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.

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Types of Equipments:

  • 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. 
Auto Clave (1)
Stability Chamber (1) (1)
Vacuum Oven (1)

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
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