TABLE VIa

Practical Process Simulation Test 1 Using High Bioload at Leak Position F 0.4 (CFU per Sampling Plate 25 cm2; “pos.” = Growth)

Test 1Day 1Day 2Day 3Day 4Day 5
Glass ball TSBNeg.Neg.Neg.Pos.Pos.
Glass ball FTMNeg.Neg.Neg.Neg.Pos.
Fingers glove 110000
Fingers glove 200001
Fingers glove 300006
Fingers glove 400001
Sleeve glove 100000
Sleeve glove 200002
Sleeve glove 300000
Sleeve glove 400000
Bottom isolator00000
Sidewall isolator00000
Settling plate 100000
Settling plate 200000