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Research ArticleTechnology/Application

Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation and Global Implementation

Sven Deutschmann, Mousumi Paul, Marja Claassen-Willemse, Jonas van den Berg, Pieta IJzerman-Boon, Viviane Grunert da Fonseca, Ellen Brunbech, Lynn Johnson, Chris Knutsen, Lucile Plourde, Joanny Salvas, Philip Villari and Lisa Wysocki
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 211-235; DOI: https://doi.org/10.5731/pdajpst.2021.012672
Sven Deutschmann
1Roche Diagnostics GmbH, Penzberg, Germany;
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Mousumi Paul
2Merck & Co., Inc., Kenilworth, NJ;
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Marja Claassen-Willemse
3MSD, Oss, The Netherlands;
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Jonas van den Berg
4Roche Diagnostics GmbH, Mannheim, Germany;
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Pieta IJzerman-Boon
3MSD, Oss, The Netherlands;
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Viviane Grunert da Fonseca
5Roche Diagnostics GmbH, Penzberg, Germany;
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Ellen Brunbech
6Novo Nordisk A/S, Bagsvaerd, Denmark;
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Lynn Johnson
7Takeda, Lexington, MA;
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Chris Knutsen
8Bristol-Myers Squibb, New Brunswick, NJ;
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Lucile Plourde
9Sanofi Pasteur, Marcy-l'Etoile, France;
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Joanny Salvas
10Pfizer, Kirkland, QC, Canada; and
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Philip Villari
2Merck & Co., Inc., Kenilworth, NJ;
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Lisa Wysocki
11GlaxoSmithKline, Collegeville, PA
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PDA Journal of Pharmaceutical Science and Technology: 77 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 3
May/June 2023
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Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation and Global Implementation
Sven Deutschmann, Mousumi Paul, Marja Claassen-Willemse, Jonas van den Berg, Pieta IJzerman-Boon, Viviane Grunert da Fonseca, Ellen Brunbech, Lynn Johnson, Chris Knutsen, Lucile Plourde, Joanny Salvas, Philip Villari, Lisa Wysocki
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 211-235; DOI: 10.5731/pdajpst.2021.012672

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Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation and Global Implementation
Sven Deutschmann, Mousumi Paul, Marja Claassen-Willemse, Jonas van den Berg, Pieta IJzerman-Boon, Viviane Grunert da Fonseca, Ellen Brunbech, Lynn Johnson, Chris Knutsen, Lucile Plourde, Joanny Salvas, Philip Villari, Lisa Wysocki
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 211-235; DOI: 10.5731/pdajpst.2021.012672
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Keywords

  • Alternative and rapid microbiological methods
  • Alternative sterility test
  • Method validation
  • Microbiological method transfer
  • Regulatory filing
  • Statistical methodology

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