Validation of Sterilization Process by Gamma Radiation
The Laboratory of Technological Assays in Clean Environment (LETAL) provides to the community the unique national service of evaluation of gamma radiation as a sterilization process for health care products, namely medical devices, active principles, raw materials and packaging.
This service allows to estimate the microbial bioburden of the product; the minimal radiation dose (Dmin) to attain the sterilization of the product; and for some products the maximum radiation dose (Dmax) that the product can tolerate without degradation, using spectrometric and chromatographic technics.
The Validation of the Sterilization Dose by Gamma Radiation service is based on the International Standard ISO 11137. Our consulting services can guide you to evaluate the best approach to lower the microbial contamination of your product in order to permit the validation of the sterilization by gamma radiation.
We work closely with industry and other academic groups to evaluate the extent to which gamma radiation methods can be used as sterilization processes that guarantee the Safety and Quality of different kinds of products.
Doctor Sandra Cabo Verde