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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleTechnology/Application

Development of Conductivity Method as an Alternative to Titration for Hydrolytic Resistance Testing Used for Evaluation of Glass Vials Used in Pharmaceutical Industry

Kiyoshi Fujimori, Hans Lee, Joseph Phillips and Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology January 2017, 71 (1) 50-58; DOI: https://doi.org/10.5731/pdajpst.2016.007005
Kiyoshi Fujimori
Amgen Inc., Drug Product Development, Thousand Oaks, CA, USA
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Hans Lee
Amgen Inc., Drug Product Development, Thousand Oaks, CA, USA
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Joseph Phillips
Amgen Inc., Drug Product Development, Thousand Oaks, CA, USA
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Yasser Nashed-Samuel
Amgen Inc., Drug Product Development, Thousand Oaks, CA, USA
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  • For correspondence: snashed@amgen.com
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Article Information

vol. 71 no. 1 50-58
DOI 
https://doi.org/10.5731/pdajpst.2016.007005
PubMed 
27593692

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 6, 2017.

Article Versions

  • previous version (September 4, 2016 - 12:45).
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Copyright & Usage 
© PDA, Inc. 2017

Author Information

  1. Kiyoshi Fujimori,
  2. Hans Lee,
  3. Joseph Phillips and
  4. Yasser Nashed-Samuel*
  1. Amgen Inc., Drug Product Development, Thousand Oaks, CA, USA
  1. ↵* Corresponding Author: Yasser Nashed-Samuel; Amgen Inc., One Amgen Center Dr. Mail Stop: 30E-1-C, Thousand Oaks, CA 91320; Telephone: (805) 447-5483; e-mail: snashed{at}amgen.com.
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  • A Holistic Approach of Extractables and Leachables Assessment of Rubber Stoppered Glass Vial Systems for Biotechnology Products
    Li Qi, Jian Liu, Michael Ronk, Alejandra Gallegos, Kiyoshi Fujimori, Yanxin Luo, Kim Li, Hans Lee, Yasser Nashed-Samuel
    Journal of Pharmaceutical Sciences 2021 110 11
  • Observation and Mitigation of Lamellar Silica Particles Formed in Pharmaceutical Products Packaged in Glass Vials
    Yasser Nashed-Samuel, Jeremy Gastwirt, Ruchi B. Kotia, Stephanie Moore, Peter Masatani, Gianpiero Torraca, Monica Goss, David G. Dolan, Michael Akers, Chakradhar Padala, Jette Wypych, David J. Semin
    Journal of Pharmaceutical Sciences 2022 111 12
  • Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems
    Alejandra Gallegos, Jian Liu, Michael Ronk, Li Qi, Kim Li, David Semin, Yasser Nashed-Samuel
    Journal of Pharmaceutical Sciences 2022 111 6
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PDA Journal of Pharmaceutical Science and Technology: 71 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 1
January/February 2017
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Development of Conductivity Method as an Alternative to Titration for Hydrolytic Resistance Testing Used for Evaluation of Glass Vials Used in Pharmaceutical Industry
Kiyoshi Fujimori, Hans Lee, Joseph Phillips, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology Jan 2017, 71 (1) 50-58; DOI: 10.5731/pdajpst.2016.007005

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Development of Conductivity Method as an Alternative to Titration for Hydrolytic Resistance Testing Used for Evaluation of Glass Vials Used in Pharmaceutical Industry
Kiyoshi Fujimori, Hans Lee, Joseph Phillips, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology Jan 2017, 71 (1) 50-58; DOI: 10.5731/pdajpst.2016.007005
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    • I. Introduction
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  • An Evaluation of the Glass Vial Hydrolytic Resistance Method
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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

  • Glass
  • Vials
  • Delamination
  • Alkalinity
  • conductivity

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