, a hospital or mental nursing home
to ill-treat or wilfully to neglect a patient for the time being receiving treatment for
mental disorder as an in-patient in that hospital or home; or to ill-treat or wilfully to
neglect, on the premises of which the hospital or home forms part, a patient for the
time being receiving such treatment there as an out-patient.”

Any person guilty of an offence under this Section shall be liable:-

(a) “On summary conviction, to imprisonment for a term not exceeding six
months or to a fine not exceeding the statutory maximum, or to both”.

(b) “On conviction on indictment to imprisonment for a term not exceeding two
years. or to a fine of any amount or to both”.
16. MENTAL HEALTH ACT (Continued)

16.04 Sexual Offences - Section 128, Mental Health Act 1959 (not repealed by Mental
Health Act 1983). Also Section 128(5) Sexual Offences Act 1956

“Without prejudice to Section seven of the Sexual Offences Act 1956, it shall be an
offence for a man who is an officer on the staff of or is otherwise employed in, or
as one of the Managers of, a hospital or mental nursing home to have unlawful
sexual intercourse with a woman who is for the time being receiving treatment for
mental disorder in that hospital or home, or to have such intercourse on the
premises of which the hospital or home forms part with a woman who is for the
time being receiving such treatment there as an out-patient”.

Any person found guilty of an offence under this Section shall be liable on
conviction on indictment to imprisonment for a term not exceeding two years.

16.05 Financial Transactions.

No member of staff, or staff of Contractors working on the premises, is permitted

to enter into any financial transactions or arrangements with any patient.
PARTICULAR SPECIFICATION FOR THE ANNUAL

TESTING OF STERILIZERS
PARTICULAR SPECIFICATION

1. REGULATIONS

All work shall be carried out in accordance with.

1.01 All relevant Acts or Parliament, statutory instruments and regulations.

1.02 Any public health, security and conduct requirements as from time to time be
issued to the Contractor by the Employer.

1.03 Any relevant Safety Regulations published by the Employer copies of which are
available from the Contract Administrator.

2. COMPLIANCE WITH BRITISH STANDARDS

2.01 All work and material shall company with relevant European and British Standards
and Codes of Practice.

3. OBLIGATIONS OF THE EMPLOYER

The Employer shall be responsible for:

3.01 The keeping of each item of Mechanical and Electrical Plant in such a condition
that its functions in accordance with the requirements of HTM 2010, BS3970,
BS2646 and BS3421.

3.02 Arranging for statutory inspections to be carried out (under a separate contract).

3.03 Maintenance of a record for each item of Mechanical and Electrical Plant in
accordance with the requirements of HTM 2010.

This shall contain details of all maintenance and remedial works carried out on
each item of equipment to the following standards:

A. Failures Date
Symptoms of failure

B. Visits by other Date

Contractors Details of Work carried out
including details of tests and
replacements.
Date and time of completion

C. Statutory Inspections Date

Details of any remedial work required.
Signature of competent person carrying out
inspection.
4. ACCESS TO SITE

4.01 The expression ‘normal working hours’ in this Contract means the hours between
0800 and 1700 Monday to Friday (except Bank and Public Holidays). All other
times are referred to as ‘outside normal working hours’.

4.02 So far as practicable the Contractor shall arrange for routine visits to be made
during normal working hours, if it is necessary for a routine visit to be made
outside these hours the prior agreement of the Contract Administrator must be
obtained. No extra payment will be made for routine visits carried out outside
normal working hours unless these have been specifically requested by the
Contract Administrator.

4.03 Access to the site is to be only by those routes indicated by the Contract
Administrator and vehicles may only be parked in those areas designated by the
Contract Administrator.

4.04 During normal working hours the Contractor’s staff must report to the Local
Liaison Officer or his deputy which Plant they will be working on. On completion
of their task the Contractor’s staff must on each occasion enter the necessary details
in the Plant History Record and inform the Representative that they have completed
their task.

4.05 Outside normal working hours the Contractor’s staff must report to the main
reception desk when they must inform the duty personnel of the reason for their
visit. On completion of their task the Contractor’s staff must on each occasion
enter the necessary details in the he Plant History Record and inform main reception
desk before leaving the site.

5. HEALTH AND SAFETY

5.01 It is essential that equipment is rendered and kept safe whilst it is being worked on.
Also that protective clothing and other safeguards are worn and used when
necessary.

5.02 Working areas associated with sumps, pits, wells, manholes etc must be guarded
and warning notices displayed. The Contractor must ensure that any of his staff
required to enter a confined space are made aware of the guidance contained in the
Health and Safety Executive Note GS5 ‘Entry into confined spaces’ and must
follow (so far as reasonably practicable) the recommendations contained therein.
steps, ladders, equipment plan or things employed in the execution of this contract
shall be adequate for their purpose and be free from defects.

5.03 The requirements of the Health and Safety at Work etc 1974 must be observed at
all times.
6. FIRE PRECAUTIONS

6.01 The Contractor must ensure that he, his employees and sub-contractors comply
with the provisions of Section 1 of the Standard Fire Precautions P5 (1980
Edition) published by Her Majesty’s Stationery Office.

6.02 All combustible refuse, eg shavings, packing materials, etc must always be
collected and removed from the site as soon as practicable.

6.03 If at any time the Contractor, his employees or Sub-Contractors notice anything that
they consider could be a potential fire risk they must report this to the
Contract Administrator.

7. SECURITY AND PUBLIC HEALTH PRECAUTIONS

7.01 Certain areas are subject to special security precautions. These areas are listed in
the Abstract of Particulars.

7.02 Certain areas are subject to special public health precautions. These are listed in
the Abstract of Particulars.

8. FACILITIES ON SITE

8.01 The Employer will supply electricity, for use by the Contractor from 240 volt
13 amp socket outlets placed within reasonable reach of each item of plan at no cost
to the Contractor.

8.02 The Contractor’s staff may use the toilet, washroom and canteen facilities provided
for staff use at the site.

8.03 Any other facilities for the works must be provided by the Contractor.

9.00 WORKMANSHIP AND MATERIALS

9.01 The Contractor shall be responsible for providing all tools, equipment and
instruments necessary for the complete execution of the work. This is to include
provision of 3 sets of Huckaback Towels to the requirements of HTM 2010,
Part 3, Chapter 13, Paragraph 13.39 -13.56.

9.02 The Contractor is required to provide labour of the requisite standard of

workmanship at all times in connection with this Contract. The work shall be
executed in a workman like manner and to the satisfaction in all respects of the
Contract Administrator. If any workmanship does not so accord the same shall at
the cost of the Contractor be rectified or replaced as instructed by the Contract
Administrator. The Contractor shall, if required by the Contract Administrator,
provide evidence of a workman’s competence.
10. REQUISITIONING OF WORKS

10.01 The Persons from whom the Contractor will be required to accept requisitions at
attend any urgent or necessary recommissioning are listed in the Abstract of
Particulars.

10.02 All requisitions for emergency action will be made by telephone to the
Contractor’s office or central control point and will be confirmed in writing within
7 days by the Contract Administrator.

11. DOCUMENTATION

11.01 The Contractor must ensure that on each occasion his staff enter the details of any
work carried out on the plant in the Plant History Record before leaving the site.

11.02 The Contractor, within 14 days of the completion of the tests, shall supply the
Contract Administrator with a Test Report carried out under this contract as
detailed in Appendix D, together with 3 copies.

12 DESCRIPTION OF THE WORK

12.0l The Contractor shall undertake annual tests as described in Appendix B - Testing
Philosophy & Procedures and Appendix C - Annual Performance Tests on those
Sterilizers listed in Appendix A - Sterilizer Inventory.

12.02 The Contractor shall employ persons, experience, qualified and preferably
certificated to a minimum City and Guilds standard, who would be competent to
perform all the required tests, documentary evidence of this shall be provided. The
Employer may require the said persons to demonstrate his/her competence by
performing a test laid down by the Contract Administrator, to be witnessed by
Contract Administrator or his/her nominated representative, prior to the letting of
the Contract or during the period of the Contract. (City and Guilds courses in
Sterilizer Testing Technology are available at the N.H.S.T.A. at Eastwood Park,
Falfield, Glos).

12.03 The Contractor shall demonstrate that he has all the necessary equipment which is
detailed in Chapter 6, Paragraph 6.1 - 6.63 of the current edition of Health
Technical Memorandum 2010 (HTM) and the means of calibrating them.

Current certification of accuracy traceable to the National Physical Laboratory will

be required.
12. DESCRIPTION OF WORK (Continued)

12.04 The Contractor shall prepare a schedule of the order and time in which he would
perform the tests on the Sterilizers listed in Appendix A, to be agreed by the
Contract Administrator prior to the awarding of the Contract.

12.05 The Contractor will confirm his intention to perform the scheduled test with the
Contract Administrator or his/her nominated representative 14 days in advance.

12.06 The Contract Administrator or his nominated representative will arrange for the
Local Maintenance Engineer to be available to rectify any faults which the
Contractor identifies during the test.

12.07 The Contractor shall on completion of an annual test, make a signed and dated entry
in the Plant History Record that the Sterilizer complies or does not comply, with the
performance requirements. In the event of non-compliance the Contractor shall
notify the Contract Administrator or his local nominated representative within 24
hours.
12.08 The Contractor shall issue to the Contractor Administrator, or his/her nominated
representative, within 21 days of any test being carried out, the results of the tests in
a test report as demonstrated in Appendix D together with 3 copies.

12.09 The Contractor shall inspect the Plant History Records of each Sterilizer to ensure
that the service maintenance records, and where appropriate, the microbiological
records are kept for all routine tests and ascertain they have been performed on each
Sterilizer throughout the previous year. Comments shall be included in the Test
report.

12.10 The Contractor shall nominate on the “Invitation to Tender Form” Sheet 2 a person
who will act for the Contractor to liaise with the Contract Administrator on all
matters relating to the Contract.
12.11 The Contractor will take up any problems of the Contract with the Contract
Administrator or his/her nominated representative.
12.12 The Contract Administrator or his/her nominated representative may visit any site at
any time to inspect the Contractor’s test procedures and results.

12.13 The Contractor when requested, on the appropriate form (See Appendix E) will be
required to retest any sterilizer that has not satisfactorily passed the annual test
criteria.

Repeat tests will be paid for at not more than the cost of the test of the said
Sterilizer as listed in Appendix A.

12.14 The Contractor shall carry out the retesting of Sterilizers where applicable within 2
working days of receiving the request.
STERILIZER INVENTORY AND UNIT COSTS
TESTING PHILOSOPHY AND PROCEDURES
TESTING PHILOSOPHY & PROCEDURES

The Testing of Sterilizers required under the contract are those called for in the Health
Technical Memorandum No. 2010, Part 3 (HTM 2010).

The relevant clauses required for the execution of this contract in fulfilling the procedures
for annual testing are presented in full in Appendix C.

Calibration of Instruments

It is the Contractors responsibility to ensure that all instruments used in executing the work
are suitably calibrated and hold current certificate of calibration clearly traceable to
National Physical Laboratory, British Accreditation Service and that the test system
calibration is checked immediately before and immediately after each annual test and ‘is
recorded and included in each Test Report. Copies of current certificates are to be
forwarded to the Contract Administrator.

Test Equipment

The relevant clauses required for compliance of equipment used for sterilizer testing are
those called for in the Health Technical Memorandum No. 2010 Part 3 (HTM 2010)
Chapter 6, Pages 35-44.
ANNUAL PERFORMANCE TESTS
YEARLY AND REVALIDATION TESTS

The tests are listed in the Health Technical Memorandum 2010, Part 3, Chapters 7 - 19.

The results of tests done should be recorded in the Plant History Record for each sterilizer
in the form of a report as described in Appendix D.

This contract requires only the yearly tests to be carried out on those Sterilizers which are
listed in HTM 2010, Part 3, Chapters 4 - 5 (Check the relevant detail in Schedule of
periodic tests to establish those tests only required for yearly testing in the tables).

The Contractor shall include in his report to the Contract Administrator if he becomes
aware that the daily, weekly or quarterly tests have not been satisfactorily carried out.

Schedule of Periodic Tests. Reference HTM2010 Part 3.

REFERENCE
HTM 2010 PART 3 SCHEDULE OF TEST

C H A P T E R
4 5
STERILIZER PROCESS TYPE VALIDATION PERIOD TEST
TABLE TABLE
Porous Load 2a 4a

Fluids 2b 4b

Unwrapped Instrument and Utensil 2c 4c

Dry Heat 2d 4d
Low Temperature Steam and 2e 4e
Low Temperature Steam and Formaldehyde 2e 4e
Ethlylene Oxide 2f 4f
Laboratory 3a 5a
Laboratory Culture Media Preparators 3b 5b
REPORTS
REPORTS

Each annual test carried out must be fully reported in the format shown.
Each report will consist of:

1. Title page with details of NHS Trust or Hospital, Department,

Manufacturer, Sterilizer type, References and date of test and person(s)
carrying out the test.

2. Sequence Test Sheet listing each test carried out, a brief statement on test
result and any adjustments or actions taken.

3. Test Report Sheet giving detailed analysis of the test carried out with a
conclusion and recommendations.

4. Test Sheets showing details of test carried out (See specimen test sheets).

NOTE: Test sheets may be replaced by suitable computer printouts providing they
are authorised by Contract Administrator.

5. Associated test recorder thermocouple charts, including calibration checks,

sterilizer recorder charts, and/or print-outs, Bowie/Dick sheet where
applicable. All annotated and suitably identified.

6. Each reports must be suitably bound and forwarded to the Contract

Administration together with 2 copies.
 1. TITLE PAGE

STERILIZER ANNUAL TEST REPORT

NHS TRUST/EMPLOYER ...............................................................

HOSPITAL .......................................................

DEPARTMENT ...........................................................

MANUFACTURER .......................................................

MACHINE TYPE .......................................................

REFERENCE .......................................................

FILE REF .......................................................

TEST DUE NO LATER THAN .................................19..

DATE OF TEST .......................................................

TEST CARRIED OUT ....................................................

