Automation and improved performance of a 62Zn/62Cu microgenerator system

376 Objectives: Proportional Technologies (PTI) has developed a 62Cu (T1/2 = 9.7 min) microgenerator for clinical use in PET imaging. This project seeks to: 1) Establish improved and highly reproducible elution performance of the microgenerator. 2) Evaluate automated elution equipment and sensor monitoring of microgenerator operation. 3) Demonstrate increased elution yield and decreased 62Zn breakthrough through improvements in the generator anion exchange column. Methods: Over 50 microgenerators have been produced at PTI under GMP conditions and shipped via overnight courier for use at clinical sites or for external customer studies. Significant improvement in microgenerator function has been realized through use of automated elution equipment enabling push-button system operation. Positron sensors have also been installed along the elution pathway to provide live-time dose measurement. Reduction of anion-exchange resin particle size has been exploited to improve both yield and 62Zn breakthrough performance. Results: All microgenerators shipped from PTI have demonstrated reliable performance in clinical or clinic-like settings using the automated elution equipment. In addition, all of these generators have exhibited negative sterility and pyrogenicity tests. Recent innovations utilizing specially sized anion exchange resin have improved the 62Cu radiochemical yield to >70% and lowered the 62Zn breakthrough by more than 1000-fold to Conclusions: PTI’s improved Cu microgenerator has demonstrated reliable performance in a variety of remote settings. Ongoing sensor improvements will improve the feasibility for future commercial distribution by providing improved on-site quality control and convenience of use.