09.02.2011 16:31 Uhr Seite 2 Experience and modern technology – a winning combination Transcoject has been a reliable partner in the ethylene oxide sterilization of thermo-sensitive products for the medical and pharmaceutical industries for over 40 years. We have sterilized using a dual-chamber system, each with a volume of 33 m3, in various cycles according to ISO 11135-1 for the past decade. Our experienced team of experts advise and assist our customers through the individually tuned sterilization cycle right up to product sterilization. This also includes the microbiological testing in our in-house laboratories. We remain at your disposal with our wide range of individual services, from concept development to market launch as a fullservice partner in the ethylene oxide sterilization STERILIZATION TRA10004_PB_Sterilization_eng:Layout 1 TRA10004_PB_Sterilization_eng:Layout 1 09.02.2011 16:31 Uhr Seite 3 Process Development Sampling and Testing Validation/ Revalidation Transcoject Sterile Solutions Logistic Services Sterilization Laboratory Services Process Development The properties and features of a product requiring sterilization often call for the development and employment of specific sterilization cycles. Sterilization Our expert team advise and support our customers in process development and routine sterilization as well as in selecting optimal solutions regarding both quality and economics. The ethylene oxide sterilization is performed in different cycles and rests on a comprehensive quality assurance system in accordance with current legislation and standards. Validation / revalidation Additional laboratory services We define the scope of the pending work packets and assist in the execution of all stages right up to and including the entire implementation of the validation according to DIN EN ISO 11135-1 in close dialogue with our customers. Due to maintaining our own laboratory, we are in the position to offer a variety of additional services, such as bio burden or residual gas examinations as well as seal integrity tests. Logistics A comprehensive offer of logistic services rounds off our range. Whether new palletising, commissioning or shipping – even in this area, we facilitate corresponding services for our customers, which we gladly adapt to fit individual wishes. Special services We offer solutions at the highest level of quality to enable our partners to realise their tasks in a fast and cost-effective manner, whether it is the development or testing of alternative packaging or carrying out sampling. Transcoject GmbH D-24539 Neumünster, Rügenstraße 8 Fon +49 4321 885-0 • Fax +49 4321 885-65 www.transcoject.com • info@transcoject.com