Why would anyone install a facility monitoring system?
Many facilities choose to install facility monitoring systems to monitor particle counts and other environmental parameters within a manufacturing facility because it makes great business sense. Benefits include waste reduction, improved yield and profits. The system warns when a process is drifting out of control. Proactive action can be taken before action levels are exceeded and product is wasted or manufacturing is interrupted. However, given the choice, there are still facilities that choose not to install a facility monitoring system. There are mountains of data that require analysis.
Alert and action level excursions lead to time consuming root cause investigations. Plus, there is all the maintenance, calibration and validation overhead considerations. These challenges seems overwhelming when benefits of a facility monitoring system are not completely understood.
Why do current aseptic process regulatory guidelines expect to see a facility monitoring system?
A facility monitoring system is a risk reduction tool. Improved probability of hazard detection leads to risk reduction. Risk occurs if too many airborne particles find their way into sterile products, compromising patient safety. If there are no particle monitoring probes installed close to the critical processing location, the probability of detecting particles entering the process is zero. A facility monitoring system improves process understanding. It turns data into information. Historic trends, reports and alarm annunciation all lead to increased knowledge and a better understanding of the manufacturing process. Recognizing when the process is drifting out of control, before it’s too late, means less segregated product, less product waste, and fewer interruptions during manufacturing---without compromising patient safety. Why wouldn’t you choose to monitor? It makes great business sense.
What does Pharma 4.0 mean for the future of monitoring of aseptic processes?
As industry moves toward Real Time Release Testing (RTRT), the importance of monitoring the environment surrounding sterile manufacturing processes increases. Alternative Microbiological Methods (AMMs) such as laser induced florescence used in combination with a facility monitoring system delivers the exciting possibility of an immediate understanding of the microbiological quality of the air surrounding the process. Pharma 4.0 means facility monitoring systems need to be able to exchange this data quickly and in real-time with multiple vendor platforms in a modern factory. Technologies that are leading the way are OPC UA protocol, facilitating seamless integration with multiple platforms without costly, time-consuming software development.
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