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A validated laboratory facilityA new £500,000 FDA-validated control and data acquisition system has been commissioned by AstraZeneca for its Large Scale Laboratory (LSL) facility in Macclesfield The LSL facility is a multi-purpose production unit, manufacturing kilo-scale quantities of primary pharmaceutical products for use in clinical trials. It consists of 18 independent production units, which include heat cool reactors, cryogenic reactors, a hydrogenator and chromatographic unit, plus support utilities. Engineers from Eurotherm, prime contractors Jacobs Engineering Group and AstraZeneca have developed a sophisticated DCS based on a number of Eurotherm Visual Supervisor controllers and EurothermSuite software. The system will monitor and control all local operations as well as provide management reports and other secure data. The control system architecture is based on 18 Visual Supervisors (Eurotherm T800) providing stand-alone unit control with local monitoring of individual laboratory reactors, tray dryers, etc., I/O is provided using Eurotherm 2500 System I/O controllers. This is supported by a central supervisory system featuring redundant EurothermSuite Operation Servers to provide management visualisation, long-term tamper proof logged data and audit trails. Distributed Operations Viewer nodes allow an overall view of the complete facility for management purposes. EurothermSuite Operations Viewer/ Server is a PC-based system designed to provide overall management and control of a complete process. It includes Invensys Wonderware's world leading software InTouch software and is designed to meet the diverse needs of operations, maintenance and plant management. The simple to use display structure provides data to users in a fast and meaningful way. Standard features include client/server architecture with master/backup servers, defined display structure, trending, sophisticated alarm functionality, single global database, and time synchronisation. Security issues21CFR Part 11 related security issues in this system are handled by the Security Manager utility, which provides a central point for managing user accounts. With 18 Visual Supervisors and 5 PC nodes the routine ageing of passwords could create a significant management task. Each operator would have to update each unit, which would have raised the probability of numerous locked out passwords. Security Manager provides a central point for administrating users and password control, removing the barrier completely. Once users have updated their password within Security Manager the security information is deployed to the subscribed nodes. This package creates a tamperproof, audit trails file, which includes password access security. Visual Supervisor (Eurotherm T800) is a powerful multifunction controller with data logging and integrated display. It provides all the features required to control and monitor processes, functioning as either a stand-alone unit or as a building block within a larger system. Standard features include batch management to ISA-S88 with batch log, recipe and setpoint programmer, accurate continuous and sequential control, support for Modbus and Profibus, barcode reader and printer support, as well as time synchronisation. Visual Supervisor's Auditor feature supports Electronic Records and Electronic Signatures. Additionally on multiple Visual Supervisor node systems, the central control of all security functionality can be achieved with the Security Manager utility. The implementation is seen by Jacobs' Lead Control and Instrumentation Engineer Chris Southan as providing capabilities normally inherent within a considerably more expensive DCS and representing a much lower-risk option than PLC/SCADA architectures, where computer validation and 21CFR part 11 compliance were considered more difficult.
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