Validation and qualification of vans, trucks, reefers, and
other vehicles.
The process of vehicle validation involves testing and certification vehicles for the transportation of medicines and vaccines in various climatic conditions. The customer and client are responsible for deciding on the temperature range, whether the vehicle should be certified for temperature alone or humidity, and whether to test for different seasons like summer and winter.
The major parameters to be decided include the temperature range, which can be 2-8 Deg C and 15-25 DegC, the tests to be carried out apart from temperature mapping, the ideal loading at which the test should be carried out, and the details provided by the customer. These details include the vehicle model, type, registration number, details of the evaporator and cooling unit, details of sensors with calibration certificates, details and model no. of the temperature control unit, the operational manual of the temperature control unit, and parameters for testing.
The testing and qualification process takes around 48-56 hours for each temperature qualification range. For example, for testing the vehicle for 2-8 Deg C, the general procedure includes start-up test, empty testing, first loaded condition, second loaded condition, power failure test, and temperature recovery test. If the vehicle is to be tested for a second temperature range, the entire vehicle must be tested again for the cycle.
The complete procedure for the study is written before the commencement of the tests, known as the protocol SOP for the qualification. This ensures that the vehicle is suitable for transporting medicines and vaccines under various conditions.
