Stem Cells International / 2016 / Article / Tab 6

Review Article

Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

Table 6

Recommended limits for viable airborne particles in the environment according to FDA-cGMP, EU-GMP, and USP.

Clean area typeMaximal number of cfu in the environment
FDA-cGMPEU-GMPUSP
FS209EISOEU-GMPAir sample (cfu/m3)Settle plates (diam. 90 mm; cfu/4 h)Air sample (cfu/m3)Settle plates (diam. 90 mm; cfu/4 h)Air sample (cfu/m3)

M3.5 (100)5A11<1<1<3
M4.5 (1,000)673
M5.5 (10,000)7B105105<20
M6.5 (100,000)8C1005010050<100
D200100

The additional use of settling plates is optional.
Individual settle plates may be exposed for less than 4 hours.
Samples from class 100 (ISO 5) environments should normally yield no microbiological contaminants.

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