August, 2000

During the past year, four major pharmaceutical manufacturers had a similar problem. They were expanding their facilities and needed a way to monitor and alarm their system from a central location. These systems included boilers, chillers, clean steam generators, HVAC, utilities, and other process and service systems. But the questions were how do we get these systems to easily communicate with one another and how do we monitor and alarm the systems from one location?

Superior Controls had the solution and was hired by each of these pharmaceutical companies to design and implement a networked, PC-based, central control and monitoring system that would collect thousands of measurements and alarm points from these disparate systems.

Although each facility manufactured different products, their control and monitoring systems had a lot in common. The goal of each project: a central monitoring system for all monitored, critical process points throughout the facility. The centralized monitoring could include just alarming and/or real-time graphic representation of each system. Their facilities ranged from 2,000 to 10,000 I/O points that needed to be automatically monitored and/or controlled.

Each custom Superior Controls solution was based on using standard desktop servers and workstations and Supervisory Control and Data Acquisition (SCADA) software networked and configured to interface with the numerous individual systems and sub-systems. Some of the equipment and system manufacturers interfaced included:

• HVAC building automation systems by Andover Controls, Siemens, Invensys
• Water, waste, and energy PLCs by Allen-Bradley, Modicon, and General Electric
• DCS and PLC controlled manufacturing suites

Simultaneously, some of the systems directly monitored and controlled included:

Several hundred, sometimes as many as 1,000, pages of real-time graphics are not uncommon in such systems. This allows operators to view each sub-system on the network, access and acknowledge alarms, and access historical data, if necessary.

Additionally, systems were designed to automatically contact appropriate personnel should critical alarms occur. The systems alert on-call support technicians through pagers. If the alarm is not acknowledged within the specified time, systems were configured to automatically sequence a number of phone calls to designated personnel.

For all four companies, the systems being monitored have significant impact on the production processes and even the quality of their products. Some of the generated reports become part of individual batch records. Other data is stored as Electronic Records as defined by the FDA.

Superior Controls used several databases (SQL and Oracle) to record critical production data and alarms. To address requirements of 21CFR Part 11, databases for validated systems were configured with an audit trail to record database changes to ensure critical data reliability.

Ethernet TCP/IP is often the network of choice. Typically, the server storing the process data has a CD writer, redundant hot swappable power supplies, hot swappable hard disks, and UPS power. The more critical the data, the more robust the servers and the storing system.

Although each of the four facilities was different, each was intraconnected using similar, off-the-shelf technology and Superior Controls expertise.