Risk-Based Recommendations for Monitoring Practices for Cell Therapy Manufacturinga
| Manufacturing Environment | Air Cleanliness Standards | Environmental Monitoring Frequency | Environmental Monitoring Action Levels (CFU) | Aseptic Process Simulation Requirements | Microbial Testing |
|---|---|---|---|---|---|
| BSC in a classified area | ISO 5/ISO 7 | Each shift /Each operator | <1/<5 | Initial 3 batches/semi-annual | In-process and final product testing |
| Barrier system in a classified area | ISO 5/ISO 7 | Each shift | <1/<5 | Initial 3 batches/semi-annual | In-process and final product testing |
| Open isolator system | ISO 5/ISO 7 | Each shift | <1/<5 | Initial 3 batches/semi-annual | In-process and final product testing |
| Closed isolator system | ISO 5/ISO 8 | Periodic | <1/<50 | Initial 3 batches/annual | Final product testing |
| Gloveless, robotic, isolator system | ISO 5/ISO 8 | None | None | None | None |
↵a Each manufacturer should perform a risk assessment to determine the type of environmental monitoring program and to determine the product testing strategy.