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
Ken Victor
Lighthouse Instruments, LLC., Charlottesville, VA 22902, USA
Michael Timmins
Lighthouse Instruments, LLC., Charlottesville, VA 22902, USA
James Veale
Lighthouse Instruments, LLC., Charlottesville, VA 22902, USA

References
- 1.↵U.S. Pharmacopeial Convention, General Chapter <1207> Package Integrity Evaluation - Sterile Products, In USP 39—NF 34, USP: Rockville, MD, 2016.
- 2.↵
- Brown H.,
- Mahler H.-C.,
- Mellman J.,
- Nieto A.,
- Wagner D.,
- Schaar M.,
- Mathaes R.,
- Kossinna J.,
- Schmitting F.,
- Dreher S.,
- Roehl H.,
- Hemminger M.,
- Wuchner K.
- 3.↵
- Denyer S. P.,
- Baird R. M.
- Kirsch L.
- 4.↵
- Duncan D.
- 5.↵
- Victor K. G.,
- Levac L.,
- Timmins M.,
- Veale J.
- 6.↵
- Lysfjord J.
- Veale J.
- 7.↵
- Templeton A. C.,
- Han Y.-H. R.,
- Mahajan R.,
- Chern R. T.,
- Reed R. A.
- 8.↵
- Cook I. A.,
- Ward K. R.
- 9.↵
- Duncan D.,
- Cundell T.,
- Levac L.,
- Veale J.,
- Kuiper S.,
- Rao R.
- 10.↵
- Lin T. P.,
- Hsu C. C.,
- Kabakoff B. D.,
- Patapoff T. W.
- 11.↵
- Zuleger B.,
- Werner U.,
- Kort A.,
- Glowienka R.,
- Wehnes E.,
- Duncan D.
- 12.↵
- Morton D. K.
- 13.↵
- Peláez S. S.,
- Mahler H.-C.,
- Herdlitschka C.,
- Wertli T.,
- Kahl M.,
- Koulov A.,
- Matter A.,
- Singh S. K.,
- Widmer M.,
- Germershaus O.,
- Mathaes R.
- 14.↵
- Morrical B. D.,
- Goverde M.,
- Grausse J.,
- Gerwig T.,
- Vorgrimler L.,
- Morgen R.,
- Büttiker J.-P.
- 15.↵
- Nieto A.,
- Roehl H.,
- Brown H.,
- Adler M.,
- Chalus P.,
- Mahler H.-C.
- 16.↵
- Yoon S.-Y.,
- Sagi H.,
- Goldhammer C.,
- Li L.
- 17.↵
- 18.↵U.S. Food and Drug Administration, Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2008.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 2
March/April 2021
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
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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