Cleanroom validation and testing are critical steps to ensure your controlled environment consistently meets the required GMP, ISO 14644, and industry-specific standards. Whether you operate a pharmaceutical plant, semiconductor facility, medical device factory, or biotech laboratory, proper validation guarantees stable air quality, minimized contamination risks, and long-term compliance.
Why Cleanroom Validation Is Essential
Validation confirms that the cleanroom performs exactly as designed. It is required by global regulatory bodies and helps prevent product defects, operational downtime, and contamination-related failures. Regular testing also identifies performance deviations early, ensuring long-term reliability of cleanroom systems.
Key Cleanroom Testing Services We Provide
1. Airflow Velocity and Air Change Rate Testing
We measure airflow velocity, uniformity, and ACH (Air Change Rates) to ensure the HVAC and clean air systems deliver the required performance for your clean zone classification.
2. HEPA/ULPA Filter Integrity Testing
Using professional scanning methods like PAO/DOP testing, we evaluate filter leakage, frame tightness, and sealing efficiency to maintain ultra-clean environments.
3. Particle Count and Cleanliness Classification
Using ISO-certified particle counters, we validate that your cleanroom meets the correct cleanliness level, including ISO 5, ISO 6, ISO 7, and ISO 8 classifications.
4. Temperature and Humidity Validation
We confirm that environmental conditions remain within the required ranges—crucial for sensitive manufacturing such as electronics, biopharma, and medical products.
5. Pressure Differential Testing
Room-to-room pressure mapping ensures that directional airflow prevents contamination flow from low-grade to high-grade zones.
6. Recovery Time Testing
This test evaluates how quickly a cleanroom returns to target particle levels after disturbance—an important ISO 14644 requirement.
7. Light, Sound, and Vibration Testing
We assess environmental comfort and stability parameters that directly impact operator efficiency and production accuracy.
8. Microbial Testing (Optional)
For GMP facilities, we offer microbial sampling to detect airborne and surface contamination, ensuring compliance with pharmaceutical guidelines.
Industries That Require Cleanroom Validation
- Pharmaceutical & Biotech Manufacturing
- Semiconductor & Electronics Production
- Medical Device Assembly
- Food & Beverage Processing
- Laboratory & Research Facilities
- Optics and Precision Engineering
Our Validation Process
Our validation team follows a strict methodology:
- Review design and engineering documents
- Create a project-specific validation plan
- Perform on-site testing using calibrated equipment
- Issue a full validation report with data and recommendations
- Provide ongoing monitoring and re-validation services
Get Reliable Cleanroom Testing and Compliance Support
With extensive experience in global cleanroom engineering, we help ensure your facility meets operational and regulatory requirements. Our validation services support product safety, quality stability, and long-term cleanroom performance.
