Table IV

Static Monitoring in Isolators

Isolator	Total Volume Sampled	Sampling Time	Mean ≥ 0.5 μm Total Particles per Cubic Meter	Mean ≥5.0-μm Total Particles per Cubic Meter	Mean Viable Particles per Cubic Meter
3-glove transfer	28.00 m³	16 h 25 min	231	8	0^a
8-glove transfer	28.37 m³	16 h 37 min	241	6	0^b
12-glove filling	29.00 m³	16 h 43 min	2	0	0^c

↵a Seven (7) individual viable particle events were detected during the course of the sampling run.
↵b Eight (8) individual viable particle events were detected during the course of the sampling run.
↵c Six (6) individual viable particle events were detected during the course of the sampling run.