Stem Cells International / 2016 / Article / Tab 7

Review Article

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

Table 7

Recommended limits for viable airborne particles on surfaces according to EU-GMP and USP.

Clean area typeMaximal number of cfu on surfaces
FS209EISOEU GMPContact plates (diam. 55 mm; cfu/plate)Contact plates (area 24–30 cm2; cfu/plate)

M3.5 (100)5A<133
M4.5 (1,000)6
M5.5 (10,000)7B5510
M6.5 (100,000)8C25

Contact plate areas vary from 24 to 30 cm2. When swabbing is used in sampling, the area covered should be greater than or equal to 24 cm2 but no larger than 30 cm2.

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