GETINGE ISOFLEXMULTI-PURPOSE ISOLATOR
2 | GETINGE ISOFLEX
Apart from the clean room zone itself, you need trained
operators and strict procedures to prepare the room and
the people involved to be ready for the process.
Getinge, with its 3- and 4-glove ISOFLEX isolators, can be
the answer to your sterile handling needs by providing:
• Simplicity of the ISO 8 location and easy gowning for
most applications since isolator systems dedicated
to sterility testing may be located in a non-classified
room with restricted access;
• Security with validated sterility of the working area
and cross-protection of product/operator/environ-ment.
• Traceability for all the steps of the sterile handling
process.
THE ANSWER TO YOUR DAILY NEEDS FOR STERILE HANDLING
In any sterile operation, maintaining the sterility of goods -- whether you have purchased them
sterile or sterilized them yourself -- is a complex task, for which aseptic conditions are only one part
of the requirement.
• The initial sterility is provided by a dedicated H2O2
vapor (HPV) program to bio-decontaminate the isola-
tor and the outside of the sterile components thanks
to the integrated STERITRACE II system.
• The sterility is maintained with the positive pres-
sure of HEPA-filtered air. The outlet HEPA prevents
against any return of non-sterile air.
• The work can be either a strict batch process with
loading/bio-decontamination/work/opening or a
semi-batch process which includes upstream and
downstream transfer systems.
GETINGE ISOFLEX | 3
• Getinge 3-glove ISOFLEX is for one operator and offers a large storage capacity.
• Getinge 4-glove ISOFLEX is for two operators working side by side.
• DPTE® transfer systems can be installed at both ends instead of the standard lateral doors.
• Additional items, e.g. interfaced instruments and liquid/solid transfers equipment, can be installed if necessary.
• The integration of STERITRACE II avoids unneces-sary hose connections during the bio-decontami-nation process.
TWO TYPES OF ISOFLEX MULTI-PURPOSE MODULAR ISOLATORS
Getinge supplies two types of ISOFLEX isolators to cover all your needs.
ISOFLEX-S, a soft wall isolator with flexible
transparent walls for optimal visibility.
ISOFLEX-R, a rigid wall stainless steel and glass isolator with lift-up front window for easy load-ing.
4 | GETINGE ISOFLEX
COST-EFFECTIVE GETINGE ISOFLEX WITH HIGH-END STERITRACE II STERILIZERTraceability
Important parameters are monitored and may be recorded; they
can be either directly sent to a printer or stored on a remote PC.
This means:
• Theprocessisalwayscontrolledbytheoperator.
• Securityforboththeoperatorandtheprocess.
• Dataexchangetableavailableonethernetnetwork.
Siemens PLC controller and touchscreen display
Both the isolator and integral Getinge Steritrace II HPV sterilizer are
controlled by a single Siemens PLC control system. This assures
repeatable, reliable operation. The Siemens PLC is an industry
standard and has communication capabilities for remote monitor-
ing.
• Theoperatorcontrolpanelisacolortouchscreen,whichpro-
vides access to the PLC for parameter setting (by authorized
persons) and critical parameter monitoring. Alarms are also
clearly presented on the display.
• Thesingle,easilynavigatedoperatorpanelassuressimpleop-
eration, minimized errors, and maximized productivity.
Validated process
Validated process thanks to new integrated
STERITRACE II H2O2 sterilizer:
• Integrated:cost-effective,reliable,noadditionalequipmentto
manipulate and maintain (no dessicant), only one user interface
to control both the isolator and the sterilizer. H2O2: no odor,
easy to monitor during the validation process.
• Validationiseasier,increasedproductivityasaresultofthemini-
mized cycle times.
Leak tightness
Automatic leak testing procedure for the bio-decontamination
airlock and for the whole work area.
• Leaktightnessisassured.
• Highprotectionofoperatorandenvironment.
H2O2 bottle with RFID chip
• DedicatedGETINGEH2O2 bottle with RFID chip
• Fulltraceability:lotnumber,expirationdate,andremaining
H2O2 level in the bottle.
• Highsecurity,safeandeasymanipulation.
• Noresidue.
