GETINGE ISOFLEX MULTI-PURPOSE ISOLATOR

GETINGE ISOFLEX MULTI-PURPOSE ISOLATOR

2 GETINGE ISOFLEX 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. 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/environment. Traceability for all the steps of the sterile handling process. The initial sterility is provided by a dedicated H 2 vapor (HPV) program to bio-decontaminate the isolator and the outside of the sterile components thanks to the integrated STERITRACE II system. The sterility is maintained with the positive pressure 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 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 loading. 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 unnecessary hose connections during the bio-decontamination process.

4 GETINGE ISOFLEX COST-EFFECTIVE GETINGE ISOFLEX WITH HIGH-END STERITRACE II STERILIZER Traceability 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: The process is always controlled by the operator. Security for both the operator and the process. Data exchange table available on ethernet network. 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 monitoring. The operator control panel is a color touchscreen, which provides access to the PLC for parameter setting (by authorized persons) and critical parameter monitoring. Alarms are also clearly presented on the display. The single, easily navigated operator panel assures simple operation, minimized errors, and maximized productivity. Validated process Validated process thanks to new integrated STERITRACE II H 2 sterilizer: Integrated: cost-effective, reliable, no additional equipment to manipulate and maintain (no dessicant), only one user interface to control both the isolator and the sterilizer. H 2 : no odor, easy to monitor during the validation process. Validation is easier, increased productivity as a result of the minimized cycle times. Leak tightness Automatic leak testing procedure for the bio-decontamination airlock and for the whole work area. Leak tightness is assured. High protection of operator and environment. H 2 bottle with RFID chip Dedicated GETINGE H 2 bottle with RFID chip Full traceability: lot number, expiration date, and remaining H 2 level in the bottle. High security, safe and easy manipulation. No residue.

GETINGE ISOFLEX 5 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. 3-glove ISOFLEX-S 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 H 2 monitoring in room H 2 monitoring inside isolator DPTE Technology A Crucial Success Factor 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

6 GETINGE ISOFLEX GETINGE ISOFLEX-R RIGID WALL MULTI-PURPOSE MODULAR ISOLAT 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 con

GETINGE ISOFLEX 7 OR 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 nected with a transfer hatch (left)

8 GETINGE ISOFLEX GETINGE ISOFLEX-S SOFT WALL MULTI-PURPOSE MODULAR ISOLATO 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 R 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. 4-glove ISOFLEX-S 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

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. Aseptic processing experience 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 H 2 sterilizer function with a high level of accuracy that saves both H 2 and time, thus also protecting the equipment and improving operational efficiency. Getinge ISOFLEX isolators are used for low-throughput sterile processing in clinical batches, pediatric TPN, innovative products and prescription mixing.

GETINGE ISOFLEX 11 Accessories, consumables, continuous support and service Our Philosophy Getinge s aim is not only to provide high quality, industry-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. 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, connectors) Spare parts quickly delivered from Getinge s regional centers A dedicated supply program for all required disposables Related products from getinge Getinge: a unique supplier Getinge can take care of virtually all your needs for contamination prevention in the Life Sciences. We supply: Pharmaceutical steam generators. Laboratory washers & sterilizers. Custom hardwall and flexible film isolators for manipulation and transfer, including autoclave interface isolators. Consult Getinge for details.

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 ENG 2013.12 Göteborgstryckeriet We reserve the right to make technical and construction changes Credit photos p.6-7 Joel David Getinge Infection Control AB P O Box 69 SE-305 05 Getinge SWEDEN Phone: +46 (0) 10 335 00 00 E-mail: info@getinge.com 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.