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PDA Journal of Pharmaceutical Science and Technology

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Case ReportCase Study

Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnes

Edward C. Tidswel and Kenneth Boone
PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 408-422; DOI: https://doi.org/10.5731/pdajpst.2019.010975
Edward C. Tidswel
1Merck, West Point, PA 19486; and
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  • For correspondence: Edward.tidswell@merck.com
Kenneth Boone
2The Maurice R. Hilleman Center for Vaccine Manufacturing, Merck, Durham, NC 27712.
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Article Information

vol. 74 no. 4 408-422
DOI 
https://doi.org/10.5731/pdajpst.2019.010975
PubMed 
32060223

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online July 31, 2020.

Article Versions

  • previous version (February 14, 2020 - 07:26).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2020

Author Information

  1. Edward C. Tidswel1,* and
  2. Kenneth Boone2
  1. 1Merck, West Point, PA 19486; and
  2. 2The Maurice R. Hilleman Center for Vaccine Manufacturing, Merck, Durham, NC 27712.
  1. ↵*Corresponding Author: Merck, West Point, PA 19486; Telephone: 224-931-9059; E-mail: Edward.tidswell{at}merck.com
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PDA Journal of Pharmaceutical Science and Technology: 74 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 4
July/August 2020
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Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnes
Edward C. Tidswel, Kenneth Boone
PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 408-422; DOI: 10.5731/pdajpst.2019.010975

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Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnes
Edward C. Tidswel, Kenneth Boone
PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 408-422; DOI: 10.5731/pdajpst.2019.010975
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  • Article
    • Abstract
    • Introduction
    • The Microorganism Cutibacterium acnes
    • Cutibacterium acnes and the Skin
    • Culturing Cutibacterium acnes
    • Adequacy of Industry Standard Monitoring and Sterility Testing For Cutibacterium acnes
    • FDA Form 483s concerning Cutibacterium acnes
    • Patient Risk from Cutibacterium acnes
    • Conclusion
    • Conflict of Interest Declaration
    • References
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  • References
  • Info & Metrics
  • PDF

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Cited By...

  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
  • Reducing the risk of non-sterility of aseptic handling in hospital pharmacies, part C: applying risk assessment and risk control in practice
  • Reducing the risk of non-sterility of aseptic handling in hospital pharmacies, part C: applying risk assessment and risk control in practice
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More in this TOC Section

  • Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working Towards Alignment with USP<790> Visible Particulates in Injections
  • Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
  • Risk-Based Approach for Analytical Comparability and Comparability Protocols
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Keywords

  • Microbiological risk
  • Cutibacterium acnes
  • Culture medium
  • Incubation conditions
  • Monitoring
  • Controls

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