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Research ArticleTechnology/Application

Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas

Allison Alix Caudill, Ken Victor, Michael Timmins and James Veale
PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 157-172; DOI: https://doi.org/10.5731/pdajpst.2020.011502
Allison Alix Caudill
Lighthouse Instruments, LLC., Charlottesville, VA 22902, USA
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  • For correspondence: acaudill@lighthouseinstruments.com
Ken Victor
Lighthouse Instruments, LLC., Charlottesville, VA 22902, USA
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Michael Timmins
Lighthouse Instruments, LLC., Charlottesville, VA 22902, USA
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James Veale
Lighthouse Instruments, LLC., Charlottesville, VA 22902, USA
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References

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PDA Journal of Pharmaceutical Science and Technology: 75 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 2
March/April 2021
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Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
Allison Alix Caudill, Ken Victor, Michael Timmins, James Veale
PDA Journal of Pharmaceutical Science and Technology Mar 2021, 75 (2) 157-172; DOI: 10.5731/pdajpst.2020.011502

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Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
Allison Alix Caudill, Ken Victor, Michael Timmins, James Veale
PDA Journal of Pharmaceutical Science and Technology Mar 2021, 75 (2) 157-172; DOI: 10.5731/pdajpst.2020.011502
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Cited By...

  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Comparing Container Closure Integrity Test Methods--Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
  • Container Closure Integrity Test Method Development on Vials Stored at -80{degrees}C Using Headspace Carbon Dioxide 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
  • USP <1207>
  • Headspace gas analysis
  • Frequency modulation spectroscopy
  • Laser-drilled defects
  • Microwires
  • Blue dye ingress test
  • Microbial ingress test

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