Validated lab facility commissioned by AstraZeneca

A new GBP 0.5Million FDA validated control and data acquisition system has been commissioned by AstraZeneca for its Large Scale Laboratory (LSL) Facility at Macclesfield in Cheshire

A new GBP 0.5Million FDA validated control and data acquisition system has been commissioned by AstraZeneca for its Large Scale Laboratory (LSL) Facility at Macclesfield, Cheshire.

Engineers from Eurotherm, prime contractors Jacobs Engineering Group, and AstraZeneca developed the 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 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.

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 world leading 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.

21CFR 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 set-point programmer, accurate continuous and sequential control, support for Modbus and Profibus, barcode reader and printer support, as well as time synchronisation.

The 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 LSL solution was a joint effort, in which Eurotherm engineers worked closely with AstraZeneca staff and Jacobs, who managed the project on behalf of AstraZeneca.

Chris Southan, Lead Control and Instrumentation Engineer at Jacobs, has been delighted with the smooth running of the project.

He comments: "We felt, right from the start of this project, that the proposed EurothermSuite/Visual Supervisor solution could be ideally suited to meeting the requirements of the new LSL facility.

It provides capabilities normally inherent within considerably more expensive DCS solutions and represents a much lower-risk option than PLC/SCADA architectures, where computer validation and 21CFR part 11 compliance were considered more difficult.

In addition, Eurotherm demonstrated its commitment to the project by assigning highly competent project management and engineering personnel within their team.

Applications requirements were reflected accurately within high-quality design documentation fully compliant with GAMP requirements.

The attention to detail at this stage contributed to successful code implementation and customer acceptance testing.".

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