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Disinfectant Validation Studies are an FDA requirement to demonstrate the broad-spectrum antimicrobial efficacy of one or more disinfectant products employed for pharmaceutical production area qualification prior to use. Test designs are custom to the specific disinfectant(s) chosen by the facility, application method, contact time, surface materials cleaned and relevant microbes (some isolated from the validation site).
Our team of experts will work with you to develop a study-specific GLP protocol, outlining the study step by step to ensure it meets FDA requirements.
Scientists in our In-Vitro testing labs are well trained on ASTM, AATCC, AOAC, CLSI and EN standard methods. The efficacy testing services of this laboratory include MIC/MBC, biofilm prevention and removal, time-kill kinetics, clean room disinfectant validation, zone of inhibition and custom efficacy studies for disinfectants, antimicrobials and other products requiring EPA registrations and FDA 510(k) submissions. Studies in our…