....................................................
SIGNATURE
 2. TEST SEQUENCE SHEET

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .NHS TRUST/EMPLOYER

Hospital: Department: Date Tested:

Manufacturer: Ref No: Our Ref or

File No:

SEQUENCE OF TEST

NO. TEST UNDERTAKEN PASS/FAIL COMMENTS

BRIEF STATEMENT

...............................
...............................
1. ......................... ................................ ...............................

.................................
...............................
2. ......................... ................................ ...............................

...............................
...............................
3. ............................ .................................... ...............................

...............................
.................................
4. ............................ ...................................... ...............................

...............................
...............................
5. ............................... ...................................... .................................

ETC.
 3. TEST REPORT SHEET

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .NHS TRUST/EMPLOYER

Hospital: Department: Date Tested:

Manufacturer: Ref No: Our Ref or

File No:

1. DETAIL REPORT

Detailed report of findings as to conforming to standards, faults found,

action taken, and recommendations.

2. RECORDS

HTM 2010 APPENDIX 3. Thermometric Charts/Data Logged/Summary

Sheets for process type
Statement on findings of Plant History Record regarding Maintenance and
Periodic Testing status.

3. CONCLUSIONS

Brief statement from above detailed report.

4. TESTER’S NAME

.......................................................................

5. TESTER’S SIGNATURE

. . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6. DATE

..........................................................
 4. SPECIMEN TEST SHEETS REFERENCES

UNWRAPPED INSTRUMENT & UTENSIL STERILIZER REF 46/130V

POROUS LOAD STERILIZER REF 46/129V

FLUIDS STERILIZER REF 46/132V

DRY HEAT STERILIZER

LABORATORY REF 46/133

LOW TEMPERATURE STEAM WITH AND WITHOUT FORMALDEHYDE

(The above test sheets are D.O.H. approved and are available from
Printing Services,
NHS Supplies Authority,
South & West Division,
St. Modwen Road,
Parkway Industrial Estate,
PLYMOUTH PL6 8LH.)

LABORATORY - MEDIA
RETEST REQUEST FORM
 STERILIZER PERIODIC TESTING

REQUEST FOR RETEST

CONTRACT NO.. . . . . . . . . . . . . . . . . . . . . . .

Request for Retest Form No. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

FROM: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NHS
.. TRUST HEALTH EMPLOYER

TO: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CONTRACTS
...

Request for retesting following rectification of faults:

TRUST/EMPLOYER ...........................................................................

HOSPITAL ...........................................................................

CLINIC ............................................................................

STERILIZER ............................................................................

PLANT NO. ............................................................................

DEPARTMENT ..........................................................................

ROOM NUMBER ............................................................................

Signature of Contracts Manager or Liaison Persomrel: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Date of request: ............................................

Note: The retesting following any remedial works shall be carried out within three working days
of receiving notice, unless requested later.
Section E

Procedures for determining the sound power

generated by a sterilizer

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Contents

E.1 Introduction page 175

E.4 Apparatus page 175

E.6 Test procedur

e page 177

E.13 Test result page 177

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E.0 Procedures for determining the
sound power generated by a
sterilizer
Introduction

E.1 This test, to be carried out by the manufacturer of a sterilizer, is based on

the test in Appendix D of BS 3970: Part 1: 1990 and in Section 23 of EN 285.

E.2 Except where otherwise stated here, the sound power levels of sterilizers
are determined by the method described in BS 4196: Part 6: 1981 (equivalent
to ISO 3746: 1979) The information given here is by itself not sufficient to
permit the test to be carried out by personnel unfamiliar with the requirements
of BS 4196.

E.3 Measurements made by this method have a standard deviation of up to 5

dB for discrete tone sources and up to 4 dB for wide-band noise sources. The
uncertainties can be minimised by careful consideration of the conditions in
which the test is carried out.

a. The environmental correction factor, K, depends on the relative sizes of

the sterilizer and the test room and the sound absorbing qualities of the
room. For a given sterilizer, the larger the room the smaller the value of
K. Although EN 285 specifies that K should be less than 7 dB, this is a
relatively high value and the manufacturer should aim to achieve K = 2
dB or less. This figure can normally be achieved by carrying out the test in
a sufficiently large room. The assembly hall in which the sterilizer is
constructed should be suitable;
b. Another source of error is the ambient background noise. Table 4 of
BS 4196: Part 6 gives correction factors for different levels of background
noise, but the lower the correction factor the more reliable the result will
be. The correction is essentially zero if the background noise level is 10 dB
or more below the level measured when the sterilizer is operating. It
should be possible to achieve this on the manufacturer’s premises if the
test is carried out when the factory is closed and all other plant is shut
down. Steam and compressed air plant not part of the sterilizer should be
run on storage during the test, with boiler feed pumps and compressors
switched off.

Apparatus
E.4 Sound-level meter, complying with type 1 of EN 60651: 1994, or an
integrating-averaging sound level meter complying with type 1 of EN 60804:
1994. The sound power level is determined from at least six microphone
positions (Figure E1). If the sound meter has insufficient input channels,
additional instruments and/or repeated operating cycles are required.

E.5 Test room, configured so that the distance between any wall or other
object in the room is not less than 3 m from any reference surface (see
paragraph E.6) on the sterilizer to be tested. The room in which the sterilizer is
assembled may be suitable providing the conditions discussed in paragraph E3
are met.

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Procedures for determining the sound power generated by a sterilizer
Test procedure

E.6 The test determines the A-weighted sound power using a rectangular
measurement surface. The “reference surface” defined in BS 4196: Part 6 is the
smallest rectangular box that just encloses the sterilizer, with a width and depth
measured from the outside of the vessel lagging and a height measured from
the floor to the top of the vessel lagging. The box does not include pipes and
valves used to connect the sterilizer to its services.

E.7 Determine the sound absorption area, A, of the test room using the
experimental method described in A.3.1.2 of BS 4196: Part 6. The method of
estimation described in A.3.1.1 may be used as a check.

E.8 Determine the environmental correction factor, K, as described in A.3.1 of

BS 4196: Part 6. Although EN 285 allows K to be as high as 7 dB, a figure of
around 2 dB should be achievable as described in paragraph E.3a.

E.9 Sterilizers should be regarded as “large sound sources” as defined in

7.4.3.2 of BS 4196: Part 6. The measurement distance, d, should be 1.0 ± 0.1
m. Microphones should be placed on the measurement surface as described in
7.4 of BS 4197: Part 6. At least six microphones will be required.

E.10 The test is to be carried out with all integral equipment (for example,
water pumps, vacuum pumps, compressors) operating normally.

E.11 Load the sterilizer with a full load as described in Part 3 of this HTM. If
there is a choice of operation cycle, select the cycle with the highest
sterilization temperature. Ensure that the pressure and flow from the steam and
water services are set to levels which cause the maximum noise and are within
the ranges specified for normal operation. Start the operating cycle.

E.12 Using the procedure for measuring the rectangular measurement surface
described in BS 4196: Part 6, determine the A-weighted sound power level and
the peak sound power level of the sterilizer either for one complete operating
cycle or for a 30-min period that contains the most prominent sounds.

Test result

E.13 Record the calculated mean and peak A-weighted sound power levels in
decibels to the nearest integer. Other information should be recorded in
accordance with BS 4196: Part 6.

