Scada solution facilitates FDA compliance

AstraZeneca has used CitectScada to replace its existing process control system, achieving compliance with FDA 21 CFR Part 11 regulations to meet the demands of the American market.

AstraZeneca has used CitectScada to replace its existing process control system, achieving compliance with FDA 21 CFR Part 11 regulations to meet the demands of the American market.

The reliability of the Scada system is also allowing AstraZeneca to increase productivity and maintain the high quality of the drugs it produces at its Plankstadt site in Germany, while the scalability of the Citect system means that AstraZeneca is able to upgrade its system easily and at minimal cost to meet future requirements for its products.

AstraZeneca is one of Germany's four leading pharmaceutical research companies with production sites at Wedel, Hamburg and Plankstadt, Heidelberg.

At the Plankstadt site, AstraZeneca produces therapeutic drugs in tablet form for anaesthesia, infection and pain control, and also for the treatment of respiratory, cardiovascular and gastrointestinal illnesses, tumours and the central nervous system.

The site consists of two plants, which work independently of each other: the S5 Dryer plant houses a fluidised-bed dryer where a variety of tablets are processed.

The tablets are then transported to the Cota 48 plant to be coated.

AstraZeneca's objective for these two plants was to achieve compliance with new FDA 21 CFR Part 11 regulations - as required by any company exporting to 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 Cota 48 and S5 Dryer plants, with a newer, more flexible and scaleable system which could meet all compliance requirements, including: electronic records for production procedures; electronic signatures; audit trail for production procedures; redundant batch control; batch documentation in compliance with 21 CFR Part 11 (batch record); audit trail of all operating actions performed during the process; and audit trail of all arisen events and alarms.

The contract to replace the existing system hardware and software at the two plants with a fully integrated CitectScada system was awarded to major German automation company Felten Automation.

Felten divided the project into two stages.

Stage one comprised the replacement of the existing control system using CitectScada, and stage two initially envisaged replacing the Siemens 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 Cota 48 and S5-Dryer plants, both of which are designed to be explosion-proof and operate under strict safety conditions due to the potentially hazardous materials.

In view of this, Felten decided against replacing the Siemens system, deciding instead to use the high performance Teleperm driver available with CitectScada to interface the Siemens controller via a local bus (CS-275).

The layout of the new control system provides an operating and display client for each plant, both connecting to dual redundant CitectScada servers via Ethernet.

AstraZeneca's local network, in turn, connects to the plant, also using Ethernet.

The operating and display components in the hazardous production area have a mouse, touchpad keyboard, barcode scanner and TFT display.

An existing AstraZeneca file server is responsible for swapping out data for long-term archiving 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 have partnered to produce CitectScada Batch, which is based on the process management system installed at the Plankstadt site.

The new Batch product includes: operating, monitoring, process control and reporting of process data; administration of production and order master data; administration and creation of FDA-compliant batch reports; and tracing of all process parameters as well as a comprehensive audit trailing.

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