Vincenti Sara, Scotognella Teresa, Bruno Stefania, Mariani Marco, Boninti Federica, Cambieri Andrea, Damiani Gianfranco, Laurenti Patrizia, Giordano Alessandro
Department of Women and Child Health and Public Health -Public Health Area, Fondazione Policlinico Universitario A. Gemelli IRCCS; Roma, Italia.
Unit of Nuclear Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS; Roma, Italia.
Curr Radiopharm. 2022;15(2):104-109. doi: 10.2174/1874471014666210303152908.
The 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 Mo/Tc generator, we used aMo/Tc 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.
使用制备不当的静脉输液可能会导致医疗相关感染。放射性药物生产产品的质量和无菌保证必须通过模拟无菌生产过程性能的培养基灌装试验来评估。本研究的目的是展示培养基灌装试验特定步骤的方法改进，概述其可能带来的经济和组织优势。
进行培养基灌装试验，以确保尽可能严格地重现常规无菌生产过程以及内部标准操作规程中描述的所有关键步骤。我们在步骤1中引入了一项创新改进：不是使用完全衰变的钼/锝发生器，而是在即将废弃前使用钼/锝发生器，用抽空的空真空瓶中吸入的盐溶液对其进行洗脱。
共进行了47次生产运行，共检测了799个小瓶的无菌性。对13名核医学技术人员进行了评估。我们在所分析的小瓶总数中发现1%存在污染。
所提出的改进显示出若干优势：降低了培养基灌装试验的成本，无需借助外部服务即可进行管理，并且减少了进行试验的技术人员受到的伤害。
