ML15351A282

Official Exhibit - SHN-027-MA-CM01 - Shine Presentation Slides: Safety Panel 1

ML15351A282
Person / Time
Site:	SHINE Medical Technologies
Issue date:	12/15/2015
From:	SHINE Medical Technologies
To:	NRC/OCM
SECY RAS
References
Mandatory Hearing 2, RAS 28628, 50-608-CP
Download: ML15351A282 (6)

Text

United States Nuclear Regulatory Commission Official Hearing Exhibit In the Matter of: SHINE MEDICAL TECHNOLOGIES, INC.

(Medical Radioisotope Production Facility)

Commission Mandatory Hearing Docket #: 05000608 Exhibit #: SHN-027-MA-CM01 Identified: 12/15/2015 Admitted: 12/15/2015 Withdrawn:

Rejected: Stricken:

Other: Exhibit SHN-027 Commission Mandatory Hearing SHINE Construction Permit Application S f Safety - Panel P l1 Facility December 15,, 2015

SHINE Process Overview Supercell Recycle y Loop p Product TSV and Recycle tank Irradiation Unit Cell Hold tank Periodic Cleanup Loop UREX and associated cleanup processes Target Solution Preparation 2

Design of Structures, Systems, and Components Certain structures structures, systems, systems and components (SSCs) are designated safety-related because they are relied upon to perform safety functions during normal operation or design basis events SSCs must be able to perform their design basis functions during normal operation and under required accident conditions SSCs that are determined to have safety significance are designed, fabricated, and tested commensurate with the criteria set forth in ANSI/ANS-15.8 (Quality (Q y Assurance Program Requirements for Research Reactors) 3

Safety-Related SSC Definition Safety-related SSCs are those SSCs that are relied upon to remain f

functional ti l during d i normall conditions diti and dd during i and d ffollowing ll i d design i basis b i events to assure:

1. The integrity of the primary system boundary; p

2. The capability y to shutdown the target g solution vessel ((TSV)) and maintain the target solution in a safe shutdown (SSD) condition;

3. The capability to prevent or mitigate the consequences of accidents which could result in potential exposures comparable to the applicable guideline exposures set forth in 10 CFR 20;

4. That all nuclear processes are subcritical, including use of an approved margin of subcriticality;

5. That acute chemical exposures to an individual from licensed material or hazardous chemicals produced from licensed material could not lead to irreversible or other serious, long-lasting health effects to a worker or cause mild transient health effects to any individual located outside the owner controlled area; or

6. That an intake of 30 mg g or g greater of uranium in soluble form byy any y individual located outside the owner controlled area does not occur 4

Seismic Design and Quality Levels Plant SSCs are designed to withstand the effects of the design basis earthquake (DBE) if they perform a safety-related function or if necessary to ensure they do not degrade the function and performance of a safety-related SSC SHINE Quality Levels (QLs):

QL-1: Safety-related SSCs are designated as QL-1 in the Quality Assurance Program Description (QAPD), and the full measure of the QAPD is applied to these SSCs QL-2: Selected SSCs that support or protect the safety function of safety-related equipment are designated QL-2, and quality elements are applied commensurate with the importance to safety QL-3: Nonsafety SSCs that do not support or protect the safety function of safety-related SSCs are designated QL-3 5

Design of Structures, Systems, and Components Single g failure criterion is appliedpp to safety y systems y

Sufficient redundancy and independence that a single failure of an active component does not result in loss of capability to perform its safety function A single failure, in conjunction with initiating event, does not result in the loss of the systems ability to perform its safety function SHINE system t designs d i b based d on d defense-in-depth f i d th practices, with preference for engineered and passive controls over administrative controls 6

United States Nuclear Regulatory Commission Official Hearing Exhibit In the Matter of: SHINE MEDICAL TECHNOLOGIES, INC.

(Medical Radioisotope Production Facility)

Commission Mandatory Hearing Docket #: 05000608 Exhibit #: SHN-027-MA-CM01 Identified: 12/15/2015 Admitted: 12/15/2015 Withdrawn:

Rejected: Stricken:

Other: Exhibit SHN-027 Commission Mandatory Hearing SHINE Construction Permit Application S f Safety - Panel P l1 Facility December 15,, 2015

SHINE Process Overview Supercell Recycle y Loop p Product TSV and Recycle tank Irradiation Unit Cell Hold tank Periodic Cleanup Loop UREX and associated cleanup processes Target Solution Preparation 2

Design of Structures, Systems, and Components Certain structures structures, systems, systems and components (SSCs) are designated safety-related because they are relied upon to perform safety functions during normal operation or design basis events SSCs must be able to perform their design basis functions during normal operation and under required accident conditions SSCs that are determined to have safety significance are designed, fabricated, and tested commensurate with the criteria set forth in ANSI/ANS-15.8 (Quality (Q y Assurance Program Requirements for Research Reactors) 3

Safety-Related SSC Definition Safety-related SSCs are those SSCs that are relied upon to remain f

functional ti l during d i normall conditions diti and dd during i and d ffollowing ll i d design i basis b i events to assure:

1. The integrity of the primary system boundary; p

2. The capability y to shutdown the target g solution vessel ((TSV)) and maintain the target solution in a safe shutdown (SSD) condition;

3. The capability to prevent or mitigate the consequences of accidents which could result in potential exposures comparable to the applicable guideline exposures set forth in 10 CFR 20;

4. That all nuclear processes are subcritical, including use of an approved margin of subcriticality;

5. That acute chemical exposures to an individual from licensed material or hazardous chemicals produced from licensed material could not lead to irreversible or other serious, long-lasting health effects to a worker or cause mild transient health effects to any individual located outside the owner controlled area; or

6. That an intake of 30 mg g or g greater of uranium in soluble form byy any y individual located outside the owner controlled area does not occur 4

Seismic Design and Quality Levels Plant SSCs are designed to withstand the effects of the design basis earthquake (DBE) if they perform a safety-related function or if necessary to ensure they do not degrade the function and performance of a safety-related SSC SHINE Quality Levels (QLs):

QL-1: Safety-related SSCs are designated as QL-1 in the Quality Assurance Program Description (QAPD), and the full measure of the QAPD is applied to these SSCs QL-2: Selected SSCs that support or protect the safety function of safety-related equipment are designated QL-2, and quality elements are applied commensurate with the importance to safety QL-3: Nonsafety SSCs that do not support or protect the safety function of safety-related SSCs are designated QL-3 5

Design of Structures, Systems, and Components Single g failure criterion is appliedpp to safety y systems y

Sufficient redundancy and independence that a single failure of an active component does not result in loss of capability to perform its safety function A single failure, in conjunction with initiating event, does not result in the loss of the systems ability to perform its safety function SHINE system t designs d i b based d on d defense-in-depth f i d th practices, with preference for engineered and passive controls over administrative controls 6