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PDA Journal of Pharmaceutical Science and Technology

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Critical Process Parameters of Capping Equipment used in GMP DP 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 January 2016, pdajpst.2015.005918; DOI: https://doi.org/10.5731/pdajpst.2015.005918
Roman Mathaes
1 Roche;
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  • For correspondence: roman.mathaes@gmail.com
Hanns-Christian Mahler
1 Roche;
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Yves Roggo
1 Roche;
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Joerg Huwyler
2 University Basel
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Juergen Eder
1 Roche;
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Kamila Fritsch
1 Roche;
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Tobias Posset
1 Roche;
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Silke Mohl
1 Roche;
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Alexander Streubel
1 Roche;
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PDA Journal of Pharmaceutical Science and Technology: 79 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 2
March/April 2025
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Critical Process Parameters of Capping Equipment used in GMP DP 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 Jan 2016, pdajpst.2015.005918; DOI: 10.5731/pdajpst.2015.005918

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Critical Process Parameters of Capping Equipment used in GMP DP 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 Jan 2016, pdajpst.2015.005918; 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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More in this TOC Section

  • A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
  • A Proof-of-Concept Study on a Universal Standard Kit to Evaluate the Risks of Inspectors for Their Foundational Ability of Visual Inspection of Injectable Drug Products
  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
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Keywords

  • Capping
  • Computer Tomography
  • Container closure integrity
  • Container closure system
  • Crimping
  • Residual seal force

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