Stem Cells International / 2016 / Article / Tab 4

Review Article

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

Table 4

Recommended frequency of environmental monitoring testing.

Clean area type⁢Frequency sampling
FDA-cGMPEU-GMPUSP
FS209EISOEU-GMPAt restIn operation

M3.5 (100)5AShould cover all production shiftsFrequent to detect system deteriorationFor the duration of critical operationsEach operating shift
M4.5 (1,000)6Should cover all production shiftsEach operating shift
M5.5 (10,000)7BShould cover all production shiftsFrequent to detect system deteriorationFor the duration of critical operationsEach operating shift
M6.5 (100,000)8CShould cover all production shiftsFrequent to detect system deteriorationIn line with quality risk managementTwice a week
Once a week
DIn line with quality risk managementIn line with quality risk management

There is no correspondence between FS209 M3.5 (100) and ISO 6 classes with EU-GMP cleanroom classification.
Other support areas to aseptic processing areas but nonproduct contact.

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