Contamination Control in the Pharmaceutical Industry
Particle Measuring Systems
33 episodes
8 months ago
Conversations focused on contamination monitoring and control, best practices, and meeting regulatory regulations (21CFR Part 11, EU GMP Annex 1, ISO14644-1, ISO 14644-2).
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Conversations focused on contamination monitoring and control, best practices, and meeting regulatory regulations (21CFR Part 11, EU GMP Annex 1, ISO14644-1, ISO 14644-2).
S2E6: Marc and Mark: Airborne Particle Sampling Techniques
Contamination Control in the Pharmaceutical Industry
15 minutes 41 seconds
1 year ago
S2E6: Marc and Mark: Airborne Particle Sampling Techniques
In this podcast episode, Marc Machauer and Mark Hallworth, both with 25 years of experience in pharmaceutical clean and aseptic manufacturing, discuss the newly published ISO 14644-21 standard for pharmaceutical contamination monitoring. They discuss the misinterpretation of the standard, the difference between classification and monitoring, and the importance of ISO classification.
Contamination Control in the Pharmaceutical Industry
Conversations focused on contamination monitoring and control, best practices, and meeting regulatory regulations (21CFR Part 11, EU GMP Annex 1, ISO14644-1, ISO 14644-2).
