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 expectations
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Author: Maurizio Della Pietra, MPhys
Maurizio is the Associated Product Line Manager Advisory Services for Life Science at Particle Measuring Systems. In this role, he collaborates and consults with pharmaceutical companies and with developers of pharmaceutical equipment and isolation technologies for improving the sterility assurance on science-based strategies. He also is the EMEA Field Application Specialist for Data Management and Analysis.