Lanxess subsiary Saltigo, a service-provider for custom synthesis and custom manufacturing, is to convert and expand an existing plant complex at the integrated Leverkusen site into an ultra-modern, multi-functional plant structure for cGMP-compliant production, processing and purification of APIs and intermediates.
The new production complex will consist of four modular multi-purpose units, one of which is to be used exclusively for the production of intermediates. The units are set up for the use of solvents and solids as well as the handling of corrosive APIs, such as hydrochlorides. They have an automatic, recipe-managed process control system. Total capacity will be more than 200 tonnes/year and the system will allow for the use of reaction units of between 2.5 and 8m3, made from various materials. Outlining the project, Saltigo's managing director Axel Westerhaus said: 'According to current plans, investments of around Euro 10m will allow us to make significant additional cGMP capacities available by as early as mid-2007. We experience a high demand for this capacity.
'Making use of an existing plant approved several times by the US FDA is allowing us to respond to this demand quickly and with a relatively low level of investment.' Alongside broad, general cGMP technologies, which in the future will also include low-temperature organometallic reactions, customers will also have access to challenging chemistries under cGMP conditions, such as phosgenations, hydrogenations at high pressure, fluorinations and the ability to handle reagents with a high energy content and highly exothermic reactions.
Saltigo has recently achieved cGMP status for a high-pressure hydrogenation production facility. The production unit, which has an annual capacity of 500 tonnes, achieved CGMP status in record time: the whole process, from the planning of the project to the first customer audit and finally to the start of production for the first CGMP product in September 2006, took only nine months. The main component of the ISO 9001- and ISO 14001-certified facility is a 5m3 Hastelloy HC4 reactor of that is designed to function at reaction pressures of up to 250 bar and reaction temperatures of up to 230 °C.
'The plant enables us to carry out practically any typical hydrogenation reaction and a wide range of special reactions,' said Dr Claus Dreisbach, hydrogenation plant manager at Saltigo. These reactions range from hydrogenation of aromatic nitro compounds and nuclear hydrogenation of aromatics to reduction of aldehydes, ketones, imines, nitriles and compounds with carbon-carbon multiple bonds, and reductive aminations and alkylations.
An extremely wide range of catalysts can be used for these applications. Typical heterogeneous catalysts (e.g. Raney metals or carrier-fixed platinum metals) can be used, as can homogeneous catalysts, for example combinations of ruthenium compounds and chiral bisphosphane ligands for homogeneous enantioselective hydrogenation.