Summary of the Four Different Data Sets.
| Data Set | Location | Data Set Period | BFPC System Monitoring | Traditional Environmental Monitoring | Assignable Cause? | Summary Comments | ||
|---|---|---|---|---|---|---|---|---|
| Particles | AFU | Particles | CFU | |||||
| 1 | Grade A - At Rest | 10 days continuous monitoring. 402 m3 (sequential) | ≥0.5 μm: max 5/m3 5.0 μm: max 4/m3 | 5 AFU of which 3 ≥5.0 μm No sample capture on gelatin filter | No data collected | 0 CFU (settle plates) | No assignable cause was found: No personnel in the manufacturing area 0 CFU measured with traditional methods | Data resolution of 1 m3 insufficient to evaluate source of AFUs, 1-minute resolution would be required |
| 2 | Grade A - Restricted Access Barrier Systems (RABS) Water Run | 5.6 days continuous monitoring. 231 m3 | ≥0.5 μm: max 1890/m3 5.0 μm: max 159/m3 (only once above the Annex I limit of 20/m3) | 5 AFU of which 0 ≥5.0 μm No sample capture on gelatin filter | No data collected | 0 CFU (settle plates) | - 1 AFU were mopping activities - 3 AFU and max particle counts were cleaning/setup - 1 unassigned: no operations, no product exposed | Continuous monitoring gives more insight in particle loads created by staff operations. |
| 3 | Sterility Testing Isolator- At Rest | 24, 48, and 96 h continuous monitoring. 41, 82, 164 m3 | Total (max/m3): 0.5 μm: 24 h: 333 (33) 48 h: 1591 (98) 96 h: 439 (27) 5.0 μm: 24 h: 11 (3) 48 h: 2 (1) 96 h: 3 (1) | 24, 48, 96 h: 0, 0, 1 AFU No sample capture on gelatin filter | No data were collected with traditional methods | No assignable cause was found | System is reliable and provides continuous coverage. The low counts provide confidence that the sterility isolator is properly assembled | |
| 4 | Sterility Testing Grade A Biosafety Cabinet | 40-min continuous monitoring. 1.13 m3 | ≥0.5 μm: 1 5.0 μm: 0 | 0 AFU gelatin filter: 0 CFU | 0 (particle counter) | 0 CFU (viable active air sampler) | 1 particle was measured at the time of alcohol spraying | Low AFU and particle counts in line with the high level of 0 control in a biosafety cabinet BFPC system not prone to false positives BFPC system seemed to correctly identify 1 particle as nonviable during alcohol spray |