Development and validation of a semi-automated [13N]Ammonia preparation system for clinical research
Year: 2025
Type: article
Abstract: [ 13 N]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 [ 13 N]ammonia batches assessed against FDA standards for radiochemical purity, sterility, and quality. The module consistently delivered [ 13 N]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 [ 13 N]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. • A new purification system reduces radiation exposure during tracer production. • Microcontroller-controlled valves automate fluid paths and simplify operation. • Trap and elute method removes manual dilution steps used in other systems. • Cleaning and sterilization between batches takes only 12 min. • Built for under $1100 using commercially available components.
Source: Applied Radiation and Isotopes
Authors: Victor Amador Diaz, Peter M. Hall, Melissa J. Brown, Amy L. Vavere
Institution: St. Jude Children's Research Hospital
Language: English
Subfield: Radiology, Nuclear Medicine and Imaging
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,220
OpenAlex ID: W4409738284