Hand Sanitiser Testing Services

To verify the efficacy and safety of hand sanitiser formulations, Mérieux NutriSciences AQ offers a full suite of testing services aligned with internationally recognised standards. Products are first evaluated in vitro using EN 13727, a quantitative suspension test designed to assess bactericidal activity under laboratory conditions.

Following successful in vitro performance, products must undergo in vivo testing to simulate real-world usage. Depending on the product type and intended use, this is conducted using one of the following validated methods:

• EN 1500 – Hygienic Handrub Study
• EN 1499 – Hygienic Handwash Study
• EN 12791 or ASTM E1174 – Surgical Hand Scrub/Handwash Studies

These studies evaluate the effectiveness of hand sanitisers in reducing transient or resident microbial flora when applied to the hands of volunteers under controlled, simulated-use conditions.

For a product to proceed to in vivo testing, it must meet minimum efficacy benchmarks during the in vitro phase — achieving a ≥5 log reduction in clean conditions for hand rubs and a ≥3 log reduction in dirty conditions for handwash products. Standard test organisms include Staphylococcus aureus (ATCC 6538), Escherichia coli (NCTC 10538), Pseudomonas aeruginosa (ATCC 15442), and Enterococcus hirae (ATCC 10532).

These robust methodologies help ensure your hand sanitiser product meets regulatory requirements and substantiates antimicrobial efficacy claims.

Hand sanitiser testing process in summary

Handrub and Handwash tests involve simulated contamination of volunteers’ hands with E. coli NCTC 10538, followed by rubbing/ washing hands aseptically with the product. Each volunteer does this twice, once with the product and once with a reference product. The calculation is done by determining the log reduction of E. coli by-product in comparison to the reference product.

Surgical Hand scrub and Surgical Handwash studies on the other hand involve no simulated contamination as the test is done against normal flora present on volunteers’ hands. To ensure there is normal flora present, all volunteers ensure to not wash their hands with any antibacterial products such as sanitisers and alcohol-based products for a week before doing the test. Surgical studies take much longer than normal Hand scrub/ Handwash studies as product and reference product has to be applied in different weeks to allow normal flora to grow on the volunteers’ hands.

Do you need to validate the safety and efficacy of your sanitisers? Contact us to discover how Mérieux NutriSciences AQ can help.