ISO 11137: VDMax Irradiation Dose Study
ISO 11137: VDMax Study (Irradiation Validation)
The VDMax study (irradiation validation) is the substantiation of the required minimum irradiation dose. The required processing irradiation dose is chosen based on knowledge of the products.
The initial sterilization validation begins by calculating the average bioburden for samples from three different batches/lots of product. Using the irradiation dose tables from ISO 11137/13004, bioburden count is used to calculate the sub-lethal verification dose. The verification dose is applied to ten samples of product in one of our sterilization facilities and then returned to the lab for testing of sterility. If there is 1 or less failures, the validation is passed and the routine processing irradiation dose that was chosen is substantiated.
The VDMax study doses are shown in the table along with the maximum allowable bioburden level for each dose.
Sterilization validations are performed for:
- CE marked products
- FDA registered products
- Products with a sterility claim
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