Have you looked for “stranger things” in your automated PET dose dispensing system? A process and operators qualification scheme

EJNMMI Radiopharmacy and Chemistry

Table 1 Initial Trasis Unidose® IQ/OQ/PQ

IQ	OQ	PQ
• Setup check-list • Network configuration • Trainings	• Labels data consistency • Air bubble size • Cartridge closure	• Requested activity vs filled activity precision • Internal dose calibrators • precision vs external calibrated dose calibrator • Particular qualification • Microbiological qualification (externalized) • External dose rate • PC/Unidose bridge

Legend: This table provides summarized data about installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) initially performed by the supplier.