|
|
(2 intermediate revisions by the same user not shown) |
Line 16: |
Line 16: |
|
| |
|
| =Text= | | =Text= |
| {{#Wiki_filter:September 28, 2015 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555 SMT-2015-051 10 CFR 50.30 | | {{#Wiki_filter:September 28, 2015 SMT-2015-051 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555 |
|
| |
|
| ==References:== | | ==References:== |
| | (1) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013, Part One of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML130880226) |
| | (2) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013, Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML13172A361) |
| | SHINE Medical Technologies. Inc. Application for Construction Permit SHINE Strategy for Extended Plant Shutdowns Pursuant to 10 CFR 50.30, SHINE Medical Technologies, Inc. (SHINE) submitted an application for a construction permit to construct a medical isotope facility to be located in Janesville, WI (References 1 and 2). provides the SHINE strategy for addressing an extended shutdown of the SHINE facility. |
| | If you have any questions, please contact Mr. Jim Costedio, Licensing Manager, at 608/210-1730. |
| | I declare under the penalty of perjury that the foregoing is true and correct. |
| | Executed on September 28, 2015. |
| | Very truly yours, Gregory Piefer, Ph.D. |
| | Chief Executive Officer SHINE Medical Technologies, Inc. |
| | Docket No. 50-608 Enclosure cc: Administrator, Region Ill, USNRC Project Manager, USNRC Environmental Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health 2555 Industrial Drive I Monona, WI 53713 I P (608) 210-1060 I F (608) 210-2504 I www.shinemed.com |
|
| |
|
| (1) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013, Part One of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML 130880226)
| | ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC. |
| (2) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013, Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML 13172A361)
| | SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT SHINE STRATEGY FOR EXTENDED PLANT SHUTDOWNS The SHINE facility has the capability to store the target solution batches and processing liquids in multiple locations. Those locations are designed to hold the liquids safely for an indefinite period of time. For example, the SHINE facility provides for eight target solution vessel (TSV) dump tanks, eight target solution hold tanks, and three recycle target solution tanks. Each of these tanks are sized to store at least one batch of target solution and include radiation shielding designed for storing such solution. Approximately twice as many tanks are capable of holding target solution as the number of batches of target solution planned to be in process at a given time, providing SHINE with flexibility in transferring and storing liquids. |
| SHINE Medical Technologies.
| | SHINE will develop procedure(s) during detailed design that will address actions to be taken for extended plant shutdowns (i.e., shutdowns longer than planned periodic maintenance outages). |
| Inc. Application for Construction Permit SHINE Strategy for Extended Plant Shutdowns Pursuant to 10 CFR 50.30, SHINE Medical Technologies, Inc. (SHINE) submitted an application for a construction permit to construct a medical isotope facility to be located in Janesville, WI (References 1 and 2). Enclosure 1 provides the SHINE strategy for addressing an extended shutdown of the SHINE facility.
| | The procedure(s) will document the potential hazards or undesirable conditions that may develop, and means to prevent or mitigate those conditions. |
| If you have any questions, please contact Mr. Jim Costedio, Licensing Manager, at 608/210-1730.
| | Examples of topics the procedure(s) will address include: |
| I declare under the penalty of perjury that the foregoing is true and correct. Executed on September 28, 2015. Very truly yours, Gregory Piefer, Ph.D. Chief Executive Officer SHINE Medical Technologies, Inc. Docket No. 50-608 Enclosure cc: Administrator, Region Ill, USNRC Project Manager, USNRC Environmental Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health 2555 Industrial Drive I Monona, WI 53713 I P (608) 210-1060 I F (608) 210-2504 I www.shinemed
| | * Safe conditions for process vessels to reduce corrosion potential. |
| .com Page 1 of 2 ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.
| | * Chemical solutions in the radioisotope production facility (RPF) that will need to be transferred to alternate containers or vessels for extended storage, and the acceptable storage locations. |
| SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT SHINE STRATEGY FOR EXTENDED PLANT SHUTDOWNS The SHINE facility has the capability to store the target solution batches and processing liquids in multiple locations. Those locations are designed to hold the liquids safely for an indefinite period of time. For example, the SHINE facility provides for eight target solution vessel (TSV) dump tanks, eight target solution hold tanks, and three recycle target solution tanks. Each of these tanks are sized to store at least one batch of target solution and include radiation shielding designed for storing such solution. Approximately twice as many tanks are capable of holding target solution as the number of batches of target solution planned to be in process at a given time, providing SHINE with flexibility in transferring and storing liquids | | * Requirements for handling and storing in-use and spent chemical extraction columns in the Mo-99 extraction and uranium extraction (UREX) subsystems. |
| . SHINE will develop procedure(s) during detailed design that will address actions to be taken for extended plant shutdowns (i.e., shutdowns longer than planned periodic maintenance outages).
