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Cleanroom Construction Guide: Design, Standards & Best Practices
Created on 2024.08.08
Looking to build a cleanroom that meets ISO 14644 or GMP standards?
This guide explains everything you need to know — from cleanroom design and material selection to HVAC control, contamination prevention, and final validation.
1. Cleanroom Design Considerations
1.1 Define Cleanroom Classification (ISO 14644-1)
Choose the correct ISO class (Class 5–9) based on your industry — pharmaceutical, semiconductor, biotechnology, or aerospace.
This step determines airflow rates, materials, and HVAC design.
1.2 Modular vs. Traditional (Stick-Built) Cleanroom Construction
- Modular Cleanrooms:
Faster installation, flexible expansion, minimal downtime.
- Stick-Built Cleanrooms:
Fully customizable structure for unique layouts.
1.3 Airflow and Layout Design
- Choose between laminar flow (for high-purity zones) and turbulent flow.
- Ensure optimal
air changes per hour (ACH) and directional airflow to prevent contamination.
2. Material Selection
Choose non-shedding, smooth, and chemical-resistant materials:
- Walls & Ceilings:
Powder-coated steel, HPL, or PVC panels.
- Flooring:
Epoxy or vinyl with anti-static properties.
- Windows & Doors:
Flush-mounted, double-glazed, easy to clean.
3. HVAC and Environmental Control
A robust HVAC system ensures temperature, humidity, and pressure control:
- HEPA/ULPA filters
for particle removal
- Air Handling Units (AHUs)
designed for low vibration
- Maintain pressure differentials between cleanroom zones
4. Construction Best Practices
- Maintain strict site cleanliness
- Limit access to authorized personnel
- Use cleanroom-approved materials
- Implement vibration and noise isolation
5. Validation and Certification
After construction:
- Conduct
particle count testing, airflow visualization, and pressure tests
- Obtain third-party
cleanroom certification per ISO 14644 or GMP standards
6. Maintenance and Monitoring
Ongoing maintenance ensures performance:
- Replace HEPA filters regularly
- Calibrate HVAC systems
- Use real-time environmental monitoring and alarm systems
Conclusion
Building a compliant cleanroom requires careful design, quality materials, and strict validation.
Partnering with a professional cleanroom contractor ensures full compliance, safety, and long-term reliability.
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