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Research ArticleTechnology/Application

Container Closure Integrity Test Method Development on Vials Stored at −80°C Using Headspace Carbon Dioxide Analysis

Ken Victor, Allison Alix Caudill and James Veale
PDA Journal of Pharmaceutical Science and Technology September 2022, 76 (5) 395-415; DOI: https://doi.org/10.5731/pdajpst.2021.012641
Ken Victor
Lighthouse Instruments, LLC., Charlottesville, VA 22902, USA
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  • For correspondence: kvictor@lighthouseinstruments.com
Allison Alix Caudill
Lighthouse Instruments, LLC., Charlottesville, VA 22902, USA
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James Veale
Lighthouse Instruments, LLC., Charlottesville, VA 22902, USA
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  • Article
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PDA Journal of Pharmaceutical Science and Technology: 76 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 5
September/October 2022
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Container Closure Integrity Test Method Development on Vials Stored at −80°C Using Headspace Carbon Dioxide Analysis
Ken Victor, Allison Alix Caudill, James Veale
PDA Journal of Pharmaceutical Science and Technology Sep 2022, 76 (5) 395-415; DOI: 10.5731/pdajpst.2021.012641

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Container Closure Integrity Test Method Development on Vials Stored at −80°C Using Headspace Carbon Dioxide Analysis
Ken Victor, Allison Alix Caudill, James Veale
PDA Journal of Pharmaceutical Science and Technology Sep 2022, 76 (5) 395-415; DOI: 10.5731/pdajpst.2021.012641
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Cited By...

  • Comparing Container Closure Integrity Test Methods--Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
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More in this TOC Section

  • Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • 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
  • Headspace gas analysis
  • Deep cold storage
  • Frozen product
  • −80°C storage
  • Frequency modulation spectroscopy
  • Method development
  • USP 1207
  • Carbon dioxide

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