| | * Limits on storage parameters (e.g., temperature, pressure), especially if more restrictive than normal operational limits. |
| The procedure(s) will document the potential hazards or undesirable conditions that may develop, and means to prevent or mitigate those conditions | | * Chemical or radioactive solutions that will be processed and disposed of to reduce potential for long term chemical reactions (e.g., in-use UREX solvent). |
| . Examples of topics the procedure(s) will address include:
| | * Requirements for draining, flushing, and decontaminating equipment and piping. |
| Safe conditions for process vessels to reduce corrosion potential | | * Removal of moisture (e.g., drying, purging) from certain systems. |
| . Chemical solutions in the radioisotope production facility (RPF) that will need to be transferred to alternate containers or vessels for extended storage, and the acceptable storage locations
| | * Required operating parameters of ventilation systems and the process vessel vent system (PVVS). |
| . Requirements for handling and storing in
| | * Acceptable storage locations for prepared target solution batches in the irradiation facility (IF) and RPF, including any chemical or physical measurements required during storage. |
| -use and spent chemical extraction columns in the Mo-99 extraction and uranium extraction (UREX) subsystems | | * Measurement processes (e.g., turbidity, pH, concentration) to be performed for target solution batches and other process chemicals prior to reuse and restart of the facility, associated acceptance criteria, and guidance for restoring the target solution or other chemicals to an acceptable state or processing for safe disposal, if necessary. |
| . Limits on storage parameters (e.g., temperature, pressure), especially if more restrictive than normal operational limits
| | * Operational requirements and procedural steps for safe startup following extended shutdowns. |
| . Chemical or radioactive solutions that will be processed and disposed of to reduce potential for long term chemical reactions (e.g., in-use UREX solvent).
| | Page 1 of 2 |
| Requirements for draining, flushing, and decontaminating equipment and piping | | |
| . Removal of moisture (e.g., drying, purging) from certain systems
| | SHINE will develop the procedure(s) during detailed design and will ensure that the final design of structures, systems, and components within the facility accommodates the completion of the procedural actions (e.g., sufficient capability to measure process parameters, sufficient storage capacity). An Issues Management Report (IMR) has been initiated to track development and implementation of the procedure(s). |
| . Required operating parameters of ventilation systems and the process vessel vent system (PVVS). Acceptable storage locations for prepared target solution batches in the irradiation facility (IF) and RPF, including any chemical or physical measurements required during storage. Measurement processes (e.g., turbidity, pH, concentration) to be performed for target solution batches and other process chemicals prior to reuse and restart of the facility, associated acceptance criteria, and guidance for restoring the target solution or other chemicals to an acceptable state or processing for safe disposal, if necessary
| | Page 2 of 2}} |
| . Operational requirements and procedural steps for safe startup following extended shutdowns.
