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

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 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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For correspondence: david.riesop@abbvie.com

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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For correspondence: dbonvin@its.jnj.com

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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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 1

January/February 2025

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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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Comparing Container Closure Integrity Test Methods--Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls

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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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Parenteral Drug Association, Inc.