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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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References

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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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Cited By...

  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Container Closure Integrity of Vial Primary Packaging Systems under Frozen Storage Conditions: A Case Study
  • Container Closure Integrity Test Method Development on Vials Stored at -80{degrees}C Using Headspace Carbon Dioxide Analysis
  • A New Integrated Modeling Approach with Case Studies for Gas Transmission of Container Closure Headspace
  • Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
  • Long-Term Study of Container Closure Integrity of Rubber-Glass Vial Systems by Multiple Methods
  • Time Temperature Superposition Evaluation and Modeling for Container Closure System's Seal Performance at Low Temperatures
  • Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
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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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