ML21095A221
| ML21095A221 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 03/23/2021 |
| From: | SHINE Medical Technologies |
| To: | Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML21095A241 | List: |
| References | |
| 2021-SMT-0032 | |
| Download: ML21095A221 (30) | |
Text
ENCLOSURE 6 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL TECHNOLOGIES, LLC OPERATING LICENSE APPLICATION RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION AND SUPPLEMENT NO. 7 FINAL SAFETY ANALYSIS REPORT PUBLIC VERSION
THE FACILITY TABLE OF CONTENTS tion Title Page INTRODUCTION .................................................................................................. 1.1-1
SUMMARY
AND CONCLUSIONS ON PRINCIPAL SAFETY CONSIDERATIONS ............................................................................................. 1.2-1 1.2.1 CONSEQUENCES FROM THE OPERATION AND USE OF THE FACILITY .................................................................................... 1.2-1 1.2.2 SAFETY CONSIDERATIONS ............................................................ 1.2-2 1.2.3 INHERENT AND PASSIVE SAFETY FEATURES, DESIGN FEATURES, AND DESIGN BASES ................................................... 1.2-3 1.2.4 POTENTIAL ACCIDENTS AT THE FACILITY ................................... 1.2-5 GENERAL DESCRIPTION OF THE FACILITY ................................................... 1.3-1 1.3.1 GEOGRAPHICAL LOCATION ........................................................... 1.3-1 1.3.2 PRINCIPAL CHARACTERISTICS OF THE SITE ............................. 1.3-1 1.3.3 PRINCIPAL DESIGN CRITERIA, OPERATING CHARACTERISTICS, AND SAFETY SYSTEMS .............................. 1.3-1 1.3.4 ENGINEERED SAFETY FEATURES ................................................. 1.3-3 1.3.5 INSTRUMENTATION, CONTROL, AND ELECTRICAL SYSTEMS .......................................................................................... 1.3-4 1.3.6 TSV COOLING AND OTHER AUXILIARY SYSTEMS ....................... 1.3-4 1.3.7 RADIOACTIVE WASTE MANAGEMENT AND RADIATION PROTECTION .................................................................................... 1.3-4 1.3.8 EXPERIMENTAL FACILITIES AND CAPABILITIES .......................... 1.3-5 1.3.9 RESEARCH AND DEVELOPMENT ................................................... 1.3-5 SHARED FACILITIES AND EQUIPMENT ........................................................... 1.4-1 NE Medical Technologies 1-i Rev. 0
THE FACILITY TABLE OF CONTENTS tion Title Page COMPARISON WITH SIMILAR FACILITIES ....................................................... 1.5-1 1.5.1 COMPARISON OF PHYSICAL PLANT AND EQUIPMENT ............... 1.5-1 1.5.2 COMPARISON OF CHEMICAL PROCESSES .................................. 1.5-1 1.5.3 COMPARISON OF SUPPORT SYSTEMS ........................................ 1.5-2
SUMMARY
OF OPERATIONS ............................................................................ 1.6-1 COMPLIANCE WITH THE NUCLEAR WASTE POLICY ACT OF 1982 .............. 1.7-1 FACILITY MODIFICATIONS AND HISTORY ...................................................... 1.8-1 REFERENCES ..................................................................................................... 1.9-1 NE Medical Technologies 1-ii Rev. 0
mber Title e
NE Medical Technologies 1-iii Rev. 0
mber Title 1 Main Production Facility Building General Arrangement 2 Main Production Facility Building General Arrangement Section A-A 3 Site Overview NE Medical Technologies 1-iv Rev. 1
onym/Abbreviation Definition CFR Title 10 of the Code of Federal Regulations acre RA as low as reasonably achievable L Argonne National Laboratory MS continuous air monitoring system A design basis accident E U.S. Department of Energy engineered safety feature FAS engineered safety features actuation system WS facility demineralized water system R Final Safety Analysis Report hectare U highly enriched uranium S highly integrated protection system Interstate-39 Interstate-90 NE Medical Technologies 1-v Rev. 2
onym/Abbreviation Definition initiating event irradiation facility Interim Staff Guidance irradiation unit kilometer low enriched uranium PS light water pool system PS molybdenum extraction and purification system V million electron volt A maximum hypothetical accident miles S molybdenum isotope product packaging system molybdenum 99 molybdenum-99 S nitrogen purge system AS neutron driver assembly system NE Medical Technologies 1-vi Rev. 2
onym/Abbreviation Definition operating license NL Oak Ridge National Laboratory LS primary closed loop cooling system S process integrated control system B primary system boundary VS process vessel vent system MS radiation area monitoring system A radiologically controlled area S radioactive drain system WI radioactive liquid waste immobilization system WS radioactive liquid waste storage system CS radioisotope process facility cooling system F radioisotope production facility radiological ventilation system SS subcritical assembly support structure AS subcritical assembly system NE Medical Technologies 1-vii Rev. 2
onym/Abbreviation Definition S standby generator system M special nuclear material WP solid radioactive waste packaging C structure, system, and component 99m technetium-99m AP thermal cycling absorption process tritium purification system GS TSV off-gas system PS TSV reactivity protection system S target solution preparation system target solution vessel 35 uranium-235 SS uninterruptible electrical power supply system C volts - direct current NE Medical Technologies 1-viii Rev. 2
INTRODUCTION Final Safety Analysis Report (FSAR) is submitted in accordance with the provisions of 10 of the Code of Federal Regulations (10 CFR) Part 50 Domestic Licensing of Production Utilization Facilities, in support of the application by SHINE Medical Technologies, LLC INE) to operate a medical isotope production facility.
