Sterile, single-use device for preparing a radiopharmaceutical drug, system and method implementing this device

摘要

The sterile device comprises a ramp (10) equipped with five three-way valves (V1, V2, V3, V4, V5) in series, four extensions (P1, P2, P3, P4) including a first extension connected at its first end to the first valve and at its second end to a buffer syringe (13), a second extension connected at its first end to the fourth valve and at its second end to a second needle, a third extension connected at its first end to the fifth valve and at its second end to a third nozzle and a fourth extension equipped with a valve having check valve connected at its first end to a first end of the ramp. The sterile device comprises a ramp (10) equipped with five three-way valves (V1, V2, V3, V4, V5) in series, four extensions (P1, P2, P3, P4) including a first extension connected at its first end to the first valve and at its second end to a buffer syringe (13), a second extension connected at its first end to the fourth valve and at its second end to a second needle, a third extension connected at its first end to the fifth valve and at its second end to a third nozzle and a fourth extension equipped with a valve having check valve connected at its first end to a first end of the ramp and at its second end to a fourth pointer to penetrate in a tank for dilution of sodium chloride pouch (12), a first nozzle connected to the second valve, an air sterilizing filter connected to the third valve and a plug (11) closing the second end. The dilution tank contains an injectable isotonic dilute solution. Independent claims are included for: (1) a system for preparing a radiopharmaceutical medicament for single-use; and (2) a process for in situ preparation of a radiopharmaceutical medicament for single-use.