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.

  • The load space should be kept clean at all times and only cleaning agents that will not affected 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 -30°C and +40 °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 25 set at -30°C (to simulate average winter temperatures in Northern Europe) and maximum +40 °C (to simulate average high summer temperatures in the South of Europe).

Door Openings:

  1. Truck body of max 42m3 with THERMO KING refrigerated unit T-800R

  2. Truck body of max 48m3 with THERMO KING refrigerated unit T-1000R

  3. Truck body of max 58m3 with THERMO KING refrigerated unit T-1200R

  4. Truck body of max 46m3 with THERMO KING refrigerated unit UT-1200

    • 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 body, depending on the difference in ambient temperature and temperature inside the box. To minimise this effect, this is recommended to open doors of the truck 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.

  5. 45 feet container with THERMO KING refrigerated unit T-1200R Intermodal

  • The equipment 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 container, depending on the difference in ambient temperature and temperature inside the truck. To minimize this effect, this is recommended to open doors of the container only at loading and unloading at temperature controlled warehouse. In these warehouses the product and the environment is temperature controlled.

  • If the equipment 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.

  • For optimum temperature management and air distribution, the refrigeration unit’s continuous operation mode should be used for all temperature ranges.

  • 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 are to be found in the document pouch located within the unit enclosure.

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

Parent topic: Operational Qualification