Skip to main content

Table 3 Environmental parameters of WCB validation. Table summarizing the environmental parameters collected during the analyses of WCB batches. The concentration of airborne particles in 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 line 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 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 MCB Thawing Pass Pass Pass
1st passage Pass Pass Pass
WCB Generation Pass Pass Pass
≥ 5 µm particles/m3 MCB Thawing Pass Pass Pass
1st passage Pass Pass Pass
WCB generation Pass Pass Pass
Glove Print CFU MCB Thawing 0 0 0
1st passage 0 0 0
WCB generation 0 0 0
Settle plates CFU HEK293T Thawing 0 0 0
1st passage 0 0 0
WCB generation 0 0 0