| |
| Page 2 of 2 SHINE will develop the procedure(s) during detailed design and will ensure that the final design of structures, systems, and components within the facility accommodates the completion of the procedural actions (e.g., sufficient capability to measure process parameters, sufficient storage capacity). An Issues Management Report (IMR) has been initiated to track development and implementation of the procedure(s).}} | |
|
---|
Category:Letter
MONTHYEARML24128A2162024-05-0707 May 2024 Shine Technologies, LLC, Submittal of Annual Financial Report ML24047A0392024-02-16016 February 2024 Shine Technologies, LLC - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 ML23229A0202023-08-17017 August 2023 Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 ML23087A2272023-05-0505 May 2023 Shine Technologies, LLC - Issuance of Amendment No. 4 to Construction Permit No. CPMIF-001 for the Receipt and Possession of Contained Special Nuclear Material ML23086C0502023-04-27027 April 2023 Shine Technologies, LLC - Letter, Environmental Assessment and Finding of No Significant Impact ML23088A3382023-04-0505 April 2023 Shine Technologies, LLC - Review of the Physical Security Plan in Support of an Operating License for a Medical Radioisotope Production Facility ML23010A1982023-02-24024 February 2023 Shine Technologies, LLC - Letter: Safety Evaluation Report for the Shine Medical Radioisotope Production Facility Operating License Application ML23048A2442023-02-17017 February 2023 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML23010A2382023-02-0303 February 2023 Shine Technologies, LLC - Individual Notice of Consideration FRN Letter ML23034A1872023-02-0303 February 2023 Shine Medical Technologies, LLC Notice of Availability of Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility (Docket Number: 50-608) ML23023A0922023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23023A0942023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23023A0862023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23024A1682023-02-0101 February 2023 Letter to Ken Westlake, EPA Region 5 - Issuance of Final EIS Supplement Related to the Operating License ML22287A1852023-02-0101 February 2023 Shine Technologies, LLC Regulatory Report on the Audit of Phased Startup Operations Application Supplement ML23024A1742023-02-0101 February 2023 Dr. Gregory Piefer, Chief Executive Officer - Issuance of Final EIS Supplement Related to the Operating License ML22308A2332023-01-0909 January 2023 Shine Technologies LLC - Regulatory Audit Report for Chapter 8 - Irradiation Facility and Radioisotope Production Facility Electrical Power Systems ML22347A2142023-01-0404 January 2023 Shine Technologies LLC - Regulatory Audit Report for I&C Combined Sessions ML22356A1932022-12-22022 December 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Confirmatory Information ML22347A1772022-12-14014 December 2022 Shine Technologies LLC - Regulatory Audit Report for Programmable Logic Lifecycle ML22301A1492022-12-0707 December 2022 Shine Technologies, LLC - Regulatory Audit Report for Chapter 13 - Accident Analysis and Criticality Safety ML22322A2122022-12-0202 December 2022 Shine Medical Technologies - Cybersecurity Audit Summary Report ML22322A2232022-12-0202 December 2022 Shine Medical Technologies - Fire Protection Audit Summary Report ML22348A0672022-12-0101 December 2022 Shine Technologies, LLC - Request for Confirmatory Information Related to Instrumentation and Control Systems ML22335A5722022-12-0101 December 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22292A3192022-11-30030 November 2022 Shine Medical Technologies, LLC Issuance of Order and Amendment No. 3 to Construction Permit No. CPMIF-001 ML22318A1782022-11-14014 November 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22304A1262022-10-31031 October 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22279A9512022-10-0606 October 2022 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 ML22271A9632022-09-28028 September 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 31 Revision to the Phased Startup Operations Application Supplement ML22263A3442022-09-20020 September 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Additional Information ML22263A0272022-09-19019 September 2022 Shine Technologies, LLC - Application for an Operating License - Response to Request for Confirmatory Information ML22220A2612022-09-12012 September 2022 Shine Technologies LLC - Regulatory Report on the Audit Chapter 14, Technical Specifications ML22251A3272022-09-0808 September 2022 Shine Technologies, LLC Application for an Operating License Revision 1 of Shine Response to Requests for Additional Information 7-38, 7-40, and 7-48 ML22249A1252022-08-31031 August 2022 Shine Technologies, LLC Final Safety Analysis Report - Application for an Operating License Supplement No. 30, Cover Letter ML22105A1102022-08-26026 August 2022 Shine Medical Technologies LLC - Request for Additional Information Related to the OGC Review of Phrase Approach ML22061A2122022-08-24024 August 2022 Shine Medical Technologies LLC - Regulatory Audit Plan for Phased Approach - Session 1 ML22187A1342022-08-0101 August 2022 Shine Technologies, LLC - Update to Operating License Application Technical Review Schedule ML22213A0492022-08-0101 August 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22206A2082022-07-27027 July 2022 Shine Medical Technologies, LLC - Request for Confirmatory Information Related to Radiation Protection Program and Waste Management ML22207A0062022-07-26026 July 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 29 ML22202A4492022-07-21021 July 2022 Shine Technologies, LLC Operating License Application Supplement No. 28 - Submittal of a Revision to the Shine Emergency Plan ML22188A2412022-07-14014 July 2022 Meeting with Shine Medical Technologies, LLC (EPID No. L-2019-NEW-0004), to Discuss Development of Shine'S Cybersecurity Program for It'S Medical Isotope Production Facility ML22175A0392022-07-11011 July 2022 Letter to Reid Nelson, Achp Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22175A0542022-07-0808 July 2022 Letter to Gregory Piefer - Notice of Availability of the Draft EIS Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML22175A0912022-07-0808 July 2022 Notice of Availability and Request for Comments on the Draft Environmental Impact Statement Supplement Related to the Operating License for the Shine (Multiple Tribal Letters) ML22175A0772022-07-0808 July 2022 Letter to Daina Penkiunas - Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22175A0632022-07-0808 July 2022 Letter to Ken Westlake, EPA Region 5 - Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22188A1942022-07-0707 July 2022 Shine Technologies, LLC, Application for an Operating License Supplement No. 27 ML22188A0562022-07-0707 July 2022 Shine Technologies, LLC Operating License Application Supplement No. 26 Submittal of a Revision to the Shine Material Control and Accounting Plan 2024-05-07
[Table view] |
Text
September 28, 2015 SMT-2015-051 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555
References:
(1) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013, Part One of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML130880226)
(2) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013, Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML13172A361)
SHINE Medical Technologies. Inc. Application for Construction Permit SHINE Strategy for Extended Plant Shutdowns Pursuant to 10 CFR 50.30, SHINE Medical Technologies, Inc. (SHINE) submitted an application for a construction permit to construct a medical isotope facility to be located in Janesville, WI (References 1 and 2). provides the SHINE strategy for addressing an extended shutdown of the SHINE facility.
