Synthesis

The cleanroom laboratory at TRIGA is designed in accordance with the guidelines on Good Manufacturing Practice for medicinal products for human use (GMP). The nucleides produced in the cyclotron are transported via capillaries to a hot cell in the GMP laboratory, where they are either bottled for further distribution or undergo further synthesis.

Quality control laboratory for GMP-compliant radiopharmaceutical production in a cleanroom (Photo: J.P. Timpe)
Quality control laboratory for GMP-compliant radiopharmaceutical production in a cleanroom (Photo: J.P. Timpe)

The JGU holds a manufacturing license for fluorine-18-FP and fluorine-18-DMFP. The manufacture of other radiopharmaceuticals would be permitted according to ยง13 (2b) AMG; these must be notified and agreed with the supervising authority.

Synthesis room for GMP-compliant PET radiopharmaceutical production in the cleanroom of the GMP area at TRIGA Mainz, equipped with hot cells and a laminar flow cabinet (Photo: J.P. Timpe)
Synthesis room for GMP-compliant PET radiopharmaceutical production in the cleanroom of the GMP area at TRIGA Mainz, equipped with hot cells and a laminar flow cabinet (Photo: J.P. Timpe)

The GMP unit is overseen by the Rhineland-Palatinate State Office for Social Affairs, Youth and Care.

For questions regarding syntheses please contact radiopharmaka@uni-mainz.de.