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Article CommentaryCommentary

Survey Report on Complaints Related to the Interconnectivity between Vial Containers and Transfer Devices

Cathy Zhao, Edwin Burnard, Joanne Beyer, Robin Samuel and Naresh Budhavaram
PDA Journal of Pharmaceutical Science and Technology March 2022, 76 (2) 163-176; DOI: https://doi.org/10.5731/pdajpst.2021.012643
Cathy Zhao
1West Pharmaceutical Services Inc., Exton, PA 19341;
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Edwin Burnard
2B. Braun Medical Inc., Bethlehem, PA 18018;
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Joanne Beyer
3Becton Dickinson (BD), Franklin Lakes, NJ 07417-1880;
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Robin Samuel
4AstraZeneca, Cambridge CB2 0AA, UK; and
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Naresh Budhavaram
5Eli Lilly and Company, Indianapolis, IN 46285.
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  • For correspondence: naresh.budhavaram@lilly.com
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Abstract

To address the challenges related to the interconnectivity between vial container closure systems and vial transfer devices, pharmaceutical, elastomer, and transfer device manufacturers have formed a working group under the Product Quality Research Institute (PQRI) to establish best practices for the evaluation of the assembly of vial transfer devices and vial systems. As part of the project, the first activity was to quantify the nature and frequency of issues (complaints). To this end, the working group conducted a survey with questionnaires related to categories and numbers of complaints, regions/countries where complaints were received, and the nature of the manufacturers who received the complaints. The survey was distributed to the 16 companies participating in the working group, and 11 companies submitted a response. Besides quantifying and ranking the frequency of issues, the survey determined what issues are common across all companies and what issues may be product-specific or specific by manufacturer. In this article, the analysis and outcomes of the survey will be presented, and the next steps will be discussed.

  • Vial transfer devices
  • CSTD
  • Vial system
  • Vial spikes
  • Survey
  • Complaints
  • © PDA, Inc. 2022
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PDA Journal of Pharmaceutical Science and Technology: 76 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 2
March/April 2022
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Survey Report on Complaints Related to the Interconnectivity between Vial Containers and Transfer Devices
Cathy Zhao, Edwin Burnard, Joanne Beyer, Robin Samuel, Naresh Budhavaram
PDA Journal of Pharmaceutical Science and Technology Mar 2022, 76 (2) 163-176; DOI: 10.5731/pdajpst.2021.012643
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Keywords

  • Vial transfer devices
  • CSTD
  • Vial system
  • Vial spikes
  • Survey
  • Complaints

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Survey Report on Complaints Related to the Interconnectivity between Vial Containers and Transfer Devices
Cathy Zhao, Edwin Burnard, Joanne Beyer, Robin Samuel, Naresh Budhavaram
PDA Journal of Pharmaceutical Science and Technology Mar 2022, 76 (2) 163-176; DOI: 10.5731/pdajpst.2021.012643

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