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Cleanroom & Critical Room Pressure Monitoring

A high-precision, non-intrusive environmental telemetry system engineered for continuous measurement of room differential air pressure and containment boundary integrity, preventing cross-contamination, ensuring sterile air balance, and simplifying regulatory compliance across healthcare and life science facilities.

  • Heightened sterile room boundary control and contamination prevention

  • Minimal risk of airflow direction reversal, unmonitored door-open events, and compliance audit failures

  • Instantaneous remote access to micro-differential pressure metrics for dynamic HVAC control

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Solution

The PM-HV-CR Remote Cleanroom & Critical Room Pressure Monitoring Solution provides continuous differential air pressure tracking, positive/negative isolation room verification, door-open detection, and airborne contaminant containment alerting across pharmaceutical labs, operating theaters, and clean manufacturing spaces without complex wiring. Utilizing high-accuracy CMOSens micro-thermal mass flow differential pressure sensing technology, the system continuously logs micro-pascal pressure drops between zones and arrives fully pre-configured out of the box to automatically stream encrypted sensor telemetry to the Ellenex Software Platform.   


This IoT-driven critical room pressure monitoring solution offers key operational benefits:

  • Zero-Touch Plug-and-Play Setup: Shipped fully pre-programmed for immediate site installation in under 5 minutes without requiring local software setup, driver downloads, or manual developer provisioning.   

  • Flexible Dual LPWAN Wireless Protocols: Choice of LoRaWAN (ideal for private hospital networks or dense pharmaceutical complexes with zero ongoing airtime fees) or NB-IoT / LTE-M (for direct-to-tower public cellular connectivity across distributed healthcare clinics).   

  • Micro-Thermal CMOSens Differential Sensing: Features micro-thermal mass flow differential pressure sensing technology with zero-point drift stability across configurable ranges such as +/-500 Pa or +/-125 Pa.   

  • Cleanroom-Compatible Enclosure: Built with dual-port 1/8 inch NPT process fittings and an IP66 UV-stabilized enclosure designed for washdown environments and sterile facility walls.   

  • Extended Battery Autonomy: Powered by an internal replaceable 3.6V Lithium primary battery combined with ultra-low-power firmware routines to deliver up to 10 years of continuous operation.   

  • Rapid Financial Returns: Delivers fast ROI by eliminating manual room pressure logbooks, protecting high-value batch processing, preventing healthcare-acquired infection outbreaks, and streamlining audits. Learn More

Cleanroom & Critical Room Pressure Monitoring
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Easy Install

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Pre-Configured

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Secure

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Quick ROI

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Rugged Design

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Battery Operated

Uninterrupted room differential pressure logging and real-time containment boundary tracking are critical to maintaining sterile environments, preventing cross-contamination, and passing stringent regulatory compliance audits in healthcare and specialized manufacturing. Our Remote Airflow Monitoring Solution provides a comprehensive approach to efficient HVAC management and ventilation control. By leveraging cutting-edge technology in CMOSens micro-thermal differential pressure sensors, industries and facility managers can track, control, and optimize their air handling systems. The result is a future-proof solution that not only addresses current operational challenges but also adapts to the changing demands of industrial compliance, ultimately protecting our infrastructure, indoor air quality, and energy efficiency.   

Connecting ISO cleanrooms, hospital isolation rooms (positive and negative pressure), compounding pharmacies, semiconductor fabrication facilities, bio-containment laboratories (BSL-3/BSL-4), and sterile processing departments to a central digital network transforms static room enclosures into an intelligent environmental safety grid. By streaming real-time room differential pressure, isolation status, and boundary breach events directly to a cloud platform, facility engineers maintain continuous oversight of air containment. 


