Active ingredient and fine chemicals plant goes into operation in Spain
Connecting link between process development and high-tech chemistry
Leverkusen ? Customer requirements for the production of fine chemicals under cGMP conditions (current Good Manufacturing Practice) cover a very broad spectrum. With its Central organics Pilot Plant (ZeTOTM) in Leverkusen, Bayer AG is able to respond to customer needs for complex process developments and highly specialized chemical technologies such as Phosgenation, azide chemistry, low-temperature reactions and continuous chromatography. The new production plant for active ingredients and intermediates at Novochem 2000 S.A. in the Spanish city of Murcia, some 90 km from Alicante, will now extend its portfolio in the area of traditional process engineering. In this triad of process development and reaction control with enhanced safety and equipment standards in the ZeTOTM, Novochem stands for cost-effective active ingredient production.
With highly developed processes and known quality-critical parameters, this new multi-product plant is geared for flexibility and quick product change. It is designed for production capacities ranging from 100 kg ? for phase 3 clinical testing, for example ? to over 100 tons. The plant, which will be used exclusively by Bayer, is owned by Novochem, a subsidiary of Derivados Químicos S.A. (DQ). DQ is a Spanish company with decades of experience in contract manufacturing for fine chemicals, with whom Bayer has been working since 1993.
Novochem is designed for all mainstream organic chemistry reactions and represents an excellent opportunity for combining a cost-effective production facility with Bayer's process engineering expertise. Some EUR 30 million have been invested in the plant, which from mid-2002 will also operate under cGMP conditions. Production planning and logistics are fully integrated into the supply chain management processes in Bayer's Basic and Fine Chemicals Business Group ? and will benefit from all of the advantages of strong backwards integration.
The modern cGMP plant in Murcia was designed by Bayer's engineering department. It has six production lines featuring "top-to-bottom" material flow. Five of them are intended for solids production, one for hydrogenation and distillation. All of the principal items of equipment can be combined with one another. This flexibility, which derives from the interconnection of the individual product lines, has created an extremely versatile and efficient toolbox. The use of glass, enamel, stainless steel and hastelloy satisfied requirements in terms of the chemical resistance of the materials.
Special coupling techniques facilitate rapid conversion and offer advantages during cleaning. Particular attention in the design of the plant was paid to the flexibility of equipment while at the same time ensuring that cross-contamination is avoided. The clean rooms (class E) for each line are equipped with air filter systems and air locks for materials and personnel. The entire production process ? right through to packaging of the dried product ? 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 (clean in place). Also included in the array of high- tech products are the distillation column and film evaporator for temperature-sensitive products and the Biazzi reactor for hydrogenation of intermediates.
Just as important as the equipment engineering is the integration into Bayer's process development systems. The ZeTOTM supports process development, the definition of critical process parameters, the setting of operating ranges and their adjustment to Novochem's plant engineering as designed by Bayer. Another key element is the quality assurance system.
Novochem and Bayer have worked closely together to develop the quality and training system. The quality system is sustained by the ongoing exchange of experience, joint training courses and the coordinated implementation of guidelines. Routine inspections by Bayer inspectors supplement the quality assurance system. The products that are manufactured are Bayer products, so the control of materials, technology transfer and clearance for dispatch all fall within Bayer's responsibility.
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Chromatography enables us to separate, identify and thus understand complex substances. Whether in the food industry, pharmaceutical research or environmental analysis - chromatography opens up a treasure trove of information about the composition and quality of our samples. Discover the fascinating world of chromatography!
Topic World Chromatography
Chromatography enables us to separate, identify and thus understand complex substances. Whether in the food industry, pharmaceutical research or environmental analysis - chromatography opens up a treasure trove of information about the composition and quality of our samples. Discover the fascinating world of chromatography!
