cGMP double hot cell with common intermediate airlock and saturated steam autoclave, shielded with lead 150 mm.
The hot cell covers the complete production process of 177Lu, starting from target ampoule loading, opening, target dissolution and HPLC purification to product dispensing, final sterilization and product retrieval in shielded containers.
The production hot cell is equipped with a floor port for target ampoule container introduction and a shielded waste compartment for process liquids. The dispensing cell is equipped with an internal high precision robotic dispenser with formulation unit, a dose calibrator, an integrated saturated steam autoclave, a multi-format product retrieval system and a shielded waste for process liquids.
All the operations inside the production hot cell are performed using a single tele-tong and shielded hand ports, while all the operations inside the dispensing hot cell suite are performed using a couple of master-slave tele-manipulators.
Class-2 Containment boxes, according to ISO 10648, are made of stainless steel AISI 316L with internal anti-acid protective coating.
All interlock features have been certified and validated up to SIL-1 according to IEC 61508, IEC 61511.