See OverShield in Action
The challenge for this team in this case study was preventing equipment malfunctions that led to system failure. They have a traditional monitoring system that alerts the on-call staff to shifts in temperature and relative humidity (RH) conditions. The chamber also receives biannual preventive maintenance. However, traditional monitoring and preventive maintenance are not advanced enough to address potential issues the way that predictive technology does.
In this situation, the steam generator in a 25°C/40%RH stability room was struggling. The chamber’s RH varied but did not go out of specifications, therefore the monitoring system did not alarm. The struggling steam generator would eventually fail if left untouched, and the stability of the RH for the chamber would have significantly worsened.
Since there was no noticeable shift in relative humidity, the team was not alerted to correct the issue. This would have led to system failure and a range of possible outcomes.
In the best-case scenario, the chamber would have failed and been fixed within 24 hours, adding one day to the stability testing and making the product late to market. This would have resulted in the loss of tens of millions of dollars and the accrual of thousands of dollars in paperwork fees.
In the worst-case scenario, the chamber would have failed in a manner that damaged the product in testing. The product would have had to be replaced, and the stability test would restart, costing $10,000,000+. Other costs include hundreds of millions of lost drug sales, reputational damage, and paperwork. Worst of all, the time to market would have increased substantially, leaving hopeful patients waiting even longer for a new medicine.
Thankfully, OverShield was protecting this chamber. 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.
OverShield’s capabilities enabled the company to identify the struggling steam generator before it led to system failure.
As seen in Chart #1, the steam generator temperature fluctuated wildly. The RH varied on the chamber’s monitoring readout, seen in Chart #2, but did not go out of specifications. OverShield notified on-call staff of the issue, so they were able to replace the malfunctioning equipment for a minimal cost and in little time. Most importantly, they avoided system failure, and the stability study was never compromised.
The cost was $2,000 for the component and one hour of labor in this situation. Without OverShield, the consequences and costs could have been extensive.
- $2,000 —a new component
- 80 x 4 hours of overtime labor
- $10,000,000 — drug replacement costs
- $20,000 — restart stability study
- $100,000,000+ — lost drug sales
- $2,800— mandatory CAPA documentation
In any scenario, the highest cost would have been the increased time in getting the drugs to market. Patients would have been waiting on drugs that could significantly impact their lives.
Pharmaceutical companies implementing high-stakes stability studies can’t afford failure because they can’t waste time getting drugs to market. With predictive monitoring, pharmaceutical companies can get ahead of issues before they lead to the disaster of restarting a stability study.
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.