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Verification Dose Audit Per ISO 11137

(1-010-22)

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.