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Article CommentaryCommentary

Sterility Assurance—Current and Future State

Edward C. Tidswell, James P. Agalloco and Radha Tirumalai
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 263-277; DOI: https://doi.org/10.5731/pdajpst.2020.012526
Edward C. Tidswell
1Merck, West Point, PA 19486;
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  • For correspondence: edward.tidswell@merck.com
James P. Agalloco
2Agalloco & Associates Inc., PO Box 899, Belle Mead, NJ 08502-0899; and
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Radha Tirumalai
3U.S. Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852-1790
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PDA Journal of Pharmaceutical Science and Technology: 76 (3)
PDA Journal of Pharmaceutical Science and Technology
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Sterility Assurance—Current and Future State
Edward C. Tidswell, James P. Agalloco, Radha Tirumalai
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 263-277; DOI: 10.5731/pdajpst.2020.012526

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Sterility Assurance—Current and Future State
Edward C. Tidswell, James P. Agalloco, Radha Tirumalai
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 263-277; DOI: 10.5731/pdajpst.2020.012526
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  • Article
    • Abstract
    • Introduction
    • Sterility Assurance—Current State
    • Current US Legislation Governing Sterility and Sterility Testing
    • Testing Sterility
    • Sterility Assurance—Evolution of a New Perspective
    • Sterility Assurance–Future State
    • Principles Governing Parametric Release
    • 1. Quantification of Assurance of Sterility
    • 2. Process Parameters and Critical Process Parameters
    • 3. Risk Assessment and Microbial Control Strategy
    • Summary
    • Conflict of Interest Declaration
    • References
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Keywords

  • Sterility assurance
  • sterility
  • Sterile manufacture
  • Parametric Release
  • Design space
  • Microbial control

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