Description
Development of instructions for radiation sterilization (Determination of bioburden, determination of the magnitude of the calculated radiation dose, exposure, sterility tests, tests for cytotoxicity and san. Chem. Testing, registration protocol)
Validation of gas sterilization of medical devices (Preparation of Protocols 10, OC), RO, sterilization of test batches, bioburden tests, sterility, residual ethylene oxide, conclusion conclusion)
Validation of aseptic filling of medical products from sterile components
(Preparation of PQ, PP protocols, conclusion processing, quality control. Work package: preparation of medical devices for monitoring indicators, for bioburden, sterility, package integrity, generation of reporting documentation for the registration dossier)
