Cleanroom Validation Guide: Steps, Checklists & ISO 14644 Compliance
Cleanroom validation is a rigorous documented process used to prove that a controlled environment consistently meets its specified design intent and regulatory standards. For industries like pharmaceuticals and semiconductors, validation is not just a best practice—it is a legal requirement for ISO 14644 and GMP compliance.
The 4 Essential Stages of Cleanroom Qualification
At Farclean, we follow the industry-standard “V-Model” approach to qualification, divided into four distinct phases:
1. Design Qualification (DQ)
Before construction begins, DQ verifies that the proposed design (blueprints, HVAC specs, material choices) meets the user requirement specifications (URS) and regulatory mandates.
2. Installation Qualification (IQ)
Once the facility is built, IQ confirms that all equipment and systems are installed correctly.
Checklist focus: Are the sandwich panels airtight? Are the HEPA filters the correct model? Is the HVAC ductwork sealed?
3. Operational Qualification (OQ)
OQ tests the cleanroom “at-rest.” We run the systems to ensure they operate within specified limits.
Key tests: Airflow velocity, pressure differentials, and HEPA filter leak testing (PAO test).
4. Performance Qualification (PQ)
PQ is the final step, conducted while the cleanroom is “operational” (with equipment running and personnel present). This proves the environment remains stable during actual production cycles.
Critical Cleanroom Validation Checklist
To help you prepare for your next audit, here are the primary parameters that must be tested and documented:
| Testing Parameter | Standard (ISO 14644-1) | Frequency |
|---|---|---|
| Airborne Particle Count | Limits based on Class (5-9) | Every 6-12 Months |
| Airflow Velocity/Volume | +/- 20% of design value | Every 12 Months |
| Air Pressure Difference | Typically 5-15 Pa | Continuous Monitoring |
| Filter Leakage (PAO) | 0.01% penetration limit | Every 12 Months |
Common Pitfalls in Cleanroom Validation
Many facilities fail validation not because of poor equipment, but due to poor documentation or environmental factors. Common issues include:
- Inadequate Gowning Protocols: Human interference is the #1 cause of PQ failure.
- Poor Airflow Optimization: Dead zones that trap particles during operational cycles.
- Uncalibrated Sensors: Using testing instruments that haven’t been certified.
Partner with Farclean for Turnkey Validation Services
Navigating the complexities of ISO 14644 validation can be overwhelming. Farclean provides comprehensive EPC services, including full documentation and on-site commissioning to ensure your facility passes every audit with flying colors.
Need an Audit-Ready Validation Plan?
Our engineering team can help you draft your DQ/IQ/OQ/PQ protocols and perform all necessary testing using calibrated, high-precision instruments.
