Temperature Qualification Study

Temperature qualification study of cold chainTemperature qualification study is a detailed process involving lot of tests and analysis to ensure that the asset is designed and installed properly and is capable of maintaining the desired temperature and humidity. After this elaborate process, the asset is certified as qualified for achieving and maintaining the desired levels of temperature and humidity.

Main tests under the temperature qualification study

  • Design qualification process
  • Design qualification is analyzing that the asset is designed properly to carry out the desired function of achieving and maintaining the desired temperature and humidity. This process will involve checking the design aspects with accepted engineering practices and relevant requirements of the country in which the asset is maintained

  • Installation qualification process
  • Temperature qualification study of coldroomInstallation qualification is the process of verifying that all major components of the assets are installed and maintained as per the design and as per the recommendations of the manufacturers of the respective items. Also relevant local guidelines need to be verified.

    Installation qualification is generally known as IQ.

  • Operation qualification process
  • Operation qualification is verifying methods of operation of the entire assets and its major components. All these should be operated as per the manufacturer’s guidelines and SOPs implemented by the user.

    Operation qualification is generally known as OQ.

  • Document verification
  • Temperature qualification study of reeferAll documents such as calibration certificates, maintenance check lists, operation check lists etc. have to be maintained as per the written procedures which are verified in this stage.

  • Temperature mapping study (and Humidity if required)
  • Please see our separate page on Temperature mapping study for details on this procedure

What is Temperature and Humidity qualification process?

Temperature qualification study of vanThe only addition is that humidity is also covered under this study and all equipment related to humidity also will be verified. The mapping study will include humidity as well

What are the deliverable and results of a qualification study?

  1. Facility mapping protocol and report (empty load) with detailed study testing methodology, results, data interpretation and recommendations for the controlled-room temperature warehouses.
  2. Facility mapping protocol and report (full load – summer & winter profile) with detailed study testing methodology, results, data interpretation and recommendations for the controlled-room temperature warehouses.
  3. Qualification protocols and reports with detailed study testing methodology, results, data interpretation and recommendations for the cold room.
  4. Certificate indicating results of the asset and major deviations if any
  5. Various charts indicating analysis of Temperature & Humidity at various locations
  6. Temperature qualification study of medicine boxVarious charts indicating analysis of Temperature & Humidity during specific operational conditions as per the protocol
  7. Excursions of Temperature & Humidity
  8. Hot points and Cold Points
  9. Recommendations for improvements if any
  10. Locations for placing continuous monitoring instruments (if applicable)
  11. Certificate of calibration for all data loggers used during the study.