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Cleanrooms &
Regulated Manufacturing


Pharmaceutical Manufacturing & Storage
Medical Devices · High Tech Manufacturing

Increase uptime, quality, and efficiency.
Your process demands precise environmental monitoring. From temperature and humidity to air pressure, flow, and containment, our system delivers unprecedented precision and access to data in laboratories and manufacturing environments.

Compliance is part of the job.
When it comes to bio/pharmaceutical manufacturing and laboratory environments, our team is comprised of experts in cGMP, ISO, USP and laboratory requirements and regulations. We work with your team to implement and maintain the optimum monitoring solution for your facility.





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Cleanroom Environmental Monitoring System

Easily monitor the environment in cleanrooms with one system that is connected to your existing network, accessible remotely, and easily scalable up to thousands of monitored locations.

CEMS software provides alarming, real-time trend data, and reports for compliance with ISO Certifications and GxP regulations. Integration and installation of your Monitoring System is fast and easy with Setra’s industry leading sensors that monitor temperature, relative humidity, particle count, CO₂, differential pressure, air velocity, door contact, and more.

environmental-parameters

 

CEMS Cleanroom Application Features
  • CONTINOUS MONITORING of Temp, RH, ACH, Diff. Pressure, Particulate Count, Door Status, CO₂, and many more parameters.
  • MEET REGULATORY REQUIREMENTS contained in FDA 21 CFR Part 11, EU Annex 11, USP 797/800 and ISO 14644.
  • ENTERPRISE WIDE facility monitoring all within the same system for distributed access which is easily restricted to individuals on a ‘need to know’ basis”.
  • ALARM NOTIFICATIONS issued in real-time via SMS / Email with the ability to customize escalation levels.
  • MAPS AND FLOOR PLANS provide a quick overall snapshot of facility status.
  • DATA INTEGRITY ensured through secure hosting in the SetraCLOUD or an on-premises installation.
  • EASY TO DEPLOY AND USE by connecting CEMS software and associated measurement sensing hardware to an existing network via Ethernet, WiFi or Cellular.
  • WEB-BASED USER INTERFACE is all that you need to interface with CEMS software from anywhere, at anytime.

 

Cleanroom Application Dashboard Tile View 5222020
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