In a refrigerated vehicle the unit makes the cold, temperature control is a function of the vehicle, and the vehicle is the subject of qualification. In a passive setup eutectic plates or dry ice make the cold, the vehicle only carries, and temperature performance is a property of the container. Section 9.4 of the EU GDP guideline likewise asks for qualified equipment for temperature-sensitive products (thermal packaging, temperature-controlled containers or vehicles) and does not require just one of them.
| Setup | Subject of qualification | What is checked on the vehicle |
|---|---|---|
| Refrigerated vehicle | Body and refrigeration unit | Temperature mapping across seasons, alarms, records |
| Insulated container, passive | Container and plate set | Loading pattern, waiting time |
| Mixed | Both, separately | The transfer points |
The backbone of a passive container's file is a measurement showing how long it holds the target band under real conditions. It is taken under the hardest conditions: the hottest season, the longest route and the lowest fill; the easy case passes anyway. Loggers go inside the load in the upper zone near the lid, the middle and the floor, because one point gives a curve while three show the temperature spread.
GEBHARDT states that the Isotec TBX holds the cold chain for up to 24 hours with eutectic plates or dry ice; the duration written into your file is the one measured for your route. The guideline bases container selection on transport time and expected external temperature extremes (section 9.3).
When product, route or packaging changes, the file is updated; monitoring equipment is calibrated at least once a year (section 9.2).
