Monitoring During Interventions
| Activity | Total Volume Sampled | Sampling Time | Mean ≥0.5-μm Total Particlesa | Mean ≥5.0-μm Total Particlesa | Mean Viable Particlesa |
|---|---|---|---|---|---|
| Sterile filling needle replacement | 0.05 m3 | 1 min 47 s | 0 | 0 | 0 |
| Non-sterile filling needle replacement | 0.06 m3 | 1 min 54 s | 0 | 0 | 0 |
| Detaching stopper bowl, moving bowl to opposite side of isolator, returning bowl to original position, and reattaching | 0.07 m3 | 2 min 29 s | 1 | 0 | 0 |
| Stopping and starting line, adding new vials, and repositioning of vials | 1.32 m3 | 45 min 52 s | 6 | 0 | 2 |
↵a Data is presented as the number of particles detected per total volume sampled.