In the pharmaceutical industry, maintaining a controlled environment in the cleanroom is critical to product integrity and compliance. The recent CrowdStrike incident caused a significant IT outage globally, impacting aviation, banking, logistics and pharmaceutical controls.

Our FacilityPro® environmental monitoring system demonstrated outstanding performance during recent events, ensuring uninterrupted and continuous cleanroom monitoring and control. FacilityPro is a critical component of our Facility Monitoring Systems (FMS) product line, which integrates sampling, reporting, and storage of particle, microbial, and environmental data. It complies with strict Data Integrity requirements, including 21 CFR Part 11, which provides efficient data access, enhanced automation, reduced human error, and regulatory compliance.

Advanced Technology and Infrastructure

Multi-layer Infrastructure: Unlike common systems that rely on single-layer computer-based solutions, FacilityPro uses a three-layer infrastructure. The first layer involves sensors that store data in internal buffer memory in case of disconnection from the processor. The second layer includes our proprietary processor, which offers additional memory capable of storing up to 8 hours of data from hundreds of sensors until the server is restored. The third layer involves server redundancy, ensuring that the twin servers are always operational; if one server fails, another server can take over.

Seamless Integration: FacilityPro integrates seamlessly with network infrastructure and third-party systems using SQL data transfer and OPC UA communications, ensuring continuous data flow and system interoperability.

Customer Experience During Internet Outage Incidents

During the IT outage caused by CrowdStrike, pharmaceutical manufacturers using FacilityPro reported uninterrupted cleanroom monitoring. Despite server issues, FacilityPro continues to collect data, provide real-time alarms, and manage configured automation such as communication with charging lines, alarm towers, and notification tools. This ensures regulatory compliance and prevents production disruptions, saving millions of dollars in drug production and ensuring timely delivery of drugs to patients.

Regulatory Compliance: FacilityPro meets 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 strong after-sales support with agents available worldwide, in different time zones, and local languages. This ensures immediate action to prevent data loss and production disruption, thereby supporting our customers in critical situations.

Conclusion

Recent IT challenges have highlighted the importance of robust monitoring solutions in the pharmaceutical industry. Facility Pro’s performance during the CrowdStrike incident underscores our commitment to providing a reliable, compliant and secure environmental monitoring system. With Facility Pro, our customers can maintain sustainable operations and focus on providing safe and effective products.

Learn more about the Facility’s Particle Measuring Systems (PMS) and Environmental monitoring systems and products at the following links:

Environmental Monitoring System: FacilityPro®

FacilityPro® Cleanroom Software for Pharmacy

PharmaceuticalNet™ Pro: Environmental Monitoring Software


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