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University Medical Center Goettingen

Prof. Dr. med. H. Dunkelberg (M.D.)

Dr. med. U. Schmelz (M.D.)







Assessing the compatibility of the packaging with the microbial challenge during transport and storage, we provide evidence-based guidance for post-sterilization storage. Using the exposure chamber method we perform laboratory tests with defined microbial exposure conditions and tests with the mobile exposure chamber as an on-site application procedure in respect to the actual current storage conditions (e.g. hospitals, CSSD, shipping and logistic halls). Depending on the microbial barrier performance, specifications are identified for storage conditions to maintain sterility up to the point of use. We help ensure safe practices for storing sterile medical devices and help create a culture of safety for transport and storage by:

•          using the whole package microbial challenge test for verifying the

           barrier-basedreduction of airborne microbial challenge(laboratory

           tests and on-site application);

•          assisting the medical device manufacturer to select an appropriate

           package which maintains sterility throughout shelf life (containers,

           pouches, paper and nonwovenmaterials); 

•          calculation of the barrier efficiency as a percentage which shows the

           probability of  microbial reduction under field conditions.