Development of qualification protocols for a coaxial high-purity germanium gamma spectrometer in radiopharmaceutical quality control. Part II: Operational and performance qualification
摘要
This study outlines a systematic approach for the operational and performance qualification of a coaxial high-purity germanium (HPGe) gamma spectrometer. Operational qualification (OQ) includes checking the storage tank gauge, restoring the detector’s vacuum, verifying alarms, calibrating the liquid nitrogen level system, and performing energy resolution, peak shape, peak-to-Compton ratio, and relative efficiency. For performance qualification (PQ), identification by energy and period calculation, minimum detectable activity (MDA), and robustness were tested using a sample of an appropriate radiopharmaceutical (131I). All results complied with manufacturer specifications and international standards, confirming the instrument qualification.