Skip to main content
  • Main menu
  • User menu
  • Search

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
Review ArticleReview

Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity

Fran L. Degrazio
PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 15-34; DOI: https://doi.org/10.5731/pdajpst.2017.007658
Fran L. Degrazio
West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: fran.degrazio@westpharma.com
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

Reference

  1. 1.↵
    United States Pharmacopeial Convention. <1207> Packaging Integrity Evaluation—Sterile Products.
    Google Scholar
  2. 2.↵
    ASTM D2240 Standard Test Method for Rubber Property—Durometer Hardness.
    Google Scholar
  3. 3.↵
    West Pharmaceutical Services Materials Development, Review of Historic Formulations, 2016.
    Google Scholar
  4. 4.↵
    1. Ward I. M.,
    2. Sweeney J.
    An Introduction to the Mechanical Properties of Solid Polymers, 2nd ed.; John Wiley & Sons: Hoboken, NJ, 2004.
    Google Scholar
  5. 5.↵
    1. Hiemenz P. C.,
    2. Lodge T. P.
    Polymer Chemistry, 2nd ed.; CRC Press: Boca Raton, FL, 2007.
    Google Scholar
  6. 6.↵
    1. Zeng Q,
    2. Zhao C.
    Critical Consideration in Time-Dependent Evaluation and Modeling for Rubber Stopper Seal Performance. Presented at the PDA Europe Parenteral Packaging Meeting, Barcelona, Spain, 2017.
    Google Scholar
  7. 7.↵
    United Seal & Rubber Co., Inc. Designing and Producing a High Performance Gasket or Seal. e-book, 2013.
    Google Scholar
  8. 8.↵
    1. Chose T.
    Live Science, June 4, 2013, Live Science Publication, Tia Chose, Senior Writer.
    Google Scholar
  9. 9.↵
    1. Dorison A.,
    2. Ludema K. C.
    Chapter 9. Lubricated Friction. In Mechanics and Chemistry In Lubrication, Dorison A., Ludema K. C., Eds.; Elsevier Science Publishers B. V.: Amsterdam, The Netherlands, 1985; Tribology Series Vol. 9, pp 178–197.
    Google Scholar
  10. 10.↵
    1. Jones L. S.,
    2. Kaufmann A.,
    3. Middaugh C. R.
    Silicone Oil Induced Aggregation of Proteins. J. Pharm. Sci. 2005, 94 (4), 918–927.
    OpenUrlCrossRefPubMedGoogle Scholar
  11. 11.↵
    1. Thirumangalathu R.,
    2. Krishnan S.,
    3. Ricci M. S.,
    4. Brems D. N.,
    5. Randolph T. W.,
    6. Carpenter J. F.
    Silicone Oil- and Agitation-Induced Aggregation of a Monoclonal Antibody in Aqueous Solution. J. Pharm. Sci. 2009, 98 (9), 3167–3181.
    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
  12. 12.↵
    1. Rey L.,
    2. May J.
    1. DeGrazio F.
    Chapter 9. Closure and Container Considerations in Lyophilization. In Freeze-Drying Lyophilization of Pharmaceutical and Biological Products, 2nd ed.; Rey L., May J., Eds.; Informa Healthcare: New York, 2010; Vol. 137.
    Google Scholar
  13. 13.↵
    1. Vincent J.
    Chapter 1. Structural Biomaterials. In Basic Elasticity and Viscoelasticity, 3rd ed.; Princeton University Press: Princeton, NJ, 2012.
    Google Scholar
  14. 14.↵
    1. Morton D. K.,
    2. Lordi N. G.
    Quantitative and Mechanistic Measurements of Container/Closure Integrity: Viscoelastic Measurements of Elastomeric Closures. PDA J. Pharm. Sci. Technol. 1988, 42 (4), 57–61.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  15. 15.↵
    1. Davidson K.,
    2. Mangus J.
    Selecting and Verifying Integral Packaging Systems for Injectable Drug Products. Poster presented at the PDA Annual Meeting, Las Vegas, NV, 2015.
    Google Scholar
  16. 16.↵
    PDA Technical Report No. 76. Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging; PDA: Bethesda, MD, 2016.
    Google Scholar
  17. 17.↵
    1. Lam P.,
    2. Stern A.
    Visualization Techniques for Assessing Design Factors That Affect Interaction between Pharmaceutical Vials and Stoppers. PDA J. Pharm. Sci. Technol. 2010, 64 (2), 182–187.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  18. 18.↵
    1. Lysfjord J.
    1. Bogle F. W.,
    2. Asselta R. P.,
    3. Pepper L.
    Chapter 13. Crimp Sealing Parenteral Vials. In Practical Aseptic Processing: Fill Finish, Lysfjord J., Ed.; PDA and Davis Healthcare International Publishing: Bethesda, MD and River Grove, IL, respectively, 2009; Vol. 1, pp 261–273.
    OpenUrlGoogle Scholar
  19. 19.↵
    1. Mathaes R.,
    2. Mahler H. C.,
    3. Buettiker J. P.,
    4. Roehl H.,
    5. Lam P.,
    6. Brown H.,
    7. Luemkemann J.,
    8. Adler M.,
    9. Huwyler J.,
    10. Streubel A.,
    11. Mohl S.
    The Pharmaceutical Vial Capping Process: Container Closure Systems, Capping Equipment, Regulatory Framework, and Seal Quality Tests. Eur. J. Pharm. Biopharm. 2016, 99, 54–64.
    OpenUrlPubMedGoogle Scholar
  20. 20.↵
    1. Mathaes R.,
    2. Mahler H.,
    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 TextGoogle Scholar
  21. 21.↵
    1. Asselta R.
    Parenteral Vial Sealing and Integrity Webinar. Genesis Packaging Technologies: Exton, PA; January 2017.
    Google Scholar
  22. 22.↵
    United States Pharmacopeia. <1207.1> Package Integrity Testing in the Product Life Cycle—Test Method Selection and Validation. United States Pharmacopeial Convention: Rockville, MD, 2016.
    Google Scholar
  23. 23.↵
    United States Pharmacopeia. <1207> Section 5. Product-Package Quality Requirements and the Maximum Allowable Leakage Limit. United States Pharmacopeial Convention: Rockville, MD, 2016.
    Google Scholar
  24. 24.↵
    1. Paskiet D.,
    2. Asselta R.
    Qualifying Integral Container Closure Systems. Presented at the PDA Annual Meeting, San Antonio, TX, 2014.
    Google Scholar
  25. 25.↵
    1. Morton D. K.,
    2. Lordi N. G.
    Residual Seal Force Measurements of Parenteral Vials. I. Methodology. PDA J. Pharm. Sci. Technol. 1988, 42 (1), 23–29.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  26. 26.↵
    1. Mathaes R.,
    2. Mahler H.,
    3. Roggo Y.,
    4. Huwyler J.,
    5. Eder J.,
    6. Fritsch K.,
    7. Posset T.,
    8. Mohl S.,
    9. Streubel A.
    Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity in GMP Drug Product Manufacturing. PDA J. Pharm. Sci. Technol. 2016, 70 (2), 109–119.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  27. 27.↵
    FDA Guidance for Industry. Drug Stability Guidelines. Section C3. Temperature. December 9, 2008.
    Google Scholar
  28. 28.↵
    Fisher BioServices. Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics, e-book, August 14, 2013.
    Google Scholar
  29. 29.
    1. Zuleger B.,
    2. Werner U.,
    3. Kort A.,
    4. Glowienka R.,
    5. Wehnes E.,
    6. Duncan D.
    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 (5), 453–465.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 72 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 1
January/February 2018
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Email Article
Citation Tools
Share
Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity
Fran L. Degrazio
PDA Journal of Pharmaceutical Science and Technology Jan 2018, 72 (1) 15-34; DOI: 10.5731/pdajpst.2017.007658
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget

Jump to section

  • Article
    • Abstract
    • Introduction
    • 1. Materials
    • 2. Equipment
    • 3. Process
    • 4. Measurement
    • 5. Environment
    • 6. People
    • Conclusion
    • Conflict of Interest Declaration
    • Acknowledgements
    • Reference
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • A New Integrated Modeling Approach with Case Studies for Gas Transmission of Container Closure Headspace
  • A Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up Analyses
  • Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
  • Time Temperature Superposition Evaluation and Modeling for Container Closure System's Seal Performance at Low Temperatures
  • Long-Term Study of Container Closure Integrity of Rubber-Glass Vial Systems by Multiple Methods
  • Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
  • Time-Dependent Testing Evaluation and Modeling for Rubber Stopper Seal Performance
  • Google Scholar

More in this TOC Section

  • The Role of Microbiologists in Drug Product Development
  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
Show more Review

Similar Articles

Keywords

  • CCI
  • Container closure integrity
  • Integral System
  • Leak rate
  • Vial system
  • Leakage sealing optimization
  • Seal Integrity
  • Residual seal force

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
Alerts for this Article
Sign In to Email Alerts with your Email Address
Email this 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.
Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity
(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.
9 + 8 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity
Fran L. Degrazio
PDA Journal of Pharmaceutical Science and Technology Jan 2018, 72 (1) 15-34; DOI: 10.5731/pdajpst.2017.007658

Citation Manager Formats

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

We use cookies on this site to enhance your user experience

By clicking any link on this page you are giving your consent for us to set cookies.