Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies

Sarah S Peláez; Hanns-Christian Mahler; Christoph Herdlitschka; Anton Wertli; Matthias Kahl; Atanas Koulov; Anja Matter; Satish K Singh; Martina Widmer; Oliver Germershaus; Roman Mathaes

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, Anton Wertli, Matthias Kahl, Atanas Koulov, Anja Matter, Satish K Singh, Martina Widmer, Oliver Germershaus and Roman Mathaes

PDA Journal of Pharmaceutical Science and Technology January 2019, pdajpst.2018.009332; DOI: https://doi.org/10.5731/pdajpst.2018.009332

Sarah S Peláez

1 Lonza;

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For correspondence: sarah.pelaez@lonza.com

Hanns-Christian Mahler

1 Lonza;

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For correspondence: hanns-christian.mahler@lonza.com

Christoph Herdlitschka

2 Wilco;

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For correspondence: christoph.herdlitschka@wilco.com

Anton Wertli

2 Wilco;

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For correspondence: anton.wertli@wilco.com

Matthias Kahl

2 Wilco;

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For correspondence: matthias.kahl@wilco.com

Atanas Koulov

1 Lonza;

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For correspondence: atanas.koulov@lonza.com

Anja Matter

1 Lonza;

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For correspondence: anja.matter@lonza.com

Satish K Singh

1 Lonza;

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For correspondence: satish.singh@lonza.com

Martina Widmer

1 Lonza;

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For correspondence: martinawidmer@bluewin.ch

Oliver Germershaus

3 School of Life Sciences, University of Applied Sciences Northwestern

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For correspondence: oliver.germershaus@fhnw.ch

Roman Mathaes

1 Lonza;

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For correspondence: roman.mathaes@lonza.com

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 3

May/June 2025

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Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies

Sarah S Peláez, Hanns-Christian Mahler, Christoph Herdlitschka, Anton Wertli, Matthias Kahl, Atanas Koulov, Anja Matter, Satish K Singh, Martina Widmer, Oliver Germershaus, Roman Mathaes

PDA Journal of Pharmaceutical Science and Technology Jan 2019, pdajpst.2018.009332; 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, Anton Wertli, Matthias Kahl, Atanas Koulov, Anja Matter, Satish K Singh, Martina Widmer, Oliver Germershaus, Roman Mathaes

PDA Journal of Pharmaceutical Science and Technology Jan 2019, pdajpst.2018.009332; DOI: 10.5731/pdajpst.2018.009332

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Keywords

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

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Parenteral Drug Association, Inc.