20 G U I DA N C E N OT E

Industrial Processing
of Heat-Chill Foods
Guidance Note 20: Industrial Processing of Heat-Chill Foods



 Guidance Note No. 20
Industrial Processing of Heat-Chill Foods

Published by:
Food Safety Authority of Ireland
Abbey Court
Lower Abbey Street
Dublin 1

Tel: +353 1 817 1300 Fax: +353 1 817 1301

Email: info@fsai.ie Website: www.fsai.ie
©2006

Applications for reproduction should be made to the FSAI Information Unit

ISBN 1-904465-39-0
Other food safety Guidance Notes available
from the Food Safety Authority of Ireland:

Guidance Note No.1 Inspection of a Food Business (2000)

ISBN 0-9539183-2-7

Guidance Note No.2 EU Classification of Food (2001)

ISBN 0-9539183-3-5

Guidance Note No.3 Interpretation of Results of Microbiological Analysis of Some Ready-

to-Eat Foods Sampled at Point of Sale (2001)
ISBN 0-9539183-5-1

Guidance Note No.4 Approval and Operation of Independent Meat Production Units
under EC Meat Legislation. Meat Products, Minced Meat & Meat
Preparations (2001)
ISBN 0-9539183-6-X

Guidance Note No.5 Approval and Operation of Independent Meat Production Units
under EC Fresh Meat Legislation (2001)
ISBN 0-9539183-7-8

Guidance Note No.6 Implementation of European Communities (Infant Formulae and

Follow-on Formulae) Regulations, 1998 to 2002 (2001)
ISBN 0-9539183-9-4

Guidance Note No.7 The Labelling of Fish and Aquaculture Products according to
European Communities (Labelling of Fish and Aquaculture Products)
Regulations, 2003 (S.I. No.320 of 2003) (2005) Revision 1
ISBN 1-904465-26-9

Guidance Note No.8 The Implementation of Food Safety Management Systems in Beef
and Lamb Slaughter Plants based on HACCP Principles (2002)
ISBN 0-9540754-6-3

Guidance Note No.9 Flavourings Legislation (2002)

ISBN 0-9540754-2-0

Guidance Note No.10 Product Recall and Traceability (2002)

ISBN 0-9540754-9-8
Guidance Note No.11 Compliance with Regulation 4.2 of the European Communities
(Hygiene of Foodstuffs) Regulations, 2000 (S.I. No. 165 of 2000)
(2002)
ISBN 1-904465-07-2

Guidance Note No.12 The Inspection of Food Safety Training and

Competence (2003)
ISBN 1-904465-07-2

Guidance Note No.13 Use of Enforcement Powers Under the Food Safety
Authority of Ireland Act, 1998 (2003)
ISBN 1-904465-05-6

Guidance Note No.14 The Application of Commission Directive 2001/101/EC as Amended

by Commission Directive 2002/86/EC on the Definition of Meat
(2003)
ISBN 1-904465-09-9

Guidance Note No.15 Cook - Chill Systems in the Food Service Sector (2004)
ISBN 1-904465-19-6

Guidance Note No.16 Food Stalls (2005)

ISBN 1-904465-32-3

Guidance Note No.17 The Labelling of Meat (2005)

ISBN 1- 904465-30-7

Guidance Note No.18 Determination of Product Shelf-Life (2005)

ISBN 1-904465-33-1

Guidance Note No.19 The Notification of Dietary Foods for Special Medical Purposes
under the European Communities (Foods for Special Medical
Purposes) 1999, S.I. No. 64 of 2001 (2006)
ISBN 1-904465-35-8
Contents Page

Background and Purpose 1

Scope 1

Disclaimer 2

Main Recommendations 3

1. Legislation 7

2. Application of HACCP Principles 8

3. Optimising the Process (Process Selection) 9

3.1 Product Development and Specification 11
3.2 Product Shelf-life 12
3.3 Mathematical Principles of Heat Processing 12
3.3.1 Decimal Reduction Time (D-value) 12
3.3.2 z-value 13
3.4 Intrinsic and Extrinsic Properties of Food 13
3.5 Requirements for Pathogenic Survival and Growth 13
3.6 Product, Process, Equipment and Packaging Properties 14
3.6.1 Product 15
3.6.2 Process 16
3.6.3 Equipment 16
3.6.4 Packaging 17
3.7 Selection of Target Pathogen 18
3.8 Minimum Target for Heat Processing 20
3.8.1 Test Uncertainty Ratio 21
3.9 Other Targets for Heat Processing 22
3.10 Minimum Target for Chilling 23
3.11 Best Practice for Chilling Specific Meat Products 25
3.12 Other Chilling Practices 26

4. Process Validation 27
4.1 Instrumentation for Temperature Measurement 28
4.2 Thermocouples 28
4.3 Data Loggers 29


5. Calibration 30
5.1 Calibration of Instrumentation 30
5.2 Calibration Interval for Instrumentation 32

6. Setting the Process 34

6.1 Temperature Mapping 35
6.1.1 When is temperature mapping required? 35
6.1.2 What is required before temperature mapping? 35
6.1.3 Temperature mapping procedure 36
6.2 Heat Penetration Tests 38
6.2.1 When are heat penetration tests required? 39
6.2.2 What is required before heat penetration tests? 39
6.2.3 Heat penetration test procedure 39

7. Monitoring and Verification 44

7.1 Monitoring 44
7.2 Verification 44
7.3 Data Collection and Record Keeping 45
7.4 Non-Conforming Product 46

Glossary 47

Appendix 1 Intrinsic and Extrinsic Properties 49

Appendix 2 Other Validation Techniques 52

Bibliography 53
Abbreviations

BS British Standard
BPF Base Product Fill
EC European Commission
EU European Union
FBO(s) Food Business Operator(s)
FSAI Food Safety Authority of Ireland
GHP Good Hygiene Practices
GMP Good Manufacturing Practices
HACCP Hazard Analysis Critical Control Point
ISO International Standards Organisation
INAB Irish National Accreditation Board
MAP Modified Atmosphere Packed/Packaged
Min Minutes
NSAI National Standards Authority of Ireland
s Seconds
S.I. Statutory Instrument
SOP(s) Standard Operating Procedure(s)
RTE Ready-to-eat
VP Vacuum Packed/Packaged
VTEC Verotoxigenic Escherichia coli
Background and Purpose

This Guidance Note has been prepared by the Food Safety Authority of Ireland (FSAI) in
consultation with an industry working group.

The FSAI believes that Guidance Notes have a major role to play in assisting food business
operator(s) (FBOs) and regulators in Ireland to achieve compliance with legislation and
with good practice.

A Guidance Note is not a substitute for legislation. However, the FSAI believes a Guidance
Note provides a more detailed elaboration of requirements. Adherence to the guide should
make compliance easier and provide the basis for a high degree of consistency in the
application of legislation.

Scope

The document is applicable to FBOs processing batches of heat-chill pre-packaged foods

under static heating conditions which are distributed to retail* food businesses. These
foods will require chilled storage at 5oC (recommended ≤ 3oC) to maintain shelf-life during
distribution, display and sale.

The document is not applicable to:

i. Food business operators involved in the preparation and direct sale or supply of
products directly to consumers, e.g. food service operations such as restaurants,
hospitals etc.
ii. Cook-chill food produced under FSAI Guidance Note No. 15 (1)
iii. Liquid and liquid containing particulate foods which are heat processed by pumping
through a direct or indirect heat exchanger, e.g. steam injection, steam infusion,
plate, tubular or scraped surface before passing through a holding tube
iv. Heat processed ambient stable foods
v. Heat processed milk and milk products (2)
vi. Dried, fermented, cold or hot smoked meat, poultrymeat and fish which is heat
and/or chill processed
vii. Live bivalve molluscs (i.e. bivalve molluscs are filter-feeding lamellibranch
molluscs) (2)

* Retail means the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer,
and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other simi-
lar food service operations, shops, supermarket distribution centres and wholesale outlets(5).


Disclaimer

1. All FBOs must comply with the legislative requirements of all current legislation (2-7).

2. This document is intended to act as a guideline to current legislation which requires

FBOs to ensure the safety of their foods (2-7).

3. Responsibility for food safety rests with the FBO (5).

4. It must be noted that legislation is continually being updated and/or amended. Up-to-
date information on food legislation is available from the FSAI website: www.fsai.ie.

5. This document is advisory in nature and outlines agreed best practice to be used by
FBOs processing heat-chill foods.

6. This document does not purport to be comprehensive or to be a legal interpretation

or to constitute legal or other professional advice.

7. The document should be read in conjunction with current food safety and hygiene
legislation (2-7), relevant Irish standards (8-12), Irish guidelines (1, 13-21), European guidelines (22-26),
international guidelines (27-30), scientific opinions (31-33) and industry best practice documents
(34-40)
.

8. Where a FBO has existing procedure(s) not outlined in this document, it is strongly
recommended that the FBO take account of the information contained in this Guidance
Note and/or seek advice from a competent body.

9. Where a FBO has alternative procedure(s) not outlined in this document, it is strongly
recommended that advice from a competent body is sought prior to commencement
of production.

10. Reference to any commercial products, process, service, manufacturer, or company does
not constitute its endorsement or recommendation by the FSAI.

11. The FSAI is not responsible for the contents of any website referenced in this
document.

12. All examples used in this document are for illustration purposes only and are not
intended to be exhaustive.

13. All websites referenced in the bibliography were last accessed in June 2006. All legislation
referenced in the bibliography will indicate the relevant European legislation, followed
by the equivalent Irish Statutory Instrument where available.


Main Recommendations

General

1. It is the responsibility of a FBO to ensure that the safety of food produced is assured
at all times and under all circumstances.

2. Food business operators should clearly identify any step in the activities of their business
which is critical in ensuring food safety. A systematic approach, based on the principles
of Hazard Analysis Critical Control Point (HACCP), should always be followed to
ensure adequate safety procedures are identified, implemented, maintained and reviewed
consistently.

3. Best practice for accurate, consistent and safe processing of heat-chill foods requires the
development and implementation of validated and verified heating and chilling processes
to ensure food safety.

4. If a FBO does not have sufficient expertise or resources within the business to develop
and implement a validated and verified heat-chill process, external consultation is strongly
recommended.

5. In the event that a non-conforming product is identified due to a failure in the heating
or chilling processes (or otherwise), the product batch should be clearly identified and
segregated to ensure that it is not inadvertently used or dispatched by the FBO. The
FBO should then carry out a risk assessment on the segregated product to assess its
safety.

Food Business Operators

6. Food business operators should determine the properties of the foods they produce
which are likely to have an impact on food safety under all reasonably foreseeable
conditions of processing, storage and use.

7. Food business operators should have a general understanding of the mathematics behind
heat processing.

8. Food business operators should have a general understanding of the factors affecting
the growth and survival of pathogens and the factors affecting heating and chilling
processes.

Heating and Chilling

9. When developing and implementing a heat-chill process, it should be designed to

eliminate or reduce to safe levels, pathogen(s) identified through risk assessment as
the most heat resistant, the most likely to outgrow during chilling, or presenting the
greatest risk as regards food safety.


10. The heating and chilling processes should ensure the uniform and complete heating
and chilling of every food unit in every product batch processed.

11. Ata minimum, heat processing should achieve a six decimal reduction in numbers of
the vegetative cells of the target pathogen, Listeria monocytogenes, in food.

