Valutazione Meccanica e Ultrastruturale di Materiali per Confezionamento di Dispositivi Medici, Prima e Dopo Process di Sterilizzazione. (Mechanical and Ultrastructural Evaluation of Medical Device Packing Materials before and after Sterilization Process.

摘要

The objective of this work has been analyzing some of the most used primary packing materials: amorphous polyethylene terephthalate/polyethylene, polypropylene/polyethylene-medical paper, aluminium in neutral, purple, beige, yellow shades and tyvek, before and after the standard methods of sterilization used according to the current normative, which include gamma rays, under pressure vapour, ethylene oxide and hydrogen peroxide, in order to evaluate the integrity of different materials and assure safety and efficiency of these products, from their appearance on the market until their use on patients. The investigation methods used were: ultra-structural analysis, mechanical and gas cromatographic tests. After an ultra-structural observations, the obtained results showed: a variation in the colour scale of aluminium sterilized with hydrogen peroxide, the thinning of tyveks texture sterilized with ethylene oxide, amorphous polyethylene terephthalate/polyethylene and polypropylene/polyethylene critical issues of breaking mechanical behaviour confirmed by electronic scanning microscopy, medical paper critical issues of breaking mechanical behaviour and a thinning of tyveks texture after ultra-structural analysis, sterilized by means of gamma rays.