Molybdenum-99 for Medical Imaging (2016) / Chapter Skim
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3 Global Production of Molybdenum-99 and Future Prospects
3 Global Production of Molybdenum-99 and Future Prospects
Pages 51-86
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From page 51... ...
A list of facilities that produce molybdenum-99 for medical use, including an indication of whether these facilities utilize highly enriched uranium.
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From page 52... ...
Available production capacity is determined by the capacity of a reactor to irradiate targets on a routine basis. Available supply capacity is determined by capacity of a target processing facility to process irradiated targets on a routine basis.
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From page 53... ...
LEU Belgium LEU Maria HEU Mallinckrodt U.S.-based Poland 3,500 Cardinal Health LEU Mallinckrodt 20% CERCA Netherland Triad Isotopes HEU HEU BR2 HEU Belgium Lantheus Independent LEU and HEU (UPPI) Back-up arrangements LEU LVR-15 HEU GE Healthcare <2% Czech Rep 3,000 NTP Radioisotopes NTP NTP LEU SAFARI-1 HEU/ South Africa LEU South Africa 8% European Y-12 market HEU IBA (~25%)
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From page 54... ...
Nordion (Canada) a HEU NOTES: CERCA = Compagnie pour l'Etude et la Réalisation de Combustibles Atomiques; HEU = highly enriched uranium; LEU = low enriched uranium; NTP = Nuclear Technology Products Radioisotopes.
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From page 55... ...
; the United States supplies the HEU used in these targets;6 the LEU used in these targets is provided by various suppliers. CERCA also produces LEU targets for the Australian Nuclear Science and Technology Organisation (ANSTO)
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From page 56... ...
BR-2 Belgium 100 HEU HEU 1961 HFRe Netherlands 45 LEU HEU 1961 LVR-15 Czech Republic 10 LEU HEU 1957 Maria Poland 30 LEU HEU 1974 NRU Canada 135 LEU HEU 1957 OPAL Australia 20 LEU LEU 2006 SAFARI-1 South Africa 20 LEU HEU/ 1965 LEUc NOTES: BR-2 = Belgian Reactor 2; HEU = highly enriched uranium; LEU = low enriched uranium; HFR = High Flux Reactor; NRU = National Research Universal; OPAL = Open Pool Australian Lightwater; SAFARI-1 = South African Fundamental Atomic Research Installation 1. a Most reactors do not have the capability to produce Mo-99 all of the days they operate.
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From page 57... ...
It is a measure of actual capacity and target usage levels. d A reactor's percent global available production capacity is calculated by dividing the available production capacity per year for that reactor by the total available capacity per year for the seven reactors (i.e., 998,750 6-day Ci of Mo-99/year)
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From page 58... ...
(%) ANSTO Australia LEU N/Ab 43 1,100c 47,300c 6 IRE Belgium HEU 2016 52 3,600e 187,200 24 Mallinckrodt Netherlands HEU 2017 52 3,500f 182,000 24 Nordion Canada HEU 2018d 48 4,680 224,640 29 NTP South Africa HEU/LEU 2010 44 3,000 132,000 17 Totals: 15,880 773,140 100 NOTES: ANSTO = Australian Nuclear Science and Technology Organisation; HEU = highly enriched uranium; LEU = low enriched uranium; IRE= Institut National des Radioéléments; NTP= Nuclear Technology Products Radioisotopes.
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From page 59... ...
3.1.2 Irradiation Services Suppliers Almost all of the Mo-99 for medical use is currently produced by irradiating uranium targets in seven research reactors: • Belgian Reactor-2 (BR-2) , Belgium • High Flux Reactor (HFR)
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From page 60... ...
irradiate LEU targets to pro duce Mo-99 for medical use. About 25 percent of the global supply of Mo-99 is produced with LEU targets.
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From page 61... ...
The reactor supports nuclear research and development, radioisotope production, and industry irradiation services. HFR started operation in 1961 and was converted from HEU to LEU fuel in 2006.
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From page 62... ...
Its main missions are in materials testing, industry irradiation services, and radioisotope production. LVR-15 currently accounts for about 7 percent of global available production capacity.
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From page 63... ...
The reactor is used for industrial and medical radioisotope production, neutron beam research, and materials research and development for CANDU power reactors.19 The NRU reactor started operation in 1957 and was converted from HEU to LEU fuel in 1991. It produces Mo-99 and Xe-133 from HEU targets and I-131 from tellurium targets.
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From page 64... ...
All of the reactor's activities are scheduled around medical isotope production. ANSTO increased its available production capacity in 2016 from 1,000 to 1,750 6-day Ci per week and currently accounts for about 8 percent of global available production capacity.
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From page 65... ...
About 48 percent of Mo-99 production was from LEU targets in 2015; 80 percent of Mo-99 production was from LEU targets in the first quarter of 2016. 3.1.2.8 OSIRIS OSIRIS is a 70 MWt, pool-type, LEU-fueled, light-water-cooled research reactor located at Saclay Centre, France.
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From page 66... ...
