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1. (WO2018125798) ARTICLE AND METHODS TO DETERMINE EFFICACY OF DISINFECTION PROCESS
Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

WHAT IS CLAIMED IS:

1. An article, comprising:

a nonwoven substrate having a copolymer grafted thereto, the copolymer comprising interpolymerized monomer units of

a cationic nitrogen-containing ligand monomer selected from quaternary ammonium- containing and/or guanidinyl-containing ligand monomers;

an amide monomer;

an oxy monomer; and

a dried coating adhered to the substrate, the coating comprising

an optional water-soluble or water-dispersible polymeric binding agent; and a plurality of test microorganisms.

2. The article of claim 1, wherein the grafted copolymer comprises:

a. 10 to 50 parts by weight of the cationic nitrogen-containing ligand monomer; b. 10 to 80 parts by weight of the amide monomer;

c. 10 to 40 parts by weight of the oxy monomer; and

d. 0 to 30 parts by weight of a poly(alkylene oxide) monomer,

wherein the sum of a) to d) is 100 parts by weight.

3. The article of claim 1 or claim 2, wherein the dried coating further comprises a water-soluble or water-dispersible polymeric binding agent.

4. The article of claim 3, wherein at least a portion of the plurality of test microorganisms is dispersed in the polymeric binding agent.

5. The article of any one of the preceding claims, wherein the nonwoven substrate comprises meltblown microfibers of a hydrophobic thermoplastic polyolefin.

6. The article of any one of the preceding claims, wherein the nonwoven substrate has a surface area of 15 to 50 m2 per square meter of nonwoven substrate.

7. The article of any one of the preceding claims, wherein the nonwoven substrate has a solidity of less than 20%.

8. The article of any one of the preceding claims, the article can have a weight ratio of copolymer to nonwoven substrate, wherein the weight ratio is about 0.5 to 3 parts copolymer to 1 part nonwoven substrate.

9. The article of any one of the preceding claims, wherein the water-soluble or water-dispersible polymeric binding agent is selected from the group consisting of agarose, polyvinylpyrrolidone, poly(alkylene oxide), and a combination of any two or more of the foregoing polymeric binding agents.

10. The article of any one of the preceding claims, wherein the test microorganisms comprise spores.

11. The article of claim 10, wherein the spores comprise spores of a species of filamentous fungi.

12. The article of claim 11, wherein the spores comprise spores of a species of Aspergillus .

13. The article of claim 12, wherein the spores comprise spores of Aspergillus brasiliensis,

Aspergillus oryzae, Aspergillus niger, or Aspergillus nidulans.

14. The article of any one of the preceding claims, wherein the plurality of viable test

microorganisms consists of about 10 test microorganisms to about 108 test microorganisms.

15. The article of any one of the preceding claims, wherein the water-soluble or water-dispersible polymeric binding agent comprises poly(alkylene oxide), wherein the poly(alkylene oxide) has a weight average molecular weight of 400 Daltons, 4,000 Daltons, or 20,000 Daltons.

16. The article of any one of the preceding claims, wherein the quaternary ammonium -containing monomer used to make the copolymer comprises [3-(Methacryloylamino)propyl]trimethylammonium chloride.

17. The article of any one of the preceding claims, wherein the quaternary ammonium -containing monomer used to make the copolymer comprises [3-(Methacryloylamino)propyl]trimethylammonium chloride, the oxy monomer used to make the copolymer comprises glycidyl methacrylate, and the amide monomer used to make the copolymer comprises N-vinyl pyrrolidone.

18. A process challenge device, comprising:

a body with a hollow channel having a first aperture and a second aperture spaced apart from the first aperture; and

the article of any one of the preceding claims fixedly disposed in the hollow channel.

19. The process challenge device of claim 18, further comprising a reservoir containing a detection medium, wherein the reservoir is disposed in selective fluid communication with the article.

20. The process challenge device of claim 19, wherein the detection medium comprises a reagent selected from the group consisting of an effective amount of a nutrient that facilitates germination and/or growth of the test microorganisms, an indicator compound facilitates detection of a test microorganism metabolic activity, an effective amount of a neutralizer compound that inhibits an antimicrobial activity of a disinfectant, and a combination of any two or more of the foregoing reagents.

21. The process challenge device of claim 20, wherein the nutrient is selected from the group consisting of serine, proline, arginine, glutamate, asparagine, aspartate, threonine, lipids, fatty acids, potato infusion, yeast extract, malt extract, peptones, dextrose, and a combination of any two or more of the foregoing nutrients.

22. The process challenge device of claim 20 or claim 21, wherein the indicator compound is selected from the group consisting of a chromogenic enzyme substrate, a fluorogenic enzyme substrate, a pH indicator, a redox indicator, a chemiluminescent enzyme substrate, a dye, and a combination of any two or more of the foregoing indicator compounds.

23. The process challenge device of any one of claims 20 through 22, wherein the neutralizer compound is selected from the group consisting of lethicin, glycine, sodium carbonate, potassium bicarbonate, ascorbic acid, sodium metabisulfite, horse serum, polyoxyethylene (20) sorbitan monooleate, catalase, sodium bisulfite, sodium bisulphate, sodium thioglycolate, and sodium thiosulfate.

24. The process challenge device of any of claims 18 through 23, wherein the article is disposed in the hollow channel such that a fluid passing through the hollow channel from the first aperture to the second aperture contacts the article.

