EPA Registration

Extensive laboratory testing has proven that Antimicrobial Copper continuously kills bacteria*, never wears out, and is safe to use.

 

In order to obtain the first EPA public health registration for a touch surface material, Antimicrobial Copper alloys had to demonstrate efficacy under rigorous, EPA-approved test protocols. Three test protocols were developed to test Antimicrobial Copper's ability to kill bacteria* that cause infections.  A description of the testing is provided below:

Required Testing for Regulatory Approval

The three EPA approved Good Laboratory Practice (GLP) test protocols used to register Antimicrobial Copper with public health claims are:

1.  Efficacy as a Sanitizer-which measures viable bacterial count after two hours. For full protocol details, click here.

2.  Residual Self-Sanitizing Activity-which measures bacterial count before and after six wet and dry wear cycles during which bacteria are added in a standard wear apparatus (shown as a schematic in Figure 1). For full protocol details, click here.

3.  Continuous Reduction of Bacterial Contaminants-which measures bacteria after inoculating an alloy surface eight times in a 24-hour period without intermediate cleaning or wiping. For full protocol details, click here.

Figure6

Figure 1:  Residual Self-Sanitizing test protocol schematic.

The results of the 216 GLP tests, involving three test protocols, two to three lots of six different alloys, and six bacteria*, are summarized in Table 1. In both the Efficacy as a Sanitizer test and Residual Self-Sanitizing test (wear test), a reduction in live bacteria greater than 99.9% is seen in all seventy two tests when compared to S304. In the Continuous Reduction of Bacterial Contaminants test, a reduction of greater than 99.9% is found in sixty-three out of the seventy-two tests, again when compared to S304. In the remaining nine tests, reductions ranged from 99.3% to 99.9%.  In summary, a reduction greater than 99.9% was seen on 207 out of 216 tests. The reduction seen in the remaining nine tests ranged from 99.3% to 99.9%. These results indicate that the antimicrobial response of copper alloys is effective, enduring and reproducible.

Figure5

Figure 2: Continuous Reduction test results for MRSA on copper alloy C11000 and stainless steel S30400.  Each inoculation adds 650,000 CFUs. - Click on graph to enlarge

Table 1: Average Percent Reduction of Bacterial Contamination (Good Laboratory Practice Studies)

 

Group

Alloy

%Cu

S.aureus

E.aerogenes

MRSA

P.aeruginosa

E. coli O157:H7

Efficacy as a sanitizer

I

C110

99.9

>99.9

>99.9

>99.9

>99.9

>99.9

 

II

C510

94.8

>99.9

>99.9

>99.9

>99.9

>99.9

 

III

C706

88.6

>99.9

>99.9

>99.9

>99.9

>99.9

 

IV

C260

70

>99.9

>99.9

>99.9

>99.9

>99.9

 

V

C752

65

>99.9

>99.9

>99.9

>99.9

>99.9

 

VI

C280

60

>99.9

>99.9

>99.9

>99.9

>99.9

 

 

 

 

 

 

 

 

 

Residual Self Sanitizing

I

C110

99.9

>99.9

>99.9

>99.9

>99.9

>99.9

 

II

C510

94.8

>99.9

>99.9

>99.9

>99.9

>99.9

 

III

C706

88.6

>99.9

>99.9

>99.9

>99.9

>99.9

 

IV

C260

70

>99.9

>99.9

>99.9

>99.9

>99.9

 

V

C752

65

>99.9

>99.9

>99.9

>99.9

>99.9

 

VI

C280

60

>99.9

>99.9

>99.9

>99.9

>99.9

 

 

 

 

 

 

 

 

 

Continuous Reduction

I

C110

99.9

>99.9

>99.9

>99.9

>99.9

>99.9

 

II

C510

94.8

>99.9

>99.9

>99.9

>99.9

>99.9

 

III

C706

88.6

>99.9

>99.9

99.9

>99.9

>99.9

 

IV

C260

70

99.6

>99.9

>99.9

>99.9

>99.9

 

V

C752

65

99.7

>99.9

>99.9

>99.9

>99.9

 

VI

C280

60

99.8

>99.9

99.9

>99.9

>99.9

 

 

Copper and copper alloys are engineering materials that are durable, colourful and recyclable and are widely available in various product forms suitable for a range of manufacturing purposes. Copper and its alloys offer a suite of materials for designers of functional, sustainable and cost-effective products.

Copper and certain copper alloys have intrinsic antimicrobial properties (so-called ‘Antimicrobial Copper’) and products made from these materials have an additional, secondary benefit of contributing to hygienic design. Products made from Antimicrobial Copper are a supplement to, not a substitute for standard infection control practices. It is essential that current hygiene practices are continued, including those related to the cleaning and disinfection of environmental surfaces.

*Laboratory testing shows that, when cleaned regularly, antimicrobial copper surfaces kill greater than 99.9% of the following bacteria within 2 hours of exposure: MRSA, VRE, Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, and E. coli O157:H7. Antimicrobial copper surfaces are a supplement to and not a substitute for standard infection control practices and have been shown to reduce microbial contamination, but do not necessarily prevent cross contamination or infections; users must continue to follow all current infection control practices.

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