Validation of an ergonomic method to withdraw [^99mTc] radiopharmaceuticals

Abstract

The main objective of the present work was to ensure quality of radiopharmaceuticals syringes withdrawn with a “Spinal needle/obturator In-Stopper” system. Methods: Visual examinations and physicochemical tests are performed at T0 and T+4h for [^99mTc]albumin nanocolloid and T+7h for [^99mTc]eluate, [^99mTc] HydroxyMethylene DiPhosphonate and [^99mTc]Human Serum Albumin. Microbiological validation was performed according to European pharmacopoeia. Fingertip radiation exposure was evaluated to confirm the safety of the system. Results: Results show stable visual and physicochemical properties. The integrity of the connector was not affected after 30 punctures (no cores). No microbiological contamination was found on tested syringes. Conclusion: The system could be used 30 times. The stability of syringes drawing with this method is guaranteed up to 4 hours for [^99mTc]albumin nanocolloid and 7 hours for [^99mTc]eluate, [^99mTc]HydroxyMethylene DisPhosphonate and [^99mTc]Human serum albumin.