Simple Solution for Single Final Vial Filling of Ga-68 Radiopharmaceuticals in One Hot Cell Isolator at Small-Scale Radiopharmacy Laboratories under Aseptic Conditions

Abstract

A simple solution for fulfilling biosafety and national drug agency demands of radiation and biosafety during Ga-68 radionuclide containing radiopharmaceutical production (RP) by small scale laboratories has been demonstrated based on a novel sterile seal concept of multi-layer bag system prototype. These mid-and inner enclosures of the prototype with vial inside were sterilized by 50 kGy of gamma radiation. The microbial safety validation based on two-week testing confirmed successful sterilization of the sealing bags with vails. The analysis of physicochemical properties, namely mechanical properties, gel fraction studies revealed that sterilization did not cause any undesired changes in developed materials, compared to non-irradiated control samples.