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

Yusuf Oni; Jason Franck; Christina Evans; Daniel Paniagua; Ankur Kulshrestha; Rao V Mantri

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 Oni, Jason Franck, Christina Evans, Daniel Paniagua, Ankur Kulshrestha and Rao V Mantri

PDA Journal of Pharmaceutical Science and Technology August 2022, pdajpst.2021.012719; DOI: https://doi.org/10.5731/pdajpst.2021.012719

Yusuf Oni

1 Bristol-Myers Squibb;

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For correspondence: yusuf.oni@bms.com

Jason Franck

2 Bristol Myers Squibb

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For correspondence: jason.franck@bms.com

Christina Evans

2 Bristol Myers Squibb

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For correspondence: christina.evans@bms.com

Daniel Paniagua

2 Bristol Myers Squibb

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For correspondence: daniel.paniagua@bms.com

Ankur Kulshrestha

1 Bristol-Myers Squibb;

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For correspondence: ankur.kulshrestha@bms.com

Rao V Mantri

2 Bristol Myers Squibb

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For correspondence: rao.mantri@bms.com

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pdajpst.2021.012719

DOI

https://doi.org/10.5731/pdajpst.2021.012719

PubMed

35987519

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received November 4, 2021
Accepted July 14, 2022
Published online August 19, 2022.

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You are currently viewing a previous version of this article (August 19, 2022 - 21:18).
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Author Information

Yusuf Oni1,3 (yusuf.oni{at}bms.com),
Jason Franck2 (jason.franck{at}bms.com),
Christina Evans2 (christina.evans{at}bms.com),
Daniel Paniagua2 (daniel.paniagua{at}bms.com),
Ankur Kulshrestha1 (ankur.kulshrestha{at}bms.com) and
Rao V Mantri2 (rao.mantri{at}bms.com)

¹ Bristol-Myers Squibb;
² Bristol Myers Squibb

↵* Corresponding author; email: yusuf.oni{at}bms.com

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

Yusuf Oni, Jason Franck, Christina Evans, Daniel Paniagua, Ankur Kulshrestha, Rao V Mantri

PDA Journal of Pharmaceutical Science and Technology Aug 2022, pdajpst.2021.012719; 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 Oni, Jason Franck, Christina Evans, Daniel Paniagua, Ankur Kulshrestha, Rao V Mantri

PDA Journal of Pharmaceutical Science and Technology Aug 2022, pdajpst.2021.012719; DOI: 10.5731/pdajpst.2021.012719

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Keywords

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

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