Clean Room Environment Monitoring System with Wireless Sensor USFDA 21CFR Part 11 Compliant
- USFDA 21 CFR Part 11 compliant environment monitoring system for the monitoring, display and data archiving of humidity, temperature and differential pressure of clean room area
- The software required to provide real-time monitoring as well as archiving features without any loss of data due to communication failure, network failure, etc.
- The sensors for humidity and temperature should be both wired as well as wireless type based on the site condition
Systems and Tools
- Masibus EMS consists of following: LED, LCD clean room display units, flameproof variants, wireless humidity and temperature sensor
- Assured data logging at sensor and CDU level with back filling to SCADA using DNP 3.0 protocol
- Ensured reliability and availability by redundancy at software and hardware server level
- Supply, engineering, development, installation, and commissioning of sensors, CDUs flameproof and non-flameproof variants, networking hardware, cables (Signal, Power and communication), tray/conduit etc.
- 21CFR Part 11- DQ, IQ, OQ documentation and validation