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{{#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)
(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)
(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.
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.
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.
If you have any questions, please contact Mr. Jim Costedio, Licensing Manager, at 608/210-1730.
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
I declare under the penalty of perjury that the foregoing is true and correct.
.com Page 1 of 2 ENCLOSURE 1   SHINE MEDICAL TECHNOLOGIES, INC.
Executed on September 28, 2015.
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
Very truly yours, Gregory Piefer, Ph.D.
. 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).
Chief Executive Officer SHINE Medical Technologies, Inc.
The procedure(s) will document the potential hazards or undesirable conditions that may develop, and means to prevent or mitigate those conditions
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
. Examples of topics the procedure(s) will address include:
 
Safe conditions for process vessels to reduce corrosion potential
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
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).
-use and spent chemical extraction columns in the Mo-99 extraction and uranium extraction (UREX) subsystems
The procedure(s) will document the potential hazards or undesirable conditions that may develop, and means to prevent or mitigate those conditions.
. Limits on storage parameters (e.g., temperature, pressure), especially if more restrictive than normal operational limits
Examples of topics the procedure(s) will address include:
. 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).
* Safe conditions for process vessels to reduce corrosion potential.
Requirements for draining, flushing, and decontaminating equipment and piping
* 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.
. Removal of moisture (e.g., drying, purging) from certain systems
* Requirements for handling and storing in-use and spent chemical extraction columns in the Mo-99 extraction and uranium extraction (UREX) subsystems.
. 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
* 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 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).}}
* 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}}

Latest revision as of 06:15, 31 October 2019

Shine Medical Technologies. Inc. Application for Construction Permit, Shine Strategy for Extended Plant Shutdowns
ML15271A314
Person / Time
Site: SHINE Medical Technologies
Issue date: 09/28/2015
From: Piefer G
SHINE Medical Technologies
To:
Document Control Desk, Office of Nuclear Reactor Regulation
References
SMT-2015-051
Download: ML15271A314 (3)


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