In microbiological validation, the radiation dose is determined which will change a non-sterile product into a sterile one. To do this, the initial microbiological state, i.e. the numbers and types of microorganisms present, first has to be ascertained. Here we cooperate with accredited microbiological laboratories. Dependent on the bioburden and the resistance to ionizing radiation of the microorganisms found, proof is provided by irradiation that this dose can convert all parts into a sterile state.