Cleanroom Classification and Standards
2024.07.29
Cleanroom Classification and Standards
Introduction: The development of cleanrooms is closely tied to modern industry and advanced technology. They are widely used and well-established in various sectors, including biopharmaceuticals, healthcare, food and daily chemicals, electronics and optics, energy, and precision instruments.
1. ISO 14644-1 International Standard—Air Cleanliness Levels
Class | Particle Count Limit (particles/m³) |
≥0.1μm |
|
------------- | -------- |
ISO Class 1 | 10 |
ISO Class 2 | 100 |
ISO Class 3 | 1,000 |
ISO Class 4 | 10,000 |
ISO Class 5 | 100,000 |
ISO Class 6 | 1,000,000 |
ISO Class 7 | - |
ISO Class 8 | - |
ISO Class 9 | - |
2. GB 50073-2013 National Standard—Air Cleanliness Levels
Class | Particle Count Limit (particles/m³) |
≥0.1μm |
|
------------- | -------- |
Class 1 | 10 |
Class 2 | 100 |
Class 3 | 1,000 |
Class 4 | 10,000 |
Class 5 | 100,000 |
Class 6 | 1,000,000 |
Class 7 | - |
Class 8 | - |
Class 9 | - |
3. China GMP (2010 Revision)—Sterile Pharmaceutical Cleanroom Standards
Cleanliness Level | Maximum Particle Count (particles/m³) |
5μm |
|
------------------- | -------- |
Grade A | 3,520 |
Grade B | 3,520 |
Grade C | 352,000 |
Grade D | 3,520,000 |
4. International Cleanliness Level Comparison
Particle Count ≥0.5μm (particles/m³) | ISO14644-1 (1999) | US209E (1992) | US209D (1988) | EEC cGMP (1989) | FRANCE AFNOR (1981) | GERMANY VDI 2083 | JAPAN JAOA (1989) |
Class 1 | - | - | - | - | - | - | - |
Class 2 | - | - | - | - | - | - | 35.3 |
Class 3 | M1.5 | 1 | - | - | 1 | 3 | 100 |
Class 4 | M2.5 | 10 | - | 2 | 4 | 1,000 | 353 |
Class 5 | M3.5 | 100 | A+B | 4,000 | 3 | 5 | 10,000 |
Class 6 | M4.5 | 1,000 | 1,000 | - | 4 | 6 | 35,300 |
Class 7 | M5.5 | 10,000 | C | 400,000 | 5 | 7 | 100,000 |
Class 8 | M6.5 | 100,000 | D | 4,000,000 | 6 | 8 | 10,000,000 |
Cleanroom Level Explanation
- Class X (at Y μm)
- Status Description
- Acceptance Criteria
Semiconductor Industry Cleanroom Case Studies
- Biology laboratory
- Semiconductor Cleanrooms
- Food facotry Cleanrooms
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