Summary of the Four Different Data Sets.

Data SetLocationData Set PeriodBFPC System MonitoringTraditional Environmental MonitoringAssignable Cause?Summary Comments
1Grade A - At Rest10 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 filterNo data collected0 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
2Grade A - Restricted Access Barrier Systems (RABS) Water Run5.6 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 filterNo data collected0 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.
3Sterility Testing Isolator- At Rest24, 48, and 96 h continuous monitoring. 41, 82, 164 m3Total (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 methodsNo assignable cause was foundSystem is reliable and provides continuous coverage. The low counts provide confidence that the sterility isolator is properly assembled
4Sterility Testing Grade A Biosafety Cabinet40-min continuous monitoring.
1.13 m3
≥0.5 μm: 1
5.0 μm: 0
0 AFU gelatin filter: 0 CFU0 (particle counter)0 CFU (viable active air sampler)1 particle was measured at the time of alcohol sprayingLow 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