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Research ArticleResearch

Quantifying the Vial Capping Process: Residual Seal Force and Container Closure Integrity

Robert Ovadia, Alexander Streubel, Yenny Webb-Vargas, Lea Ulland, Joerg Luemkemann, Kamila Rauch, Juergen Eder, Philippe Lam, Vassia Tegoulia and Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology January 2019, 73 (1) 2-15; DOI: https://doi.org/10.5731/pdajpst.2018.008797
Robert Ovadia
1Pharmaceutical Processing and Technology Development, Genentech, CA, USA;
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Alexander Streubel
2Pharmaceutical Development & Supplies, Technical Development Biologics Europe, Basel, Switzerland;
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Yenny Webb-Vargas
3Nonclinical Biostatistics, Genentech, CA, USA; and
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Lea Ulland
2Pharmaceutical Development & Supplies, Technical Development Biologics Europe, Basel, Switzerland;
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Joerg Luemkemann
2Pharmaceutical Development & Supplies, Technical Development Biologics Europe, Basel, Switzerland;
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Kamila Rauch
4Manufacturing Science and Technology, Parenterals Manufacturing Kaiseraugst, Kaiseraugst, Switzerland.
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Juergen Eder
4Manufacturing Science and Technology, Parenterals Manufacturing Kaiseraugst, Kaiseraugst, Switzerland.
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Philippe Lam
1Pharmaceutical Processing and Technology Development, Genentech, CA, USA;
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Vassia Tegoulia
1Pharmaceutical Processing and Technology Development, Genentech, CA, USA;
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Yuh-Fun Maa
1Pharmaceutical Processing and Technology Development, Genentech, CA, USA;
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  • For correspondence: maay@gene.com
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Article Information

vol. 73 no. 1 2-15
DOI 
https://doi.org/10.5731/pdajpst.2018.008797
PubMed 
29954924

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 1, 2019.

Article Versions

  • previous version (June 27, 2018 - 21:50).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Robert Ovadia1,
  2. Alexander Streubel2,
  3. Yenny Webb-Vargas3,
  4. Lea Ulland2,
  5. Joerg Luemkemann2,
  6. Kamila Rauch4,
  7. Juergen Eder4,
  8. Philippe Lam1,
  9. Vassia Tegoulia1 and
  10. Yuh-Fun Maa1,*
  1. 1Pharmaceutical Processing and Technology Development, Genentech, CA, USA;
  2. 2Pharmaceutical Development & Supplies, Technical Development Biologics Europe, Basel, Switzerland;
  3. 3Nonclinical Biostatistics, Genentech, CA, USA; and
  4. 4Manufacturing Science and Technology, Parenterals Manufacturing Kaiseraugst, Kaiseraugst, Switzerland.
  1. ↵* Corresponding Author: Genentech, a member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080, USA; e-mail: maay{at}gene.com
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PDA Journal of Pharmaceutical Science and Technology: 73 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 1
January/February 2019
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Quantifying the Vial Capping Process: Residual Seal Force and Container Closure Integrity
Robert Ovadia, Alexander Streubel, Yenny Webb-Vargas, Lea Ulland, Joerg Luemkemann, Kamila Rauch, Juergen Eder, Philippe Lam, Vassia Tegoulia, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Jan 2019, 73 (1) 2-15; DOI: 10.5731/pdajpst.2018.008797

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Quantifying the Vial Capping Process: Residual Seal Force and Container Closure Integrity
Robert Ovadia, Alexander Streubel, Yenny Webb-Vargas, Lea Ulland, Joerg Luemkemann, Kamila Rauch, Juergen Eder, Philippe Lam, Vassia Tegoulia, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Jan 2019, 73 (1) 2-15; DOI: 10.5731/pdajpst.2018.008797
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  • Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
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Keywords

  • Residual seal force
  • RSF
  • Vial capping
  • Container closure integrity
  • CCI
  • Primary packaging components
  • Helium leakage
  • Vial
  • Stopper
  • Crimp cap

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