Contamination Control in the Pharmaceutical Industry

著者： 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
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あらすじ・解説

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
科学 経済学
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エピソード
  • 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
    2023/09/08

    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 分
  • 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
    2022/12/16

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

    S1E9: Marc and Mark - Environmental Monitoring During Toxic Product Manufacturing
    2022/12/07

    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 分

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