Cleanroom design plays a critical role in maintaining required cleanliness levels. Effective cleanroom design involves detailed planning, precise standards, and proper airflow management.
Key Standards for Cleanroom Design
1.Airflow Management
Efficient airflow management is fundamental in cleanroom design. Clean air must be directed initially toward operational zones, minimizing contamination.
Rduce turbulence.
Prevent dust recirculation.
Ensure uniform airflow.
Maintain appropriate airflow velocity.
2.Filtration System Selection
Cleanroom design standards emphasize selecting suitable air filters, typically High-Efficiency Particulate Air (HEPA) or Ultra-Low Particulate Air (ULPA) filters.
HEPA filters capture 99.97% of particles ≥0.3 µm.
ULPA filters remove 99.999% of particles ≥0.12 µm.
Choose filters based on environmental factors and contamination control requirements.
3.Cleanroom Layout
Cleanroom layout directly affects operational effectiveness.
Minimum 4m² per person for operational safety.
Separate areas clearly (gowning rooms, material transfer zones).
Design to prevent cross-contamination.
Organize spaces logically from high to low cleanliness.
4.Temperature and Humidity Control
Maintain optimal conditions per cleanroom design standards:
Class 100k and 1M: Temperature 20°C – 24°C, Humidity 45%-65%.
Class 10k and 300k: Temperature 18°C – 26°C, Humidity 45%-65%.
Personnel rooms:
Winter: 16°C – 20°C
Summer: 26°C – 30°C
5.Sterility Testing Room Requirements
Sterility rooms need independent HVAC systems and comply with higher cleanliness levels (ISO Class 5).
Include:
Personnel airlocks (gowning, handwashing)
Material transfer rooms
Dedicated sterility testing zones
Maintenance and Compliance
Regular inspection and meticulous maintenance are essential to uphold cleanroom standards. Compliance ensures sustained operational efficiency and effectiveness in contamination prevention.
Proper cleanroom design ensures reliable, contaminant-free environments, vital for industries like pharmaceuticals, electronics, and medical device manufacturing.
