How are Cleanrooms Classified?
What is a Cleanroom?
A Cleanroom is a highly regulated facility used in specialised industries such as manufacturing of pharmaceuticals and scientific research, designed to control airborne particles and subsequently reduce the risk of contamination.
Why are Cleanroom’s Classified?
Due to the sensitive nature of materials processed in a Cleanroom, classification is required to determine the level of risk to the external environment. By measuring the concentration of airborne particles, an engineer can conduce the class a Cleanroom should be placed in and what ISO 14644:2015/CGMP guidelines it must comply with as a result.
Cleanrooms are classified based on the concentration of air particles from a range of 0.1μm to 5μm in accordance with ISO 14644-1 standards. Cleanrooms can be placed in any of the 9 ISO groups. The lower the class of the Cleanroom, the more risk of contamination from sensitive airborne particles.
The table below displays the maximum particles/ m3 each ISO class can contain.
|Class||maximum particles/ m3|
|>=0.1 µm||>=0.2 µm||>=0.3 µm||>=0.5 µm||>=1 µm||>=5 µm|
Fully Independent Cleanroom Specialists
Crowthorne Group are an unbiased solution for Cleanroom services including classification and validation. Our services adhere to ISO 14644:2015, Medicines and Healthcare Products Regulatory Agency (MHRA) and Food and Drug Administration (FDA), and our experienced engineers are Certification Board (CTCB-I) qualified. Speak to one of our Cleanroom specialists to book our classification service today.