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Facility Monitoring Systems

Acquisition Systems have many years experience in the provision of facility monitoring systems for pharmaceutical and silicon wafer clean room facilities.A clean room facility is required to manufacture products that would be contaminated if produced in normal atmospheric conditions, therefore the clean room facility is closely controlled to provide the ideal environment for specialised production. Control of temperature, room pressure, airborne particles, relative humidity, air flow and conductivity are of paramount importance. The clean room facility in general utilises a dedicated building management system to control the environment.

A Facility Monitoring System provides operational personnel with information on the performance of the clean room facility. This is required to meet the legislation requirements of the governing bodies, which in the case of pharmaceutical production are the Food and Drugs Administration (FDA) and Medicines Control Authority (MCA).

The Facility Monitoring System consists of a personal computer connected to a range of distributed data acquisition modules. The data acquisition modules provide a method of connecting to clean room mounted sensors to monitor temperature, differential pressure, relative humidity, air flow and conductivity. Each room within the clean room facility would be monitored for each parameter, with alarm limits applied to notify users of "out of limits" operation.

Fig 1 : A Wall mounted Data Acquisition Outstation

Airborne particles are monitored in a similar fashion but with specialist laser scanning particle counters. Samples of the air are sequentially drawn from each room via probes at a rate of one cubic foot per minute. The particle counter "counts" particles (during the one minute sample time) greater than certain sizes dependent upon the classification of the clean room facility. For example, pharmaceutical facilities are interested in particles greater than 0.5 microns and 5.0 microns, whereas semiconductor wafer production facilities are interested in most particle sizes starting at greater than 0.1 microns.

This method of particle counting is known as background counting and monitors the complete facility, typically returning to each monitored probe every 30 minutes. For continuous monitoring at a filling machine, for example, a dedicated particle counter would continually monitor the "point of use" every minute, this provides a higher rate of acquisition for alarm checking.

The data acquisition modules and the particle counter are connected to the PC via two communications cables (RS232) with the PC located in the facility control room. A local printer provides alarm print outs and graphic/tabular reports. A local area network connection may also be available to network data to other remote PC's and for archiving of the logged data.

Fig 2 : Facility Overview Mimic showing real time values

The PC is furnished with Lookout-FMS software which provides a Windows 95/NT platform for an integrated Supervisory Control and Data Acquisition system (SCADA). Lookout-FMS provides mimics, trends, reports, data logging, SPC/SQC analysis, data to MS Excel, alarms, calculations and networking. The user access to the system is managed through a simple to use menu system with password control.

All monitored parameters are displayed on the PC screen with a graphic mimic of the Facility. Real time values are shown next to the relevant areas with alarms highlighted as a colour change or flashing red.

Remote alarm annunciators provide clean room personnel with both visual and audible indications of "out of limits" conditions which require corrective action. Alarm occurrences and acknowledgements are time and date stamped and provide a permanent printed record.

The "point and click" interface allows users to select any particular area or room to display a trend of parameters over the last four hours, day, week, month etc.

The main purpose of the facility monitoring system is to notify and record any alarm conditions that may arise during the course of production or whilst the facility is unoccupied, therefore alarm monitoring is an integral part of the facility monitoring system. With the ability to define up to four alarm levels per monitored parameter, alarms may also be grouped to individual areas and prioritised depending upon importance.

Fig 3 : Trend panels provide data over last hour, day, week, month

The acquired data is logged to the PC disk to create daily files for the production facility. The data is logged in a secure binary format so that the data may not be tampered with, thereby ensuring complete records for all facility operating parameters. Daily production files may be displayed graphically as a Trend graph to show that no "out of limit" conditions occurred during production. Disaster recovery also features within the system requirement in order that a system reboot will be performed upon a system crash without the loss of data and a minimal interruption of service.

Facility monitoring systems that are installed into pharmaceutical facilities that are governed by FDA and MCA legislation require such systems to be validated. Acquisition Systems have installed many such systems both in the UK and Europe. Such systems are approached from the "life cycle" model to meet the EC directives for Good Manufacturing Practice (GMP).

This entails a formal documentation and testing procedure with well defined project milestones. These milestones are defined by the following document life cycle...

... all within a comprehensive Change Control Procedure.

Once installed, the system is subject to a maintenance schedule to enable validation criteria to be met, including regular calibration of sensors and hardware/software change control to cover additions and amendments.

Acquisition Systems provide systems that meet these exacting demands in full.

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