Refrigerator temperature mapping study and refrigerator vaidation are mainly for pharma applications. Temperature mapping study, qualification & validation are carried out for various assets used in the Pharmaceutical segment for the transportation and storage of medicines & vaccines.

This process is generally for a cold room, warehouse, refrigerator, freezers, walk-in freezers, vans, boxes etc. used for medicines and vaccines.

(The word qualification and validation are used in this article interchangeably)

We are explaining about Temperature mapping study & Qualification of a refrigerator in this article.

Refrigerator Temperature Mapping Study & Refrigerator Validation

We will consider a double-door refrigerator maintained between 2-8°C.

Parameters to be tested and verified

The primary aim of this temperature mapping study is to qualify the refrigerator for storage of medicines by checking the following parameters:

Under normal conditions, the refrigerator is keeping the temperature within the desired limits?
When a door is opened, what are the effects on the storage areas of the refrigerator?
What is the optimum time for which a door can be opened without affecting the inside temperature?
In case of a power failure, how long the temperature remains unaffected?
What are the effects of temperature distribution under different loaded conditions viz. empty condition, half loaded condition etc?
When the refrigerator is started, how long it takes for the temperature to reach within limits? This test is carried out so that the user will know when he can start keeping the medicines inside the refrigerator after starting up.
Whether the temperature controller and cooling units are working satisfactorily?
The critical components of the refrigerator are properly calibrated?
Is there an operating procedure properly maintained?

Once a refrigerator is thus qualified, it means that this refrigerator is suitable for storing medicines. Also, it implies that if the recommendations of the study are followed, the medicines will remain within the desired temperature.

Methodology for Refrigerator Temperature mapping study & Refrigerator validation

Prior to commencing the study, a procedure known as qualification protocol is prepared. This protocol explains various points to be checked and also described the procedure for each test to be carried out.

The Protocol will consist of the following main categories:

Operation verification protocol to verify that the refrigerator is operated properly.
Installation verification protocol to verify that the critical and non-critical components are installed correctly
Performance verification mainly includes a temperature mapping study (humidity also if required). Additionally, various other tests are also part of this procedure to test the performance. A temperature mapping study is carried out by placing data loggers inside the refrigerator and by collecting the data for a couple of days.
Various calibration certificates are verified to ensure that the critical components are properly calibrated.

At the end of these tests, the data is downloaded from the data loggers and analyzed to study the performance of the refrigerator. Such data is compiled and if all the acceptance criteria are met, the refrigerator is qualified and a certificate will be issued for the same.

Live Temperature mapping study of refrigerators and validation

We have introduced live mapping study, validation and qualification of refrigerators, warehouses, cold rooms, vehicles etc. We will install real-time monitoring systems and will continuously monitor based on the validation rules. In such a case, users can take corrective actions such as adjusting the temperature settings while the test is in progress. Thus you can save time on waiting for the test reports, retest etc.

Maintaining Humidity inside a medical refrigerator

The humidity inside a medical refrigerator will be generally high due to frequent openings. Most pharma manufacturers specify certain humidity levels for storage. It is extremely difficult to incorporate humidity control inside a refrigerator. Also, the storage duration of medicines might be low compared to a cold room. Hence please check with the manufacturer of the medicine whether humidity control is important. If that is the case we can provide a temperature mapping study combined with humidity. Also, our air quality control division can propose suitable equipment for humidity control.

Reasons for failure of Temperature mapping study & Qualification of a cold room

Temperature Mapping study & Temperature Qualification Study

Download: Typical Protocol for Temperature Mapping Study & Qualification

Details of our service on the refrigerator temperature mapping study

Name: Temperature mapping study for refrigerators
Service Type: Temperature Mapping Study
Description: Temperature mapping study (combined with Humidity if required) to study the capability of a medical refrigerator to retain the temperature. This mapping study is essential for medical refrigerators and freezers for the storage of medicines, vaccines etc.
Area Served: UAE, KSA, Qatar, Bahrain, Kuwait, Oman, Jordan, Kenya, Nigeria, Ethiopia, Tanzania, Rwanda, Uganda, Djibouti, USA, Germany, India, and Pakistan.
Offered Services: Temperature mapping study of the medical refrigerators, and medical freezers; We provide monitoring systems for recording the temperature of these refrigerators.
Service Provider: VackerGlobal, PO Box 92438, Deira, Dubai, United Arab Emirates, Tel: +971 42 66 11 44.

We carry out temperature studies, validation and qualification of refrigerators in UAE, KSA, Qatar, Oman, Bahrain, Kuwait, Kenya, Nigeria, Rwanda, Uganda, Ethiopia, South Africa, Tanzania etc.

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Temperature Mapping, Qualification & Validation of Refrigerators