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Research ArticleResearch

Test Process and Results of Potential Masking of Sterilizing-Grade Filters

Stephanie Ferrante, Leesa McBurnie, Mandar Dixit, Brian Joseph and Maik Jornitz
PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 509-523; DOI: https://doi.org/10.5731/pdajpst.2019.011189
Stephanie Ferrante
1Millipore Sigma Life Science Research, 17 Cherry Hill Drive, Danvers, MA 01923;
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Leesa McBurnie
2Meissner Filtration Products, 1001 Flynn Road, Camarillo, CA 93012 USA;
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Mandar Dixit
3Sartorius Stedim North America Inc., 5 Orville Dr., Bohemia, NY 11716;
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Brian Joseph
4Pall Corporation World Headquarters, 25 Harbor Park Drive, Port Washington, NY 11050; and
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Maik Jornitz
5G-CON Manufacturing Inc., 6161 Imperial Loop, College Station, TX 77845
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Abstract

Pre-use/post-sterilization integrity testing (PUPSIT) has been a widely debated topic for the last several years. To a large extent, the debate is because of the fact that scientific data were not available to provide additional clarity that could inform appropriate risk-based judgements and commensurate actions. To gain clarity, the Parenteral Drug Association (PDA) and BioPhorum Organizations Group (BioPhorum) formed the Sterile Filtration Quality Risk Management (SFQRM) consortium in late 2017. The consortium goals have been to fill existing gaps in scientific data as adequately as possible with studies and industry guidance that would provide professionals and license holders with the ability to make informed decisions about appropriate risk-management strategies. This paper is one in a series of publications that are the result of the collaboration, and these should be considered together and viewed holistically in order to determine the best course of action with regard to PUPSIT. In total, the four papers cover the following areas: (1) data mining to determine the influence of fluid properties on integrity test values, (2) filter masking studies and results (this publication), (3) risk assessment and management from filter production to end use, and (4) points to consider in the best practice of the use of PUPSIT. In total, 25 manufacturers and filter suppliers have contributed to the work of the Consortium, deploying their filtration experts and pooling their collective knowledge and applied science experience to address these questions. This effort has also been supported by many independent experts currently available who have contributed to and driven the Filtration Interest Group in the PDA for many years. Both PDA and BioPhorum have prioritized this program and combined their approaches to deliver this comprehensive body of work. We hope that collectively the publications aid decision making and create greater certainty and confidence and above all alignment between suppliers, manufacturers, and regulators alike on these important questions.

  • PUPSIT
  • Sterilizing-grade filters
  • Annex 1
  • Sterile drug products
  • Filtration risk management
  • © PDA, Inc. 2020
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PDA Journal of Pharmaceutical Science and Technology: 74 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 5
September/October 2020
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Test Process and Results of Potential Masking of Sterilizing-Grade Filters
Stephanie Ferrante, Leesa McBurnie, Mandar Dixit, Brian Joseph, Maik Jornitz
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 509-523; DOI: 10.5731/pdajpst.2019.011189

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Test Process and Results of Potential Masking of Sterilizing-Grade Filters
Stephanie Ferrante, Leesa McBurnie, Mandar Dixit, Brian Joseph, Maik Jornitz
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 509-523; DOI: 10.5731/pdajpst.2019.011189
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  • Article
    • Abstract
    • Introduction
    • Reviewing the Sterilizing-Grade Filtration Step
    • Need for Masking Studies
    • Activities Description and Reasoning
    • Result Reporting and Discussions
    • Results Conclusion
    • Recommendation
    • Conflict of Interest Declaration
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  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
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Keywords

  • PUPSIT
  • Sterilizing-grade filters
  • Annex 1
  • Sterile drug products
  • Filtration risk management

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