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

Abstract

The effectiveness of an oxidative sterilization process is determined by exposing a substrate having 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 on the substrate 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 a substrate and an indicator chemical, where the indicator chemical is a primary amine or an aldehyde.

1 . A method for rapidly determining the effectiveness of an oxidative germicidal process, said method comprising: 
 providing a substrate having a known amount of a first chemical on the substrate, wherein said first chemical is selected from the group consisting of a primary amine, mixtures of primary amines, an aldehyde, and mixtures of aldehydes, wherein said first chemical has a first color;    exposing the substrate having the known amount of the first chemical to an oxidative germicide, thereby decreasing the known amount of the first chemical to a final amount of the first chemical;    contacting the substrate having the final amount of the first chemical having the first color with a second chemical having a second color, thereby generating a third chemical having a third color, said third color having an intensity, wherein the intensity of said third color is related to the final amount of said first chemical on said substrate, wherein said second chemical is a chemical selected from the group consisting of a primary amine and mixtures of primary amines when said first chemical is a chemical selected from the group consisting of an aldehyde and a mixture of aldehydes, and said second chemical is a chemical selected from the group consisting of an aldehyde and a mixture of aldehydes when said first chemical is a chemical selected from the group consisting of a primary amine and a mixture of primary amines;    determining the intensity of said third color; and    determining the effectiveness of the germicidal process from the intensity of said third color.    
   
   
       2 . The method of  claim 1 , wherein the step of determining the effectiveness of the germicidal process comprises correlating the intensity of said third color with results from biological indicators.  
   
   
       3 . The method of  claim 1 , wherein said oxidative germicide is a sterilant.  
   
   
       4 . The method of  claim 1 , wherein said oxidative germicide is a disinfectant.  
   
   
       5 . The method of  claim 1 , wherein said substrate is an absorbent substrate.  
   
   
       6 . The method of  claim 1 , wherein said substrate is a nonabsorbent substrate.  
   
   
       7 . The method of  claim 1 , wherein said oxidative germicide is a liquid, a vapor, or a gas.  
   
   
       8 . The method of  claim 1 , wherein the intensity of said third color is determined visually.  
   
   
       9 . The method of  claim 1 , wherein the intensity of said third color is determined spectrophotometrically in the visible or ultraviolet region.  
   
   
       10 . The method of  claim 1 , wherein at least one of said first chemical and said second chemical is colorless.  
   
   
       11 . The method of  claim 1 , wherein said oxidative germicide is selected from the group consisting of hydrogen peroxide, peracetic acid, ethylene oxide, ozone, and chlorine dioxide.  
   
   
       12 . The method of  claim 1 , further comprising exposing said substrate and said oxidative germicide to plasma.  
   
   
       13 . 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.  
   
   
       14 . 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-phthalaldehyde and glutaldehyde.  
   
   
       15 . An integrator for determining the effectiveness of a germicidal process with an oxidative germicide, said integrator comprising: 
 a substrate with a known amount of a first chemical on the substrate, wherein said first chemical is selected from the group consisting of a primary amine, mixtures of primary amines, an aldehyde, and mixtures of aldehydes;    wherein said substrate is in a enclosure;    wherein said first chemical is capable of reacting with said oxidative germicide when exposed to said oxidative germicide;    a reservoir of a second chemical, wherein said second chemical is a chemical selected from the group consisting of a primary amine and mixtures of primary amines when said first chemical is a chemical selected from the group consisting of an aldehyde and a mixture of aldehydes, and said second chemical is a chemical selected from the group consisting of an aldehyde and a mixture of aldehydes when said first chemical is a chemical selected from the group consisting of a primary amine and a mixture of primary amines;    wherein said second chemical is capable of reacting with said first chemical to form a third chemical having a color;    wherein said reservoir has a breakable barrier that isolates the second chemical from the first chemical and from the oxidative germicide during the contacting of the first chemical with the oxidative germicide, wherein breaking said breakable barrier in the reservoir contacts said second chemical with said first chemical, thereby forming said third chemical having the color; and    wherein said reservoir is in said enclosure.    
   
   
       16 . The integrator of  claim 15 , wherein said breakable barrier in said reservoir comprises a frangible ampoule in said enclosure.  
   
   
       17 . The integrator of  claim 16 , further comprising a second barrier, wherein said second barrier is inside said enclosure between said frangible ampoule and said first chemical, wherein said second barrier in said enclosure is permeable to said second chemical, and wherein said second barrier prevents fragments from the frangible ampoule from contacting the first chemical.  
   
   
       18 . The integrator of  claim 15 , further comprising a window in said enclosure, wherein said window is permeable to said oxidative germicide, said window allowing said oxidative germicide to enter said enclosure.  
   
   
       19 . The integrator of  claim 15 , 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-phthalaldehyde and glutaldehyde.  
   
   
       20 . The integrator of  claim 15 , wherein said enclosure further comprises a transparent window, wherein a color change on said substrate can be observed through said transparent window visually or with a spectrophotometer.