EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2015

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emdt.co.uk European Medical Device Technology Spring 2015 | 41 marketplace In Focus Sterilisation Gamma irradiation services A supplier of gamma irradiation services to the medical device industriy offers expanded capacity following the opening of a fully automated large-scale processing facility in southern France. The extra capacity of 100,000 pallets per year enables Synergy Health to optimise lead times, logistics and contingency opportunities. An industrial gamma irradiator provides a maximum cobalt loading of 6 million Ci, treats 1 × 1.2 × 1.95-m pallets weighing as much as 1000 kg, and includes a conveyor system. It is accompanied by an experimental irradiator for product trials, dose verification and setting, sample treatment, small-batch processing and technical support. This system, with a top capacity of 1 million Ci, consists of 60 turntables that can be positioned at various horizontal and vertical distances from the cobalt-60 source. An analytical laboratory is situated next to the experimental cell to allow continuous irradiation and in-line measurement of irradiated samples. Synergy Health Marcoule, France +33 4 6690 3940 www.synergyhealthplc.com Contract sterilisation ser- vices A provider of outsourced contract sterilisation services to medical device manufacturers, with 40 facilities in the Americas, Europe and Asia, Sterigenics International LLC has invested in plant expansion in Belgium and in two US cities. The large facility in Belgium offers sterilisation by means of ethylene oxide, along with laboratory services and capabilities in validation and cycle development. An additional 32-pallet chamber increases the number of installed sterilisation chambers to 14 and provides 2 million more cubic feet of EtO processing capacity. The company uses a proprietary operations management platform that makes possible real-time order tracking and just-in-time supply- chain activities. Sterigenics International LLC Oak Brook, IL, USA +1 630 928 1700 www.sterigenics.com Production sterilisers The GEV line of steam-and-air sterilisers, designed for terminal sterilisation of parenteral and ophthalmic components and medical devices, includes the GEV TS series, which features process controls that allow even highly delicate items to be sterilised by a steam and air mixture. Offered by Getinge Infection Control AB as complete system solutions, the machines incorporate purpose-designed rack-and-conveyor handling systems to optimise production flow. They use sterile compressed air as a support pressure to balance the pressure in the autoclave chamber as the steam heats the container and pharmaceutical contents to generate greater internal pressure; this pressure balance helps prevent closure and container disruption. A key feature of these sterilisers is their modular chamber design with product zones. Each zone is equipped with a single-speed fan, two banks of efficient heat exchangers, and a steam entry and drain connection. A natural effect of the unidirectional flow of the steam-air mixture is the creation of a temperature gradient in the direction of the flow, which ultimately results in a uniform total heating effect throughout the product load. The sterilisers are suitable for processing large-volume parenterals in glass or plastic containers; vials and ampoules; blister-packed contact lenses; and prefilled syringes, whether nested or as bulk single items. Getinge Infection Control AB Getinge, Sweden +46 1 08 637 070 www.getinge.com

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