Tests on Volunteers

Handwashing and handrubbing are emphasised as the most important measure to prevent cross transmission of viruses and microorganisms and thus to prevent diseases and infections from spreading. 

The new EN 17430 standard, that entered into force on April 2024, represents a turning point  with regards to evaluating the effectiveness of hand disinfectants. 

This standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of virus contamination on hands when rubbed onto the artificially contaminated hands of volunteers.

This document is applicable to products for hygienic handrub for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
-  in hospitals, in community medical facilities and in dental institutions;
-  in clinics of schools, of kindergartens and of nursing homes;
and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patient.

Many products on the market now have to be tested in accordance with the standard. Eurofins BioPharma Product Testing Italy dedicated laboratory is already aligned with this standard. 

Every new formulation for hand antisepsis should be tested for its antimicrobial efficacy to demonstrate that it has superior efficacy over normal soap or it meets an agreed performance standard. The formulation with all its ingredients should be evaluated to ensure that chemical components added to ensure better skin tolerance do not in any way compromise its antimicrobial action. 

Many test methods are currently available for this purpose, but some are more useful and relevant than others. For example, determination of the minimum inhibitory concentration (MIC) of such formulations against bacteria has no direct bearing on the “killing effect” expected of such products in the field.

Conditions in suspension and in vitro or ex vivo testing do not reflect those on human skin. This reinforces the utility of laboratory-based tests on volunteers to provide sufficient data to assess a given formulation’s potential benefits under field use.

• With over 20 years’ experience in assessing the efficacy of disinfectant products, we offer a one-stop-shop solution to evaluate the virucidal and antimicrobial efficacy of handrub, handwash agents and surgical handscrub formulation.
• The breadth of our knowledge allows us to assist clients with new product development, R&D projects and marketing claims by providing proven efficacy to the end user. 
• We are constantly conducting controlled laboratory tests by simulating practical conditions on hands of volunteers to determine the effectiveness of hand wash, handrub and surgical hand disinfectants
• Our accurate control level of our testing services enables us to provide scientifically sound and reliable test results supporting clients to bring safe and effective products to market.
• Tests are performed following international validated standards and guidance (CEN, FDA and ASTM).