Search academic texts

Information × Registration Number 0219U000321, 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 25-01-2019 Organization Sceintific Center "Inststute for nuclear reaseach National Academy of sciences Ukraine popup.description2 Report on research work 57 p., 6 figures, 9 tables, 18 normative and technical sources. The object of the study - regulatory and technical requirements for microbiological control laboratory (MBC) of conditions for production and quality of radiopharmaceuticals. The purpose of the work is to create the "clean" premises of the laboratory of the MBC, conditions of production and quality of the RFP in the Institute of Nuclear Science of the National Academy of Sciences of Ukraine; development of basic standard operating procedures (SOPs) for monitoring the sanitary and hygienic condition of premises for the production of RFP and microbiological purity and sterility of finished products. The results of the research work - based on the analysis of the requirements for "clean" premises and the work on sources of ionizing radiation in the open form, set out in the normative and technical documents, developed conceptual design documentation for the creation of "clean" premises of the laboratory MBC. According to it, the "clean" laboratory premises (total area 47.35 m2) were assembled and equipped: boxes with purity classes C (for controlling MB purity of production facilities and manufactured RFP) and B (for monitoring of sterility of RFP) and transitional sanitary check valves classes D, D / C, C / B to separate rooms of different grade of purity. Stainless steel laboratory furniture (in accordance with GLP WHO) and desk laminar airflow boxes that provide a cleanliness class A. The program of monitoring of sanitary conditions in industrial premises in their equipped and operating conditions is developed; instructions for SOPs have been developed: the definition of aerosol particles and microorganisms in the air of industrial premises; control of MB contamination of surfaces of premises and equipment, technological clothes. The number and location of sampling points for analysis, frequency of sampling and required volumes of samples are determined. SOPs for testing on MB purity of sodium iodide solution 131I (for oral use) and sterility of portable technetium 99mTc (for receiving injectable PPP sodium pertechnetate 99mTc in clinic conditions) were developed. The number of specimens for analysis for each series of radiopharmaceuticals and the timing of tests after their production have been determined. Key words: laboratory of microbiological control, "clean" premises, radiopharmaceuticals, technetium generator-99m, sodium iodide solution I137, standard operating procedure, microbiological purity, sterility. Product Description popup.authors Бездробна Л.К. Божок О.В. Тришин В.В. Федорченко В.І. Циганок Т.В. popup.nrat_date 2020-04-02 Close