Cleanroom Validation

Cleanroom validation is a structured process that ensures the design and operation of your cleanroom meet industry standards and your project’s specific requirements. The five phases of cleanroom validation are:

1. Design Qualification (DQ)
   This initial phase ensures that the cleanroom design meets all applicable requirements and regulations. During the Design Qualification phase, we will:
2. Verify that the cleanroom design is aligned with your operational needs and the required cleanroom classification.
3. Assess whether all systems, materials, and equipment meet regulatory and performance standards (e.g., ISO standards, GMP).
4. Review all design documents and specifications to ensure that they will deliver the desired cleanroom performance.
5. Installation Qualification (IQ)
   Once the design is approved, the next step is ensuring that the cleanroom and its associated systems are installed according to the specifications. The Installation Qualification phase includes:
6. Verifying that all equipment and systems are installed correctly.
7. Ensuring that all necessary components, such as HVAC, filtration, lighting, and electrical systems, are functioning as per the design requirements.
8. Documenting the installation process to confirm that everything has been set up correctly and complies with regulatory standards.
9. Operation Qualification (OQ)
   The Operation Qualification phase focuses on verifying that the cleanroom systems operate according to the intended performance criteria. During this phase, I will:
10. Test all critical systems (e.g., airflow, temperature, humidity, pressure differentials) to ensure they meet the cleanroom specifications.
11. Conduct operational testing to ensure that all equipment functions as required in a cleanroom environment.
12. Document the results of these tests to confirm that the cleanroom’s operational performance meets the necessary standards.
13. Performance Qualification (PQ)
    The Performance Qualification phase ensures that the cleanroom performs consistently under real-world conditions. This phase includes:
14. Conducting performance tests to verify that the cleanroom can maintain the desired air quality, temperature, humidity, and other critical parameters during normal operations.
15. Evaluating the cleanroom’s performance over a defined period to ensure that it meets all functional and regulatory requirements.
16. Verifying that the cleanroom can consistently maintain operational standards under varying conditions, ensuring it is reliable for its intended use.
17. Cleanroom Certification
    Once the cleanroom has passed all the previous phases, the final step is Cleanroom Certification. During this phase:
18. A third-party auditor or regulatory body will conduct final testing and certification to confirm that the cleanroom meets all required standards (e.g., ISO 14644, GMP).
19. Certification ensures that the cleanroom is officially recognized as meeting the required cleanroom classification and can be used for its intended purpose.

As your Cleanroom Specialist, I am here to support you through each phase of cleanroom validation. I will work with you to ensure that all tests are conducted thoroughly and in compliance with the required standards, helping you achieve a fully operational and certified cleanroom facility.