E.14 The test should be considered satisfactory if the peak A-weight sound
power level at no time exceeds the mean A-weighted sound power level by
more than 15 dB.
Section F

Accommodation for ethylene oxide gas cylinders,

manifolds and canisters

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is blank
Contents

F.1 General page 183

F.3 Ethylene oxide cylinders page 183

F.5 General principles

F.11 Ethylene oxide cartridges page 184

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is blank
F.0 Accommodation for ethylene
oxide gas cylinders, manifolds
and canisters
General

F.1 For use in large sterilizers operating at above atmospheric pressure,

ethylene oxide is mixed with carbon dioxide or chlorofluorocarbon. Given
recent concerns about environmental issues however, the use of the latter is
deprecated and is no longer in widespread use. The cylinders therefore are less
hazardous than those of pure ethylene oxide.

F.2 Single-shot cartridges of pure ethylene oxide for use in in sub-atmospheric

pressure machines require care but in view of the modest volumes involved do
not pose a major safety problem.

Ethylene oxide cylinders

F.3 Cylinders are categorised in accordance with Table F1 and, although

ethylene oxide is supplied in mixture with inert gas, they should be stored
under the toxic and/or corrosive and flammable category.

F.4 Cylinders may be stored with other industrial and medical gas cylinders in
accommodation designed in accordance with HTM 2022.

General principles

F.5 Accommodation should be well ventilated and labelled clearly to describe

the gases contained. The labelling should include details of emergency action
procedures and the location of keys should be identified. Cylinder storage
should be designated as a“no smoking” area and appropriate labels should be
posted.

F.6 Clear and secure access is required to permit safe cylinder

loading/unloading and handling with vehicular access.

F.7 The maximum temperature in the cylinder store should be that

recommended by the gas supplier/manufacturer. Normally this should not
exceed 38°C.

F.8 Accommodation should be free from naked flames and sources of ignition
and appropriate fire extinguishing equipment should be available. Lighting
protection may be necessary for isolated buildings and British Standards CP362
should be consulted.

F.9 For electrical equipment in the vicinity of the gas cylinders the
recommendations of BS5345: 1976, Zone 2 classification will usually be
appropriate for the open-air type of installation.

F.10 Safety equipment in the form of protection goggles, gloves and a

respirator should be available inside this space and also at the point of entry.

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is blank
Ethylene oxide cartridges

F.11 Sufficient secure storage within the loading area in the form of a locked
cabinet is satisfactory for cartridges for use in a single day.

F.12 Additional cartridges will be required for an operational unit and external
storage, for example one week’s supply, should be held externally. Small
special-purpose cabins typically used for the storage of LPG containers fully
protected from the elements will be appropriate.

Table F1 Clarification of gas cylinders typically found on hospital sites

Group classification of Medical gases Non-medical gases
gas cylinder contents

1 Flammable Cyclopropane - this is Acetylene

no longer manufactured LPG (e.g. propane, butane)
STG (synthetic town gas)
Methane, natural gas,
hydrogen

2 Oxidising and/or Medical compressed air Compressed air oxygen

supports combustion oxygen Nitrous oxide
Nitrous oxide Oxygen/nitrous oxide
Oxygen/nitrous dioxide mixtures
Oxygen/carbon dioxide
Oxygen/helium mixtures

3 Toxic and corrosive

3.1 Toxic and/or Ammonia
corrosive and flammable Ethylene oxide (C2H 4O)
Carbon monoxide
C 2H 4 O/CO 2 mixtures
> 6% C2H 4O

3.2 Toxic and/or Nitric oxide mixtures

corrosive and Sulphur dioxide
oxidising Chlorine

3.3 Toxic and/or Ethylene oxide/halo-carbon

corrosive only mixtures < 15% C 2H 4O.
Certain conditions only -
ethylene oxide/carbon
dioxide mixtures
< 6% C2 H4 O

4 Others including Carbon dioxide Carbon dioxide

inert, but excluding Helium Nitrogen
toxic or corrosive Argon
Helium
Halo-carbon
Refrigerants

NHS Estates Library and Information Service

1 Trevelyan Square
Boar Lane
LEEDS LS1 6AE
Tel: 0113 254 7092/1
References and bibliography

NHS Estates publications

Health Building Note 13. Sterile services department. NHS Estates, HMSO 1992.

Health Building Note 29. Accommodation for pharmaceutical services. Department of Health, HMSO 1988.

HTM 2010. Sterilization. NHS Estates, HMSO 1994, 1995.

British and European Standards

BS6001 Sampling procedures and tables for inspection by attributes.

Part 1: 1991 Specification for sampling plans indexed by acceptable quality level (AQL) for lot-by-lot
inspection. AMD 8026, 2/94; AMD 8223, 7/94.

BS6068 Water quality.

Part 6: Sampling.

Section 6.3: 1986(1990) Guidance on the preservation and handling of samples.

Section 6.5: 1991 Guidance on sampling of drinking water and water used for food and beverage
processing.

Section 6.7: 1994 Guidance on sampling of water and steam in boiler plants.

BS EN 25667 Water quality. Sampling.

25667-1: 1994 Guidance on the design of sampling programmes. AMD 7435, 2/94.

25667-2: 1993 Guidance on sampling techniques. AMD 7436, 8/93.

EN 285 (draft) Sterilization. Steam sterilizers - large sterilizers.

EN 550: 1994 Sterilization of medical devices. Method for validation and routine control of sterilization by
ethylene oxide.

EN 552: 1994 Sterilization of medical devices. Method for validation and routine control of sterilization by
irradiation.

EN 554: 1994 Sterilization of medical devices. Method for validation and routine control of sterilization by
moist heat.

EN 556: 1995 Sterilization of medical devices. Requirements for a device to be labelled sterile.

EN 724 (92/58310/DC) Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002
for non-active medical devices.

EN 868 Packaging materials and systems for medical devices which are to be sterilized.

EN 868-1 (92/58621/DC) General requirements. Requirements and test methods. Guidance on the use of this
standard.

EN 868-2 (92/58622/DC) Sterilization wrap - Requirements and tests.

EN 868-3 (92/58623/DC) Paper for use in the manufacture of paper bags (specified in Part 4 of this Standard) and
in the manufacture of pouches and reels (specified in Part 5 of this Standard) -
Requirements and tests.
 EN 868-4 (92/58624/DC) Paper bags - Requirements and tests.

EN 868-5 (92/58625/DC) Heat sealable pouches and reel material manufactured from paper and plastic -
Requirements and tests.
EN 868-6 (92/58626/DC) Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or
irradiation - Requirements and tests.

EN 868-7 (92/58627/DC) Adhesive coated paper for the manufacture of packs for medical use for sterilization by
ethylene oxide or irradiation - Requirements and tests.

EN 868-8 (92/58628/DC) Re-usable containers - Requirements and tests.

EN 867 Non-biological systems for use in sterilizers.

EN 867-2 (92/57872/DC) Process indicators (Class A).

EN 980 (93/58310/DC) Terminology, symbols and information provided with medical devices. Graphical
symbols for the labelling of medical devices.

EN 10411 Terminology, symbols and information provided with medical devices. Information supplied by the
manufacturer with medical devices. (Not yet available as draft for comment).

