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What is a Cleanroom?

Many industry sectors like electronic manufacturing, medical devices, Aerospace and pharmaceuticals require  production areas or rooms that are sterile environments and free of pollutants, particles and contaminants from outside air. Cleanrooms are designed to specific requirements of the product being produced as well as being compliant with the relevant governing body. The Federal Drugs Administration (FDA) for example may have different requirements and guidelines to the EMEA or GMP.

Cleanrooms are built to a particular standard depending on what the cleanroom's function is. The classification of a cleanroom falls into 1 of the 6 possible options as set out by the Federal Standard FS 209 (US) and ISO Standard 14644-1. The maximum number of particles allowed varies depending on the cleanroom classifications you wish to obtain. Inside 209E cleanrooms, the particles equal to and greater than 0.5µm are measured in 1 cubic foot of air, whereas ISO classes are in cubic meters of air.

Cleanroom Classifications

The Fed209e standard shown above is for reference only and should not be used for cleanroom designs.

US Fed. Standard 209E was officially cancelled by the General Services Administration of the US Dept. of Commerce November 29, 2001.

Cleanrooms in general require higher air changes per hour than a normal production area and also uses air pressure differential between rooms to ensure the direction of the ambient air. A cleanroom is normally maintained at a higher pressure than the adjacent rooms like material/personnel airlocks which would also be maintained at a higher pressure than atmospheric pressure. There are also other factors to be considered like the installation of hepa filters in the supply air and the installation of de-humidifiers to ensure that the quality or integrity of the products are not compromised.

With the installation of this type of plant it is critical that the personnel operating within the cleanroom are aware of the environmental status at all times.

The Visio-3 and Visio-4 Touchscreens have been deployed in many cleanroom installations because of their unambiguous readings of the pressure, temperature or humidity. The traffic light colour indications alone allow workers to quickly assess the status of the cleanroom environment which allows them to take action before an alarm becomes critical.

Cleanroom Monitor
Cleanroom Construction
Visio-3 showing Pressure Warning

 

There are a number of different ways of monitoring the performance of the ventilation installation to ensure that the design criteria is met.

Room Pressure Differential Monitoring.

The traditional method was to install magnahelic gauges which had the advantage of not requiring power but in many other ways lacked the functionality available on modern devices like the Visio-3 and Visio-4 touchscreens.

Supply & Extract Air Volume Monitoring

This method used air volume transmitters fitted to the supply and extract ductwork to ensure that the minimum air changes for the isolation room is achieved. These transmitters can be connected to a Building Management System or connected to the Visio-3 & Visio-4 touchscreen.

Hepa Filter Monitoring

As a HEPA filter collects particulate matter and gets clogged over time, the pressure drop across the filter will increase. When the predetermined HEPA filter pressure drop limit is reached, the filter element must be changed. A clogged HEPA filter on the exhaust side can, for example, result in a dramatically reduced exhaust airflow rate that can compromise isolation room suite containment performance.

Monitoring of ventilation performance
Take me to the Visio-3 Cleanroom Monitor
Take me to the Visio-4 Cleanroom Monitor
Cleanroom Monitor

Useful References
& Downloads

ISO 14644-1:2015 Cleanrooms and associated controlled environments--Part 1
Cleanroom Technology Monthly Publication

Cleanrooms in general require higher air changes per hour than a normal production area and also uses air pressure differential between rooms to ensure the direction of the ambient air. A cleanroom is normally maintained at a higher pressure than the adjacent rooms like material/personnel airlocks which would also be maintained at a higher pressure than atmospheric pressure. There are also other factors to be considered like the installation of hepa filters in the supply air and the installation of de-humidifiers to ensure that the quality or integrity of the products are not compromised.

With the installation of this type of plant it is critical that the personnel operating within the cleanroom are aware of the environmental status at all times.

The Visio-3 and Visio-4 Touchscreens have been deployed in many cleanroom installations because of their unambiguous readings of the pressure, temperature or humidity. The traffic light colour indications alone allow workers to quickly assess the status of the cleanroom environment which allows them to take action before an alarm becomes critical.

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