Article and methods to determine efficacy of disinfection process

Patent metadata

Field	Value
Publication number	US-11629371-B2
Application number	US-201716475258-A
Country	US
Kind code	B2
Filing date	Dec 22, 2017
Priority date	Dec 28, 2016
Publication date	Apr 18, 2023
Grant date	Apr 18, 2023

Abstract

An article is provided. The article comprises a nonwoven substrate having a copolymer grafted thereto, and a dried coating adhered to the substrate. The copolymer comprises interpolymerized monomer units of a quaternary ammonium-containing ligand monomer, an amide monomer, and an oxy monomer. The coating comprises a plurality of test microorganisms. Optionally, the coating further comprises a water-soluble or water-dispersible polymeric binding agent. A process challenge device comprising a body having a hollow channel with said article fixed disposed therein is also provided. Methods of using the article or the process challenge device for determining the efficacy of a disinfection process are also provided.

First claim

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;

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; 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 dried coating further comprises a water-soluble or water-dispersible polymeric binding agent.

3. The article of claim 2 , wherein at least a portion of the plurality of test microorganisms is dispersed in the polymeric binding agent.

4. The article of claim 1 , wherein the nonwoven substrate comprises meltblown microfibers of a hydrophobic thermoplastic polyolefin.

5. The article of claim 1 , wherein the nonwoven substrate has a surface area of 15 to 50 m 2 per square meter of nonwoven substrate.

6. The article of claim 1 , wherein the nonwoven substrate has a solidity of less than 20%.

7. The article of claim 1 , 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.

8. The article of claim 1 , wherein the plurality of viable test microorganisms consists of about 10 test microorganisms to about 10 8 test microorganisms.

9. The article of claim 1 , 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.

10. The article of claim 1 , wherein the quaternary ammonium-containing monomer used to make the copolymer comprises [3-(Methacryloylamino)propyl]trimethylammonium chloride.

11. The article of claim 1 , 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.

12. 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
an article fixedly disposed in the hollow channel, the 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;

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; 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.

13. The process challenge device of claim 12 , further comprising a reservoir containing a detection medium, wherein the reservoir is disposed in selective fluid communication with the article.

14. The process challenge device of claim 13 , wherein the detection medium comprises a reagent selected from the group consisting of a nutrient that facilitates germination and/or growth of the test microorganisms, an indicator compound facilitates detection of a test microorganism metabolic activity, a neutralizer compound that inhibits an antimicrobial activity of a disinfectant, and a combination of any two or more of the foregoing reagents.

15. The process challenge device of claim 14 , 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.

16. The process challenge device of claim 14 , 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.

Assignees

• 3M Innovative Properties Company

Inventors

• Bennaars-Eiden Assumpta A G
• Bonilla Tonya D
• Connell Jodi L
• Schmidt John J
• Vail Andrew W
• Sgolastra Federica

Classifications

• A61L2103/15

  Laboratory, medical or dentistry appliances, e.g. catheters or sharps · CPC title

• C12Q1/22 Primary

  Testing for sterility conditions · CPC title

• A61L2/28

  Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour · CPC title

• D06M14/26

  on to materials of synthetic origin · CPC title

• C11D17/049

  Cleaning or scouring pads; Wipes · CPC title