Cleanrooms are one of the most strictly regulated critical environments that require continuous monitoring. The most common cleanrooms are in compounding pharmacies, medical device manufacturers, and biotechnology facilities, as they need to guarantee the safety of their products for patients. However, a variety of other applications utilize cleanrooms to ensure accuracy, such as clinical research spaces, semiconductor manufacturers, and aerospace manufacturers.
A combination of sensor hardware and environmental monitoring software help continuously monitor these spaces and ensure the quality of the products manufactured. Setra’s Continuous Environmental Monitoring System (CEMS) is an environmental monitoring software that collects data in real-time from room measurement sensors to track trends and provide alerts.
Why Choose CEMS?
Setra CEMS users can access data on any device whenever necessary. User-friendly data visualization graphics and an intuitive UI design make Setra CEMS simple to navigate. Data is presented in simple, actionable formats like alarm notifications, which are kept in the alarm event log for quick reference. Formatted reports and exportable data make it easy to use said data however it’s needed.
Setra CEMS accepts data from both Setra and 3rd party hardware through multiple types of inputs:
Easily scale Setra CEMS to the size of any monitored space, from a small single point installation to thousands of monitored locations across a wide geographic area. With no limit to how many hardware sensors or data inputs can be connected to Setra CEMS, the software can adapt to fit any cleanroom environmental monitoring application.
Setra has industry experts dedicated to guiding customers in finding the best environmental monitoring solution for their space. Providing life-cycle support of Setra CEMS, from project planning through technical software support, ensures the successful integration of Setra CEMS.
Setra CEMS users can personalize the dashboard view display of important data. The Setra CEMS interface is unique to each customer’s location with the ability to input site specific floor plans and hardware locations. In addition, users can build out their own specific escalation protocols for warnings and alarms via SMS texts, emails, or dashboard notifications.
Setra CEMS maintains compliance with a number of regulations, including FDA 21 CFR Part 11. Users have access to audit logs to record which personnel completed certain actions and at what time. Data can be easily exported, and reports can be scheduled for automatic sends to personnel for adherence to internal standard operation procedures and documentation.
In addition to FDA 21 CFR Part 11, Setra CEMS is compliant with regulations such as:
- USP 797
- USP 800
- ISO 9001:2015 Certified