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Research ArticleResearch

Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing

Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl and Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 109-119; DOI: https://doi.org/10.5731/pdajpst.2015.005918
Roman Mathaes
1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
6Current address: Drug Product Services, Lonza AG, Basel, Switzerland
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  • For correspondence: roman.mathaes@lonza.com
Hanns-Christian Mahler
1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
6Current address: Drug Product Services, Lonza AG, Basel, Switzerland
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Yves Roggo
2Complaints and Counterfeits, Quality Control for Commercial Bulk Products, F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland;
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Joerg Huwyler
3Department of Pharmaceutical Technologies, University Basel, Switzerland;
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Juergen Eder
4Manufacturing Science and Technology, Parenterals Manufacturing Kaiseraugst, F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland;
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Kamila Fritsch
4Manufacturing Science and Technology, Parenterals Manufacturing Kaiseraugst, F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland;
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Tobias Posset
5Production Support, Parenterals Manufacturing Mannheim, Roche Diagnostics GmbH, Mannheim, Germany; and
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Silke Mohl
1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
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Alexander Streubel
1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
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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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Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl, Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 109-119; DOI: 10.5731/pdajpst.2015.005918

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Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl, Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 109-119; DOI: 10.5731/pdajpst.2015.005918
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Cited By...

  • Use of a Predictive Regression Model for Estimating Hold-Up Volume for Biologic Drug Product Presentations
  • 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
  • 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
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Keywords

  • Capping
  • Residual seal force
  • Container closure integrity
  • Process control

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