WHICH TESTS SHOULD BE PERFORMED?
▐ DISINFECTANTS TEST
■ Analytical methods development and validation
■ Active substance(s) qualitative-quantitative analysis (title)
■ Accelerated stability studies according to CIPAC method MT 46.3
EFFICACY STUDIES AGAINST TARGET ORGANISMS
Bactericide and fungicide efficacy test
■ Bactericidal efficacy of chemical disinfectants and antiseptics - EN 1276
■ Fungicidal activity of chemical disinfectants and antiseptics - EN 1650
■ Bactericidal activity in the medical area - EN 13727
■ Fungicidal or yeasticidal activity in the medical area - EN 13624
Virucide efficacy test
■ Hygienic hand rub and hand wash - EN 14476
■ Instrument disinfection - EN 14476
■ Surface disinfection - EN 14476
▐ CLEANING VALIDATION
Validation of cleaning method gives documented evidence that an approved cleaning procedure will provide clean equipment, suitable for its intended use.
▐ STERILIZATION VALIDATION
For medical devices and health care products that must be sterilized before use, the appropriate sterilization cycle parameters must be determined through a sterilization validation process.
Our service includes validation of sterilization processes according to different standards such as (not exhaustive list): ISO 11137 (Radiation) - ISO 17665 (Moist Heat) - ISO 20857 (Dry Heat) - ISO 11135 (Ethylene Oxide).