To ensure these controlled environments function as intended, cleanroom validation is essential. Several critical parameters must be monitored and maintained to meet regulatory requirements and ensure consistent product quality. This blog explores the six key parameters in cleanroom validation: Pressure differential checks, air change rates, filter integrity testing, particle count test, recovery test, temperature & humidity

1. Airflow and Air Changes per Hour (ACPH)

Why it Matters:
• Proper airflow helps remove airborne contaminants, preventing particle buildup.
• High-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters ensure clean air circulation.

Validation Process:
• Air velocity and uniformity are tested using anemometers.
• Air changes per hour (ACPH) are measured to confirm compliance with ISO and GMP classifications.
• Smoke visualization tests assess airflow patterns to detect turbulence and dead zones.

2. Temperature Control

Why it Matters:
• Many industries require precise temperature regulation to prevent product degradation.
• Unstable temperatures can affect microbial growth, impacting sterility.

Validation Process:
• Sensors and data loggers are placed in different cleanroom areas.
• Temperature stability is monitored over time to ensure uniformity.
• Acceptable temperature ranges vary by industry but typically fall between 18°C to 22°C for pharmaceutical applications.

3. Humidity Levels

Why it Matters:
• High humidity can lead to condensation, promoting microbial contamination.
• Low humidity can cause static electricity buildup, affecting sensitive electronic components.

Validation Process:
• Hygrometers measure relative humidity (RH) in different cleanroom zones.
• The typical acceptable RH range is 40% to 60%, depending on the application.
• Humidity control systems are assessed for reliability in maintaining stable conditions.

4. Pressure Differentials

Why it Matters:
• Maintaining correct pressure gradients prevents contamination from entering critical areas.
• Positive pressure is used in sterile cleanrooms, while negative pressure is required in containment areas.

Validation Process:
• Digital manometers are used to measure pressure differentials between adjacent cleanroom areas.
• Cleanrooms must maintain a pressure differential of 10-15 Pascals between classified and non-classified areas.
• Door opening tests confirm that airflow direction remains controlled.

5. Particle Count and Microbial Monitoring

Why it Matters:
• Ensures that airborne particle levels comply with ISO 14644 - 1, 2, 3, and GMP classifications.
• Excessive particle presence can indicate filtration failures or contamination risks.

Validation Process:
• TSI INC, USA makes Aerotrack series optical laser particle counters to measure airborne particle concentrations.
• Set limits for particles ≥0.5 µm and ≥5.0 µm must be maintained as per classification standards.
• Microbial testing (e.g., settle plates, and air samplers) ensures biological contamination control.

6. Recovery Test

Why it Matters:
• Evaluate the cleanroom's ability to return to an acceptable particle level after contamination.
• Ensures compliance with ISO 14644-3 standards for effective ventilation and filtration performance.

Validation Process:
• Introduce a controlled particle challenge within the cleanroom.
• Use TSI INC, USA Aerotrack series optical laser particle counters to monitor particle decay over time.
• Measure the time required for the particle concentration to return to baseline levels.
• Ensure compliance with specified recovery time limits based on cleanroom classification.

Conclusion:-

• Pressure differential checks, air change rates, filter integrity testing, particle count test, recovery test, temperature & humidity By regularly testing and validating these elements, industries can ensure compliance with regulatory standards, protect product integrity, and enhance operational efficiency. Cleanroom validation is not just a regulatory requirement—it is a crucial step in maintaining a contamination-free production environment.