The Schwabe Group, headquartered in Karlsruhe, Germany, has grown significantly over the past 140 years. In this time, the company has secured a prominent position in the development and production of herbal pharmaceutical products (phytopharmaceuticals).
At its Karlsruhe plant, Dr Willmar Schwabe GmbH & Co. KG produces liquid and solid pharmaceuticals for the Schwabe Group. Liquid bulk solutions are produced in Diessel brand stainless steel processing vessels, in which raw materials are weighed and blended.
Although the production process had been automated for some time, the system was no longer being supported by software and hardware. For this reason, Schwabe needed to implement a new system for production – one that would fulfil the current requirements of an industry-specific production management system. This was intended to provide more than just mere regulatory conformity; the objective was also to provide the latest, state-of-the-art weighing solution and process control technology. To accomplish this, the incumbent PLCs were completely replaced with a contemporary control system running software solution from Rockwell Automation.
Local system integrator Systec & Services was able to address these challenges thanks to its many years of experience in MES projects, the experience of its employees and the capabilities of the Rockwell Automation Software it supplied. ‘Systec & Services convinced us with its service and competitive prices. We were also pleased by its proximity to us and by the fact that it had a high-performance partner on board – M+W Process Automation,’ says Dr Christoph Scherübl, project manager at Dr Willmar Schwabe.
The goal was to implement a pre-validated weighing system for liquid bulk production and to document and validate it according to governmental guidelines. The existing control system also needed updating, while the corresponding interfaces had to be prepared for SAP.
Using Rockwell Automation RS PMX MES, Systec & Services was able to develop a custom-tailored solution. As part of a FIT GAP analysis, the RS PMX MES Suite was adapted to not only meet the special requirements of Dr Willmar Schwabe, but also stay as close to the RS PMX standard product as possible. ‘During the planning phase, we managed to take full advantage of our experience; we found the best solution in close co-operation with the people in charge at Schwabe,’ says Fred Schiffmacher, managing director and responsible for project delivery at Systec & Services.
RS PMX MES offers increased flexibility in state-of-the-art data management and process execution. It allows life sciences companies to access key manufacturing information on demand to help optimise production processes and make manufacturing capabilities a competitive advantage. The latest version provides for on-demand manufacturing information to help improve productivity and reduce time-to-market. It extends capabilities in automation information integration and assists with regulatory compliance initiatives throughout the product manufacturing process.
A test lab set up by Schwabe allowed Systec & Services to test the system on site and to co-ordinate constantly with the project team members at Schwabe. The system was then implemented over the course of a two-month conversion phase, which was accompanied by a halt in production.
The interfaces to the control system, using OPC, were provided by M+W Process Automation. In addition to a new pasteurisation unit and a laminar flow weighing booth, Systec & Services provided hardware from its GMP-IT business unit. Systec & Services supplied: six monitors in stainless steel casing, some of which were equipped with touch screens; a computer, also in a stainless steel case; explosion-protected wireless barcode scanners and printers; and other GMP-IT hardware components.
Thanks to the implementation of the RS PMX MES software with the RS PMX Dispense MES, RS PMX EBR MES and RS PMX Recipe MES function sets, Dr Willmar Schwabe now possesses a weighing system that satisfies the utmost in modern requirements. The new system can be used to completely document the weighing process and recipes with complex compensation calculations can now be weighed automatically. Furthermore, recipe management has been completely converted to an electronic system, which increases the transparency and security of the data.
With the innovative RS PMX EBR MES (Electronic Batch Recording) function set, the entire production process can in essence be paperless. Through EBR, the data can now be transferred automatically, resulting in a fully electronic batch record at the end of the process.
‘The pharmaceutical security and processing times have been significantly optimised,’ says Scherübl. Since going live in June 2008, it was possible to implement several recipes immediately – including the group’s top-selling liquid pharmaceutical product, Umckaloabo.
Harvesting the Ginkgo