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: info@getinge.com

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