12. At a minimum, chilling should prevent or reduce the opportunity for any surviving
spores of Clostridium perfringens, Cl. botulinum and Bacillus cereus to germinate and grow
in the food following heat processing. As such, chilling should decrease the temperature
of a heat processed food as described in Section 3.10 of this document.

Calibration

13. All instrumentation should be initially calibrated prior to use.

14. Alldaily or working and reference temperature instrumentation should be calibrated

against measurement standards traceable to the International Temperature Scale
ITS90.

15. Thecalibration frequency for daily or working thermometers should be at least annual
or at shorter intervals determined by risk assessment by the FBO.

16. The calibration frequency for reference thermometers should be as specified by the
manufacturer, or by risk assessment by the FBO but at minimum, should be at least
every three years.

17. Valid
certificates of calibration should be kept on file for all instrumentation used in
the validation and verification of heat-chill processes.

18. Uncertainty of measurement in relation to the calibration of temperature measuring

instrumentation should be used by FBO when setting the minimum targets for heat-
chill processes.

Instrumentation

19. Instrumentationshould have sufficient accuracy and precision. It is recommended that

the accuracy of daily or working temperature monitoring instrumentation should be a
minimum of ± 1.0oC (preferably ± 0.5oC).

20. Reference
thermometers used to calibrate daily working thermometers should have a
minimum test uncertainty ratio of 4:1.


Setting the Process

21. Whensetting a process, it is prudent that the FBOs plan and test for all expected
batch sizes, operating conditions and product types under worst case scenarios.

22. During
temperature mapping, the arrangement of probes within the processing chamber
should ensure that data collected are representative of the heating/chilling capacity
of the equipment at specific positions/zones within the chamber. A minimum of 7 to
15 probes per/m3 should be used with at least one probe placed in close proximity
to the equipment’s own internal temperature controlling probe (i.e. master probe).

23. Heatpenetration tests should continue until the required time/temperature combination
is achieved in product cold-spots and/or products positioned at the slowest heating
point(s) of the processing chamber. Tests should further extend for a short period after
the required time/temperature combination is achieved so that a definite temperature
profile can be established for all thermocouples used.

Monitoring and Verification

24. On-going product temperature monitoring is required for all heat-chill processes
for verification that the specific requirements of product safety (i.e. minimum time/
temperature combination in heating and chilling) have been achieved.

25. When a FBO uses a validated and verified heat-chill process, on-going process
validation and verification, e.g. temperature checks, should be undertaken on
a scheduled, routine basis based on risk assessment. The temperature and time
combination should be monitored at the centre of the largest product unit placed
at the identified slowest heating point in the heating chamber.

Processing and Equipment

26. Processingof mixed batches of product is not recommended unless the FBO can
validate and verify the process.

27. Processing
of batch sizes, e.g. half or quarter batch maximum capacity not typically
processed by the FBO, is not recommended unless the FBO has validated and verified
the process for that specific batch size.

28. Anychange in processing such as product stacking, racking and orientation of product
in the heating chamber, type of racks used to stack product during processing, design
and use of separator or divider sheets between layers of product units and/or location
of point of slowest heating in the heating chamber, e.g. stacking arrangement of product
during heating, can effect the safety of the product.


29. The requirements and selection of processing equipment should be based on the
specific requirements of the FBO.

30. Allequipment should be fit for purpose, capable of the required accuracy and
repeatability and lend itself to validation and ongoing monitoring.


1. Legislation

The intent of this document is to provide guidance to FBOs on compliance with:

1. Regulation (EC) No 178/2002 of the European Parliament and of the Council laying
down the general principles and requirements of food law, establishing the European
Food Safety Authority and laying down procedures in matters of food safety (5)

2. Regulation (EC) No 852/2004 of the European Parliament and of the Council on the
hygiene of foodstuffs (3)

3. Regulation (EC) No 853/2004 of the European Parliament and of the Council laying
down specific hygiene rules for food of animal origin (2)

4. Regulation (EC) No 2073/2005 of the European Parliament and of the Council on the
microbiological criteria for foodstuffs (6).

Legislation specific to heating and chilling of foods exists, but is largely unstandardised
throughout the European Union (EU) (2). Foods typically receive heating and chilling based
on agreed best practice, national standards or guidelines.

Specific requirements for temperature control are specified in EU legislation for the
preparation, handling and storage of raw meats, fish, poultry, shellfish, milk and egg products.
However, specific requirements for the chilling of foods following heat processing is not
specified except in cases where it is stated that rapid cooling must follow heat processing,
e.g. processed fishery products (2).

Under Regulation No 852/2004 (Annex II; CHAPTER XI; Heat Treatment) the following
requirements apply to food placed on the market in hermetically sealed containers(3):

1. Any heat treatment process used to process an unprocessed product or to process

further a processed product, is:

i. To raise every part of the product treated to a given temperature for a given
period of time
ii. To prevent the product from becoming contaminated during the process.

2. To ensure that the process employed achieves the desired objectives, FBOs are to
check regularly, the main relevant parameters (particularly temperature, pressure, sealing
and microbiology), including the use of automatic devices.

3. The process used should conform to an internationally recognised standard, e.g.

pasteurisation, ultra high temperature or sterilisation.

4. Where foodstuffs are to be held or served at chilled temperatures, they are to be

cooled as quickly as possible following the heat-processing stage, or final preparation
stage if no heat process is applied, to a temperature which does not result in a risk
to health.


2. Application of HACCP Principles

Hazard Analysis Critical Control Point (HACCP) is a logical science based system designed
to assure the safety of food. In the context of this document, all aspects of heating and
chilling processes should be included as integral parts of a FBO’s HACCP plan.

All FBOs, except primary producers, e.g. farms, are legally required to establish and operate
procedures based on the principles of HACCP (2-3).The application of HACCP will require
FBOs to train staff.

Food business operators should ensure that any step in the activities of the business which
is critical to ensuring food safety is identified, e.g. heating and chilling, and that adequate
safety procedures are identified, implemented, maintained and reviewed on the basis of the
principles used to develop the system of HACCP.

A solid foundation of control, based on a robust prerequisite programme, is required prior

to the development and implementation of HACCP. The programme should include the
following:

1. Good Management Practices

2. Good Manufacturing Practices (GMP)
3. Good Hygiene Practices (GHP)
4. Standard Operating Procedures (SOP).

The prerequisites should provide the basic environmental and operational conditions
necessary to produce safe food.

Six sector specific national guides to good practice for hygiene and the application of
HACCP, have been published under the aegis of the National Standards Authority of
Ireland (NSAI) (8-12).

The European Commission (EC) has also recently produced a guidance document on the
implementation of procedures based on the HACCP principles (23).

FBOs may use these guides on a voluntary basis to implement prerequisites and as an aid
to compliance with food hygiene requirements.

Good Management Practices, GMP, GHP and SOPs are also very important. However, only
a scientifically based system such as HACCP can be accurately measured and validated
to allow for the detection and correction of deviations from critical limits. Adherence to
critical limits has been scientifically shown to assure the production of safe food (19).


3. Optimising the Process (Process Selection)

A heating process should eliminate or reduce to safe levels, pathogens that could endanger
public health, maintain product shelf-life and retain the organoleptic attributes of the
product.

A chilling process should prevent the outgrowth of spore forming pathogens by rapidly
reducing the temperature of the food to a low storage temperature to preserve product
safety and shelf-life.

Foods typically receive a heat process that heats the food to a suitable temperature and
holds the food at or above that temperature for an appropriate period of time.

The heat process should ensure that the food, if consumed within its shelf-life and not
exposed to contamination or temperature abuse during storage, will not endanger the
health of the consumer due to pathogenic survival and growth. As such, some heat-chill
products are referred to as ready-to-eat (RTE).

With heat-chill processes, it is also important to ensure that levels of spoilage

microorganisms are reduced so that bio-deterioration of the product will not occur
within the designated shelf-life of the food.

Figure 1 outlines the general stages in the development and implementation of a heat-chill
process designed to produce a safe product.


Figure 1. Stages in the Development, Approval and Implementation of a
Heat-Chill Process

Product development, specification & shelf-life

Development of initial product HACCP plan

Setting the Process

Determining the target process values for heating & chilling

Ongoing Monitoring of the Process

Calibration of temperature measuring equipment

Temperature mapping tests Validation & Verification

Heat penetration tests

Chilling

Finalise HACCP Plan (Monitoring & verification)

Data collection & product review

Product Release

10
3.1 Product Development and Specification

The development and implementation of a safe heat-chill process for food begins at the
product development level.

Food product development involves the initial product conception, development of product
specification, production of samples and finally, commercial scale production.

Food business operators should develop SOPs to allow the consistent and safe development
of foods. To ensure consistent, safe and controlled production of heat-chill processed foods,
it is best practice to implement a validated safe process and to verify performance during
each production run. This will require FBOs to:

1. Clearly define the product and its characteristics in a specification. At a minimum, the
specification should include:
i. A product description
ii. Ingredient listing
iii. Shelf-life required to meet safety, quality and marketing requirements
iv. Required processing, packaging, storage and distribution characteristics
v. Proposed HACCP plan and any available risk assessment data
vi. Legislative requirements, e.g. microbiological, chemical, nutritional, allergens, packaging,
labelling etc, and/or customer requirements
vii. Nutritional characteristics (i.e. as applicable)
viii. Quality characteristics (i.e. as applicable).

2. Use personnel suitably trained commensurate with their duties and responsibilities. If this
is not possible, the FBO should employ a suitably competent organisation or person, e.g.
consultant, to assist
3. Have a good general understanding of the mathematics behind heat processing, the
factors affecting heat resistance of pathogens, the factors affecting heating and chilling
processes and the factors which may adversely affect safe processing
4. Use suitable equipment, instrumentation and facilities
5. Use recognised, standardised procedures where appropriate, e.g. ISO, BS etc.
6. Calibrate equipment and instrumentation to an accuracy required for effective validation
and verification
7. Develop and implement temperature mapping tests of heating and chilling processes
8. Develop and implement heat penetration tests of heating and chilling processes
9. Collect and review data
10. Verify adequacy of heating and chilling processes
11. Implement on-going monitoring and SOPs for heating and chilling processes.

11
3.2 Product Shelf-life

The required shelf-life for a food is a key factor in developing and implementing a safe heat-
chill process. The desired shelf-life of a product in conjunction with product characteristics
(including processing and packaging), determines the target pathogen (Section 3.8) for
destruction during heat processing.

A validated product shelf-life is critical to the control for specific pathogens, particularly if
the food has an extended shelf-life and can support the growth of pathogens. It is important
to determine if a pathogen will grow to unacceptable/potentially hazardous levels during
the shelf-life. For a food to be microbiologically safe and commercially viable, a FBO must
produce a product which has a consistently reproducible and acceptable microbiological
safety.

Food business operators are responsible for determining the characteristics of the foods
they produce or pack and the subsequent shelf-life (20). Therefore, shelf-life of food is an
integral part of food safety. An incorrect shelf-life has the potential to endanger consumer
health.

Foods that are highly perishable from a microbiological perspective may constitute a danger
to public health after a short period of time and as such, must have the appropriate shelf-
life clearly indicated by means of a ‘use-by’ date (7).

The ‘use-by’ date will indicate the date up until which the food can be safely consumed,
provided it has been stored correctly, e.g. packaging, storage temperature (20). Further details
on specific issues related to product shelf-life including labelling are given in FSAI Guidance
Note No. 18 (21).

