Since companies usually operate many trucks and vans as fleets, the qualifying processes are performed in fleets as follows:
1. Gather the fleet of trucks and arrange them into homogenous groups.
2. Apply the Vmodel to each group.
3. Perform design qualification in the cluster group by checking a few defined points on one truck/van , like the model and configurations.
4. Since one truck or van per cluster group has already been mapped, it is now possible for the remaining trucks/vans of the same group to leave out the "dry run"
qualification and to directly conduct a performance qualification (Mapping of the full truck) during normal operation. Of course the mapping should be performed with data loggers which are calibrated and compliant.
How to Qualify a Transport Box or Container
Qualifying a transport box or container is not as easy since the object to be qualified moves around in an uncontrolled environment. First, clarify its purpose and shipment method, whether via road, air, or water. Take into consideration the transportation time and the temperature range at the beginning, during transit, and at the destination.
There are two ways to confirm the appropriate ambient temperatures during GxP validation:
• Use empirical data to arrange the shipment into segments and define the extreme seasonal changes.
• Map the ambient temperatures by effectively measuring temperatures in specified routes.
There are differences between passive insulated boxes and active heating/cooling containers. Here is what you should know about the two:
Passive Insulated Box
• Technology Used: Thermal packs filled with phase change material (PCM) having a defined melting point (5°C melting point for 2-8°C shipments) and insulation materials such as vacuum panels.
• Process at Origin: Phase change material must be pre-conditioned and have the right temperature when loaded. To ensure the promised performance, the box must be built-up exactly as designed: product surrounded by one layer (minimum) of PCM, surrounded by one layer (minimum) of vacuum panels, held together by a cardboard box.
• Process During Shipment: Ensure the shipment is not exceeding the defined shipment lengths. For example, if the box is built to keep temperature for 72 hours, a longer shipment time could result in damaging the goods.
High-level Risk Appraisal: The highest risk is a packaging error (e.g., wrong conditioning of PCM). As soon as a shipment is on its way, the solution is very stable and there are only minimal risks.
• Technology Used: Insulated container with air ventilation, heating and cooling unit (typically compressor cooling and electrical heating), and battery including a charging unit.
• Process at Origin: The battery must be charged before loading and the right set temperature must be defined.
• Process During Shipment: Re-charge the unit at hubs and airports. Prevent manipulation of the set temperature or door openings.
High-level Risk Appraisal: While active containers are easy to load, there are significant risks during shipment involving human error (e.g., no recharging) and mechanical failure. Heating and cooling containers consist of hundreds of mechanical and electronic components which have the potential to fail.
Once you choose the container and define its purpose, you can start the qualifying process by applying the v-model steps, as explained earlier.