EN 1174-1 (93/507344/DC) Sterilization of medical devices - estimation of the population of micro-organisms

on product.

Department of the Environment publications

Methods for the Examination of Waters and Associated Materials

Measurements of electrical conductivity and the laboratory determination of the pH value of natural, treated
and waste waters. Department of the Environment/National Water Council Standing Committee of Analysts, HMSO.
(out of print)

Atomic absorption spectrophotometry 1979 version. Department of the Environment/National Water Council
Standing Committee of Analysts, HMSO. (out of print)

The determination of anions and cations, transition metals, other complex ions and organic acids and bases in
water by chromatography 1990. Department of the Environment/National Water Council Standing Committee of
Analysts, HMSO 1990.

Colour and turbidity of waters, 1981. Department of the Environment/National Water Council Standing Committee of
Analysts, HMSO. (out of print)

Mercury in waters, effluents, soils and sediments etc, additional methods 1985. Department of the
Environment/National Water Council Standing Committee of Analysts, HMSO. (out of print)

Lead in potable waters by atomic absorption spectrophotometry 1976. Department of the Environment/National
Water Council Standing Committee of Analysts, HMSO. (out of print)

Cadmium in potable waters by atomic absorption spectrophotometry 1976. Department of the

Environment/National Water Council Standing Committee of Analysts, HMSO. (out of print)

Lead and cadmium in fresh waters by atomic absorption spectrophotometry (second edition) - a general
introduction to electrothermal atomization atomic absorption spectrophotometry 1986. Department of the
Environment/National Water Council Standing Committee of Analysts, HMSO. (out of print)

Phosphorus and silicon in waters, effluents and sludges 1992. Department of the Environment/National Water
Council Standing Committee of Analysts, HMSO 1993.
Iron in raw and potable waters by spectrophotometry (using 2,4,6-tripyridyl-1,3,5-triazine) 1977. Department of
the Environment/National Water Council Standing Committee of Analysts, HMSO. (out of print)

Iron and manganese in potable waters by atomic absorption spectrophotometry 1983. Department of the
Environment/National Water Council Standing Committee of Analysts, HMSO. (out of print)

Chloride in waters, sewage and effluents 1981. Department of the Environment/National Water Council Standing
Committee of Analysts, HMSO. (out of print)

General principles of sampling and accuracy of results 1980. Department of the Environment/National Water
Council Standing Committee of Analysts, HMSO. (out of print)

Total hardness, calcium hardness and magnesium hardness in raw and potable waters by edta titrimetry 1981.
Department of the Environment/National Water Council Standing Committee of Analysts, HMSO. (out of print)

The determination of alkalinity and acidity in water 1981. Department of the Environment/National Water Council
Standing Committee of Analysts, HMSO. (out of print)

The measurement of electrical conductivity and the laboratory determination of the pH value of natural,
treated and waste waters 1978. Department of the Environment/National Water Council Standing Committee of
Analysts, HMSO. (out of print)

The determination of pH in low ionic strength waters 1988. Department of the Environment/National Water
Council Standing Committee of Analysts, HMSO 1988.

Health and Safety Executive publications

Safety in health service laboratories: safe working and the prevention of infection in clinical laboratories.
Health and Safety Executive, HMSO 1991.

Steam boiler blowdown systems (Guidance Note PM 60). Health and Safety Executive, HMSO 1987.

Automatically controlled steam and hot water boilers (Guidance Note PM 5). Health and Safety Executive, HMSO
1989.

Miscellaneous references

The Rules governing medicinal products in the European Community. Volume IV : good manufacturing
practice for medicinal products. Commission of the European Communities, HMSO 1992.

Guidelines for the safe production of heat preserved foods. Department of Health, HMSO 1994.

International standards for drinking water. Third edition, World Health Organisation, HMSO 1971.

75/107/EEC Directive on the approximation of the laws of the member states relating to bottles used as measuring
containers. Official Journal of the European Communities, L42, 15/2/75.

80/778/EEC Council Directive relating to the quality of water intended for human consumption. OfficialJournal of the
European Communities, 1980.

Alder, VG and Alder, Fl. Preserving the sterility of surgical dressings wrapped in paper and other materials.
Journal of Clinical Pathology, vol 14, pp 76-79, 1961.

Biglow, WD. The logarithmic nature of thermal death time curves. Journal of infectious Diseases, vol 29, pp
528-536, 1921.

Chick, H. An investigation of the laws of disinfection. Journal of Hygiene, vol 8, pp 92-158, 1908.
Christie, JE. Muslin vs. paper autoclave wrappers - a hospital study. Hospital Topics, Pt 1, vol 35, pp 117-121; Pt 2,
vol 35, pp 111-116 (March-April) 1957.

Duncan, MH. Double wrapping - is it really necessary? Journal of the Association of Sterile Supply Administrators,
vol 1, no 2, pp 12-14, 1972.

Esty, JR and Meyer, KF. The heat resistance of the spores B. botulinus and allied anaerobes. Xl. Journal of
Infectious Diseases, vol 31, pp 650-663, 1922.

Favero, MS. The dual meaning of heat activation. Spore Newsletter, vol 2, no 12, pp 153-164.

Fallon, RJ. Wrapping of sterilized articles. Lancet, vol II, p 785, 1963.

Finley, N and Fields, ML. Heat activation and heat-induced dormacy of Bacillus stearothermophilus spores.
Applied Microbiology, vol 10, pp 231-236, 1962.

Hughes, KEA, Drewett, SE and Darmady, EM. The risk of contamination of sterile dressings packed in paper bags.
British Hospital Journal and Social Service Review, vol 77, pp 764-765,781, 1967.

Hunter, CLF, Harbord, PE and Riddett, DJ. Packaging papers as bacterial barriers. Symposium on Sterilization of
Surgical Materials, April 11-13, 1961.

Jevitt, D. Indefinite shelf life . . . Amen! Journal of Healthcare Material Management, vol 2, no 6, pp 36-37, 1984.

Knox, Penikett and Duncan. The avoidance of excessive superheating during steam sterilization of dressings.
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Lewith, S. Ueber die Ursache der Widerstandsfähigkeit der Sporen gegen hohe Temperaturen. Ein Beitrag zur
Theorie der Desinfektion. Archives Exploring Path Pharmacol, vol 26, pp 341-354, 1890.

Mayworm, D. Sterile shelf life and expiration dating. Journal of Hospital Supply Processing and Distribution, vol 2,
no 6, pp 32-35, 1984.

Moates, DW, Dabbah, R and Edwards, VM. Interpretation of non-logarithmic survivor curves of heated bacteria.
Journal of Food Science, vol 36, pp 523-526, 1971.

Pflug, IJ and Schmidt, CF. Thermal destruction of micro-organisms: in Disinfection, sterilization and preservation, Eds
CA Lawrence and SS Block, pp 63-105, Lea and Febiger, 1968.

Russell, AD. The destruction of bacterial spores: in Inhibition and destruction of the microbial cell, Ed. WB Hugo,
Academic Press, 1971.

Shull, JJ, Cargo GT and Ernst, RR. Kinetics of heat activation and of thermal death of bacterial spores. Applied
Microbiology, vol 11, pp 485-487, 1963.

Speers, R Jr and Shooter, RA. Use of double wrapped packs to reduce contamination of the sterile contents
during extraction. Lancet, vol II, pp 469-470, 1966.

Standard, PG, Mallison, GF and Mackel, DC. Microbial penetration through three types of double wrappers for
sterile packs. Applied Microbiology, vol 26, pp 59-62, 1973.

Sturdy, JH, Baird, RM and Gerein, AN. Surgical sponges: a cause of granuloma and adhesion formation. Annals of
Surgery, vol 165, pp 123-134, 1967.

Walter, CW. Letter on an article ‘An Evaluation of paper used for wrapping articles to be sterilized’ in vol 10,
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Other publications in this series

(Given below are details of all Health Technical Component Data Base (HTMs 54 to 70)
Memoranda available from HMSO. HTMs marked (*) are
54.1 User manual, 1993.
currently being revised, those marked (†) are out of print.
55 Windows, 1989.
Some HTMs in preparation at the time of publication of
56 Partitions, 1989.
this HTM are also listed.)
57 Internal glazing, 1995.
58 Internal doorsets, 1989.
59 Ironmongery.†
60 Ceilings, 1989.
61 Flooring.*
62 Demountable storage systems, 1989.
1 Anti-static precautions: rubber, plastics and 63 Fitted storage systems, 1989.
fabrics.† 64 Sanitary assemblies.*
2 Anti-static precautions: flooring in anaesthetising 65 Health signs.*
areas (and data processing rooms), 1977. 66 Cubicle curtain track, 1989.
3 - 67 Laboratory fitting-out system, 1993.
4 - 68 Ducts and panel assemblies, 1993.
5 Steam boiler plant instrumentation.† 69 Protection, 1993.
6 Protection of condensate systems: filming amines.† 70 Fixings, 1993.
2007 Electrical services: supply and distribution, 1993. 71 Materials management modular system.*
8 - 72 to 80 -
2009 Pneumatic air tube transport systems, 1995.
2011 Emergency electrical services, 1993.
- Firecode
12
13 - 81 Firecode: fire precautions in new hospitals.*
2014 Abatement of electrical interference, 1993 81 Supp 1 1993.
2015 Bedhead services, 1994, 1995. 82 Firecode: alarm and detection systems, 1989.
16 - 83 Fire safety in healthcare premises: general fire
17 Health building engineering installations: precautions, 1994.
commissioning and associated activities, 1978. 85 Firecode: fire precautions in existing hospitals,
18 Facsimile telegraphy: possible applications in 1994.
DGHs.† 86 Firecode: fire risk assessment in existing hospitals,
19 Facsimile telegraphy: the transmission of pathology 1994.
reports within a hospital - a case study.† 87 Firecode: textiles and furniture, 1993.
2020 Electrical safety code for low voltage systems, 88 Fire safety in health care premises: guide to fire
1993. precautions in NHS housing in the community for
2021 Electrical safety code for high voltage systems, mentally handicapped/ill people, 1986.
1993, 1994.
2022 Medical gas pipeline systems, 1994.
New HTMs in preparation
2023 Access and accommodation for engineering
services.* 2024 Lifts
2025 Ventilation in healthcare premises, 1994. 2030 Washers for sterile production
26 Commissioning of oil, gas and dual fired boilers:
with notes on design, operation and Health Technical Memoranda published by HMSO can be
maintenance.† purchased from HMSO bookshops in London (post orders
2027 Hot and cold water supply, storage and mains to PO Box 276, SW8 5DT), Edinburgh, Belfast,
services, 1995. Manchester, Birmingham and Bristol, or through good
28 to 39 - booksellers. HMSO provide a copy service for publications
2040 The control of legionellae in healthcare premises - which are out of print; and a standing order service.
a code of practice, 1993.
41 to 49 - Enquiries about Health Technical Memoranda (but not
2050 Risk assessment in the NHS estate, 1994. orders) should be addressed to: NHS Estates, Department
51 to 53 - of Health, Marketing Unit, 1 Trevelyan Square, Boar Lane,
2055 Telecommunications (telephone exchanges), 1994. Leeds LS1 6AE.
About NHS Estates

NHS Estates is an Executive Agency of the Department of Health Facilities Notes - debate current and topical
Health and is involved with all aspects of health estate issues of concern across all areas of healthcare
management, development and maintenance. The Agency provision. HMSO
has a dynamic fund of knowledge which it has acquired
during 30 years of working in the field. Using this Firecode - for policy, technical guidance and specialist
knowledge NHS Estates has developed products which are aspects of fire precautions. HMSO
unique in range and depth. These are described below.
NHS Estates also makes its experience available to the field Capital Investment Manual Database - software
through its consultancy services. support for managing the capital programme. Compatible
with the Capital Investment Manual. NHS Estates
Enquiries about NHS Estates should be addressed to:
NHS Estates, Marketing Unit, Department of Health, Model Engineering Specifications - comprehensive
1 Trevelyan Square, Boar Lane, Leeds LS1 6AE. advice used in briefing consultants, contractors and
Telephone 0113 254 7000. suppliers of healthcare engineering services to meet
Departmental policy and best practice guidance. NHS
Estates
Some other NHS Estates products
Quarterly Briefing - gives a regular overview on the
Activity DataBase - a computerised system for defining construction industry and an outlook on how this may
the activities which have to be accommodated in spaces affect building projects in the health sector, in particular
within health buildings. NHS Estates the impact on business prices. Also provides information
on new and revised cost allowances for health buildings
Design Guides - complementary to Health Building Published four times a year; available on subscription
Notes, Design Guides provide advice for planners and direct from NHS Estates. NHS Estates
designers about subjects not appropriate to the Health
Building Notes series. HMSO Works Guidance Index - an annual, fully cross-
referenced index listing all NHS Estates publications and
Estatecode - user manual for managing a health estate. other documents related to the construction and
Includes a recommended methodology for property equipping of health buildings. NHS Estates
appraisal and provides a basis for integration of the estate
into corporate business planning. HMSO Items noted “HMSO” can be purchased from HMSO
Bookshops in London (post orders to PO Box 276,
Concode - outlines proven methods of selecting contracts SW8 5DT), Edinburgh, Belfast, Manchester,
and commissioning consultants. Reflects official policy on Birmingham and Bristol or through good
contract procedures. HMSO booksellers.

Works Information Management System - a

computerised information system for estate management
tasks, enabling tangible assets to be put into the context NHS Estates consultancy service
of servicing requirements. NHS Estates
Designed to meet a range of needs from advice on the
Health Building Notes - advice for project teams oversight of estates management functions to a much
procuring new buildings and adapting or extending fuller collaboration for particularly innovative or exemplary
existing buildings. HMSO projects.

Health Guidance Notes - an occasional series of Enquiries should be addressed to: NHS Estates
publications which respond to changes in Department of Consultancy Service (address as above).
Health policy or reflect changing NHS operational
management. Each deals with a specific topic and is
complementary to a related HTM. HMSO

Printed in the United Kingdom for HMSO

Dd 300377 3/95 C15 5600 35335
Part 6 – Testing and validation protocols

131
Appendix 5 – Sample log book for porous load
sterilizers

Sterilizer log book

This log book contains sufficient log sheets for one year and has been
designed to comply with the guidance given in Health Technical Memorandum
2010 and the requirements specified in BS 3970, EN 285 and EN 554. This log
book should be used with porous load sterilizers and provided with a sterilizer
after successful completion of validation.