3.3 Mathematical Principles of Heat Processing

To design and implement a safe heat process requires FBOs to have a good general
understanding of the mathematics behind heat processing, associated with the effect of
heat processing on pathogens (i.e. thermal destruction). In addition, the FBO should have a
general understanding of the factors affecting heat resistance of pathogens and the factors
affecting heating and chilling processes.

3.3.1 Decimal Reduction Time (D-value)

For every target pathogen or spoilage microorganism under specific conditions of
substrate, e.g. food, and temperature, there is a specific time required at a particular
temperature to ensure destruction of 90% of all viable (i.e. vegetative) cells and/or
spores present. This time (i.e. in minutes or seconds) is referred to as the decimal
reduction time or D-value (41-42). A 90% reduction is also referred to as a 1 Log10
cycle reduction or a ten-fold reduction.

12
 D-values are temperature specific with the temperature at which the D-value is
measured, generally given as a subscript to the D-value, e.g. D-value at 75ºC is
expressed as D75. D-values are also specific to a particular microorganism. They
can also be affected by the composition of the food (i.e. substrate) in which
the microorganism is found. The severity of a heat process can be described in
terms of D-values, e.g. a 6D process is a heat process which reduces a particular
microorganism type by 6 Log10 cycles.

3.3.2 z-value
As previously stated, the D-value is temperature specific. If the Log10 of a series
of D-values for a target pathogen or spoilage microorganism is plotted against
temperature (oC), a straight line relationship is generally found. The reciprocal of
the slope of this graph can be described by the number of degrees Celsius which
results in a 1 log10 (i.e. ten-fold or 90%) decrease or increase in the D-value. This
temperature change is called the z-value (C deg).

3.4 Intrinsic and Extrinsic Properties of Food

It’s important to understand the factors which may affect the ability of a FBO to achieve
a target heat-chill process. The intrinsic (i.e. water activity, pH, food composition etc.) and
extrinsic properties (i.e. storage temperature, gas atmosphere, relative humidity etc.) of
a food will affect the heat resistance of pathogens and the ability of a FBO to achieve a
target heating process (43). As such, FBOs should determine the properties of the foods
they produce, under all reasonably foreseeable conditions of processing, storage and use.

Some of the more important intrinsic and extrinsic properties of food are outlined in
Appendix 1. Greater detail on intrinsic and extrinsic properties of foods can also be found
in FSAI Guidance Note No. 18 (21).

3.5 Requirements for Pathogenic Survival and Growth

All pathogens have specific requirements for survival and growth in food. The survival and
growth of pathogens will depend on the intrinsic and extrinsic properties of the food
(Section 3.4).

It is important to note that the intrinsic and extrinsic properties of foods are inherently
variable. Further, while each intrinsic and extrinsic property may affect pathogenic growth
and survival, it is the interaction between these properties which determines whether a
pathogen will grow or survive in a food.

It is important that a FBO understands the ability of pathogens to evolve in response

to environmental stresses, e.g. cold-shock, heat-shock, low water activity (aw), low pH
etc. Therefore, the efficiencies of processing, e.g. heating and chilling, should be assessed,
especially with regard to the potential of pathogens to adapt and increase their resistance
to a wide variety of environmental stresses.

13
Specific pathogens are often associated with specific foods. Some common associations
are given in Table 1.
Table 1. Common Associations between Pathogens and Foods

Pathogen Commonly Associated Food Products

Salmonella species Eggs, poultry, meats & dairy products

Clostridium botulinum
Canned foods, vacuum packed (VP) & modified
Mesophilic/Proteolytic:
atmosphere packed (MAP) foods
Types A, B & F
Clostridium botulinum
Psychrotrophic/Non-Proteolytic: Canned foods,VP/MAP foods & jarred foods
Types B, E & F

Staphylococcus aureus Eggs, poultry, meats, dairy products & confectionary

Campylobacter jejuni Poultry, meats & milk products

Yersinia enterocolitica Fresh meats & milk
Listeria monocytogenes Ready-to-eat foods
Clostridium perfringens Cooked meat & poultry products
Escherichia coli O157 & other
Verotoxigenic E. coli Meat, poultry, milk & vegetable products
(VTEC)
Cooked rice & pasta, spices, meats, milk, vegetables,
Bacillus cereus fish, sauces, puddings, soups, casseroles, pastries, &
salads
Vibrio parahaemolyticus Fish & seafood products

3.6 Product, Process, Equipment and Packaging Properties

It is important to note that any change in the product, process, equipment or packaging
may have an impact on whether an existing heat process is valid. A FBO should be
aware of the following issues which may affect heating and chilling in achieving target
requirements.

14
 3.6.1 Product
1. Product nature, formulation and composition, e.g. high levels of starch based
ingredients, can increase product viscosity and reduce aw. Product nature,
formulation and composition will influence the mode, e.g. convection, conduction,
and speed of heat transfer during processing, e.g. convection is faster than
conduction.
2. Examples of how product formulation and composition affect mode and speed
of heat transfer are given below:
i. Fast convection heating, e.g. milk, juices, broths, thin soups etc.
ii. Slow convection heating, e.g. vegetable soups, fruit syrups, some thin purees
– sauces, usually low starch, etc.
iii. Convection and conductive heating, e.g. some thick soups or gravies
which contain starch, may change their heating behaviour due to starch
gelatinisation at a particular temperature. Small variations in product
formulation or ingredients may cause the transition from convection to
conduction heating to occur at a different temperature and related time.
Special care should be taken to identify and control specific product and
process variables related to the heating rates of these products
iv. Conductive heating, e.g. pasta, rice, thick purees - usually high starch
content, meat and fish products, confectionary, dairy products, usually high
fat content.

3. Consistency and viscosity of product, particularly in semi-liquid or liquid

components and non-homogenous products.

4. Solids to liquids ratio in product.

5. Size, shape and weight of solid components.

6. Initial product temperature.

7. Initial microbial load of product.

8. Thermal properties of the product (i.e. thermal conductivity, thermal diffusivity,

specific heat capacity).

9. Hot or cold filling of product.

10. Behaviour of product components during heat processing, e.g. in some products
clumping may occur. This is particularly important with sliced products, e.g. meats
which can stick or clump together during heat processing. Products which are
prone to clumping may affect temperature sensor placement in the product
and the cold spot location.

15
3.6.2 Process
1. Raw material preparation techniques prior to heat processing:
i. Mixing/agitation techniques, e.g. incorporation of air, emulsification etc.
ii. Mixing/agitation, e.g. rotating, stationary etc., of the product during
processing
iii. Initial product temperature prior to heat processing
iv. Blanching of fruit/vegetables which can cause swelling or shrinkage which
can effect heat processing efficiency
v. Rehydration of dried components may affect the process with respect to
inactivation of microbial spores as they may be less resistant to heat in
this rehydrated form.

2. Nature of heat transfer in equipment:

i. Conduction
ii. Convection
iii. Radiation.

3. Type of cooking equipment:

i. Immersion, e.g. water, oil
ii. Saturated steam
iii. Water and steam/air mixture (i.e. rate of heat transfer here is dependent
on heating medium velocity)
iv. Water showering.

4. Equipment operation:
i. Process temperature and time
ii. Time taken for heating chamber to achieve the operational temperature
(i.e. temperature come-up time)
iii. Venting procedure if steam used
iv. Excess/over pressure if using steam/air or water
v. Product stacking, racking and orientation of product in the heating
chamber
vi. Type of racks and/or baskets used to stack product during processing
vii. Design and use of separator or divider sheets between layers of product
units
viii. Location of points of slowest heating in the heating chamber.

3.6.3 Equipment
The requirements and selection of equipment, e.g. ovens, should be based on the
specific requirements of the FBO. Equipment manufacturers and suppliers are best
positioned to give advice to a FBO on the choice of equipment for specific foods,
particularly in relation to capacity and design issues. However, it is recommended
that wherever possible, FBOs obtain objective information in relation to equipment.
The following should be considered by FBOs in selecting and using equipment:

16
1. Obtain objective information in relation to the performance and practicalities
of use, in relation to equipment
2. Selected equipment should have a sufficient performance capability for the
required process
3. Selected equipment should use the appropriate mode of heat transfer based
on the physical and thermal properties of the food. Some equipment will use
saturated steam for the heat transfer medium while others will use water
and steam mixtures
4. Selected equipment should have sufficient capacity to allow for projected future
production levels
5. Selected equipment should allow for the required pack orientation in the heating
chamber (i.e. stacking/racking orientation of individual food units in
the chamber)
6. Selected equipment should have good design to allow for effective cleaning
and disinfection and minimisation of the risks of cross contamination, e.g.
movement of raw product to cooked product
7. Selected equipment should allow for calibration of all monitoring probes, both
internal and external, e.g. temperature, pressure probes etc.
8. Selected equipment should allow for validation and verification of the process
9. Selected equipment should be included in planned preventative maintenance
programs at each processing site. Planned maintenance should include air velocity
checks, checks on flaps, pistons, motors, belts, steam pressure, etc. For conveyor
cookers, conveyor speed and loading should also be included.

3.6.4 Packaging
1. Change of packaging.
2. Type of packaging material used, e.g. plastics, laminates, glass, metals etc.
3. Thermal properties of the packaging materials.
4. Type of containers, e.g. pouches, jars, cans etc.
5. Unit pack size, shape, thickness and other dimensions, e.g. the thickness of
packaging has a direct effect on the ability of heat to penetrate into a food.
6. Packaging atmosphere which could affect the heat process required, e.g. vacuum.
packaged, modified atmosphere packaged.
7. Sealing characteristics of packaging, e.g. can seals fail during processing?
8. Products fill characteristics, e.g. fill temperature, fill weight, and headspace in
packages.
9. Presence of entrapped gases in the headspace of packages, e.g. this can have
an insulating effect resulting in decreased heat penetration.
10. Product fill weight measured before and after processing.
11. The percent overfill of key product components such as the solids content.

17
 Having considered all the factors covered in Sections 3.1 to 3.6, the next step for
the FBO is to select the target pathogen and the heat-chill process required to
achieve an appropriate, e.g. 6-D, reduction of the target organism while preserving
the sensory quality of the food product.

3.7 Selection of Target Pathogen

When developing and implementing a heat process, it should be designed to inactivate

a pathogen or group of pathogens, e.g. vegetative pathogens and/or spore-formers. This
is typically described as the target pathogen(s) for the heat process (44). Based on the
specification for a product and the desired shelf-life, the target pathogen for the heat
process should be identified which will ensure the safety of the product for its entire
marked shelf-life.

At a minimum, heat processing should eliminate all vegetative pathogens, e.g. Listeria
monocytogenes, Salmonella spp., Staphylococcus aureus, Campylobacter jejuni, and Escherichia
coli O157:H7 in foods.

Inactivation of pathogens is influenced by the characteristics of the pathogen, the required

product shelf-life (Section 3.2) and the intrinsic and extrinsic characteristics of the product
(Sections 3.4 – 3.7). Table 2 summarises some of the characteristics of pathogens which
can influence their thermal inactivation.

18
Table 2. Characteristics of Target Pathogens

Characteristics Effect
Different pathogens will have different levels of heat
Genus, Species and Strain
resistance based on genus, species and strain, e.g.
of Target Pathogen
L. monocytogenes serovar 4b.

Some pathogens are inherently more heat resistant

than others, depending on their type and form. Gram
Type and Form of Target positive bacteria are typically more heat resistant
Pathogen than Gram negative bacteria, while bacterial spores
are more heat resistant than the vegetative cells of
either Gram positive or negative bacteria.

