OxyFile #251

[Hydrogen peroxide as despyrogenation agent for medical 
and hospital product components]


Author:  Pinto TJ

Source:  Rev Saude Publica 1995 Feb; 29(1):75-9

Abstract:

The current search for alternative solvents to fluorinated 
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 potential 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 confirmation 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 contained 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.