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Research ArticleResearch

Stopper Movement and Headspace (Air Bubble Size) Limitations for 2.25 mL Prefilled Syringe

Christina Evans, Yusuf Oni, Daniel Paniagua, Jason Franck, Charles Dahlheim and Ankur Kulshrestha
PDA Journal of Pharmaceutical Science and Technology November 2023, 77 (6) 472-484; DOI: https://doi.org/10.5731/pdajpst.2022.012749
Christina Evans
1Drug Product Development, Global Product Development & Supply, Bristol Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901; and
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  • For correspondence: Christina.Evans@bms.com
Yusuf Oni
1Drug Product Development, Global Product Development & Supply, Bristol Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901; and
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Daniel Paniagua
1Drug Product Development, Global Product Development & Supply, Bristol Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901; and
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Jason Franck
2Manufacturing Science & Technology, Global Product Development & Supply, Bristol Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901
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Charles Dahlheim
1Drug Product Development, Global Product Development & Supply, Bristol Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901; and
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Ankur Kulshrestha
1Drug Product Development, Global Product Development & Supply, Bristol Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901; and
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PDA Journal of Pharmaceutical Science and Technology: 77 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 6
November/December 2023
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Stopper Movement and Headspace (Air Bubble Size) Limitations for 2.25 mL Prefilled Syringe
Christina Evans, Yusuf Oni, Daniel Paniagua, Jason Franck, Charles Dahlheim, Ankur Kulshrestha
PDA Journal of Pharmaceutical Science and Technology Nov 2023, 77 (6) 472-484; DOI: 10.5731/pdajpst.2022.012749
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Keywords

  • 2.25ML PFS
  • CCI
  • Container closure integrity
  • PFS
  • prefilled syringe
  • Sterile barrier

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Stopper Movement and Headspace (Air Bubble Size) Limitations for 2.25 mL Prefilled Syringe
Christina Evans, Yusuf Oni, Daniel Paniagua, Jason Franck, Charles Dahlheim, Ankur Kulshrestha
PDA Journal of Pharmaceutical Science and Technology Nov 2023, 77 (6) 472-484; DOI: 10.5731/pdajpst.2022.012749

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