FSAR generally follows the content and organization of NUREG-1537, Part 1, Guidelines for paring and Reviewing Applications for the Licensing of Non-Power Reactors, Format and tent, as augmented by the Final Interim Staff Guidance (ISG) Augmenting NUREG-1537, t 1, Guidelines for Preparing and Reviewing Applications for Licensing Non-Power Reactors:
mat and Content for Licensing Radioisotope Production Facilities and Aqueous mogeneous Reactors, October 17, 2012.
applicant for this operating license (OL) and owner of the medical isotope production facility HINE Medical Technologies, LLC, a Delaware company. SHINE is a private organization that created for the purpose of designing, constructing, and operating the facility described ein. The purpose of the facility is to produce molybdenum-99 (Mo-99) and other medical opes. Additional information about the SHINE organization and key personnel is provided in tion 12.1.
facility is located on previously-undeveloped property in the City of Janesville, Rock County, consin. The SHINE site and details regarding the geographical location and the surrounding as are presented in Chapter 2, including site features that address the basic attributes of the such as geography, demography, nearby facilities, meteorology, hydrology, and geology.
NE has developed a new method for the manufacture of medical isotopes, primarily Mo-99.
99 is the precursor of the diagnostic imaging isotope, technetium-99m (Tc-99m), which is d in diagnostic imaging procedures worldwide. Technetium becomes a light source within body to provide a high-quality view of internal organs. It is primarily used in cancer screening in stress tests to detect heart disease.
NEs technology involves the use of a non-reactor based, subcritical fission process. The cess includes the combination of a high-output deuterium-tritium gas-target neutron source a low enriched uranium (LEU) target in a target solution vessel (TSV). Neutrons created by accelerator-driven neutron source induce fission in the LEU, creating Mo-99 as a byproduct.
ether the neutron driver, subcritical assembly, light water pool, TSV off-gas system (TOGS),
other supporting systems comprise an irradiation unit (IU). Eight IUs and their supporting tems comprise the irradiation facility (IF).
main production facility also includes the radioisotope production facility (RPF). The RPF is re the irradiated material is processed to separate medical isotopes, and includes packaging he resulting materials for shipment to customers.
ailed descriptions of the IF and the RPF, including IU power level, are provided in Chapter 4.
ummary of the principal safety considerations is provided in Section 1.2, including inherent passive safety features as well as design features that address the basic safety concerns h as functional, radiological, and criticality safety.
NE Medical Technologies 1.1-1 Rev. 1
section identifies safety criteria, principal safety considerations and conclusions for the NE facility structures, systems, and components (SSCs). The purpose of the safety criteria he SHINE facility is to limit adverse effects on the public and workers due to operation of the lity. These criteria are assured by designing, constructing, and operating the plant such that ty-related SSCs remain functional during normal conditions and during and following design is events.
accident analysis uses the most conservative operational condition or operating mode to ermine potential radiological consequences. See Chapter 13 for a description of the accident lysis for the SHINE facility. Section 4a2.6 and Section 7.3 provide a description of operating des of the irradiation unit.
1 CONSEQUENCES FROM THE OPERATION AND USE OF THE FACILITY primary consequences resulting from the operation of the SHINE facility are radiological.
SHINE facility produces molybdenum-99 (Mo-99) and other medical isotopes from irradiation w enriched uranium (LEU). Within the irradiation facility (IF), the LEU in the target solution is e form of a uranyl sulfate. In the irradiation units (IUs), the target solution is irradiated in a critical assembly by neutrons produced by a fusion neutron source. The irradiated target tion is then processed in the radioisotope production facility (RPF) to extract and purify the 99 and other medical isotopes. Radioactive waste materials are processed and/or converted olid wastes for shipment to off-site disposal facilities. The main production facility is designed e a zero radioactive liquid effluent discharge facility as described in Section 11.1.
