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Research ArticleResearch

Evaluation of Container Closure System Integrity for Frozen Storage Drug Products

Alejandra Nieto, Holger Roehl, Helen Brown, Jonas Nikoloff, Michael Adler and Hanns-Christian Mahler
PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 120-133; DOI: https://doi.org/10.5731/pdajpst.2015.006098
Alejandra Nieto
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
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  • For correspondence: alejandra.nieto-pena@roche.com
Holger Roehl
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
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Helen Brown
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
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Jonas Nikoloff
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
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Michael Adler
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
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Hanns-Christian Mahler
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
2Lonza AG, Drug Product Services, Basel, Switzerland
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Article Information

vol. 70 no. 2 120-133
DOI 
https://doi.org/10.5731/pdajpst.2015.006098
PubMed 
26797976

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 13, 2016.

Article Versions

  • previous version (January 21, 2016 - 17:53).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2016

Author Information

  1. Alejandra Nieto1,*,
  2. Holger Roehl1,
  3. Helen Brown1,
  4. Jonas Nikoloff1,
  5. Michael Adler1 and
  6. Hanns-Christian Mahler1,2
  1. 1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
  2. 2Lonza AG, Drug Product Services, Basel, Switzerland
  1. ↵* Corresponding Author: F. Hoffmann-La Roche Ltd., Pharmaceutical Development & Supplies (PTDE-P), 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: 70 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 2
March/April 2016
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Evaluation of Container Closure System Integrity for Frozen Storage Drug Products
Alejandra Nieto, Holger Roehl, Helen Brown, Jonas Nikoloff, Michael Adler, Hanns-Christian Mahler
PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 120-133; DOI: 10.5731/pdajpst.2015.006098

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Evaluation of Container Closure System Integrity for Frozen Storage Drug Products
Alejandra Nieto, Holger Roehl, Helen Brown, Jonas Nikoloff, Michael Adler, Hanns-Christian Mahler
PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 120-133; DOI: 10.5731/pdajpst.2015.006098
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  • Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation
  • Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
  • Container Closure Integrity Testing--Practical Aspects and Approaches in the Pharmaceutical Industry
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Keywords

  • Container closure integrity
  • Frozen product
  • Container closure system
  • Vial
  • headspace analysis
  • He leakage test

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