Research ArticleResearch
A New Integrated Modeling Approach with Case Studies for Gas Transmission of Container Closure Headspace
Qingyu Zeng
PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 394-406; DOI: https://doi.org/10.5731/pdajpst.2020.012351
Qingyu Zeng
West Pharmaceutical Services, Inc.

References
- 1.↵U.S. Food and Drug Administration, Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 1999.
- 2.↵U.S. Pharmacopeial Convention, General Chapter <1207> Package Integrity Evaluation Sterile Products. In USP 39–NF34, USP: Rockville, MD, 2016.
- 3.↵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, 2008.
- 4.↵International Conference for Harmonisation, Harmonized Tripartite Guideline Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products. ICH: Geneva, 1995.
- 5.↵
- Crank J.
- 6.↵
- Cussler E. L.
- 7.↵
- Kirsch L. E.,
- Nguyen L.,
- Moeckly C. S.,
- Gerth R.
- 8.↵
- 9.↵
- DeGrazio F. L.
- 10.↵
- Zeng Q.,
- Zhao X.
- 11.↵
- Zeng Q.,
- Bucci A.,
- Ho L.
- 12.↵
- Asselta R.
- 13.↵
- Ovadia R.,
- Streubel A.,
- Webb-Vargas Y.,
- Ulland L.,
- Luemkemann J.,
- Rauch K.,
- Eder J.,
- Lam P.,
- Tegoulia V.,
- Maa Y.-F.
- 14.↵
- Prisco M. R.,
- Ochoa J. A.,
- Yardimci A. M.
- 15.↵
- Victor K. G.,
- Levac L.,
- Timmins M.,
- Veale J.
- 16.↵
- Hede J. O.,
- Fosbøl P. L.,
- Berg S. W.,
- Dahl S.
- 17.↵
- Crowe C. T.,
- Elger D. F.,
- Roberson J. A.
- 18.↵
- Chaudhry M. H.
- 19.↵
- Morton K. W.,
- Mayers D. F.
- 20.↵
- Press W. H.,
- Teukolsky S. A.,
- Vetterling W. T.,
- Flannery B. P.
- 21.↵
- Billing G. D.,
- Mikkelsen K. V.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 5
September/October 2021
A New Integrated Modeling Approach with Case Studies for Gas Transmission of Container Closure Headspace
Qingyu Zeng
PDA Journal of Pharmaceutical Science and Technology Sep 2021, 75 (5) 394-406; DOI: 10.5731/pdajpst.2020.012351
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