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Research ArticleResearch

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 May 2022, 76 (3) 216-235; DOI: https://doi.org/10.5731/pdajpst.2021.012633
Roman Mathaes
1Drug product services, Lonza AG, Basel, Switzerland;
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Klaus Wuchner
2Analytical Development, BioTherapeutics Development, Janssen Research & Development, Hochstrasse 201, 8200 Schaffhausen, Switzerland;
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  • For correspondence: kwuchne1@its.jnj.com
David Riesop
3NBE Formulation Sciences, Drug Product Development, AbbVie Deutschland GmbH & Co. KG, Knollstrasse 50, 67061 Ludwigshafen, Germany;
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Daniel Wagner
4Global CMC Development – Synthetics Platform, Sanofi, Industriepark Hoechst, 65926 Frankfurt, Germany;
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Sascha Dreher
5Device and Packaging Development, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland;
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Florian Woelfle
6Pharmaceutical Development Biologicals, Boehringer Ingelheim Pharma GmbH&Co, Birkendorferstrasse 65, 88397 Biberach an der Riss, Germany;
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Prudvi Raj Mudumala
7Analytics&Testing, Global Device and Packaging Development, Novartis Pharma AG, 4056 Basel, Switzerland; and
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Debora Bonvin
2Analytical Development, BioTherapeutics Development, Janssen Research & Development, Hochstrasse 201, 8200 Schaffhausen, Switzerland;
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Christian Müller
5Device and Packaging Development, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland;
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Kerstin Traub-Hoffmann
4Global CMC Development – Synthetics Platform, Sanofi, Industriepark Hoechst, 65926 Frankfurt, Germany;
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Henri Hebting
8Global Platforms Technical Support – Parenteral Network, Lilly France SAS, 2, Rue du Colonel Lilly, 67412 Illkirch, France
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Article Information

vol. 76 no. 3 216-235
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 
  • Published online June 1, 2022.

Article Versions

  • previous version (November 15, 2021 - 03:48).
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Copyright & Usage 
© PDA, Inc. 2022

Author Information

  1. Roman Mathaes1,i,
  2. Klaus Wuchner2,*,,ii,
  3. David Riesop3,
  4. Daniel Wagner4,
  5. Sascha Dreher5,
  6. Florian Woelfle6,
  7. Prudvi Raj Mudumala7,
  8. Debora Bonvin2,
  9. Christian Müller5,
  10. Kerstin Traub-Hoffmann4 and
  11. Henri Hebting8
  1. 1Drug product services, Lonza AG, Basel, Switzerland;
  2. 2Analytical Development, BioTherapeutics Development, Janssen Research & Development, Hochstrasse 201, 8200 Schaffhausen, Switzerland;
  3. 3NBE Formulation Sciences, Drug Product Development, AbbVie Deutschland GmbH & Co. KG, Knollstrasse 50, 67061 Ludwigshafen, Germany;
  4. 4Global CMC Development – Synthetics Platform, Sanofi, Industriepark Hoechst, 65926 Frankfurt, Germany;
  5. 5Device and Packaging Development, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland;
  6. 6Pharmaceutical Development Biologicals, Boehringer Ingelheim Pharma GmbH&Co, Birkendorferstrasse 65, 88397 Biberach an der Riss, Germany;
  7. 7Analytics&Testing, Global Device and Packaging Development, Novartis Pharma AG, 4056 Basel, Switzerland; and
  8. 8Global Platforms Technical Support – Parenteral Network, Lilly France SAS, 2, Rue du Colonel Lilly, 67412 Illkirch, France
  1. ↵*Corresponding Author: Janssen Research & Development, Cilag AG, Hochstrasse 205, CH-8205 Schaffhausen, Switzerland; E-mail: kwuchne1@its.jnj.com
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    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: 76 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 3
May/June 2022
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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 May 2022, 76 (3) 216-235; DOI: 10.5731/pdajpst.2021.012633
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    • Abstract
    • Introduction
    • Methods and Materials
    • Methods
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    • Performance Evaluation of He Leak Measurements
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    • Conflict of Interest Declaration
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Keywords

  • Container closure integrity testing
  • Helium leak test
  • Artificial leaks
  • Industry multicompany study
  • Container closure system
  • Primary packaging
  • USP <1207>

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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 May 2022, 76 (3) 216-235; DOI: 10.5731/pdajpst.2021.012633

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