GETINGE ISOFLEX | 5
COST-EFFECTIVE GETINGE ISOFLEX WITH HIGH-END STERITRACE II STERILIZER
Ventilation
• Inlet and outlet HEPA filters in 316 L stainless steel housing
• Inlet and outlet blowers to maintain pressure and high air flow rate.
Extension with DPTE® side connections
• The installation can be extended with DPTE® side connections to other Getinge ISO-
FLEX isolators, DPTE® containers, etc.
Modular approach
• Easy to upgrade.
• Possible to start with one isolator and add others afterwards
Replaceable gloves
• Gloves are replaceable without breaking
containment.
• Gloves may be replaced in-process,
saving time and maximizing productivity.
Options
• Workbench DPTE® waste systems
• DPTE®-XS 190 on base for waste and/or
filtrate extraction
• DPTE® tubing systems for side installation
• Removable perforated floor
• Stainless steel transfer bridge for transfer
of loads to a connected isolator
• Range of peristaltic pumps available
• H2O2 monitoring in room
• H2O2 monitoring inside isolator
Although placing a physical barrier between the process and the user provides significant safety and
contamination control benefits, it also introduces operational challenges: how to move material into and out
of an isolator without breaking the sterile containment?
Fortunately this is nothing new for Getinge. Many years ago, La Calhène developed a system that has become
an industry standard worldwide. The DPTE® Port System was originally developed for the nuclear industry, where
Getinge La Calhène remains a key supplier.
Widely known as an Alpha-Beta or RTP port, it is now used for numerous applications in the pharmaceutical
industry, where contaminated, toxic and/or sterile material needs to be transferred without compromising the
integrity of the contained environment.
Read more at www.getinge.com
DPTE® Technology– A Crucial Success Factor
3-glove ISOFLEX-S
6 | GETINGE ISOFLEX
GETINGE ISOFLEX-R RIGID WALL MULTI-PURPOSE MODULAR ISOLATOR
4-glove ISOFLEX-R connected with a transfer hatch (left)
Stainless steel structure
• 316 L stainless steel shell
• 304 L frame on braked casters
Modular approach
• A transfer hatch can be installed, giving a larger area for loading and/or
storage prior to biodecontamination
• Lateral transfer using appropriate DPTE® port systems can be installed
(option).
• Another isolator can be added
• Batch or continuous operation are possible
4-glove ISOFLEX-R
GETINGE ISOFLEX | 7
GETINGE ISOFLEX-R RIGID WALL MULTI-PURPOSE MODULAR ISOLATOR
4-glove ISOFLEX-R connected with a transfer hatch (left)
Stainless steel and glass
• The ISOFLEX-R is highly resistant to chemicals : cleaning
products, disinfectant and toxic materials.
Mobility as required
• The ISOFLEX-R is placed on static feet; castors can be
added if required.
Accessibility
• Lift-up window made of safety glass for easy access when
loading
• The window comprises a safety lock connected to the
control system so there is no risk of the window opening
during the process.
4-glove ISOFLEX-R
8 | GETINGE ISOFLEX
GETINGE ISOFLEX-S SOFT WALL MULTI-PURPOSE MODULAR ISOLATOR
Getinge ISOFLEX-S isolators combine the robustness of a 316L
stainless steel working area with the comfort of working with
glove-sleeves on a flexible wall.
Visibility
• Tough PVC transparent walls give a panoramic view of the working
area and its tools and components.
• Transparent back for quick easy visibility.
Mobility and Modularity
• ISOFLEX-S units are light-weight and mobile with castors to facilitate
movement and connection to other isolators or filling lines using the
DPTE® system.
• Two conventional doors on sides with 565 mm diameter
• The side doors can be replaced by appropriate DPTE® systems (option)
Stainless steel structure
• 316 L stainless steel workbench
• 304 L frame on braked casters
GETINGE ISOFLEX | 9
GETINGE ISOFLEX-S SOFT WALL MULTI-PURPOSE MODULAR ISOLATOR
DPTE Beta-Bags®
– A New Range for improved efficiency
A recognized standard in the industry since production started, the DPTE-BetaBag® is a simple,
efficient solution for transferring materials inside sterile production areas.
