IP Library Granted Patent US 8,343,768
Granted Patent B2
US 8,343,768 · App. 11/527,273 · Granted Jan 1, 2013

Integrator system and method for rapidly determining effectiveness of a germicidal treatment

Assignee: Ethicon, Inc.
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Quick Facts
Patent No.
US 8,343,768
App. No.
11/527,273
Granted
Jan 1, 2013
Kind
B2
Abstract

The effectiveness of an oxidative sterilization process is determined by exposing a known amount of a primary amine or aldehyde indicator chemical to an oxidative germicide. The oxidative germicide reacts with the indicator chemical. The amount of indicator chemical remaining after exposure to the germicide is determined by reacting the indicator chemical with a dye precursor chemical to form a colored product. The amount of indicator chemical remaining is determined from the intensity of the color of the colored product. The amount of indicator chemical remaining on the substrate is a measure of the effectiveness of the germicidal treatment. The dye precursor is an aldehyde when the indicator chemical is a primary amine and a primary amine when the indicator chemical is an aldehyde. An integrator for determining the effectiveness of the germicidal process includes an indicator chemical, where the indicator chemical is a primary amine or an aldehyde.

Claims (45)

1. A method for determining the effectiveness of an oxidative germicidal process, the method comprising:

testing the oxidative germicidal process by treating a known amount of a first chemical with an oxidative germicide selected from the group consisting of hydrogen peroxide, peracetic acid, ethylene oxide, ozone, and chlorine dioxide, the oxidative germicide thereby decreasing the known amount of the first chemical to a final amount of the first chemical; wherein the first chemical has a first color and is selected from a first group consisting of at least one primary amine or a second group consisting of at least one aldehyde that reacts with the at least one primary amine;

contacting the final amount of the first chemical having the first color with a second chemical having a second color, wherein the second chemical is a chemical selected from the first group when the first chemical is a chemical selected from the second group or wherein the second chemical is a chemical selected from the second group when the first chemical is a chemical selected from the first group;

producing a third chemical compound having a third color, the third color having an intensity, wherein the intensity of the third color is related to the final amount of the first chemical;

determining the intensity of the third color; and

determining the effectiveness of the oxidative germicidal process from the intensity of the third color.

2. The method of claim 1 , wherein the step of determining the effectiveness of the oxidative germicidal process comprises correlating the intensity of the third color with results from biological indicators.

3. The method of claim 1 , wherein the oxidative germicide is a sterilant.

4. The method of claim 1 , wherein the oxidative germicide is a disinfectant.

5. The method of claim 1 , wherein the first chemical is pelletized into a powdered tablet.

6. The method of claim 5 , wherein the first chemical is glycine.

7. The method of claim 1 , wherein the intensity of the third color is determined spectrophotometrically in the visible or ultraviolet region.

8. The method of claim 1 , further comprising exposing the oxidative germicide to plasma.

9. The method of claim 1 , wherein a percent completeness of the germicidal process is determined by comparing the intensity of the third color with an intensity of a color of a standard.

10. The method of claim 1 , wherein the primary amine is selected from the group consisting of glycine and histidine and the aldehyde is selected from the group consisting of ortho-phtalaldehyde and glutaldehyde.

11. The method of claim 1 , wherein the determining the intensity occurs in 6 minutes or less.

12. The method of claim 1 , wherein the method is a quantitative method for determining the effectiveness of an oxidative germicidal process.

