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.
OUR TESTS
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.
