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 type			Maximal number of cfu on surfaces
			EU GMP	USP
FS209E	ISO	EU GMP	Contact plates (diam. 55 mm; cfu/plate)	Contact plates (area 24–30 cm^2; cfu/plate)
				Surfaces	Floor
M3.5 (100)	5	A	<1	3	3
M4.5 (1,000)	6		—	—	—
M5.5 (10,000)	7	B	5	5	10
M6.5 (100,000)	8	C	25	—	—
		D	50	—	—

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.