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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleResearch

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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Article Information

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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© PDA, Inc. 2018

Author Information

  1. Alejandra Nieto*,
  2. Holger Roehl,
  3. Michael Adler and
  4. Silke Mohl
  1. Pharmaceutical Development & Supplies—PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland
  1. ↵*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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PDA Journal of Pharmaceutical Science and Technology: 72 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 6
November/December 2018
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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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