Skip to Content

Developed and built in Belgium

By Belgian engineers with years of experience in automation projects within large pharmaceutical companies.

A stable and scalable system that guarantees reliable monitoring 24/7.


Request a demo


In accordance with GMP, FDA 21 CFR Part 11 and NIS2

CleanShield monitoringsysteem

CleanShield EMS

Reliable monitoring for critical environments


Why monitoring is essential


In pharmaceutical production, cleanrooms, hospitals, and high-tech environments, nothing should be left to chance. Temperature, humidity, pressure, and particle concentration must be continuously controlled to ensure quality, safety, and compliance.

CleanShield EMS provides you with that certainty. The system automatically monitors all critical parameters — day and night — so that your environment remains stable, safe, and fully compliant.

Smartly designed for quick and cost-effective installation


CleanShield EMS is designed for easy installation, without complex electrical cabinets or extensive cabling.

Thanks to the modular architecture, a single cable is sufficient between the controller and the Connect & Play measuring stations.

The installation is clearer and significantly more efficient than traditional wired systems.


Connect & Play measuring stations


The measuring stations can be placed centrally or decentrally, depending on your infrastructure.

Each Connect & Play supports multiple types of sensors.


Result

  • Shorter installation time
  • Lower installation costs
  • Less impact on existing infrastructure
  • Simple expansion or relocation of the system


Autonomous operation

The system operates autonomously for measurements and alarming.

Even when the IT network is temporarily unavailable, monitoring and alarming remain guaranteed.

 

CleanShield modulair systeem

 

Automatic sensor recognition & calibration


Always the right sensor in the right place

Each sensor withinCleanShield EMSis digital and has a unique serial number.

The system automatically recognises which sensor is installed at which measurement location.

That means:

  • No risk of swapping measurement points
  • Measurements remain correctly linked to the right location
  • Complete and automatic history per sensor
  • No manual configuration after replacement

After calibration or replacement, the sensor is automatically re-registered correctly.

Your measurement data always remains linked to the correct room or installation.



Calibration without interruption (if desired)


CleanShield EMS supports different procedures, depending on your internal processes.


1️⃣ On-site calibration


Sensors are temporarily removed, calibrated, and reinstalled.

The system automatically recognises them and reassigns them to the correct measurement location.


2️⃣ Changeover system without downtime


For critical applications, a backup set of sensors can be used:

  • A pre-calibrated sensor is placed immediately
  • Monitoring and alarming remain active
  • The removed sensor is calibrated externally

This keeps your production environment continuously monitored.




Audit-ready documentation — immediately available


Calibration certificates are digitally linked to the unique serial number of each sensor.

  • Each changeover and calibration is automatically logged
  • No loose documents or manual searches
  • During audits, all certificates are immediately available
  • Complete traceability per sensor

👉 Compliance without extra administration.




 

Real-time monitoring, predictive analysis and immediate alarming

CleanShield EMScontinuously monitors all critical parameters within the cleanroom and detects deviations in real-time. This ensures that environmental conditions and filtration systems always function optimally.

CleanShield GMP - PIC/S compliance

What is being monitored?

    • Cleanroom conditions– Temperature, humidity, CO2, pressure differences, particle counts, …
    • Filtration systems– Pressure loss across filters, saturation and replacement status.
    • Airflows– Air displacement and laminar flow monitoring.

Smart customised alarming

    • Visual warnings– LED beacons in various colours for immediate indication.
    • Acoustic alarms– Sound notifications for critical deviations.
    • Notifications via email, SMS or voice calls– Immediate alerts for responsible parties.
    • Predictive warnings– Predict filter replacement and maintenance to minimise downtime.
    • Escalation procedures– Alarm follow-up with pre-set protocols.

With CleanShield EMS, you are always assured of a stable and safe production environment, without unexpected disruptions.

Cybersecurity & NIS2 compliance

In regulated environments, data protection is a basic requirement.

CleanShield EMS has been developed according to the strictest standards for industrial cybersecurity and data integrity.

Your measurement data, alarms and reports are securely stored — both locally and in the cloud.


In accordance with international standards


CleanShield EMS is designed in accordance with, among others:

  • NIS2 Directive
  • IEC 62443
  • GMP Annex 1
  • FDA 21 CFR Part 11

This ensures that your monitoring infrastructure remains technically and legally compliant.


Security at every level


  • End-to-end encryption– Secure data transfer between sensors, controller and platform
  • Zero-trust architecture– Security at sensor, network and software levels
  • Edge processing– Local processing of data and alarms, even during network interruptions
  • Access control & logging– Complete audit trail of user actions


Ready to make your environmental monitoring smarter, safer and more efficient?Contact us for a demo and discover how CleanShield EMS supports your organisation.