Temperature Qualification & Validation

Temperature qualification study of cold chainTemperature qualification study is a detailed process involving a lot of tests and analysis. This is 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

The procedure and tests consist of the following sequence of tests:

  1. Design qualification process (DQ)

    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.

  2. Installation qualification process (IQ)

    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.

  3. Operation qualification process(OQ)

    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.

  4. Performance Qualification (PQ)

    The performance qualification involves various tests under operating conditions such as full load, 60% load, etc. A series of tests covering door opening tests, power failure tests, recovery tests, etc. are included in performance qualification.

  5. Document verification

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

  6. Temperature mapping study (and Humidity if required)

    Please see our separate page on Temperature mapping study for details on this procedure

What is the 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 during different tests will be indicated.
  8. Hot points and Cold Points will be indicated in a layout drawing.
  9. Recommendations for improvements if any will be included in the report.
  10. A layout drawing indicating the proposed locations for placing continuous monitoring instruments (if applicable).
  11. The report will include certificates of calibration for all data loggers used during the study.

Temperature validation process

Temperature mapping study and temperature qualification study are for individual assets. However, temperature validation is for a whole set of actions. It is possible to carry out temperature validation for assets such as a thermal box. Please read below examples of a validation process.

  1. Consider that you are a pharma distributor. From the moment a medicine arrives at your warehouse, it is your responsibility. You have to ensure that you maintain the temperature of the medicine until it reaches the pharmacy a few weeks or months later. In this case, we assume that the pharmacy is owned by someone else. Hence your responsibility ends once you deliver the medicine to them. There are various set of actions happening at your warehouse during this period. Also, you are transporting the medicine to its final destination few weeks later. We study this entire process to check various parameters including temperature variations. This is the process of validation.
  2. Consider an example that you are regularly despatching a medicine in a thermal box to another city by flight. You would want to validate the entire process from your warehouse to the final destination. The box goes through different environmental conditions.  We carry out tests of these entire process throughout its journey. This is also a process of validation.

As you see from the above examples, the validation is mainly for a process. It definitely involves a number of assets.

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In the Middle East, we serve the United Arab Emirates, Kingdom of Saudi Arabia, Oman, Qatar, Bahrain, Iraq, Lebanon, Egypt, Jordan, Libya, Tunisia, etc.
In Africa, we serve countries including Kenya, Algeria, Tanzania, Djibouti, Chad, Ghana, Rwanda, Uganda, Nigeria, Ethiopia, Morocco, Angola, South Africa, etc.

Also, we carry out temperature qualification and validation in India, Bangladesh, Pakistan, Afghanistan, Kazakhstan, Srilanka, Maldives, and Cyprus.