Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program

References

1. 1.↵
   U.S. Food and Drug Administration, 21 CFR part 211–Current Good Manufacturing Practice for Finished Pharmaceuticals, Section 211.67 Equipment Cleaning and Maintenance. U.S. Department of Health and Human Services. Government Publishing Office: Washington D.C., 2016.
2. 2.↵
   U.S. Food and Drug Administration, 21 CFR part 211–Current Good Manufacturing Practice for Finished Pharmaceuticals, Section 211.182 Equipment Cleaning and Use Log. U.S. Department of Health and Human Services. Government Publishing Office: Washington D.C., 2016.
3. 3.↵
   U.S. Pharmacopeial Convention, General Chapter <1072> Disinfectants and Antiseptics. https://www/uspnf.com (accessed Aug 28, 2018).
4. 4.↵
   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.
5. 5.↵
   ASTM International, ASTM E2614-15 Standard Guide for Evaluation of Cleanroom Disinfectants. ASTM: West Conshohocken, PA, 2018.
6. 6.↵
   ASTM International, ASTM E2197-17 Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals. ASTM: West Conshohocken, PA, 2018.
7. 7.↵
   International Organization for Standardization, ISO 14698: Cleanrooms and Associated Controlled Environments. ISO: Geneva, 2003.
8. 8.↵
   Parenteral Drug Association Inc. Technical Report No. 70: Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities; Bethesda, MD, 2015.
9. 9.↵
   Parenteral Drug Association Inc. Technical Report No. 29—Revised 2012: Points to Consider for Cleaning Validation; Bethesda, MD, 2012.
10. 10.↵
    British Standard, EN 13697: Quantitative Surface Test for the Evaluation of Bactericidal or Fungicidal Activity, London, UK, 2015.
11. 11.↵
    ASTM International, ASTM E1153-14 Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate, Hard, Nonporous Non-Food Contact Surfaces. ASTM: West Conshohocken, PA, 2018.
12. 12.↵
    Hard Surface Carrier Test Methods. In Official Methods of Analysis; AOAC International, 2016; Chapter 6.2.
13. 13.↵
    U.S. Pharmacopeial Convention, General Chapter <1231> Water for Pharmaceutical Purposes. https://www/uspnf.com (accessed Aug 28, 2018).
14. 14.↵
    1. Fraise A. P.,
    2. Lambert P. A.,
    3. Maillard J. -Y.

    Russell, Hugo & Ayliffe's Principles and Practice of Disinfection, Preservation and Sterilization; Fraise A. P., Lambert P. A., Maillard J. -Y., Eds.; Blackwell Publishing Ltd, Oxford, UK, 2004.
15. 15.↵
    U.S. Pharmacopeial Convention, General Chapter <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. https://www/uspnf.com (accessed Aug 28, 2018).
16. 16.↵
    1. Clayton J.

    Demystifying Disinfectant Contact Time. Healthcare Purchasing News [Online], Sept 21, 2017. http://www.hpnonline.com/demystifying-disinfectant-contact-time (accessed Aug 28, 2018).
17. 17.↵
    European Commission, Eudralex–The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 15: Qualification and Validation. European Commission: Brussels, 2018.
18. 18.↵
    U.S. Pharmacopeial Convention, General Chapter <1227> Validation of Microbial Recovery from Pharmacopeial Articles. https://www/uspnf.com (accessed Aug 28, 2018).
19. 19.
    1. McDonnell G. E.

    Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance; ASM Press: Washington DC, 2007.
20. 20.
    1. Rutala W. A,
    2. Weber D. J.

    ; and the Healthcare Infection Control Practices Advisory Committee. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Center for Disease Control and Prevention Web Site http://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf (accessed Aug 28, 2018).