Questions and Answers on Transport and Vehicle Qualification (Part 2)

During the ECA Live Online Training “Temperature-Sensitive Pharmaceuticals – Transport and Vehicle Qualification”, a number of interesting and practice-oriented questions were raised by the participants. These questions have been answered in writing after the event. To share some of the key insights with a broader audience, we have compiled a selection of these Q&As for general access.

Please find Part 2 below. Part 1 (Qualification of Vehicles and Passive Shipping Systems) can be found in our news archive.

Part 2: Temperature Mapping and Monitoring in Distribution

2.1 – About dataloggers: three heights are used and kept constant throughout the vehicle. Should these heights vary across different areas considering air flow or temperature differences? Is there a methodology or technical justification that supports the selection of these specific height levels?
Logger locations should be risk-based and derived from OQ/PQ mapping data. Typically, three height levels (top, middle, bottom) provide a baseline, but additional loggers should be placed near identified hot or cold spots (e.g., near doors, ceiling, or air outlets). The rationale for height selection must be documented and supported by qualification data.

2.2 – Is there any requirement for the number of data loggers per shipment? In our company, we place a data logger in each pallet.
No specific number is defined. The system must provide sufficient monitoring to confirm that product temperatures remained within specification during shipment. The number and placement of loggers should be justified by a documented risk assessment considering product sensitivity, shipment size, and route characteristics. For critical shipments, data loggers are often placed at least in one unit per pallet or per temperature zone, depending on risk assessment.

2.3 – Should setpoints be documented, or is this not required?
Yes. Defined temperature ranges, alarm limits, and intervention thresholds must be documented and justified based on product stability data and marketing authorisation requirements. The calibration status of measurement devices must also be traceable.

2.4 – Is the logger placed in the vehicle at the location where the worst-case temperature value was observed during qualification?
Yes. At least one reference logger should be placed at the identified hot or cold spot based on qualification results. Additional loggers can be positioned to ensure representative coverage of the entire load area.

2.5 – About accuracy requirements: Is there a difference between the reference standard (etalon) and the logger, or should total uncertainty also be considered?
Total measurement uncertainty must be considered - including logger specification, calibration uncertainty, and installation effects. Standards EN 12830 and EN 13486 define accuracy and verification requirements. The WHO recommends documenting overall measurement uncertainty in qualification and monitoring records.