Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation

Alejandra Nieto; Holger Roehl; Michael Adler; Silke Mohl

doi:10.5731/pdajpst.2017.008383

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Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation

Alejandra Nieto, Holger Roehl, Michael Adler and Silke Mohl

PDA Journal of Pharmaceutical Science and Technology November 2018, 72 (6) 544-552; DOI: https://doi.org/10.5731/pdajpst.2017.008383

Alejandra Nieto

Pharmaceutical Development & Supplies—PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland

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For correspondence: alejandra.nieto-pena@roche.com

Holger Roehl

Pharmaceutical Development & Supplies—PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland

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Michael Adler

Pharmaceutical Development & Supplies—PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland

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Silke Mohl

Pharmaceutical Development & Supplies—PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland

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vol. 72 no. 6 544-552

DOI

https://doi.org/10.5731/pdajpst.2017.008383

PubMed

29853608

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online December 4, 2018.

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previous version (May 31, 2018 - 12:56).
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Alejandra Nieto*,
Holger Roehl,
Michael Adler and
Silke Mohl

Pharmaceutical Development & Supplies—PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland

↵*Corresponding Author: F. Hoffmann-La Roche Ltd., Pharmaceutical Development & Supplies—PTD Biologics Europe, Grenzacherstrasse 124, CH-4070 Basel, Switzerland; e-mail: alejandra.nieto-pena{at}roche.com

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Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation

Alejandra Nieto, Holger Roehl, Michael Adler, Silke Mohl

PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 544-552; DOI: 10.5731/pdajpst.2017.008383

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Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation

Alejandra Nieto, Holger Roehl, Michael Adler, Silke Mohl

PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 544-552; DOI: 10.5731/pdajpst.2017.008383

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Keywords

Container closure integrity
Frozen drug product
Vial
Helium-leakage test
headspace analysis
Transportation
Capping
Residual seal force

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