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MIRP) March 31, 2015 I 5-Year Strategic Plan Brookhaven National Laboratory, Medical Isotope Research and Production Program (MIRP) March 31, 2015 I. Summary The mission of the BNL Isotope Program is to produce and sell (through the National Isotope Development Center - NIDC) medical and industrial radioactive isotopes generally not available elsewhere, and provide related isotope services. Our highest priority goal is the desire to be a radioisotope producer of outstanding quality and in full compliance with current Good Manufacturing Practice (cGMP) protocols. To support this effort it is necessary to maintain and improve the current infrastructure. We also strive to perform outstanding research in the development of radioisotopes for medical and industrial purposes that will further the benefits of nuclear science to society. For the future, it is essential to conduct the necessary R&D on new and improved isotope production and processing techniques in response to changing user community needs and feedback from national advisory bodies, such as NSAC. The present facilities, operations and authorized staff support a robust program of year round availability of needed radioisotopes and a program of research for the future. In this strategic plan we aspire for the BNL Isotope Program to enhance its role in the DOE complex as a significant distributor of radioisotopes for medicine and industry and the development of the next generation of radioisotopes for the nuclear science community. II. Radioisotope Program Overview This program uses the Brookhaven Linac Isotope Producer (BLIP), and the associated radiochemistry laboratory and hot cell complex in Building 801 to develop, prepare, and distribute to the nuclear medicine community and industry some radioisotopes that are difficult to produce or are not available elsewhere. The BLIP, built in 1972, was the world’s first facility to utilize high energy protons for radioisotope production by diverting the excess beam of the 200 MeV proton LINAC to special targets. After several upgrades BLIP continues to serve as an international resource for the production of selected isotopes that are generally unavailable elsewhere. The overall effort entails: 1) target design, fabrication and testing 2) irradiations 3) radiochemical processing by remote methods in the 9 hot cells of the Target Processing Laboratry (TPL) 4) Quarantining of materials and Quality Control (which includes chemical and radiochemical analysis) 5) waste disposal 6) facility maintenance 7) new isotope and application development 8) isotope packaging, and shipping 9) service irradiations (without chemistry) upon request and as appropriate with costs recovered 1 III. Present Facilities and Capabilities The current and five year goals of the BNL Medical Isotopes Research and Production Program (MIRP) are: 1) To conduct research and development into production of research radioisotopes in response to changing needs of the medical community taking into account feedback from National Isotope Development Centre (NIDC) and national advisory bodies, such as the National Academy of Science and the Nuclear Science Advisory Committee (NSAC). 225 Research radioisotopes currently under investigation include Ac (alpha emitter, t1/2 = 10 67 72 days), Cu production at moderate proton energies (< 45 MeV), As (positron emitter, t1/2 = 44 44 26 hour), Ti (gamma emitter, t1/2 = 60 yr; parent to positron emitter Sc, t1/2 = 3.35 hour), 191,195m,188 Pt (gamma emitter, t1/2 = 2.83 days; auger emitter t1/2 = 4.02 days and gamma 186 emitter, t1/2 = 10.2 days, respectively) and Re (beta emitter, t1/2 = 3.72 days). 2) To produce and sell medical and other industrial radioisotopes generally not available elsewhere. The current portfolio (2015) of radioisotopes sold from BNL (through NIDC) is summarized in Table 1 below. Table 1. Radioisotopes produced using MIRP facilities and sold through NIDC as at start 2015. Radioisotope Characteristics Demand 82 Sr gamma emitter, t1/2 = 25.34 days high 63 Ni* beta emitter, t1/2 = 101.2 years high 55 Fe* low energy X-rays, t1/2 = 2.74 years) moderate 65 Zn Gamma emitter, t1/2 = 243.9 days) moderate 83 Rb Gamma emitter, t1/2 = 86.2 days) moderate 86 Y Gamma emitter, t1/2 = 14.74 hours) low 67 Cu Gamma and beta emitter, t1/2 = 2.58 days) low 7 Be Gamma and beta emitter, t1/2 = 53.22 days) low * The 63Ni, 55Fe isotopes are produced in the HFIR at ORNL are shipped to BNL for final preparation for distribution. As of Janurary 2015 63Ni will no longer be dispensed at BNL as this isotope will be dispensed at ORNL. The MIRP facilities can be divided into three distinct areas or capabilities: 1) Irradiation capabilities [which includes Brookhaven Linac Isotope Producer (BLIP) and supported by 2.0 FTE BLIP Operators] 2) Chemical processing capabilities [which includes Target Processing Facilities with 7 hot- cells, one chemistry, 3 radiochemistry and instrumentation