Are radiopharmaceuticals self-sterilizing? Radiation effect of gallium-68 and lutetium-177 on bacillus pumilus and staphylococcus succinus

Abstract Background For radiopharmaceuticals, aseptic preparation in combination with filtration is the most commonly used sterilizing method. In general, production of radiopharmaceuticals needs to fulfil requirements good manufacturing practice. scope this work, we focused on positron emitter gallium-68 and therapeutically beta- gamma-emitter lutetium-177, as they are routinely for in-house synthesis nuclear medicine departments. Our hypothesis is, that might be self-sterilizing due a high radioactivity concentration high-energy radionuclides intravenous injections. Results Incubation lutetium-177 both 30 minutes 5 hours post-dispensing did not cause any significant effect bacteria growth. As theoretical dose only 0.1–0.6 % Ph. Eur. recommended 25 kGy, conclude beta energy standard radiopharmaceutical sufficient decrease number colony forming units compared control values. Conclusions Based these findings, labeled under tested conditions respect bacillus pumilus staphylococcus succinus. Consequently, strict addition end-sterilization e.g. through membrane strongly advised productions.