Gamma Sterilization Validation

Establish and validate the dose at which your product will be irradiated using gamma sterilization. Millstone Testing Service experts generate a protocol for the client, perform bioburden testing, determine the low dose, and ship your product to your contract sterilizer. After sterilization, we receive the product, perform sterility testing and provide a final report of the validation. Gamma Sterilization Validation includes quarterly dose audit checks. All coordination with your sterilizer is handled in-house for a streamlined workflow.


Bioburden Testing

Bioburden Recovery Test

Sterility Testing

Bacteriostasis and Fungistasis Test

Final Reports

Upon completion of test, a final report will be issued and all records and raw data will be held for five years.

Experience you can trust

Millstone Testing Services offers comprehensive regulatory testing services backed by more than 90 years of combined experience in the medical device and pharmaceutical sectors.