PROCESS FOR DECONTAMINATING OR STERILIZING AN ARTICLE

• US 20150306266A1
• Filed: 11/11/2014
• Published: 10/29/2015
• Est. Priority Date: 04/28/2014
• Status: Active Grant

• Current Assignee: American Sterilizer Company (Steris Corporation)
• Original Assignee: American Sterilizer Company (Steris Corporation)
• Inventors: Burke, Peter A., Centanni, Michael A., Leggett, Mark James
• Granted Patent: US 10,463,754 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A01N 2300/00 Combinations or mixtures of active ingredients covered by classes A01N27/00 - A01N65/48 with other active or formulation relevant ingredients, e.g. specific carrier materials or surfactants, covered by classes A01N25/00 - A01N65/48
• CPC Class Codes: A01N 37/16 containing the group; Thio analogues thereof
• CPC Class Codes: A01N 59/00 Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
• CPC Class Codes: A61L 2/183 Ozone dissolved in a liquid
• CPC Class Codes: A61L 2/186 Peroxide solutions
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

This invention relates to a a process for decontaminating or sterilizing an article contaminated with spores. The process comprises contacting the spores with a liquid sterilant for a sufficient period of time to effect a desired reduction (e.g., at least a 4 log reduction) in the number of spores capable of returning to vegetative growth. The liquid sterilant may comprise water, an antimicrobial agent (e.g., peracetic acid) and a peroxide (e.g., hydrogen peroxide).

Claims

1. A process for decontaminating or sterilizing an article contaminated with spores, comprising:

contacting the article with a liquid sterilant comprising water, an antimicrobial agent and a peroxide for a sufficient period of time to effect at least a 4 log reduction in the number of spores capable of returning to vegetative growth, the aqueous composition having a concentration of peroxide in the range from about 0.01 to about 14% by weight.

2. The process of claim 1 wherein the concentration of the antimicrobial agent is in the range from about 0.001 to about 95% by weight.

3. The process of claim 1 wherein the concentration of the antimicrobial agent is in the range from about 0.005 to about 0.5% by weight.

4. The process of claim 1 wherein the weight ratio of the antimicrobial agent to the peroxide is in the range from about 0.001 to about 0.5.

5. The process of claim 1 wherein the article is made of a material comprising brass, copper, aluminum, stainless steel, carbon steel, plastic, glass, adhesive or a combination of two or more thereof.

6. The process of claim 1 wherein the article comprises a medical, dental, pharmaceutical, veterinary or mortuary instrument or device.

7. The process of claim 1 wherein the article comprises an endoscope.

8. The process of claim 1 wherein the pH of the liquid sterilant is in the range from about 2 to about 11.

9. The process of claim 1 wherein the temperature of the liquid sterilant is in the range from about 20 to about 80°

C.

10. The process of any of claim 1 wherein the exposure time of the article to the liquid sterilant is in the range from about 0.5 to about 240 minutes.

11. The process of claim 1 wherein the process is conducted in a sterilizing apparatus, the sterilizing apparatus comprising a sterilization chamber and a sterilant introduction system, the process comprising:

placing the article in the sterilization chamber;

flowing the liquid sterilant in the sterilization chamber in contact with the article;

draining the liquid sterilant from the sterilization chamber;

flowing rinse water in the sterilization chamber in contact with the article; and

removing the article from the sterilization chamber.

12. The process of claim 1 wherein the water comprises tap water, deionized water, distilled water, water purified by osmosis, or a mixture of two or more thereof.

13. The process of claim 1 wherein the peroxide is a compound containing an oxygen-oxygen single bond, a peroxide group and/or a peroxide ion.

14. The process of claim 1 wherein the peroxide comprises an organic peroxide, a peroxy acid, an organic hydroperoxide, an inorganic peroxide, an acid peroxide, or a mixture of two or more thereof.

15. The process of claim 1 wherein the peroxide comprises hydrogen peroxide.

16. The process of claim 1 wherein the antimicrobial agent comprises a disinfectant, antibiotic, antiseptic, biocide and/or sanitizer.

17. The process of claim 1 wherein the antimicrobial agent comprises peracetic acid.

18. The process of claim 1 wherein the antimicrobial agent comprises an alcohol, chlorine, a chlorine compound, an aldehyde, an oxidizing agent, iodine, ozone, a phenolic, a quaternary ammonium compound, or a mixture of two or more thereof.

19. The process of claim 1 the antimicrobial agent comprises formaldehyde, ortho-phthalaldehyde, glutaraldehyde, silver dihydrogen citrate, polyaminopropyl biguanide, sodium bicarbonate, lactic acid, chlorine bleach, or a mixture of two or more thereof.

20. The process of claim 1 wherein the antimicrobial agent comprises methanol, ethanol, n-propanol, 1-propanol, 2-propanol, isopropanol, or a mixture of two or more thereof.

