Ferro Pfanstiehl Laboratories, part of the pharmaceuticals and fine chemicals division of Ferro Corporation, has commissioned a new validated Class IV containment facility specifically designed and engineered for low-volume production of high potency active pharmaceutical ingredients (HAPIs) and early phase small molecule new chemical entities.
The 2000ft2 facility offers production of preclinical through to commercial quantities ranging from less than 1kg to 5kg. The new kilo lab complements current batch production facilities of 3-50kg in the plant's existing commercial containment facility. It includes two 100-litre capacity reactors, the first of which has cryogenic capability, hastelloy C construction and hydrogenation capabilities and a processing window of -70°C to +200°C. The second reactor is of glass-lined steel construction and glass overheads, with temperature capabilities from -60°C to +200°C.
The company is also expecting completion of a cGMP supercritical fluid-based particle size engineering pilot lab by the second quarter of 2006. It will provide additional capabilities in particle sizing, purification and formulation applications.