Stem Cells International / 2016 / Article / Tab 3

Review Article

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

Table 3

Airborne particulate classification for these grades, according to the PIC/S GMP and EU-GMP.

GradeMaximum number of particles permitted/m3
At restIn operation
≥0.5 µm≥5.0 µm≥0.5 µm≥5.0 µm

A3,520203,52020
B3,52029352,0002,900
C352,0002,9003,520,00029,000
D3,520,00029,000Not definedNot defined

All areas must be free particles of size greater than 5 μm. Limits are set to 1 particle/m3 because it is impossible to ensure the absence of particles with any statistical significance. The periodic classification of facilities (cleanroom) must show that all areas meet the defined limits.

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