The Case for a Facility Monitoring System

A facility monitoring system can be used to monitor a number of parameters to demonstrate the state of control for cleanrooms and other critical manufacturing equipment. These systems offer many benefits for life sciences facilities, such as:

• Improved product quality
• Reduced waste
• Improved yield
• Increased profits

Still, some install a facility monitoring system based solely on regulatory compliance without an understanding of these benefits. Given the choice, in absence of any regulatory requirement, many may hesitate. Initial capital, validation, and ongoing maintenance costs seem expensive. The mountains of data require analysis, and excursions lead to time-consuming root cause investigations. 

Monitoring in Everyday Life   

Think of a facility monitoring system like a home refrigerator or freezer. They efficiently monitor their internal temperature to support the preservation of items stored inside.

Food stored at a temperature that is too high will perish quickly, making it a risk to health and needing disposal. Food stored at a temperature that is too low might freeze, making it inedible and also needing disposal. Either way, the food is wasted, the appliance may be running inefficiently, and the food could even cause someone to become sick.

Continuously monitoring the internal temperature of a refrigerator or freezer helps reduce the risk of food spoiling and helps avoid food poisoning. Efficient temperature monitoring saves energy, maintains food quality, and reduces waste while saving money.

In the same way, it makes sense to continuously monitor the manufacturing environment and other equipment that are critical in assuring product quality.

Why do Aseptic Processing Regulations Require a Facility Monitoring System?

A facility monitoring system is a risk reduction tool and aseptic processing is inherently risky. Continuous data collection improves the probability of detecting out of control conditions in a manufacturing process. Simply collecting data is not enough though, turning critical data into useable information is key. Systems provide real-time data, reports, and alarm notifications. This results in increased knowledge and a better understanding of the manufacturing process. Increased knowledge helps teams recognize when the process drifts out of control to allow for proactive actions to be taken to prevent an issue. This means less segregated product, less product waste, and fewer interruptions during manufacturing — meeting patient demand for product safety and availability.

For example, airborne particles can compromise patient safety if they find their way into sterile products. Only when you deploy and correctly position particle monitoring probes as part of a facility monitoring system to continuously collect data do you have a chance of detecting unwanted particle contamination events. If a facility lacks particle monitoring probes close to critical processing locations, the probability of detecting particles that can contaminate product is zero.

The purpose of a facility monitoring system: Data to Information to Knowledge. 

How Does a Facility Monitoring System Benefit Business Operations?

A facility monitoring system benefits business operations by supporting energy savings, enabling real-time process control, and helping reduce product waste.

Today, companies use facility monitoring systems to support energy-saving initiatives. Cleanrooms are often overengineered to assure control is maintained. A facility monitoring system provides data that can support setting back air change rates and air velocities - achieving significant energy savings while still maintaining optimal environmental conditions. 

Continuous particle monitoring in a facility provides the exact time of a particle excursion. Immediate notification of the excursion by the facility monitoring system supports timely root cause investigations and minimizes how much of the batch needs to be segregated. The availability of Alternative Microbiological Methods (AMMs), such as biofluorescent particle counters (BFPC), can similarly deliver an immediate understanding of the microbiological quality of the air surrounding the process. This can provide real-time process control with no delay or risk to the process from interventions. It can also greatly reduce downtime through the elimination of manual viable sampling.

Smart factories of the future will feature fully interoperable systems where platforms exchange data seamlessly. Sharing and centralizing facility monitoring system data transforms it into holistic information that aids decision-making. This holistic information could predict that an excursion is likely, enabling teams to take proactive steps that positively impact yield and save on manufacturing costs before they occur.

Click here for more information about TSI Facility Monitoring Software.

Frequently Asked Questions (FAQ)

What parameters does a facility monitoring system track?

A facility monitoring system tracks critical environmental parameters such as airborne particle counts, airborne viable contamination, temperature, relative humidity, and differential pressure to help maintain compliant cleanroom conditions. It can also track critical equipment parameters, for example, the temperature, relative humidity, and CO2 in an incubator.

How does a monitoring system support data integrity during audits?

An automated facility monitoring system collects and securely stores environmental data in real time. This eliminates manual data entry errors and provides reliable and readily available records for regulatory compliance audits.

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Click here for more information about TSI Facility Monitoring Software.