Application of Enzyme Indicators in Hydrogen Peroxide Biodecontamination Cycle Development: A Critical Evaluation of Indicator Variability and Correlation to Biological Indicator Results

References

1. 1.↵
   1. Agalloco J.,
   2. Akers J.

   , Eds. Advanced Aseptic Processing Technology, 1st ed.; CRC Press: Boca Raton, 2010; https://doi.org/10.3109/9781439825440.
2. 2.↵
   1. Sandle T.

   Biodecontamination of Cleanrooms and Laboratories Using Gassing Systems. J. GxP Compliance 2017, 21, 1–12.

   OpenUrl
3. 3.↵
   U.S. Food and Drug Administration, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2004.
4. 4.↵
   Parenteral Drug Association Inc. Technical Report No. 34: Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products; Bethesda, MD, 2001.
5. 5.↵
   1. Hopkins A.

   VHP (Vapour Hydrogen Peroxide) Fragility https://mhrainspectorate.blog.gov.uk/2018/04/20/vhp-vapour-hydrogen-peroxide-fragility/ (accessed Jun 16, 2020).
6. 6.↵
   1. Godden P.

   VHP as sterilant for use in isolators? https://www.cleanroomtechnology.com/news/article_page/VHP_as_sterilant_for_use_in_isolators/142378 (accessed Aug 19, 2020)
7. 7.↵
   Parenteral Drug Association Inc. Technical Report No. 51: Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use; Bethesda, MD, 2010.
8. 8.↵
   1. Sandle T.

   Rogue Biological Indicators: Are They a Real Phenomenon? J. Valid. Technol 2020, 26 1–10.

   OpenUrl
9. 9.↵
   International Organization for Standardization. ISO 11138-1:2017 Sterilization of Health Care Products - Biological Indicators - Part 1: General Requirements. ISO: Geneva, 2017.
10. 10.↵
    U.S. Pharmacopeial Convention, General Chapter <55> Biological Indicators—Resistance Performance Tests. In USP 42—NF 37, USP: Rockville, MD, 2019.
11. 11.↵
    1. McLeod N. P.,
    2. Clifford M.,
    3. Sutton J. M.

    Evaluation of Novel Process Indicators for Rapid Monitoring of Hydrogen Peroxide Decontamination Processes. PDA J. Pharm. Sci. Technol. 2017, 71 (5), 393–404. https://doi.org/10.5731/pdajpst.2016.007435.

    OpenUrlAbstract/FREE Full Text
12. 12.↵
    1. Kleinmann S.,
    2. Scheu M.,
    3. Fecht C.

    7 Steps for a Reproducible Cycle Development Plan. PDA Lett. 2016, 30–38.
13. 13.↵
    1. Tukey J.

    Exploratory Data Analysis, 1st ed.; Addison-Wesley Publishing Company: Reading, MA, 1977.
14. 14.↵
    1. Thouand G.,
    2. Marks R.

    1. Lundin A.

    Optimization of the firefly luciferase reaction for analytical purposes. In Bioluminescence: Fundamentals and Applications in Biotechnology, Thouand G., Marks R., Eds.; Springer Berlin Heidelberg: Berlin, Heidelberg, 2014; Vol. 2, pp 31–62. https://doi.org/10.1007/978-3-662-43619-6_2.

    OpenUrl
15. 15.↵
    1. Pusztai É.,
    2. Kemény S.,
    3. Vágó E.,
    4. Horváth A.

    Decision Risk Approach to the Application of Biological Indicators in Vapor Phased Hydrogen Peroxide Bio-Decontamination. J. Chemom. 2018, 32 (4), 1–12.

    OpenUrl
16. 16.↵
    1. Halvorson H. O.,
    2. Ziegler N. R.

    Application of Statistics to Problems in Bacteriology: I. A Means of Determining Bacterial Population by the Dilution Method. J. Bacteriol. 1933, 25 (2), 101–121.

    OpenUrlFREE Full Text