Study on fabrication of C-11 acetate synthesizer module

Objectives The purpose of this study is to develop a fully automated controlled system for the synthesis of sodium 1-C-11-acetate with a compact synthesizer module.

Methods Main procedures of the process include:1. collection of C-11 carbon dioxide;2. reduction with Grignard reagent;3. hydrolysis and evaporation; 4. neutralization; 5. separation; and 6. collection.

Results The advantages of this fabricated synthesizer module are illustrated as follows. Firstly, the whole processes are operated in a closed system with a liquid nitrogen trapper used to condense the release gases of leaked radioactive material and organic solvent that can reduce the environmental radiation. Secondly, the assembly of the module is made as small as possible. Thirdly, this module is functioned with a fully automated control for synthesis of 1-C-11-acetate making the process time reduced to 20mins. The products obtained with yield of 70% and purity of greater than 99.9% is sufficient to meet the requirements of the specifications for PET in nuclear medicine applications. Furthermore, the production can be carried out continuously for six batches. Other than the previous statements, the software designed can be used to execute the process step by step precisely under the command to be called.

Conclusions During the process performance, the temperature, pressure and variation of radiation dose can be monitored and recorded simultaneously to reflect the reaction situation at that time. Eventually, every recorded data are filed and reserved automatically to compliant with the regulation of GLP/cGMP