Low cost and open source purification apparatus for GMP [13N] Ammonia production

Nitrogen-13 labeled ammonia ([N-13]NH3) has been used for myocardial perfusion imaging with Positron Emission Tomography for decades. Recent increases to regulatory oversight have led to stricter adherence to Good Manufacturing Practice (GMP) when producing this short half-life (9.97 min) radiopharmaceutical. This has increased production costs. Our cyclotron facility initially developed a manual GMP production method, but it was prone to human error. With increased costs in mind, we developed and validated an Arduino-based device to purifying [N-13]NH3 for clinical use. Construction, programming, and GMP validation results are discussed. The automated method was found to produce equivalent quality radiopharmaceutical but was more reproducible and robust.

Automated summary

This study developed and validated an Arduino-based device for purifying [N-13]NH3, aiming to address the increased production costs caused by stricter regulatory oversight. The results showed that the automated method could produce equivalent quality radiopharmaceutical as the manual method, with better reproducibility and robustness.