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
Research ArticleTechnology/Application

Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at −80 °C

Brigitte Zuleger, Uwe Werner, Alexander Kort, Rene Glowienka, Engelbert Wehnes and Derek Duncan
PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 453-465; DOI: https://doi.org/10.5731/pdajpst.2012.00884
Brigitte Zuleger
1Bavarian Nordic GmbH, Robert Roessle Strasse 10, D-13125 Berlin, Germany;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Uwe Werner
1Bavarian Nordic GmbH, Robert Roessle Strasse 10, D-13125 Berlin, Germany;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Alexander Kort
2IDT Biologika GmbH, Am Pharmapark, D-06861 Dessau-Rosslau, Germany; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Rene Glowienka
2IDT Biologika GmbH, Am Pharmapark, D-06861 Dessau-Rosslau, Germany; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Engelbert Wehnes
1Bavarian Nordic GmbH, Robert Roessle Strasse 10, D-13125 Berlin, Germany;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Derek Duncan
3Lighthouse Instruments, Science Park 406, NL-1098 XH Amsterdam, The Netherlands
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

Article Information

vol. 66 no. 5 453-465
DOI 
https://doi.org/10.5731/pdajpst.2012.00884
PubMed 
23035029

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 3, 2012.

Copyright & Usage 
© PDA, Inc. 2012

Author Information

  1. Brigitte Zuleger1,
  2. Uwe Werner1,
  3. Alexander Kort2,
  4. Rene Glowienka2,
  5. Engelbert Wehnes1 and
  6. Derek Duncan3
  1. 1Bavarian Nordic GmbH, Robert Roessle Strasse 10, D-13125 Berlin, Germany;
  2. 2IDT Biologika GmbH, Am Pharmapark, D-06861 Dessau-Rosslau, Germany; and
  3. 3Lighthouse Instruments, Science Park 406, NL-1098 XH Amsterdam, The Netherlands
  1. * Correspondence author: Brigitte Zuleger, Bavarian Nordic GmbH, Robert Roessle Strasse 10, D-13125 Berlin, Germany. brigitte.zuleger{at}bavarian-nordic.com. Phone: +49 (30) 9406 3917
View Full Text

Cited By...

  • 14 Citations
  • Google Scholar

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

  • Impact of Residual Impurities and Contaminants on Protein Stability
    Wei Wang, Arun Alphonse Ignatius, Santosh V. Thakkar
    Journal of Pharmaceutical Sciences 2014 103 5
  • Acceleration of Translational Mesenchymal Stromal Cell Therapy Through Consistent Quality GMP Manufacturing
    Premkumar Jayaraman, Ryan Lim, Jacqueline Ng, Mohan C. Vemuri
    Frontiers in Cell and Developmental Biology 2021 9
  • Formulation of Cell-Based Medicinal Products: A Question of Life or Death?
    Karin H. Hoogendoorn, Daan J.A. Crommelin, Wim Jiskoot
    Journal of Pharmaceutical Sciences 2021 110 5
  • Investigation of Fogging Behavior in a Lyophilized Drug Product
    Min Huang, Ethan Childs, Kirk Roffi, Fawziya Karim, Jennifer Juneau, Bakul Bhatnagar, Serguei Tchessalov
    Journal of Pharmaceutical Sciences 2019 108 3
  • Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data
    Fotini Boufidou, Sophia Hatziantoniou, Kalliopi Theodoridou, Helena C. Maltezou, Konstantinos Vasileiou, Cleo Anastassopoulou, Snežana Medić, Athanasios Tsakris
    Vaccines 2023 11 3
  • The pharmaceutical vial capping process: Container closure systems, capping equipment, regulatory framework, and seal quality tests
    Roman Mathaes, Hanns-Christian Mahler, Jean-Pierre Buettiker, Holger Roehl, Philippe Lam, Helen Brown, Joerg Luemkemann, Michael Adler, Joerg Huwyler, Alexander Streubel, Silke Mohl
    European Journal of Pharmaceutics and Biopharmaceutics 2016 99
  • Drug product Formulation and Fill/Finish Manufacturing Process Considerations for AAV-Based Genomic Medicines
    Madhura Som, Benson Gikanga, Varna Kanapuram, Sandeep Yadav
    Journal of Pharmaceutical Sciences 2024 113 7
  • Challenges in Protein Product Development
    Roman Mathaes, Alexander Streubel
    2018 38
  • Sterile Product Development
    Lei Li
    2013 6
  • 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
  • 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
  • Impact of vial quality on interactions, particle formation, container closure integrity, and gas permeability for frozen drug product storage
    Daniela Henle, Lukas Muehlfeld, Daniel Molnar, Patrick Garidel, Wolfgang Friess
    European Journal of Pharmaceutical Sciences 2025 206
  • Principles and Practices of Lyophilization in Product Development and Manufacturing
    Derek Duncan, James R. Veale, Ken Victor, Adriaan H. de Goeij
    2023 59
  • Process Scale Purification of Antibodies
    Hanns‐Christian Mahler, Roman Mathäs
    2017
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 66 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 5
September/October 2012
  • 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 and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at −80 °C
(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 + 14 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at −80 °C
Brigitte Zuleger, Uwe Werner, Alexander Kort, Rene Glowienka, Engelbert Wehnes, Derek Duncan
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 453-465; DOI: 10.5731/pdajpst.2012.00884

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 and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at −80 °C
Brigitte Zuleger, Uwe Werner, Alexander Kort, Rene Glowienka, Engelbert Wehnes, Derek Duncan
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 453-465; DOI: 10.5731/pdajpst.2012.00884
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Materials and Methods
    • Results and Discussion
    • Conclusions
    • Conflict of Interest Declaration
    • Acknowledgements
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Comparing Container Closure Integrity Test Methods--Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Assessment of Functional and Physical Performances of Pre-filled Syringes in Deep Cold Storage Conditions
  • Container Closure Integrity of Vial Primary Packaging Systems under Frozen Storage Conditions: A Case Study
  • Container Closure Integrity Test Method Development on Vials Stored at -80{degrees}C Using Headspace Carbon Dioxide Analysis
  • Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
  • A Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up Analyses
  • Time Temperature Superposition Evaluation and Modeling for Container Closure System's Seal Performance at Low Temperatures
  • Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
  • Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity
  • The Application of Noninvasive Headspace Analysis to Media Fill Inspection
  • Evaluation of Container Closure System Integrity for Frozen Storage Drug Products
  • Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes
  • Integration of Regulatory Guidelines into Protein Drug Product Development
  • Google Scholar

More in this TOC Section

  • Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
Show more Technology/Application

Similar Articles

Keywords

  • Storage at −80 °C
  • Live viral vaccines
  • Container closure integrity
  • headspace analysis
  • Frequency modulation spectroscopy
  • Glass transition temperature

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

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire