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Research ArticleResearch

Container Closure Integrity of Vial Primary Packaging Systems under Frozen Storage Conditions: A Case Study

Yusuf O. Oni, Jason Franck, Christina Evans, Daniel Paniagua, Ankur Kulshrestha and Rao V. Mantri
PDA Journal of Pharmaceutical Science and Technology January 2023, 77 (1) 45-52; DOI: https://doi.org/10.5731/pdajpst.2021.012719
Yusuf O. Oni
1Drug Product Development, Global Product Development & Supply, Bristol-Myers Squibb Company, New Brunswick, NJ 08901; and
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  • For correspondence: yusuf.oni@bms.com
Jason Franck
1Drug Product Development, Global Product Development & Supply, Bristol-Myers Squibb Company, New Brunswick, NJ 08901; and
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Christina Evans
1Drug Product Development, Global Product Development & Supply, Bristol-Myers Squibb Company, New Brunswick, NJ 08901; and
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Daniel Paniagua
1Drug Product Development, Global Product Development & Supply, Bristol-Myers Squibb Company, New Brunswick, NJ 08901; and
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Ankur Kulshrestha
1Drug Product Development, Global Product Development & Supply, Bristol-Myers Squibb Company, New Brunswick, NJ 08901; and
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Rao V. Mantri
2Integrated Product Strategy, Global Product Development & Supply, Bristol-Myers Squibb Company, New Brunswick, NJ 08901
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PDA Journal of Pharmaceutical Science and Technology: 77 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 1
January/February 2023
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Container Closure Integrity of Vial Primary Packaging Systems under Frozen Storage Conditions: A Case Study
Yusuf O. Oni, Jason Franck, Christina Evans, Daniel Paniagua, Ankur Kulshrestha, Rao V. Mantri
PDA Journal of Pharmaceutical Science and Technology Jan 2023, 77 (1) 45-52; DOI: 10.5731/pdajpst.2021.012719

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Container Closure Integrity of Vial Primary Packaging Systems under Frozen Storage Conditions: A Case Study
Yusuf O. Oni, Jason Franck, Christina Evans, Daniel Paniagua, Ankur Kulshrestha, Rao V. Mantri
PDA Journal of Pharmaceutical Science and Technology Jan 2023, 77 (1) 45-52; DOI: 10.5731/pdajpst.2021.012719
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Keywords

  • Frozen storage
  • Helium leak
  • Container closure integrity test
  • Corning Valor® glass
  • Crystal Zenith® plastic
  • Residual seal force

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