ARTICLES BY MAIK JORNITZ

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    Navigating The Pros And Cons In Annex 1's PUPSIT Requirements
    7/12/2023

    Annex 1 made Pre-use Post Sterilization Integrity Testing, or PUPSIT, a requirement, and enforcement has begun in earnest over the last few years. This article digs into the problems that downstream filter manipulation can cause and questions whether the risks outweigh any benefits.

Maik W Jornitz

Maik Jornitz

Maik W. Jornitz is a technical expert with over 35 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published 11 books, 18 book chapters, and more than 100 scientific papers. He is a member of multiple PDA Task Forces, a former chair of the PDA Board of Directors, and the PDA’s Science Advisory Board.