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

22 October 2021, Version 1
This content is a preprint and has not undergone peer review at the time of posting.

Abstract

Nitrogen-13 labeled ammonia ([13N]NH3) has been used for myocardial perfusion imaging with Positron Emission Tomography for decades. Recent increases to regulatory oversight have led to stricter adherence Good Manufacturing Practice (GMP) to produce 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 validation an Arduino-based device to purifying [13N]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.

Keywords

radiopharmaceuticals
Good Manufacturing Practice
DIY Automation
Positron Emission Tomography
Arduino
radiochemistry

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