Towards the Full Automation of QC Release Tests for [18F]fluoride-labeled Radiotracers

The automation of quality control methods used for release of [18F]fluoride-labeled radiotracers is a logical next step for increasing reliability and decreasing exposure in day-to-day clinical manufacture. In this work we evaluate the suitability for automation in six key release tests: Radiochemical purity and identity, determination of pH, kryptofix and residual solvents, as well as filter membrane integrity test. Results obtained for [18F]FDG, as proof of concept, were comparable to certified standards and conventional quality control following both USP and EP guidelines. The automated methods can be performed in 20 minutes without the need of an operator, and exhibited an overall higher precision compared to conventional quality control. A perspective on the potential significance of this automated approach is presented.