DPTE -EN 1 DPTE TRANSFER SYSTEM THE GLOBAL REFERENCE

Transcription

1 DPTE -EN 1 DPTE TRANSFER SYSTEM THE GLOBAL REFERENCE

2 2 DPTE -EN GETINGE-LA CALHÈNE DPTE SYSTEM A CLEVER TRANSFER SYSTEM The DPTE transfer system enables the user to introduce material into, or to extract material from a closed barrier, or to connect two devices with identical environments (e.g. isolators) without affecting their ambient characteristics. A global reference Originally designed in the 1963s for transferring extremely hazardous radioactive substances (a field where Getinge-La Calhène is a benchmark supplier), the DPTE system is now used in a large range of life sciences applications when sterile and/or toxic materials are transferred. With more than 25,000 units in use throughout the world, this clever innovation is the highest performance standard transfer system in the market. Secure and certified transfers The DPTE -S system contains safety systems preventing accidental operation: - the Alpha door cannot open if the Beta component is not correctly connected or positioned, - the devices cannot be separated if the Alpha-Beta door assembly is open. Recognition of the DPTE system as secure and certified without any microbiological and particulate risk was Getinge-La Calhène s aim. A test program proved that the DPTE system was not contaminated even after multiple connections and disconnections. A flexible system In order to meet users varying transfer needs, the DPTE is available in five standard sizes (105, 190, 270, 350 and 460 mm). A key element to this system is its ability to carry out successive transfer operations without breaching integrity of the sterile or toxic environment contained within the alpha and beta component. DPTE flexibility is also derived from the materials used in it s construction allowing for multiple sterilization methods: autoclave, ethylene oxide (ETO), gamma sterilization, H 2 O 2, etc. DPTE : Double Porte pour Transfert étanche (Double Door for leaktight Transfer) Getinge-La Calhène s exclusive system

3 DPTE -EN 3 Transfert container TLT - DPTE Beta component leak tight integrity tester DPTE-BetaBag Liquid transfer container Solid or liquid wastes disposal Transfert isolator Adaptation of DPTE (CPS)

4 4 DPTE -EN DPTE SYSTEM ALPHA PART The DPTE system is based on the interaction of two separate units Alpha and Beta each fitted with a door, a lock and a sealing function. The Alpha unit is mounted on a support (e.g. an isolator surface), while the Beta unit is movable and seals off a container, a transfer isolator or any other suitable device. Alpha part : Flange Door Lip seal Beta part : Flange & Body Door Lip seal Alpha DPTE - Fixed Mounting The Alpha part is the core of the system with its secure interlock enabling totally safe connections and disconnections. Its refined design results in surfaces which can easily be cleaned and decontaminated. The opening/closing system is composed of an easily actuated handle and a hinged door which can be removed without any tools, using a sleeve-glove or half-suit. In most configurations, the Alpha part is intended to be fixed to a rigid wall, connection being provided by rotating the Beta part. Operating principle The two parts are connected by a 60 rotation which detaches the doors from their supports and joins them together, but tightness (corresponding to class 1 of standard) is still secured by the lip seals of the new assembly. 1 Inside Outside ALPHA BETA Diagram 1 shows the container approaching the Alpha part of the isolator. Alpha DPTE on a rigid wall Alpha DPTE - Flexible Mounting When the device equipped with the Beta part is too large or too heavy to be rotated, the Alpha part provides the rotation. It is mounted on a flexible membrane for easy connection to the Beta part and is generally mounted on the bottom or the top of the barrier system. In this configuration, 105 and 190mm diameters are available as a standard. 2 3 Diagram 2 shows the interaction of both parts with a 60 degrees rotation. Diagram 3 shows the opening of connected doors. Exemple of an Alpha DPTE mounted on a flexible membrane

5 DPTE -EN 5 DPTE SYSTEM BETA PART Getinge-La Calhène offers a wide range of DPTE Beta parts made of various materials (stainless steel, polyethylene, injected plastic) to suit your manufacturing processes and today s sterilization methods. The various configurations and their adaptations provide total security in all fields of confined production. Rigid or flexible containers The standard rigid containers are made of polyethylene or stainless steel. Their dimensions depend on the diameter required. You should find the container you require among the wide variety of containers we propose and we can also design and develop containers specifically adapted to your application. Flexible or DPTE-BetaBag containers are made of polyethylene (PE/EVA) or Tyvek complexes mounted on Beta parts made of stainless steel, polyethylene or injected plastic (PSU or PEHD). Gamma sterilization or autoclave The sterilization method determines the type of container to be used: - Gamma sterilization Beta part: polyethylene or injected plastic (PSU or PEHD) Body: polyethylene, PE/EVA or Tyvek - Autoclave Beta part: stainless steel or injected plastic (PSU) Body: stainless steel, tyvek. Gamma-sterilizable DPTE-BetaBag Autoclave-sterilizable DPTE-BetaBag Rigid plastic containers Single use or re-usable containers Depending on the material used for the Beta part and on the application concerned, the containers are: - single use Beta part: injected plastic (PSU or PEHD) Body: PE/EVA or Tyvek - reusable (multiple connections and disconnections) Beta part: stainless steel or polyethylene Body stainless steel, polyethylene. Consumable containers Stainless steel containers Re-usable stainless steel container DPTE-BetaBag flexible containers Re-usable plastic container Transfer isolators When mounted on bellows and fixed to a ring, the main adaptation of the DPTE Beta part is the transfer isolator. This provides a large volume available for transferring or preparing and sterilizing batches of products. Adaptation Beta DPTE can be mounted on the elements of a process, e.g. formulation tank, reactor, processor, CPS (Closure Processing System Plugs sterilisation process developed by Getinge). Transfer isolator Adaptation of a Beta DPTE to a process device

