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Table 5 Alert and action limit of CFU per plate for in-process environmental monitoring

From: Quality management overview for the production of a tissue-engineered human skin substitute in Malaysia

Environmental monitoring

CFU alert limit

CFU action limit

Gown swabs

 ≥ 2 per plate

 ≥ 5 per plate

Finger dabs

 ≥ 2 per plate

 ≥ 5 per plate

Finger dabs—at the end of process

N/A

 > 1 per plate

In process settle plate EM

N/A

 > 1 per plate

In process swab plate EM

N/A

 > 1 per plate