It currently accounts for about 24 percent of available supply capacity (3,600 6-day Ci per week) from processing HEU targets irradiated in BR-2, HFR, and LVR-15.21 It plans to obtain irradiated targets from Maria, JHR, and Forschungsreaktors München II (FRM-II)
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From page 67... ...
for processing and sale.22 3.1.3.3 Mallinckrodt Mallinckrodt23 processes irradiated targets at the Petten site in the Netherlands in a joint venture with NRG, the operator of HFR. It currently accounts for about 24 percent of available annual supply capacity (3,500 6-day Ci per week)
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From page 68... ...
• IBA Molecular, France • Lantheus Medical Imaging, United States • Mallinckrodt, the Netherlands and United States • NTP, South Africa These are not the only technetium generator suppliers in the world. For example, there are also suppliers in India, Japan, Poland, Russia, and Turkey.
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From page 69... ...
The Australian government has loaned the necessary funding to ANSTO to construct a new target processing facility and a new radioactive waste treatment plant to enable this increased supply capacity. Construction of these facilities is under way.
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From page 70... ...
However, if expansions are not realized on time, available production capacity would fall below desired capacity. Plans by existing global suppliers to expand their available supply capacities are described in the text.
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From page 71... ...
(Brazil currently imports all of the Mo-99 needed for medical use.) The reactor is expected to start commercial production of Mo-99 with an available supply capacity of 1,000 6-day Ci per week (OECD-NEA, 2016)
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From page 72... ...
. The available supply capacity for Mo-99 is expected to be 2,000 6-day Ci per week, with initial supply of 400 6-day Ci per week.
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From page 73... ...
Other countries may produce Mo-99/Tc99m exclusively for local use. 3.3 RECENT SUPPLY INTERRUPTIONS The global Mo-99 supply chain is inherently fragile.
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From page 74... ...
Increased Mo-99 supplies from Europe could not offset these supply losses because there was insufficient target processing capacity. The United States was among the countries most seriously impacted by the 2009-2010 supply shortages, likely due to the country's heavy reliance
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From page 75... ...
This is particularly true for IRE and Mallinckrodt, the two global Mo-99 suppliers that obtain target irradiation services from multiple reactors in Europe. There have been two major shutdowns of target processing facilities since 2009: • In 2013, positive pressure in a hot cell caused a leak of radioactive noble gases at NTP's target processing facility.
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From page 76... ...
The Belgian government prohibited transport of all radioactive material in the country for a couple of days, causing IRE to halt production for one day. 3.4 ACTIONS TO MITIGATE SUPPLY DISRUPTIONS Since the 2009-2010 Mo-99 supply shortages, organizations participating in the global supply chain for Mo-99/Tc-99m have worked together to improve the stability of supply through the following four initiatives: 1.
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From page 77... ...
Reserve capacity levels can also differ between irradiation services suppliers and Mo-99 suppliers. In 2015, for example, technetium generator suppliers and Mo-99 suppliers had access to reserve capacities that were estimated to be on average about 14,800 6-day Ci per week with a large week-to-week variation (see Figure 3.3)
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From page 78... ...
. SOURCE: Adapted and modified from Bernard Ponsard, SCK•CEN, written communication, February 11, 2016, by authorization of AIPES.
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From page 79... ...
; the planned cessation of Mo-99 production in the NRU reactor (after October 2016) ; and the expected 2016-2017 transition period to production of Mo-99 from LEU targets in Europe.33 3.4.3 Enhanced Communications The 2009-2010 Mo-99 supply shortages demonstrated that frequent communications among supply chain participants can help to mitigate 32 AIPES provides a forum for addressing specific radiopharmaceutical issues, similar to CORAR (Council on Radionuclides and Radiopharmaceuticals)
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From page 80... ...
refurbishment NOTES: BR-2 = Belgian Reactor 2; HFR= High Flux Reactor; NRU = National Research Universal; NTP = Nuclear Technology Products; SAFARI-1 = South African Fundamental Atomic Research Installation 1. the consequences of supply disruptions.
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From page 81... ...
: • Diversifying purchases of technetium generators across suppliers. • Improving efficiencies of technetium generator elutions.
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From page 83... ...
SOURCE: Bernard Ponsard, SCK•CEN, written communication, February 11, 2016.
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From page 84... ...
FINDING 2A: New molybdenum-99 supplies have become available since 2009, and expansions in available supply capacity are planned by current and new suppliers: A supplier in Australia (Australian Nuclear Science and Technology Organisation) has entered the global supply market and plans to expand its available supply capacity; existing global suppliers in Europe (Mallinckrodt)
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From page 85... ...
FINDING 2C: Molybdenum-99 production and supply were disrupted unexpectedly in 2009-2010 because of prolonged unplanned reactor and target processing facility shutdowns. These shutdowns caused protracted and severe molybdenum-99 supply shortages in the United States and some other countries.
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From page 86... ...
Several actions have been taken since the 2009-2010 supply shortages to improve the resilience of the Mo-99 supply chain. These actions, which are described in Section 3.4, involve the development of ORC, coordination of reactor and target processing facility outages, enhanced communications among supply chain participants, and the creation of Mo-99 supplier alliances.
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