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Article CommentaryAssociation Commentary

Pre-use/Post-sterilization Integrity Testing of Sterilizing Grade Filters

PDA Pre Use/Post-Sterilization Integrity Test Task Force:, Karen Bartel, Hal Baseman, Gabriele Gori, Richard Levy, Hemisha Ly, Maik Jornitz, Russell Madsen, Michiel Rook and Sue Schniepp
PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 394-395; DOI: https://doi.org/10.5731/pdajpst.2012.00885
1Roche-Genentech;
Karen Bartel
1Roche-Genentech;
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Hal Baseman
2ValSource;
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Gabriele Gori
3Novartis;
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Richard Levy
4PDA;
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Hemisha Ly
5Merck, Task Force Chair;
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  • For correspondence: Merck.hemisha_ly@merck.com
Maik Jornitz
6Sartorius-Stedim Biotech;
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Russell Madsen
7The Williamsburg Group, LLC;
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Michiel Rook
8Global-Consepts; and
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Sue Schniepp
9OsoBio
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PDA Journal of Pharmaceutical Science and Technology: 66 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 5
September/October 2012
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Pre-use/Post-sterilization Integrity Testing of Sterilizing Grade Filters
PDA Pre Use/Post-Sterilization Integrity Test Task Force:, Karen Bartel, Hal Baseman, Gabriele Gori, Richard Levy, Hemisha Ly, Maik Jornitz, Russell Madsen, Michiel Rook, Sue Schniepp
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 394-395; DOI: 10.5731/pdajpst.2012.00885

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Pre-use/Post-sterilization Integrity Testing of Sterilizing Grade Filters
PDA Pre Use/Post-Sterilization Integrity Test Task Force:, Karen Bartel, Hal Baseman, Gabriele Gori, Richard Levy, Hemisha Ly, Maik Jornitz, Russell Madsen, Michiel Rook, Sue Schniepp
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 394-395; DOI: 10.5731/pdajpst.2012.00885
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  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
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  • PDA Letter to the FDA Regarding Process Simulation Testing
  • PDA Comments on Draft Guidance for Industry, ANDAs: Blend Uniformity
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