Abstract
The aim of the present investigation was to evaluate the microbial efficacy against highly resistant bacterial spores on different substrates using the lowest effective concentration of a market liquid sporicide based on peracetic acid. The validation was carried out following modified European regulatory agencies procedures or test methods and USP guidelines, employing carriers of materials usually treated with the sporicidal solution and present in grade A cleanrooms and spores of four different microorganisms: Bacillus subtilis and Clostridium sporogenes, both from the ATCC collection, and Bacillus cereus and Bacillus sphaericus as environmental isolates. A statistical evaluation of data was made to estimate the variance for different study conditions. The experiments highlighted that 70% suitable dilution of the ready-to-use peracetic acid solution was effective in both clean and dirty conditions, showing at least 2 log spore reduction after treatment. To obtain effective sporicidal action on the surfaces in cleanrooms it is sufficient to use a sporicidal solution with a ready-to-use concentration of 70% while ensuring a contact time of 10 min. In any case, the reduction of sporicide concentration ensures a high degree of disinfection and provides a consumption savings.Lay abstract
Wide-spectrum disinfectants are used in the pharmaceutical industry for the decontamination of work surfaces and equipment, but these products have some degree of toxicity for operators. This work arises from the needs of pharmaceutical companies to find the lowest effective concentration of sanitizers in order to reduce toxicity to personnel. The sanitizer used in the study was a market liquid sporicide based on peracetic acid. When we started our work no similar studies were reported in the literature, so we took European regulatory agencies and USP guidelines as a starting point, employing carriers of hard, non-porous materials usually treated with the sporicidal solution and present in sterile rooms and spores of four different microorganisms. The experiments highlighted that it is sufficient to use a 70% sporicidal solution concentration with a contact time of 10 min to reduce the number of spores to acceptable values for medicinal production. The reduction of sporicide concentration both ensures a high degree of disinfection and provides a safer working environment and consumption savings.