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Research ArticleResearch

Impact of Vial Capping on Residual Seal Force and Container Closure Integrity

Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Robert Ovadia, Philippe Lam, Oliver Stauch, Martin Vogt, Holger Roehl, Joerg Huwyler, Silke Mohl and Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 12-29; DOI: https://doi.org/10.5731/pdajpst.2015.005876
Roman Mathaes
1Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
5Current address: Drug Product Services, Lonza AG, Basel Switzerland
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  • For correspondence: roman.mathaes@lonza.com
Hanns-Christian Mahler
1Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
5Current address: Drug Product Services, Lonza AG, Basel Switzerland
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Yves Roggo
4Complaints and Counterfeits, Quality Control for Commercial Bulk Products, F. Hoffmann–La Roche Ltd., Basel, Switzerland; and
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Robert Ovadia
2Pharmaceutical Processing and Technical Development, Genentech Inc., USA;
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Philippe Lam
2Pharmaceutical Processing and Technical Development, Genentech Inc., USA;
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Oliver Stauch
2Pharmaceutical Processing and Technical Development, Genentech Inc., USA;
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Martin Vogt
1Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
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Holger Roehl
1Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
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Joerg Huwyler
3Department of Pharmaceutical Technologies, University Basel, Switzerland;
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Silke Mohl
1Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
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Alexander Streubel
1Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
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Article Information

vol. 70 no. 1 12-29
DOI 
https://doi.org/10.5731/pdajpst.2015.005876
PubMed 
26889053

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 16, 2016.

Copyright & Usage 
© PDA, Inc. 2016

Author Information

  1. Roman Mathaes1,5,*,
  2. Hanns-Christian Mahler1,5,
  3. Yves Roggo4,
  4. Robert Ovadia2,
  5. Philippe Lam2,
  6. Oliver Stauch2,
  7. Martin Vogt1,
  8. Holger Roehl1,
  9. Joerg Huwyler3,
  10. Silke Mohl1 and
  11. Alexander Streubel1
  1. 1Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
  2. 2Pharmaceutical Processing and Technical Development, Genentech Inc., USA;
  3. 3Department of Pharmaceutical Technologies, University Basel, Switzerland;
  4. 4Complaints and Counterfeits, Quality Control for Commercial Bulk Products, F. Hoffmann–La Roche Ltd., Basel, Switzerland; and
  5. 5Current address: Drug Product Services, Lonza AG, Basel Switzerland
  1. ↵Corresponding Author: Roman Mathaes, roman.mathaes{at}lonza.com
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PDA Journal of Pharmaceutical Science and Technology: 70 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 1
January/February 2016
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Impact of Vial Capping on Residual Seal Force and Container Closure Integrity
Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Robert Ovadia, Philippe Lam, Oliver Stauch, Martin Vogt, Holger Roehl, Joerg Huwyler, Silke Mohl, Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology Jan 2016, 70 (1) 12-29; DOI: 10.5731/pdajpst.2015.005876

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Impact of Vial Capping on Residual Seal Force and Container Closure Integrity
Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Robert Ovadia, Philippe Lam, Oliver Stauch, Martin Vogt, Holger Roehl, Joerg Huwyler, Silke Mohl, Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology Jan 2016, 70 (1) 12-29; DOI: 10.5731/pdajpst.2015.005876
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  • Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
  • A Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up Analyses
  • 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
  • Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
  • Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies
  • Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals
  • 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
  • Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity
  • 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
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Keywords

  • Capping
  • Residual seal force
  • Container Closure Integrity
  • Helium leakage
  • Container closure system
  • Stopper
  • Vial
  • Cap
  • Seal
  • Process control

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