Antiseptic & disinfectant testing
✔ Do you need to test the activity of your formulations in accordance with standard requirements and in line with your product’s claims for use?
👉We offer you a complete range: bactericidal, fungicidal, sporicidal, mycobactericidal, virucidal to assess your products! Our teams can help you carry out activity tests on antiseptics and disinfectants in accordance with current standards and guidelines.
📌 Our expertise, coupled with the diversity of our strain libraries, means we can adapt our protocols to your specific uses, offering you an assessment of activity on a panel of additional strains, including difficult-growth strains.
ACM Pharma Fonderephar adapts to each need
👉 In order to meet the regulatory requirements for marketing, your antiseptic and disinfectant products must demonstrate microbicidal efficacy in accordance with the standards and/or benchmarks recognised by the authorities.
Microbicidal activity must be assessed under defined experimental conditions (temperature, contact time, interfering substance, etc.) in accordance with standard requirements and in line with your product’s claims for use.
The tests are carried out in accordance with the main standards in force:
- Determination of the activity of antiseptic drugs in accordance with Ph. Eur, chap 5.1.11
- Suspension test:
- Bactericidal activity (Phase 1 – Phase 2, Stage 1) : NF EN 1040, NF EN 1276, NF EN 13727, NF EN 1656
- Fungicidal and/or yeasticidal (Phase 1 – Phase 2, Stage 1) : NF EN 1275, NF EN 1650, NF EN 13624, NF EN 1657
- Mycobactericidal (Phase 2 – Stage 1 and 2): NF EN 14204, NF EN 14348
- Sporicidia (Phase 2 – Stage 1): NF EN 13704 and NF EN 17126 (particularly against Clostridium difficile)
- Surface test :
- Bactericidal (Phase 2 – Stage 2) : NF EN 13697, NF EN 14561, NF EN 14349, NF EN 17387 and NF EN 16615 (with mechanical action)
- Fungicidal and/or yeasticidal (Phase 2 – Stage 2) : NF EN 13697, NF EN 14562, NF EN 16438, NF EN 17387 and NF EN 16615 (with mechanical action)
- Mycobactericidal ( Phase 2 – Stage 2) : NF EN 14563
- Evaluation of airborne surface disinfection processes (DSVA) in accordance with NF EN 17272
👉 Or by taking into account your own strategy for validating the effectiveness of disinfectants under “in-use” conditions on your environmental strains and on your substrates (for example: stainless steel, glove, floor, wall, ceiling, PVC, machine housing) according to the protocol of standard NF EN 13697, NF EN 16615 (with mechanical action) and USP <1072>.
🤝 Our personalised support:
- Help with drafting the protocol and/or defining the validation strategy.
- Support with risk analysis and rationalisation of tests.
- Over 100 studies and 50 products tested
- Experimental protocol & study report
- Dedicated project team
- Reactivity & meeting deadlines
👉 In order to meet the regulatory requirements for marketing, your antiseptic and disinfectant products must demonstrate virucidal efficacy in accordance with the standards and/or benchmarks recognised by the authorities.
Virucidal activity must be assessed under defined experimental conditions (temperature, contact time, interfering substance, etc.) in accordance with standard requirements and in line with your product’s claims for use.
The tests are carried out in accordance with the main standards in force:
- Virucidal activity in suspension (Phase 2 – Stage 1) : NF EN 14476 and NF EN 14675 on mandatory viruses and additional viruses
- Virucidal activity on surfaces (Phase 2 – Stage 2): NF EN 16777 and NF EN 17111
- Evaluation of airborne surface disinfection processes (DSVA): NF EN 17272
🔎 List of our viruses :
- Naked viruses :
Poliovirus type 1, adenovirus type 5, murine norovirus S99, Crawford murine parvovirus, porcine parvovirus NADL2, bovine enterovirus E (ECBO), rhinovirus 14, Human rotavirus HRV89-12C2, polyomavirus 1 (simian virus 40), feline calicivirus F9.
- Enveloped viruses :
Elstree vaccine, H1N1 influenza virus, para-influenza 3, Human herpes virus 1 2 and 3 (VZV), coronavirus 229E, bovine herpes virus, bovine respiratory syncitial virus, bovine viral diarrhoea virus (hepatitis C model), speudo-rage virus (hepatitis B model)
🤝 Our personalised support:
- Help with drafting the protocol and/or defining the validation strategy.
- Support with risk analysis and rationalisation of tests.
- Experimental protocol & study report
- Dedicated project team
- Reactivity & meeting deadlines
Salvatico S, Feuillolay C, Mas Y, Verrière F, Roques C.Med Mal Infect. 2015 Mar;45(3):89-94. doi: 10.1016/j.medmal.2015.01.006.
Michel C, Salvatico S, Belkhelfa H, Haddioui L, Roques C.Eur Ann Otorhinolaryngol Head Neck Dis. 2013 Sep;130(4):189-93. doi: 10.1016/j.anorl.2012.09.009.
Our expertise
Diverse strain libraries
Protocol and customised study on your strains and/or surfaces
Real expertise from our teams
Strong involvement in national and international standards work: AFNOR T72Q – CEN/TC 216/ TC 330
