Antiseptics and disinfectant products Efficacy

Antiseptics and disinfectant products Efficacy

Is the product actually sufficiently effective against the claimed organisms under the conditions specified?

Efficacy is defined as the ability of a product to fulfil the claims made for it when used according to the directions for use on the proposed product label.

The manufacturer must submit studies which clearly demonstrate the efficacy of the active substance/product. (Concentration, application method, etc.), is sufficiently effective.

Types of efficacy studies

We distinguish various types of studies develop for our proficiency testing clients, and how these tests are simulated in our programs.

  • Screening tests
  • Laboratory studies
  • Simulation tests in laboratory to field conditions

Screening tests are usually not related to practical/field conditions and are often not implemented with the complete product but only with the active substance. Such tests are therefore primarily useful for providing supplementary information, for example to demonstrate that the concentration used is optimal. These corresponding to our proficiency phase I testing.

Laboratory studies are performed to validate the efficacy in a laboratory according to criteria defined. These tests permit to validate for example a level of mortality during a given time, a knock down (KD) effect and if need be, the palatability of the product. These corresponding to our proficiency phase II testing.

Simulation tests are more linked to practical/field conditions and can, in some cases, be sufficient for demonstrating the efficacy. These corresponding to our proficiency according to tests methods and requirements (phase 2/step 2)

Standard protocols

Tests should preferably be carried out in accordance with standard protocols, e.g. CEN, ISO, OECD, ASTM, etc. If standard protocols are not available or are not suitable for the field of use concerned, other methods may also be used on condition that the studies concerned have a sound scientific basis. Preferably, available standard methods should be modified to meet the actual application in such cases. Ideally, tests are carried out in accordance with Good Laboratory Practice (GLP) or similar quality assurance systems (ISO), although this is not mandatory for efficacy tests.

In our proficiency testing programs, our clients follow CEN methods. Even, we could offer proficiency testing program in all standard protocols, included tailor-made studies with a sound scientific basis.

From SHAPYPRO help to biocidal efficacy testing laboratories around the word to demonstrate their technical competence in our proficiency testing programs. 2 weeks left to final registration date to the proficiency testing program according to EN14476 Quantitative suspension test for the evaluation of virucidal activity in medical area.

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