Documentation & Validation

What is Validation?

Validation is a critical quality assurance process that involves verifying and documenting that an installed system consistently produces accurate, reliable, and reproducible results according to specified requirements.

HVAC Validation Procedures

HVAC system validation ensures that the heating, ventilation, and air conditioning setup meets performance and environmental control standards. The key validation parameters include:

CFM (Cubic Feet per Minute) Measurement
Accurate measurement of airflow volume to verify the system’s capacity and efficiency.
Pressure Difference Testing
Monitoring differential pressure between zones to maintain correct airflow direction and prevent contamination.
Temperature Mapping
Comprehensive recording of temperature variations throughout the controlled environment to ensure uniformity.
Relative Humidity (RH) Mapping
Assessment of humidity levels to maintain conditions that meet comfort and process specifications.

Cleanroom Lower Side Validation

Validation of the cleanroom environment is essential for maintaining strict contamination control. The following tests are performed:

Particle Count Analysis
- Viable Particle Count: Microbial sampling to detect living contaminants such as bacteria and fungi.
- Non-Viable Particle Count: Measurement of inert particles using laser particle counters to ensure compliance with cleanliness standards.
Air Changes Per Hour (ACPH)
Verification of air exchange rates to maintain the cleanroom classification and control airborne contaminants.
HEPA Filter Integrity Testing (HAPA Integrity)
High-efficiency particulate air (HEPA) filters are tested for leaks using aerosol challenge methods to confirm filter efficiency.
Sound Level Testing
Measuring ambient noise levels in the cleanroom to ensure compliance with safety and comfort regulations.

Documentation Requirements

Proper documentation of all validation activities is vital for:

Demonstrating compliance with regulatory standards (e.g., ISO 14644, GMP).
Providing traceability and accountability.
Supporting ongoing system maintenance and audits.
Ensuring reproducibility of the validated conditions.

Conclusion

Thorough Documentation & Validation of HVAC and cleanroom systems guarantees environmental control integrity, operational efficiency, and regulatory compliance — essential for product quality and safety.