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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