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Research ArticleResearch

Comparing Container Closure Integrity Test Methods—Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls

Christian Proff, Ken Victor, Allison Alix Caudill, Jirakan Nunkaew, Gemma AlmatÓ Bellavista, Holger RÖhl and James Veale
PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 681-698; DOI: https://doi.org/10.5731/pdajpst.2023.012881
Christian Proff
1F. Hoffmann-La Roche Ltd, Global Device and Packaging Development, PTDZ, 4070 Basel, Switzerland; and
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  • For correspondence: christian.proff@roche.com
Ken Victor
2Lighthouse Instruments, LLC., Charlottesville, VA 22902
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Allison Alix Caudill
2Lighthouse Instruments, LLC., Charlottesville, VA 22902
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Jirakan Nunkaew
2Lighthouse Instruments, LLC., Charlottesville, VA 22902
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Gemma AlmatÓ Bellavista
1F. Hoffmann-La Roche Ltd, Global Device and Packaging Development, PTDZ, 4070 Basel, Switzerland; and
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Holger RÖhl
1F. Hoffmann-La Roche Ltd, Global Device and Packaging Development, PTDZ, 4070 Basel, Switzerland; and
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James Veale
2Lighthouse Instruments, LLC., Charlottesville, VA 22902
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Article Information

vol. 78 no. 6 681-698
DOI 
https://doi.org/10.5731/pdajpst.2023.012881
PubMed 
39054064

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 26, 2024.

Article Versions

  • previous version (July 25, 2024 - 10:51).
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Copyright & Usage 
© PDA, Inc. 2024

Author Information

  1. Christian Proff1,*,
  2. Ken Victor2,
  3. Allison Alix Caudill2,
  4. Jirakan Nunkaew2,
  5. Gemma AlmatÓ Bellavista1,
  6. Holger RÖhl1 and
  7. James Veale2
  1. 1F. Hoffmann-La Roche Ltd, Global Device and Packaging Development, PTDZ, 4070 Basel, Switzerland; and
  2. 2Lighthouse Instruments, LLC., Charlottesville, VA 22902
  1. ↵* Corresponding Author: F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, CH-4070 Basel, Switzerland; Telephone: +41 61 68 82508; E-mail: christian.proff{at}roche.com
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PDA Journal of Pharmaceutical Science and Technology: 78 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 6
November/December 2024
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Comparing Container Closure Integrity Test Methods—Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
Christian Proff, Ken Victor, Allison Alix Caudill, Jirakan Nunkaew, Gemma AlmatÓ Bellavista, Holger RÖhl, James Veale
PDA Journal of Pharmaceutical Science and Technology Nov 2024, 78 (6) 681-698; DOI: 10.5731/pdajpst.2023.012881

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Comparing Container Closure Integrity Test Methods—Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
Christian Proff, Ken Victor, Allison Alix Caudill, Jirakan Nunkaew, Gemma AlmatÓ Bellavista, Holger RÖhl, James Veale
PDA Journal of Pharmaceutical Science and Technology Nov 2024, 78 (6) 681-698; DOI: 10.5731/pdajpst.2023.012881
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Keywords

  • Container closure integrity
  • USP
  • <1207>
  • Headspace gas analysis
  • Helium leakage
  • Frequency modulation spectroscopy
  • Carbon dioxide

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