In order to meet the increasing demand for microbiological products in pharmaceutical applications and human nutrition supplements, Lonza Biotec in Kourim, Czech Republic, has built a multi-product manufacturing facility which increases its previous fermentation capacities by 50 %. PM-Scada PMS/WDS, the combined production management and weighing system, is responsible for the efficiency and reliability of the process in this facility.
Elmar Schumacher, Helga Frommholz
Food additives, antibiotics, vitamins, enzymes and amino acids are produced in an environmentally friendly way on a large industrial scale by means of biotechnical processes. Lonza Biotec has invested 50 million euros in a new, multi-product manufacturing facility with two 75 m3 fermentation reactors. Various active pharmaceutical ingredients (APIs) and intermediates will be produced here for further processing. This multifunctional facility complements the four existing production lines. Each production unit is equipped with state-of-the-art control equipment and several fermenters. To meet stringent international legal requirements, the new production line will be provided with a production management system and a weighing system which can be fully integrated into the existing architecture. All weighing processes will be organised, coordinated and monitored automatically. With international customers and authorities placing increasingly tough demands on the quality, flexibility, reproducibility and traceability of production processes, compliance with FDA, GMP and ISO 9001 regulations and the implementation of the entire project according to the validation life cycle were the focus of the order.
The Felten solution for automated process control combines the PM-Scada PMS production management system with the PM-Scada WDS weighing and dispensing system. This web-based system primarily convinced Lonza with its upgradeability based on modular structures, its full integratability in the existing automation and system architecture, its easy, quick and safe operability and its strict compliance with FDA and cGMP regulations.
The PM-Scada modules are an essential part of Lonza’s grassroots fermentation plant. The software combines external hardware from different suppliers in one homogeneous system. The PM-Scada PMS production management system organises and manages all tasks in the production process. The integrative solution connects business order processing by ERP systems with control systems in the automation world. It represents a cost-effective alternative that meets all requirements and reveals weak points as well as bottlenecks in the production process. Since the software is implemented as a web portal, all business-relevant data and processes are made available throughout the company. Operation is intuitive using a standard web browser with mobile clients (PDAs), which are connected to the Scada system via a wireless LAN.
Compliance with regulations
The PM-Scada PMS production management system, which was developed on the basis of national and international quality standards such as GAMP, FDA and cGMP, ensures process preparation and management in compliance with regulations. PMS focuses on process organisation, quality improvement and optimisation, as well as on simplification and standardisation of the workflow. Material, batch and product traceability are standard along with process analysis and tracking/tracing in conformity with GAMP and FDA. Due to the modular structure and numerous interfaces, it is possible to connect additional subsystems from Felten or systems from other manufacturers both easily and flexibly.
High system availability
The PM-Scada WDS integrated weighing and dispensing system installed at Lonza consists of weighing, discharge and washing modules that control the production process according to recipes. Both WDS and PMS work independently of any special hardware but with all available scales and terminals. Weighing can be concurrently performed on as many weighing stations as required. As all available scales are integrated in the superior production management system, production orders are directly converted into weighing orders with simultaneous documentation of all process data. The use of barcode scanners to identify equipment and products permits easy and quick data entry. This consequently reduces input errors to a minimum. The system makes decisions automatically and carries them out as far as possible. Thanks to the basic Scada structures, the weighing system operates with utmost reliability and high system availability. Process-relevant data is stored redundantly. A special login security system restricts access to authorised persons only.
PM-Scada PMS/WDS performs comprehensive control and documentation tasks designed to guarantee a smooth production flow at Lonza. During the emptying, weighing and cleaning processes, each batch recipe is continuously monitored with regard to the raw material used, its correct weight and automatic or manual cleaning. Any operator interventions or alarms are recorded in an audit trail and documented in the weighing log. In integrated mode, the Felten system is connected to the batch system, the distributed control system (DCS) for reporting the raw material used and the Oracle database for central storage and documentation of the weighing process. The required data and recipes and the respective production steps can also be controlled in stand-alone mode. In this case, the final batch report is saved in a separate directory for the DCS. The DCS, batch automation and weighing are combined in one fully automated system at Lonza. The weighing area receives its information via a direct interface from the DCS, which decides on the basis of the batch recipe which material has to be weighed, filled and transferred to the fermentation reactor. WDS subsequently reports the actual quantity of material used back to the DCS. The weighing server is connected to the Oracle database, in which all data is finally stored and made available for long-term archiving.
The user is guided through the production process by a series of dialogs on a handheld PC, which communicates with the server online. Special dialogs suggest the optimum combination of individual work steps, such as weighing, loading and cleaning. To further simplify operation, product and equipment identification is supported by barcode readers. Felten designed and implemented the entire Lonza system in a period of just six months. The system is open for future extensions, including a SAP connection.
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