Cleanroom classes table ISO and GMP as pdf for download
As Cleanroom can theoretically be defined as any room in which precautions are taken to ensure that the product or application remains free from contamination.
But what distinguishes one Cleanroom from another?
This is where cleanroom classifications and cleanroom classes come into play. The classification of a cleanroom depends on how clean the air inside the room is. The lower the particle concentration, the higher the classification of the cleanroom.
But beware: the higher the classification, the lower the ISO cleanroom class designation. A Cleanroom of cleanroom class ISO 5 therefore has a higher cleanliness level than a Cleanroom ISO 7. GMP cleanroom classes, on the other hand, are marked with letters A-D. More on this later.
To classify a Cleanroom, air samples are taken at various points in the room using a particle counter and the number of particles found is measured. These measurements are used to classify the cleanliness of the room. The classification into cleanroom classes describes the exposure of the room atmosphere to particles of different sizes per room volume. The Cleanroom standard is qualified according to a cleanroom class table.
ISO 14644-1 provides an international standard for classifying cleanrooms. The International Organization for Standardization – ISO for short – is an independent organization dedicated to setting international standards for procedures.
The ISO cleanroom classes are identified by the numbers 1-9.
An Cleanroom ISO 1 is the cleanest possible room, while an Cleanroom ISO 9 corresponds to almost normal room air.
So if you want to achieve the cleanest of cleanrooms, you need an ISO 1 classification. To achieve this, samples must be detected that contain 10 or fewer particles with a size of 0.1 micrometers per cubic meter.
From then on, the scale allows for more and larger particles.
In an ISO class 5, which corresponds to the very strict requirements for microchip production, for example, up to 100,000 particles of 0.1 micrometers may be measured. Particles of 1.0 micrometers must not exceed 823.
ISO 9 is the “worst” cleanroom class and is considered normal room air. In these rooms, particle sizes of 0.1 micrometers are no longer considered. Allowed here are 8,320,000 or fewer particles of 1 micrometer and 293,000 or fewer particles of 5 micrometers.
Typical applications for a Cleanroom ISO 8 are the automotive industry, for a Cleanroom ISO 7 medical technology, for a Cleanroom ISO 6 the optical industry and for a Cleanroom ISO5 electronics and semiconductor technology. However, the classification differs depending on the process and requirements and must always be determined individually.
The pharmaceutical industry defines its own GMP cleanroom classes A, B, C and D, which are based on the ISO standards in terms of particle concentration, but also specify limit values for harmful microorganisms. Cleanroom class D allows the most particles, cleanroom class A the fewest.
The permitted number of airborne particles is shown in cleanroom class tables.
For ISO 5-9 and GMP A, B, C and D you can download a cleanroom class pdf here.
