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

Ken Victor; Allison Alix Caudill; James Veale

doi:10.5731/pdajpst.2021.012641

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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vol. 76 no. 5 395-415

DOI

https://doi.org/10.5731/pdajpst.2021.012641

PubMed

35296563

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online October 3, 2022.

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previous version (March 16, 2022 - 13:32).
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Ken Victor*,
Allison Alix Caudill and
James Veale

Lighthouse Instruments, LLC., Charlottesville, VA 22902, USA

↵*Corresponding Author: Lighthouse Instruments, LLC., 2050 Avon Ct., Charlottesville, VA 22902. Telephone +1 434 293 3081, ext. 231; E-mail: kvictor{at}lighthouseinstruments.com

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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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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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