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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 May 2018, pdajpst.2017.008383; DOI: https://doi.org/10.5731/pdajpst.2017.008383
Alejandra Nieto
1 F. Hoffmann- La Roche Ltd.;
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  • For correspondence: alejandra.nieto@roche.com
Holger Roehl
2 F. Hoffmann - La Roche Ltd.
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  • For correspondence: holger.roehl@roche.com
Michael Adler
2 F. Hoffmann - La Roche Ltd.
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  • For correspondence: michael.adler@roche.com
Silke Mohl
2 F. Hoffmann - La Roche Ltd.
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Article Information

pdajpst.2017.008383
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 
  • Received October 13, 2017
  • Accepted May 10, 2018
  • Published online May 31, 2018.

Article Versions

  • You are currently viewing a previous version of this article (May 31, 2018 - 12:56).
  • View the most recent version of this article
Copyright & Usage 
Copyright © 2018, Parenteral Drug Association

Author Information

  1. Alejandra Nieto1,3 (alejandra.nieto{at}roche.com),
  2. Holger Roehl2 (holger.roehl{at}roche.com),
  3. Michael Adler2 (michael.adler{at}roche.com) and
  4. Silke Mohl2 (silke.mohl{at}roche.com)
  1. 1 F. Hoffmann- La Roche Ltd.;
  2. 2 F. Hoffmann - La Roche Ltd.
  1. ↵* Corresponding author; email: alejandra.nieto{at}roche.com

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PDA Journal of Pharmaceutical Science and Technology: 79 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 2
March/April 2025
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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 May 2018, pdajpst.2017.008383; 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 May 2018, pdajpst.2017.008383; DOI: 10.5731/pdajpst.2017.008383
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Keywords

  • Capping
  • Container closure integrity
  • Frozen drug product
  • headspace analysis
  • Helium leakage test
  • Vial

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