Getinge’s production has reached a low particulate level unique in the industry, thanks to investment
in new manufacturing technologies and the use of new materials. The Vendôme (France) production
site produces the cleanest possible product. Particles are reduced to a minimum thanks to new
materials such as silicon used for the gaskets.
Read more at www.getinge.com
4-glove ISOFLEX-S
Flexible canopy
• The canopy is made of 0.3 mm PVC film attached to the 316L steel
base.
• Canopy can be disconnected as required.
• PVC makes the unit light, portable and quick to assemble inside the
production room.
Stainless steel base
• The stainless steel base which is in contact with the product is easy to
clean.
10 | GETINGE ISOFLEX
GETINGE ISOFLEX ISOLATORS SAVE YOU TIME AND SUSTAIN YOUR RESULTS
Getinge ISOFLEX isolators can be summed up in one word: EASY
• Easy installation
• Easy in validation with the bio-decontamination of standard volumes and surfaces
• Easy training of operators
Other important facts about Getinge ISOFLEX ISOLATORS:
• Getinge ISOFLEX isolators allow strict application of cGMP.
• With a leak rate of just 0.1 % of the volume, Getinge ISOFLEX isolators offer air tightness
that fully complies with ISO 10648-2.
• Routine maintenance assures compliance with USP<1116> for microbiological monitoring
and ISO 14644 for non-viable particulates.
• The monitoring devices can either be permanently installed or be a part of a DPTE® transfer
system for use on an iterative basis.
• Traceability figures are available electronically or via printouts.
Do you have experience in aseptic processing ?
Getinge has over 35 years of pioneering and solid experience in this field. We have designed and manufactured close to 3000 types of
isolators. Our isolators with STERITRACE II H2O2 sterilizer function with a high level of accuracy that saves both H2O2 and time, thus also
protecting the equipment and improving operational efficiency.
GetingeISOFLEXisolatorsareusedforlow-throughputsterileprocessinginclinicalbatches,pediatricTPN,innovativeproductsandpre-
scription mixing.
Aseptic processing experience
GETINGE ISOFLEX | 11
Our PhilosophyGetinge’s aim is not only to provide high quality, indus-
try-leading, reliable equipment. Our objective is also to
be your chosen partner within specific application areas
of infection control and contamination prevention.
Our products and services are available globally,
provided and supported by 32 Getinge sales and service
companies and a network of more than 65 authorized
distributors. We presently distribute and support our
products locally in more than 100 countries.
ACCESSORIES, CONSUMABLES, CONTINUOUS SUPPORT AND SERVICE
Our Scope of Supply
In addition to the Getinge ISOFLEX isolator, we can also
provide:
• A dedicated study of your application
• Installation, start-up assistance and qualification
• Training of involved personnel
• All accessories for your application (e.g. DPTE®, con-
nectors)
• Spare parts quickly delivered from Getinge’s regional
centers
• A dedicated supply program for all required dispos-
ables
RELATED PRODUCTS FROM GETINGEGetinge: a unique supplier
Getinge can take care of virtually all your needs for
contamination prevention in the Life Sciences.
We supply:
•Pharmaceuticalsteamgenerators.
•Laboratorywashers&sterilizers.
•Customhardwallandflexiblefilmisolatorsforma-
nipulation and transfer, including autoclave interface
isolators.
Consult Getinge for details.
getinge.com
Getinge Infection Control ABP O Box 69SE-305 05 GetingeSWEDENPhone: +46 (0) 10 335 00 00E-mail: [email protected]
GETINGE GROUP is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. We operate under the three brands of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleigh focuses on patient mobility and wound management solutions. GETINGE provides solutions for infection control within healthcare and contamination prevention within life sciences. MAQUET specializes in solutions, therapies and products for surgical interventions, interventional cardiology and intensive care.
Getinge Infection Control is the world leading provider of solutions for sterile processing in the healthcare sector. We aim to ensure the highest quality and safety at the lowest total cost. We offer complete solutions for a seamless work-flow, reducing the risk of contamination while helping healthcare to increase efficiency.
2306
EN
G·
201
3.12
·G
öteb
orgs
tryc
kerie
t·
We
rese
rve
the
right
to
mak
ete
chni
cala
ndc
onst
ruct
ion
chan
ges
Cre
dit
pho
tos
p.6
-7 J
oel D
avid