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Cleanroom classes to ISO 14644-1 and GMP
Cleanrooms are classified by how many particles the air may contain. We build cleanrooms in ISO class 5 to 9 and GMP grade A to D – here we explain what the classes mean and which one fits your operation.
ISO classes – cleanroom class 5 to class 9
ISO 14644-1 is the international standard for cleanroom classes. The class states the maximum number of particles ≥ 0.5 µm per cubic metre of air. The lower the class, the cleaner the air – and the higher the demands on ventilation, airlocks and surfaces.
| Class | Particle limit ≥ 0.5 µm | Typical use |
|---|---|---|
| Cleanroom class 5 | 3,520 particles/m³ | Sterile manufacturing, filling lines and advanced optics. Corresponds to GMP A/B. |
| Cleanroom class 6 | 35,200 particles/m³ | Sensitive electronics and medtech production with high cleanliness demands. |
| Cleanroom class 7 | 352,000 particles/m³ | The most common class for medtech, laboratories and GMP C zones. |
| Cleanroom class 8 | 3,520,000 particles/m³ | Preparatory production, packing and GMP D zones. A common entry-level class. |
| Cleanroom class 9 | 35,200,000 particles/m³ | Controlled environments without personnel airlocks, such as storage and support areas. |
GMP grades A–D for pharmaceuticals and medicine handling
GMP (Good Manufacturing Practice) applies within pharmaceuticals and medicine handling. Grade A is the cleanest and is used for high-risk steps such as sterile filling, while grade D covers less critical stages. GMP measures particles both at rest and in operation, and also requires microbiological control.
GMP A
High-risk steps such as aseptic filling. Corresponds to ISO 5.
GMP B
Background environment around zone A in aseptic manufacturing. ISO 5–7.
GMP C
Cleaner manufacturing steps with lower risk. ISO 7–8.
GMP D
Least critical steps, such as washing and component handling. ISO 8.
Which cleanroom class do you need?
The class is set by your process, your customers' requirements and applicable regulations. We help you land on the right class already in the URS phase – so you do not overbuild, but never underclassify the facility either.
Air change rates are driven by the heat load in the room and the number of people working there.
Cleanroom airlocks are adapted to the class and the flows of staff and materials.
Surfaces, lighting and ventilation are chosen to hold the class energy-efficiently.
Validation to ISO 14644 documents that the cleanroom holds its class – at rest and in operation.
Planning to build a cleanroom?
Tell us about your operation and we will get back to you with a suggested cleanroom class, layout and an initial budget price.