Pharmaceutical production plants are subject to strict regulations for the qualification of technology and the validation of manufacturing procedures. That means the corresponding requalification and / or revalidation expenditure is necessary in the case of every change to a running plant. It is the aim of every operator to minimize this in term of time and costs. Bayer AG was confronted with the task of replacing the obsolete operator control and monitoring system in one of its agent plants, whereby the subordinate control level and the superimposed system for the recording of batch data were to remain unchanged.

The by-pass had to take place with production running at high capacity. After intensive enquiry by its process control engineering (PCE) specialist department, Bayer AG decided to install the innovative process control system (PCS) Plant iT from ProLeiT AG within this complex project. The properties of this PCS and the project procedure plan drawn up mutually by Bayer and ProLeiT were the guarantor for the successful completion of the project in 2001 whereby the stipulated ancillary conditions of minimal requalification expenditure and shortest possible installation duration were met.

Bayer is a chemical-pharmaceuticals corporation which is represented in almost every country of the world by around 350 companies. At the Wuppertal / Elberfeld site the pharmaceuticals corporation is pursuing among other things an agent manufacturing business for a very high-revenue broad-spectrum antibiotic. This agent is subsequently being processed into an actual drug in various pharmaceutical forms. A sales market for Bayer for this agent among others is the USA. The Food and Drug Administration (FDA), the American regulatory body for food and drugs, has compiled strict regulations in order to permanently ensure quality of pharmaceutical products. Included is a validation obligation for the drug manufacturing process.