Description of the Qualified Operation

The trailer shall be used:

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

  • To maintain and control air temperature at a set temperature.

  • In single-temperature operation (< -20°C, +2°C to +8 °C or +15°C to +25°C)

  • In single-temperature operation (< -20°C, between +2°C and +8 °C or between +15°C and +25°C) in ZONE 1 compartment.

  • In multi-temperature operation (< -20°C, between +2°C and +8 °C or between +15°C and +25°C) in two compartments with the dividing wall in place.

  • At ambient temperatures between -25 °C and +40 °C

  • At ambient temperatures between -30 °C and +45 °C

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

  • According to the driver's instructions supplied by Thermo King on use of Thermo King equipment.

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

  • To maintain and control air temperature at a set temperature.

The objective of this qualification is to successfully qualify the designed use of this equipment.

The Operational Qualification conforms to the requirements of the Design Qualification: GDP-TK-DQ-TRA-ST.

The Operational Qualification conforms to the requirements of the Design Qualification: GDP-TK-DQ-TR-MT_A.