IF and RPF within the main production facility are identified on Figure 1.3-1. Radioactive erials are primarily present in the following locations within the SHINE facility buildings:
- Main production facility - IF
- IU cells
- Target solution vessel (TSV) off-gas shielded cells
- Tritium purification system (TPS) area
- Radiologically controlled area (RCA) ventilation equipment areas
- Main production facility - RPF
- Target solution preparation and storage areas
- Supercell
- Target solution hold tanks
- Carbon delay beds
- Radioactive liquid waste storage tanks
- Radioactive liquid waste immobilization (RLWI) shielded cell
- Labs and storage rooms
- Main production facility - other areas
- Shipping and receiving area
- Material staging building NE Medical Technologies 1.2-1 Rev. 3
idents as described in the Chapter 13 accident analysis.
2 SAFETY CONSIDERATIONS hin the IF, medical isotopes are produced in a subcritical assembly. The subcritical assembly ifferent from a nuclear reactor because it is designed to remain subcritical in all operating des. Processes in the RPF are maintained subcritical with approved margins of subcriticality.
subcritical assembly uses target solution consisting of LEU in the form of uranyl sulfate tion. The use of LEU as the source material meets U.S. government non-proliferation ctives related to elimination of the use of highly enriched uranium (HEU) for the production of dical isotopes.
main production facility building, which contains the IF and RPF, is designed to withstand ere natural phenomena, including seismic events and tornados, as described in Chapter 3.
building structure is robust enough to remain intact following an aircraft impact as described ection 3.4.
mary functions of the IUs, including the power level within the TSV, are described in pter 4a2. Primary functions of the RPF are described in Chapter 4b. Major processes ormed at the SHINE facility are summarized in Sections 1.3 and 1.6.
ety considerations that influenced the selection of the specific site for the SHINE facility ude:
- The size and shape of the proposed parcel,
- Proximity to an airport,
- Proximity to an interstate highway, and
- Seismic characteristics.
sideration of the size and shape of the proposed parcel includes distance to the boundaries
., greater distance from the facility to the site boundary decreases potential radiological acts on the public). Of the parcels considered, the Janesville site had the largest minimum ance to the site boundary. Considering seismic characteristics, each potential site was parably attractive because there are no major fault lines in Wisconsin.
close proximity to the Southern Wisconsin Regional Airport increases safety because the dical isotope product spends less time and travels less distance being transported to the ort than it would if the airport were farther away. Although the close proximity to an airport eases the probability of an aircraft crash impact, the IF and RPF are designed to withstand an raft crash impact in order to mitigate this risk. The transportation safety improvement offsets risk related to the increased probability of an aircraft crash impact.
close proximity to Interstate-39/Interstate-90 (I-39/I-90) increases safety because of the d to spend less time and distance transporting radioactive cargo, such as waste or product, ugh populated areas. Although the close proximity to I-39/I-90 reduces the distance to ardous chemicals that are transported on interstate highways, an analysis, described in tion 2.2, has been performed to ensure that these chemicals will not pose a threat to SHINE NE Medical Technologies 1.2-2 Rev. 3
ets the risk related to the reduced distance to hazardous chemicals transported on interstate ways.
3 INHERENT AND PASSIVE SAFETY FEATURES, DESIGN FEATURES, AND DESIGN BASES 3.1 Safety Features of Structures, Systems, and Components SHINE facility utilizes a number of inherent safety features that represent good engineering ctice for nuclear facilities.
- a. The RCA of the main production facility is located within seismic Category I structures, as described in Chapter 3, that are designed to survive the design basis earthquake and other design basis events.
- b. Tanks and piping that are expected to contain significant concentrations of fissile material are designed and controlled to be geometrically favorable for criticality safety as described in Section 6b.3.
- c. Confinement is used to prevent or minimize the spread of radioactive materials as described in Sections 6a2.2 and 6b.2.
- d. Shielding is used to minimize occupational exposures in normally-occupied areas of the facility as described in Sections 4a2.5 and 4b.2.
- e. Ventilation systems for normally-occupied areas are separate from ventilation systems for areas containing radioactive materials. The ventilation system in the RCA is designed to pull air from the least contaminated areas to the most contaminated areas as described in Section 9a2.1.
- f. Areas, tanks, equipment, and piping that contain radioactive materials drain to favorable geometry sump tanks that are provided with leak detection as described in Section 9b.7.
se SSCs whose intended functions are to prevent accidents that could cause undue risk to lth and safety of workers and the public, and to control or mitigate the consequences of such idents, are classified as safety-related SSCs. SSCs are designed, constructed, and operated h that safety-related SSCs remain functional during normal conditions and during and wing design basis events. Principal design criteria for the facility are described in tion 3.1. SSCs that perform an engineered safety feature (ESF) function are classified as ty-related. ESFs for the IF and RPF are described in Chapters 6a2 and 6b, respectively.
