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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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Article Information

vol. 74 no. 1 147-161
DOI 
https://doi.org/10.5731/pdajpst.2019.010223
PubMed 
31420507

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 3, 2020.

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  • previous version (August 16, 2019 - 04:26).
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© PDA, Inc. 2020

Author Information

  1. Matthew R. Gehrmann and
  2. T. Page Mcandrew*
  1. West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341
  1. ↵* Corresponding Author: West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341; e-mail: page.mcandrew@westpharma.com
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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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  • Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
  • Practical application of setting up an annual Contamination Control Strategy (CCS) assessment
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
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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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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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