laboratory, supported by 3 TPL Operators and a 4th TPL operator was hired this month] 3) Research capabilities [which include four radiochemistry laboratories and 2-4 Hot-Cells, supported by 3 FTE scientists] 2 By the far the most demanding requirements for the MIRP program come with the production of radioisotopes to meet cGMP requirements and or current Good Clinical Research Practices (cGRCP). Compliance with cGMP is essential for the production of 82Sr, an Active Pharmaceutical Ingreditent (API) use in the production of the commerical available 82Sr/82Rb generator. The 82Rb is used in Positron Emission Tomography (PET) cardiac imaging. Long term, compliance with cGRCP is potentially required if the large scale production of the 225Ac is implemented and it is used in human clinical trials of radiotherapeutic agents. An overview of capabilities in each area will be summarized below. The current status, improvements implemented in FY14/FY15 and identified deficiencies and single point failures that require attention over the next 5 years (FY2015 - FY2020) are also presented. BLIP-irradiation capability The BLIP was constructed in 1972 and was the world’s first facility to utilize high energy protons for radioisotope production. BLIP utilizes excess beam capacity of the 200 MeV Linear Accelerator (Linac) that injects protons into the Booster synchrotron for injection into the AGS then RHIC. (see Figure 1). The Linac and is capable of accelerating H- ions to produce 66, 90, 118, 140, 162, 184 or 202 MeV protons at 37-48 mA current for 425 μs duration with a 6.67 Hz repetition rate. Averaged maximum intensity of 115 μA was routinely reached in FY2014. In 2015 FY, with the intial phase of the Linac Intensity Upgrade project complete, the Linac has reached currents of 142 μA. At present, an administrative limit of 115 A has been placed on the beam current to BLIP due to target heating considerations. Once the Raster Project (described later in this document) is complete in 2016 the target beam heating problem will be resolved so the full Linac beam current can be utilized, subject to the usual limitations when proton beams are used in RHIC. When running concurrent with the RHIC polarized proton program BLIP receives about 90% of the available beam pulses. A 30m transport line delivers the protons to a shielded target area for radioisotope production. The target area at BLIP consists of an underground 2.44 m diameter tank containing sand shielding, a 9.2 m high by 40 cm diameter shaft filled with water and a 9.2 m high by 20cm diameter inspection shaft (see Figure 2). A hot-cell, situated over the inspection shaft, is used to transfer the two target assemblies boxes, to and from the irradiation area. The target boxes are immersed in a water tank at the base of the shaft and cooling water is forced past each face of the targets and degraders in each box. BLIP contains a single hot-cell for delivery of targets to the beam line for irradiation. The building floor layout is shown in Figure 3 and is divided into three distinct areas: 1) the Hot Cell room (where targets are loaded and removed) 2) the Garage room [where monitoring equipment (air sampling for above hot-cell) and Health Physics shielded area for monitoring contamination and the access to target cooling water storage is decayed prior to disposal] 3 3) the Control Room (where operation of beams is controlled by in-house design LabView software). Personel access to building is through the Garage (note there are a number of exits door to the building), most of the irradiated targets are removed from the hot cell into a lead cask and transported by fork lift to the TPL for processing. There are no processing capabilities at the BLIP facility. In 2014, in an effort to reduce cost and handling time of moderately activated irradiated materials (foils), a new transfer process was developed that allows the transfer of low level targets in Biodex containers in motor vehicles to the TPL. The BLIP facility has been upgraded twice, in 1986 and 1996. There are two upgrades in progress that will (and have) improved the beam to BLIP, one to the Linac (Linac Intensity Upgrade) and the other an upgrade to the BLIP beam line (BLIP Raster Upgrade). These upgrade projects are managed by the C-AD Accelerator Division as Accelerator Improvement Projects (AIP’s) and are funded by the DOE Isotope Program Office. The status of these upgrades follows: Figure 1. Aerial view of Linac relative to BLIP and TPL facilities at BNL 4 Figure 2. BLIP target shaft Figure 3. Building 931, BLIP, floor layout 1) BLIP Raster Project: This $4.5M project provides a 5 kHz beam raster system with new beam instrumentation. With this the BLIP targets will be ably to handle the full beam presently available from the Linac, an increase from 115 A (administrative limit) to 142 A (present Linac maximum intensity) and >200 A that could be available with future Linac intensity upgrades.
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