25. The process challenge device of any one of claims 18 through 24, wherein the body comprises a wall that forms the hollow channel, wherein a portion of a wall permits optical evaluation of the test microorganisms or a product of metabolic activity of the test microorganisms.

26. A method, comprising:

flowing a disinfectant through the hollow channel of the process challenge device of claim 24, wherein the process challenge device comprises the reservoir containing the detection medium, wherein

the detection medium comprises the effective amount of the nutrient and the indicator compound, wherein flowing the disinfectant through the hollow channel comprises contacting the article with the disinfectant; while flowing the disinfectant through the hollow channel and/or after flowing the disinfectant through the hollow channel, contacting the article with the disinfectant in the hollow channel at a predefined temperature for at least a predetermined minimum contact time;

after contacting the article with the disinfectant for at least the predetermined minimum contact time, contacting the article with an effective amount of a neutralizer compound that inhibits an antimicrobial activity of the disinfectant;

contacting the article with the detection medium in the hollow channel for a period of time and after contacting the article with the detection medium in the hollow channel for the period of time, analyzing the detection medium in the hollow channel to determine whether the indicator compound changed from a first state to a second state.

27. The method of claim 26, wherein flowing the disinfectant through the hollow channel of the process challenge device comprises flowing a disinfectant selected from the group consisting of ortho-phthalaldehyde, glutaraldehyde, peracetic acid, a disinfecting composition comprising peracetic acid and hydrogen peroxide, 12% (w/w) 2-propanol, a disinfecting composition comprising 2% (w/w)

glutaraldehyde and 12% (w/w/) 2-propanol, and hydrogen peroxide.

28. The method of claim 26 or claim 27, wherein analyzing the detection medium in the hollow channel to determine whether the indicator compound changed from a first state to a second state comprises analyzing the indicator compound visually.

29. The method of any one of claims 26 through 28, wherein analyzing the detection medium in the hollow channel to determine whether the indicator compound changed from a first state to a second state comprises analyzing the indicator compound by using an automated detector.

30. A method, comprising:

flowing a disinfectant through the hollow channel of the process challenge device of any one of claims 18-25, wherein flowing the disinfectant through the hollow channel comprises contacting the article with the disinfectant for a minimum contact time period;

while flowing the disinfectant through the hollow channel and/or after flowing the disinfectant through the hollow channel, contacting the article with the disinfectant in the hollow channel at a predefined temperature for at least a predetermined minimum contact time;

after contacting the article with the disinfectant for at least the predetermined minimum contact time, contacting the article with an effective amount of a neutralizer compound that inhibits an antimicrobial activity of the disinfectant;

contacting the article with a detection medium for a period of time; and

after contacting the article with the detection medium for a period of time, analyzing the detection medium to detect a biological activity of the test microorganisms.

31. The method of claim 30 wherein, before contacting the article with the detection medium for a period of time, the method further comprises removing the article from the process challenge device.

32. A method, comprising:

contacting the article of any one of claims 1 through 17 with a disinfectant in a flow stream for at least a predefined minimum contact time;

after contacting the article with the disinfectant for at least the minimum contact time, contacting the article with an effective amount of a neutralizer compound that inhibits an antimicrobial activity of the disinfectant;

contacting the article with a detection medium for a period of time; and

after contacting the article with the detection medium for a period of time, analyzing the detection medium to detect a biological activity of the test microorganisms.

33. The method of any one of claims 26 through 32, wherein the minimum contact period is about 3 minutes to about 90 minutes.

34. The method of any one of claims 26 through 33, wherein contacting the article with the detection medium for a period of time comprises contacting the article with the detection medium for about 5 minutes to about 48 hours.

35. The method of any one of claims 26 through 34, wherein analyzing the detection medium to detect a biological activity of the test microorganisms comprises detecting vegetative cells derived from germination and/or outgrowth of a spore.

36. The method of any one of claims 26 through 34, wherein analyzing the detection medium to detect a biological activity of the test microorganisms comprises detecting an enzyme activity of the spores and/or an enzyme activity of vegetative cells derived from germination and/or outgrowth of a spore.

37. The method of claim 36, wherein detecting an enzyme activity comprises detecting an enzyme activity selected from the list of consisting of phosphatase (e.g., acid phosphatase or alkaline phosphatase) activity, beta-glucosidase activity, alpha-glucosidase activity, cellulase activity, xylanase activity, beta-glucuronidase activity, alpha-glucuronidase activity, alpha-galactosidase activity, beta-galactosidase

activity, laccase activity, protease activity, peptidase activity, amylase activity, glucose oxidase activity, lyase activity, esterase activity, lipase activity oxidoreductase activity, and a combination of any two or more of the foregoing enzyme activities.

38. The method of any one of claims 26 through 37, wherein contacting the article with the detection medium for a period of time comprises contacting the article with the detection medium at a predefined temperature.

39. The method of any one of claims 26 through 38, wherein contacting the article with the effective amount of the neutralizer compound comprises contacting the article with the effective amount of the neutralizer compound before contacting the article with the detection medium.

40. The method of any one of claims 26 through 38, wherein contacting the article with the effective amount of the neutralizer compound comprises contacting the article with the detection medium that comprises the effective amount of the neutralizer compound.