The unit operations approach applied to the synthesis of [1(-11)C]2-deoxy-D-glucose for routine clinical applications

An approach to the design of remote semiautomated chemical processing systems has been developed and tested in more than 750 production runs. This design stresses the idea of unit operations, which allows maximum flexibility while maintaining the highest possible standards regarding safety, reliability, efficiency, and practicality. Application of this approach has resulted in the development of a simple and reliable remote semiautomated synthesis system for the routine production of [1(-11)C]2-deoxy-D-glucose. Use of this system results in the preparation of a sterile, pyrogen-free product suitable for human injection after a synthesis time of 50 min, with radiochemical purity of greater than 98% and yields (25-30%) permitting quantitative measurements using positron computed tomography.