Differences in Disinfection Protocols of Raw Material Vials Intended for the Production of Parenteral Nutrition Mixtures

Abstract

AbstractBackgroundPreparation of parenteral nutrition (PN) mixtures is performed in a controlled atmosphere area (CAA) under a laminar flow hood. In 2014 and 2015 quality controls have revealed contaminations of PN bags by Bacillus. The different products used to avoid this contamination were Aniosurf premiumMethodsFive protocols have been tested by varying the disinfection step: hydrogen peroxide (H2O2) or sodium hypochlorite (immersion or spray), ethanol (non sporicidal) only by immersion. Prewash and aerosolization steps remained unchanged. For each series, a quantity of 30 vials have been prewashed, then disinfected according to the tested protocol, and finally aerosolized. In order to quantify the effectiveness of disinfection 10 vials were sampled using contact plates at every step of treatment.ResultsMicroorganisms were found after ethanol disinfection (n=4) and aerosolization (n=2). No germs were found when hydrogen peroxide or sodium hypochlorite were used. The atmospheric rates of H2O2 were 0.2 ppm by immersion and 0.8 ppm by spray, these values are below the recommended value level (1 ppm).ConclusionsThis study has validated the use and effectiveness of these disinfecting products. Taking into account the efficiency and ease of use for staff, immersion has been preferred to spray and hydrogen peroxide to sodium hypochlorite.