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Review ArticleCase Studies

A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT)

Kelly Waldron, Amanda McFarland, Hal Baseman and Maik Jornitz
PDA Journal of Pharmaceutical Science and Technology February 2025, pdajpst.2024-003038; DOI: https://doi.org/10.5731/pdajpst.2024.003038
Kelly Waldron
BioProcess Resources LLC, 12 Manorview Way, Manorville, NY 11949, UNITED STATES OF AMERICA
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  • For correspondence: mwjornitz@hotmail.com
Amanda McFarland
BioProcess Resources LLC, 12 Manorview Way, Manorville, NY 11949, UNITED STATES OF AMERICA
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Hal Baseman
BioProcess Resources LLC, 12 Manorview Way, Manorville, NY 11949, UNITED STATES OF AMERICA
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Maik Jornitz
BioProcess Resources LLC, 12 Manorview Way, Manorville, NY 11949, UNITED STATES OF AMERICA
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Article Information

pdajpst.2024-003038
DOI 
https://doi.org/10.5731/pdajpst.2024.003038
PubMed 
39929721

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received December 4, 2024
  • Accepted January 21, 2025
  • Published online February 10, 2025.

Copyright & Usage 
Copyright © 2025, Parenteral Drug Association

Author Information

  1. Kelly Waldron⇑ (mwjornitz{at}hotmail.com),
  2. Amanda McFarland,
  3. Hal Baseman and
  4. Maik Jornitz
  1. BioProcess Resources LLC, 12 Manorview Way, Manorville, NY 11949, UNITED STATES OF AMERICA
  1. corresponding author Maik Jornitz, BioProcess Resources LLC, 12 Manorview Way, Manorville, NY 11949, UNITED STATES OF AMERICA mwjornitz{at}hotmail.com

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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT)
Kelly Waldron, Amanda McFarland, Hal Baseman, Maik Jornitz
PDA Journal of Pharmaceutical Science and Technology Feb 2025, pdajpst.2024-003038; DOI: 10.5731/pdajpst.2024.003038

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A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT)
Kelly Waldron, Amanda McFarland, Hal Baseman, Maik Jornitz
PDA Journal of Pharmaceutical Science and Technology Feb 2025, pdajpst.2024-003038; DOI: 10.5731/pdajpst.2024.003038
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