Covid-19 | Hand Sanitizers | Testing and Certification services
Hand Sanitizers
Hand sanitizers or hand rubs are a means of rapidly and effectively deactivating a broad-spectrum harmful microorganism on hands and surfaces.
Chemical disinfection refers to the reduction of the number of microorganisms in or on a matrix, this is achieved by irreversible action to structure or metabolism of a product, to a level judged to be appropriate for a defined purpose.
Disinfectants do not necessarily kill all organisms (sterilisation) but reduce them to a harmless level for human and/or animal health.
Disinfection claims relating to microorganisms we refer to: vegetative bacteria, yeasts, mould spores, bacterial spores, and viruses.
Hand sanitizers, gels and rubs can be categorised as cosmetics or biocide products, depending on the product’s primary function, claims, ingredients and intended use.
Cosmetics products are designed to primarily clean and / or moisturise the skin. When categorised as cosmetics, the product would be referred to as a hand rub or hand gel and would fall within the cosmetics regulations with efficacy testing required to support claims.
Test methods and requirements for hand hygiene products Basic quality control
- Chemical product appearance – Visual examination
- Weight or Volume – Gravimetry
- Density at 20 °C – PE 2.2.5
- pH – Potentiometry
- Ethanol – GC/FID Default variation; Digital photography – Default variation
- Glycerol
- Isopropanol
- “Brookfield viscosity” test
- “H2O2” dosage
- Alcohol concentration of raw materials and final product
- Additives – Should be as non-toxic as possible (considering accidental ingestion)
- Perfumes or dyes – Not recommended, in order to avoid risk of allergic reactions
- Labelling – In accordance with national and international regulations
- Flammability
Test methods
Dependent on a product’s classification and claims, some specific test methods should applied, the following tests are required for disinfectants:
- Germ kill efficacy test
- Hand rub and hand wash studies
- Minimum Inhibitory Concentration (MIC)
- Virucidal activity versus standard and specific human viruses including Betacoronavirus models
- Virucidal activity, Clinical trial studies as per CDSO, DCGI and ICMR
Efficacy testing standards
| Description | Guidelines |
|---|---|
| Virucidal | EN 14476, ASTM E1052 |
| Virucidal on Corona +ve patients | Clinical trial studies as per CDSO, DCGI and ICMR |
| Fungicidal / yeasticidal | EN 1650, EN 13624, ASTM E2613 |
| Bactericidal activity | EN 1276, EN 14348, EN 13727, EN 1500, EN 1040, EN 1499, ASTM E2752, ASTM E2755, ASTM E1174, ASTM E1115, ASTM E2315 |