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 design and installation of an asset are capable of maintaining the desired temperature and humidity. After this elaborate process, we certify and qualify the asset 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 design of the asset is adequate. It should be suitable to achieve and maintain a specific range of temperature under all conditions. 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 the installation of all major components. Also, we verify the recommendations of the manufacturer of the respective items. All design and installation should be as per relevant local guidelines as well.

    Installation qualification is generally known as IQ.

  3. Operation qualification process(OQ)

    Operation qualification is verifying methods of operation of the entire assets and their major components. The operation of the equipment should be as per the manufacturer’s guidelines and the user’s SOPs.

    Operation qualification is generally known as OQ.

  4. Performance Qualification (PQ)

    The performance qualification involves various tests under normal operating conditions. These include conditions such as full load, 60% load, etc. there are a series of tests covering door opening tests, power failure tests, recovery tests, etc.

  5. Document verification

    Temperature qualification study of reeferIt is essential to maintain all documents such as calibration certificates, maintenance checklists, operation checklists etc. Based on the scope, we verify these have to be as per the written procedures of the user.

  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. Hence we verify all equipment related to humidity in addition to equipment for temperature control. The mapping study report will include humidity as well

What are the deliverable and results of a qualification study?

  1. The first part will be Facility mapping protocol and report under empty load. This will cover study testing methodology, results, data interpretation and recommendations for the controlled-room temperature warehouses.
  2. The next part is facility mapping protocol and reports under full load in summer & winter climates. It will have detailed study testing methodology, results, data interpretation and recommendations.
  3. The third part is qualification protocols and reports for all the relevant equipment. It will have detailed study testing methodology, results, data interpretation and recommendations for the cold room.
  4. The report will include a summary and certificate. They will indicate the 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 sets of actions happening at your warehouse during this period. Also, you are transporting the medicine to its final destination a 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 this 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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Details of Temperature Qualification & Validation Services

  1. Service Type: Temperature Qualification & Validation – Testing the temperature control equipment and processes for storage and transportation of medicines.
  2. Description: The temperature Qualification & Validation is mainly for pharma and food segments. This is to find out that all the cooling or heating equipment and the processes ensure uniformity of temperature distribution inside the storage area or vehicles of medicines.
  3. Area Served: The United Arab Emirates, Saudi Arabia (Riyadh, Jeddah, Dammam, Jubail), Qatar, Oman, Bahrain, Kuwait, Kenya, Tanzania, Ethiopia, Rwanda, Uganda, Jordan, Lebanon, United States of America, United Kingdom, Europe, Germany, France, Canada.
  4. Service Offer: Temperature Qualification & Validation of the warehouse, Temperature Qualification & Validation of cold room, Temperature Qualification & Validation of the freezer, Temperature Qualification & Validation of the refrigerator, Temperature Qualification & Validation of reefer trucks, Temperature Qualification & Validation of vans, Temperature Qualification & Validation of thermal boxes, Temperature Qualification & Validation of autoclaves, Temperature Qualification & Validation of stability chambers.
  5. Additional Type: Temperature & Humidity Qualification & Validation with Qualification.
  6. Service Output: Reports and Certification
  7. Contact Details: VackerGlobal, PO Box 92438, Dubai, United Arab Emirates, sales@vackerglobal.com

FAQ on Temperature Qualification and Validation

  1. What is the difference between temperature mapping study and temperature qualification?
    A temperature mapping study checks only the temperature distribution across the entire area. The study report shows whether the temperature is maintained properly at all times.
    A qualification study checks all the cooling or heating equipment, the accuracy of their sensors, their calibration reports etc. Tests like door opening test, power failure test etc. can be included in both of them.
  2. How to decide whether to do a temperature mapping study or temperature qualification?
    This largely depends on the critical nature of the medicines being stored. We recommend a qualification study for all assets except for warehouses of 15 to 25 °C.
  3. What is the difference between temperature qualification and temperature validation?
    Temperature qualification is for an asset. Temperature validation is for a process. eg. you may have two cold rooms at different locations and one refrigerated van. The qualification process is for each of these assets.
    Consider that you regularly shift medicines from Cold room 1 to Cold room 2 using the refrigerated van. Now this involves loading, unloading, handling, transportation etc. This is a complete process. You may want to ensure that the medicines are within the temperature limits during this entire process. You will need to do validation to ensure this.
  4. What is the difference between temperature mapping and temperature validation?
    Temperature mapping is for each asset. Temperature validation is for an entire process. You may have warehouses and cold rooms at different locations.  Each of them will have temperature mapping certification. You will be using a van to transport medicines, which again will have mapping certification.
    Suppose you are shifting medicines from one warehouse to another warehouse. This involves temperature fluctuations. If you do a validation study, you can ascertain that the entire process does not affect the temperature of the medicines.

For further reading, you may go through our detailed guide on Temperature mapping study & qualification.

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, Kazakhstan, Srilanka, Maldives, and Cyprus.