Types Of Cleanroom Classification Within The UK
Cleanrooms are used in a wide range of industries which require controlled environments to carry out their processes. But with high specification environments comes a range of classifications and regulations to adhere to.
Cleanrooms are contained spaces designed to maintain a controlled environment with low levels of pollutants. They are used to reduce contamination and to control variables including temperature, humidity and pressure. In this article we will look at the UK classification for cleanrooms – ISO 14644-1.
ISO 14644 defines a cleanroom as “a defined space within which the number and concentration of airborne particles is controlled and classified, and which is constructed and operated in a manner to control the introduction, generation, and retention of contaminants inside the space.”
How Are Cleanrooms Classified?
Cleanrooms are classified by the cleanliness of the air, specifically the number of particles per cubic meter at a specific particle size. The classes are often enforced by guidelines or certifications – in the UK, cleanrooms are classified by BS EN ISO 14644-1 (which recently superseded British Standard 5295).
But dependent on your industry, and country, there may be a range of guidelines that your cleanroom must adhere to. Or there may be parameters defined by your specific company. For example, within the pharmaceutical industry, its likely you will be required to comply with GMP.
Different types of cleanroom classification
In the UK, cleanrooms are classified by ISO 14644-1 and they are classified from ISO 1 to ISO 8. Outside of the UK there are other cleanroom classifications and guidelines to adhere to and be aware of dependent on your location and industry.
ISO Cleanroom Classifications
Within the ISO cleanroom classification, the lower the classification, the cleaner the air. The cleanroom classification standard ISO 14644-1 requires specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area.
Cleanrooms are classified according to the number and size of particles permitted per volume of air. They are defined by the maximum concentration limit (particles/m3 of air) for particles equal to and larger than sizes defined below.
The higher the cleanliness level within a cleanroom, the more air changes are required to ensure the cleanroom is adequately filtered to ensure the cleanliness of the air.
ISO Class 8: 5-60 air changes per hour, with a ceiling coverage of 5-15%
ISO Class 7: 60-150 air changes per hour, with a ceiling coverage of 15-25%
ISO Class 6: 150-240 air changes per hour, with a ceiling coverage of 25-40%
ISO Class 5: 240-600 air changes per hour, with a ceiling coverage of 35-70%
ISO Class 4: 400-750 air changes per hour, with a ceiling coverage of 50-90%
ISO Class 3: 500-750 air changes per hour, with a ceiling coverage of 60-100%
ISO Class 2: 500-750 air changes per hour, with a ceiling coverage of 80-100%
ISO Class 1: This is the ‘cleanest’ cleanroom, used in industries such as life science and electronics which require nanotechnology. The recommended air changes per hour for an ISO class 1 clean room is 500-750, and the ceiling coverage should be 80–100%.
Cleanrooms classifications of 8 and above require airlocks to ensure there is a reduced risk of contamination. Dependent on the classification and function of the cleanroom, specific PPE clothing may also have to be worn to reduce the risk of contamination.
When designing a cleanroom, it is vital to understand the classifications required by your industry, your business and your processes. Understanding the classification required is key to designing a cleanroom to suit your application and to adhere to strict regulations.
If you’re looking to design and build a cleanroom for your business, or you’d like to understand more about the implications of cleanroom classifications – get in touch with the MTCSS team! Call us on 01886 833381, email us at sales@mtcss.flywheelsites.com, or fill in an enquiry form here!
