I-123 automated plant
Automated Ioflupane I-123 Injection production and dispensing plant

• Number of working chambers:
  • 12
• Type of process:
  • “Aseptic manufacturing”
• Type of shielding:
  • Lead 75mm / Lead 50mm / Lead 30mm
• Automation systems available:
  • Automatic synthesis and purification of 123I Ioflupane by HPLC process
  • Automatic vial filling machine, including vial stoppering, capping and crimping, 100% weight control
  • Dispensing mode in open and closed vials
  • Automatic buffer for 500 vials
  • Semi-automatic Visual Inspection (VI)
  • Automatic vial and shielded container labelling
  • Automatic vial discharge in automatic container
• Particularly interesting features:
  • Management and development of HPLC purification in automatic
  • Scale up and process chemistry development
  • Automatic bulk formulation management
  • Decontamination with VPHP
  • Format changeover management with considerable reduction in operator radio-exposure
  • Semi-automatic visual inspection of radioactive product
• Productivity:
  • 6 vials / minute in dispensing (filling 2,5ml)
  • 4 vials / minute in VI, labelling and packaging.

The plant is composed of shielded isolators in which transport, aseptic filling, visual inspection and labelling systems are integrated. The radiopharmaceutical formulation part integrates devices to perform the formulation and labelling process of the 123I in a fully automatic way. The system involves the use of 4 HPLC, disposable pipes, valves and peristaltic pumps. The aseptic dispensing part meets all the requirements of sterile pharma production lines and uses a continuous feed system where vial de-capping, filling with weight feedback, capping and crimping operations take place. The vial is then buffered through a Cartesian robotic system to allow a semi-automatic visual inspection over the entire batch to verify the absence of particulate matter and aesthetic defects. Finally, the vials leaving the inspection area are labelled and placed in the transport container.