Validation of an ergonomic method of withdrawing 99mTc-radiopharmaceuticals

Abstract

The main objective of the present work was to ensure the quality of radiopharmaceutical syringes withdrawn with a system consisting of a spinal needle and an obturator IN-Stopper. Methods: Visual examinations and physicochemical tests were performed at baseline and 4 h for 99mTc-albumin nanocolloid and at baseline and 7 h for 99mTc-eluate, 99mTc-hydroxymethylene diphosphonate, and 99mTc-human serum albumin. Microbiologic validation was performed according to the European pharmacopoeia. Fingertip radiation exposure was evaluated to confirm the safety of the system. Results: The results showed stable visual and physicochemical properties. The integrity of the connector was not affected after 30 punctures (no cores). No microbiologic contamination was found on tested syringes. Concerning radiation safety, no overexposure was reported with the system. Conclusion: The system could be used 30 times. The stability of syringes withdrawing radiopharmaceuticals with this method is guaranteed up to 4 h for 99mTc-albumin nanocolloid and 7 h for 99mTc-eluate, 99mTc-hydroxymethylene diphosphonate, and 99mTc-human serum albumin.