3.2 Radiological Safety Radiation Protection Program is provided to protect the radiological health and safety of kers and members of the public in compliance with the regulatory requirements in 10 CFR 19 10 CFR 20. This program includes an as low as reasonably achievable (ALARA) program, ation monitoring and surveying, exposure control, dosimetry, contamination control, and ironmental monitoring. The Radiation Protection Program is described in Section 11.1. The ioactive Waste Management Program is described in Section 11.2. The Respiratory tection Program is described in Section 11.3.
elding is used extensively to minimize personnel exposures. The IU cell walls and the light er pool provide neutron and gamma shielding. The IU cells and light water pool are described NE Medical Technologies 1.2-3 Rev. 3
ase and spread of contamination.
trol of gaseous, liquid, and solid radioactive wastes is provided by the process vessel vent tem (PVVS) (Section 9b.6), the radioactive liquid waste storage system (RLWS) ction 9b.7), the radioactive liquid waste immobilization system (RLWI) (Section 9b.7), and the d radioactive waste packaging system (SRWP) (Section 9b.7). Potentially radioactive drains part of the radioactive drain system (RDS) as described in Section 9b.7. Radiation Protection gram equipment and procedures are described in Section 11.1, including the use of area ation monitors, continuous air monitors, the detection and monitoring of gaseous and liquid ent release streams, control point monitoring, and the use of radiation surveys within the NE facility.
3.3 Reactivity Control in the IF subcritical assembly is designed to remain subcritical in all operating modes. To maintain subcritical state, reactivity control is provided in the TSV through passive, active, and inistrative controls. The IUs, which include the subcritical assembly, are identified as zation facilities as defined in 10 CFR 50.2. Operating limits applicable to the TSV are cribed in Section 4a2.6. During TSV filling, neutron flux detectors combined with a fixed tron source are used for reactivity increase measurements during the 1/M fill process and roach to critical. The fill process is normally stopped at approximately 5 percent by volume w critical. The 1/M fill process is described in Subsection 4a2.6.1. During TSV irradiation, the tron flux detectors are used to determine fission power and reactivity. During both filling and diation, if neutron flux exceeds predetermined magnitudes, the TSV reactivity protection tem (TRPS) initiates an IU Cell Safety Actuation. The TRPS is discussed in Section 7.4.
rtion of excess reactivity scenarios have been analyzed as described in Chapter 13a2, uding inadvertent target solution fill scenarios (see Subsection 13a2.1.2).
3.4 Criticality Control in the RPF nuclear criticality safety program for operations in the RPF is described in Section 6b.3.
lear criticality safety evaluations are conducted for each fissile material operation within the F to ensure that under normal and credible abnormal conditions, all nuclear processes remain critical with an approved margin of subcriticality. A fissile material operation is any process or tem that has the potential to contain more than 250 g of non-exempt fissile material. For the poses of application of this limit, all fissionable isotopes in the process or system are sidered to be fissile.
ystems where the equipment is not safe-by-design, the double contingency principle is used uring at least two unlikely, independent, and concurrent changes in process conditions are uired before a criticality accident is possible. The preferred hierarchy of nuclear criticality ty controls is (1) passive engineered, (2) active engineered, (3) enhanced administrative, (4) administrative. Use of explicit nuclear criticality safety controls is preferred to reliance on natural and credible course of events. Generally, control on two independent criticality ameters is preferred over multiple controls on a single parameter. If redundant controls on a le parameter are used, a preference is given to diverse means of control on that parameter.
NE Medical Technologies 1.2-4 Rev. 3
ential design basis accidents (DBAs) at the SHINE facility were identified by the application of ard analysis methodologies to evaluate the design of the facility and processes for potential ards, initiating events (IEs), scenarios, and associated controls. As described in Chapter 13, e methodologies were applied to both the IF and the RPF. The list of accident categories and that were the basis for the identification of potential DBAs are described in Chapter 13. The wing accident categories and IEs are addressed for the SHINE facility. Some are applicable he IF, some are applicable to the RPF, and some are applicable to both.
- Maximum hypothetical accident (MHA)
- Insertion of excess reactivity
- Reduction in cooling
- Mishandling or malfunction of target solution
- Loss of off-site power
- External events
- Mishandling or malfunction of equipment
- Large undamped power oscillations
- Detonation and deflagration in the primary system boundary
- Unintended exothermic chemical reactions other than detonation
- System interaction events
- Facility-specific events
- Critical equipment malfunction
- Inadvertent nuclear criticality in the RPF
- RPF fire
- Hazardous chemical accidents NE Medical Technologies 1.2-5 Rev. 3
SHINE main production facility consists of an irradiation facility (IF), radioisotope production lity (RPF), shipping and receiving area, and other areas that contain various support systems equipment. General arrangement floor plan and section drawings of the facility showing the ut of major structures are provided in Figures 1.3-1 and 1.3-2. The SHINE facility site rview is provided in Figure 1.3-3.