References noted on each log sheet refer to clauses in HTM 2010 Part 3.

The log book is part of the records for process control and monitoring and
should be kept by the User for a period at least equivalent to the lifetime of
the last product sterilized as defined by the supplier. This period must not be
less than two years from the date of despatch of the product from supplier.

A copy of each log sheet should be kept with the validation report and the
second copy may be kept by others.

The User must ensure that prescribed tests and maintenance are carried out by
suitably qualified persons and that all relevant log sheets are completed and
signed. Data from the relevant test carried out during validation must be
written into the spaces provided on each log sheet. Batch process records,
together with data obtained from any relevant thermometric test, must also be
attached to each log sheet.

The units for temperature, pressure and time are degrees centigrade (°C),
kPascals (kPa) (absolute), and minutes and seconds respectively. When
instruments are calibrated in different units, for example bar for pressure, the
type of unit should be stated on the log sheet.

The yearly record is valid as performance requalification for load items

randomly located in the chamber and presenting less of a challenge to the
process than the challenge from the load use in the small load and full load
tests. Load items falling into this category should be listed in the record for
performance qualification. All other loading conditions should be subjected to
performance qualification and performance requalification.

The provision of technical services and the management of sterilization should

be available from qualified persons. A list of designated officers and their
responsibilities are detailed in HTM 2010 Part 1. The User is ultimately
responsible for declaring a sterilizer as “fit for use”. Advice on the services
available from an authorised person is also given in Part 6.

132
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Contents

1. Information details page 134

1.1 Schedule of validation tests
1.2 Schedule of periodic tests

2 Validation tests page 138

2.1 Installation record sheet
2.2 Commissioning record
2.3 Performance qualification record

3 Periodic tests page 145

3.1 User daily record
3.2 Weekly record
3.3 Quarterly record
3.4 Yearly record
3.5 Performance requalification record

4 Sterilizer record page 155

4.1 Sterilizer modification and repair record

133
Appendix 5 – Sample log book for porous load sterilizers

Section 1 – Information details

134
 Appendix 5 – Sample log book for porous load sterilizers

POROUS LOAD STERILIZER LOG BOOK

INFORMATION SHEET

MANAGEMENT * ................................................................ Cost Code No. ......................

SERVICE PROVIDER ................................................................ Cost Code No. ........................

(eg HOSPITAL.)

LOCATION ............................................................................... Cost Code No. ......................

USER ............................................................................... Cost Code No. .......................

DEPARTMENT ................................................................. Cost Code No. ......................

INSURANCE COMPANY .......................................................... Telephone No.........................

SPECIALIST SERVICES

AUTHORISED PERSON......................................................... Telephone No......................

TEST PERSON........................................................................ Telephone No......................

MAINTENANCE PERSON..................................................... Telephone No......................

COMPETENT PERSON......................................................... Telephone No......................

MICROBIOLOGIST ............................................................................. Telephone No......................

STERILIZER DETAILS

PLANT REFERENCE .....................................................................

MANUFACTURER.......................................................................... Serial No...............................

DATE OF MANUFACTURE...........................................................

MODEL & PROCESS TYPE........................................................... Cubic Capacity.......................

WORKING PRESSURE............Chamber...............Bar Jacket.................Bar Hydrostatic Test Date................

COMMISSIONING DATE...............................VALIDATION FILE REFERENCE.................................................

PRESSURE SYSTEMS AND TRANSPORTABLE GAS CONTAINERS REGULATIONS (1989)

INSPECTION TEST DATE AND CERTIFICATE NUMBER ............................................................

1st SITE TEST............................................................ 4th SITE TEST.................................................

2nd SITE TEST........................................................... 5th SITE TEST.................................................

3rd SITE TEST........................................................... 6th SITE TEST.................................................

* KEY PERSONNEL ARE DEFINED IN HTM 2010 PART 1

135
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136
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137
Appendix 5 –sample log book for porous load sterilizers

Section 2 – Validation test records

138
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139
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140
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141
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142
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143
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144
 Appendix 5 –sample log book for porous load sterilizers

Section 3 – Periodic test records

145
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146
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147
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148
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149
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150
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151
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152
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153
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154
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Section 4 – Schedule of repairs and maintenance

155
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156
Appendix 6 – Procedures for the procurement,
validation, revalidation and operational management
of sterilization
CONTENTS Operational Procedures – Unwrapped Instruments and
Utensils page 188
Procurement and Validation page 159 Validation
Procurement Commissioning Tests
Loading Analysis Performance Qualification Tests
Sterilization Process Revalidation
Type of Sterilizer Performance Requalification Tests
Specification Analysis Maintenance & Periodic Testing
Procurement Weekly
Documentation Quarterly
Installation Checks and Tests Revalidation
Documentation Validation Report Yearly Tests and Recommissioning
Documentation Handover Maintenance Schedules P.P.M.
Operational Management Daily Housekeeping
Weekly Maintenance
Operational Procedures – Porous Load page 170 Quarterly
Validation Yearly
Commissioning Tests
Performance Qualification Tests Operational Procedures – Dry Heat page 197
Revalidation Validation
Performance Requalification Tests Commissioning Tests
Maintenance and Periodic Testing Performance Qualification Tests
Weekly Revalidation
Quarterly Performance Requalification Tests
Revalidation (Yearly Tests) Maintenance and Periodic Testing
Recommissioning Weekly
Maintenance Schedules P.P.M. Quarterly
Daily Housekeeping Revalidation
Weekly Maintenance Yearly Tests and Recommissioning
Maintenance Schedules P.P.M. Maintenance Schedules P.P.M.
Quarterly Daily Housekeeping
Yearly Weekly Maintenance
Maintenance Schedules P.P.M.
Operational Procedures – Fluids page 179 Quarterly
Validation Yearly
Commissioning Tests
Performance Qualification Tests Operational Procedures -Low Temperature Steam
Revalidation Disinfectors, Low Temperature Steam and Formaldehyde
Performance Requalification Tests page 206
Maintenance and Periodic Testing Validation
Weekly Commissioning Tests
Quarterly Performance Qualification Tests
Revalidation Revalidation
Yearly Recommissioning Performance Requalification Tests
Maintenance Schedules P.P.M. Maintenance and Periodic Testing
Daily Housekeeping Weekly
Weekly Maintenance Quarterly
Quarterly Maintenance Revalidation
Yearly Maintenance Yearly Tests and Recommissioning
Maintenance Schedule P.P.M.
Daily Housekeeping

157
Appendix 6 – Procedures for the procurement, validation, revalidation and operational management of sterilization

Weekly Maintenance
Maintenance Schedule P.P.M.
Quarterly
Yearly

Operational Procedures – Ethylene Oxide page 215

Validation
Commissioning Tests
Performance Qualification Tests
Revalidation
Performance Requalification Tests
Maintenance and Periodic Testing
Weekly
Quarterly
Revalidation
Recommissioning Tests
Maintenance Schedule P.P.M.
Daily Housekeeping
Weekly Maintenance
Maintenance Schedule P.P.M.
Quarterly
Yearly

