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Information × Registration Number 0220U101433, 0119U001610 , R & D reports Title Investigation of the bioequivalence of generic radiopharmaceutical sodium iodide (I-131), developed by the INR of NAS of Ukraine, and organization of its manufacturing popup.stage_title Head Trishin Vladimir V., Кандидат фізико-математичних наук Registration Date 11-02-2020 Organization Institute for Nuclear Research of NAS of Ukraine popup.description2  The reconstruction and preparation of technical premises of the radiochemical laboratory (RCL) and class of laboratory of radionuclides and radiopharmaceuticals (PH and RFP) in accordance with the requirements of the State Service of Ukraine for medicinal products to premises for the production of medicinal products have been carried out. In particular, the following activities were carried out: reduction of the volume of the operator room of "hot" cameras (cleanliness class C) in order to achieve the required air exchange rate in accordance with the possibilities of an existing air preparation unit (Swegon BASIC & BCEA); modernization of supply air ventilation ducts to ensure the installation of HEPA filters; The specifications for the purchase of wall cladding panels (partially purchased) for cleanliness class C premises (operator "hot" chambers, closure zone, sanitary gateway) have been compiled. Reconstruction work has started on the III class RCL premises intended for quality control of RFP. The units for the synthesis of sodium iodide (131I) solution in the form of solution and capsules have been modernized, namely, the volume of columns has been increased to increase their productivity; a remote controlled unit for dispensing sodium iodide solution (131I) into capsules and packing them into vials was designed and manufactured. Specifications for the purchase of RFP quality control equipment within the IAEA technical cooperation project UKR6012 have been developed. The Regulations on the Laboratory of PH and RFP and the Laboratory Passport were developed. A package of documents has been prepared to get SanPassport to work with radioactive substances in the laboratory. Product Description popup.authors popup.nrat_date 2020-04-02 Close