The right temperature for sure
Active temperature control is particularly important for the GDP-compliant transportation of pharmaceutical and medical products. If the temperature is not continuously monitored and regulated, this can result in a loss of quality in the transported goods, which would be fatal, especially in the case of medicines. As part of a network validation, we were able to prove that the temperature range between + 15 °C and + 25 °C can be consistently maintained during the shipment of a dummy pallet - within three weeks across Germany with several envelopes.
We strictly adhere to the EU's GDP guidelines for the good distribution practice of medicinal products for human use. These require that equipment, procedures and processes are qualified or validated before use and after any significant change or maintenance. "Our core process is temperature-controlled transportation. We therefore have a duty to prove that our temperature data is reliable."
Dummy pallet for pharmaceutical transport
As part of the validation, a 285 kg Euro pallet consisting of 56 packages on seven layers was fitted with 17 data loggers - 15 inside and two outside the boxes. It was transported over 8,454 km between the branches and the main transshipment point in Kassel. This involved 46 sections and 36 transshipments. Temperature data from 365 hours and 7,776 measuring points were collected and analyzed. The transport took place under real conditions with loaded pharmaceutical goods. We successfully overcame the technical hurdle of integrating the data from various telematics systems into a central system in real time, as well as the necessary documentation.
The result: the temperature is right!
During the monitored period, the temperatures on the pallet were between + 18.9 °C and + 21.4 °C. The average delivery time was 21.81 hours. The validation therefore proved that the specified transport at + 15 °C to + 25 °C and a target throughput time of a maximum of 48 hours can take place reproducibly in the network. "As our customers also have to meet special requirements - e.g. in accordance with GDP, GMP, AMWHV or AMG - network validation is of great benefit to them in order to qualify their service providers." The temperature data can also be used for a detailed risk analysis. "With the proof from the validation, we can not only fulfill our performance promise, but also prove compliance with the regulations from the GDP directive."