Setting New Standards
There is a welcome recent effort by the passive thermal packaging industry to propose methodology for enabling fit for purpose evaluation of multiple shipping systems. We recently covered a novel effort from Cold Chain Technologies, Modality Solutions and Eli Lilly, and the following is a more traditional proposal from Pelican Biothermal:
With the ever evolving developments in the Biopharmaceutical industry there has never been a greater need for assured reliability when it comes to the transportation of Pharmaceutical payload and the guaranteed robustness of temperature-controlled packaging is proving ever more vital.
There needs to be a more universal approach for a standardized measure of performance. Currently many vendors demonstrate the performance of temperature-controlled packaging by showing an example of performance, most often carried out with an ambient pro le that shows how the temperature-controlled packaging will respond to a particular simulated shipment route.
There needs to be a collaborative call for a new industry standardized measurement system that is easy to implement and can be adopted worldwide within the sector. There is an even greater urgency to address the situation especially with the new generation growth of biopharmaceutical products that are highly temperature sensitive and must be stored and transported within the speci ed temperature range.
Why not implement a thermal stress score, a standardized procedure, calculated by stress testing with universal acceptance?For greater reliability the industry is calling out for a standardized method such as Kelvin Hours (KH), which could be universally adopted and recognized as a new industry standard for the global temperature-controlled packaging industry. It brings to the fore the shipping system’s performance capabilities.
While the approached described in this White Paper is a step in the right direction, it should not be considered a silver bullet for the industry, as factors such as temperature spikes, conditioning temperatures of PCM, exposure of components to room temperature during assembly, can all have an impact on the final overall performance of a passive shipping system. This method, by a different name, has been proposed in the past, and while its strength lies in its relative simplicity, the user should be aware of its shortcomings.