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Research ArticleTechnology/Application

Long-Term Study of Container Closure Integrity of Rubber–Glass Vial Systems by Multiple Methods

Matthew R. Gehrmann and T. Page Mcandrew
PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 147-161; DOI: https://doi.org/10.5731/pdajpst.2019.010223
Matthew R. Gehrmann
West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341
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T. Page Mcandrew
West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341
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  • For correspondence: page.mcandrew@westpharma.com
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References

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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. PDA J. Pharm. Sci. Technol. 2016, 70 (2), 109–119.
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    1. Ludwig J.,
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    Automated Method for Determining Instron Residual Seal Force of Glass Vial/Rubber Closure Systems. J. Parenter. Sci. Technol. 1993, 47 (5), 211–253.
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    1. Robeson L.
    Correlation of Separation Factor versus Permeability for Polymeric Membranes. J. Membr. Sci. 1991, 62 (2), 165–185.
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    Residual Seal Force Measurement of Parenteral Vials. I. Methodology. PDA J. Pharm. Sci. Technol. 1988, 42 (1), 23–29.
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    Time-Dependent Testing Evaluation and Modeling for Rubber Stopper Seal Performance. PDA J. Pharm. Sci. Technol. 2018, 72 (2), 134–148.
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    Quantifying the Vial Capping Process: Residual Seal Force and Container Closure Integrity. PDA J. Pharm. Sci. Technol. 2019, 73 (1), 2–15.
    OpenUrlAbstract/FREE Full Text
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PDA Journal of Pharmaceutical Science and Technology: 74 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 1
January/February 2020
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Long-Term Study of Container Closure Integrity of Rubber–Glass Vial Systems by Multiple Methods
Matthew R. Gehrmann, T. Page Mcandrew
PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 147-161; DOI: 10.5731/pdajpst.2019.010223

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Long-Term Study of Container Closure Integrity of Rubber–Glass Vial Systems by Multiple Methods
Matthew R. Gehrmann, T. Page Mcandrew
PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 147-161; DOI: 10.5731/pdajpst.2019.010223
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  • Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
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Keywords

  • Container closure integrity
  • CCI
  • Vial system
  • Leak rate
  • Residual seal force
  • Tracer gas leak detection
  • Frequency modulated spectroscopy
  • Gas permeability

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