Monitoring Aseptic Filling
| Activity | Total Volume Sampled | Sampling Time | Mean ≥0.5-μm Total Particlesa | Mean ≥5.0-μm Total Particlesa | Mean Viable Particlesa |
|---|---|---|---|---|---|
| Monitoring fill next to filling needle | 1.01 m3 | 35 min 23 s | 21 | 3 | 0 |
| Monitoring transfer of vials into filling isolator | 0.10 m3 | 3 min 23 s | 0 | 0 | 0 |
↵a Data is presented as the number of particles detected per total volume sampled.