21. The process of claim 1 wherein the antimicrobial agent comprises a hypochlorite, chlorine dioxide, a dichloroisocyanurate, a monochloroisocyanurate, a halogenated hydantoin, or a mixture of two or more thereof.

22. The process of claim 1 wherein the antimicrobial agent comprises sodium hypochlorite, calcium hypochlorite, sodium dichloroisocyanurate, sodium chlorite, N-chloro-4-methylbenzenesulfonamide sodium salt, 2,4-dichorobenzyl alcohol, or a mixture of two or more thereof.

23. The process of claim 1 wherein the antimicrobial agent comprises performic acid, potassium permanganate, potassium peroxymonosulfate, or a mixture of two or more thereof.

24. The process of claim 1 wherein the antimicrobial agent comprises phenol, o-phenylphenol, chloroxylenol, hexachlorophene, thymol, amylmetacresol, or a mixture of two or more thereof.

25. The process of claim 1 wherein the antimicrobial agent comprises benzalkonuim chloride, cetyltrimethyl ammonium bromide, cetylpyridinium chloride, benzethonium chloride, boric acid, Brilliant green, chlorhexidine gluconate, tincture of iodine, providone-iodine, mercurochrome, manuka honey, octenidine dihydrochloride, polyhexamethylene biguamide, balsum of Peru, or a mixture of two or more thereof.

26. The process of claim 1 wherein the liquid sterilant further comprises acetic acid, sulfuric acid, or a mixture thereof.

27. The process of claim 1 wherein the liquid sterilant comprises from about 0.005 to about 0.16% by weight peracetic acid, and from about 0.1 to about 6.4% by weight hydrogen peroxide.

28. The process of claim 1 wherein the liquid sterilant further comprises a surfactant, a buffer, a corrosion inhibitor, a chelator, or a mixture of two or more thereof.

29. The process of claim 27 wherein the surfactant comprises a detergent, wetting agent, emulsifier, foaming agent and/or dispersant.

30. The process of claim 27 wherein the surfactant comprises an organic compound that contains hydrophobic groups and hydrophilic groups.

31. The process of claim 27 wherein the surfactant comprises an anionic, cationic, zwitterionic and/or nonionic compound.

32. The process of claim 27 wherein the surfactant comprises:

an alkanolamine;

alkylarylsulfonate;

amine oxide;

poly(oxyalkylene);

block copolymer comprising alkylene oxide repeat units;

carboxylated alcohol ethoxylate;

ethoxylated alcohol;

alkyl phenol;

ethoxylated alkyl phenol;

ethoxylated amine;

ethoxylated amide;

oxirane;

ethoxylated fatty acid;

ethoxylated fatty ester;

ethoxylated oil;

fatty ester;

fatty acid amide;

glycerol ester;

glycol ester;

sorbitan;

sorbitan ester;

imidazoline;

lecithin;

lignin;

glyceride;

olefin sulfonate;

phosphate ester;

ethoxylated fatty acid;

propoxylated fatty acid;

ethoxylated fatty alcohol;

propoxylated fatty alcohol;

sucrose ester;

sulfate, alcohol and/or ethoxylated alcohol of a fatty ester;

sulfonate of dodecyl and/or tridecyl benzene;

sulfosuccinate;

dodecyl and/or tridecyl benzene sulfonic acid;

ethanolamine;

triethanolamine;

octyldimethylamine oxide;

nonylphenoxy poly(ethyleneoxy)ethanol;

polyalkylene glycol;

or a mixture of two or more thereof.

33. The process of claim 28 wherein the buffer comprises an alkali metal phosphate, an alkali metal carbonate, or a mixture thereof.

34. The process of claim 28 wherein the corrosion inhibitor comprises benzotriazole, tolyltriazole, a sodium salt of benzotriazole, a sodium salt of tolyltriazole, or a mixture of two or more thereof.

35. The process of claim 28 wherein the chelator comprises ethylenediaminetetraacetic acid, hydroxyethylidenediphosphonic acid, a sodium salt of ethylenediaminetetraacetic acid, a sodium salt of hydroxyethylidenediphosphonic acid, or a mixture of two or more thereof.

36. The process of any of the preceding claims claim 1 wherein the spores comprise bacterial spores.

37. The process of claim 1 wherein the spores comprise bacteria of the Bacillus or Clostridia genera.

38. The process of any of the preceding claims claim 1 wherein the spores comprise Geobacillus stearothermophilus, Bacillus atrophaeus, Bacillus subtilis, Bacillus pumilus, Bacillus coagulans, Clostridium sporogenes, Bacillus subtilis globigii, Bacillus cereus, Bacillus circulans, Bacillus anthracis, or a mixture of two or more thereof.

39. The process of claim 1 wherein the spores comprise one or more Bacillus subtilis strains.