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 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. 
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Autoclave

Stability-Chamber-200x300 (1)

Stability Chamber

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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
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