ISO 11137: Method 1 Irradiation Validation
ISO 11137: Method 1 study (Irradiation Validation)
A Method 1 study is performed to verify a minimum irradiation dose for a particular bioburden level on a product.
The initial sterilization validation is started by calculating the average bioburden for samples from three different batches/lots of product. Using the irradiation dose tables from ISO 11137, bioburden count is used to calculate the sub-lethal verification dose. The verification dose is applied to 100 samples of product in one of our sterilization facilities and then returned to the lab for testing of sterility. If there are two or less failures, the validation is passed and the routine processing irradiation dose is calculated from ISO 11137 based on the verification dose.
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