BARRIER TECHNOLOGY

RABS & ISOLATORS FOR ASEPTIC PROCESSING

ISOLATORS

In the pharmaceutical sector the need to protect the product from

contamination due to the presence of personnel or the environment
is one of the major drivers for containment.
What matters most in pharmaceutical aseptic processes is the
maximum reduction of the risk of product contamination which is
basically due to particles and micro-organisms.

Combined with automated filling systems for liquids or powders,

barrier technology minimizes the direct human intervention in the
processing area and is now a technology that is being increasingly
and rapidly adopted by the pharmaceutical industry.
Internationally recognized as expert in advanced aseptic processing
applications, IMA LIFE has gained a wealth of experience in Cross
Contamination Control and can offer a solid understanding of
the risks associated with the handling of potent and cytotoxic
compounds.

Barrier technology is now used with

increasing frequency.

A variety of reliable containment solutions

have been developed to meet customer’s
specific requirements.

IMA LIFE can boast an in-house technology

and wide range of applications, including:

◾◾ Isolators for aseptic filling lines

◾◾ Sterility Test Isolators

◾◾ dispensing isolators

◾◾ Closed RABS

◾◾ Active / Passive Open RABS

DIFFERENT SOLUTIONS FOR DIFFERENT NEEDS

INSPIRED BY EXCELLENCE
The IMA LIFE new range of isolators
combines essential features and the
simplicity of proven technology with widely
appreciated high standards of quality and
reliability.

Example of Isolated Processing Line during Factory Acceptance Test

activities at IMA plant
ISOLATORS

IMA LIFE isolator systems can ensure optimum

operator and product protection and a full
integration isolator-machine with cost-
effectiveness and ease of use.
The increasing amount of toxic products treated by the
pharmaceutical industry calls for more and more sophisticated
containment technologies that can reduce the risks posed
to operators and the environment and guarantee the basic
requirement of patient safety.

Consequently, the use of cleanrooms for aseptic filling and

processing is going to decrease, following an inversely proportional
trend related to the isolator systems demand, which are best in
handle specialty environments required by some of these products
as low relative humidity or low oxygen levels.
Complete vials/syringes filling lines for aseptic and/or toxic products
are installed is several countries world-wide. After a difficult start,
they are day by day more accepted and EMA and FDA are strongly MATERIAL TRANSFER ISOLATOR (MTI)
suggesting the adoption of Isolators in any new production plant The Material Transfer Isolator is recommended to decontaminate
for aseptic products. components, tools, or whatever unit that must be introduced inside
the isolated filling line, without breaking the aseptic environment.
A state-of-the-art technology: a fully closed enclosure, equipped It is a section of the “main filling line isolator” but it can be
with a dedicated air circuit, where machines can be segregated. This decontaminated independently, while other sections are in a
system ensures the highest product protection and a full operator different status.
protection. Production area can be downgraded to class C and is
the ideal solution to handle highly toxic products. Its closed environment allows fast and secure decontamination
procedures using H2O2, ensuring a high level of aseptic environment.
IMA LIFE isolator systems provide the highest It shares the same Heating Ventilation Air Conditioning (HVAC)
and most reliable machine configuration to and H2O2 generator system of main isolator.
grant:
◾◾ Highest SAL (sterility assurance level)
◾◾ Highest operator protection
◾◾ Highest automated operations

Material Transfer Isolator – internal overview

 ISOLATION TECHNOLOGY KEY ELEMENTS

◾◾ Significant increase of sal relative to

conventional cleanrooms and open rabs

◾◾ Reduced risk of viable contamination

during filling operation

◾◾ Humidity and temperature inside the

isolator can be controlled adopting a
dedicated HVAC

◾◾ Possibility to recycle the air used inside,

saving hvac enery consumption

◾◾ Automatic, reproducible,
OPERATION COST SAVINGS well documented system for
bio-decontamination for all critical
◾◾ Less quantity of air required by the machine parts in situ
production room
◾◾ Possibility to perform
◾◾ Less air sampling (particulate and WIP (wash in place) cycles
microbiological)
◾◾ Possibility to perform automatic
◾◾ Less time spent by operators to enter/ decontamination cycles (i.e. with H2O2)
exit the classified room, and consequent
increase of product protection ◾◾ Reduced microbiological monitoring

◾◾ Less expensive gowning ◾◾ Reduced business risk

The following table compares the amount of conditioned air required by the same filling line, installed in the same production room, but with different
barrier technologies.

