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5°C Cold Room
5°C Cold Room
OverShield by Predictive Monitor protects life sciences companies’ high-value products and refrigeration systems through the power of predictive AI technology and Predictive Monitor’s expert insights. OverShield is a predictive maintenance software service that uses IoT sensor technology and Machine Learning assisted data analysis to prevent equipment problems by identifying the early signs of malfunction.
This case study reviews a situation with a pharmaceutical company storing drug products in a 5°C cold room. If their chamber fails to maintain temperature within its specified operating range, it could lead to many costly situations. For example, the company could face replacing expensive refrigeration equipment and losing millions of dollars of valuable drug products.
See OverShield in Action
The company in this case study implements preventive maintenance every six months and has a traditional monitoring system that reports the chamber's temperature conditions. If a temperature excursion occurs, the system alerts the on-call staff, who must respond regardless of the time of day to ensure the chamber contents are not compromised. The challenge is preventive maintenance doesn't prevent equipment malfunctions that occur off-hours, on weekends, or holidays.
In this instance, an electrical malfunction led to a hot gas valve failure in their 5°C cold room which has redundant cooling systems. When the alternate refrigeration system was supposed to be off, the hot gas valve was fully opened instead of being fully closed. The hot gas valve was operating at double the temperature required, causing overheated gas to circulate throughout the system when it was supposed to be cooling off. Despite the malfunction, the chamber temperature was not affected since the redundant compressor was operational. The issue would have continued and massively increased wear and tear on the refrigeration system.
Electrical malfunctions like this are challenging because they aren't normally detectable until the malfunction severely degrades overall chamber performance and eventually causes an excursion detectable by the traditional monitoring system. By then, it's too late. In this case, the system would have failed, leading to a range of possible outcomes.
In a best-case scenario, the equipment would have self-destructed, and the redundant system would have kept the chamber in temperature specifications. The cost would have been the replacement of the destroyed system, which would have been around $100,000, plus lengthy investigations and labor costs.
In a worst-case scenario, there would have been catastrophic equipment failure and product loss of around $15 million. In addition, there would have been the cost of investigations, reputation, and employee morale and retention.
Outcomes
Thankfully, neither failure scenario happened because this company had the predictive monitoring power of OverShield. OverShield’s AI technology trends chamber performance, detects anomalies, and provides expert, prescriptive recommendations so maintenance staff can prevent failures by performing condition-based maintenance.
As seen in Chart 1, the hot gas line ran at double the required temperature, while the chamber temperature was unaffected. OverShield alerted the team to the temperature increase in the hot gas line. The team ordered a replacement and swapped out the malfunctioning part during business hours. The chamber and the product were never at risk.
In this case, the company purchased the replacement part ($175) and incurred labor costs during regular business hours, not premium overtime costs. Without OverShield, the malfunction would have continued causing the system to deteriorate. Eventually, if left untouched for long enough, this malfunction would lead to a catastrophic failure and a crisis for the stored product. The consequences and costs could have been extensive.
- $100,000 — replacement system
- $80 x 28 hours of overtime labor
- $2,800 — mandatory paperwork and CAPA
- $8,000 — chamber revalidation
- $15,000,000 — product loss
Companies with high-value refrigeration systems are well aware of the catastrophic costs incurred by reacting to failures and can now choose to avoid them with predictive technology.
Conclusion
OverShield empowers facilities staff to get ahead of issues and avoid the stress of chamber failure. This new technology is a game-changer for several reasons:
- Confidence and security: OverShield provides confidence in knowing that priceless assets are protected.
- Operational efficiency: Moving from schedule-driven preventive maintenance to condition-based predictive maintenance provides cost savings and allows facilities teams to operate more efficiently.
- Maximized equipment uptime: With OverShield, maintenance staff spend less time fixing failed equipment and more time on their day-to-day jobs, increasing existing bandwidth at a time when the life-sciences sector is experiencing unprecedented growth.
Predictive technology is where GMP maintenance programs are headed, and Predictive Monitor LLC is leading the charge. With OverShield, chamber failures are avoidable because they are predictable.
Predictive Monitor’s mission is to develop innovative technology that improves patient lives by protecting life-saving products.
Company names have been non-disclosed for privacy.
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