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

Article Information

vol. 77 no. 3 211-235
DOI 
https://doi.org/10.5731/pdajpst.2021.012672
PubMed 
36697213
Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online June 8, 2023.

Article Versions

Copyright & Usage 
© PDA, Inc. 2023

Author Information

  1. Sven Deutschmann1,
  2. Mousumi Paul2,
  3. Marja Claassen-Willemse3,
  4. Jonas van den Berg4,
  5. Pieta IJzerman-Boon3,
  6. Viviane Grunert da Fonseca5,
  7. Ellen Brunbech6,
  8. Lynn Johnson7,
  9. Chris Knutsen8,
  10. Lucile Plourde9,
  11. Joanny Salvas10,
  12. Philip Villari2 and
  13. Lisa Wysocki11
  1. 1Roche Diagnostics GmbH, Penzberg, Germany;
  2. 2Merck & Co., Inc., Kenilworth, NJ;
  3. 3MSD, Oss, The Netherlands;
  4. 4Roche Diagnostics GmbH, Mannheim, Germany;
  5. 5Roche Diagnostics GmbH, Penzberg, Germany;
  6. 6Novo Nordisk A/S, Bagsvaerd, Denmark;
  7. 7Takeda, Lexington, MA;
  8. 8Bristol-Myers Squibb, New Brunswick, NJ;
  9. 9Sanofi Pasteur, Marcy-l'Etoile, France;
  10. 10Pfizer, Kirkland, QC, Canada; and
  11. 11GlaxoSmithKline, Collegeville, PA
  1. *Corresponding Author: BioPhorum Operations Group Limited, 5 Westbrook Ct., Sharrowvale Rd., Sheffield, S11 8YZ, United Kingdom. E-mail: margit.franz-riethdorf{at}biophorum.com
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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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