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PDA Journal of Pharmaceutical Science and Technology

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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
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Article Information

vol. 72 no. 1 15-34
DOI 
https://doi.org/10.5731/pdajpst.2017.007658
PubMed 
29030527

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online January 30, 2018.

Article Versions

  • previous version (October 12, 2017 - 19:14).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. Fran L. Degrazio*
  1. West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341
  1. ↵*Corresponding Author: Fran L. DeGrazio. Telephone (610) 594-3190; e-mail: fran.degrazio{at}westpharma.com
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PDA Journal of Pharmaceutical Science and Technology: 72 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 1
January/February 2018
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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

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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
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  • Article
    • Abstract
    • Introduction
    • 1. Materials
    • 2. Equipment
    • 3. Process
    • 4. Measurement
    • 5. Environment
    • 6. People
    • Conclusion
    • Conflict of Interest Declaration
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    • Reference
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  • A New Integrated Modeling Approach with Case Studies for Gas Transmission of Container Closure Headspace
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  • 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

  • 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
  • A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management
Show more Review

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Keywords

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

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