Operational Procedures – Laboratory page 224

Validation
Commissioning Tests
Performance Qualification Tests
Revalidation
Performance Requalification Tests
Maintenance and Periodic Testing
Weekly
Quarterly
Revalidation
Recommissioning
Maintenance Schedule
Daily Housekeeping
Weekly Maintenance
Maintenance Schedule
Quarterly
Yearly

Operational Procedures Culture Media Preparators

page 233
Validation
Commissioning Tests
Revalidation
Recommissioning Tests
Maintenance Schedule P.P.M.
Daily Housekeeping
Weekly Maintenance
Maintenance Schedule P.P.M.
Yearly

Corrective Action page 238

Pressure Vessels Failures
Process Cycle Failures

158
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Operational procedures – Procurement and validation

159
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160
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161
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162
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163
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164
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165
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166
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167
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168
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169
Appendix 5 –sample log book for porous load sterilizers

Operational procedures – Porous load

170
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171
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172
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173
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174
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175
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176
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177
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178
 Appendix 5 –sample log book for porous load sterilizers

Operational procedures – Fluids

179
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180
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181
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182
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183
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184
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185
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186
Appendix 5 –sample log book for porous load sterilizers

187
Appendix 5 –sample log book for porous load sterilizers

Operational procedures – Unwrapped instruments and utensils

188
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189
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190
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191
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192
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193
Appendix 5 –sample log book for porous load sterilizers

194
Appendix 5 –sample log book for porous load sterilizers

195
Appendix 5 –sample log book for porous load sterilizers

196
 Appendix 5 –sample log book for porous load sterilizers

Operational procedures – Dry heat

197
Appendix 5 –sample log book for porous load sterilizers

198
Appendix 5 –sample log book for porous load sterilizers

199
Appendix 5 –sample log book for porous load sterilizers

200
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201
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202
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203
Appendix 5 –sample log book for porous load sterilizers

204
Appendix 5 –sample log book for porous load sterilizers

205
Appendix 5 –sample log book for porous load sterilizers

Operational procedures – Low temperature steam disinfectors,

Low temperature steam and formaldehyde sterilizers

206
Appendix 5 –sample log book for porous load sterilizers

207
Appendix 5 –sample log book for porous load sterilizers

208
Appendix 5 –sample log book for porous load sterilizers

209
Appendix 5 –sample log book for porous load sterilizers

210
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211
Appendix 5 –sample log book for porous load sterilizers

212
Appendix 5 –sample log book for porous load sterilizers

213
Appendix 5 –sample log book for porous load sterilizers

214
 Appendix 5 –sample log book for porous load sterilizers

Operational procedures – Ethylene oxide sterilizers

215
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216
Appendix 5 –sample log book for porous load sterilizers

217
Appendix 5 –sample log book for porous load sterilizers

218
Appendix 5 –sample log book for porous load sterilizers

219
Appendix 5 –sample log book for porous load sterilizers

220
Appendix 5 –sample log book for porous load sterilizers

221
Appendix 5 –sample log book for porous load sterilizers

222
Appendix 5 –sample log book for porous load sterilizers

223
Appendix 5 –sample log book for porous load sterilizers

Operational procedures – Laboratory sterilizers

224
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225
Appendix 5 –sample log book for porous load sterilizers

226
Appendix 5 –sample log book for porous load sterilizers

227
Appendix 5 –sample log book for porous load sterilizers

228
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229
Appendix 5 –sample log book for porous load sterilizers

230
Appendix 5 –sample log book for porous load sterilizers

231
Appendix 5 –sample log book for porous load sterilizers

232
 Appendix 5 –sample log book for porous load sterilizers

Operational procedures – Cultural media preparator

233
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234
Appendix 5 –sample log book for porous load sterilizers

235
Appendix 5 –sample log book for porous load sterilizers

236
Appendix 5 –sample log book for porous load sterilizers

237
Appendix 5 –sample log book for porous load sterilizers

Corrective action – Sterilizers

238
Appendix 5 –sample log book for porous load sterilizers
239
Appendix 5 –sample log book for porous load sterilizers
240
About NHS Estates

NHS Estates is an Executive Agency of the Department of Health Technical Memoranda – guidance on the design,
Health and is involved with all aspects of health estate installation and running of specialised building service
management, development and maintenance. The Agency systems, and on specialised building components. SO
has a dynamic fund of knowledge which it has acquired
during over 30 years of working in the field. Using this Health Facilities Notes – debate current and topical
knowledge NHS Estates has developed products which are issues of concern across all areas of healthcare provision.
unique in range and depth. These are described below. SO
NHS Estates also makes its experience available to the field
through its consultancy services. Encode – shows how to plan and implement a policy of
energy efficiency in a building. SO
Enquiries about NHS Estates should be addressed to:
NHS Estates, Publications Unit, Department of Health, Firecode – for policy, technical guidance and specialist
1 Trevelyan Square, Boar Lane, Leeds LS1 6AE. aspects of fire precautions. SO
Telephone 0113 254 7000.
http://www.nhsestates.gov.uk Capital Investment Manual Database – software
support for managing the capital programme. Compatible
with Capital Investment Manual. NHS Estates

Some NHS Estates products Model Engineering Specifications – comprehensive

advice used in briefing consultants, contractors and
Activity DataBase – a computerised briefing and design
suppliers of healthcare engineering services to meet
system for use in health buildings, applicable to both new
Departmental policy and best practice guidance.
build and refurbishment schemes. NHS Estates
NHS Estates

Design Guides – complementary to Health Building

Quarterly Briefing – gives a regular overview on the
Notes, Design Guides provide advice for planners and
construction industry and an outlook on how this may
designers about subjects not appropriate to the Health
affect building projects in the health sector, in particular
Building Notes series. SO
the impact on business prices. Also provides information
on new and revised cost allowances for health buildings.
Estatecode – user manual for managing a health estate.
Published four times a year; available on subscription
Includes a recommended methodology for property
direct from NHS Estates. NHS Estates
appraisal and provides a basis for integration of the estate
into corporate business planning. SO
Items noted “SO” can be purchased from The Stationery
Office Bookshops in London (post orders to PO Box 276,
Concode – outlines proven methods of selecting contracts
SW8 5DT), Edinburgh, Belfast, Manchester, Birmingham
and commissioning consultants. Reflects official policy on
and Bristol or through good booksellers.
contract procedures. SO

Works Information Management System –

a computerised information system for estate NHS Estates consultancy service
management tasks, enabling tangible assets to be put into
the context of servicing requirements. NHS Estates Designed to meet a range of needs from advice on the
oversight of estates management functions to a much
Health Building Notes – advice for project teams fuller collaboration for particularly innovative or exemplary
procuring new buildings and adapting or extending projects.
existing buildings. SO
Enquiries should be addressed to: NHS Estates Consultancy
Health Guidance Notes – an occasional series of Service (address as above).
publications which respond to changes in Department of
Health policy or reflect changing NHS operational
management. Each deals with a specific topic and is
complementary to a related HTM. SO