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A Multicompany Survey Study for Helium Leak Container Closure Integrity Test

Roman Mathaes, Klaus Wuchner, David Riesop, Daniel Wagner, Sascha Dreher, Florian Woelfle, Prudvi Raj Mudumala, Debora Bonvin, Christian Müller, Kerstin Traub Hoffmann and Henri Hebting
PDA Journal of Pharmaceutical Science and Technology November 2021, pdajpst.2021.012633; DOI: https://doi.org/10.5731/pdajpst.2021.012633
Roman Mathaes
1 Lonza;
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  • For correspondence: roman.mathaes@lonza.com
Klaus Wuchner
2 Janssen;
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  • For correspondence: kwuchne1@its.jnj.com
David Riesop
3 Abbvie;
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Daniel Wagner
4 Sanofi;
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  • For correspondence: daniel.wagner@sanofi.com
Sascha Dreher
5 Roche;
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  • For correspondence: sascha.dreher@roche.com
Florian Woelfle
6 Boehringer Ingelheim;
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  • For correspondence: florian.woelfle@boehringer-ingelheim.com
Prudvi Raj Mudumala
7 Novartis;
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  • For correspondence: raj.mudumala@novartis.com
Debora Bonvin
2 Janssen;
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Christian Müller
5 Roche;
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  • For correspondence: christian.mueller.cm23@roche.com
Kerstin Traub Hoffmann
4 Sanofi;
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  • For correspondence: kerstin.traub-hoffmann@sanofi.com
Henri Hebting
8 Lilly
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  • For correspondence: hebting_henri@lilly.com
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Article Information

pdajpst.2021.012633
DOI 
https://doi.org/10.5731/pdajpst.2021.012633
PubMed 
34782444

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received February 23, 2021
  • Accepted November 8, 2021
  • Published online November 15, 2021.

Article Versions

  • You are currently viewing a previous version of this article (November 15, 2021 - 03:48).
  • View the most recent version of this article
Copyright & Usage 
Copyright © 2021, Parenteral Drug Association

Author Information

  1. Roman Mathaes1 (roman.mathaes{at}lonza.com),
  2. Klaus Wuchner2,9 (kwuchne1{at}its.jnj.com),
  3. David Riesop3 (david.riesop{at}abbvie.com),
  4. Daniel Wagner4 (daniel.wagner{at}sanofi.com),
  5. Sascha Dreher5 (sascha.dreher{at}roche.com),
  6. Florian Woelfle6 (florian.woelfle{at}boehringer-ingelheim.com),
  7. Prudvi Raj Mudumala7 (raj.mudumala{at}novartis.com),
  8. Debora Bonvin2 (dbonvin{at}its.jnj.com),
  9. Christian Müller5 (christian.mueller.cm23{at}roche.com),
  10. Kerstin Traub Hoffmann4 (kerstin.traub-hoffmann{at}sanofi.com) and
  11. Henri Hebting8 (hebting_henri{at}lilly.com)
  1. 1 Lonza;
  2. 2 Janssen;
  3. 3 Abbvie;
  4. 4 Sanofi;
  5. 5 Roche;
  6. 6 Boehringer Ingelheim;
  7. 7 Novartis;
  8. 8 Lilly
  1. ↵* Corresponding author; email: kwuchne1{at}its.jnj.com

Cited By...

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This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking.

  • Industry perspective on a holistic container closure integrity approach to parenteral combination products
    Klaus Wuchner, Helen C. Brown, Fabiana Canal, Debora Bonvin, Craig Goldhammer, Henri Hebting, Carine Huon, Sebastian M. Kuhn, Prudvi Raj Mudumala, Karen Neuhold, David Riesop, Jean-Sebastien Steffen, Florian Woelfle
    European Journal of Pharmaceutics and Biopharmaceutics 2024 194
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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
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A Multicompany Survey Study for Helium Leak Container Closure Integrity Test
Roman Mathaes, Klaus Wuchner, David Riesop, Daniel Wagner, Sascha Dreher, Florian Woelfle, Prudvi Raj Mudumala, Debora Bonvin, Christian Müller, Kerstin Traub Hoffmann, Henri Hebting
PDA Journal of Pharmaceutical Science and Technology Nov 2021, pdajpst.2021.012633; DOI: 10.5731/pdajpst.2021.012633

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A Multicompany Survey Study for Helium Leak Container Closure Integrity Test
Roman Mathaes, Klaus Wuchner, David Riesop, Daniel Wagner, Sascha Dreher, Florian Woelfle, Prudvi Raj Mudumala, Debora Bonvin, Christian Müller, Kerstin Traub Hoffmann, Henri Hebting
PDA Journal of Pharmaceutical Science and Technology Nov 2021, pdajpst.2021.012633; DOI: 10.5731/pdajpst.2021.012633
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Keywords

  • Artificial leaks
  • Container closure integrity testing
  • Container closure system
  • Helium leak test
  • Industry round robin study
  • USP <1207>

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