Validation of the sterile manufacture of the AAEC MARK III molybdenum-99/techtnetium-99m generator
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Date
1982-07
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Australian Atomic Energy Commission
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.
Description
Keywords
Molybdenum 99, Radioisotope generators, Technetium 99, Fabrication, Sterilization
Citation
Saunders, M. T., Drummond, C. M., & Harrison, M. A. (1982). Validation of the sterile manufacture of the AAEC MARK III molybdenum-99/techtnetium-99m generator. (AAEC/E543). Lucas Heights, NSW: Australian Atomic Energy Commission.