Unsere LS-Referentin Katharina Schlereth wird im November beim ECA - Isolator Technology Workshop einen Vortrag zum Thema “Isolator used for Sterility testing” halten.
Requirements for the isolator
- Background of the isolator
- Performance Qualification
- Qualification of operators
- Test for gas-tightness of primary packaging materials
Handling in isolator
- Capacity
- Testing the tightness of gloves
Microbiological Monitoring
- Sample plan
- Contamination level; contamination source
- OOS/CAPA (example)
