Antiseptic & disinfectant testing – microbiology

👉 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

👉 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