The Boil Test—Strategies for Resistance Determination of Microorganisms

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.
2. 2.↵
   U.S. Food and Drug Administration. 21 CFR 2111.110, 2008.
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.
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.
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.
6. 6.↵
   USP 39, Sterilization of Compendial Articles <1229>, 2013.
7. 7.↵
   USP 39, Moist Heat Sterilization of Aqueous Liquids <1229.2>,2013.
8. 8.↵
   1. Agalloco J.

   Kill the Bioburden, Not the Biological Indicator. BioPharm International, 2017, 30 (4), 50–52.

   OpenUrl
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.)

   OpenUrl
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 Text
11. 11.↵
    1. Agalloco J.,
    2. Akers J.

    Achieving Balance in Sterile Product Manufacturing. Pharmaceutical Technology, 2015, 39 (12), 36–41.

    OpenUrl
12. 12.↵
    International Organization for Standardization. Sterilization of Health Care Products—Biological and Chemical Indicators—Test Equipment; ISO 18472:2006,.
13. 13.↵
    https://www.cdc.gov/healthywater/emergency/drinking/making-water-safe.html (accessed October 9, 2018).
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.

    OpenUrl
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 Science
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 Text
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 Text
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 Text
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 Text
20. 20.↵
    USP 39, Monitoring of Bioburden <1229.3>, 2013.
21. 21.↵
    USP 30, Parametric Release <1222>, 2004.
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.
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.