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PDA Journal of Pharmaceutical Science and Technology

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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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  • For correspondence: mjornitz@gconbio.com
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Article Information

vol. 74 no. 5 509-523
DOI 
https://doi.org/10.5731/pdajpst.2019.011189
PubMed 
32467175

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 5, 2020.

Article Versions

  • previous version (May 28, 2020 - 09:03).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2020

Author Information

  1. Stephanie Ferrante1,
  2. Leesa McBurnie2,
  3. Mandar Dixit3,
  4. Brian Joseph4 and
  5. Maik Jornitz5,*
  1. 1Millipore Sigma Life Science Research, 17 Cherry Hill Drive, Danvers, MA 01923;
  2. 2Meissner Filtration Products, 1001 Flynn Road, Camarillo, CA 93012 USA;
  3. 3Sartorius Stedim North America Inc., 5 Orville Dr., Bohemia, NY 11716;
  4. 4Pall Corporation World Headquarters, 25 Harbor Park Drive, Port Washington, NY 11050; and
  5. 5G-CON Manufacturing Inc., 6161 Imperial Loop, College Station, TX 77845
  1. ↵*Corresponding Author: G-CON Manufacturing Inc., 6161 Imperial Loop, College Station, TX 77845; E-mail: mjornitz{at}gconbio.com
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    Membranes 2023 13 1
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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
    • Acknowledgments
    • Appendix
    • References
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Keywords

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

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