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Article CommentaryCommentary

Parametric Release of Moist Heat Sterilized Products: History and Current State

Michael J. Sadowski and Stephen E. Langille
PDA Journal of Pharmaceutical Science and Technology November 2022, 76 (6) 527-536; DOI: https://doi.org/10.5731/pdajpst.2022.012740
Michael J. Sadowski
1Baxter Healthcare, Round Lake, IL 60073; and
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  • For correspondence: mike_sadowski@baxter.com
Stephen E. Langille
2ValSource, Inc., Downingtown, PA 19335
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Abstract

The sterility test has been utilized for many years to formally support the sterile release of products terminally sterilized by moist heat and other sterilization modalities. It is well-known that the sterility test is severely limited in providing a meaningful scientific and statistical basis to support the sterility of finished products. Accordingly, parametric release was developed as a sterility assurance release program that defines critical manufacturing process and sterilization control parameters that are essential for sterile product release, thereby eliminating the use of the sterility test. This article examines the limitations and shortcomings of the sterility test and reviews the findings from a case study to illustrate the risks associated with the overreliance on this test for the disposition of sterile products. The history of parametric release of products terminally sterilized with moist heat is presented with a summary of the current status, including a listing of global regulatory standards and guidances along with a discussion of applicable results from an industry survey of moist heat sterilization practice. This article is intended to be the initial step to establish a basic understanding of the parametric release concept and practices that can be leveraged as a baseline for future promotion and expanded implementation.

  • Parametric Release
  • Real Time Release
  • Process Control Release
  • Moist Heat Sterilization
  • Terminal Sterilization
  • Test for Sterility
  • Sterility Test
  • Sterility Assurance
  • Sterilization
  • © PDA, Inc. 2022
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PDA Journal of Pharmaceutical Science and Technology: 76 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 6
November/December 2022
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Parametric Release of Moist Heat Sterilized Products: History and Current State
Michael J. Sadowski, Stephen E. Langille
PDA Journal of Pharmaceutical Science and Technology Nov 2022, 76 (6) 527-536; DOI: 10.5731/pdajpst.2022.012740

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Parametric Release of Moist Heat Sterilized Products: History and Current State
Michael J. Sadowski, Stephen E. Langille
PDA Journal of Pharmaceutical Science and Technology Nov 2022, 76 (6) 527-536; DOI: 10.5731/pdajpst.2022.012740
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  • Article
    • Abstract
    • I. Introduction
    • II. Definition and Origin of the Product Sterility Test
    • III. Limitations and Shortcomings of the Product Test for Sterility
    • IV. Case Study — Overreliance on Viability/Test for Sterility Results to Disposition Irradiated Anthrax Spores
    • V. There Must Be a Better Approach — the History of the Parametric Release for Drug Products Terminally Sterilized with Moist Heat in the United States
    • VI. Global Definitions of Parametric Release
    • VII. Current Global Regulatory Status of Parametric Release
    • VIII. Current State of Parametric Release—Summarized Results from PAT Moist Heat 2020 Survey
    • IX. Use of Risk Assessment to Support Parametric Release Programs
    • X. Summary/Conclusion
    • Conflict of Interest Declaration
    • Acknowledgment
    • References
  • Figures & Data
  • Info & Metrics
  • References
  • PDF

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Keywords

  • Parametric Release
  • Real Time Release
  • Process Control Release
  • Moist Heat Sterilization
  • Terminal Sterilization
  • Test for Sterility
  • Sterility Test
  • Sterility Assurance
  • Sterilization

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