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PDA Journal of Pharmaceutical Science and Technology

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Article CommentaryCommentary

Visible Particulate Contamination Control for Injectable Products: A Life-Cycle Approach

Stephen E. Langille
PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 359-366; DOI: https://doi.org/10.5731/pdajpst.2019.010462
Stephen E. Langille
ValSource, Inc., 918A Horseshoe Pike, Dowingtown, PA 19335
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Article Information

vol. 74 no. 3 359-366
DOI 
https://doi.org/10.5731/pdajpst.2019.010462
PubMed 
31732691

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online May 26, 2020.

Article Versions

  • previous version (November 15, 2019 - 07:57).
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Copyright & Usage 
© PDA, Inc. 2020

Author Information

  1. Stephen E. Langille
  1. ValSource, Inc., 918A Horseshoe Pike, Dowingtown, PA 19335
  1. Corresponding Author: ValSource, Inc., 918A Horseshoe Pike, Dowingtown, PA 19335. Telephone: 301-807-9372. E-mail: slangille{at}valsource.com
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PDA Journal of Pharmaceutical Science and Technology: 74 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 3
May/June 2020
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Visible Particulate Contamination Control for Injectable Products: A Life-Cycle Approach
Stephen E. Langille
PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 359-366; DOI: 10.5731/pdajpst.2019.010462

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Visible Particulate Contamination Control for Injectable Products: A Life-Cycle Approach
Stephen E. Langille
PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 359-366; DOI: 10.5731/pdajpst.2019.010462
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  • Article
    • Abstract
    • Introduction
    • Cost of Visible Particulate Contamination
    • Life-Cycle Approach to Visible Particulate Control
    • FDA Regulations and the Life-Cycle Approach
    • Summary
    • Conflict of Interest Declaration
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More in this TOC Section

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  • Principles for Management of Extractables and Leachables in Ophthalmic Drug Products
  • Survey Report on Complaints Related to the Interconnectivity between Vial Containers and Transfer Devices
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Keywords

  • Particulate
  • Life cycle
  • Visible
  • Contamination
  • Injectable
  • control

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