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<p>To guide radiopharmaceutical quality control professionals in starting the equipment qualification process, we have developed design and installation qualification protocols for hyper-pure germanium (HPGe) gamma spectrometers. These protocols include detailed user requirement specifications covering gamma energy range, accuracy, relative efficiency, count rate and cooling option. They also provide a description of the supplied documentation, licensed software and other hardware accessories, as well as the installation qualification process. The results highlight the importance of using well-established and harmonized protocols for the qualification of this equipment. These protocols facilitate the appropriate choice in relation to the quality control requirements. They also ensure the conformity of the installation process.</p>

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Development of qualification protocols for a coaxial high-purity germanium gamma spectrometer in radiopharmaceutical quality control. Part I: Design and installation qualification

  • 期刊论文

  • 发表日期：

    2026年2月14日

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  • Ayoub El Kamel,
  • Naoual Bentaleb,
  • Kaddour Ben Hamou

摘要

To guide radiopharmaceutical quality control professionals in starting the equipment qualification process, we have developed design and installation qualification protocols for hyper-pure germanium (HPGe) gamma spectrometers. These protocols include detailed user requirement specifications covering gamma energy range, accuracy, relative efficiency, count rate and cooling option. They also provide a description of the supplied documentation, licensed software and other hardware accessories, as well as the installation qualification process. The results highlight the importance of using well-established and harmonized protocols for the qualification of this equipment. These protocols facilitate the appropriate choice in relation to the quality control requirements. They also ensure the conformity of the installation process.