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

OtherResearch

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;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: sarah.pelaez@lonza.com

Hanns-Christian Mahler

1 Lonza;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: hanns-christian.mahler@lonza.com

Christoph Herdlitschka

2 Wilco;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: christoph.herdlitschka@wilco.com

Anton Wertli

2 Wilco;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: anton.wertli@wilco.com

Matthias Kahl

2 Wilco;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: matthias.kahl@wilco.com

Atanas Koulov

1 Lonza;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: atanas.koulov@lonza.com

Anja Matter

1 Lonza;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: anja.matter@lonza.com

Satish K Singh

1 Lonza;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: satish.singh@lonza.com

Martina Widmer

1 Lonza;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: martinawidmer@bluewin.ch

Oliver Germershaus

3 School of Life Sciences, University of Applied Sciences Northwestern

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: oliver.germershaus@fhnw.ch

Roman Mathaes

1 Lonza;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: roman.mathaes@lonza.com

Article
References
Info & Metrics
PDF

Article Information

pdajpst.2018.009332

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

Received August 1, 2018
Accepted December 14, 2018
Published online January 16, 2019.

Article Versions

You are currently viewing a previous version of this article (January 16, 2019 - 07:46).
View the most recent version of this article

Author Information

Sarah S Peláez1 (sarah.pelaez{at}lonza.com),
Hanns-Christian Mahler1 (hanns-christian.mahler{at}lonza.com),
Christoph Herdlitschka2 (christoph.herdlitschka{at}wilco.com),
Anton Wertli2 (anton.wertli{at}wilco.com),
Matthias Kahl2 (matthias.kahl{at}wilco.com),
Atanas Koulov1 (atanas.koulov{at}lonza.com),
Anja Matter1 (anja.matter{at}lonza.com),
Satish K Singh1 (satish.singh{at}lonza.com),
Martina Widmer1 (martinawidmer{at}bluewin.ch),
Oliver Germershaus3 (oliver.germershaus{at}fhnw.ch) and
Roman Mathaes1,4 (roman.mathaes{at}lonza.com)

¹ Lonza;
² Wilco;
³ School of Life Sciences, University of Applied Sciences Northwestern

↵* Corresponding author; email: roman.mathaes{at}lonza.com

Cited By...

5 Citations
Google Scholar

This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking.

Air, Helium and Water Leakage in Rubber O-ring Seals with Application to Syringes

C. Huon, A. Tiwari, C. Rotella, P. Mangiagalli, B. N. J. Persson

Tribology Letters 2022 70 2
Container Closure Integrity of a Glass Prefillable Syringe in Deep Frozen Storage Conditions

Jessica Baseggio, Anton Zverev, Odra Pinato, Anthony Vico, Jason E. Fernandez, Satish K. Singh

Journal of Pharmaceutical Sciences 2024 113 5
Defect Detection Sensitivity of Bubble-Point-Type Tests for Sterilizing-Grade Membrane Cartridge Filters

Sal Giglia, Anand Alembath, Joseph Hersey

Membranes 2023 13 1
Leakage Dynamics of Glass Bottles on Container Closure Integrity Testing: Influence of Different Laser-Drilled Microhole Geometries

Weina Han, Xiaofeng Duan, Jianying Wu, Lan Jiang, Hao Wu, Zhaolun Chen

Journal of Pharmaceutical Sciences 2023 112 5
Principles and Practices of Lyophilization in Product Development and Manufacturing

Robert Ovadia, Phillippe Lam, Holger Roehl, Renaud Janssen, Roger Asselta

2023 59

In This Issue

PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 3

May/June 2025

Table of Contents
Index by Author
Complete Issue (PDF)

Download PDF

Article Alerts

User Name *

Password *

Email *

Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Your Email *

Your Name *

Send To *

Enter multiple addresses on separate lines or separate them with commas.

You are going to email the following Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies

Message Subject (Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology

Message Body (Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.

Your Personal Message

CAPTCHA

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Math question * 2 + 17 =

Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

Citation Tools

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

Citation Manager Formats

BibTeX
Bookends
EasyBib
EndNote (tagged)
EndNote 8 (xml)
Medlars
Mendeley
Papers
RefWorks Tagged
Ref Manager
RIS
Zotero

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

Share This Article:

Tweet Widget
Facebook Like
Google Plus One

Jump to section

Article
References
Info & Metrics
PDF

No related articles found.

PubMed
Google Scholar

Cited By...

Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
Comparing Container Closure Integrity Test Methods--Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
A Multicompany Survey Study for Helium Leak Container Closure Integrity Test
Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas

Google Scholar

Keywords

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

Main menu

User menu

Search

Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies

Article Information

Article Versions

Author Information

Cited By...

In This Issue

Citation Manager Formats

Related Articles

Cited By...

More in this TOC Section

Similar Articles

Keywords

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.