Technical and User Data

Assumptions that are made:

• The temperature qualification is performed on 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 box is used to maintain the temperature of the products do not change the temperature, though this is possible over time.

• The spectrum of the physical state (dry, liquid), pharmaceutical forms (tablets, capsules, crèmes) of the medicines, the primary package material (plastic, glass) used to pack these are enormous. The secondary package materials are understood to 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 -30°C and +45 °C

  • Worst-case scenario for single temperature trailers:

    The greatest difference in the set-temperatures between ZONE 1 and ZONE 2 operating in two 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 the registered data loggers Ti1-01 to Ti1-15 to Ti2-01 to Ti02-15 (seen in figure 7) must not exceed maximum deviation as mentioned in section “Acceptance Criteria”.

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

• Ambient temperature logged. Te01 toTe12 (seen in figure 9) for both Single and Multi-Temperature operation. The logged temperature must not exceed +/-2 °C of required temperature.

• Return air and discharge air temperature of the unit evaporators is logged. The data loggers are named EAIT-1, EAOT-1 (ZONE 1 / seen in figure 7 and 8) and EAIT-2, EAOT-2 (ZONE2 seen in figure 7). Temperatures must not exceed the requirement for the specific temperature being tested.

• Test time is 2.5 hours once steady state is achieved.