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What Are the Real Requirements for a 100,000-Class Cleanroom?
Many assume that building a 100,000-class (ISO 8) cleanroom is simply about meeting a cleanliness rating. In reality, several other crucial conditions must be met to maintain this classification and ensure stable, high-quality production. Let’s explore the key requirements.
1. Cleanliness Level
A 100,000-class cleanroom refers to a space where:
- Particles ≥ 0.5µm: ≤ 3,520,000 particles/m³
- Particles ≥ 5µm: ≤ 29,300 particles/m³
This is achieved using HEPA filtration systems, controlled airflow design, and regular maintenance to ensure continuous air purification.
2. Temperature & Humidity Control
To maintain product quality and staff comfort:
- Temperature Range: 18°C to 26°C
- Humidity Range: 45% to 65% RH
Proper climate control prevents product damage, microbial growth, and equipment malfunction—critical in sectors like food packaging, medical devices, and electronics.
3. Personnel & Material Management
Even the best-engineered cleanroom can fail without proper usage:
- Workers must wear full cleanroom garments
- Air shower rooms are essential for decontamination
- Unauthorized entry, especially in everyday clothes, risks cross-contamination
Training and strict protocols are key. Everyone plays a role in upholding cleanliness standards.
Conclusion
A 100,000-class cleanroom is more than a rating—it’s a system. From air filtration to disciplined operations, each element is vital to ensuring a stable, contaminant-free production environment.