Empleo de las radiaciones gamma como método de esterilización en biomateriales

Abstract

The sterilization of medical products is one of the principal applications of the radiations, which at commercial scale were applied to half-filled of the years 50. In 70 years, the average of radio sterilised materials was less than 10%, but at the beginning of the years 90 ascended at more than the 70%, with tendency at the increase for dry raw materials, principally. The objective of the present work was determine the dose of sterility for the batch of Alginato of Sodium, Quitosana and Apafill-BP, in being solid, studied in order to achieve the sterilization of the same with a Sterility Assurance Level of 10-6. It was carried out the bacteriostatic and fungistatic effect determination, previously, and the determination of the bioburden by means ISO 11737-1. The sterilised dose was calculated by means of mathematical expression that relates the bioburden of the product, the D10 value of the most resistant micro organism at the product and the Sterility Assurance Level. It was gotten that the products didn't have bacteriostatic neither fungistatic effects. The sterilized dose for each batch of product was less than 25 kGy for each one. The verification dose experiment was successful; all the irradiated samples were sterile. It was gotten that the studied products could be sterilized gamma by means of the employment of the radiations achieving the sterility with a level of insurance of 1: 1000000.