Thermal validation

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

image8
image9

Temperature and Humidity Mapping

A temperature mapping study is an exercise to qualify temperatures (and humidity if required) of storage environments used for temperature sensitive 

products.  

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.

Sterilizer Thermal Validation

Thermal Validation for Autoclaves

image10

Thermal validation of autoclaves consists of accurately measuring the temperature at critical points within the autoclave chamber throughout the process

  • Heat Distribution and Penetration Study
  • Cold and Hot Points Detecting
  • Sterilization Period Calculation 
  • ( Min , Max , Sterilization Time)
  • Lethality Calculations

Depyrogenation Validation:

image11

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.

  • Heat Distribution and Penetration Study
  • Cold and Hot Points Detecting
  • Depyrogenation Period Calculation 
  • ( Min , Max , Sterilization Time)
  • Lethality Calculations 

Thermal Validation for ETO Sterilizers

image12

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.

  • Cycle Physical performance Analysis
  • Temperature and Relative Humidity monitoring
  • Pressure monitoring

Temperature and Humidity Mapping

TEMPERATURE MAPPING FOR WAREHOUSES

image13

  • Empty & With load (product)
  • Summer & Winter
  • External ambient temperature (outside of facility)
  • Date stamp of any notable 

events (e.g. power failure)

  • Mapped during normal operations
  • Impact tests (e.g. HVAC power down, Door open tests)
  • MKT (Mean Kinetic Temperature)

TEMPERATURE MAPPING FOR COLD STORES, VEHICLES, CONTAINERS, CABINETS (FRIDGES, FREEZERS, STABILITY CHAMBERS):

image14

  • 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

EESS Thermal Validation - Temperature Mapping System

 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