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 ArticleResearch

Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers

Alejandra Nieto and Holger Roehl
PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 367-381; DOI: https://doi.org/10.5731/pdajpst.2017.008391
Alejandra Nieto
Pharmaceutical Development & Supplies—Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: alejandra.nieto-pena@roche.com
Holger Roehl
Pharmaceutical Development & Supplies—Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland
  • 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

Reference

  1. 1.↵
    1. Murphy B. M.,
    2. Swarts S.,
    3. Mueller B. M.,
    4. van der Geer P.,
    5. Manning M. C.,
    6. Fitchmun M. I.
    Protein instability following transport or storage on dry ice. Nat. Methods 2012, 10 (4), 278–279.
    OpenUrl
  2. 2.↵
    1. Rey L.,
    2. May J. C.
    Freeze Drying/Lyophilization of Pharmaceutical and Biological Products, 3rd ed.; Informa Helthcare: London, UK, 2010; p. 402.
  3. 3.↵
    1. Cummings P.,
    2. Jacobs B.
    Testing Closure Integrity at Low Temperatures. West Pharmaceutical. Website: Contract Pharma on 1 Apr. 2014. http://www.contractpharma.com/issues/2014-04-01/view_features/testing-closure-integrity-at-low-temperatures/.
  4. 4.↵
    1. Zuleger B.,
    2. Werner U.,
    3. Kort A.,
    4. et al
    . Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at −80°C. PDA J. Pharm. Sci. Technol. 2012, 66, 453–465.
    OpenUrlAbstract/FREE Full Text
  5. 5.↵
    1. Nieto A.,
    2. Roehl H.,
    3. Brown H.,
    4. Nikoloff J.,
    5. Adler M.,
    6. Mahler H.-C.
    Evaluation of Container Closure System Integrity for Frozen Storage Drug Products. PDA J Pharm Sci Technol. 2016, 70, 120–133, 2016.
    OpenUrlAbstract/FREE Full Text
  6. 6.↵
    U.S. Pharmacopoeia. USP <1207> Sterile Product Packaging-Integrity Evaluation. United States Pharmacopoeial Convention, Inc.: Rockville, MD, 2011.
  7. 7.↵
    1. Brown H.,
    2. Mahler H.-C.,
    3. Mellmann J.,
    4. Nieto A.,
    5. et al
    . Container Closure Integrity Testing - Practical Aspects and Approaches in the Pharmaceutical Industry. PDA J. Pharm. Sci. Technol. 2017, 71 (2), 147–162.
    OpenUrlAbstract/FREE Full Text
  8. 8.↵
    1. Lam P.,
    2. Stern A.
    Visualization Techniques for Assessing Design Factors That Affect the Interaction between Pharmaceutical Vials and Stoppers. PDA J. Pharm. Sci. Technol. 2010, 64 (2), 182–187.
    OpenUrlAbstract/FREE Full Text
  9. 9.↵
    1. Duncan D.,
    2. Asselta R.
    Correlating Vial Seal Tightness to Container Closure Integrity at Various Storage Temperatures, PDA Europe Parenteral Packaging Conference, Frankfurt, Germany, 2015.
  10. 10.↵
    1. Nieto A.,
    2. Roehl H.,
    3. Adler M.,
    4. Mohl S.
    Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation. PDA J. Pharm. Sci. Technol. 2018, doi: 10.5731/pdajpst.2017.008383.
    OpenUrlAbstract/FREE Full Text
  11. 11.↵
    1. Hibler S.,
    2. Gieseler H.
    Heat Transfer Characteristics of Current Primary Packaging Systems for Pharmaceutical Freeze-Drying. J. Pharm. Sci. 2012, 101 (11), 4025–4031.
    OpenUrlPubMed
  12. 12.↵
    1. Zienkiewicz O. C.
    The Finite Element Method, 3rd ed.; McGraw-Hill: London, 1977.
  13. 13.↵
    1. Iacocca R. G.,
    2. Li L.
    Mechanical Modelling of Parenteral Packaging. Parenteral Drug Association—Parenteral Packaging Conference, Venice, Italy, 2016.
  14. 14.↵
    Webpage (23 April 2016): http://www.healthcarepackaging.com/applications/healthcare/finite-element-analysis.
  15. 15.↵
    1. Castleman L.
    Simulating Seal Life with Finite Elemental Analysis. BioProcess International 2015, 13 (2), 30–35.
    OpenUrl
  16. 16.↵
    Webpage (20 June 2016): www.viscodata.de.
  17. 17.↵
    Webpages (19 April 2016): www.schott.com; www.materialarchiv.ch.
  18. 18.↵
    1. Mathaes R.,
    2. Mahler H.-C.,
    3. Roggo Y.,
    4. Huwyler J.,
    5. Eder J.,
    6. Fritsch K.,
    7. Posset T.,
    8. Mohl M.,
    9. Streubel A.
    Critical Process Parameters of Capping Equipment Used in GMP DP Manufacturing. PDA J. Pharm. Sci. Technol. 2016, 70, 109–119.
    OpenUrlAbstract/FREE Full Text
  19. 19.↵
    1. Nieto A.,
    2. Roehl H.,
    3. Brown H.,
    4. Adler M.,
    5. Chalus P.,
    6. Mahler H. C.
    Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial. PDA J. Pharm. Sci. Technol. 2016, 70 (4), 313–324.
    OpenUrlAbstract/FREE Full Text
  20. 20.↵
    1. Mathaes R.,
    2. Mahler H.-C.,
    3. Roggo Y.,
    4. Ovadia R.,
    5. Lam P.,
    6. Stauch O.,
    7. Vogt M.,
    8. Roehl H.,
    9. Huwyler J.,
    10. Mohl S.,
    11. Streubel A.
    Impact of Vial Capping on Residual Seal Force and Container Closure Integrity. PDA J. Pharm. Sci. Technol. 2016, 70 (1), 12–29.
    OpenUrlAbstract/FREE Full Text
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 72 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 4
July/August 2018
  • 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.
Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
(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.
5 + 1 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
Alejandra Nieto, Holger Roehl
PDA Journal of Pharmaceutical Science and Technology Jul 2018, 72 (4) 367-381; DOI: 10.5731/pdajpst.2017.008391

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
Alejandra Nieto, Holger Roehl
PDA Journal of Pharmaceutical Science and Technology Jul 2018, 72 (4) 367-381; DOI: 10.5731/pdajpst.2017.008391
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • 1. Introduction
    • 2. Materials and Methods
    • 3. Results and Discussion
    • 4. Conclusions
    • Conflict of Interest Declaration
    • Acknowledgments
    • Reference
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
  • Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation
  • Google Scholar

More in this TOC Section

  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
  • Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
  • A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
Show more Research

Similar Articles

Keywords

  • Container closure integrity
  • Finite element analysis
  • Frozen drug product
  • Container closure system
  • Vial
  • parenteral primary packaging

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