Conventional CLEAN ROOM OPEN or CLOSED RABS ISOLATOR

Filling Surrounding Filling Surrounding Filling Surrounding
Class A B A B A C

Clean room area m 2

68 41 27 20.6 47.4
Air changes per hour
60 40
(considering the ceiling at 3 m)
Total air per hour 110,16 66,42 4,86 33,372 5,688
Total air per day (24 hours) 2,643,840 1,594,080 116,640 800,928 136,512
Total air per day
2,643,840 1,710,720 937,440
(24 hours) in m3
Saving respect to an installation with
-35.29% -64.54%
conventional clean room
Saving respect to an installation with
-45.20%
OPEN or CLOSED RABS
ISOLATORS

IMA LIFE SOLUTIONS ARE FULLY

COMPLIANT WITH INTERNATIONAL
REGULATORY STANDARDS AND
GUIDELINES (I.E. FDA, EMA).

THE IMA LIFE PROPOSAL TYPICAL CHARACTERISTICS

OF ISOLATORS RANGE FROM: OF IMA LIFE ISOLATORS

◾◾ Isolators for liquid aseptic production ◾◾ Wall Isolator - Isolator fully integrated
lines (aseptic and toxic) on machine base plate – bottom of
isolator is the machine base plate – no
◾◾ Isolators for powder aseptic
interface required
production lines
◾◾ Single Wall principle
◾◾ Isolators for lyo loading/unloading
systems (aseptic and toxic) ◾◾ Sloped Equipment/Isolator base plate (to
improve cleanability)
◾◾ Sterility test isolators
◾◾ Fully integrated design with equipment
◾◾ Formulation and compounding
isolators ◾◾ Easy access to the equipment operating
units
◾◾ Dispensing isolators
◾◾ Highly ergonomic

RAPID TRANSFER PORT (RTP)

Fixed to one of the wall of the isolator, the Rapid Transfer Port
system (RTP) is a bi-directional contamination-free transfer system
which allows for a wide range of sterile transfer applications into
and out of an isolator.
The double-lid principle of the RTP technology is usually applied for
the introduction in the Class A production area of:
• Pre-washed and pre-sterilized stoppers and alu-caps
• Petri plates
• Tools, change parts, etc.
◾◾ High-grade stainless steel construction ◾◾ Customized H2O2 cycles
◾◾ GMP compliant ◾◾ One process philosophy and one design
◾◾ FDA approved material concept for both toxic and non-toxic
products
◾◾ Automatic leak test
◾◾ Bag in – Bag Out HEPA filters in return
◾◾ HEPA filters for air inlet and exhaust ducts in case of toxic product
◾◾ Air handling system ◾◾ WIP in air return ducts and in
◾◾ Pressure zone management production section
◾◾ Closed recirculation System ◾◾ Spray nozzles & Spray guns for Isolator
and equipment cleaning
◾◾ Dedicated HVAC system (customized
design, flexibility, modularity)

Each section can be isolated from others

by installing a dedicated cover made of
ptfe, which can be easily cleaned and
decontaminated.

The perfect locking is ensured by inflatable

gaskets and constantly controlled by a
dedicated sensor.
ISOLATORS

WALL DESIGN NO GASKETS

BETWEEN ISOLATOR
AND MACHINE BASEMENT
ENSURING A PERFECT
INTEGRATION A
LONG TERM HIGHER
LEAK TIGHTNESS.

H2O2 DECONTAMINATION CYCLES

Automatic decontamination cycles H2O2 decontamination cycles can be
with H2O2 systems are currently used as subdivided in the following steps:
rapid, low temperature techniques for • Dehumidification
decontamination of production filling
• Conditioning
lines, sterility testing isolators, sealable
enclosures, and various types of pass- • Decontamination
through systems within pharmaceutical • Aeration
production, research, and bio-safety
IMA LIFE can supply a complete package
laboratory facilities.
that includes Cycle Development (CD) and
Performance Qualification (PQ).
STERILITY TESTING AND DISPENSING ISOLATORS

STERILITY TEST ISOLATOR

IMA LIFE’s production range also includes the ideal solution to
perform Sterility Tests, drastically decreasing false positive results.
Designed for QC Labs, pharmaceutical production and pharmacies,
IMA LIFE’s Sterility Test Isolators are equipped with an unidirectional
air flow system and guarantee a constant positive pressure gradient
between the chambers and the external lab environment.

MAIN FEATURES
◾◾ GMP Class A ISO 5 isolator system

◾◾ Air quality assured by Ultra

Low Penetration Air (ULPA U15),
unidirectional down flow and return
filters

◾◾ Isolator leak tightness test according

to ISO 10648-2, CLASS 2

◾◾ Integrated sterility test pump

◾◾ Fully automated bio-decontamination

procedure

◾◾ Fully integrated viable and non-viable

monitoring systems

◾◾ Easy-to-use integrated glove leak

testing system: requires no external
piping, power or compressed air
DISPENSING ISOLATOR
Designed to meet the pharma industries requirements for highest
containment levels during manipulation of potentially dangerous
compounds for R&D, production and QC.

MAIN FEATURES
◾◾ GMP Class C ISO 7/8 isolator system

◾◾ Air quality assured by High Efficiency

Particulate Air (HEPA H14) inlet and
outlet filters

◾◾ Isolator leak tightness test according

to ISO 10648-2, CLASS 2

◾◾ Fully automatic or manual WIP cycles

available

◾◾ Rapid Transfer Ports or High

Containment Alpha/Beta valves to
introduce and/or remove products
from the Isolator, without breaking the
containment level.

◾◾ Easy-to-use integrated glove leak

testing system: no external piping, power
or compressed air required
CLOSED R ABS

RABS
The Restricted Access Barrier System (RABS), is a rigid protection
made of transparent walls (polycarbonate or glass), equipped with
an adequate number of glove flanges and gloves. It is installed on
top of the filling and/or capping machines, separating them from
the surrounding area.
Gloves must be positioned in order to allow the operator to
perform all operations inside the machine, such as cleaning, caps/
stoppers loading, vials removal, etc. so that these can be performed
by operators without opening the protection walls.

CLOSED RABS
The closed RABS is an intermediate solution between isolators
and open RABS. The unidirectional air flow (inlet and outlet) is
fully controlled by the system, allowing a correct pressure control.
The air is recycled and exhausted via a well defined channel, thus
making this system suitable to be used with slightly toxic products.

Due to the lack of leak tight certification, these systems cannot be

used for highly toxic products.

Class A environment must be assured whilst the surrounding must

be classified as B.
Filling area

MAIN CHARACTERISTICS
◾◾ Easy to validate (air flow, air
classification, doors interlocks)

◾◾ Possibility to downgrade the

production area to class b

◾◾ Production area access control (doors

can be interlocked)
Gaskets and details of filling area Alu-capping area

◾◾ Automatic or semiautomatic WIP cycles ◾◾ Surrounding production area must be

class b
◾◾ Humidity and temperature inside the
crabs can be controlled adopting a ◾◾ Limited operator protection, not useful
dedicated HVAC with highly toxic products

◾◾ Possibility to recycle the air used inside, ◾◾ No possibility to perform automatic

saving HVAC energy consumption decontamination cycles (i.E. With H2O2)
OPEN R ABS

OPEN RABS
A RABS is considered OPEN when the air used for the laminar
flow is not recycled, but it is exhausted into the production room,
without any control or filtration.

The open RABS can be either ACTIVE or PASSIVE:

- ACTIVE: equipped with an independent air ventilation system.
In this case, the unidirectional airflow required is generated by fans
and filters that are parts of the RABS itself.
In both cases, the area inside the RABS must be “A” class, and the
surrounding area must be classifies as “B”.
- PASSIVE: not equipped with a dedicated air system. In that case,
the unidirectional air flow inside the RABS should be generated
externally by fans and filters embedded in the false ceiling of the
production room.

In both cases, the area inside the RABS must be “A” class and the
sorrounding area must be classified as “B”.

Active RABS
 MAIN CHARACTERISTICS
◾◾ Easy to install, also on existing
machines
◾◾ Easy to validate (air flow, air
classification, doors’ interlocks)
◾◾ Possibility to downgrade the
production area to class b
◾◾ Surrounding production area must
be class b (with an isolator it can be
downgraded to the less expensive class c)
◾◾ No operator protection, not useful with
toxic products
◾◾ Humidity and temperature inside the
open RABS depend on the production
room conditions
◾◾ There is no possibility to recycle the
air used inside, saving HVAC energy
consumption
◾◾ No possibility to perform WIP cycles
(wash in place)
◾◾ No possibility to perform automatic
decontamination cycles (i.E. With H2O2)

Passive RABS
 December 2018 - 991ZS025101
www.ima-pharma.com

IMA S.p.A. reserves the right to make any changes to the described machine characteristics.

IMA S.p.A.
IMA LIFE division
Via Emilia 428-442 - 40064 Ozzano dell’Emilia (Bologna) - Italy
Tel. +39 051 6514111 - Fax +39 051 6514666
IV mktg.life@ima.it - www.ima.it