Cleanroom Classification, Qualification, Monitoring
Get the latest Annex 1 draft insights on definitions and guidance regarding Cleanroom Classification, Qualification, and Monitoring.
In this paper, Maurizio Della Pietra, MPhys, discusses various aspects of these topics 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
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