Martell Winters and Dr. Wendy Wangsgard discuss radiation sterilization validation testing.
Radiation Sterilization determines appropriate radiation sterilization doses for products which require a sterile label claim. It incorporates bioburden testing, a bioburden recovery efficiency test, a low radiation dose (verification dose), sterility testing and bacteriostasis/fungistasis testing. If a sterile label claim is required and if the sterilization method will be radiation, a validation is required to determine the appropriate sterilization dose. Nelson Labs has vast experience providing validations for complex or unique products or products which cannot handle large doses of radiation. Test complies with Radiation Sterilization standard AAMI/ISO 11137 and AAMI TIR 33.