Helsinn Advanced Synthesis has completed a new production bay at its Swiss site, increasing its production capacity from 16m3 to 24m3. Two additional production bays are also available to allow further expansion in the future.
The new bay consists of a 4,000-litre glass-lined reactor; a 4,000-litre Hastelloy reactor; two 4,000-litre receivers; a 1,000-litre dosing reactor; a 0.8m2 Hastelloy pressure-filter-dryer; and a 2.5m2 Hastelloy pressure-filter-dryer.
The addition of pressure-filter-dryers and Hastelloy reactors is adding technology and flexibility to the site that already has in place several horizontal peeler centrifuges and bicon dryers. With minor modifications, this new bay with double containment could be adapted in order to produce High Potency Active Ingredients (HPAI) at large scale (10-50kg).
Helsinn has made several major investments in recent years, beginning with a new high containment finishing plant in 1998. The latest step was the construction of Helsinn Advanced Synthesis, operative in 2000, which offers not only the API production suites but also a HPAI production plant incorporating a new containment concept: isolated production bays with air-conditioned system.
There were two reasons for taking this route, says Helsinn. First, there are some APIs that would not come under class 3 or 4 classification but require special handling and containment to protect the operators and should therefore not be manufactured in a classical open space. Second, the real last chemical step is the final crystallisation and isolation of the API that should be performed in a pharmaceutical environment, not only the final drying step, the company says.
