The hot cell covers the complete production process of 223Ra dichloride, starting from 227Ac generator loading, processing, separation and purification, product dispensing and final sterilization in autoclave, as well as final product retrieval with vials singulation to final inspection and packaging line. The hot cell integrates the semi-automatic modules for 227Ac/223Ra Chemistry processing, purification and separation.
The production hot cell is equipped with a floor port for 227Ac generator, waste management, as well as centralized shielded solid and liquid waste connection to basement. The dispensing cell is equipped with an internal high precision filling machine with automatic vial supply buffer. The Comecer Vials Filling Line can fill open vials in two different formats: 10ml vial – 20ml vials.
Comecer Vials Filling Line is suitable for Class A – ISO5 environments. The machine is integrated into a shielded laminar air flow isolator, with vertical direction.
Working pressure can be both positive and negative, compared to the laboratory pressure. The filling machine is suitable for pharmaceutical compound dispensing, as well as radiopharmaceuticals (alpha, beta and gamma compounds).
The vials are filled by a Flexicon® peristaltic pump. The product is dispensed by volume, but vials are 100% weight controlled by a WIPOTEC high precision scales with feedback control on the control system.
All the operations inside the hot cells are performed using a single tele-tong and shielded hand port. The hot cell suite is comprise of specific hot cell unit for 227Ac Generator Maintenance and recovery.
Class-2 Containment boxes, according to ISO 10648, made of stainless steel AISI 316L.