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Research ArticleTechnology/Application

A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis

Allison Alix Caudill, Ken Victor and James Veale
PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 707-729; DOI: https://doi.org/10.5731/pdajpst.2022.012813
Allison Alix Caudill
Lighthouse Instruments, LLC., Charlottesville, VA 22902
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  • For correspondence: acaudill@lighthouseinstruments.com
Ken Victor
Lighthouse Instruments, LLC., Charlottesville, VA 22902
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James Veale
Lighthouse Instruments, LLC., Charlottesville, VA 22902
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PDA Journal of Pharmaceutical Science and Technology: 78 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 6
November/December 2024
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A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
Allison Alix Caudill, Ken Victor, James Veale
PDA Journal of Pharmaceutical Science and Technology Nov 2024, 78 (6) 707-729; DOI: 10.5731/pdajpst.2022.012813

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A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
Allison Alix Caudill, Ken Victor, James Veale
PDA Journal of Pharmaceutical Science and Technology Nov 2024, 78 (6) 707-729; DOI: 10.5731/pdajpst.2022.012813
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  • Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
  • Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
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Keywords

  • Container closure integrity
  • USP <1207>
  • Cryogenic storage
  • Headspace gas analysis
  • Headspace oxygen
  • FMS

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