A cleanroom is a controlled space where the number, concentration and size of airborne particles are classified and tightly maintained to create a sterile environment.
There are 9 ISO classifications, ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8, and ISO 9. ISO 1 is considered the cleanest while ISO 9 is considered the dirtiest. The table refers to the concentration of particles in a 1 cubic meter sample according to particle size as a micrometer or micron μm.
Table 1 of the ISO14644-1:2015 shows each classes maximum limit of air cleanliness by particle concentration.
ISO14644-1:2015 Table 1 showing Fed-Std-209EBefore choosing an ISO classification, determine what size and number of particles can negatively affect your experiment, procedure or process.
An ISO 8 cleanroom has to go through the ISO 9 classification first. An ISO 8 classification requires that the air contain less than 3 520 000 particles >0.5 micron per cubic meter, less than 293,000 >5 micron per cubic meter. In order to achieve this you will need a series of filters for example a G4 and a H15 and it is recommended that you dilute the particulate levels by achieving a complete air change rate of up to 60 air changes per hour.
ISO 8 cleanrooms are used to protect products and procedures that are sensitive to a particular size and number amount of particle size. Industries that might require this level of cleanroom include aerospace, automotive, aviation, chemicals, defence, digital, technology and computer services, pharmaceutical, electronics, machinery and parts, life sciences, oil and gas production, research and innovation, space and lots more.
One of the main design differences between an ISO 8 cleanroom and other, cleaner classes is that the ISO 8 Cleanroom does not require an airlock. However we usually advise you do still use an airlock for gowning as it aids your SOP and compliance. It uses a non-unidirectional airflow and goes through up to 60 air changes per hour.
ISO 8 Cleanroom requires extensive care and maintenance. This is usually done with:
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