Antiseptic & disinfectant testing – microbiology
✔ Do you need to test the microbicidal activity of your formulations in accordance with standard requirements and in line with your product’s claims for use?
👉 Carrying out activity tests on antiseptics and disinfectants in accordance with current standards and guidelines.
ACM Pharma Fonderephar adapts to each need
To meet the regulatory requirements for market approval, your antiseptic and disinfectant products must demonstrate microbicidal effectiveness according to the standards and/or reference frameworks recognized by the authorities.
The microbicidal activity must be assessed under defined experimental conditions (temperature, contact time, interfering substance, etc.) according to normative prescriptions and in accordance with the claims of use for your product.
Tests are conducted according to the main current reference frameworks:
- Determination of the activity of drugs intended for antiseptic use according to Ph. Eur, chap 5.1.11
- Suspension test:
- Bactericidal (Phase 1 – Phase 2, Step 1): NF EN 1040, NF EN 1276, NF EN 13727, NF EN 1656
- Fungicidal and/or yeasticidal (Phase 1 – Phase 2, Step 1): NF EN 1275, NF EN 1650, NF EN 13624, NF EN 1657
- Mycobactericidal: NF EN 14204, NF EN 14348
- Surface test:
- NF EN 13697, NF EN 14561, NF EN 14562, NF EN 14563, NF EN 17387, and NF EN 16615 (with mechanical action)
- Antimicrobial activity of surfaces according to JIS Z2801, ISO 22196, NF S 90-700, NF ISO 7581
- Antimicrobial activity of textiles according to ISO 20743
- Sporicidal: NF EN 14347, NF EN 13704, and NF EN 17126 (especially against Clostridium difficile)
- Evaluation of surface disinfection processes by aerial way (DSVA) according to NF EN 17272.
Or considering your own strategy for validating the effectiveness of disinfectants under “in-use” conditions on your environmental strains and on your surfaces (for example: stainless steel, glove, floor, wall, ceiling, PVC, machine housing) according to the protocol of the standard NF EN 13697, NF EN 16615 (with mechanical action) and USP <1072>:
- Assistance in writing the protocol and/or defining the validation strategy
- Support in risk analysis and rationalization of tests
- More than a hundred studies and fifty products tested
- Experimental protocol & study report
- Dedicated project team
- Responsiveness & respect for deadlines
Our expertise
For your formulas under development, a “screening” approach enables you to limit testing to a relevant selection of the test conditions specified in the reference documents.
Strong involvement in national and international standards work: AFNOR T72Q – CEN/TC 216
Possibility of testing your strains of interest and/or undesirable strains
Customised protocols and studies on your surfaces
Large collection of strains
Study of microbial kinetics (growth/decay)
