Thermal Validation
THERMAL VALIDATION is the process of establishing an evidence to demonstrate that a process carried out in a defined manner can consistently produce desired results complying with its pre-determined process application & quality aspects.
One of the objectives of Thermal Validation of equipment & rooms is to ensure that the process parameters have been adequately & uniformly distributed throughout the useful workspace under empty & acceptable extreme test conditions & Thermolab Testing does exactly that for its customers in India & abroad.
Thermolab testing’s scope of services are designed to ensure reliable & precise measurement results traceable to National / International Standards.
Services offered by Thermolab Testing:
A team of trained & dedicated professionals carry-out testing of process, laboratory & scientific equipment & rooms under Thermal Validation to evaluate some critical parameters like F0, FH, Fd, Lethality, Lag time, Uniformity, Mean Kinetic Temperature & Hot & Cold Spot as applicable.Thermolab performs Thermal Validation for a wide range of equipment & rooms & assure 100% reliable results.
Types of Rooms:
Temperature & Relative Humidity – Control Sample Rooms, Label Library Rooms, Ware Houses, In Process Stores, Raw Material Stores, Packing Material Store, Finished Goods Stores, containers etc.
Types of Equipment:
- Temperature – Dry Heat Sterilizers, Depyrogenation Tunnels, Ovens, LOD Ovens, Driers, Tray Driers, Furnaces, Deep Freezers, Refrigerators, Walk in Coolers, Cooling Cabinets, Cold Storages, Gas Chromatographs, BOD Incubators, HPLC Column Ovens & Sample Compartments etc.
- Temperature & Pressure – Autoclaves, Vacuum Ovens etc.
- Temperature & Relative Humidity – Stability Chambers, Walk in Stability Chambers, Photo stability Chambers etc.
Autoclave
Stability Chamber
Vaccum Oven
Validation Standards
| Sr. No | Name of Standard | Equipment Range | Accuracy | Traceability |
| 1 | Wireless Data Loggers | -30 to 70°C & 0 to 100%RH | ± 0.5°C & ± 2%RH | National |
| 2 | Wired Data Loggers (21 CFR Part 11 Compliant) | Universal ± 0.3mV & ± 0.02mA | & better than ± 1°C & ± 2°C for T & K Type T/Cs & ± 0.5°C for RTDs | National |
| 3 | Temperature & RH Transmitter | 0 to 50°C & 0 to 100%RH | ± 0.5°C & ± 2%RH | National |
| 4 | Wired Data loggers Thermocouple | All Types | ± 1°C | National |
| 5 | Thermocouple Sensors “T‟ Type Thermocouples | -100 to 400°C | ± 0.5% | National |