NRRC-SG-07-Application For Authorization of Radioisotope Production Using Accelerators
NRRC-SG-07-Application For Authorization of Radioisotope Production Using Accelerators
NRRC-SG-07-Application For Authorization of Radioisotope Production Using Accelerators
Application for
Authorization of
Radioisotope Production
Using Accelerators Practice
NRRC-SG-007
2023
NRRC-SG-007
Classification: Public
Stakeholder Guideline
Application for Authorization of Radioisotope Production Using Accelerators Practice
2023
NRRC-SG-007
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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NRRC-SG-007
Classification: Public
Preamble
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
Contents
1. Purpose 3
2. Scope 3
3. Definitions 3
4. Abbreviations 4
5. Authorization Stages 4
5.1 Stage 1: Site authorization 4
5.2 Stage 2: Design, Construction, and installation of
the accelerator and other equipment 5
5.3 Stage 3: Testing and commission 6
5.4 Stage 4: Operation 6
5.5 Stage 5: Decommissioning 7
6. Relevant information in Support of the Authorization
Process 7
6.1 General and Administrative Information 7
6.2 Integrated Management System (Applicable for Stage 2 and 4). 7
6.3 Technical information (Applicable for Stage 2, 3 and 4). 8
6.4 Safety Assessment (Applicable for Stage 2 and 4). 10
6.5 Radiation Protection Programme (Applicable for Stage 2, 3 and 4). 10
6.6 Radioactive Waste Management Plan (Applicable for
Stage 2, 3 and 4). 12
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
1. Purpose
Nuclear and Radiological Regulatory Commission (NRRC) has devel-
oped an effective regulatory framework for the safe and secure autho-
rization of radioisotopes production in a cyclotron practice throughout
its life cycle. Under the regulatory framework, the prime responsibility
for safety and security within industrial radiography practice lies with
the authorized person.
The purpose of this guideline document is to give the applicant and/
or the authorized person clear and specific guidance on the submission
for the purpose of authorization of radioisotopes production in a cy-
clotron.
2. Scope
This guideline addresses facilities and activities who practice radioiso-
topes production in a cyclotron, in particular, will address the man-
agement system, radiation protection, safety, including storage and
transport. However, it is considered appropriate that a graded approach
in the application of the requirements will be taken into account and
should be adapted to the risks inherent to each facility.
This guideline includes the required information relating to radiation
safety and security by the NRRC in order to verify the adequacy of
the proposed safety and security measures as part of the authorization
process.
This guideline includes the required information relating to authoriza-
tion of new license, renewal as well as amendment of license.
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3. Definitions
Site
A geographical area that contains an authorized facility, authorized ac-
tivity or source, and within which the management of the authorized
facility or authorized activity or first responders may directly initiate
emergency response actions.
Commissioning
The process by means of which systems and components of facilities and
activities, having been constructed, are made operational and verified to
be in accordance with the design and to have met the required perfor-
mance criteria.
Construction
The process of manufacturing and assembling the components of a fa-
cility, the carrying out of civil works, the installation of components and
equipment, and the performance of associated tests.
Design
The process and the result of developing a concept, detailed plans, sup-
porting calculations and specifications for a facility and its parts.
Operation
All activities performed to achieve the purpose for which an authorized
facility was constructed.
Decommissioning
Administrative and technical actions taken to allow the removal of some
or all of the regulatory controls from a facility.
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
Controlled area
A defined area in which specific protection measures and safety provi-
sions are or could be required for controlling exposures or preventing
the spread of contamination in normal working conditions, and pre-
venting or limiting the extent of potential exposures.
Supervised area
A defined area not designated as a controlled area but for which occupa-
tional exposure conditions are kept under review, even though specific
protection measures or safety provisions are not normally needed.
4. Abbreviations
Abbreviation Definition
NRRC Nuclear and Radiological Regulatory Commission
RPP Radiation Protection Program.
RSO Radiation Safety Officer.
QC Quality Control
SP Security Plan
5. Authorization Stages
5.1. Stage 1: Site authorization
5.1.1. Project Details
• Description of the facility
- Nature of the planned activities; purpose of oper-
ation
- Type of accelerator to be installed.
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- Particles to be accelerated.
- Beam specifications (Max beam current and ener-
gy)
- Type of radioactive materials that will be produced.
- Site specific requirements for the facility
• Description of the infrastructure supporting the facil-
ity, proposed vendor company and technical and sci-
entific expertise that will support the development and
operation.
• Information on the financial assurance for establish-
ing, operating, and decommissioning of the facility.
5.1.2. Proposed location of the facility, site specific information
• Location of the facility
• Site characteristics (site geography, seismology, meteo-
rology, hydrogeology,).
• Surrounded area (Road map, adjacent facilities, public
and nearby residential localities, and ground water)
• Environmental radioactivity analysis report (Back-
ground radiation on site).
• Layout and civil engineering drawings.
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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NRRC-SG-007
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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• Safe transport.
• Import and export of radioactive sources.
• Control of visitors.
• Program for the improvement of the integrated man-
agement system.
6.3. Technical information (Applicable for Stage 2, 3 and 4).
6.3.1. Equipment
The applicant should provide detailed description of the
following equipment:
• Description of the Cyclotrons (technical and operation-
al characteristics, shielding, access points, under pres-
sure, alarms, flow velocity, indication of flow, finishing
of surfaces and materials).
• Description of the hot cells, laminar fume hoods.
• Description of the synthesis and dispensing modules to
be used, model, manufacturer, capabilities.
• Compressed air and gas systems;
• Special drains system for liquid radioactive effluents
and decay or delay systems;
• Back-up or emergency electrical system: should supply
services essential for safety such as: emergency lighting,
safety systems, radiation protection systems, etc.;
• Radiation monitoring system: identification and de-
scription of equipment, location;
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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- Audit and review of the RPP and the Security Program (SP).
- Specify the methods for periodic auditing and review of im-
plementation of the RPP and SP.
6.5.2. Protection of Public
• System of protection and safety to protect members of the
public:
- Describe the system of protection and safety to protect
members of the public.
- Demonstrate that optimization of radiation protection
of public is in place.
- Demonstrate that assessment, control, and surveil-
lance of external exposure of public are in place, i.e.,
use of dose constraints for the member of the public.
Provide assumptions used to assess external exposure
of public.
- Describe training of personnel having functions rele-
vant to protection and safety of members of the public.
Demonstrate that monitoring program and manage-
ment of records are in place.
- Describe the use of signs, labels, marks, and notices
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
• Reporting
The report should include the following:
- A detailed description of the emergency, including
specifics of the equipment and source(s) involved.
- Environmental and working conditions at the time of
the emergency, with reference to whether or not these
conditions played any significant part in causing the
emergency or affecting the outcome.
- The root causes of the emergency.
- A detailed description of the emergency response tak-
en.
- The personnel involved, the work they performed, and
their skills and qualifications.
- An assessment and summary of the doses received by
all affected individuals.
- Corrective actions identified with the aim of prevent-
ing similar emergencies in the future and necessary for
improving overall radiation safety, security, and emer-
gency arrangements.
- Proposed means and time frames for implementation
of the corrective actions identified and responsible
staff.
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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Classification: Public
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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Classification: Public
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice
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Classification: Public
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Kingdom of Saudi Arabia
@saudinrrc
nrrc.gov.sa