6 6 DPTE -EN DPTE SYSTEM BETA PART APPLICATIONS, ACCESSORIES, MONITORING DPTE transfer systems are present in all Life Sciences activities and industries related: pharmaceutical laboratories (from fine chemical, formulation and packaging to sterility tests), research units, biotechnology, hospital pharmacies, etc. In association with the various accessories and monitoring devices we propose, the DPTE system constitutes a key element in isolation technology. APPLICATION: solids transfer APPLICATION: liquids transfer Containers may be flexible and ready for use (DPTE- Containers for liquid transfer are generally rigid and made BetaBag ), rigid plastic or stainless steel (for an autoclave- of stainless steel (autoclave- or CIP- (Clean In Place) sterilization). sterilizable) or flexible and ready-to-use. - Incoming transfers: closure components (plugs, syringes - Incoming or outgoing transfers: formulation, production pistons, capsules, etc.), elements for microbiological solution (filling line), filtrates disposal, etc. control (contact box, swabs), miscellaneous equipment (maintenance tools, spare parts, pump needles), semifinished products, powder, etc. - Outgoing transfers: samples, miscellaneous equipment, products in bulk (powder), waste products (toxic waste, broken vials or ampules, syringes, capsules), etc. Filtrates disposal Pump feeding Pump feeding (outside the isolator) Pump feeding (inside the isolator) Transfer of solutions Transfer of solutions from a formulation tank Components Inlet Outlet of samples Microbiological control elements DPTE-Tubing for continuous outlet of products Wastes disposal

7 DPTE -EN 7 ACCESSORIES With a view to optimizing the use of our DPTE transfer system and containers, we are designing and developing accessories for ease of use while preserving or improving operational safety: - Transport and docking trolleys for DPTE containers - Stainless steel baskets for transferring filling pump needles, plugs, Petri dishes, etc. - Protection cover and closure for polyethylene containers - Protection or pressure cover for seals on autoclavable containers - Protection of DPTE seals for solid transfer (e.g. powder) by polyethylene or stainless steel systems. Trolley Basket Trolley Protection cover MONITORING - CHECKING When materials are transferred into or out of isolators and when containers are stored between two production cycles, tightness must be proved to be at least equal to that of the isolators themselves. TLT makes it possible to test DPTE systems tightness, i.e. the beta part (flexible or rigid containers, beta part alone) without affecting the quality of the internal volume. Seal protection Chute for the protection of seal TLT (Transfer Leak Tester) - DPTE systems controller TESTING AND DOCUMENTATION From the design specification and through component selection, fabrication, assembly operations, all stages of the manufacturing process are examined and documented, in compliance with Good Manufacturing Practices (GMP). For our customers, it saves time and money along the validation chain. In-process checking In-process checks ensure that only the specified materials and components are being used. During assembly, a variety of inspections may be performed e.g. leak and pressure testing, assembly operations and control of surface finish when applicable. Documentation The documentation package includes installation, operation and technical manuals. Qualification Our validation department will provide all-inclusive solutions for the qualification of equipment in accordance with all major international regulations. We also provide operator and technician training, tailored according to the application.

8 8 DPTE -EN Getinge-La Calhène - DPTE -EN / Novembre 2012 FROM INSPIRATION TO INSTALLATION Getinge specializes in early planning consultation and smart contamination prevention solutions for bio-pharmaceutical production, biomedical research, medical device manufacturing, laboratories and highly contaminated environments. Backed by more than 100 years of experience, global reach and the largest installed base for many equipment areas, we help our customers plan for maximum productivity in the most cost-efficient way. From logistics planning and premium equipment to un matched service and training, count on Getinge right from the start. Getinge-La Calhène 1 rue du Comté de Donegal F Vendôme cedex FRANCE Phone: +33 [0] Fax: +33 [0] Linac Technologies Dept. 23 av. de la Baltique F Villebon sur Yvette FRANCE Phone: +33 [0] Fax: +33 [0] Getinge-La Calhène USA 1325 Field Avenue South Rush City, MN USA Phone: +1 [0] Fax: +1 [0] Getinge Infection Control AB PO Box 69 SE Getinge SWEDEN Phone: Fax: 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.