1 GEOGRAPHICAL LOCATION SHINE facility is located on the south side of the City of Janesville corporate boundaries, in k County, Wisconsin. Geographical coordinates of the SHINE site are provided in tion 2.1.
2 PRINCIPAL CHARACTERISTICS OF THE SITE SHINE site consists of a previously undeveloped, approximately 91-acre (ac.)
8-hectare [ha]) parcel that has been historically farmed. Safety-related structures are located in a rectangular area located near the center of the property. The region of the SHINE site is rely contained within Rock County, Wisconsin. The dominant land use in the region is cultural/cultivated crops. The northern limits of the City of Beloit are located approximately miles (mi.) (6.0 kilometers [km]) to the south. Principal characteristics of the site are further cribed in Chapter 2.
3 PRINCIPAL DESIGN CRITERIA, OPERATING CHARACTERISTICS, AND SAFETY SYSTEMS SHINE facility is licensed under 10 CFR 50. Classifications of systems, structure, and ponents (SSCs) of the SHINE facility are described in Section 3.1.
3.1 Principal Design Criteria cipal design criteria for the facility are described in Section 3.1.
3.2 Operating Characteristics irradiation units (IUs) are operated in a batch mode with an approximate week-long rating cycle. An operating cycle includes the following steps:
- irradiation in the subcritical assembly for approximately 5.5 days,
- shut down, and
- transfer of the irradiated target solution to the RPF for isotope extraction.
ing the irradiation in the subcritical assembly system, the target solution is maintained in a critical state. Operating characteristics of the IUs, including power level, are discussed in e detail in Chapter 4a2.
NE Medical Technologies 1.3-1 Rev. 4
- preparation of uranyl sulfate solution from raw feed materials,
- extraction of molybdenum-99 (Mo-99) from processed target solution,
- purification of extracted Mo-99, and
- packaging of Mo-99 for shipment to customers.
rating characteristics of the RPF are discussed in more detail in Chapter 4b.
3.3 Facility Systems IF consists of eight IUs. Each IU consists of a neutron driver assembly system (NDAS), a critical assembly system (SCAS), a primary closed loop cooling system (PCLS), a light water l, a TSV off-gas system (TOGS), and related support systems.
NDAS is an accelerator-based assembly that accelerates a deuterium ion beam into a tritium target chamber. The resulting fusion reaction produces 14 million electron volt (MeV) trons, which move outward from the tritium target chamber in all directions. The NDAS is cribed in Section 4a2.3. Potential upsets in the neutron driver system that would otherwise ult in higher unplanned fission rates are prevented by systems that cause the IU to trip. The wing actions occur on an IU Cell Safety Actuation:
- the neutron driver is de-energized by opening the safety-related circuit breaker for its high voltage power supply;
- the TSV dump valves are opened to drain the target solution to the geometrically favorable TSV dump tank; and
- the primary system boundary is isolated.
neutron driver is located directly above the subcritical assembly. Most of the neutrons enter SCAS, where they are slowed down to thermal energies. The resulting thermal neutron flux racts with the uranium-235 (U-235) atoms in the target solution, causing the atoms to fission.
h SCAS includes a TSV, a neutron multiplier, a subcritical assembly support structure SS), and a TSV dump tank. The SCAS and its subcomponents are described in tion 4a2.2. The PCLS provides cooling to the SCAS and is described in Section 5a2.2. The AS is located inside of the light water pool. The light water pool is described in Section 4a2.4.
TOGS removes the off-gas from the TSV and is described in Section 4a2.8.
function of the RPF is to extract, purify, and package Mo-99 and other medical isotopes for end users. Additionally, the RPF prepares feed target solution for the IU. The RPF includes lity features and systems where the processes that support the IUs are performed and where cessing of the irradiated target solution occurs. The major systems and processes are cribed below.
target solution preparation system (TSPS) prepares fresh target solution from either uranium al or uranium oxide. Recycled target solution is adjusted between cycles, as needed, by the ition of small volumes of acid or uranyl sulfate solution through TSPS. The TSPS is described ection 4b.1.
NE Medical Technologies 1.3-2 Rev. 4
r to packaging and shipping. The MEPS is described in Section 4b.1.
process vessel vent system (PVVS) collects and processes radioactive gases from the vents rocess vessels that handle the main process fluids. This system is briefly discussed in tion 4b.1 and described in detail in Section 9b.6.
molybdenum isotope product packaging system (MIPS) receives the Mo-99 from MEPS and kages it for shipment to the customers. This system is briefly discussed in Section 4b.1 and cribed in detail in Section 9b.7.
er systems located in the RPF are briefly discussed in Section 4b.1 and are described in e detail in the following chapters of this report.
4 ENGINEERED SAFETY FEATURES Cs that perform an engineered safety feature (ESF) function are classified as safety-related.
