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Table 5 Simulation tests results. Table summarizing results obtained with the three simulation test batches. Particles equal or greater than 0.5 µm and particles equal or greater than 5 µm in the cabinet (Grade A) met defined acceptance criteria. Gloves of the operating personnel and airborne microorganisms in cabinet (A grade) were monitored at each step of the simulation test. No microorganisms were detected in agreement with the acceptance criteria. Samples of the TSB, used throughout the simulation, were subjected to sterility tests

From: Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing

Parameter Culture Day Batch code:
MF-HE-01
Batch code:
MF-HE-02
Batch code:
MF-HE-03
≥ 0.5 µm particles/m3 1st entrance Pass Pass Pass
2nd entrance Pass Pass Pass
3rd entrance Pass Pass Pass
4th entrance Pass Pass Pass
≥ 5 µm particles/m3 1st entrance Pass Pass Pass
2nd entrance Pass Pass Pass
3rd entrance Pass Pass Pass
4th entrance Pass Pass Pass
Glove Print CFU 1st entrance 0 0 0
2nd entrance 0 0 0
3rd entrance 0 0 0
4th entrance 0 0 0
Settle plates CFU 1st entrance 0 0 0
2nd entrance 0 0 0
3rd entrance 0 0 0
4th entrance 0 0 0
TSB sterility test TSB used during the entire procedure Sterile Sterile Sterile