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