Product category:
Pharmaceutical Processing News
News Release from: Citect | Subject: CitectSCADA
Edited by the Processingtalk Editorial
Team on 22 October 2004
AstraZeneca uses CitectSCADA for FDA
compliance
AstraZeneca at Plankstadt 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
This article was originally published on Processingtalk on 8 Jan 2008 at 8.00am (UK)
Related stories
Extended production life at St Fergus gas terminal
A 10,000+ point CitectSCADA system provides monitoring - with full dual redundancy - of the control and safety systems for the Total E+P St Fergus gas terminal in Scotland
Getting more out of process control networks
The latest version of CitectSCADA offers all the cost reduction benefits of Clustering; but what is Clustering, and how are its benefits applicable to process environments?
AstraZeneca GmbH 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.
Further reading
Get more out of process control networks
The advanced clustering technology now available in CitectSCADA V7.0 allows users to create new control system architectures that will help safeguard plant reliability
The problems of alarm management
Too many alarms can make safety and productivity systems less functional and liable to "overwhelm operators": Paul Hurst of Citect UK discusses why, and suggests a solution
Collect plant data from all types of plant control
The UK water industry must comply with numerous regulatory data reporting requirements: 'CitectSCADA Reports' delivers data from multiple plant control systems using industry standard reporting tools
The tablets are then transported to the Cota48 plant to be coated.
The AstraZeneca 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, whilst 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.
These included the following.
* 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.
* 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 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 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 Cota48 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.
The AstraZeneca local network, in turn, connects to the plant, also using Ethernet.
The operating and 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-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.
* Tracing of all process parameters as well as a comprehensive audit trailing. Request a free brochure from Citect ...
• Citect: contact details and other news
• Email this article to a colleague
• Register for the free Processingtalk email newsletter
• Processingtalk Home Page
Search the Pro-Talk network of sites