Predictive Performance

Continuous differential pressure telemetry recorded by drift-free micro-thermal sensors captures subtle pressure balance shifts across airlocks and HEPA filter banks over time. By tracking progressive resistance increases across terminal supply filters or monitoring gradual supply fan airflow decay, the Ellenex Software Platform generates predictive maintenance insights. Facilities personnel can schedule HEPA filter replacement, re-balance air handling dampers, or service exhaust fans based on actual pressure differential degradation trends rather than waiting for room pressure alarms to disrupt active production runs.


Resilient Operation

Real-time telemetry streams from high-sensitivity CMOSens differential pressure transmitters deliver uninterrupted containment oversight through a single cloud platform. Instead of discovering pressure boundary breaches hours after an event occurs, room managers receive immediate notifications when differential pressure crosses safe threshold limits. Automated high and low pressure alerts instantly flag open anteroom doors, failed air balancing dampers, or fan motor tripping, enabling environmental safety teams to re-establish required positive or negative pressure barriers before airborne particulates contaminate sterile product lines or escape bio-containment zones.


Compliance Assurance

Deploying automated differential pressure logging delivers an unalterable, audit-proof digital ledger of sterile boundary conditions across all critical rooms. Continuous telemetry transmitted directly to the Ellenex Software Platform replaces manual physical check sheets, ensuring total compliance with ISO 14644 cleanroom standards, USP <797>/<800> compounding rules, FDA cGMP requirements, and CDC isolation guidelines. Furthermore, eliminating manual clipboards reduces personnel entries into controlled spaces, preserving environmental cleanliness while supplying inspectors with continuous, time-stamped compliance documentation. 

Battery-Powered Cleanroom And Critical Room Differential Pressure Monitoring With LoRaWAN Or NB-IoT / LTE-M Connectivity For Healthcare And Manufacturing.   


Core Operational Capabilities

  • CMOSens® Micro-Thermal Differential Pressure Sensing Element

  • Compatible with air and other non-conductive and non-corrosive Media

  • LoRaWAN / NB-IoT / LTE-M

  • IP68 Submersible Sensor

  • IP66 UV-Protected Enclosure

  • Up to 10-Year Battery Life

  • Cloud / API / SCADA Integration


Cleanroom & Critical Room Pressure Monitoring

PM-HV-CR
Purple Podiums

Uninterrupted room differential pressure logging and real-time containment boundary tracking are critical to maintaining sterile environments, preventing cross-contamination, and passing stringent regulatory compliance audits in healthcare and specialized manufacturing

Industrial Outdoor LoRaWAN Gateway Specifications

For customers deploying the LoRaWAN package, the high-performance industrial gateway provides complete self-managed coverage. It is pre-configured to forward packet data to the Ellenex Platform.

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System Architecture

The integrated Solution telemetry platform is designed around a dual-LPWAN (Low Power Wide Area Network) hardware architecture, giving operators the flexibility to deploy either LoRaWAN or cellular-based (supporting NB-IoT and LTE Cat M1) network configurations depending on local infrastructure and regional topology. Both communication technologies represent the cutting edge of industrial IoT, designed to penetrate challenging physical barriers and achieve multi-kilo meter propagation distances while maintaining extremely low electrical current draws.

 

The Ellenex telemetry pipeline follows a streamlined 4-step end-to-end data flow designed to give customers total choice over their network infrastructure and software platform:

  1. Sensor: The single Ellenex battery-powered field device directly measures physical parameters, digitizes analog signals, applies factory calibration parameters, packages telemetry into AES-128 encrypted payloads, and manages low-power sleep modes within a unified unit. Learn More:

  2. Wireless Infrastructure Options:

    • Option A (LoRaWAN Option): Transmits sub-GHz radio packets to an Ellenex Pre-Configured Outdoor Gateway. The gateway acts as a transparent Layer-1/Layer-2 RF-to-IP bridge. Learn More

    • Option B (Cellular NB-IoT / LTE-M Option): Transmits encrypted telemetry directly across licensed 3GPP cellular networks to public mobile base station towers. Learn More.​​

Cleanroom & Critical Room Pressure Monitoring

   3. Network Core & Data Routing Layer: Encrypted sub-GHz packets are securely routed from the gateway to the Ellenex Network               Server (LNS). The LNS manages crucial network functions—including device authentication, payload decryption, and frame                   deduplication—ensuring clean, secure sensor data is seamlessly delivered to Ellenex Software Platform.

