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Table 1 Environmental parameters of MCB process validation. Table summarizing the environmental parameters obtained during the production of MCB batches. Airborne particles concentration in the sterile cabinet (Grade A) was measured at each step of the procedure. Particles equal or greater than 0.5 µm met defined acceptance criteria. Particles equal or greater than 5 µm met defined acceptance criteria. Glove prints of personnel operating in the cabinet (Grade A) were sampled at each step of the procedure. No microorganisms were detected in agreement with the acceptance criteria. The presence of airborne microorganisms in the cabinet (Grade A) was monitored at each step of the procedure by using settle plates. No microorganisms were detected on the plates, meeting defined acceptance criteria

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

Environmental Parameters Culture Day Batch code:
MCB-HE-01
Batch code:
MCB-HE-02
Batch code:
MCB-HE-03
≥ 0.5 µm particles/m3 HEK293T Thawing Pass Pass Pass
1st passage Pass Pass Pass
2nd passage Pass Pass Pass
MCB Generation Pass Pass Pass
≥ 5 µm particles/m3 HEK293T Thawing Pass Pass Pass
1st passage Pass Pass Pass
2nd passage Pass Pass Pass
MCB generation Pass Pass Pass
Glove Print CFU HEK293T Thawing 0 0 0
1st passage 0 0 0
2nd passage 0 0 0
MCB generation 0 0 0
Settle plates CFU HEK293T Thawing 0 0 0
1st passage 0 0 0
2nd passage 0 0 0
MCB generation 0 0 0