Van & Vehicle Validation & Qualification for Pharmaceutical Distribution

Validation & Qualification of Vans, Vehicles, Reefers etc.

This is the process by which vehicles, vans, reefers etc. which are assigned for transportation of medicines and vaccines are tested and certified that they are suitable to maintain the required temperature levels through various practical conditions in all climatic conditions.

Parameters to be decided by the customer

The customer and he client are more aware of the goods being transported and can decide based on the recommendations of the medicine / vaccine manufacturer.vehicle-validation-uae

The major parameters to be decided are:

a. The temperature range for which certification to be done: Same vehicle can be used for transportation of different goods at different times. Hence same vehicle can be certified for 2-8 Deg C & 15-25 DegC. Customer can decide the range to be certified according to the utilisation.

b. Whether the vehicle to be qualified for Temperature alone or for Humidity also. This also is based on the goods being transported.

c. Whether the vehicle to be tested for different climatic seasons viz. summer and winter. Our recommendation is that the vehicle should be tested in both the seasons, since the performance of the vehicle is influenced by the ambient conditions.

d. What are the tests to be carried out apart from Temperature mapping study. Temperature mapping study is general part of the qualification process. Various other tests are power failure test, recovery time verification, start up verification

e. What is the ideal loading at which the test to be carried out. Depending upon the usage and capacity utilization, the test can be carried out at different loads such as empty vehicle, 50% good loaded, 100% good loaded etc.As an example if the vehicle is generally used t 75% capacity, it would be ideal that testing be done at empty condition, 75% loaded condition, 100% loaded condition etc.

Details to be provided by the customervan-validation-dubai-uae

Prior to preparation of the protocols & SOW for the testing process, the following details need to be provided by the customer.

a. Vehicle model, type, registration number etc.

b. Details of the Evaporator and cooling unit with serial number,model details etc

c. Details of sensors with calibration certificate

d. Details and model no.of temperature control unit

e. Operational manual of the temperature control unit

f. Parameters for testing as per above topic

Testing and Qualification process and protocol

For each range of temperature qualification, the vehicle will have to be made available for around 48-56 hours. Eg. for testing the vehicle  for 2-8 Deg C, the general procedure will be as under:

Start up test – around 4 hoursthermoking-control-unit-validation

Empty testing – 12 to 16 hours

First loaded condition -12 to 16 hours (loading of goods to be arranged by customer)

Second loaded condition -12 to 16 hours (loading of goods to be arranged by customer)

Power failure test – 4 hours

Temperature recovery test – 4 hours

If the vehicle is to be tested for a second temperature range eg.  15-23 Deg C, the whole vehicle has to be tested once again for the cycle as above.

Also see our post on Temperature Mapping Study

Complete procedure for the study is written before commencement of the tests This procedure is known as protocol SOP for the qualification.

Considering extreme climatic conditions, such validation is especially important in all Middle East countries such as United Arab Emirates, Saudi Arabia, Kuwait, Qatar, Bahrain, Oman, Jordan, Iraq etc.

Posted in Temperature Mapping & Validation, temperature qualification, Validation, Validation & Qualification Tagged with: , , , , , , , , , , , ,

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