Bacteria have four phases of growth during their life-

cycle: the lag, log, stationary and death phases.
Microbial cells tend to be more heat resistant as they
grow older particularly during the stationary phase
Stage of Growth of the Target and less resistant during the log phase of growth.
Pathogen Heat resistance has also been reported to be high
at the beginning of the lag phase and decreases as
the cell enters the log phase. Old bacterial spores
also tend to be more heat resistant than younger
bacterial spores (43).

The previous conditions to which pathogens have

been subjected can affect their response to heat
treatment. For example, under prolonged exposure
The History of the Target
to adverse environmental conditions such as sub-
Pathogen
lethal temperature or acidic conditions,
L. monocytogenes can develop a stress response
which can make it more resistant to heat processing.

The Number of Typically, the larger the numbers of microorganisms

Microorganisms Present present in a food product, the greater the degree of
in the Food heat resistance (43).

Determining the degree of elimination of the target pathogen is very critical. A basic
understanding of mathematical principles of heat processing is required to design and
implement a safe heat process.

19
3.8 Minimum Target for Heat Processing

Unless a legal specification for a heat process exists, the FSAI currently recommends a
minimum target for heat processing of a 6-D reduction in numbers of the vegetative cells
of the target pathogen, L. monocytogenes (1).

Listeria monocytogenes is regarded as the most heat resistant, foodborne pathogen that
does not form spores. Therefore, other non-spore forming vegetative pathogens such as
Salmonella spp., S. aureus, Y. enterocolitica, V. parahaemolyticus and E. coli O157:H7 that may
be present in the food, should also be destroyed by a 6-D heat process (1, 45). The Stumbo
equation can be used to calculate a 6-D reduction (Equation 1) (42):

Equation 1 Where:
F = Required process lethality
F = D log

r 10n

Dr = D-value at the reference temperature
n = Required decimal reduction

The FSAI recommends a reference time and temperature combination of 70oC for 2
minutes, with a z-value of 7.5 Centigrade degrees (C deg) to achieve a 6-D reduction
in numbers of L. monocytogenes (1, 45). Equivalent time temperature combinations to this
reference temperature (Equation 1) can then be calculated using the lethal rates equation
(Equation 2) from Stumbo (42):

Equation 2 Where:
L = Lethal rate

(
10 z
T-T )

x


T =
Tx =
z =
Target temperature (ºC)
Reference temperature (ºC)
z-value (C deg)

Equivalent time and temperature combinations (using Equation 2) are given in Table
3 as an example of the necessary process to achieve a 6-D reduction in numbers of
L. monocytogenes in foods (18).

20
Table 3. Example of Equivalent Time/Temperature Combinations to Achieve a
6-D Reduction in L. monocytogenes A

Temperature (oC) Time Temperature (oC) Time

64 12min 37s 70 B 2min

65 9min 17s 71 1min 28s

66 6min 50s 72 1min 5s

67 5min 73 48s

68 3min 42s 74 35s

69 2min 43s 75 26s C

A
Assuming a linear z-value = 7.5C° with a reference temperature of 70°C. The interaction between foods
intrinsic and extrinsic properties may alter these equivalent lethal rates and as such values must only
be used as an indication of the lethal effect of the heat process on L. monocytogenes (18).
B
Recommended by the FSAI as the reference temperature and time required for a 6-D reduction in
numbers of L. monocytogenes.
C
With such short times above the reference temperature of 70°C, it is assumed that when 75°C is
reached, the equivalent process to 70°C for 2 minutes has been achieved(18).

Some products may change their mode of heat transfer due to a physical change in the
product during heat processing, e.g. if a product gels or solidifies during heating. For
example, dry pouched rice and pasta products during cooking may have a changing D-
value (i.e. as the dry product cooks the D-value changes). Therefore, with these products,
e.g. dry rice/pasta etc. a more severe heat treatment may be required to achieve the
appropriate, e.g. 6-D reduction of the target organism while preserving the sensory quality
of the food product.

3.8.1 Test Uncertainty Ratio

When setting the minimum temperature target for heat processing, the test
uncertainty ratio should be included. To apply the test uncertainty ratio you must
know the target temperature for the product, e.g. after cooking 72ºC and the
tolerance, e.g. ± 2ºC for the process. From this example the true temperature of
the product must lie between 70ºC and 74ºC.

Typically, the instrumentation used to measure the temperature have a

tolerance which is four times better (i.e. test uncertainty ratio of 4:1)
than the tolerance of the process (i.e. in the example used ± 0.50 ºC)
(See Section 5.1). Therefore, the total uncertainty of measurement of the

21
 process must be ± 0.50 ºC which takes into account the instrumentation and the
medium used to measure the temperature. Applying the test uncertainty ratio to
instrumentation used to measure temperature will help ensure products achieve
the minimum temperature target for a 6-D process.

3.9 Other Targets for Heat Processing

Further controls may be necessary where risk assessment indicates that the growth and
toxin production of Clostridium botulinum or other spore-forming bacteria is a particular
risk. The actual risk will depend on the likely occurrence of Cl. botulinum spores in the
ingredients (38), the absence of intrinsic controlling factors and an anaerobic environment
which would allow outgrowth of spores. Products which may provide such conditions may
include; sous vide products (43) and other products which may present anaerobic conditions,
e.g. reformed meat products, MAP or VP products.

However, the risk that a hazard will occur should be evaluated in each case, and control
measures identified should be applied where this evaluation indicates that a risk occurs,
e.g. for ingredients known to be positive for psychrotropic Cl. botulinum spores from time
to time (38). Intrinsic controlling factors which prevent the outgrowth of spores and toxin
production by non-proteolytic strains of Cl. botulinum are (31, 38):

1. pH of less than 4.5 throughout the food

2. Salt level of 3.5% (aqueous) throughout the food
3. Water activity (aw) of 0.97 or less throughout the food
4. Any combination of heat processing and preservative factors, which has been
shown to prevent or eliminate growth and toxin production by Cl.
botulinum.

Non-proteolytic Cl. botulinum Type B is regarded as the most heat resistant form of non-
proteolytic Cl. botulinum. Therefore, all non-spore forming vegetative pathogens including L.
monocytogenes that may be present in the food should also be eliminated or reduced to
safe levels by this 6-D heating process.

A reference time and temperature combination of 90oC for 10 minutes, with a z-value of
10Co has been suggested to achieve a 6-D reduction in numbers of psychrotrophic (non-
proteolytic) Cl. botulinum Type B (34, 38).

Equivalent time and temperature combinations (using Equation 2) are given in Table 4 as an
example of the necessary process to achieve a 6-D reduction in numbers of psychrotrophic
Cl. botulinum Type B in foods (31-32, 38).

22
Table 4. Example of Equivalent Time/Temperature Combinations to
Achieve a 6-D Reduction in Psychrotrophic Cl. botulinum Type BA

Temperature (oC) Time (min) Temperature (oC) Time (min)

80 100 92 6.3
82 63 94 4.0
84 40 96 2.5
86 25 98 1.6
88 16 99 1.3
90 10 100 1.0
A
Assuming a linear z-value = 10Co with a reference temperature of 90oC. The interaction between foods
intrinsic and extrinsic properties may alter these equivalent lethal rates and as such, values must only be
used as an indication of the lethal effect of the heat process on psychrotrophic Cl. botulinum Type B.

3.10 Minimum Target for Chilling

Chilling should decrease the temperature of heat processed food as rapidly as possible.
The chilling process should ensure the uniform and complete chilling of the food (2-4). In all
cases during chilling processes, there must be adequate ventilation to prevent condensation
on the surface of products.

The chilling process should achieve a target temperature in a specified time in the food
during every chilling treatment. This will ensure that the food, if consumed within its
shelf-life, and not exposed to contamination or temperature abuse during storage, will not
endanger the health of the consumer.

It is important that FBOs note that most pathogenic and non-pathogenic bacterial spores,
including those from mesophilic Cl. botulinum and psychrotrophic Bacillus cereus and
Clostridium perfringens, are more heat resistant than psychrotrophic Cl. botulinum Type B.
As such, these microorganisms will not be eliminated or inactivated by the examples of
heat treatment combinations presented in Table 4.

Therefore, when the target heating treatment has been achieved and no post-process
contamination of the food has occurred, rapid chilling is used to prevent or reduce the
opportunity for surviving spores to germinate and grow in the food.

Clostridium perfringens is present in many foods, at low levels. Illness due to Cl. perfringens
typically occurs after ingestion of large numbers of enterotoxin producing cells present in
food. Almost all outbreaks of Cl. perfringens illness are the result of inadequate or slow
chilling of heat processed product. Slow chilling can allow Cl. perfringens spores to germinate
and multiply (32).

23
Clostridium botulinum is present less frequently than Cl. perfringens in foods. However, like
Cl. perfringens, spores of some Cl. botulinum can survive all but the most severe heat
treatments, e.g. sterilisation. Germination of Cl. botulinum spores that survive heat processing
can be inhibited by rapid chilling after heat processed and refrigerated storage (32, 47).

Bacillus cereus like Cl. perfringens can be found in low numbers in a wide range of foods.
Rapid chilling is necessary to prevent germination and growth of B. cereus spores after
heat processing (1, 39). Refrigerated storage at < 4°C is necessary to prevent growth of all
types of B. cereus.

Some foods can contain pathogenic spores of Cl. perfringens, Cl. botulinum and B. cereus.
Foods which contain untreated herbs, spices, rice, bean and pulse ingredients may have
increased levels of spores. Reformed or restructured meat, poultry and fish products may
carry an increased level of microbial contamination than whole muscle products (39).

Based on the above outlined requirements for control of Cl. perfringens, Cl. botulinum and
B. cereus in chilling, Table 5 outlines best practice for chilling of heat processed foods.

Table 5. Suggested Best Practice for Chilling Heat Processed Foods A

Chilling Stage Requirement Best Practice

Recommend a period
Begin chilling as quickly as
Commencement of ≤ 90 minutes after
possible after completion of heat
of Chilling the completion of heat
processing (3, 10, 32-33)
processing (10)
Recommend a period of not
Reduce the temperature of the
greater than 120 minutes
Initial Chilling food (at the geometric core/
after the beginning of
Process thickest point) from 55oC to ≤
chilling from
10oC as quickly as possible (32-33)
55 C to ≤ 10oC (18, 32-33)
o

Recommend a period of not

Final Chilling Continue chilling as quickly as greater than 60 minutes
Process possible from 10oC to ≤ 5oC from
10 C to ≤ 3oC (10)
o

Following completion of chilling,

the food should be immediately
placed in controlled refrigerated
Recommended ≤ 3oC
Final Storage storage which ensures a final
throughout the chill chain
product temperature (at its
geometric core/thickest point) of
≤ 5oC throughout the chill chain
All temperatures refer to readings taken at the geometric core/thickest point of the product.
A

24
3.11 Best Practice for Chilling Specific Meat Products

Due to the specific nature and characteristics of heat processed whole/intact meat products,
and those made by reforming or restructuring small pieces of meat and other ingredients
under good hygienic conditions, into large meat products, other targets for chilling can be
recommended (39).

Best practice for chilling of large uncured and cured meat products is outlined in Tables 6
and 7 (39). However, the onus is always on the FBO to prove the safety of the process.

