Validation of Peracetic Acid as a Sporicide for Sterilization of Working Surfaces in Biological Safety Cabinets

Abstract

Objectives: This study aimed to validate the use of peracetic acid as sporicide agent to decontaminate the working surface of a laminar flow biological safety cabinet (BSC), as an alternative to glutaraldehyde, including the selection of the disinfecting agent, the method of application, and the contact time. Materials and methods: The test organism was the spore-forming bacterium Bacillus atrophaeus ATCC 9372, which is a surrogate for an important infectious agent. Spore cultures were prepared from B. atrophaeus and used them to test the sporicidal efficacy of peracetic acid on a BSC stainless steel surface. The performance of the sterilant was assessed by determining minimal inhibitory concentration (MIC) and by microbial challenge in conditions that mimicked surface contamination. It was used 2.0% glutaraldehyde solution as the control. Results: The range of MICs was 0.6-1.1% for the control and 0.003–0.006% for the 0.2% peracetic acid solution. The 0.2% peracetic acid was an effective sterilant against B. atrophaeus spores (6-7 log spores, under defined conditions of use) after 40 min contact time, which was double that recommended on the product label. Conclusion: It was conclude that while the results of official methods can help to evaluate how products will perform, they are not usually reproducible in real-life user conditions and environments. Validation tests must be carried out to ensure the efficacy and safety of surface decontamination procedures.

Keywords

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Validation of Peracetic Acid as a Sporicide for Sterilization of Working Surfaces in Biological Safety Cabinets

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Kaynakça

1. U.S. Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories, 5th edn. U.S. Government Printing Office: Washington, 2007.
2. Luftman HS, Regits MA, Lorcheim P, Lorcheim K, Daniel Paznek D. Validation study for the use of chlorine dioxide gas as a decontaminant for biological safety cabinets. Appl Biosaf 2008; 13: 199-212.
3. World Health Organization -WHO. Quality assurance of pharmaceuticals: A compendium of Guidelines and Related Materials.Good manufacturing practices and inspection, vol 2. WHO: Geneva, 2007.
4. World Health Organization- WHO. Handbook: Good laboratory practice (GLP): quality practices for regulated non-clinical research and development, 2nd ed. WHO: Geneva, 2009.
5. Kort R, O’Brien AC, van Stokkum IH, et al. Assessment of heat resistance of bacterial spores from food product isolates by fluorescence monitoring of dipicolinic acid release. Appl Environ Microbiol 2005; 71: 3556-3564.
6. Setlow P. Spores of Bacillus subtilis: their resistance to radiation, heat and chemicals. J Bacteriol 2006; 101:514-525.
7. Russel AD. Bacterial spores and chemical sporicidal agents. Clin Microbiol Rev 1990; 3: 99-119.
8. Booth NH, Mcdonald LE. Veterinary Pharmacology and Therapeutics. Iowa State University Press: Ames, 1982.

