Setting up the Medical Cyclotron Facility at Cochin, Kerala. M.R.A. Pillai Ph.D; D.Sc Molecular Cyclotrons Ltd. Cochin

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1 Setting up the Medical Cyclotron Facility at Cochin, Kerala M.R.A. Pillai Ph.D; D.Sc Molecular Cyclotrons Ltd. Cochin

2 AERB Approval Stagewise Site Assessment and Approval Design and Construction Approval Commissioning Decommissioning GUIDELINES TO START MEDICAL CYCLOTRON FACILITY.

3 IAEA Documents Cyclotron Produced Radionuclides 3

4 1. Site Approval No residential occupancy within 30 meters If not a stand alone building, type of occupancy in rest of the building is important Approach road for container movement Seismic condition History of earthquakes in the region Flooding potential Ground water level

5 2. Design and Construction Approval Preliminary Safety Analysis Report (PSAR) Complete bought outs are to be finalized at this point Design of the Laboratories should be complete EU GMP or US GMP? Clean Room Class C for hot cells General laboratories with Class D Cyclotron in Basement or Ground Floor

6 Cyclotron Siemens HP 11 MeV Protons Dual beam 60 ma Four 18F targets and one 13NH3 Tantalum targets ~ 10 tones Self shielded 2 movable shielding

7 Hot cells Von Gahlen, Netherlands Four synthesis hot cells 2x100 mm Pb 2x75 mm Pb One dispensing hot cell Transfer box 75 mm Pb Unshielded Delay decay tanks

8 Radiation Protection System Rotem Medi-Smart Radiation protection program 6 Area gamma monitors One neutron Monitor Two stack monitor PM11 and GM42 Two Hand and foot contamination monitors Telectector Survey meters Contamination monitors

9 Supporting Services HVAC to maintain temperature and humidity Clean room filtered air supply Chillers Air compressors Air handling units to filter the radioactive air Most services placed on the top of the cyclotron vault

10 Cyclotron Supply of gases Hydrogen 6N purity Argon 5.5 N purity Nitrogen 5.5 N purity Hot cell Nitrogen 5N purity Compressed air Quality control/gc

11 Lay Out of the Cyclotron Facility

12 PSAR Review PSAR is reviewed by AERB officers and after that by the relevant AERB committee After review of PSAR, the construction approval is given Note: Do not deviate from the plans provided to AERB at the time of construction

13 Installation 9 m x 10 m concrete vault 60 cm sides and 75 cm shielding on the top Cyclotron installation preparation starts one meter below ground Pipelines for passing radioactivity to the hot cells Pipe lines for water vent Chilled water pipelines Gas pipelines

14 Vault Preparation

15 Mechanical Installation The Cyclotron comes in 15 tone container lorries Adequate space for the movement of the lorry inside the premise is needed Cyclotron is introduced in the vault from the roof top. Crane accessibility is crucial The vault is then plugged with the precast concrete plug which weighs ~17.5 tonnes

16

17

18 Cyclotron

19 Control Room

20 Material Preparation Laboratory

21 Hot Cells Clean Room Area (Class C) Hotcells (Class B) Dispensing Hotcell (Class A)

22 Service Area of the Hot cell

23 Synthesis Module Explora 4 Acetonitrile Water Mannose trifalte Kryptofix 2 N HCl QMA columns Purification Columns Cation

24 Quality Control Laboratory Thin Layer Chromatography Gas Chromatography Bacterial Endotoxin Reader Multichannel Analyzer Charles River Endo Safe 2 x Incubators CAPINTEC Dose Calibrator

25 Packing and Dispatch Room

26 Clean Corridors

27 Delay-Decay Tank for Radioactive Gases

28 Radiation Monitoring System

29 Air handling System and Filter Units

30 Trial Run and Commissioning APPLICATION FOR LICENCE FOR COMMISSIONING AND OPERATION OF MEDICAL CYCLOTRON FACILITY RSO available at site and approved by AERB Training of all the staff for Cyclotron operation Security plan for the facility Radiation Protection Manual License given for three months after AERB Inspection

31 Licensing Documents Final Safety Analysis Report (FSAR) Installation and Commissioning Reports Radiation Protection Manual Quality Assurance Manual Standard Operating Procedures Procedures FSAR evaluation by AERB Revised FSAR

32

33 Thank you

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