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Contamination Control in the Pharmaceutical Industry

Contamination Control in the Pharmaceutical Industry

De : Particle Measuring Systems
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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).© 2023 Contamination Control for Aseptic Manufacturing with the Pharmaceutical Industry Economie Science
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    Épisodes
    • S2E2: Marc and Mark: The New ISO 14644-21: 2023 Airborne Particle Sampling Techniques

      S2E2: Marc and Mark: The New ISO 14644-21: 2023 Airborne Particle Sampling Techniques
      Sep 8 2023

      In Season 2, Episode 2 of the Marc and Mark Contamination Control Podcast, Marc Machauer and Mark Hallworth, particle monitoring experts at Particle Measuring Systems, discuss the new release of ISO 14644-21: 2023 Airborne Particle Sampling Technique. Mark Hallworth served on the ISO task force to rewrite this standard. They discuss behind-the-scenes stories from the writing of the new standard, including topics such as tubing length, isokinetic sampling, and best practices.
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      16 min
    • S1E10: Marc and Mark: Retroactive Contamination Control Risk Assessments on Aseptic Fill Lines

      S1E10: Marc and Mark: Retroactive Contamination Control Risk Assessments on Aseptic Fill Lines
      Dec 16 2022

      In Part 10 of this Limited Series from Particle Measuring Systems' contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the topic of performing a retroactive Risk Assessment on existing fill lines as required by the release of EU GMP Annex 1 in August 2022.

      Without measurement there is no control


      Do you have questions about today's topic?
      Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.

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      23 min
    • S1E9: Marc and Mark - Environmental Monitoring During Toxic Product Manufacturing

      S1E9: Marc and Mark - Environmental Monitoring During Toxic Product Manufacturing
      Dec 7 2022

      In Part 9 of this Limited Series from Particle Measuring Systems, contamination control experts Marc Machauer, Global OEM Business, and Mark Hallworth, Global GMP Specialist, discuss the unique environmental monitoring issues encountered when manufacturing products with high toxicity profiles.

      Without measurement there is no control


      Do you have questions about today's topic?
      Our expert advisors are ready to help answer your questions. Find us on the Web at www.pmeasuring.com.

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      13 min
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