Medical Cleanroom Classification
The classification of cleanrooms determines the number of airborne particles permitted per cubic metre of space. There are three main classifications that we work with: ISO, GMP and FED.
All of these classify cleanrooms based on the maximum allowable concentrations (particles/cubic metre) for particles of certain sizes for each class.
ISO standards, derived from ISO 14644-1, are numbered 1 to 9, with 1 being the cleanest and 9 being similar to any other, non-ventilated room.
Medical cleanrooms are often built to meet the specifications of the GMP (Good Manufacturing Practice) grades and classifications. These are A, B, C and D, with A as the cleanest and D being the least clean.
Grade A and B cleanrooms are equivalent to at least an ISO 5 cleanroom when in use. Grade C is for less critical operations, requiring ISO 7 at rest and ISO 8 when in use.
The requirements of your specific cleanroom project will depend on the intended use and design. Our cleanrooms are validated by an independent inspector on completion, so you can be confident that the installation meets ISO requirements.