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Information × Registration Number 0218U001055, 0116U007036 , R & D reports Title Creating of the laboratory for microbiological control of production conditions and quality of radiopharmaceuticals in the Institute for Nuclear Research of Ukraine popup.stage_title Head Tryshyn Volodymyr, Кандидат фізико-математичних наук Registration Date 11-01-2018 Organization Sceintific Center "Inststute for nuclear reaseach National Academy of sciences Ukraine popup.description2 Report on research work, 20 p., 1 figure, 3 tables, 9 normative-technical sources. bject of research - regulatory requirements for control of class cleanliness of premises for the production of radiopharmaceuticals. The purpose of the work is to continue the equipping work on the "clean" premises of the laboratory of microbiological control for production conditions and quality of the RFP; development of the first version of the basic standard operating procedures (SOP) for monitoring the degree of purity of technological premises for the production of RFPs. The results of the research work - based on the analysis of requirements for the control of the class cleanliness of premises for the production of medicinal products, and in particular RFP, set forth in normative sources, standard operational procedures were developed and prepared for monitoring the amount of aerosol particles and microorganisms in the air of "clean" facilities, microbiological purity surfaces of production facilities and technological equipment, overalls of personnel. The "clean" facilities of the Laboratory for Microbiological Control were continued. Installed window-gateways for transmission in a "clean" test room for analysis; a system of controlled access to the laboratory was provided, installation of power supply and lighting systems was performed. Partially purchased and installed stainless steel laboratory furniture for "clean" rooms. Key words: RADIOPHARMACEUTICALS, LABORATORY OF MICROBIOLOGICAL CONTROL, "CLEAN" PREMISES, STANDARD OPERATING PROCEDURE, AEROSOL PARTICLES, BIOPOLLUTION Product Description popup.authors Бездробна Л.К. Тришин В.В. Федорченко В.І. Циганок Т.В. popup.nrat_date 2020-04-02 Close