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 multi-temperatures load.

  • The load space should be always 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 unit+body is qualified in multi-temperatures and single-temperature modes based on the details below:

    • In multi-temperature mode:

      In case of multi-temperatures operation, the dividing wall must be locked in vertical position and setpoint must be set according to the requested range in each zone. ZONE PRIORITY function must be DISABLED.

  • For T-1200R Spectrum S3+S3:

    • Ranges < -20°C, +2°C to +8 °C or +15°C to +25°C can be operated in any of the 2 zones.

  • For T-1000R Spectrum S3+S3 and UT-1200 S3+S3:

    • Ranges +2°C to +8 °C or +15°C to +25°C can be operated in any of the 2 zones.

    • The range < -20°C cannot be operated.

    • In single-temperature mode:

      In case of single-temperature operation the unit must run in SINGLE ZONE CONTROL (SZC)mode and the dividing wall must be stowed in such a way that it does not interrupt the airflow from each remote evaporator. For ease of use, SZC mode should be added to the Main (driver) menu.

  • For T-1200R Spectrum S3+S3:

    • Ranges < -20°C, +2°C to +8 °C or +15°C to +25°C can be operated.

  • For T-1000R Spectrum S3+S3 and UT-1200 S3+S3:

    • Ranges +2°C to +8 °C or +15°C to +25°C can be operated.

    • The range < -20°C cannot be operated:

  • For UT-R Spectrum S3+S3:

    • Ranges +2°C to +8 °C or +15°C to +25°C can be operated in any of the 2 zones at the same time.

    • Ranges +2°C to +8 °C or +15°C to +25°C cannot be used if one zone is set for frozen.

    • Ranges < -20°C can be operated only with single zone control.

    • In case of single zone use (one zone, both compartments) the unit must run in SINGLE ZONE CONTROL (SZC) mode and the dividing wall must be stowed in such a way that it does not interrupt the airflow from each remote evaporator. For ease of use, SZC mode should be added to the Main (driver) menu.

  • When operating the equipment in multi-temperatures mode, the splitting of the compartment zones should be up to 1/2 of the total body length:

  • 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 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).

  • 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 are 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 must be used according to the driver's instructions supplied by Thermo King on use of Thermo King Equipment. These driver instructions are to be found in the specific Operator Manual.

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

  • The load space considerations indicated here after must also be considered.

Parent topic: Operational Qualification