Skip to main content
  • Main menu
  • User menu
  • Search

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
Research ArticleTechnology/Application

The Boil Test—Strategies for Resistance Determination of Microorganisms

James Agalloco and Edward C. Tidswell
PDA Journal of Pharmaceutical Science and Technology November 2018, 72 (6) 566-573; DOI: https://doi.org/10.5731/pdajpst.2017.008532
James Agalloco
1Agalloco & Associates Inc. Belle Mead, NJ, USA; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: jagalloco@aol.com
Edward C. Tidswell
2Merck & Co. Inc., West Point, PA, USA.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

Reference

  1. 1.↵
    International Organization for Standardization. Sterilization of Medical Devices—Microbiological Methods—Part 1: Determination of a Population of Microorganisms on Products; ISO 11737-1:2006.
    Google Scholar
  2. 2.↵
    U.S. Food and Drug Administration. 21 CFR 2111.110, 2008.
    Google Scholar
  3. 3.↵
    1. Sandle T.,
    2. Tidswell E. C.
    1. Tidswell E. C.
    Bioburden Control. In Aseptic and Sterile Processing. Control, Compliance and Future Trends; Sandle T., Tidswell E. C., Eds.; DHL Press: River Grove, IL, 2017; pp 163–192.
    Google Scholar
  4. 4.↵
    International Organization for Standardization. Sterilization of Health Care Products. Radiation. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices; ISO 11137-1:2015.
    Google Scholar
  5. 5.↵
    1. Wells-Bennik M. H. J.,
    2. Eijlander R.,
    3. de Bensten H. M. W.,
    4. Berendsen E. M.,
    5. Warda A. K.,
    6. Krawczyk A. O.,
    7. Nierop Groot M. M.,
    8. Xiao Y.,
    9. Zwietering M. H.,
    10. Kuipers O. P.,
    11. Abee T.
    Bacterial Spores in Food: Survival, Emergence, and Outgrowth. Annual Review of Food Science and Technology, 2016, (7), 457–482.
    Google Scholar
  6. 6.↵
    USP 39, Sterilization of Compendial Articles <1229>, 2013.
    Google Scholar
  7. 7.↵
    USP 39, Moist Heat Sterilization of Aqueous Liquids <1229.2>,2013.
    Google Scholar
  8. 8.↵
    1. Agalloco J.
    Kill the Bioburden, Not the Biological Indicator. BioPharm International, 2017, 30 (4), 50–52.
    OpenUrlGoogle Scholar
  9. 9.↵
    1. Agalloco J.
    Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilization. Pharmaceutical Manufacturing, 2016, 15 (11), S2. (Continued online at Pharmmanufacturing.com.)
    OpenUrlGoogle Scholar
  10. 10.↵
    1. Agalloco J.
    Increasing Patient Safety by Closing the Sterile Production Gap—Part 3—Moist Heat Resistance of Bioburden. PDA J. Pharm. Sci. Technol. 2017, 71, 274–278.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  11. 11.↵
    1. Agalloco J.,
    2. Akers J.
    Achieving Balance in Sterile Product Manufacturing. Pharmaceutical Technology, 2015, 39 (12), 36–41.
    OpenUrlGoogle Scholar
  12. 12.↵
    International Organization for Standardization. Sterilization of Health Care Products—Biological and Chemical Indicators—Test Equipment; ISO 18472:2006,.
    Google Scholar
  13. 13.↵
    https://www.cdc.gov/healthywater/emergency/drinking/making-water-safe.html (accessed October 9, 2018).
    Google Scholar
  14. 14.↵
    1. Warth A. D.
    Relationship Between the Heat Resistance of Spores and the Optimum and Maximum Growth Temperatures of Bacillus Species. American Society for Microbiology, 1978, 134 (3), 699–705.
    OpenUrlGoogle Scholar
  15. 15.↵
    1. Leggett M. J.,
    2. McDonnell G.,
    3. Denyer S. P.,
    4. Setlow P.,
    5. Maillard J-Y.
    Bacterial Spore Structures and their Protective Role in Biocide Resistance. J. Appl. Microbiol., 2012, 113, 485–498.
    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
  16. 16.↵
    1. Coleman W. H.,
    2. Chen D.,
    3. Li Y.,
    4. Cowan A. E.,
    5. Setlow P.
    How Moist Heat Kills Spores of Bacillus subtilis. J. Bacteriol, 2007, 189 (23), 8458–8466.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  17. 17.↵
    1. Sanchez-Salas J-L,
    2. Setlow B.,
    3. Zhang P.,
    4. Li Y-Q,
    5. Setlow P.
    Maturation of Released Spores is Necessary for Acquisition of Full Spore Heat Resistance During Bacillus subtilis Sporulation. Appl. Environ. Microbiol. 2011, 77 (19), 6746–6754.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  18. 18.↵
    1. Setlow P.
    Germination of Spores of Bacillus Species: What We Know and Do Not Know. J. Bacteriol. 2014, 196, 1297–1305.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  19. 19.↵
    1. Berendsen E. M.,
    2. Krawczyk A. O.,
    3. Klaus V.,
    4. de Jong A.,
    5. Boekhorst J.,
    6. Eijlander R. T.,
    7. Kuipers O.,
    8. Wells-Bennik M. H. J.
    Spores of Bacillus thermoamylovorans with Very High Heat Resistances Germinate Poorly in Rich Media Despite the Presence of ger Clusters, but Efficiently Upon Non-nutrient Ca-DPA Exposure. Appl. Environ. Microbiol. 2015, 81, 7791–7801.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  20. 20.↵
    USP 39, Monitoring of Bioburden <1229.3>, 2013.
    Google Scholar
  21. 21.↵
    USP 30, Parametric Release <1222>, 2004.
    Google Scholar
  22. 22.↵
    FDA Guidance for Industry. Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes, 2008.
    Google Scholar
  23. 23.↵
    1. Block S. S.
    1. Pflug I.,
    2. Holcomb R. G.,
    3. Gomez M. M.
    Principles of the Thermal Destruction of Microorganisms. In Disinfection, Sterilization and Preservation, 5th Edition; Block S. S., Ed.; Lippincott Williams & Wilkins: Philadelphia, 2001.
    Google Scholar
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 72 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 6
November/December 2018
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Email Article
Citation Tools
Share
The Boil Test—Strategies for Resistance Determination of Microorganisms
James Agalloco, Edward C. Tidswell
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 566-573; DOI: 10.5731/pdajpst.2017.008532
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget

Jump to section

  • Article
    • Abstract
    • Introduction
    • Conclusion
    • Conflict of Interest Declaration
    • Acknowledgement
    • Reference
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Sterility Assurance--Current and Future State
  • Google Scholar

More in this TOC Section

  • Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
Show more Technology/Application

Similar Articles

Keywords

  • Microbiological tests
  • Boil test
  • Moist Heat Sterilization
  • Terminal sterilization
  • Overkill
  • Bioburden
  • Biological indicator
  • Spores
  • Spore inactivation
  • Spore germination
  • Spore outgrowth
  • Bioburden Control
  • Parametric Release

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire
Alerts for this Article
Sign In to Email Alerts with your Email Address
Email this Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
The Boil Test—Strategies for Resistance Determination of Microorganisms
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
5 + 1 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
The Boil Test—Strategies for Resistance Determination of Microorganisms
James Agalloco, Edward C. Tidswell
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 566-573; DOI: 10.5731/pdajpst.2017.008532

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero

We use cookies on this site to enhance your user experience

By clicking any link on this page you are giving your consent for us to set cookies.