Opportunities and Approaches for Supplying Molybdenum-99 and Associated Medical Isotopes to Global Markets Proceedings of a Symposium (2018) / Chapter Skim
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4 Conversion to Low Enriched UraniumSourced Production and Opportunities for Research and Development
4 Conversion to Low Enriched UraniumSourced Production and Opportunities for Research and Development
Pages 17-22
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From page 17... ...
However, conversion from HEU- to LEU-sourced Mo-99 production has been a challenging process, and Mo-99 producers and target manufacturers have had to resolve several technical challenges related to LEU target fabrication and processing, target validation, and radioactive waste management. The transition to an all-LEUsourced production has also been challenging for other members of the supply chain, including generator manufacturers and nuclear pharmacy operators.
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From page 18... ...
Radioactive Waste Management LEU-sourced Mo-99 production leads to increased volumes of radioactive waste, particularly liquid waste, because of the decreased production yield. Existing global Mo-99 suppliers are developing additional capacity to manage these wastes as part of their conversion efforts and the waste management costs are high.
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From page 19... ...
noted that, with respect to conversion from HEU- to LEU-sourced technetium generators, nuclear pharmacies do not need to seek any regulatory approvals. For example, they are not involved in validation studies that are part of the technetium generator approval process, although they may be asked by generator manufacturers who are seeking to have their generators approved to provide some cold kits for testing.
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From page 20... ...
-based technetium generators in the Europe. Regulatory authorities in Europe initially considered conversion to LEU-sourced Mo-99 production a type II variation, that is, the highest level of variation to marketing authorizations involving "substantial change to the starting material and to manufacturing process of the active substance which may have a significant impact on the quality, safety or efficacy of the medicinal product." More recently, industry sources have reported that a number of their submissions have been classified as a type 1B variation, which is the next level of variation down and requires a simpler level of assessment.
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From page 21... ...
OPPORTUNITIES FOR RESEARCH AND DEVELOPMENT The challenges of conversion from HEU- to LEU-sourced Mo-99 production has provided several opportunities for research and development to improve production and processing efficiencies and manage the larger volumes of radioactive wastes. Although the symposium organizing committees did not solicit presentations from representatives of all research and development efforts related to Mo-99 production under way, three of these activities were described at the symposium.
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From page 22... ...
Synroc Waste Treatment Technology ANSTO has for about 40 years invested in research and development of a technology called synroc (short for synthetic rock) to provide a matrix for immobilization and final disposal of various types of intermediatelevel and high-level radioactive wastes, including long-lived actinide-rich waste streams.
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