Table 6. Suggested Best Practice for Chilling Large Uncured Meat

Products A, B

Uncured Meats
Temperature Range Good Practice Maximum
Time (Minutes)
Final Cooking Temperature
60 150
to 55oC

55oC to 12oC 360 360

12oC to 5oC C 60 90

Total Cooling Time (Minutes)

D
480 600

A
All temperatures refer to readings taken at the geometric core/thickest point of the product.
B
If high levels of spores are present in the raw meat product before heat processing, a reduction in the
chilling time maybe necessary. Products which contain high levels of spores, e.g. > 105 Cl. perfringens, the
chilling time to < 5oC may be ≤ 3 hours. Products chilled in this way should not be portioned until
completion of chilling.
C
Following chilling, the product should be immediately placed in controlled refrigerated storage which
ensures a final product temperature (at its geometric core/thickest point) of ≤ 5oC (recommended ≤
3oC) throughout the chill chain.
D
FBOs who use a secondary heat treatment for products, e.g. roasting after chilling, must calculate the total
chilling time for the product by detailing the total time the product remains above 5oC (39).

The presence of salt/nitrite in cured product may allow for longer chilling times. Some
indications suggest this can be 25% longer than an equivalent uncured product (39). However,
the onus is always on the FBO to prove the safety of the process.

25
Table 7. Suggested Best Practice for Chilling Large Cured Meat
Products A

Cured Meats
Temperature Range Good Practice Maximum
Time (Minutes) B
Final Cook Temperature to
75 195
55oC

55oC to 12oC 450 450

12oC to 5oC C 75 105

Total Cooling Time (Minutes) D 600 750

A-D
See footnotes for Table 6

3.12 Other Chilling Practices

Specifications for chilling outside the recommendations given in Section 3.10 and Section
3.11, may be suitable to ensure product safety. However, appropriate microbiological risk
assessment data would be required to ensure the safety of the process. The responsibility
for the provision of such risk assessment data lies with the FBO.

26
4. Process Validation

Having selected the appropriate time/temperature parameters (Sections 3.1 to 3.12)

delivering a microbiologically safe product, the FBO must now ensure that every product
unit achieves this heat process every time.

The large capacity of many commercial cookers can make it difficult to physically
temperature probe all individual product units in a batch during cooking. Therefore, the
FBO will not know if every product unit has received the appropriate time/temperature
parameters during the heating process.

To overcome this issue, the FBO must validate the heating process and then establish
monitoring and verification procedures to ensure this validation data remains accurate. The
FSAI currently recommends temperature mapping and validation of heating processes for
the approval and operation of independent meat production units (18).

The objective of validating the heating process is to confirm that the process, e.g. heating,
in every case, effectively reduces or eliminates the target pathogen, e.g. a 6D reduction in
L. monocytogenes, for which the process was designed (Section 3.8).

It is important that process validation is repeated until consistent results are achieved. This
will ensure that the food meets all legislative requirements, e.g. microbiological criteria for
food safety and the FBO requirements for shelf-life (15). Validation is recommended when:

1. Existing equipment or process is not already validated

2. After installation of new equipment and/or significant repositioning,
modification, repair or servicing of existing equipment
3. After significant modifications are made to equipment water/steam
supplies or replacement of parts likely to affect heating capacity, e.g. new
heating element, pumps, valves etc
4. After modifications to equipment loading/stacking configuration, patterns
etc
5. For processing of new foods, or existing foods with altered composition,
packaging, sizes etc.

The significance of all these changes should be assessed by the FBO’s HACCP team and
the requirement for re-validation risk assessed.

27
4.1 Instrumentation for Temperature Measurement

Temperature measurement can be achieved using a variety of instrumentation such as

bimetal style thermometers, thermistors, thermocouples, infrared thermometers etc.
Typically, in the Irish food industry, temperature measurement is achieved using calibrated
thermocouples and data loggers.

Due to the variety of available equipment, manufacturers and suppliers are best positioned
to give advice to the FBO on the choice of temperature measurement equipment for
specific purposes and food products. However, general considerations the FBO should take
in relation to instrumentation for temperature measurement, include the following:

1. Glass and mercury thermometers should not be used by the FBO for food
temperature measurement
2. Instrumentation should be hygienically designed to allow routine cleaning and
sanitising
3. Instrumentation should be sourced from an approved supplier
4. Instrumentation should have sufficient performance in terms of capability to monitor
the required process and product temperatures (i.e. operational temperature range)
and required accuracy and precision. It is recommended that the accuracy of
temperature monitoring instrumentation should be a minimum of ± 1.0oC (preferably
± 0.5oC)
5. Instrumentation should be able to be calibrated
6. Calibrated reference instrumentation (not used in normal processing) should be
available to allow internal calibration of working instrumentation
7. Specific instructions from the manufacturer of the instrument should always be
followed.

4.2 Thermocouples

Thermocouples are devices which use the voltage generated by the junction of two
dissimilar metals, to measure temperature. The voltage output is proportional to the
temperature of the junction. The advantages of using thermocouples are that they have a
wide temperature range, practical design, wide application and good performance in the
food industry.

It is important that the FBO considers the application of a thermocouple and the factors
affecting its performance. This can influence the type of thermocouple chosen. Specific
considerations that should be taken in relation to thermocouples, include the following:

1. The required accuracy and precision (i.e. uncertainty of measurement)

28
 2. Environmental conditions the temperature probe and connecting wires will be
exposed to and operate in:

i. Expected temperature range, e.g. a wide temperature range such as -5oC to

+100oC, a narrow range such as 70oC to 75oC or at a specific temperature
point such as 70oC. These can be expressed in terms of temperature accuracy
and precision over a temperature range or at a specific temperature point
ii. Expected temperature cycle, e.g. heat-chill environment, freeze-thaw environment
etc. The expected temperature cycle will influence the design, e.g. robust design
and type of thermocouple and connecting wires required
iii. Expected material to be measured, e.g. air/gas, partial or full insertion in solid
food, partial or full immersion in liquid, semi-solid foods etc.
iv. Mechanical requirements for the thermocouple in terms of shock or vibration
performance, electrical requirements in terms of insulation or shielding.

3. Time response required for the thermocouple (i.e. how quickly should the
thermocouple be able to respond to a change in temperature?)
4. Thermocouples and connecting wires should be of an appropriate type, e.g. types
J, K, T E, R and S thermocouple probes, manual probes etc., size and length
5. Number of probes required for temperature measurement
6. Electrical interference from plant equipment on long lengths of connecting wires/
thermocouple cable (i.e. long thermocouple cables may require shielding and/or
multiple product readings to compensate for resistance. Typically, use 3 or 4 core
wires where 1 or 2 strands measure the resistance of the cable and compensate
in the calculation of the temperature)
7. Thermocouples should be calibrated before use.

4.3 Data Loggers

Data loggers can be analogue or digital devices which record temperature over time, during
heating and chilling processes. The measurements taken are then stored (i.e. on charts,
print-outs, electronically or downloaded to a computer) for further analysis or reporting.

It is important that the FBO considers the application of a data logger and the factors
affecting its performance. This can influence the type of data logger chosen. Specific
considerations that should be taken in relation to data loggers include the following:

1. Manufacturers’ instructions for use of the instrument

2. The frequency of recording temperature over time should be adjustable from continuous
to defined interval, e.g. every minute depending on the application
3. Data loggers should have a sufficient number of channels to adequately monitor and
record temperatures
4. Data loggers should be calibrated before use.

29
5. Calibration

Calibration is a process of adjusting instrumentation and equipment, so that measurements

can be correlated to the actual value being measured. Typically, in a heat-chill process, the
measurement of temperature will be the most important use of instrumentation.

5.1 Calibration of Instrumentation

Food business operators will generally use two types of temperature measurement
instrumentation. Daily or working temperature measurement instrumentation is used for
routine temperature measurement and monitoring. Reference temperature measurement
instrumentation is used to check the accuracy and calibration of working temperature
measurement instrumentation. In calibrating all temperature measuring instrumentation, the
following should be considered by FBOs:

1. Calibration should follow a written standardised procedure (i.e. SOP) to

include:

i. The manufacturers’ instructions for calibration of each instrument (where

applicable/available)
ii. The designated personnel and/or external provider authorised to perform
calibrations
iii. The training requirements for personnel authorised to perform calibrations
(where applicable)
iv. The recommended calibration interval for each instrument
v. The data to be recorded during calibration (including readings taken
before and after adjustment, identification of the instrument or instrument
component calibrated, date and time of calibration, and the name and
signature of the person who performed the calibration). If no adjustments
are made, this should also be recorded
vi. Where the records of calibration will be stored and the personnel
authorised to access them
vii. Review procedures and review frequency for calibration records to allow
comparisons of performance change over time and to confirm that all
calibrations are completed and performed correctly
viii. The designated personnel authorised to perform review procedures
ix. Procedures to be followed where calibration procedures are changed or
updated in the event of equipment modifications or changes.

2. Where an external provider is used for calibration, the FBO should only use an
accredited (i.e. accredited to ISO 17025 for a defined scope of activity) provider. The
Irish National Accreditation Board (INAB) is the national body with responsibility
for accreditation in accordance with the relevant International Organisation for
Standardisation ISO 17000 series of standards and guides and the harmonised EN
45000 series of European standards

30
3. Where an external provider is used for calibration, the FBO should specify the
following minimum requirements for traceability in calibration:

i. Instrumentation and/or equipment identification, e.g. Manufacturer X Model No.

A, Manufacturer Y Model No. B, Manufacturer Z Model No. C, Manufactured
Probes etc.
ii. Company name, address, contact details and contact name(s) of external
provider
iii. Range and conditions of calibration, e.g. 24oC to 155oC (at ambient), 20oC to
130oC, at relevant process temperature etc.
iv. Method of calibration, e.g. National Metrology Method, SOP against manufacturer
X, Y or Z of instrumentation, accuracy check against similar manufacturer’s
reference instrumentation etc.
v. Frequency of calibration, e.g. yearly, prior to use, prior to use then yearly etc
vi. Accuracy details. e.g. 0.5oC, 1.0oC, etc.
vii. Corrective action(s), e.g. send for repair and recalibrate, discard instrumentation
and alter status
viii. Documents and records, e.g. National Metrology Report, provider report to
client number etc
ix. Degree of uncertainty.

4. The factors which can affect temperature monitoring and measurement

5. Temperature measuring instrumentation should be calibrated against measurement

standards traceable to the International Temperature Scale of 1990 (ITS-90). The
ITS-90 was adopted by the International Committee of Weights and Measures at
its meeting in 1989. This scale supersedes the International Practical Temperature
Scale of 1968 (amended edition of 1975) and the 1976 Provisional 0.5 K to 30 K
Temperature Scale. The ITS-90 defines both International Kelvin Temperatures, symbol
T90, and International Celsius Temperatures, symbol t90

6. Reference instrumentation used for calibration of temperature measurement

instrumentation should, at minimum, have an test uncertainty ratio of 4:1 (i.e. be
four times more accurate) than the daily or working instrumentation it is calibrating
(see section 3.8.1). For example, if the reference thermometer has an uncertainty of
± 0.25, the tolerance specified for the working thermometer can only be specified
at or above ± -1 deg C (i.e. 4 x 0.25)

7. Records of all calibrations should be kept and the date of the next calibration
should be indicated on the temperature monitoring equipment itself or its associated
documentation

8. All instrumentation should be initially calibrated (prior to use) and re-calibrated at

specified calibration intervals

31
 9. Calibration data should be reviewed every six months or more frequently (at a
minimum, annually) based on history and risk assessment to identify deviations from
defined tolerances, e.g. accuracy

10. When instrumentation is broken or out of calibration it should not be used until
repaired or replaced and re-calibrated

11. When internal probes in equipment, e.g. cooker, are broken or out of calibration,
the equipment should not be used until the probe(s) are repaired or replaced and
re-calibrated.

