Thermal Validation
Temperature and Humidity Mapping
A temperature mapping study is an exercise to qualify temperature and humidity mapping of storage environments used for temperature sensitive products.
Applicable to: Warehouses (Controlled, uncontrolled, Dedicated or Multi Market), Cold stores/Fridges, Freezers, Containers, Vehicles, Stability Chambers, Incubators
Reports document hot & cold spots with recommendations for continuous monitoring positions.
Thermal Validation for ETO Sterilizers
EtO sterilization is used on heat sensitive products. Validation verifies temperature remains within specified parameters.
Key parameters:
- Cycle Physical performance Analysis
- Temperature and Relative Humidity monitoring
- Pressure monitoring
Depyrogenation Validation
The removal of pyrogens from glass and lab equipment in dry heat ovens or Tunnels is called Depyrogenation.
Services include:
- Heat Distribution and Penetration Study
- Cold and Hot Points Detecting
- Depyrogenation Period Calculation (Min, Max, Sterilization Time)
- Lethality Calculations
Thermal Validation for Autoclaves
Sterilizer thermal validation of autoclaves consists of accurately measuring the temperature at critical points within the autoclave chamber throughout the process.
Services:
- Heat Distribution and Penetration Study
- Cold and Hot Points Detecting
- Sterilization Period Calculation
- Lethality Calculations
Thermal Validation - Temperature Mapping System
Temperature Mapping for Cold Stores, Vehicles, Containers, Cabinets (Fridges, Freezers, Stability Chambers)
- Empty & With load (product)
- External ambient temperature (outside of cabinet/cold store/vehicle)
- Date stamp of any notable events (e.g. power failure)
- Impact tests (e.g. door open, Power cut)
- Mapped during normal operations
Temperature Mapping for Warehouses
- Empty & With load (product)
- Summer & Winter
- External ambient temperature (outside of facility)
- Date stamp of any notable events (e.g. power failure)
- Temperature and humidity mapping during normal operations
- Impact tests (e.g. HVAC power down, Door open tests)
- MKT (Mean Kinetic Temperature)
Thermal Validation
Our thermal validation software provides compliance with FDA regulation in 21CFR Part 11 It is providing a Full Automated Reporting and Report Management In addition, software provides all the essential elements for meaningful and successful validation. , all parameters including calibration data associated with a validation study are stored in a specific secured, configuration file, printable for hardcopy filing.
During the test, data is time stamped and stored at a default scan value in an unmodifiable. Operators can view in real time any or all parameters being measured with both graphical and digital displays. The configured validation test data can be printed for hardcopy in both graphical and tabular format. We Let you Know all you need from our Study Report With Clear Thermal Validation Reported contain
Calibration Report and Calibration Check Report – Cycle Analysis – Cycle Mapping Supported With Chart , Chart Zoom , Sensor positioning , Data list – Data list Calculations , and finally you will find Thermal Validation Summary Report