Construction Work – Establishment Of A Gmp Plant Producing Radiopharmaceuticals. The Task Of The Winning Tenderer Is To Establish A Manufacturing Plant Producing Radiopharmaceutical Preparations Based On Cyclotron Technology. The Net Useful Floor Area Of The Building Created By The Construction Investment: 232.34 M2. The Primary Purpose Of The Plant Created By The Investment Is To Create Radiative Isotopes (F18, O15, After Expansion N13 And C11) Using Cyclotron Technology, And Then To Manufacture Radiopharmaceuticals From Them, As In-Vitro Preparations. The Built Infrastructure Of The Manufacturing Plant And The Built-In Set Of Production Technology Tools Form A Complex Unit (Hereinafter: System). Since The Products Produced By The Production Plant That Is The Subject Of The Construction Investment And The Production Process Itself Involve Radiation Exposure, Fully Automatic Cyclotron-Based Production Technology With Self-Shielding Was Designed To Reduce This. All Planned Built-In Production Equipment Works In An Integrated Manner With The Entire Production Plant, The Radioactive Semi-Finished Products Travel On A Closed Isotope Extraction System To The Other Equipment Of The Production Process. Radiant Ion Products Must Be Produced With A Proton Energy Of At Least 7 Mev. For The Planned Production Capacity Of The Production Facility, A Minimum Of 1.5 Ci Of F18 Should Be Produced During A 2-Hour Cyclotron Cycle, But The Ideal Amount Is 2.5 Ci. For The O15 Isotope, A Minimum Of 50 Mci Is Required For A 10-Minute Cycle. However, The System To Be Created Must Also Be Suitable For Expansion With Targets For The Production Of N13 Or C11 Isotopes. The Entire Production Process Takes Place In Minimum Level C Cleanrooms, Within Which Level A Cleanliness Conditions Are Also Met In The Demarcated Areas (Radiation Protection And Manipulation Booths). The Total Floor Area Of The C-Level Clean Rooms To Be Created By The Winning Bidder: Net 46.06 M2. The Building Created As A Result Of The Investment Forms A Mass Of Buildings, But It Can Be Structurally Divided Into Two Parts. On The Entrance Side, The New Building Consists Of A Section Classified As A Controlled Area From A Radiation Protection Point Of View, And Then A Cyclotron-Radiochemistry Room Group With A Controlled Entrance, Classified As A Controlled Area. You Can Enter The Production Plant From The Boiler House. In The Area Of The Building Designated As The Supervised Area From The Point Of View Of Radiation Protection, The Staff Changing Room And Water Block, The Staff Accommodation (Tea Kitchen: 9.21 M2), The Raw Material Inspection Room (12.96 M2), And The Room For Dispensing Radiopharmaceuticals Produced For Sale (Dispatch ) (6.85 M2). The Controlled Area Of The Cyclotron-Radiochemistry Room Group Can Be Accessed From The Entrance Section Classified As A Controlled Area Through A Controlled Entrance. ). Beyond The Clean Room Airlock, Through The Clean Rooms Internal Corridor, We Can Reach The Radiochemistry Clean-Room Production (24.26 M2) And Development Warm Laboratory (24.53 M2). Positron Decay Radionuclides Are Placed In The Cyclotron Room
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