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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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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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  • Comparing Container Closure Integrity Test Methods--Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
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  • Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
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  • Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
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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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