White Paper: Automated Solutions For Monitoring Critical Environmental Factors

By Gayle Wilton, Marketing Manager, Rees Scientific Corporation

As seen in The Pharmaceutical Solutions Update, 2008 Fall Edition

The environment in which pharmaceuticals reside is critical during all phases — research and development, manufacturing, compounding, and storage. Numerous regulatory agencies set forth criteria for ensuring that environmental factors do not adversely affect these products. Key aspects to maintaining compliance include documentation, continuous recording of data, full traceability, alarm notification, and corrective action taken and documented.

There are a number of ways in which this data can be collected, ranging from fully manual actions to fully automated systems with hybrid solutions mixing human involvement and equipment. Along the continuum of options are varying degrees of cost, time, effort, and reliability, which need to be weighed against your exposure to risk.

Chart recorders, data loggers, and manual readings only check the status of a particular environmental factor at a particular point in time. Furthermore, these readings are subject to human error and oversight. Information is only available to the person taking the reading or looking at the chart at that particular instance. In an effort to automate, some facilities have looked to use what is already around them and found their building maintenance system (BMS).