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Table 4 Maximum limit for particle count and air sampling for in process environmental monitoring

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

 

0.5 um

5.0 um

Maximum allowable particle count during in process event (particles/m3)

Grade A (Inside BSC)

3520

20

Grade B (Outside BSC)

352,000

2900

Maximum allowable CFU/plate for air sampling

Grade A (Inside BSC)

 < 1

 

Grade B (Outside BSC)

10

Â