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

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 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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vol. 71 no. 6 429-453

DOI

https://doi.org/10.5731/pdajpst.2017.007518

PubMed

28733333

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online December 9, 2017.

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previous version (July 20, 2017 - 19:16).
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Author Information

Ken G. Victor*,
Lauren Levac,
Michael Timmins and
James Veale

Lighthouse Instruments, Charlottesville, VA, USA

↵* Corresponding Author: Ken G. Victor, Lighthouse Instruments, 2020 Avon Court, Suite #2, Charlottesville VA 22902, USA. Telephone: +1 434 293 3081, ext 231; e-mail: kvictor{at}lighthouseinstruments.com

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