13. The method of claim 1 , wherein the method occurs in a sterilization chamber.

14. The method of claim 1 , wherein the first chemical is on a substrate.

15. The method of claim 14 , wherein the substrate is a solid substrate.

16. A method for determining the effectiveness of an oxidative germicidal process, the method comprising:

treating a known amount of a first chemical with an oxidative germicide selected from the group consisting of hydrogen peroxide, peracetic acid, ethylene oxide, ozone, and chlorine dioxide, the oxidative germicide thereby decreasing the known amount of the first chemical to a final amount of the first chemical; wherein the first chemical has a first color and is selected from a first group consisting of at least one primary amine or a second group consisting of at least one aldehyde that reacts with the at least one primary amine;

contacting the final amount of the first chemical having the first color with a second chemical having a second color, wherein the second chemical is a chemical selected from the first group when the first chemical is a chemical selected from the second group or wherein the second chemical is a chemical selected from the second group when the first chemical is a chemical selected from the first group;

producing a third chemical compound having a third color, the third color having an intensity, wherein the intensity of the third color is related to the final amount of the first chemical;

determining the intensity of the third color; and

determining the effectiveness of the oxidative germicidal process from the intensity of the third color.

17. A method for determining the effectiveness of an oxidative germicidal process, the method comprising:

testing the oxidative germicidal process by treating a known amount of at least one primary amine with an oxidative germicide selected from the group consisting of hydrogen peroxide, peracetic acid, ethylene oxide, ozone, and chlorine dioxide thereby decreasing the known amount of the at least one primary amine to a final amount;

wherein the at least one primary amine has a first color;

contacting the final amount of the at least one primary amine having the first color with at least one aldehyde that reacts with the at least one primary amine having a second color to produce a chemical compound;

the chemical compound having a third color, the third color having an intensity, wherein the intensity of the third color is related to the final amount of the at least one primary amine;

determining the intensity of the third color; and

determining the effectiveness of the oxidative germicidal process from the intensity of the third color.

18. The method of claim 17 , wherein the primary amine is selected from the group consisting of an amino acid, arginine, histidine, alanine, proline, amino-caproic acid, phenylalanine, tryptophan, methionine, glycine, serine, cysteine, tyrosine, glutamine, aspartic acid, glutamic acid, lysine, arginine, and histidine, peptides, polypeptides, and combinations thereof.

19. The method of claim 18 , wherein the aldehyde does not react with secondary or tertiary amines.

20. The method of claim 18 , wherein the aldehyde is selected from the group consisting of ortho-phthalaldehyde, glutaldehyde, and aromatic aldehydes.

21. A method for determining the effectiveness of an oxidative germicidal process, the method comprising:

testing the oxidative germicidal process by treating a known amount of at least one aldehyde with an oxidative germicide selected from the group consisting of hydrogen peroxide, peracetic acid, ethylene oxide, ozone, and chlorine dioxide thereby decreasing the known amount of the at least one aldehyde to a final amount; wherein the at least one aldehyde has a first color;

contacting the final amount of the at least one aldehyde having the first color with at least one primary amine that reacts with the at least one aldehyde having a second color to produce a chemical compound;

the chemical compound having a third color, the third color having an intensity, wherein the intensity of the third color is related to the final amount of the at least one aldehyde;

determining the intensity of the third color; and

determining the effectiveness of the oxidative germicidal process from the intensity of the third color.

22. The method of claim 21 , wherein the primary amine is selected from the group consisting of an amino acid, arginine, histidine, alanine, proline, amino-caproic acid, phenylalanine, tryptophan, methionine, glycine, serine, cysteine, tyrosine, glutamine, aspartic acid, glutamic acid, lysine, arginine, and histidine, peptides, polypeptides, and combinations thereof.

23. The method of claim 22 , wherein the aldehyde does not react with secondary or tertiary amines.

24. The method of claim 22 , wherein the aldehyde is selected from the group consisting of ortho-phthalaldehyde, glutaldehyde, and aromatic aldehydes.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 16, 2019
From: ETHICON, INC.
To: ASP GLOBAL MANUFACTURING GMBH
Reel/Frame 050730/0209 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 15, 2007
From: SONG, KEVIN KYUNG-HEE; FRYER, BENJAMIN; ZHU, PETER
To: ETHICON, INC.
Reel/Frame 018756/0732 →
Continuity (2)
Continuation In Part 11093529 · Mar 30, 2005
Related Publication 20070092969A1 · Apr 26, 2007