5.2 Calibration Interval for Instrumentation

Inaccuracies within temperature measuring instrumentation will typically be cumulative.

Furthermore, instrumentation susceptibility to aging and contamination (both physical and
chemical) means that they can sometimes drift out of calibration quite rapidly.

The calibration frequency for reference thermometers should be as specified by the

manufacturer or by risk assessment by the FBO. However, at minimum, it should be at
least every three years.

In the absence of manufacturer’s instructions for the calibration interval, a FBO should
initially calibrate daily working instrumentation prior to use and every six months, or at
minimum, at least once per annum thereafter. An annual calibration interval (i.e. in the
absence of manufacturer’s instructions for the calibration interval frequency) is a good
starting point for determining the calibration interval frequency for a specific instrument.
However, it should not be used indefinitely. An annual calibration interval is a minimum
and it should be formally evaluated and the interval adjusted as required.

If data at the annual calibration interval indicates that the instrument is near or in excess
of its acceptable accuracy (i.e. with no other conditions of use suspected of causing the
inaccuracy), it should be concluded that the calibration interval frequency is too long. In
this case, the calibration interval frequency should be shortened.

The calibration interval should be reduced or increased (as appropriate) until the
instrumentation is within its acceptable limit of accuracy at the end of each calibration
interval.

32
More or less frequent calibration intervals may be applied based on site-specific conditions
including:

1. Type, age and general conditions of the equipment

2. Calibration history of the instrumentation (where available)
3. Risk assessment, e.g. what is the risk if the instrument is out of calibration? If a probe
is used for release of cooked product and found to be out of calibration after six
months? Has the FBO been undercooking the product for the last six months and
if so is a recall required? Such critical probes should be subject to calibration checks
in a similar fashion to other critical control points such as metal detection, e.g. start
and finish of shifts
4. Conditions of use of the instrumentation, e.g. the instrumentation is dropped on the
ground, instrumentation is frequently used at the upper/lower range of its temperature
capability or above/below its recommended maximum temperature capability for
prolonged periods it should be recalibrated
5. The operational environment of the instrumentation, e.g. wet, cold, hot,
dry etc. conditions
6. The temperature tolerance (including the uncertainty budget which should be based
on the temperature instrumentation, the stability of the medium, immersion (if any)
and repeatability of measurements), which is deemed tolerable for the production,
e.g. cooking, process
7. The calibration of all internal equipment probes should be checked against an
annually certified standard thermometer traceable to the International Temperature
Scale ITS-90.

33
6. Setting the Process

Assuming that products are heat processed by a FBO under the same conditions for each
product batch, e.g. same product type, batch size, loading etc, how does the FBO know
that every product unit receives the same specified time/temperature combination, required
to deliver a microbiologically safe product?

As previously outlined (Section 4), a FBO should validate the processes they use, e.g.
heating and chilling, and then establish monitoring and verification procedures to ensure
this validation data remains accurate. Validation should only be carried out by trained
personnel (18) and has two main stages:

1. Temperature mapping of the heating medium (i.e. temperature or heat distribution

studies/tests)
2. Heat penetration tests of the product.

A trained person should map the temperature distribution in the cooker under maximum
and/or intended/defined standard loading conditions, to determine the cold spot(s). The
product at the cold spot should be probed (in its geometric centre). If a meat joint, for
example, at the cold spot in the cooker is probed and found to achieve the specified
time/temperature combination, it can be assumed that all other meat joints in the cooker
are also adequately cooked.

If a FBO changes any aspect of a validated heat process, e.g. product type size, loading
conditions etc., then that process must be re-evaluated to ensure that each product
unit receives the same specified time/temperature combination, required to deliver a
microbiologically safe product.

Processing of different batch sizes, e.g. half or quarter batch maximum capacity, is not
recommended. Only validated batch size loadings should be processed. No deviation from
this should be allowed in production as this is critical to the efficacy of validation of the
process. When setting a process, it is prudent that the FBO plan and test for all expected
batch sizes, operating conditions and product types under worst case scenarios including:

1. Simulation of under processing of product, e.g. affects of processing on products

positioned at cold-spots
2. Simulation of over-processing of product
3. Simulation of equipment breakdown and effect on product, e.g. to identify position(s)
and/or products which may have received full processing
4. Risks of post process contamination.

34
6.1 Temperature Mapping

Temperature mapping is recording temperature readings within the heating chamber using
calibrated instrumentation. This will locate point(s) or zones of slowest (i.e. cold-spots)
and quickest heating (i.e. hot-spots) in the heating medium, e.g. air, water, steam etc. of the
heat process chamber. The slowest heating spot will be the point that must be monitored
for food safety purposes.

Temperature mapping is required to develop, implement and validate heating and chilling
processes in preparation for heat penetration studies.

6.1.1 When is temperature mapping required?

Temperature mapping should be repeated at least every three years or more frequently
if:
1. New equipment is installed
2. Existing equipment is repaired, serviced, repositioned, replaced or
modified
3. Equipment experiences a mechanical or other type of failure
4. The original performance data are invalidated
5. The load in the heating chamber changes, e.g. new loading/stacking patterns,
configurations, designs or modes of use
6. The products formulation, composition and assembly changes
7. Equipment performance deterioration with time is suspected. The FBO may
be able to recognise from equipment instrumentation and process records
when a temperature distribution problem arises. Equipment operators
should be trained to observe and identify these potential problems
8. Original performance data are invalidated in any other way (i.e. any other
changes which may influence the temperature distribution in the product
zone).

6.1.2 What is required before temperature mapping?

Before beginning temperature mapping, the following considerations should be taken
by the FBO:

1. All instrumentation should be calibrated for use with the selected

equipment to be temperature mapped (i.e. same accuracy and operational
temperature range etc.)
2. All instrumentation should be calibrated to measurement Standards
traceable to the International Temperature Scale ITS-90
3. All connectors, leads, extensions etc., for instrumentation should be
assembled as they would be under normal processing conditions
4. Minimisation of error due to variables inherent in any component of
the temperature measuring system, heating equipment or product should
be considered
5. For standardisation and consistency of temperature mapping, an SOP for
the procedure on specific pieces of equipment should be documented.

35
6.1.3 Temperature mapping procedure
The location of the zones of slowest heating (i.e. cold spots) do not always follow a
logical progression, e.g. zones of slowest heating are located at the greatest distance
from the heat source. Therefore, this is an area where the knowledge and experience
of competent personnel specialising in temperature mapping can be very important.
Best practice in temperature mapping a heating chamber is as follows (18, 29, 48):

1. The heating equipment should be loaded with product and brought up

to the operating temperature to be used during temperature mapping.
Temperature readings should be taken during this period
2. The heating equipment should then be allowed to operate for a period
of time prior to temperature mapping beginning. Temperature readings
should be taken during this period
3. Temperature mapping should proceed by checking the processing equipment
at full capacity. Where products are routinely heating below the equipments
full capacity, the worst case scenario during normal operation should be
applied in temperature mapping. From a pragmatic perspective and to
ensure effective process control, it may be prudent to keep batch loading
options to a minimum
4. Position of probes within the heating chamber should be determined and
defined. Basic guidance on the placement of probes within the chamber
can be obtained from the design of the heating equipment, the heat
supply system, e.g. steam, water etc. and the loading pattern in the heating
chamber. However, as general guidance:

i. In horizontal stacking heating chambers, the product is usually placed in

the chamber in carriages. Probes should be positioned in the centre of
each case/crate/basket at the top, centre and bottom of each carriage.
If more probes are available, they should be located at the centre of
the outside of the four sides of each carriage

ii. In vertical stacking, heating chambers probes should be positioned in

the centre of each case/crate/basket on the top, centre and bottom
shelves of the heating equipment.

iii. If more probes are available, other points along the periphery of each
case/crate/basket on the top, centre and bottom shelves of the heating
equipment should be measured

iv. The initial temperature mapping results should be reviewed in

determining all locations within the heating chamber requiring
mapping.

36
 5. The arrangement of probes within the heating chamber should ensure that
data collected are representative of the heating capacity of the equipment
at specific positions/zones within the heating chamber. However, a minimum
of 7 to 15 probes per/m3 should be used with at least one probe placed
in close proximity to the equipments own internal temperature controlling
probe (i.e. master probe)
6. A schematic drawing of the location and position of all probes used in each
temperature mapping should be kept on record. For illustration purposes
only, Figure 2 outlines the positions of probes in a simple oven

Figure 2. Exploded Views of Cooker Racks Showing Possible Probe Location

Patterns in Temperature Mapping of a Simple Oven *

Rack

Option 1: Less probes Option 2: More probes

available and/or more racks available and/or less racks

Packs to which thermocouples are attached

* Only those packs which contain probes are shown. However, for any such testing, full racks of product should
be used to emulate worst case production conditions.

37
 7. In heating equipment which uses water or steam showering techniques,
probes should not be in direct contact with the water. In steam heating
equipment, the tips of probes should be pointing upwards to prevent
droplet formation from condensing steam
8. The arrangement of probes within the heating chamber should ensure
that they are not in contact with any internal surfaces within the heating
chamber and where possible, positioned in void spaces between product
packages (Figure 3). For illustration purposes only, Figure 3 outlines the
positions of probes between products in a simple oven
9. Repeat in duplicate, all temperature mapping tests, to ensure repeatability
and consistency of results
10. Identify and indicate the location of zones of slowest (i.e. cold spots)
and fastest (i.e. hot spots) heating within the heating chamber from the
recorded temperature data on a schematic drawing covering all three
dimensions (i.e. top, centre and bottom) of the heating chamber.

Figure 3. Probe Position for Temperature Mapping of a Simple Oven

Thermocouple tip
positioned in void spaces
between packs, away from
surfaces
Food Packs

Welded tip of
thermocouple

Tape securing
thermocouple

Thermocouple cable

6.2 Heat Penetration Tests

After completion of temperature mapping and identification of cold spots, the second stage
of validation is heat penetration tests. Heat penetration tests focus on taking temperature
readings of the products rather than the heating medium, e.g. air, using calibrated
instrumentation. Heat penetration tests will confirm the product heating characteristics
at product cold spots identified in temperature mapping. Heat penetration tests therefore
allow the FBO to determine the behaviour of the product during normal processing at
the identified cold spots.

From the data gathered in both temperature mapping and heat penetration tests, the FBO
can then validate a time/temperature combination to process the food to meet safety
requirements. Therefore, this is an area where the knowledge and experience of competent
personnel specialising in heat penetration testing can be very important (30).

38
6.2.1 When is a heat penetration test required?
Heat penetration tests are required to develop, implement and validate heating
and chilling processes after completion of temperature mapping. Heat penetration
tests should always be performed after temperature mapping to validate a heating
process.

Heat penetration tests should be repeated at least every three years or more
frequently as outlined in Section 6.1.1.

6.2.2 What is required before heat penetration tests?

Before beginning heat penetration tests, the following considerations should be taken
by the FBO:

1. Review and consider points made under Section 6.1.2

2. Review collected temperature mapping data
3. Ensure:

i. Product receives the same processing as in normal processing

ii. The product temperature before loading is as low as likely during normal
process operation
iii. Equipment used is the same as used in normal processing
iv. Product formulation, composition and assembly is the same as in normal
processing
v. Product packaging is the same as used in normal processing conditions
vi. The fill weight is not less than the maximum declared under normal
processing conditions.

