It is not only important assuring the medical device’s safety and efficacy, but it is also fundamental that the medical reaches the end user intact.
Sterilization dose determination – ISO 11137
Determining the sterilizing dose using microbial load information (Bioburden):
- select the sterility assurance level: it’s important to select samples that must be representative of routinely sterilized products;
- determine the average microbial load of the batches – method based on ISO 11737-1;
- obtain the verification dose – referring to table 5 of ISO11137-2;
- conduct verification dose experiments on irradiated pieces – (method based on ISO 11737- 2;
- interpret the results;
- establish the sterilisation dose based on the results.
Sterilization site validation – β e γ rays
Verification of the ability of the site to sterilize the packaging of medical devices:
- spiking: inoculation of relevant strains with a known title on the packaging;
- sending the packaging to the site for the sterilization procedure execution;
- verification of the effective ability of the sterilization procedure by our laboratories.