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Research ArticleResearch

Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System

Yusuf Oni, Xu Song, Matthew Schrader, Ankur Kulshrestha, Jason Franck, Roger Asselta, Carolina Flores-Crespo and Rao V. Mantri
PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 572-587; DOI: https://doi.org/10.5731/pdajpst.2018.009670
Yusuf Oni
1Drug Product Science and Technology, Global Product Development & Supply, Bristol-Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901
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  • For correspondence: yusuf.oni@bms.com
Xu Song
1Drug Product Science and Technology, Global Product Development & Supply, Bristol-Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901
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Matthew Schrader
1Drug Product Science and Technology, Global Product Development & Supply, Bristol-Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901
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Ankur Kulshrestha
1Drug Product Science and Technology, Global Product Development & Supply, Bristol-Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901
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Jason Franck
1Drug Product Science and Technology, Global Product Development & Supply, Bristol-Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901
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Roger Asselta
2Genesis Packaging Technologies, 435 Creamery Way, Suite 100, Exton, PA 19341
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Carolina Flores-Crespo
2Genesis Packaging Technologies, 435 Creamery Way, Suite 100, Exton, PA 19341
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Rao V. Mantri
1Drug Product Science and Technology, Global Product Development & Supply, Bristol-Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901
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Article Information

vol. 73 no. 6 572-587
DOI 
https://doi.org/10.5731/pdajpst.2018.009670
PubMed 
31101708

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 10, 2019.

Article Versions

  • previous version (May 17, 2019 - 05:08).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Yusuf Oni1,*,
  2. Xu Song1,
  3. Matthew Schrader1,
  4. Ankur Kulshrestha1,
  5. Jason Franck1,
  6. Roger Asselta2,
  7. Carolina Flores-Crespo2 and
  8. Rao V. Mantri1
  1. 1Drug Product Science and Technology, Global Product Development & Supply, Bristol-Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901
  2. 2Genesis Packaging Technologies, 435 Creamery Way, Suite 100, Exton, PA 19341
  1. ↵* Corresponding Author: Bristol-Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901. Telephone: +1-732-227-6726; fax: +1-732-227-3824; e-mail: yusuf.oni@bms.com
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PDA Journal of Pharmaceutical Science and Technology: 73 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 6
November/December 2019
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Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
Yusuf Oni, Xu Song, Matthew Schrader, Ankur Kulshrestha, Jason Franck, Roger Asselta, Carolina Flores-Crespo, Rao V. Mantri
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 572-587; DOI: 10.5731/pdajpst.2018.009670
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Materials and Methods
    • 3. Discussion of Results
    • 4. Commercial Manufacturing: Balancing CCI vs Aesthetics for Robust Packaging Solutions
    • 5. Implications
    • 6. Concluding Remarks
    • Conflict of Interest Declaration
    • Acknowledgments
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  • Container Closure Integrity of Vial Primary Packaging Systems under Frozen Storage Conditions: A Case Study
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  • Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
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Keywords

  • Aesthetics
  • Residual seal force
  • Capping parameters
  • Container closure system
  • Process control

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Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
Yusuf Oni, Xu Song, Matthew Schrader, Ankur Kulshrestha, Jason Franck, Roger Asselta, Carolina Flores-Crespo, Rao V. Mantri
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 572-587; DOI: 10.5731/pdajpst.2018.009670

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