Cleanroom classes at a glance: Where cleanliness is crucial
Cleanroom
Cleanrooms provide controlled environmental conditions in which air purity, temperature, humidity and pressure are precisely regulated. These cleanrooms are classified according to internationally recognized standards, in particular ISO 14644-1, VDI guideline 2083 and the EU GMP guidelines.
Cleanroom classes according to ISO 14644-1 and VDI 2083
ISO 14644-1 specifies the maximum permissible number of particles per cubic meter of air depending on their size. They range from ISO 1 (highest air cleanliness) to ISO 9 (lowest cleanliness requirement) and are used to classify cleanrooms in industries such as electronics, medical technology or optics. VDI Guideline 2083 adopts ISO classes 1 to 9 from ISO 14644-1.
Maximum permitted particle count per m³ | ||||||
ISO class | ≥0,1 µm | ≥0,2 µm | ≥0,3 µm | ≥0,5 µm | ≥1,0 µm | ≥5,0 µm |
ISO 1 | 10 | 2 | – | – | – | – |
ISO 2 | 100 | 24 | 10 | 4 | – | – |
ISO 3 | 1.000 | 237 | 102 | 35 | 8 | – |
ISO 4 | 10.000 | 2.370 | 1.020 | 352 | 83 | – |
ISO 5 | 100.000 | 23.700 | 10.200 | 3.520 | 832 | 29 |
ISO 6 | 1.000.000 | 237.000 | 102.000 | 35.200 | 8.320 | 293 |
ISO 7 | – | – | – | 352.000 | 83.200 | 2.930 |
ISO 8 | – | – | – | 3.520.000 | 832.000 | 29.300 |
ISO 9 | – | – | – | 35.200.000 | 8.320.000 | 293.000 |
Applications and industries
Choosing the right cleanroom class is crucial for cleanrooms, as different particle-free requirements apply depending on the area of application and the specific application.
ISO 1 to 5:
These classes stand for maximum air purity and are primarily used in areas where even the smallest particles can have serious effects. Even a single microscopic impurity can render a product unusable. Typical areas of application or specific applications:
- Semiconductor and microchip production
- Optoelectronics and laser technology
- Production of microsystems and precision components
ISO 6 to 8:
Where cleanliness is important, but not necessarily sterile conditions, cleanrooms of classes ISO 6 to 8 are sufficient. Typical areas of application or specific applications:
- Automotive industry
- Production of technical packaging
- Areas of plastics and food processing
Cleanroom classes according to EU GMP guidelines
The cleanroom classes according to the EU GMP guidelines (Annex 1) regulate the permissible particle concentration and microbiological load in cleanrooms used for the manufacture of medicinal products. They are divided into classes A to D, whereby class A sets the strictest requirements for sterility and air purity and is primarily used for aseptic processes.
Maximum permitted particle count per m³ | ||||
Class | Idle state (≥0.5 µm) | Idle state (≥5.0 µm) | Operating status (≥0.5 µm) | Operating status (≥5.0 µm) |
A | 3.520 | 20 | 3.520 | 20 |
B | 3.520 | 29 | 352.000 | 2.900 |
C | 352.000 | 2.900 | 3.520.000 | 29.000 |
D | 3.520.000 | 29.000 | – | – |
Applications and industries
Choosing the right cleanroom class is crucial for cleanrooms, as different particle-free requirements apply depending on the area of application and the specific application.
GMP A and B:
Particularly strict requirements apply in the pharmaceutical sector. GMP classes A and B are intended for sterile work processes. The focus here is on avoiding microbial contamination, which is why production usually takes place under laminar flow conditions with highly effective filtration. Typical areas of application or specific applications:
- Production and filling of injection solutions, eye drops or vaccines
GMP C and D:
Not every pharmaceutical manufacturing process requires absolute sterility. For GMP classes C and D, lower requirements apply and a controlled but not completely sterile environment is sufficient. Typical areas of application or specific applications:
- Production of tablets and capsules, ointments and non-sterile solutions
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