6.2.3 Heat penetration test procedure

Heat penetration tests should be designed to ensure that all factors are considered
in delivery of the required heat treatment to products at the identified cold-spots.
Therefore, it is important that the FBO understands the product, package and process
factors which can affect heat penetration of the product.

Best practice in performing heat penetration tests is as follows (18, 30):

1. The probes should be positioned at the points of slowest heating in the

product. These points will vary depending on the nature of the product
and the equipment used. In relation to the product, the location of the
cold spot will depend on the dominant method of heat transfer (i.e.
conduction, convection) within the product. Location of the cold spot
can be determined by using a multi thermocouple probe in the product
and observing the slowest heating points. For illustration purposes only,
Figure 4 shows the ideal locations for thermocouples within multi (3 or
5) thermocouple probes

39
Figure 4. Ideal Locations for Thermocouples within Multi (3 or 5)
Thermocouple Probes

1/6 BPF
Upper thermocouple position

1/3 BPF

Middle thermocouple position

1/3 BPF

Lower thermocouple position

1/6 BPF

1/10 BPF
Upper thermocouple position
1/5 BPF
Upper middle thermocouple position
1/5 BPF
Middle thermocouple position
1/5 BPF
Lower middle thermocouple position
1/5 BPF
Lower thermocouple position
1/10 BPF

Note: Speed of thermocouple response will be proportional to the thermocouple wire and probe thicknesses

2. In conduction products surrounded by heating media, heat will

transfer from the outer surfaces of the product to the colder interior.
In such products, the slowest heating point will often be the geometric
centre or core of the product (1, 18) which is typically the thickest point in
a product. However, a certain amount of caution is required with irregular
shaped products. In such products surrounded on all surfaces by heating
media, heat will be approaching the interior from many directions and
as a result, the thickest point may not always correspond to the slowest
heating point. For illustration purposes only, Figure 5 shows the position
of a probe at the slowest heating point (i.e. the geometric centre) of a
simple product which heats by conduction

40
Figure 5. Probe Positions in a Product which heats by Conduction

Compression fitting to secure probe tightly

Product fill level

Probe inserted into the core/centre of the product

Measuring point at tip of probe in geometric centre of product

Product pack

Food

3. In products which are static during heating within which heat is transferred
by convection, the thermocouple should be placed at a height from the
base of 20% of the total height (40)

4. If the FBO rotates or agitates the convection product during heating,

the slowest heating point will be typically found at the geometric
centre(40). Where appropriate, probes (i.e. thermocouples) can be fitted
with a suitable spacer which allows the FBO to accurately position the
temperature sensor in the cold spot of the product on a repeated basis.
A compression fitting can also be used where appropriate, to securely
attach the probe to the package

5. In some products, a change of heating mode occurs during heat processing.

This change can be from convection to conduction (which is sometimes
called broken heating) or from conduction to convection (which is often
referred to as mixed heating). In such products, cold spots can be located
using the procedure described for convection heating

6. If the product is of a particulate or solid nature the worst case position

for the cold-spot should be used (i.e. worst case scenario in most
cases is were the largest available particulate is placed on the temperature
measuring part of the probe which is then placed in the product cold
spot)

7. Testing should proceed with the heating equipment at full capacity. Where
products are routinely heated below the equipments full capacity, the
worst case scenario during normal operation should be applied in the
heat penetration tests

41
 8. At a minimum, all products positioned at identified cold-spots (i.e. from
temperature mapping) should be tested for heat penetration. In addition,
the product which is in closest proximity to the equipments own internal
temperature controlling probe (i.e. master probe), should also be tested

9. Determine the initial temperature of the product. When determining the

initial temperature, the range of initial temperatures to be encountered
during normal processing conditions should be taken into account and
the coldest (i.e. worst case scenario) initial temperature selected

10. For determining the initial temperature, thermocouples should be placed

in a number of product units. Ideally, all product units in the heating
chamber should be equilibrated to the same identified initial temperature
before beginning testing. For illustration purposes only, Figure 6 shows the
position of a selection of probes positioned at various points (including
the identified slowest and quickest heating points) in the geometric centre
of a product which heats by conduction

Figure 6. Example of Probe Locations for Heat Penetration Tests

in a Simple Oven

Fan

Equipment probe

Product packs on top rack of heating chamber

Probe positioned at quickest heating point

identified from temperature mapping tests

Product packs on middle rack of heating chamber

Other probes positioned at selected points

Product packs on bottom rack of heating chamber

Slowest heating point identified from temperature mapping tests with product positioned at this point

42
11. The data logger should begin recording the temperature of each
thermocouple prior to beginning heat processing, e.g. steam-on in the
heating chamber, and thereafter at sufficient intervals, e.g. every minute,
throughout the heat process until the required time/temperature
combination is achieved

12. The required time interval, e.g. every minute, 2 minutes etc., for recording
product temperature during heat penetration tests, should be sufficient
to describe and verify the heating chambers operating parameters during
testing

13. Heat penetration tests should continue until the required time temperature
combination is achieved in product cold spots and/or products positioned
at the slowest heating point(s) of the heating chamber. Tests should further
extend for a short period after the required time/temperature combination
is achieved so that a definite temperature profile can be established for
all thermocouples used

14. Repeat in duplicate, all heat penetration tests to ensure repeatability and
consistency of results

15. Following heat penetration testing, if a product at the slowest heating

point(s) in the heating chamber is probed at the product cold spot(s)
and is found to achieve the required time and temperature combination
required for food safety, it can be assumed by the FBO that all other
products in the chamber are also safely heat processed.

43
7. Monitoring and Verification

When a FBO uses a validated heat-chill process, on-going process validation and verification,
e.g. temperature checks, should be undertaken on a scheduled, routine basis, based on
risk assessment.

7.1 Monitoring

On-going product temperature monitoring is required for all heat-chill processes. It

is required to verify that specific requirements for product safety (i.e. minimum time/
temperature combination necessary in cooking) have been achieved. This will allow the
FBO to positively release a batch of product following a heat-chill process.

1. On-going product temperature monitoring should be carried out on a scheduled basis

for verification purposes when a FBO operates a validated heating process.
2. Monitoring should be performed on specific products on every batch of every product
produced by the FBO.
3. Data, e.g. graphs, showing temperature profile during cooking, output of data logger
etc., from all product temperature monitoring, will provide objective evidence that the
product has been cooked and chilled on the specified (validated) programmes for that
product, necessary to ensure product safety.
4. Data from all product temperature monitoring will help verify that core probes in
products have reached the specified core temperature and that the appropriate product
stacking arrangement was used for that product to allow adequate the air, steam etc.
flow within the heating chamber.
5. On-going product temperature monitoring should provide data from products at
identified cold spot(s) and in products on the top, middle and bottom levels of
the heating chamber. In addition, the largest products in a batch should always be
monitored.
6. Prompt and regular review of all collected data is necessary to verify a process and to
quickly identify problems and implement changes to a process or product, if required.
Reference should be made to previous verification data to ensure the data gathered
are repeatable and accurate. Therefore, monitoring and verification are integral parts
of HACCP (Section 2).

7.2 Verification

Verification is the confirmation by examination (i.e. temperature monitoring) and provision

of objective evidence (i.e. data collection and recording) that specified requirements for
the process, e.g. cooking process: required temperature and time combination in every
product unit, have been achieved(4).

Verification of a validated process should be an objective assessment of process

monitoring data against the data from the validation of the process. This will verify
that the specified process has been followed, including:

44
 1. Independent checks by quality assurance staff on product temperatures
2. Stacking arrangements
3. Results of microbiological analysis
4. Results of audits
5. Customer complaints
6. Internal non-conformances
7. Changes in research data available etc.

7.3 Data Collection and Record Keeping

Data should be kept for all validation, monitoring and verification tests (i.e. temperature
mapping and heat penetration tests), trials and commercial production runs/batches for
audit and inspection purposes.

In addition, data collected on equipment, services and product time and temperatures
should be recorded for recall and traceability of product in the event of a food safety
incident occurring (5).

Best practice for data collection and record keeping should include the following:

1. Data collected and recorded should be authorised, updated and maintained. The assigned
responsible/competent employee should sign off on data recorded before product
release
2. All data collected and recorded using computers, should have a back-up copy
3. Data should be collected, collated and recorded for all validation tests, trials and
commercial production runs, batches etc. for audit and inspection purposes and should
include the following information:

i. All dates and times

ii. Identification (i.e. if more than one piece of heating equipment available), technical
specifications, performance criteria and calibration details for equipment and ancillary
equipment
iii. Location of temperature probes
iv. Calibration details of temperature probes
v. Details on personnel operating equipment or carrying out tests
vi. Detailed files/printouts of temperature/time profiles for products and equipment
vii. Product specification including: name, characteristics, e.g. pack size, number of packs,
raw materials used, any available intrinsic/extrinsic data including product prior to
heat treatment), formulation, identification code(s), e.g. batch/lot number etc.
4. In relation to the loading and stacking configurations, the exact configuration used
must be recorded. The minimum information that should be recorded includes:

i. Maximum number of cages/crates/baskets in the heating chamber

ii. Container size, loading/racking configuration

45
 iii. Maximum number of containers per level in heating chamber, e.g. top, middle or
bottom shelves, or per cage/crate/basket
iv. Aperture size and spacing of the cage/crate or basket base plates
v. The open area of the base plate and separator sheets if used in the cages/crates or
baskets.
5. Data should be collected, collated and recorded for all equipment and instrumentation
including the manufacturer, the model/type, settings and serial numbers, details on dials,
fans, motors, boilers, steam pressure monitors, etc. This record should be updated as
and when any changes are made
6. Data should be collected, collated, recorded and documented for all stacking/racking
arrangements for all products
7. If any changes are made to the above parameters, the change must be documented
and assessed by the HACCP team and the process re-validated as necessary
8. Records generated from data loggers and temperature probes, e.g. thermocouples, should
indicate the date, time, and source of reading and should be signed by the individual
responsible for the device at that time.

From a traceability perspective, the EC recommends that records should be kept by FBOs
for five years, starting from date of manufacture of a food product. However, there are
some exceptions(5, 22):
i. If the shelf-life is greater than five years, then records should be kept for the shelf-
life plus six months
ii. In the case of fresh products destined for the consumer, records should be kept up
to the use-by date plus six months or six months if no use-by date is required
iii. In the case of fresh products destined for other food businesses, records should
be kept for five years.
7.4 Non-Conforming Product

Non-conformances in product safety and quality will occur within the quality system of
every FBO. In the event that a non-conforming product is identified due to equipment
failure, e.g. heating and/or chilling processes, or process deviation, e.g. required temperature
in product during heating not obtained, the FBO should have procedures in place to
ensure that the product batch is clearly identified, segregated and not in-advertently used
or dispatched prior to the safety of the product been established.
The FBO must then carry out a risk assessment on the segregated product to assess the
products safety. Based on risk assessment, there are three possible methods of dealing with
non conforming product:
1. Accept the non-conforming product following further inspection and testing
2. Rework the non-conforming product to meet specified requirements
3. Dispose of the non conforming product.

