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Research ArticleTechnology/Application

Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial

Christopher L. Timmons, Chi Yuen Liu and Stefan Merkle
PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 379-392; DOI: https://doi.org/10.5731/pdajpst.2017.007724
Christopher L. Timmons
1Corning Incorporated, Corning, NY and
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  • For correspondence: timmonscl@corning.com
Chi Yuen Liu
2Janssen AG, Schaffhausen, Switzerland
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Stefan Merkle
2Janssen AG, Schaffhausen, Switzerland
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Article Information

vol. 71 no. 5 379-392
DOI 
https://doi.org/10.5731/pdajpst.2017.007724
PubMed 
28512178

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 11, 2017.

Article Versions

  • previous version (May 15, 2017 - 20:01).
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Copyright & Usage 
© PDA, Inc. 2017

Author Information

  1. Christopher L. Timmons1,*,
  2. Chi Yuen Liu2 and
  3. Stefan Merkle2
  1. 1Corning Incorporated, Corning, NY and
  2. 2Janssen AG, Schaffhausen, Switzerland
  1. ↵*Corresponding Author: Christopher L. Timmons, Ph.D., Corning Incorporated, Corning, NY 14831. Telephone: (607) 974-9222; e-mail: timmonscl{at}corning.com
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PDA Journal of Pharmaceutical Science and Technology: 71 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 5
September/October 2017
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Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial
Christopher L. Timmons, Chi Yuen Liu, Stefan Merkle
PDA Journal of Pharmaceutical Science and Technology Sep 2017, 71 (5) 379-392; DOI: 10.5731/pdajpst.2017.007724

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Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial
Christopher L. Timmons, Chi Yuen Liu, Stefan Merkle
PDA Journal of Pharmaceutical Science and Technology Sep 2017, 71 (5) 379-392; DOI: 10.5731/pdajpst.2017.007724
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  • Article
    • Abstract
    • Introduction
    • Filling Line and Vial Damage Characterization
    • Glass Particles on the Filling Line Results from Multiple Mechanisms
    • Lab Evaluation of Particle Generation from Each Damage Mechanism
    • New Vial Designed To Address Root Cause of Particulate Mechanisms
    • Line Trials Using the New Vial Demonstrate Substantial Reduction in Particle Risk
    • Conclusions
    • Conflict of Interest Declaration
    • Acknowledgments
    • Reference
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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  • Enhancing Patient Safety through the Use of a Pharmaceutical Glass Designed To Prevent Cracked Containers
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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

  • Particulate matter
  • Particle
  • Glass vial
  • Filling line
  • Low-COF surface
  • Glass contamination

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