Transfer of Components into the Filling Isolator
| Activity | Total Volume Sampled | Sampling Time | Mean ≥ 0.5 μm Total Particlesa | Mean ≥ 5.0 μm Total Particlesa | Mean Viable Particlesa |
|---|---|---|---|---|---|
| Transfer of autoclaved components from the 8-glove isolator into the filling isolator | 1.75 m3 | 1 h 1 min | 1 | 0 | 0 |
| Transfer of autoclaved components from the 3-glove isolator into the filling isolator | 0.33 m3 | 11 min 29 s | 0 | 0 | 0 |
↵a Data is presented as the number of particles detected per total volume sampled.