Thursday, 08. July 2004

New 80m³ bioreactor for Bayer HeathCare

For the production of Acarbose, the major ingredient of the diabetes drug Glucobay, a fully automated 80m³ bioreactor was engineered by Bayer Technology Services for Bayer HealthCare. The company offered a one-stop service from the conceptual design phase including engineering, process development, layout of the fermenter and the agitator, procurement and construction to the start up and qualification. Even the automated cleaning and sterilization procedures – contrary to the current non-automated production – were developed by Bayer Technology Services.

Optimization of cleaning guarantees highest quality

To meet current regulations in the production of pharmaceuticals, Bayer Technology Services developed a unit with optimized cleaning procedures. Fundamental characteristics include no dead spacing joints and a special designed agitator which can be purified from the top of the vessel.
Retractable cleaning nozzles guarantee that critical parts are purified sufficiently. An automated cleaning procedure makes sure that the cleaning agent is systematically spread all over the inner surface. The positioning of the cleaning nozzles was defined according to the inner structure. A rinse test to validate the locations of the nozzles was carried out successfully.

Moreover, the newly implemented process control system meets Good Automated Manufacturing Practice (GAMP) standards. It is equipped with a well proven interface to an electronic batch recording system which documents the complete process data needed.

Pipe construction was also optimized by engineering piping arrangements in a three-dimensional model. Clusters of membrane valves were designed in their locations according to the piping layout and constructed following the blue print. Due to this procedure, highest qualities in welding and surface treatment could be achieved.

“Their absolute competency in the field of bioreactors made Bayer Technology Services an ideal partner for us. We as the customer were involved in all major decisions. This has led to fruitful cooperation and ensured that the project ran smoothly”, says Bruno Sommer, Director of Production Unit, Bayer HealthCare.