Thermal Validation
Importance in Regulatory Compliance
Thermal validation is mandated by regulatory authorities to prove that cleanrooms and controlled environments maintain conditions required for sterile manufacturing. EU GMP Annex 1, WHO TRS 961, and FDA guidelines emphasize mapping as a prerequisite for qualification and ongoing monitoring.
Our validation process ensures that your thermal systems meet all regulatory requirements while maintaining optimal performance and energy efficiency throughout their operational lifecycle.
Ensuring temperature distribution meets regulatory standards
Mapping Methodology
Thermal mapping uses calibrated sensors placed at strategic points to record temperature and humidity over defined time intervals. Mapping studies are performed in both static (empty) and dynamic (operational) conditions, ensuring that the system performs consistently under real-life usage.
- Static Conditions Mapping:Temperature and humidity mapping in empty cleanrooms and controlled environments.
- Dynamic Conditions Mapping:Mapping studies performed during actual operational conditions with equipment running.
- Strategic Sensor Placement:Calibrated sensors placed at strategic points to capture worst-case scenarios.
- Time-Based Analysis:Continuous monitoring over defined time intervals to ensure consistent performance.
Key Deliverables of Validation
Validation produces documented evidence including:
- Protocols and reports aligned with regulatory guidelines
- Graphical temperature distribution analysis (heat maps, time-based plots)
- Identification of worst-case locations for continuous monitoring
- Documentation of deviations, corrective actions, and calibration traceability
Continuous Assurance
Thermal validation is not a one-time event but part of a lifecycle approach. Periodic revalidation (annually or after system modifications) ensures cleanrooms, storage areas, and equipment continue to operate within required specifications. This proactive approach helps pharmaceutical companies remain audit-ready, compliant, and product-safe.
Periodic Revalidation
Annual revalidation or after system modifications to ensure continued compliance
System Modifications
Validation of changes including equipment updates and environmental modifications
Audit Readiness
Continuous monitoring to maintain audit-ready status and regulatory compliance
Ready for Thermal Validation & Mapping?
Contact our thermal validation experts to discuss your mapping and validation requirements. We provide comprehensive validation services ensuring full regulatory compliance with EU GMP Annex 1, WHO TRS 961, and FDA guidelines.