Radiation sterilization, VDMax
In this method ten samples from three batches are tested for bioburden followed by a verification dose and test of sterility on ten additional samples from one batch. This procedure can validate a product for sterilization for three months followed by a quarterly dose audit. Validation procedures are available for a single batch also.
Optional Tests for Radiation sterilization, VDMax
VDmax dose audit AAMI/ANSI/ISO 11137
The method VDmax, or TIR 27, is an AAMI document that is approved for use by the Food and Drug Administration (FDA). This method validates a 25.0 kGy minimum sterilization dose. The method was developed for health care products with a bioburden of less than 1000 Colony Forming Units (CFU). This method is attractive to many companies. First, it requires a low number of test samples. Second, the method calculates the highest verification dose possible for your product, which results in a reduced risk of failure. Lastly, a 25.0 kGy minimum sterilization dose is standard at most irradiation facilities.
AAMI VDmax validation, three lot quarterly release AAMI TIR 33, ANSI/AAMI/ISO 11137
VDmax validation AAMI TIR 33, AAMI/ANSI/ISO 11137
The method VDmax, or TIR 33, ANSI/AAMI/ISO 11137-1,2, is an AAMI document that is approved for use by the Food and Drug Administration (FDA). This method validates a 25.0 kGy minimum sterilization dose. The method was developed for health care products with a bioburden of less than 1000 Colony Forming Units (CFU). This method is attractive to many companies. First, it requires a low number of test samples. Second, the method calculates the highest verification dose possible for your product, which results in a reduced risk of failure. Lastly, a 25.0 kGy minimum sterilization dose is standard at most irradiation facilities.
