Use of Ozone for Disinfection of PHARMODUCT Automatic System for Antineoplastic Compounding.

The purpose of this work was to demonstrate the ozone efficacy for disinfection of the PHARMODUCT automatic dispensing system for antineoplastic preparation, as a guarantee of a higher grade of cleanliness. While the use of ozone gas disinfection is almost consolidated in food and water treatment, there is a lack of scientific data in the pharmaceutical field. The scope of this study was to demonstrate the ozone efficacy for disinfection of the PHARMODUCT automatic dispensing system, before starting the antineoplastic preparation, in order to ensure a high degree of cleanliness and, at the same time, to define a biodecontamination procedure that could also be translatable to other automated compounding systems on the market. : Ozone efficacy was determined by calculating the difference (pre-exposure-post-exposure) in CFU counts on the plate. A group of four different ATCC-selected microbial strains were tested using two distinct cycles. The first one was evaluated with an ozone gas concentration of 40 ppm for 40 min; the second cycle increased the concentration to 60 ppm for the same duration. : Results showed that exposure to 40 ppm ozone gas led to a 4-log reduction of all tested ATCC strains. In contrast, exposure to 60 ppm ensured a 6-log reduction. The ozone disinfection process, applied to the PHARMODUCT system, provides a superior grade of cleanliness compared to the manual disinfection procedure, thus offering insight beyond the current anti-inflammatory and analgesic application of ozone therapy in the medical field.