TABLE 5

Main Advantages and Disadvantages of Automated Synthesis Module vs. Kit

68Ga-PSMA-11 preparationSynthesis moduleKit
Yield (%) corrected for decay>8099.9*
Time of synthesis (min)2010
68Ga/68Ge eluate and product purificationNeed to elute and purify productNo need to elute and purify product
Preparation of reagents before synthesisNeed to prepare cassette and reagentsAll necessary materials are provided with kit
Installation and maintenance issuesNeed to install and maintain moduleNo need to install and maintain module
Operational complexityNeed to train staffNeed to train staff, but less operational complexity
Radiochemical purity (%)>98>98
68Ge content (%)0.000010.0001
Ethanol contentComplied with European Pharmacopoeia specificationsNot present
Sterility and pyrogen contentComplied with European Pharmacopoeia specificationsComplied with European Pharmacopoeia specifications
  • * All 68Ga activity from generator available as radiopharmaceutical.