Jacobson Mark S, Hung Joseph C, Mays Trenton L, Mullan Brian P
Nuclear Medicine, Department of Radiology, Mayo Clinic, Rochester, MN 55905, USA.
Mol Imaging Biol. 2002 Mar;4(2):119-27. doi: 10.1016/s1536-1632(01)00007-5.
The objectives of the Mayo positron emission tomography (PET) radiochemistry facility are the production of PET drugs for clinical service of our in-house patients, commercial distribution of PET drug products, and development of new PET drugs. The factors foremost in the planning and design phases were the current regulatory climate for PET drug production, radiation safety issues, and effective production flow. A medium-energy cyclotron was preferred for its small footprint to allow a compact vault, its high-proton energy to offer a higher product radioactivity; and its research capabilities. A vault installation was chosen instead of a self-shielded machine for improved access and ease of maintenance. Adjacent to the cyclotron is an area that houses the support equipment and a large dedicated workshop to support machine maintenance and targetry development. The total floor area of the PET radiochemistry facility is 344.2 m(2) (3,705.5 ft(2)), of which the radiochemistry laboratory occupies 130.7 m(2) (1,407 ft(2)). To reduce environmental contamination of PET drug products, the laboratory contains a controlled-air environment class 10,000 (M5.5) clean room with access via an interlocking entry change area. A fully shielded isolator (class 100 [M3.5]) is located in the clean room. The PET drugs are delivered via shielded tubing between the synthesizer and isolator. Inside the isolator, there is an automated device for dispensing the PET drug into either a bulk-activity vial or a unit-dose syringe. The dispensed PET radiopharmaceutical then passes through a hatch to a dedicated area where it is packaged for in-house use or commercial distribution. Unit doses for in-house patients are transported via pneumatic tube to the PET imaging area 76.2 m (250 ft) away. There is extensive radiation area monitoring throughout the facility that continuously measures radiation levels. We believe that our new PET radiochemistry facility not only meets overall objectives, but also provides an ergonomic, efficient working environment for the production and development of PET drugs.
梅奥正电子发射断层扫描（PET）放射化学设施的目标是生产用于本院患者临床服务的PET药物、PET药品的商业分销以及新PET药物的研发。在规划和设计阶段，首要考虑的因素是PET药物生产的当前监管环境、辐射安全问题以及有效的生产流程。选择中能回旋加速器是因其占地面积小，可采用紧凑的屏蔽室，质子能量高可提供更高的产品放射性，且具备研究能力。选择屏蔽室安装而非自屏蔽机器是为了便于操作和维护。回旋加速器旁边是一个区域，里面存放着支持设备和一个大型专用车间，以支持机器维护和靶材研发。PET放射化学设施的总建筑面积为344.2平方米（3705.5平方英尺），其中放射化学实验室占地130.7平方米（1407平方英尺）。为减少PET药品的环境污染，实验室设有10000级（M5.5）的控制空气环境洁净室，通过互锁式入口更换区域进入。洁净室内设有一个完全屏蔽的隔离器（100级[M3.5]）。PET药物通过合成器和隔离器之间的屏蔽管道输送。在隔离器内部，有一个自动装置，用于将PET药物分装到大容量活性瓶或单剂量注射器中。分装后的PET放射性药物随后通过一个舱口进入一个专用区域，在那里进行包装以供院内使用或商业分销。供本院患者使用的单剂量药物通过气动管道输送到76.2米（250英尺）外的PET成像区域。整个设施都有广泛的辐射区域监测，可持续测量辐射水平。我们相信，我们新的PET放射化学设施不仅实现了总体目标，还为PET药物的生产和研发提供了一个符合人体工程学、高效的工作环境。
