The place of a passive box in pharmaceutical logistics is to carry a validated stretch of the route; it does not replace storage or the whole workflow. The EU GDP guidelines (2013/C 343/01, point 9.4) ask for qualified equipment, thermal packaging included, for temperature-sensitive products.
| Stage | What is used | Counterpart in the guidelines |
|---|---|---|
| Storage | Mapped cold room | Sensors placed according to the mapping (3.2.1) |
| Transfer and hold | Qualified box | Monitoring at these points, hold time kept short (9.2) |
| Transport | Thermal packaging or controlled vehicle | Qualified equipment (9.4) |
WHO TRS 961 Annex 9 (clause 6.8.3) asks that the qualification of a box cover the full packing arrangement including plates and partitions, the thermal conditioning regime, the minimum and maximum load, the sensor position and the outside temperature profile of the route. Qualification depends on a specific route; we obtain GEBHARDT's thermal analysis and pass it on, and the qualification itself stays with the operator's quality unit.
