Get the latest Annex 1 draft insights on definitions and guidance regarding Cleanroom Classification, Qualification, and Monitoring.
In this paper, Maurizio Della Pietra, MPhys, of Particle Measuring Systems (PMS), discusses various aspects of Cleanroom Classification, qualification and monitoring including:
- When a Risk Assessment is important
- Which particle sizes to measure
- Definitions such as cleanroom classification vs. cleanroom qualification
- Requirements for re-qualification
- Cleanroom monitoring and it’s relationship to cleanroom classification and qualification
- Cleanroom monitoring verification
- Solutions to meet the new Annex 1 expectations
Interested in learning more on cleanroom classification, qualification, and monitoring?
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- Our Contamination Control Advisory Services who can conduct a Risk Assessment for your pharmaceutical processes
- PMS Cleanroom particle counters including portable/mobile and fixed/remote
- Microbial Monitors including portable/mobile, fixed/remote, and single use.
- Data management software from Particle Measuring Systems
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