HVAC Validation as per ISO 14644 / EU GMP
Regulatory Alignment
HVAC validation demonstrates compliance with internationally recognized standards such as ISO 14644 (Cleanrooms and Associated Controlled Environments) and EU GMP Annex 1 (Manufacture of Sterile Medicinal Products). These guidelines set the framework for air cleanliness levels, environmental monitoring, and system qualification.
Our validation process ensures that your HVAC systems meet all regulatory requirements while maintaining optimal performance and energy efficiency throughout their operational lifecycle.
Ensuring air cleanliness levels meet international standards
Validation Scope
The validation process covers the qualification stages (DQ, IQ, OQ, PQ) of cleanroom HVAC systems:
- Design Qualification (DQ):Ensures the system design meets regulatory and process requirements.
- Installation Qualification (IQ):Confirms proper installation of AHUs, ducts, filters, and controls.
- Operational Qualification (OQ):Verifies system functionality under controlled conditions.
- Performance Qualification (PQ):Demonstrates performance consistency during actual operations.
Key Deliverables
Validation produces documented evidence including:
- Protocols and reports for each test parameter
- Calibration certificates for instruments used
- Acceptance criteria aligned with ISO 14644 and EU GMP limits
- Deviations, corrective actions, and traceable audit records
Continuous Assurance
HVAC validation is not a one-time event but a lifecycle approach. Requalification is required periodically, and whenever system changes occur to ensure ongoing compliance, product safety, and regulatory readiness.
Periodic Requalification
Regular requalification to ensure ongoing compliance and system performance
Change Management
Validation of system changes including filter replacement and AHU modifications
Ongoing Compliance
Continuous monitoring to ensure product safety and regulatory readiness
Ready to Validate Your HVAC Systems?
Contact our HVAC validation experts to discuss your compliance requirements. We provide comprehensive validation services ensuring full regulatory compliance with ISO 14644 and EU GMP standards.