Quincoces Gemma, López-Sánchez Luisa, Sánchez-Martínez María, Rodríguez-Fraile Macarena, Peñuelas Iván
Radiopharmacy Unit, Department of Nuclear Medicine, University Hospital, University of Navarra School of Medicine, Av. Pío XII 36, 31008 Pamplona, Spain.
Appl Radiat Isot. 2010 Dec;68(12):2298-301. doi: 10.1016/j.apradiso.2010.07.003. Epub 2010 Jul 22.
We herein describe the design and performance evaluation of single-use whole-sterile "plug & play" kits for routine automated production of [(11)C]methionine and [(11)C]choline for human use. Kits were designed for maximal simplicity and ease of using modules from Eckert & Ziegler Modular Lab System. The use of all-disposable sterile medical-grade material, helps ensure safety and cGMP compliance. The quick set-up and removal ("plug & play") also reduces radiation burden to operator.
我们在此描述了用于人类使用的[(11)C]蛋氨酸和[(11)C]胆碱常规自动化生产的一次性全无菌“即插即用”试剂盒的设计和性能评估。试剂盒的设计旨在最大程度地简化操作,并便于使用Eckert & Ziegler模块化实验室系统中的模块。使用全一次性无菌医用级材料有助于确保安全性和符合cGMP规范。快速设置和移除(“即插即用”)还减少了操作人员的辐射负担。