"Because sterility testing is a very exacting procedure, where asepsis of the procedure must be ensured for a correct interpretation of results, it is important that personnel be properly trained and qualified"USP/71
Target group
Staff working in areas of quality control | assurance involving sterility testing.
This workshop is designed to give participants theoretical knowledge and practical experience in the handling of sterility testing in clean rooms and isolators.
Theoretical aspects include:
* Sterility testing * - Regulation and guidance * - Sterility test methods|Test limitations * - Validation * - Interpretation of sterility test results * - Microbial identification of isolates recovered from a sterility test * - Microbiological monitoring
* Sterility test isolators * - Standards and regulations * - Design * - H2O2 Decontamination
Practical exercises | Interactive sessions:
* Sterility testing of different sterile products (LVPs|SVPs|ampoules|antibiotics|medical devices) * Performing sterility test in isolators * Microbiological monitoring
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