Layout of Sample-type Advancer Trailer 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-TRA-ST.

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

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 flow of temperature-controlled air in the load space must reach all parts of the load space. Therefore, a fixed return air system is essential.

  • Return air bulkhead panel to be of solid fixed type allowing a minimum return air gap of 52 mm from the evaporator panels and the top should be closed to conform to Thermo King recommended minimum standards.

• 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 Advancer trailer.

• 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.

The equipment must comply with the three requirements as laid out above and should be measured with calibrated temperature data-loggers and must be registered as such. This will be checked and confirmed during the OQ process.