Fs for the IF are described in Section 6a2.2 and include ESFs related to confinement of ological material. The SHINE facility does not have a containment feature but uses finement to minimize the release and spread of radioactive contamination. Confinement is d to describe the low-leakage boundary that surrounds radioactive materials and the ociated radiological ventilation (RV) system. Confinement systems are designed to localize ase of radioactive material to controlled areas in normal operational states and mitigate the sequences of design basis accidents (DBAs). Radiation protection control features such as lding and the RV minimize hazards normally associated with radioactive materials. The cipal design and safety objective of the confinement systems is to protect on-site personnel, public, and the environment. The second design objective is to minimize reliance on inistrative or complex active engineering controls to provide a confinement system that is as ple and as fail-safe as reasonably possible.
TSV, TSV dump tank, TOGS, and associated components act as the primary system ndary (PSB). These components act as the primary fission product boundary. The finement boundary of the IU cell and TOGS shielded cell encloses the PSB. Confinement is ieved through the RV, the TSV reactivity protection system (TRPS), and the passive finement structures provided by the steel and concrete comprising the walls, roofs, and etrations of the IU cell and TOGS shielded cell. The tritium confinement boundary provides finement for portions of the tritium purification system (TPS). Isolation of the tritium finement boundary is actuated by the engineered safety features actuation system (ESFAS).
Fs outside the IF are described in Section 6b.2 and include confinement of radiological erial and hazardous material in the RPF. The RPF confinement areas include hot cell losures and gloveboxes for process operations and trench and vault enclosures for process s and piping. Confinement is achieved through RV, ESFAS, and passive confinement ctures provided by the steel and concrete comprising the walls, roofs, and penetrations of the finement areas.
NE Medical Technologies 1.3-3 Rev. 4
process integrated control system (PICS) monitors and controls various operations ughout the IF and RPF as described in Section 7.3. The TSV is protected by the TSV ctivity protection system (TRPS) as described in Section 7.4. Various ESF functions are nitored and controlled within the ESFAS as described in Section 7.5. The highly integrated ection system (HIPS) design is used for both the TRPS and ESFAS as described in pter 7.
ign features of the control consoles and display instrumentation, and the radiation monitoring tems for both the IU and the RPF, are described in Chapter 7. Radiation monitoring systems ude process radiation monitoring, the radiation area monitoring system (RAMS), the tinuous air monitoring system (CAMS), and effluent monitoring.
SHINE facility has a common normal electrical power system which provides power to the he RPF, and other support buildings. Power service is provided by the local utility via offsite ds. The normal electrical power system is described in Section 8a2.1.
ergency electrical power for the SHINE facility is provided by a common safety-related terruptible electrical power supply system (UPSS) and a common nonsafety-related standby erator system (SGS). The UPSS consists of two independent trains, each consisting of a volts-direct current (VDC) battery subsystem with associated charger, inverter, and ribution system. The SGS includes a natural gas-fired generator and provides power for asset ection purposes to selected loads in the event of a loss of offsite power. These emergency trical power systems are described in Section 8a2.2.
6 TSV COOLING AND OTHER AUXILIARY SYSTEMS mary cooling for the TSV and related components is provided by the PCLS as described in tion 5a2.2. The TSV and related components are submerged in the light water pool. The light er pool is described in Section 4a2.4. Make-up to the light water pool and the PCLS is vided by the facility demineralized water system (FDWS) as described in Section 5a2.6.
ling for various IF and RPF systems is provided by the radioisotope process facility cooling tem (RPCS) as described in Section 5a2.3.
tilation for both the IF and the RPF is provided by the RV as described in Section 9a2.1.
ipment and processes related to handling and storage of target solution are described in tion 9a2.2. The tritium purification system (TPS) processes gas from the tritium target of the AS, including separating the deuterium from the tritium and returning the purified gases to the AS, as described in Section 9a2.7. The facility fire protection systems and fire protection gram are described in Section 9a2.3. Communications systems are described in tion 9a2.4. Other auxiliary systems are also described in Chapters 9a2 and 9b.
7 RADIOACTIVE WASTE MANAGEMENT AND RADIATION PROTECTION SHINE facility has a radiation protection program to protect the radiological health and safety s workers. This program includes an as low as reasonably achievable (ALARA) program, ation monitoring and surveying, exposure control, dosimetry, contamination control, and ironmental monitoring. The radiation protection program is described in Section 11.1. The NE Medical Technologies 1.3-4 Rev. 4
SHINE facility has a radioactive waste management program. This program is described in tion 11.2. Control of gaseous, liquid, and solid radioactive wastes is provided by the PVVS, radioactive liquid waste storage system (RLWS), the radioactive liquid waste immobilization tem (RLWI), and the solid radioactive waste packaging system (SRWP). Drains from vaults, ches, and other areas where uranium-bearing solutions may be present are part of the oactive drain system (RDS), described in Chapter 9b.
