Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects
Table 8
Recommended limits for viable airborne particles on personnel according to FDA-cGMP, EU-GMP, and USP.
Clean area type
Maximal number of cfu
EU-cGMP
USP
FS209E
ISO
EU GMP
Glove print (5 fingers) (cfu/glove)
cfu per contact plate
Gloves
Personnel clothing and garb
M3.5 (100)
5
A
<1
3
5
M5.5 (10,000)
7
B
5
10
20
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