Design of Hot-Laboratory

Seung Dae, Yang

ARTI, KAERI

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Project Planning

Factors Considered in Planning

- The need for cyclotron produced radionuclides and the requirements ofpotential users;

- The cost or benefit of having one’s own radionuclide manufacturingfacility versus purchasing radionuclides or radiopharmaceuticals from acommercial supplier within the country or importing from outside thecountry;

- The available resources, including technical and scientific expertise,infrastructure supporting the cyclotron facility and the funds forestablishing and operating the facility;

- The future availability of cyclotron produced radionuclides andradiopharmaceuticals from commercial suppliers (market competition)within and outside the country;

- The financial balance sheet through a business plan that addresses all factors

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Project Planning

Scope and Objective of the Facility

- Whether it is advisable to manufacture one’s own products or to buy froma supplier;

- What size and type of cyclotron is needed for this facility;

- What resources are required for successful implementation of thecyclotron facility;

- What are the project mission and goals?

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Facility Consideration

Definition of facility Type

Type I — Facility with only FDG production

Type II — Cyclotron facility with radionuclide production for PET.

Type III — Cyclotron facility with a research support staff

Type IV — Radionuclide production and distribution facility.

Type V — Cyclotron facility with an extensive research programme

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Facility Benefits

- Improved health care;

- Advancement of scientific expertise;

- Enhancement of technological competence in the country;

- Increasing self-sufficiency;

- Heightened national pride.

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Facility Cost

- Buildings and utilities;

- Equipment;Cyclotron (9–30 MeV); Hot cells (with or without manipulators);Radiation protection (shielding, monitoring); Synthesis modules;Chromatography (HPLC, GC, TLC scanner);Pyrogen and perhaps sterility testing (incubators, laminar flow cabinets);Gamma spectrometer; Gamma counter; Dose calibrator;QC laboratory equipment (pH meters, weighing balances, osmometers).

- Operational costsSupplies (chemicals, kits, spare parts, etc.);Utilities (power, water);Staff salaries;Maintenance;Depreciation (replacement).

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Plan of Facility Operation

- Products and services.

- Marketing plan.

- Operational plan and equipment. o Production of the radionuclides;o Synthesis of the radiopharmaceutical from the radionuclide;o Quality control and release of the radiopharmaceutical for use;o Distribution of radiopharmaceuticals;o Marketing of radiopharmaceuticals.

- Management and organization.

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Typical Cost

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Cyclotron Facility Design

General planning objectives

- Confine specific activities to functional areas and plan these areas toenhance workflow and efficiency;

- Improve and maintain overall environmental quality;

- Ensure that all regulatory requirements are met, including radiationprotection, industrial hygiene and radiopharmaceutical manufacture;

- Have sufficient staff to carry out all the required tasks, each with theappropriate level of expertise and experience.

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Cyclotron Facility Design

General Safety planning Guidelines

- Protection of the public.• Restricted access of the hot areas (in excess of 2.5 mSv/h)• adequate security provisions• Well shielded area• Minimized movement of radioactive material• Radioactive waste handling complying with all regulations.

- Protection of workers. • Radioisotope laboratories with sufficient floor space, counter

and hood space for safety (at least 3 m2/person)• Shielding around radioactive sources (less than 2.5 mSv/h)• Radiation alarm system• Materials of surfaces : easy decontamination• All radiation workers be appropriately trained

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Facility Design and Floor Plan

General planning objectives

- Confine specific activities to functional areas and plan these areas toenhance workflow and efficiency;

- Improve and maintain overall environmental quality;

- Ensure that all regulatory requirements are met, including radiationprotection, industrial hygiene and radiopharmaceutical manufacture;

- Have sufficient staff to carry out all the required tasks, each with theappropriate level of expertise and experience.

• Air flow

• Radiation level gradient

• Work Flow

Facility Design

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Cyclotron Vault and Workspace

• Self-shielded or unshieldedConcrete shielded house (vault)

• Vault Reasonably small but sufficient space for work and maintenance

• Trench and conduitPathway for cables, water, gas and product supply tubing

• AccessMaze or shielding door

• Thickness and composition of Cementneutron flux, Low alkali grade

• Minimize activation of concrete

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Cyclotron Vault and Workspace

Long-lived Activation Products in Concrete

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Utillity

• Power.

• Chilled water.

• Lighting

• Compressed air.

• Gas supplies.

• Hydrogen generator.

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Hot Laboratory

• Planned as a suite of roomsConsidering the scope of work and number of workers

• Main laboratories more than two for handlling different level of radioactivity

• Separate radioactive store

• Office for record keeping

• Local regulations precedent consulted with local authorities

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Hot-cell Design

Hot-cells with different opening design

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Workflow

Schematic Diagram of material flow(Raw materials and products)

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Workflow

Schematic diagram showing flow of people

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Examples of Cyclotron Facilities

Simple FDG production and distribution

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Examples of Cyclotron Facilities

PET radiopharmaceuticals production and distribution

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Examples of Cyclotron Facilities

Radiopharmaceutical production, distribution and research center

Thank you for your attention