New fine chemicals plant goes on stream in Spain
A new €28m (US$26m) cGMP plant for the manufacture of pharmaceutical actives and fine chemicals went into operation in Murcia in Spain last month. Novochem 2000 is a collaborative project between Bayer and Spanish fine chemical contract manufacturer Derivados Quimicos (DQ).
The plant is owned by Novochem, a subsidiary of Derivados Quimicos. The capital investment came from DQ and the running costs will be the responsibility of Bayer, which will be the sole user of the plant.
The new facility is geared for flexibility and quick product change and can handle production capacities ranging from 100kg ; eg, for Phase III clinical testing ; to more than 100 tons. It will operate under cGMP conditions from mid-2002.
Designed by Bayer's engineering department, Novochem 2000 has six production lines featuring 'top-to-bottom' material flow. Five of them are intended for solids production, and one for hydrogenation and distillation. There is space for a seventh line to be installed as and when required.
All the principal items of equipment can be combined with one another by linking the individual product lines by flexible hoses. Special coupling techniques facilitate rapid conversion and offer advantages during cleaning. Particular attention was paid in the design of the plant to the flexibility of equipment while at the same time ensuring that cross-contamination is avoided. Discharge from each production line takes place in class E clean rooms, each of which is equipped with individual air filter systems and air locks for materials and personnel. The entire production process takes place in a closed operation on one production line with no intermediate isolation.
In addition to the filter dryers, the centrifuges are especially suitable for the isolation of end products: they can be discharged to leave no residual product and feature an integral CIP system. Also included are a distillation column and film evaporator for temperature-sensitive products and a Biazzi reactor for hydrogenation of intermediates.
Novochem 2000 is designed for all mainstream organic chemistry reactions and extends Bayer's portfolio in the area of traditional process engineering. It complements the company's Central Organics Pilot Plant (ZeTO) in Leverkusen, which meets customer needs for complex process developments and highly specialised chemical technologies such as phosgenation, azide chemistry, low-temperature reactions and continuous chromatography.