Description of the Qualified Operation
The trailer shall be used:
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For transport of pharmaceuticals (in combination with Medical devices)
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To maintain and control air temperature at a set temperature.
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In single-temperature operation (< -20°C, +2°C to +8 °C or +15°C to +25°C)
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In single-temperature operation (< -20°C, between +2°C and +8 °C or between +15°C and +25°C) in ZONE 1 compartment.
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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.
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At ambient temperatures between -25 °C and +40 °C
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At ambient temperatures between -30 °C and +45 °C
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The vehicle will be used for transportation between temperature controlled loading docks of storage locations.
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According to the driver's instructions supplied by Thermo King on use of Thermo King equipment.
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For transport of pharmaceuticals (in combination with medical devices)
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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.