PROCEDURES FOR CLAIMING ACTIVITY FOR BIOCIDE EFFICACY TESTING

Does your laboratory develop biocide efficacy testing in antiseptics and chemical disinfectant products?

These biocide efficacy testing are modularly categorized as follows:

Phase 1. Quantitative suspension biocide efficacy testing to establish biocidal activity without regard to specific areas of application. These tests cannot be used to claim activity but are essential for screening tests prior to any tests in the following phases.

Phase 2, step 1 these are quantitative suspension tests to establish biocidal activity under simulated practical conditions.

Phase 2, step 2 these are quantitative suspension tests to establish biocidal activity when applied to a surface, clothing, equipment, or skin under simulated practical conditions.

General points for biocide efficacy testint

To determine that a product has biocide efficacy properties, it must be tested for compliance beforehand. Since most standards require the evaluation of at least three different concentrations including an active range concentration and a non-active range concentration, laboratories developing these techniques must be competent to perform a screening prior to the final activity claim analysis.

Therefore, laboratories developing these techniques must be competent to perform a screening prior to the final activity claim analysis. In addition, many manufacturers of chemical disinfectants and antiseptics need their trusted laboratory in the formulation process and this type of screening is essential for this formulation phase.

The European standards covering the biocide efficacy testing are:

  • EN 1040:2005 Quantitative suspension test for the evaluation of the basic bactericidal activity of chemical antiseptics and disinfectants.
  • EN 1275:2005 Quantitative suspension test for the evaluation of the basic fungicidal and yeasticidal activity of chemical antiseptics and disinfectants.
  1. Rationale for EN 1040 and EN 1275 tests

EN 1040 and EN 1275 quantitative suspension tests for the evaluation of bactericidal, yeasticidal and basic fungicidal activity of chemical antiseptics and disinfectants.

Rationale: A sample of the product as supplied and/or diluted with hard water is added to a suspension of bacteria in a solution of interfering substance. The mixture is maintained at the chosen test temperature for the adopted contact time. After this contact time, an aliquot portion is taken, and the bactericidal activity in this portion is immediately neutralized or suppressed by a validated method. Finally, the number of surviving bacteria in each sample is determined and the reduction is calculated.

Proficiency testing proposed by SHAPYPRO for 2024

All those laboratories that are accredited to ISO/IEC 17025 or are in the process of accreditation for the performance of tests according to the following standards:

  • EN 1040 Quantitative suspension test for the evaluation of the basic bactericidal activity of chemical antiseptics and disinfectants, (phase 1).
  • EN 1275 Quantitative suspension test for the evaluation of fungicidal and yeasticidal activity of chemical antiseptics and disinfectants, (phase 1).

The program will consist of analysing 3 concentrations of the product sent by SHAPYPRO in the proposed organisms.

Do you want to know what concentrations we will propose? ask us!

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