   4. Data Processing & Platform Visualization: All telemetry is ingested, decoded, and visualized seamlessly within the Ellenex Cloud           Software Platform. The software transforms raw sensor data into actionable insights through real-time dashboards, historical trend         analysis, threshold alerting, and device health management.

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Connectivity & Visualisation Platform

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With its advanced features and ease of use, Ellenex’s software platform enables effective monitoring and management of remote operations—ensuring efficient, sustainable, and reliable resource management.

  • Encrypted ultra-low power communication protocol.

  • Advanced device inventory​.

  • Integration of APIs for enterprise systems.

  • Multi-tenant role-based access control.

  • Data export and import.

  • White-label platform for enterprise runs on private accounts.

  • Variable alarm setting for high and low thresholds and multi-channel alerting.

  • Sampling and transmission interval configuration.

  • Transmission condition configuration.

  • Other configurations and customizations available on request.

Ellenex's software platform is a comprehensive, user-friendly solution specifically designed for remote monitoring and management.
The platform offers a robust range of features tailored for off grid, distributed, and critical operations, including:

  • Real-Time Data Visualization: Monitor live operational status, levels, and key metrics across all your locations from a centralized dashboard.

  • Customizable Alerts & Notifications: Receive instant warnings for threshold breaches, sudden drops, or anomalous activity before minor issues become costly failures.

  • Historical Data Analysis & Predictive Analytics: Track consumption patterns, analyze usage trends, and forecast future demand to optimize maintenance and supply schedules.

  • Seamless System & API Integration: Easily feed raw or aggregated telemetry into your existing enterprise software, SCADA, or ERP systems using Ellenex’s secure Open API.

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Key Benefits

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Ellenex Software Platform Dashboard
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Individual Device Details & Data Analytics View
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Parameter Configuration and GPS Location View
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Device Management Interface
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Historical Data & Performance Analytics 
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Remote Command and Downlink Control Log
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Ellenex Asset Monitoring App

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Custom alert and Notification Setup Interface
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Data Export and Reporting Interface
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Webhook and Data Forwarding Interface
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Sensor Calibration and Formula Configuration 

Integration Options

A core competitive advantage of the solution is its complete pre-configured, plug-and-play design. Both the cellular and LoRaWAN (with local gateway) variants arrive fully configured and ready for connection to the Ellenex platform out of the box, eliminating the complexities of local software setup, sensor programming, or manual network registration.
The end-to-end package includes the following integration characteristics:

 

  • Zero Technical Hassles: No extra power tools, driver setup, or developer configurations are required. Deployment is completed in under 5 minutes.

  • Pre-Configured Gateway Provisioning: The industrial outdoor gateway is pre-commissioned to automatically bind with the Ellenex LNS stack. Once powered via PoE or DC, it immediately discovers sensors, decrypts the payloads, and relays them directly to the centralized cloud dashboard, seamlessly routing data to the Ellenex Platform.

  • Pre-Configured SIM & Connectivity: For NB-IoT deployments, the transmitter is shipped with a pre-configured 4FF Nano-SIM card and active carrier subscription, ready to transmit on regional networks immediately upon power-up.

  • Unified Fleet Visualization: Once powered on, both device variants automatically check in and populate their respective live measurement streams to the user’s centralized mobile app or web dashboard.

Frequently Asked Questions

How does CMOSens micro-thermal mass flow differential pressure technology achieve high accuracy at ultra-low differential pressures like +/-500 Pa or +/-125 Pa?

