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AE Clean Room Monitor (CRM): Real-Time Monitoring for USP <797> and <800> Compliance

The AE Clean Room Monitor (CRM) is a comprehensive environmental monitoring solution designed for sterile compounding environments. Tailored to support USP <797> and <800> compliance, the system continuously tracks key parameters including differential pressure, temperature, humidity, airborne particulates, airflow velocity, and door status. Using connections via Analog, BACnet, or Modbus TCP, CRM delivers real-time data directly to a browser-based dashboard—accessible across major web platforms without requiring local software installation.

Alarm thresholds are fully customizable, and users can receive alerts via email, SMS, or in-app notifications with escalation capabilities. Audit trails, comment logging, and floor plan mapping provide clarity and accountability for every monitored event. The platform is compliant with FDA 21 CFR Part 11 and EU GMP Annex 11, and includes a full validation package. With Wi-Fi and Ethernet connectivity, the CRM enables centralized monitoring across multiple locations—including support for mobile cleanroom setups. Integrated wireless sensors with NIST-traceable calibration ensure performance accuracy. Its subscription-free model and real-time functionality make it a valuable tool for pharmacies, labs, and aseptic processing operations seeking both compliance and peace of mind.

  • USP <797> and <800> support
  • Browser-based, software-free access
  • Customizable alerts and audit trails
  • Multi-facility and mobile-ready monitoring

AE CRM delivers reliable, real-time insight to help maintain control and compliance in cleanroom environments.

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Posted by: Emma Cidade

Emma is a Pharmacy500 Market Analyst at RXinsider, where she uses her expertise to provide insights into the changing pharmacy industry.

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