D1 - Sterility Testing

Target group:

Staff working in the field of microbiological quality control who perform or are responsible for the performance of sterility testing.

“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)

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:

• Regulation and guidance; actual trends like "Particulate matter in injectables"
• Sterility test methods | test limitations
• Validation
• Interpretation of sterility test results
• Microbiological monitoring

Practical exercises:

• Sterility testing of different sterile products (LVPs | SVPs |ampoules | antibiotics | syringes | medical devices)
• Performing sterility test in isolators

There are no special classes reqiured for this seminar