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New PC-based SCADA system satisfies FDA regulations
AstraZeneca GmbH is one of Germany’s four leading pharmaceutical research companies with production sites at Wedel, Hamburg and Plankstadt, Heidelberg. Atthe Plankstadt site, it produces therapeutic drugs in tablet form foranaesthesia, infection and pain control, and also for the treatment ofrespiratory, cardiovascular and gastrointestinal illnesses, tumours and the central nervous system. The site consists of two plants, whichwork independently of each other: the S5 Dryer plant houses a fluidised-bed dryer where a variety of tablets are processed. The tablets arethen transported to the Cota48 plant to be coated.
AstraZeneca’s objective for these two plants was to achieve compliance with newFDA 21 CFR Part 11 regulations - as required by any company exportingto the American market, while at the same time meeting the GAMP4 standards. This involved replacing the existing process control system hardware and software in the two plants, with a newer, more flexible and scaleable system which could meet all compliance requirements. For thisthe company chose to use CitectSCADA.
The contract to replacethe existing system hardware and software at the two plants with a fully integrated CitectSCADA system was awarded to a German automation company, Felten Automation GmbH. Felten divided the project into two stages. Stage one comprised the replacement of the existing control system using CitectSCADA, while stage two initially envisaged replacing theSiemens Teleperm M AS-230F system used by both plants with a PLC; however, this proposal was later revised. The Teleperm system is well integrated into the plants, both of which are designed to be explosion-proof and operate under strict safety conditions due to the potentiallyhazardous materials. In view of this, Felten decided against replacingthe Siemens system, deciding instead to use the Teleperm driver available with CitectSCADA to interface the Siemens controller via a localbus (CS-275).
The layout of the new control system provides anoperating and display client for each plant, both connecting to dualredundant CitectSCADA servers via Ethernet. AstraZeneca’s local network, in turn, connects to the plant, also using Ethernet. The operatingand display components in the hazardous production area have a mouse,touch-pad keyboard, barcode scanner and TFT display. An existing AstraZeneca file server is responsible for swapping out data for long-termarchiving and the process system uses the real-time information available from CitectSCADA to create FDA-compliant, unalterable batch reports.
The system was designed in such a manner that, during the commissioning period, it could be switched on during production-free phases. As a result, the commissioning and fine-tuning was very production-friendly and incurred no downtime as production was not interrupted. In addition, engineering costs were reduced significantly by the development of genies for the Teleperm system, and a comprehensive data management system, which enables audit trailing and, consequently, ER-and ES-compliance.
Subsequent to the installation and commissioning of the AstraZeneca system, Felten and Citect partnered to produceCitectSCADA Batch, which is based on the process management system installed at the Plankstadt site.
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