46
Glossary

For the purposes of this document the following definitions will apply:
Accuracy is the closeness of a reading of a measurement device, e.g. temperature, to
the actual value of the quantity being measured; usually expressed as ± percent of the
reading
Aerobic microorganisms require oxygen for growth
Anaerobic microorganisms do not require oxygen for growth
Cooking is preparation of food for human consumption by the application of heat. In
the context of this document the application of heat should be sufficient to ensure
pasteurisation of the food
Competent body means the central authority in Ireland competent to ensure compliance
with the requirements of legislation or any other authority to which that central authority
has delegated that competence; it shall also include, where appropriate, the corresponding
authority of a third country (3)
Commercial Sterilisation (Commercially Sterile) is a heat treatment designed to
render a food free of microorganisms capable of growing in the food at room or ambient
temperatures
Facultative microorganisms grow with or without oxygen
Food (or foodstuff) means any substance or product, whether processed, partially processed
or unprocessed, intended to be, or reasonably expected to be ingested by humans. Food
includes drink, chewing gum and any substance, including water, intentionally incorporated
into the food during its manufacture, preparation or treatment (5)
Food business means any undertaking, whether for profit or not and whether public or
private, carrying out any of the activities related to any stage of production, processing
and distribution of food (5)
Food business operator means the natural or legal persons responsible for ensuring that
the requirements of food law are met within the food business under their control (5)
Food law means the laws, regulations and administrative provisions governing food in
general, and food safety in particular, whether at Community or national level. It covers
any stage of production, processing and distribution of food, and also of feed produced
for, or fed to, food producing animals (5)
Microbiological criteria are tools that can be used in assessing the safety and quality
of food products. The use of microbiological criteria should form an integral part of the
implementation of HACCP-based procedures and other hygiene control measures (7)
Microaerophilic microorganisms require a reduced level of oxygen for growth
Pasteurisation is a mild heat treatment applied to foods to inactivate heat labile
microorganisms such as vegetative bacteria, yeasts and moulds which may cause food
spoilage or food poisoning. Therefore, a pasteurised food is unlikely to cause illness if it

47
is stored correctly and consumed before the end of its shelf-life, typically indicated by
a use-by-date(21)
Pathogenic microorganisms are disease causing microorganisms
Precision is the degree of agreement between numbers of independent measurements
of the same property, e.g. temperature taken under the same conditions
Prerequisite(s) are practices and procedures required prior to and during the
implementation and ongoing operation of a HACCP system, e.g. premises, equipment,
staff training, pest control, waste management
Perishable food is food which is subject to rapid decay, spoilage and/or growth of
pathogenic microorganisms with or without production of toxins or metabolites in quantities
that may present an unacceptable risk for human health
Processed products are food resulting from the processing of unprocessed raw materials/
ingredients. These products may contain ingredients that are necessary for their manufacture
or to give them specific characteristics (3)
Ready-to-eat means food intended by the FBO for direct human consumption without
the need for further cooking or other processing effective to eliminate or reduce to
acceptable level microorganisms of concern (6)
Reformed products use intact meat/poultry/fish pieces physically or chemically bound
together to resemble whole unprocessed products.
Restructured products use minced, diced or chopped pieces of meat/poultry/fish
physically or chemically bound together into a restructured shape
Shelf-life means either the period corresponding to the period preceding the use-by
or the minimum durability date as defined respectively in articles 9 and 10 of Directive
2000/13/EC (6)
Sterile product is a product in which all viable microorganisms are absent
Uncertainty of measurement is a quantitative measure of the quality of a measurement
result, enabling the measurement results to be compared with other results, references,
specifications or standards (49). Typically, uncertainty of measurement is represented by
the observed reading on the reference equipment followed by ± the uncertainty of
measurement, e.g. 30oC ± 1oC
Validation is a procedure for checking if a process satisfies a specific criterion for food
safety
Verification is the confirmation by examination and provision of objective evidence that
specified requirements for a process have been achieved
Viability (Viable) is the ability of microorganisms to reproduce when conditions suitable
for growth occur

48
Appendix 1. Intrinsic and Extrinsic Properties

The intrinsic properties are those properties that are an inherent part of the food such
as pH and aw. The extrinsic properties are the properties of the environment in which
the food is stored such as temperature and packaging atmosphere. Minimum values for
pathogenic growth related to singular intrinsic or extrinsic properties are influenced by
other intrinsic and extrinsic properties. Pathogenic growth is best when intrinsic and
extrinsic properties are optimal.

Water Activity (aw)

Water activity is the availability of water in a food. Water activity will determine the
lower limit for pathogenic growth and survival. Water activity ranges in value from 0 to
1.0. Most pathogens grow best at aw near 1.0. However, minimal aw required for growth
can be between 0.88 – 0.91 (50).

The heat resistance of some pathogens may increase as aw decreases. However, many
heat processed foods will have a high aw which doesn’t significantly affect pathogenic
heat resistance in the food. In food processing aw can be decreased by the addition of
ingredients, e.g. salts, sugars, starches which bind and make water unavailable to pathogens.
Evaporation of water from foods during heat processing, e.g. cooking, drying, etc. can also
decrease aw.

pH
The pH is a measure of a foods acidity or alkalinity (43). The pH scale ranges from 1 to
14 with the relative extent of acidity and alkalinity defined by their pH value on this scale.
Most pathogens grow best at a neutral pH near 7.0. Typically, a pH of 4.0 to 4.5 will
inhibit the growth of most foodborne pathogens. However, low-acid foods with a pH of
4.5 typically require heat processing for safety reasons (i.e. growth of Clostridium botulinum
can occur at or above pH 4.5).

The pH of foods may vary with time due to microbial activity and food composition
or formulation. Specific foods such as vegetables and fresh meats may be prone to pH
change.

At a processing level a food may have a pH which prevents the growth of pathogens.
However, if the pH changes during product shelf-life, conditions may become favourable
for pathogens to grow in the product. This can increase the safety risk to the product.
Therefore, products of this nature require control of pH and/or heat processing. Organic
acids such as ascorbic, sorbic, acetic, lactic, benzoic acid etc. while antimicrobial in nature
are extensively used in the food industry to control product pH (i.e. acidity regulators).

Food Composition
The composition of foods can have an effect on the heat resistance of pathogens. Table 8
outlines the typical effects on heat resistance (43).

49
Table 8. Effect of Compositional Characteristics on General Pathogenic Heat
Resistance

Food Compositional Characteristics Increase Heat Resistance

Increasing Fat A Yes

Increasing Carbohydrate B Yes
Increasing Protein Yes
Increasing Salt C Variable
Food Structure D Variable
A
Heat-resistance studies for inactivation of L. monocytogenes have shown that heat-resistance increases with
increasing fat content
B
The heat resistance of pathogens will increase in the presence of high concentrations of sugars. This is
partially due to a decrease in aw associated with high concentrations of sugars. However, the relative
affects of different sugars on the heat resistance of pathogens varies widely even if the aw remains the
same. The heat resistance of pathogens will also increase in the presence of starch(s) in a product
C
The effect of salt on the heat resistance of pathogens is variable and largely depends on the type of
salt and its concentration. Sodium salts, e.g. sodium chloride, will decrease aw and therefore may increase
heat resistance. Other salts such as calcium and magnesium salts increase aw and thereby decrease heat
resistance
D
Many foods will not have a uniform internal structure. As a consequence micro-environments may
form within the food. The location of pathogenic cells in the food may also affect their resistance to
heat treatment. Micro-environments may have different properties to the food as a whole. This can be
problematic if the properties within these micro-environments allow the growth of pathogens if as a
whole the product’s properties do not allow their survival and growth

The effect of fats, proteins, carbohydrates and high solids contents on the heat resistance
of pathogens can be quite significant. Some of these components can increase heat
resistance of pathogens by a factor of 2–3 (44). The current industry trends to reduce
salt, sugars and other additives in foods should be considered by the FBO during product
development. Changes in these components may affect the inhibitory properties of a food
and therefore, the required heat treatment to maintain food safety.

Storage Temperature
Pathogens have different temperature requirements for survival and growth in foods.
The minimal temperature for pathogenic growth is also influenced by other intrinsic
and extrinsic properties. However, it is lowest when these properties are optimal, e.g.
pH, aw etc. for a specific pathogen. Therefore, when sub-optimal levels for other intrinsic
and extrinsic properties are combined with low storage temperature, the safety of heat
processed food increases. The effect of storage temperature on the growth and survival
of pathogens is very dependent on the relative humidity of the environment and the
presence and concentration of gases (43).

50
Gas Atmosphere
Modified atmosphere packaging (MAP) and vacuum packed (VP) alter the concentration
and types of gases found under normal atmospheric conditions. MAP and VP are inhibitory
to aerobic pathogens but may permit the survival and growth of facultative, e.g. L.
monocytogenes, anaerobic, e.g. Cl. botulinum and microaerophilic, e.g. Campylobacter jejuni,
pathogens in foods.

Modified atmosphere packaging and VP also increase product shelf-life and as such, may
also increase the risks of anaerobic, facultative or microaerophilic pathogens growing over
the extended shelf-life. This can affect the type of heat processing the food requires for
microbiological safety (21).

Relative Humidity
The relative humidity of a gaseous mixture at a particular temperature is the ratio of
the amount of water vapour in the gaseous mixture to the maximum amount of water
vapour which the mixture can hold at that temperature. Relative humidity is usually
expressed as a percentage.

When food with low aw is placed in high relative humidity environments, the food will
absorb moisture until equilibrium with the environment is established. Food with high
aw placed in low relative humidity environments will lose moisture by desorbtion until
equilibrium with the environment is established. Therefore, the selection and storage of
a product at the correct relative humidity is very important in relation to the growth
and survival of pathogens.

51
Appendix 2. Other Validation Techniques

Under specific processing conditions, e.g. heating chamber/vessel with scrapers, or due
to the characteristics of specific products it can be difficult to validate the safety of a
process based on temperature measurement using temperature probes. In these cases,
another means of validation may be employed. Typically, these processes and products will
include:

1. Products produced in steam injection, steam infusion, plate, tubular or scraped surface
heat exchangers such as milk and milk products, sauces and dressings, some soups,
jams and preserves
2. Products produced in deep fat/oil frying units and continuous ovens such as biscuits,
breads, processed meats, poultry and fish, particularly breaded products
3. Products produced in agitated steam jacketed vessels such as those containing discrete
meat, poultry, fish and vegetable pieces including soups and ready meals.

In these and other cases, alternative methods other than temperature measurement using
probes, are required for validation of product safety including:

1. Use of biochemical time-temperature integrators (TTIs). Typically, TTIs use an enzyme

that denatures on heating. If the heat reaction kinetics of the enzyme are the same as
the microbial death kinetics of the target pathogen, it is possible to use the enzyme
as an indication of product safety after heat processing
2. Simulated laboratory trials where the process conditions are replicated and the
temperature can be conventionally measured using temperature probes
3. Microbiological methods including challenge tests, inoculation studies, predictive
microbiological methods and end-product testing
4. Use of mathematical process models which predict the temperature and time
characteristics of products as they pass through a process such as cooking
5. Process safety being inferred from temperature probing of the bulk product and/or the
processing environment (where applicable)
6. Over processing of product to ensure that its core or central part(s) receive sufficient
processing to ensure product safety, e.g. heating a product at the same temperature
but for a longer period of time.

In all cases where alternative methods other than temperature measurement using probes
are required for validation of product safety, consultation with an expert is strongly
recommended.

52
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NOTES

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NOTES

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NOTES

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NOTES

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61
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