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Research ArticleResearch

Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies

Sarah S. Peláez, Hanns-Christian Mahler, Christoph Herdlitschka, Toni Wertli, Matthias Kahl, Atanas Koulov, Anja Matter, Satish K. Singh, Martina Widmer, Oliver Germershaus and Roman Mathaes
PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 220-234; DOI: https://doi.org/10.5731/pdajpst.2018.009332
Sarah S. Peláez
1Lonza Drug Product Services, Basel, Switzerland;
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Hanns-Christian Mahler
1Lonza Drug Product Services, Basel, Switzerland;
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Christoph Herdlitschka
2Wilco AG, Wohlen, Switzerland; and
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Toni Wertli
2Wilco AG, Wohlen, Switzerland; and
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Matthias Kahl
2Wilco AG, Wohlen, Switzerland; and
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Atanas Koulov
1Lonza Drug Product Services, Basel, Switzerland;
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Anja Matter
1Lonza Drug Product Services, Basel, Switzerland;
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Satish K. Singh
1Lonza Drug Product Services, Basel, Switzerland;
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Martina Widmer
1Lonza Drug Product Services, Basel, Switzerland;
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Oliver Germershaus
3Institute for Pharma Technology, School of Life Sciences, University of Applied Sciences and Arts Northwestern Switzerland, Muttenz, Switzerland.
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Roman Mathaes
1Lonza Drug Product Services, Basel, Switzerland;
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  • For correspondence: roman.mathaes@lonza.com
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Article Information

vol. 73 no. 3 220-234
DOI 
https://doi.org/10.5731/pdajpst.2018.009332
PubMed 
30651337

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online May 31, 2019.

Article Versions

  • previous version (January 16, 2019 - 07:46).
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Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Sarah S. Peláez1,
  2. Hanns-Christian Mahler1,
  3. Christoph Herdlitschka2,
  4. Toni Wertli2,
  5. Matthias Kahl2,
  6. Atanas Koulov1,
  7. Anja Matter1,
  8. Satish K. Singh1,
  9. Martina Widmer1,
  10. Oliver Germershaus3 and
  11. Roman Mathaes1,*
  1. 1Lonza Drug Product Services, Basel, Switzerland;
  2. 2Wilco AG, Wohlen, Switzerland; and
  3. 3Institute for Pharma Technology, School of Life Sciences, University of Applied Sciences and Arts Northwestern Switzerland, Muttenz, Switzerland.
  1. ↵* Corresponding Author: Roman Mathaes, Hochbergerstrasse 60A, 4057 Basel, Switzerland. E-mail: roman.mathaes{at}lonza.com
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PDA Journal of Pharmaceutical Science and Technology: 73 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 3
May/June 2019
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Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies
Sarah S. Peláez, Hanns-Christian Mahler, Christoph Herdlitschka, Toni Wertli, Matthias Kahl, Atanas Koulov, Anja Matter, Satish K. Singh, Martina Widmer, Oliver Germershaus, Roman Mathaes
PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 220-234; DOI: 10.5731/pdajpst.2018.009332

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Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies
Sarah S. Peláez, Hanns-Christian Mahler, Christoph Herdlitschka, Toni Wertli, Matthias Kahl, Atanas Koulov, Anja Matter, Satish K. Singh, Martina Widmer, Oliver Germershaus, Roman Mathaes
PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 220-234; DOI: 10.5731/pdajpst.2018.009332
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Keywords

  • Container closure integrity testing
  • Artificial leaks
  • Primary packaging
  • USP <1207>
  • Mass spectrometry-based helium leak detection
  • Laser-based headspace analysis

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