Bitte wählen Sie ihr Lieferland und ihre Kundengruppe
Sterility testing of medical devices is required during the sterilization validation process as well for routine quality control. Guidelines for both Gamma and Electron Beam Sterilization employ sterility testing as a measure of the adequacy of sterilization parameters. An understanding of sterility is beneficial in terms of designing a validation process. The need to provide adequate and reliable sterility test data is an important quality control issue. Sterility testing is a very tedious and artful process that must be performed by trained and qualified laboratory personnel. The investigation of sterility test failures is a process that requires attention to environmental data as well as many other factors including training and sample difficulty. This paper presents the general concepts and problems associated with steriliy testing as well as the various testing methodologies.