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Research ArticleResearch

Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial

Alejandra Nieto, Holger Roehl, Helen Brown, Michael Adler, Pascal Chalus and Hanns-Christian Mahler
PDA Journal of Pharmaceutical Science and Technology July 2016, 70 (4) 313-324; DOI: https://doi.org/10.5731/pdajpst.2015.006080
Alejandra Nieto
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
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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;
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Helen Brown
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
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Michael Adler
1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
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Pascal Chalus
2Solid State Properties Analytics—Pharmaceutical Technical Development, 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;
3Lonza AG, Drug Product Services, Basel, Switzerland
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Article Information

vol. 70 no. 4 313-324
DOI 
https://doi.org/10.5731/pdajpst.2015.006080
PubMed 
27020649

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online July 18, 2016.

Article Versions

  • previous version (March 28, 2016 - 17:56).
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Copyright & Usage 
© PDA, Inc. 2016

Author Information

  1. Alejandra Nieto1,*,
  2. Holger Roehl1,
  3. Helen Brown1,
  4. Michael Adler1,
  5. Pascal Chalus2 and
  6. Hanns-Christian Mahler1,3
  1. 1Late-Stage Pharmaceutical and Process Development—Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
  2. 2Solid State Properties Analytics—Pharmaceutical Technical Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
  3. 3Lonza AG, Drug Product Services, Basel, Switzerland
  1. ↵* Corresponding Author: Alejandra Nieto, 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 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 4
July/August 2016
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Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial
Alejandra Nieto, Holger Roehl, Helen Brown, Michael Adler, Pascal Chalus, Hanns-Christian Mahler
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 313-324; DOI: 10.5731/pdajpst.2015.006080

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Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial
Alejandra Nieto, Holger Roehl, Helen Brown, Michael Adler, Pascal Chalus, Hanns-Christian Mahler
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 313-324; DOI: 10.5731/pdajpst.2015.006080
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Keywords

  • Container closure integrity
  • Artificial leaks
  • Helium leak test
  • sterility
  • Microbiological quality
  • finite element simulations
  • Capping

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