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Research ArticleResearch

Failure of Glass Tubing Vials during Lyophilization

David R. Machak and Gary L. Smay
PDA Journal of Pharmaceutical Science and Technology January 2019, 73 (1) 30-38; DOI: https://doi.org/10.5731/pdajpst.2017.008276
David R. Machak
American Glass Research, a Division of AGR International, Inc., 603 Evans City Road, Butler, PA, USA.
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  • For correspondence: dmachak@agrintl.com
Gary L. Smay
American Glass Research, a Division of AGR International, Inc., 603 Evans City Road, Butler, PA, USA.
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Article Information

vol. 73 no. 1 30-38
DOI 
https://doi.org/10.5731/pdajpst.2017.008276
PubMed 
30361283

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 1, 2019.

Article Versions

  • previous version (October 25, 2018 - 06:38).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. David R. Machak* and
  2. Gary L. Smay
  1. American Glass Research, a Division of AGR International, Inc., 603 Evans City Road, Butler, PA, USA.
  1. ↵* Corresponding Author: American Glass Research, a Division of AGR International, Inc., 603 Evans City Road, Butler, PA 16001; E-mail: dmachak{at}agrintl.com
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  • Best Practices and Guidelines (2022) for Scale-up and Technology Transfer in Freeze Drying Based on Case Studies. Part 2: Past Practices, Current Best Practices, and Recommendations
    Serguei Tchessalov, Evgenyi Shalaev, Bakul Bhatnagar, Steven Nail, Alina Alexeenko, Feroz Jameel, Jayasree Srinivasan, Michael Dekner, Ekneet Sahni, Stefan Schneid, Petr Kazarin, Orla McGarvey, Bert Van Meervenne, Vaibhav Kshirsagar, Paritosh Pande, Jens Philipp, Greg Sacha, Ke Wu, Joseph Azzarella, Gayathri Shivkumar, Shreyas Bhatt, Shyam B. Mehta
    AAPS PharmSciTech 2023 24 4
  • A Regulatory Perspective on Manufacturing Processes Pertaining to Lyophilized Injectable Products
    Steve Y. Rhieu, David D. Anderson, Kumar Janoria
    The AAPS Journal 2020 22 5
  • Vial Breakage in Lyophilization- Case Studies from Commercial Manufacturing and Laboratory Studies
    Ekneet K. Sahni, Jim A. Searles, Mark Nachtigall, Eric Owen, Dina Lyne
    Journal of Pharmaceutical Sciences 2023 112 4
  • Freeze Drying and Vial Breakage: Misconceptions, Root Causes and Mitigation Strategies for the Pharmaceutical Industry
    Xin Jin, David O'Grady, Richard P. Affleck, Stefano Martini, Atul Saluja
    Journal of Pharmaceutical Sciences 2024 113 5
  • Principles and Practices of Lyophilization in Product Development and Manufacturing
    Robert Ovadia, Phillippe Lam, Holger Roehl, Renaud Janssen, Roger Asselta
    2023 59
  • Principles and Practices of Lyophilization in Product Development and Manufacturing
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PDA Journal of Pharmaceutical Science and Technology: 73 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 1
January/February 2019
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Failure of Glass Tubing Vials during Lyophilization
David R. Machak, Gary L. Smay
PDA Journal of Pharmaceutical Science and Technology Jan 2019, 73 (1) 30-38; DOI: 10.5731/pdajpst.2017.008276

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Failure of Glass Tubing Vials during Lyophilization
David R. Machak, Gary L. Smay
PDA Journal of Pharmaceutical Science and Technology Jan 2019, 73 (1) 30-38; DOI: 10.5731/pdajpst.2017.008276
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Keywords

  • Borosilicate glass
  • fracture diagnosis
  • Fracture patterns
  • Lyophilization
  • Thermal shock
  • Internal force

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