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用于以放射性药物质量常规自动化生产[(11)C]胆碱和[(11)C]蛋氨酸的一次性全无菌“即插即用”试剂盒的设计与性能评估

Design and performance evaluation of single-use whole-sterile "plug & play" kits for routine automated production of [(11)C]choline and [(11)C]methionine with radiopharmaceutical quality.

作者信息

Quincoces Gemma, López-Sánchez Luisa, Sánchez-Martínez María, Rodríguez-Fraile Macarena, Peñuelas Iván

机构信息

Radiopharmacy Unit, Department of Nuclear Medicine, University Hospital, University of Navarra School of Medicine, Av. Pío XII 36, 31008 Pamplona, Spain.

出版信息

Appl Radiat Isot. 2010 Dec;68(12):2298-301. doi: 10.1016/j.apradiso.2010.07.003. Epub 2010 Jul 22.

Abstract

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.

摘要

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。

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