Call Us Now : 866-WE-EBEAM (933-2326)

  • Default Page Image

Verification Dose Audit Per ISO 11137


Good quality practices (and ISO 11137) dictate that the response of a medical device’s existing bioburden be checked during both initial process validation and periodically thereafter. Samples are irradiated at a dose that is a fraction of the production dose and the samples are then checked for sterility. A successful verification dose experiment therefore assures a safety factor in routine sterilization. NUTEK will deliver a dose within 10% of the target or within 0.5 kGy, whichever is larger, to comply with the current regulatory requirements.