In the pharmaceutical industry, maintaining a controlled environment in cleanrooms is critical for product integrity and compliance. The recent CrowdStrike incident caused significant IT outages globally, affecting flight control, banking, logistics, and pharmaceuticals.
Our FacilityPro® environmental monitoring system showcased exceptional performance during this recent event, ensuring uninterrupted and continuous cleanroom monitoring and control. FacilityPro is a vital component of our Facility Monitoring Systems (FMS) product line, integrating sampling, reporting, and data retention of particle, microbial, and environmental data. It complies with strict Data Integrity requirements, including 21 CFR Part 11, providing efficient data access, enhanced automation, reduced human error, and regulatory compliance.
Advanced Technology and Infrastructure
Multi-layer Infrastructure: Unlike commonly available systems that rely on single-layer computer-based solutions, FacilityPro employs a three-layer infrastructure. The first layer involves sensors that store data in their internal buffer memory in case of disconnection from the processor. The second layer includes our proprietary processor, which offers additional memory capable of retaining up to 8 hours of data from hundreds of sensors until the server is restored. The third layer involves server redundancy, ensuring that twin servers are always operational; if one server fails, the other can take over.
Seamless Integration: FacilityPro seamlessly integrates with network infrastructure and third-party systems using SQL data transfer and OPC UA communication, ensuring continuous data flow and system interoperability.
Customer Experience During Internet Outage Incident
During the CrowdStrike-induced IT outages, pharmaceutical manufacturers using FacilityPro reported uninterrupted cleanroom monitoring. Despite server issues, FacilityPro continued to collect data, provide real-time alarms, and manage configured automation such as communication with filling lines, alarm towers, and notification tools. This ensured regulatory compliance and prevented production interruptions, saving millions of dollars in drug production and ensuring timely drug delivery to patients.
Regulatory Compliance: FacilityPro fulfills ISO and GMP standards governing aseptic pharmaceutical production, ensuring that customers remain compliant even during IT disruptions.
Global Support and Reliability: Especially during crises like the recent Crowdstrike outage, Particle Measuring Systems offers robust after-sales support with agents available worldwide, in different time zones, and local languages. This ensures immediate action to prevent data loss and production interruptions, supporting our customers in critical situations.
Conclusion
The recent IT challenges have highlighted the importance of resilient monitoring solutions in the pharmaceutical industry. Facility Pro’s performance during the CrowdStrike incident underscores our commitment to providing reliable, compliant, and secure environmental monitoring systems. With Facility Pro, our customers can maintain continuous operations and focus on delivering safe and effective products.
Learn more about Particle Measuring Systems (PMS) Facility and Environmental monitoring systems and products at the following links:
