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Review ArticleReview

Increasing Patient Safety by Closing the Sterile Production Gap—Part 3—Moist Heat Resistance of Bioburden

James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology July 2017, 71 (4) 274-278; DOI: https://doi.org/10.5731/pdajpst.2017.007641
James P. Agalloco
Agalloco & Associates Inc., 22 Carriage Trail, Belle Mead, NJ 08502
BE, MS, MBA
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Abstract

Terminal sterilization is considered the preferred means for the production of sterile drug products, as it affords enhanced safety for the patient because the formulation is sterilized in its sealed, final container. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is the notion that destruction of a high population of a resistant biological indicator microorganism is required. More contemporary thinking on sterilization acknowledges that the bioburden is the actual target in sterilization and its destruction must be assured. In the application of low-temperature moist heat for terminal sterilization, especially subsequent to aseptic processing, establishing the pre-sterilization bioburden to consider has proven challenging. Environmental monitoring survey data has determined the identity of potential microorganisms but not their resistance to sterilization. This review article provides information on the moist heat resistance of vegetative and sporeforming microorganisms that might be present. The first paper in this series provided the overall background and described the benefits to patient, producer, and regulator of low-temperature moist heat for terminal sterilization. The second paper outlined validation and operational advice that can be used in the implementation. This final effort concludes the series and provides insight into potential bioburden and its resistance.

LAY ABSTRACT: Terminal sterilization is considered the preferred means for the production of sterile drug products as it affords enhanced safety for the patient as the formulation is filled into its final container, sealed and sterilized. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The primary consideration in terminal sterilization is the reliable destruction of the bioburden. The earlier manuscripts in this series described the principles and implementation of low temperature terminal sterilization processes where the sterilization conditions would destroy the expected bioburden present. To accomplish that reliably knowledge of the bioburden expected resistance to moist heat is necessary. This review article will identify publications where that data can be found.

  • Terminal sterilization
  • Aseptic processing
  • Sterilization
  • Biological indicator
  • Bioburden
  • Probability of a non-sterile unit (PNSU)
  • Regulation
  • Sterility assurance
  • © PDA, Inc. 2017
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 71 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 4
July/August 2017
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Increasing Patient Safety by Closing the Sterile Production Gap—Part 3—Moist Heat Resistance of Bioburden
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Jul 2017, 71 (4) 274-278; DOI: 10.5731/pdajpst.2017.007641
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  • Article
    • Abstract
    • Introduction
    • Bioburden Expectations
    • Moist Heat Resistance of Non-Sporeforming Bioburden
    • Moist-Heat Resistance of Spore Bioburden
    • Conclusion
    • Conflict of Interest Declaration
    • Acknowledgements
    • Reference
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  • Sterility Assurance--Current and Future State
  • The Boil Test--Strategies for Resistance Determination of Microorganisms
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More in this TOC Section

  • The Role of Microbiologists in Drug Product Development
  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
Show more Review

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Keywords

  • Terminal sterilization
  • Aseptic processing
  • Sterilization
  • Biological indicator
  • Bioburden
  • Probability of a non-sterile unit (PNSU)
  • Regulation
  • Sterility assurance

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Increasing Patient Safety by Closing the Sterile Production Gap—Part 3—Moist Heat Resistance of Bioburden
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Jul 2017, 71 (4) 274-278; DOI: 10.5731/pdajpst.2017.007641

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