Packaging validation

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):

1. select the sterility assurance level: it’s important to select samples that must be representative of routinely sterilized products;
2. determine the average microbial load of the batches – method based on ISO 11737-1;
3. obtain the verification dose – referring to table 5 of ISO11137-2;
4. conduct verification dose experiments on irradiated pieces – (method based on ISO 11737- 2;
5. interpret the results;
6. 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:

1. spiking: inoculation of relevant strains with a known title on the packaging;
2. sending the packaging to the site for the sterilization procedure execution;
3. verification of the effective ability of the sterilization procedure by our laboratories.