Support of the Defined Aspects of Use

  • For transport of pharmaceuticals (in combination with Medical devices)

    Combination of pharmaceuticals and medical devices in one load is approved. Mixing loads of food and chemical substances is not permitted even when the compartments are separated as a Single-temperatures load.

    Combination of pharmaceuticals and medical devices in one load is approved. Mixing loads of food and chemical substances is not permitted even when the compartments are separated as a multi temperatures load.

  • The load space should be kept clean at all times and only cleaning agents that will not affect the products should be used.

  • To maintain and control air temperature at a set temperature

    The products (pharmaceuticals) will be loaded at the correct temperature because they are leaving a temperature controlled storage location. It is stated that the refrigeration unit and box is used to maintain and not change the temperature of the products. The trailer is not designed for cooling down or warming up pharmaceuticals, and therefore it should not be used for this purpose. However there is reserve capacity to overcome unscheduled temperature changes within the air pocket surrounding the load.

  • This equipment is only qualified in a single temperature mode (<-20°C, +2°C to +8 °C or +15°C to +25°C):

  • At ambient temperature between -25°C and +40 °C.

  • This trailer is qualified in multi-temperature and single-temperature modes based on the details below:

    When operating the equipment in multi-temperatures mode, the splitting of the compartment zones should be as stated below:

    • For the A-500 Spectrum unit with a S3A remote evaporator, ZONE 2 maximum split should be 1/3 of the total load space. If a larger ZONE 2 compartment is required, consult with your Thermo King Dealer.

    • For customers who want to use the mentioned equipment as a single-temperature load, the dividing door must be stowed in such a way that it does not interrupt the airflow from the main ZONE 1 host unit evaporator.

      • Zone 2 must be switched off.

  • Unit can operate at ambient temperature between -30°C and +45 °C.

  • This GDP qualification is performed for use in the ambient temperatures as tested. To provide qualification for the expected ambient temperatures in these regions the qualification test temperatures will be performed in the following manner, minimum to be set at -25°C (to simulate average winter temperatures in Northern Europe) and maximum +40 °C (to simulate average high summer temperatures in the South of Europe).

  • This GDP qualification is performed for use in the ambient temperatures as tested. To provide qualification for the expected ambient temperatures in these regions the qualification test temperatures will be performed in the following manner, minimum to be set at -30°C (to simulate average winter temperatures in Northern Europe) and maximum +45 °C (to simulate average high summer temperatures in the South of Europe).

  • The vehicle will be used for transportation between temperature controlled loading docks of storage locations.

    • Door openings can have a major effect on the temperature inside the trailer, depending on the difference in ambient temperature and temperature inside the trailer. To minimize this effect, this is recommended to open doors of the trailer only at loading and unloading at temperature controlled warehouse. In these warehouses the product and the environment is temperature controlled.

    • If the vehicle is to be used with multiple door openings in a non-controlled environment, based on the results of a risk analysis a complementary Performance Qualification may have to be performed by the customer.

  • The equipment has to be used according to the drivers instructions supplied by Thermo King on use of Thermo King refrigerated Equipment. These driver instructions can be found in multiple languages via a QR code decal located at the unit’s controller.

  • The equipment must be run and checked to ensure that all elements are functioning correctly.

  • The load space considerations indicated below must also be considered.

Parent topic: Operational Qualification