1. Home
  2. Pharma and Healthcare
  3. Medical Devices
  4. Packaging validation

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.

Our Services

Safety Studies

Discover More

Medical Devices

Discover More

Regulatory support & Risk assessment

Discover More

You might be interested in

You might be interested in

Share it with your network
Work with Us
Consult our positions
Contact us
Contact
Mérieux NutriSciences Corporation ©2022