[en] The Mark II molybdenum-99/technetium-99m generator now supplied to hospitals by the Australian Atomic Energy Commission is a non-sterile elution system. The Mark III version will be supplied as a sterile elution system. A validation study has been undertaken to assess the capability of the new production facility, to evaluate up-to-date procedures for manufacturing sterile generators and to demonstrate that a sterile radionuclide generator can be made. Generator manufacturing procedures and a time study of the validation are described. Microbiological methods for monitoring in-process aspects of manufacture, disinfectant efficacy and generator sterility are defined