Thermal Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the sterilization process has been and will be consistently effective.
Thermal validation consists of accurately measuring the temperature at critical points within the sterilization chamber throughout the process
A temperature mapping study is an exercise to qualify temperatures (and humidity if required) of storage environments used for temperature sensitive
This can include but is not limited to Warehouses (Controlled, uncontrolled, Dedicated or Multi Market), Cold stores/Fridges, Freezers, Containers, Vehicles, Stability Chambers, Incubators)
The temperature mapping report will document any
recorded Hot & Cold spots as well as recommendations for continuous monitoring positions where required.
Thermal validation of autoclaves consists of accurately measuring the temperature at critical points within the autoclave chamber throughout the process
The removal of pyrogens from glass and lab equipment in dry heat ovens or Tunnels is called Depyrogenation.
Most pyrogens are endotoxins, and although endotoxins are relatively thermally stable, a significant reduction in endotoxin levels can be achieved within a dry heat sterilizer.
EtO sterilization is used on heat sensitive
products. Consequently validation exercises
must verify that temperature remains within specified parameters. Other critical parameters are pressure and humidity.
events (e.g. power failure)
events (e.g. power failure)
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
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
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