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Title: Validation of the sterile manufacture of the AAEC MARK III molybdenum-99/techtnetium-99m generator.
Authors: Saunders, MT
Drummond, CM
Harrison, MA
Issue Date: Jul-1982
Publisher: Australian Nuclear Science and Technology Organisation
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.
ISBN: 0642597464
Appears in Collections:Scientific and Technical Reports

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