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What does the recent ISO 14644-2:2015 update mean for pharmaceutical cleanroom monitoring?
NOTE: Cleanroom operators should also consider the ISO 14644-1 2015 updates regarding classification, ≥5.0µm particles in Grade A and Grade B environments (ISO Class 5) and sampling changes.
The ISO 14644-2:2015 standard, referred to as Part 2, is focused on monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration. Part 2 requires a monitoring plan be created, implemented and maintained to ensure ongoing compliance. This includes:
A risk assessment to understand, evaluate and document potential for adverse contamination events
Fully documented and approved monitoring plan
Plan implementation and ongoing monitoring
Trend analysis and performance reporting
Documentation of corrective action
Periodic plan reviews
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