Development and validation of a semi-automated [¹³N]Ammonia preparation system for clinical research

[¹³N]Ammonia is a PET tracer critical for cardiac perfusion imaging. Its manual production entails significant radiation exposure and labor inefficiencies. This study aimed to develop and validate a semi-automated purification module to enhance safety, reliability, and efficiency in clinical research settings.

The system employs microcontroller-based remote controls, carefully designed fluidic pathways, and an optimized module sterilization process. Iterative prototyping guided improvements, including compact hot cell-compatible dimensions, reduced cleaning times, and user-friendly features. Validation involved producing multiple [¹³N]ammonia batches assessed against FDA standards for radiochemical purity, sterility, and quality.

The module consistently delivered [¹³N]ammonia with high radiochemical purity and compliance with all regulatory standards. Validation tests demonstrated reproducibility across consecutive batches, reducing operator intervention and radiation exposure. Features such as automated cleaning cycles and compact design enhanced operational efficiency and usability.

This semi-automated module offers a practical, low-cost solution for [¹³N]ammonia production in clinical research. Its design reduces operator exposure, increases reproducibility, and provides performance comparable to commercial synthesizers at a fraction of the cost. The system addresses the needs of facilities with limited throughput and infrastructure and serves as an accessible alternative to fully automated systems.