HVAC Validation/Clean room Validation

At Techval, we specialize in delivering comprehensive HVAC and Clean Room Validation services tailored to the pharmaceutical, biotechnology, healthcare, and manufacturing industries. Our expertise ensures that your controlled environments operate within the strict regulatory requirements set by cGMP, WHO, USFDA, EU, and ISO standards.

A well-validated HVAC system and cleanroom environment is critical for maintaining product quality, patient safety, and regulatory compliance.

2. Objectives of HVAC & Clean Room Validation

To verify that airflow, temperature, humidity, and pressure differentials meet regulatory requirements.
To ensure particulate and microbial contamination control in cleanroom environments.
To confirm the performance, consistency, and reliability of HVAC and cleanroom systems.
To provide documentation and evidence supporting regulatory audits and inspections.

3. Scope of Services by Techval

A. HVAC Validation

Air Velocity Testing – Ensure proper airflow distribution for contamination control.
HEPA Filter Integrity Testing – Verify that filters perform effectively to trap airborne contaminants.
Recovery Time Testing – Measure how quickly the cleanroom returns to defined air quality after contamination.
ACPH, Temperature & RH Validation – Assess air changes per hour, temperature, and humidity levels.
Differential Pressure Monitoring – Confirm correct pressure cascades between cleanroom grades.
NVPC and Airflow Visualization Studies – Smoke studies for airflow pattern verification.

B. Clean Room Validation

Particulate Count Testing – Evaluate cleanliness levels as per ISO 14644 guidelines.
Microbial Monitoring – Assess microbial contamination risks in controlled zones.
Temperature Mapping & Environmental Monitoring – Confirm uniformity and compliance across the cleanroom.
Clean Room Qualification – Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

4. Benefits of Choosing Techval

Expertise in pharmaceutical and biotech compliance requirements.
State-of-the-art instruments for accurate and reliable validation.
Customized validation protocols tailored to client facilities.
Comprehensive documentation packages ready for regulatory inspections.
Support for CAPA implementation and audit readiness.

5. Deliverables

Complete Validation Protocols (IQ, OQ, PQ)
Validation Summary Reports for HVAC and Clean Rooms
Regulatory-Compliant Documentation for FDA, EU, WHO, and ISO audits
Audit Support & Consultation for ongoing compliance

Air velocity testing

Techval provides precise Air Velocity Testing services to ensure controlled airflow in cleanrooms and HVAC systems, maintaining compliance, product safety, and regulatory standards with reliable validation solutions.

HEPA filter integrity testing

Techval delivers accurate HEPA Filter Integrity Testing to verify filter performance, ensuring contamination control, cleanroom safety, and regulatory compliance for pharmaceutical, biotech, and healthcare environments

Recovery time testing

Techval offers Recovery Time Testing to assess cleanroom efficiency, ensuring rapid return to controlled conditions after contamination, maintaining regulatory compliance, product quality, and patient safety.

ACPH, temperature & RH

Techval provides ACPH, Temperature & RH validation to ensure controlled cleanroom environments, maintaining air changes, thermal stability, and humidity levels in compliance with regulatory standards.

Differential pressure monitoring

Techval ensures reliable Differential Pressure Monitoring to maintain proper pressure cascades in cleanrooms, preventing cross-contamination and ensuring regulatory compliance with consistent environmental control.

NVPC and airflow visualization studies

Techval performs NVPC and Airflow Visualization Studies using smoke tests to verify airflow patterns, ensuring contamination control, cleanroom efficiency, and compliance with international regulatory standards.