If you have any questions, please contact Mr. Jim Costedio, Licensing Manager, at 608/210-1730.
I declare under the penalty of perjury that the foregoing is true and correct.
Executed on September 28, 2015.
Very truly yours, Gregory Piefer, Ph.D.
Chief Executive Officer SHINE Medical Technologies, Inc.
Docket No. 50-608 Enclosure cc: Administrator, Region Ill, USNRC Project Manager, USNRC Environmental Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health 2555 Industrial Drive I Monona, WI 53713 I P (608) 210-1060 I F (608) 210-2504 I www.shinemed.com
ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.
SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT SHINE STRATEGY FOR EXTENDED PLANT SHUTDOWNS The SHINE facility has the capability to store the target solution batches and processing liquids in multiple locations. Those locations are designed to hold the liquids safely for an indefinite period of time. For example, the SHINE facility provides for eight target solution vessel (TSV) dump tanks, eight target solution hold tanks, and three recycle target solution tanks. Each of these tanks are sized to store at least one batch of target solution and include radiation shielding designed for storing such solution. Approximately twice as many tanks are capable of holding target solution as the number of batches of target solution planned to be in process at a given time, providing SHINE with flexibility in transferring and storing liquids.
SHINE will develop procedure(s) during detailed design that will address actions to be taken for extended plant shutdowns (i.e., shutdowns longer than planned periodic maintenance outages).
The procedure(s) will document the potential hazards or undesirable conditions that may develop, and means to prevent or mitigate those conditions.
Examples of topics the procedure(s) will address include:
- Safe conditions for process vessels to reduce corrosion potential.
- Chemical solutions in the radioisotope production facility (RPF) that will need to be transferred to alternate containers or vessels for extended storage, and the acceptable storage locations.
- Requirements for handling and storing in-use and spent chemical extraction columns in the Mo-99 extraction and uranium extraction (UREX) subsystems.
- Limits on storage parameters (e.g., temperature, pressure), especially if more restrictive than normal operational limits.
- Chemical or radioactive solutions that will be processed and disposed of to reduce potential for long term chemical reactions (e.g., in-use UREX solvent).
- Requirements for draining, flushing, and decontaminating equipment and piping.
- Removal of moisture (e.g., drying, purging) from certain systems.
- Required operating parameters of ventilation systems and the process vessel vent system (PVVS).
- Acceptable storage locations for prepared target solution batches in the irradiation facility (IF) and RPF, including any chemical or physical measurements required during storage.
- Measurement processes (e.g., turbidity, pH, concentration) to be performed for target solution batches and other process chemicals prior to reuse and restart of the facility, associated acceptance criteria, and guidance for restoring the target solution or other chemicals to an acceptable state or processing for safe disposal, if necessary.
- Operational requirements and procedural steps for safe startup following extended shutdowns.
Page 1 of 2
SHINE will develop the procedure(s) during detailed design and will ensure that the final design of structures, systems, and components within the facility accommodates the completion of the procedural actions (e.g., sufficient capability to measure process parameters, sufficient storage capacity). An Issues Management Report (IMR) has been initiated to track development and implementation of the procedure(s).
Page 2 of 2