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|Title:||Validation of the sterile manufacture of the AAEC MARK III molybdenum-99/techtnetium-99m generator|
|Publisher:||Australian Atomic Energy Commission|
|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.|
|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.|
|Gov't Doc #:||373|
|Appears in Collections:||Scientific and Technical Reports|
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