Whether in pharmaceuticals, biotechnology, microelectronics, or aerospace, maintaining a validated cleanroom is essential for product integrity and regulatory compliance. This checklist provides a step-by-step guide for professionals to ensure their cleanroom meets ISO 14644 - 1, 2, 3, EU GMP, USFDA, and WHO standards.

Cleanroom Validation Checklist

1. Pre-Validation Preparation
✅ Define validation scope and regulatory requirements.
✅ Identify cleanroom classification based on ISO 14644-1 standards.
✅ Establish protocols for environmental monitoring.
✅ Ensure HEPA/ULPA filters are properly installed and certified.
✅ Verify cleanroom design meets airflow and pressure differential requirements.

2. Qualification & Testing
✅ Conduct Airflow Visualization Study (Smoke Test).
✅ Perform HEPA Filter Integrity Testing (PAO test).
✅ Measure airborne particle counts to verify compliance with cleanroom classification.
✅ Check room pressurization to prevent cross-contamination.
✅ Validate temperature and humidity control systems.
✅ Perform microbiological monitoring (settle plates, air sampling, surface swabs).

3. Cleanroom Cleaning & Gowning Validation
✅ Establish and validate cleaning procedures using approved disinfectants.
✅ Train personnel on proper gowning techniques and conduct gowning qualification tests.
✅ Ensure proper material flow and segregation to prevent contamination.
✅ Monitor personnel behavior and adherence to cleanroom protocols.

4. Documentation & Compliance
✅ Maintain validation reports, including all test results and corrective actions.
✅ Ensure Standard Operating Procedures (SOPs) are up to date and followed.
✅ Conduct regular internal audits and inspections.
✅ Implement corrective and preventive actions (CAPA) for deviations.
✅ Schedule periodic revalidation based on regulatory requirements.

Conclusion:-

A validated cleanroom is essential for maintaining high-quality standards and ensuring regulatory compliance. By following this checklist, professionals can systematically assess their cleanroom environment and implement corrective measures to maintain contamination control. Regular monitoring and periodic revalidation are key to sustaining a clean and compliant facility.