Critical cleanrooms and isolation wards operate at small differential pressures (often 12.5 Pa to 50 Pa). Traditional diaphragm pressure sensors struggle with thermal noise and mechanical drift at these low levels. CMOSens technology utilizes a micro-thermal flow channel etched directly onto a silicon chip to measure the tiny gas displacement caused by room pressure differentials. This micro-flow design eliminates mechanical hysteresis, provides long-term zero-point stability, and delivers precise, drift-free micro-pascal measurements without requiring frequent re-zeroing or recalibration.   


What pneumatic tubings and wall plate accessories are used to connect the PM-HV-CR sensor across room boundaries?

The PM-HV-CR enclosure features dual process ports with 1/8 inch NPT female connections. Field installers connect flexible medical-grade silicone or polyurethane tubing from the high-pressure port to the controlled room or isolator, and from the low-pressure port to the adjacent corridor or reference space. Tubing routes cleanly through wall penetration sleeves or flush stainless steel wall plates equipped with barbed fittings, providing a cleanroom-compatible installation that tolerates chemical wipe-downs.   


How does the Ellenex Software Platform distinguish brief door-open events from actual HVAC system failure?

When personnel enter or exit a cleanroom, opening the door causes a momentary collapse in room differential pressure. The Ellenex Software Platform incorporates configurable alarm delay timers and dynamic rate-of-change logic. Normal door crossings trigger a brief, transient pressure dip that recovers quickly once the door latches. If differential pressure remains suppressed past a pre-set threshold time (such as 60 seconds), the platform identifies the event as a prolonged door-open breach or HVAC fan failure, generating multi-channel alerts to facility staff.   


How does the PM-HV-CR monitor both positive pressure cleanrooms and negative pressure bio-isolation rooms?

The PM-HV-CR sensor features a bidirectional measurement range (such as +/-500 Pa or +/-125 Pa). In positive pressure applications (e.g., sterile drug compounding or operating rooms), the controlled space maintains higher pressure than surrounding corridors to keep contaminants out. In negative pressure applications (e.g., infectious disease isolation or hazardous drug preparation), the controlled room maintains lower pressure than reference areas to contain dangerous pathogens or chemical dust. The internal processor digitizes both positive and negative values automatically, reporting exact directionality and magnitude to the Ellenex Software Platform.   


Why are sub-GHz LPWAN protocols effective for passing through cleanroom wall panels and facility shielding?

Pharmaceutical and semiconductor facilities are constructed with thick modular wall panels, stainless steel cladding, and lead-lined insulation that severely damp standard Wi-Fi or Bluetooth signals. The LoRaWAN option (-L) uses sub-GHz radio frequencies with superior Chirp Spread Spectrum modulation, penetrating structural cleanroom wall materials to reach central gateways. The Cellular LPWAN option (-N) utilizes NB-IoT with a +20 dB link budget improvement, ensuring reliable direct-to-tower transmission from sealed inner cleanroom zones.  


How does automated cleanroom pressure logging support FDA cGMP and USP <800> audit compliance?

Regulatory frameworks such as FDA cGMP and USP <800> mandate continuous, verifiable proof that environmental contamination barriers are maintained whenever sterile or hazardous compounds are handled. The Ellenex Software Platform automatically records all differential pressure data into an immutable, time-stamped cloud database. Compliance managers can export complete historical trend reports, alarm logs, and event timelines with a single click, providing audit-ready evidence for FDA, Joint Commission, or state pharmacy board inspections.   


What battery preservation strategy allows the PM-HV-CR unit to operate up to 10 years without cleanroom power wiring?

The PM-HV-CR device is powered by an internal replaceable 3.6V Lithium primary battery (LiSOCl2) engineered for long-term stability in controlled indoor environments. Controlled by ultra-low-power firmware, the transmitter spends over 99% of its operational life in a deep sleep state. At scheduled intervals, the unit wakes up, energizes the CMOSens differential sensor, measures room pressure differential, transmits an encrypted LPWAN payload, and returns to sleep. This power management supports up to 10 years of autonomous operation, eliminating expensive electrical conduit installations across cleanroom ceilings and walls.

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