Technical and User Data

Assumptions that are made:

• The temperature qualification is performed in an empty body, as this is considered as the worst case scenario to higher temperature variation.

• The products (pharmaceuticals) will be loaded at the correct temperature, because they are leaving a temperature controlled storage. It is stated that the refrigeration unit and box is used to maintain the temperature of the products not change the temperature, though this is possible over time.

• The of the physical state (dry, liquid), pharmaceutical forms (tablets, capsules, cr?mes) of the medicines, the primary package material (plastic, glass) used to pack these are enormous. The secondary package materials will probably be boxes made from cardboard.

• The capacity of a transport refrigeration unit as well as the minimum insulation of a body is regulated by ATP testing standards. Because this guideline is the current standard for temperature testing, this test protocol is used as the basis for GDP qualification.

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

  • Worst-case scenario for single temperature trailers:

    The greatest difference in the set-temperatures in the load space and in 2 extreme ambient temperatures.

Regarding the acceptance criteria considered in Thermo King Protocol, the air temperature should remain within the required temperature range. For example, if the requirement is for temperature range +2.0°C to +8.0°C, the minimum air temperature recorded should not be below +2.0°C, and the maximum should not exceed +8.0°C.

• Deviation of registered data of all thermocouples positioned in the insulated box (ATP certified body) should not exceed maximum deviation as mentioned in section “Acceptance Criteria”.

• The average temperature of all thermocouples should not exceed maximum deviation as mentioned in section “Acceptance Criteria”.

• Ambient temperature is to be logged. The logged temperature should not exceed +/-2 °C of required temperature.

• Return air and discharge air temperature of the unit evaporators is to be logged: Temperatures should not exceed the requirement for the specific temperature being tested.

• Test time is 2.5 hours in steady state.