Hydrogen peroxide as depyrogenation agent for medical devices components

Abstract

The current search for alternative solvents to fluorina ted products, in face of the depletion of ozone in the stratosphere calls for the development of alternative processes applicable to the manufacture of medical devices. In view of the challenge and as water is serving particularly as the choice for other industrial segments, the fast macrobial proliferation in it is of concern, as it is a potencial source of endotoxins. Such a risk is inconsistent with the production of items designed for example, for use in surgical procedures in the cardio-vascular field. Thus research was undertaken for the purpose of investigating the possibility of using water as a cleansing agent for components for such products, providing that hydrogen peroxide is added. The work was carried out by inoculating water and peroxide at levels of 0. 1, 0.25, 0.5 e 1.0 UE/ml. The confimation was obtained as to the active effectiveness at a 5% concentration of hydrogen peroxide by means of analytical determination using the "in vitro" method. The effectiveness of the use of peroxide was investigated on polycarbonate injected parts designed for the manufacture of oxigenators and blood reservoirs and containated with endotoxins. The findings permit one to draw a favorable conclusion regarding the adequacy of the proposed process both biologically as well as regards the removal of impurities.