Research ArticleTechnology/Application
Container Closure Integrity Testing—Method Development for Freeze-Dried Products Using Laser-Based Headspace Oxygen Analysis
Jonas Olsen Hede, Philip Loldrup Fosbøl, Signe Willestofte Berg and Søren Dahl
PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 170-180; DOI: https://doi.org/10.5731/pdajpst.2018.008680
Jonas Olsen Hede
1Technical University of Denmark, Chemical Engineering Department, Kgs. Lyngby, Denmark; and
Philip Loldrup Fosbøl
1Technical University of Denmark, Chemical Engineering Department, Kgs. Lyngby, Denmark; and
Signe Willestofte Berg
2Novo Nordisk A/S, Nybrovej 80, Gentofte, Denmark
Søren Dahl
2Novo Nordisk A/S, Nybrovej 80, Gentofte, Denmark
References
- 1.↵U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation; Rockville, MD, May 1999.
- 2.↵ICH Harmonised Tripartite Guideline: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products: Q5C. Current Step 4 version, d. 30 November 1995.
- 3.↵Targeted Stakeholders Consultation on the Revision of Annex 1, on Manufacturing of Sterile Medicinal Products, of the Eudralex Volume 4. European Commission. https://ec.europa.eu/health/sites/health/files/files/gmp/2017_12_pc_annex1_consultation_document.pdf, p. 22. (accessed February 26, 2019).
- 4.↵U.S. Pharmacopeial Convention, General Chapter <1207> Package Integrity Evaluation – Sterile Products. In USP 39–NF34, USP: 2016; Suppl. 1.
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 2
March/April 2019
Container Closure Integrity Testing—Method Development for Freeze-Dried Products Using Laser-Based Headspace Oxygen Analysis
Jonas Olsen Hede, Philip Loldrup Fosbøl, Signe Willestofte Berg, Søren Dahl
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 170-180; DOI: 10.5731/pdajpst.2018.008680
Container Closure Integrity Testing—Method Development for Freeze-Dried Products Using Laser-Based Headspace Oxygen Analysis
Jonas Olsen Hede, Philip Loldrup Fosbøl, Signe Willestofte Berg, Søren Dahl
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 170-180; DOI: 10.5731/pdajpst.2018.008680
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