A cleanroom or clean room is an environment, typically used in manufacturing or scientific research, with a low level of environmental pollutants such as dust, aerosol particles, and chemical vapors. A cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size. The ambient air outside in a typical urban environment contains 35,000,000 particles per cubic meter in the size range 0.5 μm and larger in diameter, corresponding to an ISO 9 cleanroom, while an ISO 1 cleanroom allows no particles in that size range and only 12 particles per cubic meter of 0.3 μm and smaller. In the pharmaceutical industry, clean rooms play a crucial role in the manufacturing of pharmaceutical products which are required to be free from microbial and particulate contamination and protected from moisture. Such pharmaceutical products are manufactured and manipulated in cleanrooms, which are fitted with HEPA and, if required, ULPA filters as well as dehumidifier systems.
Cleanrooms are classified according to the number and size of particles permitted per volume of air.
ISO 14644-1 cleanroom standards:
GMP EU classification
| Class | Maximum particles per cubic meter | FED STD 209E equivalent | |||||
| ≥ 0.1 µm | ≥ 0.2 µm | ≥ 0.3 µm | ≥ 0.5 µm | ≥ 1.0 µm | ≥ 5.0 µm | ||
| ISO 1 | 10 | 2.37 | 1.02 | 0.35 | 0.083 | 0.0029 | - |
| ISO 2 | 100 | 23.7 | 10.2 | 3.5 | 0.83 | 0.029 | - |
| ISO 3 | 1 000 | 237 | 102 | 35 | 8.3 | 0.29 | class 1 |
| ISO 4 | 10 000 | 2 370 | 1 020 | 352 | 83 | 2.9 | class 10 |
| ISO 5 | 100 000 | 23 700 | 10 200 | 3520 | 832 | 29 | class 100 |
| ISO 6 | 1.0 x 106 | 237 000 | 102 000 | 35 200 | 8 320 | 293 | class 1 000 |
| ISO 7 | 1.0 x 107 | 2.37 x 106 | 1 020 000 | 352 000 | 83 200 | 2 930 | class 10 000 |
| ISO 8 | 1.0 x 108 | 2.37 x 107 | 1.02 107 | 3 520 000 | 832 000 | 29 300 | class 100 000 |
| ISO 9 | 1.0 x 109 | 2.37 x 108 | 1.02 x 108 | 35 200 000 | 8 320 000 | 293 000 | room air |
EU GMP guidelines are more stringent than others, requiring cleanrooms to meet particle counts at operation (during manufacturing process) and at rest (when manufacturing process is not carried out, but room AHU is on):
| Class | Maximum particles per cubic meter | |||
| At rest | At rest | In Operation | In Operation | |
| 0.5 µm | 5 µm | 0.5 µm | 5 µm | |
| grade A | 3 520 | 20 | 3 520 | 20 |
| grade B | 3 520 | 29 | 35 200 | 2.93 |
| grade C | 352 000 | 2 930 | 3 500 000 | 29.30 |
| grade D | 3 520 000 | 29 300 | not defined | not defined |
Our references in Clean Room technology are mainly in domain of pharmaceutical industry. Our partner in this area of business is company Imgrad based in Slovenia. With the constant development of clean room products and services, Imgrad assure clients a high-quality level of clean room production for: pharmaceutical, power, chemical and food industries, health facilities, laboratories and printing houses. The self-standing static safe modular panels with airtight doors and a combination of different materials offer a wide range of final implementation based on the client’s request.
Besides, meny more references from our partner Imgrad can be found on their web adress.
