Layout of Sample-type Truck Qualification

The objective of this GDP qualification is to successfully qualify the designed configuration of the equipment mentioned in the Design Qualification: GDP-TK-DQ-SP-ST.

For this qualification three issues are important:

  • The flow of temperature controlled air in the load space has to reach all parts of the load space.

  • The capacity of the unit that is used to manage the temperature within the load space has to be sufficient to maintain the products at the set temperature range recommended by the manufacturer of the product (pharmaceutical company). Therefore, the base colour white plus allowable 20% decal coverage is set to the DQ. Other darker colours would decrease the cooling capacity of the truck.

  • The temperature logging equipment used for the calibration process must in itself be calibrated to each temperature range. This will be checked and confirmed during the OQ (Operational Qualification) process.

Specific to 45 feet container with THERMO KING refrigerated unit T-1200R Intermodal

  • Air chute system to conform to Thermo King recommended minimum standards in the ceiling of the truck and to provide the same or better air distribution as the Thermo King Air Chute.

  • The guiding plenum opening should be a minimum square area equal to 1.5 times the square area of the evaporator outlet.

  • The outlet of the chute should also have a minimum square area equal to 1.5 times the square area of the evaporator outlet.

The equipment must comply with the three requirements as laid out above and should be measured with calibrated temperature dataloggers and must be registered as such. This will be checked and confirmed during the OQ (Operational Qualification) process.

Parent topic: Operational Qualification