Stem Cells International / 2016 / Article / Tab 8

Review Article

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 typeMaximal number of cfu
EU-cGMPUSP
FS209EISOEU GMPGlove print (5 fingers) (cfu/glove)cfu per contact plate
GlovesPersonnel clothing and garb

M3.5 (100)5A<135
M5.5 (10,000)7B51020

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