8 EXPERIMENTAL FACILITIES AND CAPABILITIES SHINE facility does not include experimental facilities or capabilities.
9 RESEARCH AND DEVELOPMENT following research and development activities were identified as ongoing in NUREG-2189, ety Evaluation Report Related to SHINE Medical Technologies, Inc. Construction Permit lication for a Medical Radioisotope Production Facility (USNRC, 2016), and have since been olved:
(1) Irradiation and corrosion testing at Oak Ridge National Laboratory (ORNL) to study the mechanical performance of materials (2) Precipitation studies at Argonne National Laboratory (ANL) to ensure precipitation of uranyl peroxide in the target solution will not occur testing of materials included zirconium alloy for the TSV as well as the stainless steel for the SS and the process piping and vessels around the facility. As the material of construction for target solution vessel has been changed to stainless steel, as described in Section 4a2.4, the a for the zirconium alloy is no longer needed. The stainless steel testing results from ORNL e used along with data from Los Alamos National Laboratory, ANL, and literature to define nding corrosion allowances for the materials of construction in the process conditions they be exposed to. The data included extensive testing of stainless steel in uranyl sulfate solution art of historical aqueous homogeneous reactor experiments at ORNL. Given the corrosion irradiation data that has been obtained, no further research and development is required.
cipitation studies at ANL were conducted using uranyl sulfate solution encompassing the NE target solution operating parameters. These studies included a range of temperatures, nium concentrations, catalyst materials, and power densities. This data was combined with a from historical operation of aqueous homogeneous reactors including HRE, KEWB, L-8, 4, and Argus to define power density limits for the SHINE target solution. Section 4a2.6 nes the operating limits to ensure that no significant uranyl peroxide precipitation occurs.
en that SHINE will operate within these limits, no further research and development is uired.
NE Medical Technologies 1.3-5 Rev. 4
Security-Related Information - Withheld under 10 CFR 2.390(d)
Chapter 1 - The Facility General Description of the Facility Figure 1.3 Main Production Facility Building General Arrangement SHINE Medical Technologies 1.3-6 Rev. 4
NE Medical Technologies 1.3-7 Rev. 4 NE Medical Technologies 1.3-8 Rev. 4 SHINE facility does not share any systems or equipment with facilities not covered by this ort.
SHINE main production facility includes the irradiation facility (IF), the radioisotope duction facility (RPF), the non-radiologically controlled seismic area, and a non-safety related
- a. The SHINE facility includes the following structures:
- Main production facility
- Resource building
- Material staging building
- Storage building
- N2PS structure NE Medical Technologies 1.4-1 Rev. 0
1 COMPARISON OF PHYSICAL PLANT AND EQUIPMENT stated in Section 1.1, the SHINE facility uses new technology for the manufacture of medical opes. The irradiation unit (IU), consisting of the neutron driver, subcritical assembly, light er pool, target solution vessel (TSV) off-gas system (TOGS), and other supporting systems, esents new technology. As such, there are no similar facilities that compare to the IUs.
se systems and components are discussed in Chapter 4a2.
neutron driver in particular has specifically been developed for use in the SHINE facility. The critical assembly, consisting of the TSV, neutron multiplier, subcritical assembly support cture (SASS), and subcritical multiplication source, is also a new design. The neutron driver iscussed in Section 4a2.3. The subcritical assembly is discussed in Section 4a2.2.
he radioisotope production facility (RPF), the irradiated target solution is processed in hot s to separate and purify the medical isotopes that are produced. The hot cell design is ventional and is similar to the design used in many other facilities. The RPF is discussed in pter 4b.
stated in Section 11.1, the objective of the as low as reasonably achievable (ALARA) program make every reasonable effort to maintain exposure to radiation as far below the dose limits 0 CFR 20.1201 and 10 CFR 20.1301 as is practical. The design and implementation of the RA program is consistent with the NRC guidance as described in Section 11.1. This pares favorably to other facilities that are required to have an ALARA program.
2 COMPARISON OF CHEMICAL PROCESSES 2.1 Molybdenum Extraction SHINE facility molybdenum (Mo) extraction system uses selective adsorption of Mo from the diated target solution as described in Chapter 4b. There are currently no NRC or U.S.
artment of Energy (DOE) facilities that use this specific process. However, the use of solid bents to remove specific components from an aqueous solution has been widely researched demonstrated on a commercial scale.
articular, cesium-137 and strontium-90 are typically isotopes that are removed from aqueous ams, due to their gamma emission driving worker and public dose rates. Cesium can be oved by crystalline silico-titanate, or sodium titanosilicate followed by alumina ntmorillonite clay. Strontium is removed by sodium titanosilicate, followed by titanium silicate rmacosiderites. These processes have been researched extensively; however, no facilities zing these technologies have been approved by DOE or NRC.
ellafield in the United Kingdom, the Site Ion Exchange Effluent Plant (SIXEP) uses optilolite to remove cesium and strontium from aqueous process streams. Clinoptilolite is a urally occurring clay-like material. The SIXEP facility has been in operation since 1985.
