Validation of the sterile manufacture of the AAEC MARK III molybdenum-99/techtnetium-99m generator

Abstract

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.