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

doi:10.5731/pdajpst.2018.008680

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

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Philip Loldrup Fosbøl

1Technical University of Denmark, Chemical Engineering Department, Kgs. Lyngby, Denmark; and

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Signe Willestofte Berg

2Novo Nordisk A/S, Nybrovej 80, Gentofte, Denmark

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Søren Dahl

2Novo Nordisk A/S, Nybrovej 80, Gentofte, Denmark

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For correspondence: sdal@novonordisk.com

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vol. 73 no. 2 170-180

DOI

https://doi.org/10.5731/pdajpst.2018.008680

PubMed

30361284

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online April 8, 2019.

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previous version (October 25, 2018 - 06:38).
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Author Information

Jonas Olsen Hede1,
Philip Loldrup Fosbøl1,
Signe Willestofte Berg2 and
Søren Dahl2,*

¹Technical University of Denmark, Chemical Engineering Department, Kgs. Lyngby, Denmark; and
²Novo Nordisk A/S, Nybrovej 80, Gentofte, Denmark

↵* Corresponding Author: Biopharm Process Support, Department 5847, Novo Nordisk A/S, Nybrovej 80, 2820 Gentofte, Denmark; e-mail sdal{at}novonordisk.com

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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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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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Keywords

Container closure integrity testing
Method development
positive controls for container closure integrity studies
Modeling leak rate for artificial leaks in vials
Laser-based headspace analysis
Oxygen
USP <1207>

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