Quality assurance system in the radio-pharmacy unit in a tertiary care hospital

1147 Objectives This study reviewed the Quality Control (QC) results performed on Tc99m/Mo99 generators and technetium radiopharmaceutical kits over a period of 4 years with the aim to identify most common QC failures. Methods The QC on the Tc99m/Mo 99 generators and the kits was performed as per recommendations of the USP (1). QC tests were performed on the generator for each elution and included radionuclidic purity (Mo99 Breakthrough) and chemical purity (Al breakthrough) (2,3). The generator’s yield at every elution was also documented and compared with the expected activity level. QC tests on the technetium radiopharmaceutical kits included radiochemical purity (free and hydrolyzed Tc99m components) for each batch and then periodicallyperformed (4). The QC results over a period of 4 years were recorded as pass or fail according to the USP QC recommendations and analyzed. Results The QC results over a period of 4 years are shown in Table 1. No Mo breakthrough failure recorded over 4 years. No Al breakthrough failure recorded over 4 years. RCP was in the range of 97-99 % in all the batches and showed excellent compliance with the manufacturer’s specification with a variation of ±0.8%. RCP QC failure was noted with MAA, DMSA and MAG3. Conclusions As per USP QC recommendation, a QC program was implemented with highly satisfactory results in a large radiopharmacy setup and clinical practice, The only problem encountered with the generator QC was Yield Failure twice in four years and among the kits RCP failure was relatively frequent with MAA, DMSA and MAG3 kits.