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Research ArticleResearch

Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy

Ken G. Victor, Lauren Levac, Michael Timmins and James Veale
PDA Journal of Pharmaceutical Science and Technology November 2017, 71 (6) 429-453; DOI: https://doi.org/10.5731/pdajpst.2017.007518
Ken G. Victor
Lighthouse Instruments, Charlottesville, VA, USA
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  • For correspondence: kvictor@lighthouseinstruments.com
Lauren Levac
Lighthouse Instruments, Charlottesville, VA, USA
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Michael Timmins
Lighthouse Instruments, Charlottesville, VA, USA
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James Veale
Lighthouse Instruments, Charlottesville, VA, USA
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PDA Journal of Pharmaceutical Science and Technology: 71 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 6
November/December 2017
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Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy
Ken G. Victor, Lauren Levac, Michael Timmins, James Veale
PDA Journal of Pharmaceutical Science and Technology Nov 2017, 71 (6) 429-453; DOI: 10.5731/pdajpst.2017.007518

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Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy
Ken G. Victor, Lauren Levac, Michael Timmins, James Veale
PDA Journal of Pharmaceutical Science and Technology Nov 2017, 71 (6) 429-453; DOI: 10.5731/pdajpst.2017.007518
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Cited By...

  • Comparing Container Closure Integrity Test Methods--Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
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  • Assessment of Functional and Physical Performances of Pre-filled Syringes in Deep Cold Storage Conditions
  • Container Closure Integrity Test Method Development on Vials Stored at -80{degrees}C Using Headspace Carbon Dioxide Analysis
  • A Multicompany Survey Study for Helium Leak Container Closure Integrity Test
  • A New Integrated Modeling Approach with Case Studies for Gas Transmission of Container Closure Headspace
  • Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
  • Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies
  • Container Closure Integrity Testing--Method Development for Freeze-Dried Products Using Laser-Based Headspace Oxygen Analysis
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Keywords

  • Container closure integrity
  • USP 39 Chapter <1207>
  • USP 1207
  • sterility
  • gas leak rate
  • Gas ingress
  • headspace analysis
  • Frequency modulation spectroscopy

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