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Production and Cleanroom Monitoring

Compliant integrated solutions for monitoring temperature, humidity, pressure, particles and more

Production and Cleanroom Monitoring

Compliant integrated solutions for monitoring temperature, humidity, pressure, particles and more

Cleanroom Monitoring Is Complex.
We Make it Easy.

The monitoring of cleanrooms is a complex project. It requires a disciplined approach and advanced planning and integration with the cleanroom builder. Whether they are in laboratories or production facilities, in cleanrooms the products are in an unpackaged state and are therefore particularly vulnerable. The entire system must also be qualified and cleanly documented. The requirements defined in the GMP guidelines are correspondingly high. You must monitor various parameters, ensure the data are processed correctly, and then transferred to other systems. For example, consider the following:

  • Temperature and humidity in the cleanroom
  • Relative humidity and CO2 in incubators
  • Pressure, pressure differential and door openings in access locks
  • Number of particles in supply air, room and exhaust air (particle counter)
  • The status of the cleanroom should be clearly visible to personnel at all times. Clear displays with clear sensor statuses are therefore elementary.
  • The alarm behavior should be able to distinguish between different operating states (day, night, cleaning) and transfer the events to the building management system (BMS)
  • The raw data of all sensors must be transferred completely to higher batch management databases for archiving
  • All system components, especially the software, must be FDA CFR 21 Part 11 compliant
  • All sensors must be calibrated regularly according to the ISO 17025 standard

Cleanroom: Temperature, Humidity, C02,
Pressure and Particles

This video below provides a brief overview of the requirements and suitable solutions for monitoring cleanrooms.

Production & Cleanroom Monitoring Solutions

ECOLOG-PRO Base

Scenario: On-premise appliance operating elproMONITOR software capable to monitor up to 50 measurement points – perfect for small cleanrooms.

 

 

  • GAMP5 validated
  • FDA CFR 21 Part 11 compliant
  • Appliance (Hardware with pre-installed software elproMONITOR)
  • Up to 50 sensors per base
  • Wired and wireless sensor options
  • Temperature, Humidity, Pressure, Pressure Differential, CO2, Particles, 4 to 20mA
  • Project management and qualification
  • Yearly maintenance and calibration
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ECOLOG Unlimited

Scenario: elproMONITOR Software operating on your infrastructure (network, server & database), connects to unlimited sensors – perfect for large facilities with many cleanrooms.

 

  • GAMP5 validated
  • FDA CFR 21 Part 11 compliant
  • Software elproMONITOR on your own server and database
  • Unlimited sensors in one installation
  • Wired and wireless sensor options
  • Temperature, Humidity, Pressure, Pressure Differential, C02, Particles, 4 to 20mA
  • Project management & qualification
  • Yearly maintenance & calibration
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Connected Monitoring Solutions
for Production and Cleanrooms

Get a quick overview of the ECOLOG Connected Monitoring Solutions made by leading Swiss manufacturer ELPRO. Learn more about the scalable GxP-compliant environmental monitoring solutions for warehouses, cleanrooms, refrigerators and systems – from simple cloud solutions all the way to integrated enterprise solutions, driven by best-in-class software elproMONITOR.

 

EXPERT GUIDANCE

Contact Our Cleanroom Monitoring Specialists Today!