Temperature mapping for GMP-regulated environments.
Independent thermal mapping and qualification studies for storage, process and distribution equipment — executed with calibrated instrumentation under approved, risk-based protocols.
Autoclaves & Ovens
Heat penetration and distribution studies for steam sterilisers, depyrogenation tunnels and dry-heat ovens.
Cold Rooms & Freezers
Mapping of 2–8 °C, –20 °C, –80 °C and ULT storage units, including loaded and empty configurations.
Incubators & Stability
Qualification of stability chambers, incubators and climatic cabinets per ICH conditions.
Transport Lanes
Thermal validation of cold-chain shipping lanes and qualified shipper performance.
Calibrated, traceable, audit-ready.
Studies are executed against a pre-approved protocol with documented acceptance criteria, sensor maps and load configurations. All instrumentation is calibrated against standards traceable to METAS / NIST.
- Calibrated wireless and wired sensors with traceability to national standards
- Sensor placement defined by risk-based mapping protocol
- Empty-load and worst-case loaded qualification cycles
- MKT, uniformity, stability and recovery analysis
- Min / max / mean and out-of-specification event reporting
- Final report with raw data, calibration certificates and conclusions
Scope a thermal qualification
Tell us about the equipment, target conditions and timing — we will propose a sensor plan, protocol and execution window.