Are you familiar with the VDmax25 method ?

The gamma irradiation sterilization process must be validated to obtain a sterility assurance level of 10-6 (i.e. sterile claim). The most common validation method is VDmax25 according to ISO 11137-1: 2006 which requires the following steps:

  1. Bioburden determination on 30 devices (10 units x 3 different batches)
  2. Determination of the verification dose according to ISO 11137-2: 2013
  3. Irradiate 10 devices at level of verification dose
  4. Perform sterility tests
  5. Depending on results, the sterilization dose is substantiated or not