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
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
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:
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
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
- 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):
- 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