9. Takigawa T, Endo Y. Effects of glutaraldehyde exposure on human health. J Occup Health 2006; 48:75-87.
10. Cowan RE. Cleaning and disinfection of equipment for gastrointestinal endoscopy. Gut- J Gastroen Hepatol 1988; 42:585-593.
11. Baldry MGC, Fraser JAL. In: Payne KR. Industrial biocides. Wiley: New York, 1988.
12. Block, SS. In: Kirk-Othmer. Encyclopedia of chemical technology. Wiley: New York, 1992.
13. Kitis M. Disinfection of wastewater with peracetic acid: a review. Environ Int 2004; 30:47-55.
14. Coleman WH, Yong-Qing Li DC, Cowan AE, Setlow P. How moist heat kills spores of Bacillus subtilis. J Bacteriol 2007; 189: 8458-8466.
15. Wirtanen G, Salo S. Disinfection in food processing - efficacy testing of disinfectants. Rev Environ Sci Biotechnol 2003; 2:293-306.
16. ASTM- American Society for Testing and Materials. Standard quantitative carrier test method to evaluate the bactericidal, fungicidal, mycobactericidal, and sporicidal potencies of liquid chemical germicides. ASTM: West Conshohocken, PA, USA, 2000.
17. European Committee of Standardization. EN14561: Chemical disinfectants and antiseptics- Quantitative carrier test for the evaluation of the bactericidal activity for instruments used in the medical area .Test method and requirements. British Standards Institute, London, UK, 2006.
18. Grand I, Bellon-Fontaine MN, Herry JM, Hilaire D, Moriconi FX, Naïtali M. The resistance of Bacillus atrophaeus spores to the bactericidal activity of peracetic acid is influenced by both the nature of the solid substrates and the mode of contamination. J Appl Microbiol 2010; 109:1706-1714.
19. Sagripanti J-L, Carrera M, Insalaco J, Ziemski M, Rogers J, Zandomeni R. Virulent spores of Bacillus anthracis and other Bacillus species deposited on solid surfaces have similar sensitivity to chemical decontaminants. J Appl Microbiol 2007; 102:11-21.
20. Sella SRBR, Guizelini BP, Vandenberghe LPS, Medeiros ABP, Soccol CR. Bioindicator production with Bacillus atrophaeus’ thermal-resistant spores cultivated by solid-state fermentation. Appl Microbiol Biotechnol 2009; 82:1019-1026.
21. International Standard ISO- 11138-4. Sterilization of health care products-Biological indicators Part 4: Biological indicators for dry heat sterilization processes. ISO: Geneva, 2006.
22. International Standard ISO 14644-1. Clean rooms and associated controlled environments-part 1: classification of air cleanliness. ISO: Geneva, 1999.
23. European Committee for standardization. European standard EN 13704: Chemical disinfectants - Quantitative suspension test for evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1). British Standards Institute: London, UK, 2002.
24. USP-United States Pharmacopeia XXXI. Second Supplement, General Information, 1072 Disinfectants & Antiseptics. United States Pharmacopoeia Convection: Rockville, MD, 2008:3792.
25. EPA- U. S. Environmental Protection Agency. What Are Antimicrobial Pesticides? http://www.epa.gov/oppad001/ad_info. html. Accessed 15 Dec 2010.
26. Driks A. The dynamic spore. Proc Natl Acad Sci USA 2003; 100:3007-3009.
27. McDonnell G, Russell AD. Antiseptics and Disinfectants: Activity, Action, and Resistance. Clin Microbiol Rev 1999:12:147-179.
28. Mohan A, Dunn J, Hunt MC, Sizer CE. Inactivation Bacillus atrophaeus spores with surface-active peracids and characterization of formed free radicals using Electron Spin Resonance Spectroscopy. J Food Sci 2009; 74: M 411-M417.
29. Oie S, Obayashi A, Yamasaki H, et al. Disinfection methods for spores of Bacillus atrophaeus, B. anthracis, Clostridium tetani, C. botulinum and C. difficile. Biol Pharm Bull 2011; 34:1325-9.
30. Nicholson WL, Munakata N, Horneck G, Melosh HJ, Setlow P. Resistance of Bacillus endospores to extreme terrestrial and extraterrestrial environments. Microbiol Mol Biol Rev 2000; 64: 548-572.
31. Food and Drug Administration-FDA. Guidance for industry and FDA Staff - Biological Indicator (BI) Intended to Monitor Sterilizers used in Heath Care Facilities: remarket Notification [510(k)] Submissions, 2007. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071261.htm. Accessed 28 Jun 2011
32. Mazzola PG, Jozala AF, Novaes LCL, Moriel P, Penna TCV. Minimal inhibitory concentration (MIC) determination of disinfectant and/or sterilizing agents. Braz J Pharm Sci 2009; 459:241-248.
33. Serry FM, Kadry AA, Abdelrahman AA. Potential biological indicators for glutaraldehyde and formaldehyde sterilization processes. J Ind Microbiol Biotechnol 2003; 30:135-140.
34. Penna TCV, Mazzola PG, Martins AM. The efficacy of chemical agents in cleaning and disinfection programs. BMC Infec Dis 2001; 1:16-21.