The column is loaded in an aseptic area (Class A – ISO 5) and the plant production process and design comply with GMP and FDA requirements. The production process includes the loading and automatic formulation in the non-sterile area, through hot cells equipped with high shielding and telemanipulators, and an aseptic area where the column loading and washing takes place. Subsequently, a series of conveyors and automatic assembly stations assist the operator during all the phases, allowing the construction of the generator and the final verification of QC and sterility of the finished product. Thanks to the integrated vaporised H2O2 generators, the aseptic chambers can be sterilised automatically and the material loaded in a sterile condition.
ISO 45001 Health and Safety Management System
ISO 14001 & ISO 50001 Environmental and energetic management system
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Radiopharma
Pharma
ATMP Cell & Gene Therapy
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