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
Ken Victor
2Lighthouse Instruments, LLC., Charlottesville, VA 22902
Allison Alix Caudill
2Lighthouse Instruments, LLC., Charlottesville, VA 22902
Jirakan Nunkaew
2Lighthouse Instruments, LLC., Charlottesville, VA 22902
Gemma AlmatÓ Bellavista
1F. Hoffmann-La Roche Ltd, Global Device and Packaging Development, PTDZ, 4070 Basel, Switzerland; and
Holger RÖhl
1F. Hoffmann-La Roche Ltd, Global Device and Packaging Development, PTDZ, 4070 Basel, Switzerland; and
James Veale
2Lighthouse Instruments, LLC., Charlottesville, VA 22902

References
- 1.↵U.S. Pharmacopeial Convention, General Chapter 〈1207.1〉 Package Integrity Testing in the Product Life Cycle—Test Method Selection and Validation. In USP 43—NF 38, USP: Rockville, MD, 2020.
- 2.↵
- 3.↵
- Kirsch L. E.,
- Nguyen L.,
- Moeckly C. S.,
- Gerth R.
- 4.↵
- Morrical B. D.,
- Goverde M.,
- Grausse J.,
- Gerwig T.,
- Vorgrimler L.,
- Morgen R.,
- Büttiker J.-P.
- 5.↵
- Sudo H.,
- O'driscoll M.,
- Nishiwaki K.,
- Kawamoto Y.,
- Gammell P.,
- Schramm G.,
- Wertli T.,
- Prinz H.,
- Mori A.,
- Sako K.
- 6.↵
- Zuleger B.,
- Werner U.,
- Kort A.,
- Glowienka R.,
- Wehnes E.,
- Duncan D.
- 7.↵
- Caudill A. A.,
- Victor K.,
- Timmins M.,
- Veale J.
- 8.↵
- Victor K.,
- Caudill A. A.,
- Veale J.
- 9.↵
- Nier A. O.,
- Stevens C. M.,
- Hustrulid A.,
- Abbott T. A.
- 10.↵
- 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.
- 11.↵
- Mathaes R.,
- Wuchner K.,
- Riesop D.,
- Wagner D.,
- Dreher S.,
- Woelfle F.,
- Mudumala P. R.,
- Bonvin D.,
- Müller C.,
- Traub-Hoffmann K.,
- Hebting H.
- 12.↵
- 13.↵
- 14.↵
- Lin T. P.,
- Hsu C. C.
- 15.↵
- Lin T. P.,
- Hsu C. C.,
- Kabakoff B. D.,
- Patapoff T. W.
- 16.↵
- Lysfjord J.
- Veale J.
- 17.↵
- Templeton A. C.,
- Han Y.-H. R.,
- Mahajan R.,
- Chern R. T.,
- Reed R.
- 18.↵
- Duncan D.,
- Cundell T.,
- Levac L.,
- Veale J.,
- Kuiper S.,
- Rao R.
- 19.↵
- Nieto A.,
- Roehl H.,
- Brown H.,
- Nikoloff J.,
- Adler M.,
- Mahler H.-C.
- 20.↵
- Hede J. O.,
- Fosbøl P. L.,
- Berg S. W.,
- Dahl S.
- 21.↵
- 22.↵
- Nguyen L. T.,
- Muangsiri W.,
- Schiere R.,
- Guazzo D. K.,
- Kirsch L. E.
- 23.↵
- Kirsch L. E.
- 24.↵
- Gehrmann M. R.,
- Mcandrew T. P.
- 25.↵
- Wolf H.,
- Stauffer T.,
- Chen S.-C. Y.,
- Lee Y.,
- Forster R.,
- Ludzinski M.,
- Kamat M.,
- Mulhall B.,
- Guazzo D. M.
- 26.↵
- Simonetti A.,
- Amari F.
- 27.↵
- 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.
- 28.↵
- Huon C.,
- Tiwari A.,
- Rotella C.,
- Mangiagalli P.,
- Persson B. N. J.
- 29.↵
- Victor K. G.,
- Levac L.,
- Timmins M.,
- Veale J.
- 30.↵European Commission. EudraLex—The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products. European Commission: Brussels, 2022
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 6
November/December 2024
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
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
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.