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SHINE Mo purification process is very similar to the Cintichem process developed in the 0s and 1960s by Union Carbide. The special nuclear material (SNM) license was transferred the Union Carbide Corporation to Cintichem, Inc. in 1984. Cintichem, Inc. operated the cess until 1990 as a means to purify Mo-99 for use as a medical isotope. There are no NRC OE licensed facilities currently using this technology. The process used by Union Carbide Cintichem, Inc. generated Mo-99 produced by fission in highly enriched uranium (HEU) solid ets. The SHINE process produces Mo-99 derived from irradiation of low enriched uranium U) target solution. The chemistry of the process has been adjusted slightly to accommodate change in chemical and isotopic composition due to the switch from HEU to LEU.
purification process is a small scale, batch chemical procedure performed in laboratory sware. This is unchanged between the previous deployment of the Cintichem process and system employed at the SHINE facility.
2.3 Tritium Purification System um is purified using the thermal cycling absorption process (TCAP) technology. TCAP was eloped at the Savannah River Site to separate tritium from deuterium and protium. Other cess equipment is used to support the TCAP separation, including impurity removal and m storage. For SHINE, TCAP and its supporting process equipment is known as the tritium fication system (TPS). TPS is similar in design to the processes within the following facilities:
- a. Savannah River Site, South Carolina.
- b. Laboratory for Laser Energetics, Rochester, New York.
to the sensitive and confidential nature of information relating to tritium production and fication, the design and operational details of these systems are not published. A comparison he SHINE system with existing facilities is therefore not possible. The same is true of other m facilities around the globe.
3 COMPARISON OF SUPPORT SYSTEMS porting systems, including ventilation, cooling water, waste processing, and electrical power, conventional in nature. In general, there are no unique features that warrant discussion here.
se systems are discussed in the corresponding chapters of this report.
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major operations to be performed in the SHINE facility are as follows:
- Target solution preparation from raw feed material.
- Irradiation of target solution.
- Molybdenum (Mo) extraction from irradiated target solution.
- Mo purification.
- Target solution adjustments.
- Solidification of radioactive liquid waste.
get solution preparation from raw feed material (uranium metal) starts with either uranium al or uranium oxide. Either form of uranium is low enriched uranium (LEU). If uranium metal is d as the feed material, it is first converted to uranium oxide by a furnace within the uranium eipt and storage system (URSS) glovebox. Uranium oxide is then dissolved in sulfuric acid to duce the uranyl sulfate target solution. Hydrogen peroxide may be used as a catalyst to aid conversion. After initial startup of the facility, receipt of uranium will be infrequent, occurring as necessary to make up for losses or to generate fresh target solution batches as needed.
irradiation facility (IF) consists of eight irradiation units (IUs). Each IU is operated for an roximately week-long cycle. The operating cycle includes the following steps:
- Prepared target solution is transferred to the target solution hold tank, and then into the target solution vessel (TSV). The volume of uranyl sulfate solution in the TSV is described in Chapter 4a2.
- The neutron driver is energized and ramped up to power.
- The subcritical assembly is operated at power for approximately 5.5 days.
- The unit is shut down and the target solution is allowed to decay.
- The target solution is transferred to the radioisotope production facility (RPF) for processing.
ybdenum extraction is performed in a hot cell in the RPF. Mo extraction from irradiated target tion involves passing the irradiated target solution through an adsorbent. The Mo and other on products are adsorbed Mo is eluted using a base. The eluate is dried and redissolved in c acid. The resulting Mo-99 product is transferred to the Mo-99 purification system. The orbent for the Mo extraction process is contained in a packed column configuration.
ybdenum purification is performed in a hot cell in the RPF. The Mo-99 product is purified in a ratory glassware system.
fission product inventory from operation of the facility is discussed in Section 11.1. Normal ent release pathways from the SHINE facility to the environment are discussed in tion 11.1.
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SHINE facility does not produce either high-level nuclear wastes or spent nuclear fuel.
refore, the Nuclear Waste Policy Act of 1982 is not applicable to this facility.
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SHINE facility described in this report is new construction. There are no existing facilities, e have been no modifications, and there is no history to report. Therefore, this section is not licable to the SHINE facility.
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NRC, 2016. Safety Evaluation Report Related to SHINE Medical Technologies, Inc.
struction Permit Application for a Medical Radioisotope Production Facility, NUREG-2189,
. Nuclear Regulatory Commission, August 2016.
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