Skip to main content

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
Article CommentaryCommentary

Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry

Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999
Helen Brown
1Late-Stage Pharmaceutical and Processing Development, Roche;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Hanns-Christian Mahler
2Drug Product Services, Lonza;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
James Mellman
3Biologics Technical Development and Manufacturing, Novartis;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Alejandra Nieto
1Late-Stage Pharmaceutical and Processing Development, Roche;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Daniel Wagner
4Pharmaceutical Sciences Operations, Sanofi;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Matthias Schaar
5Biological and Microbiological Services, Novartis;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Roman Mathaes
2Drug Product Services, Lonza;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Juergen Kossinna
3Biologics Technical Development and Manufacturing, Novartis;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Franz Schmitting
6Development Sciences, Abbvie;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Sascha Dreher
7Device Development, Roche; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Holger Roehl
1Late-Stage Pharmaceutical and Processing Development, Roche;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Markus Hemminger
7Device Development, Roche; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Klaus Wuchner
8Drug Product and Device Methods, Janssen R&D
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: kwuchne1@its.jnj.com
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

Article Information

vol. 71 no. 2 147-162
DOI 
https://doi.org/10.5731/pdajpst.2016.006999
PubMed 
27789803

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 10, 2017.

Article Versions

  • previous version (October 27, 2016 - 16:53).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2017

Author Information

  1. Helen Brown1,
  2. Hanns-Christian Mahler2,
  3. James Mellman3,
  4. Alejandra Nieto1,
  5. Daniel Wagner4,
  6. Matthias Schaar5,
  7. Roman Mathaes2,
  8. Juergen Kossinna3,
  9. Franz Schmitting6,
  10. Sascha Dreher7,
  11. Holger Roehl1,
  12. Markus Hemminger7 and
  13. Klaus Wuchner8,*
  1. 1Late-Stage Pharmaceutical and Processing Development, Roche;
  2. 2Drug Product Services, Lonza;
  3. 3Biologics Technical Development and Manufacturing, Novartis;
  4. 4Pharmaceutical Sciences Operations, Sanofi;
  5. 5Biological and Microbiological Services, Novartis;
  6. 6Development Sciences, Abbvie;
  7. 7Device Development, Roche; and
  8. 8Drug Product and Device Methods, Janssen R&D
  1. ↵* Corresponding Author: Janssen, Pharmaceutical Development and Manufacturing Sciences, Hochstrasse 201, CH-8205 Schaffhausen, Switzerland. E-mail: kwuchne1{at}its.jnj.com.
View Full Text

Cited By...

  • Citations
  • Google Scholar

This article has not yet been cited by articles in journals that are participating in Crossref Cited-by Linking.

PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 71 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 2
March/April 2017
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
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.

Enter multiple addresses on separate lines or separate them with commas.
Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
1 + 4 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger, Klaus Wuchner
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 147-162; DOI: 10.5731/pdajpst.2016.006999

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger, Klaus Wuchner
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 147-162; DOI: 10.5731/pdajpst.2016.006999
del.icio.us logo Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Methods for CCIT
    • Introduction of Artificial Leaks
    • Considerations of Microbial Challenge Container Closure Integrity Testing (mCCIT) To Establish Acceptance Criteria for Physical Container Closure Integrity Testing (pCCIT)
    • General Considerations for the Applicability of CCIT
    • CCIT in the Product Life Cycle
    • Conclusion
    • Conflict of Interest Declaration
    • Acknowledgments
    • References
  • Figures & Data
  • Info & Metrics
  • References
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
  • Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
  • Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
  • Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)
  • Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies
  • Container Closure Integrity Testing--Method Development for Freeze-Dried Products Using Laser-Based Headspace Oxygen Analysis
  • Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation
  • Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
  • Google Scholar

More in this TOC Section

  • Parametric Release of Moist Heat Sterilized Products: History and Current State
  • MIT CAACB Risk Assessment Case Study: Assessing virus cross-contamination risk between two simultaneous processes in an open biomanufacturing facility
  • Do Plant Isolates Have a Role in Method Suitability and Growth Promotion Testing in the Microbiology Laboratory? Is It a Matter of Science versus Compliance?
Show more Commentary

Similar Articles

Keywords

  • Container closure integrity testing
  • Methods for container closure integrity testing
  • Artificial leaks
  • Industry perspective
  • Container closure system
  • Primary packaging
  • USP <1207>

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2023 PDA Journal of Pharmaceutical Science and Technology ISSN: 1079-7440

Powered by HighWire