https://eutils.ncbi.nlm.nih.gov/entrez/eutils/efetch.fcgi?db=pubmed&id=33655880&retmode=xml&tool=Litmetric&email=readroberts32@gmail.com&api_key=61f08fa0b96a73de8c900d749fcb997acc09 336558802022051720221013
1874-47291522022Current radiopharmaceuticalsCurr RadiopharmMedia Fill Test for Validation of Non-Radioactive Kit for Radiopharmaceutical Preparations.104109104-10910.2174/1874471014666210303152908The administration of improperly prepared intravenous fluids might determine healthcare-associated infections. Quality and sterility assurance in radiopharmaceutical manufacturing products must be evaluated by media fill tests that simulate the performance of the aseptic manufacturing procedure. The aim of this study is to show a methodological modification of a specific step of media fill tests, giving an overview of economic and organizational advantages that it might bring.Media fill tests were conducted to ensure that they reproduce as strictly as possible the routine aseptic production process with all the critical steps described in the internal Standard Operating Procedures. We introduced an innovative modification in step 1: instead of using a completely decayed 99Mo/99mTc generator, we used a99Mo/99mTc generator just before its disposal, eluting it with saline solution aspirated in an empty vacuum vial.A total of 47 production runs were performed, and a total of 799 vials were tested for sterility. Thirteen nuclear medicine technicians were assessed. We found contamination in 1% of the total number of vials analyzed.The modification proposed shows several advantages: reduction of the costs of the media fill tests, the possibility to manage these without referring to external services, and decreased injuries for technicians who perform the tests.Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.VincentiSaraSDepartment of Women and Child Health and Public Health -Public Health Area, Fondazione Policlinico Universitario A. Gemelli IRCCS; Roma, Italia.ScotognellaTeresaTUnit of Nuclear Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS; Roma, Italia.BrunoStefaniaSSezione di Igiene, Istituto di Sanità Pubblica, Università Cattolica del Sacro Cuore; Roma, Italia.MarianiMarcoMSezione di Igiene, Istituto di Sanità Pubblica, Università Cattolica del Sacro Cuore; Roma, Italia.BonintiFedericaFDepartment of Women and Child Health and Public Health -Public Health Area, Fondazione Policlinico Universitario A. Gemelli IRCCS; Roma, Italia.CambieriAndreaADirezione Sanitaria, Fondazione Policlinico Universitario A. Gemelli IRCCS; Roma, Italia.DamianiGianfrancoGSezione di Igiene, Istituto di Sanità Pubblica, Università Cattolica del Sacro Cuore; Roma, Italia.LaurentiPatriziaPDepartment of Women and Child Health and Public Health -Public Health Area, Fondazione Policlinico Universitario A. Gemelli IRCCS; Roma, Italia.Sezione di Igiene, Istituto di Sanità Pubblica, Università Cattolica del Sacro Cuore; Roma, Italia.GiordanoAlessandroAUnit of Nuclear Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS; Roma, Italia.engJournal Article
United Arab EmiratesCurr Radiopharm1014687181874-47100RadiopharmaceuticalsIMDrug Contaminationprevention & controlHumansInfertilityRadiopharmaceuticalsMediafill testsaseptic assurancehealthcare associated infectionsmicrobial contaminationnonradioactivesterile products
20201152021120202112020213460202251860202133842ppublish3365588010.2174/1874471014666210303152908CRP-EPUB-114725