AE Clean Room Monitor (CRM)
AE CRM is a clean room monitoring system that tracks environmental data in sterile compounding spaces. It supports USP <797> and USP <800> compliance by measuring differential pressure, temperature, humidity, particulate levels, airflow velocity, and door status.
The system connects with devices using Analog, BACnet, or Modbus TCP outputs. Data is collected continuously and displayed on a browser-based dashboard. Users can view live conditions, generate reports, and receive alerts without installing local software. The platform supports Chrome, Edge, Firefox, and Safari.
Alarm thresholds are user-configurable. Notifications can be sent by email or SMS with escalation options. The system includes audit trails and allows comment logging for each alarm. Facilities can upload floor plans to map sensor locations in real time. The platform is compliant with FDA 21 CFR Part 11 and EU GMP Annex 11. A validation package is available, including IQ/OQ documentation. All sensors are NIST-traceable. Calibration services are available to maintain performance accuracy.
The cleanroom monitor offers Wi-Fi and Ethernet connectivity. Users can manage multiple facilities from one interface. It also supports mobile cleanroom installations.
The system includes a wireless temperature and humidity sensor. It operates from -40°F to 140°F and covers a 0–100% humidity range. It uses AA batteries with a one-year lifespan. Alerts are sent instantly by text, app, or email. No software license or subscription is required.
This cleanroom monitoring system helps pharmacies, laboratories, and aseptic processing environments meet regulatory standards. It enables real-time monitoring, data logging, and remote access.
Your AE CRM system supports monitoring of:
Monitoring Features
Differential pressure monitoring between cleanroom zones
Temperature tracking (-40°F to 140°F range)
Humidity monitoring (0–100% range)
Airborne particulate measurement (non-viable particles)
Door open/close status detection
Air velocity sensing for airflow control
Integration with Analog, BACnet, or Modbus TCP devices
🌐 Software & Cloud Dashboard
Web-based interface with no software installation required
Real-time graphing with historical data access
Unlimited user access via Chrome, Edge, Firefox, and Safari
Live floor plan mapping with sensor location display
Customizable alarm thresholds with escalation levels
Email and SMS alerts for critical events
Electronic audit trail with alarm comment logging
2-year rolling cloud data storage included
✅ Compliance & Validation
Meets USP <797> and USP <800> requirements
FDA 21 CFR Part 11 and EU GMP Annex 11 compliant
Optional IQ/OQ validation package available
NIST-traceable sensors with optional calibration service
📡 Connectivity & Installation
Supports Wi-Fi and Ethernet connections
Central control of multiple facilities from one system
Compatible with mobile cleanroom installations
Wireless sensor options available for remote zone
