Most temperature-controlled shipping packages for pharmaceuticals are designed for the refrigerative 2-8°C range, but an increasing concern is for controlled room-temperature (CRT) shipping, generally in the 15-25° range. This concern arises from adoption of international Good Distribution Practices (GDPs), which oblige shippers to manage the environmental conditions of refrigerated and CRT packages equally rigorously. CRT shipments, however, present new problems: the higher temperature range makes water ice (or water-based phase-change materials [PCMs]) problematic; either the lower or upper temperature limit can be addressed, but not both. One solution is a seasonal packout—one PCM for winter shipping, and another for summer.
Now, Pelican Biothermal, one of the leading suppliers in this field, is proposing a different approach: using PCMs with two phase-change setpoints. It is offering the Series 22 PCMs, which undergo phase change at either 16 or 24°C (the phase change point is where the latent heat of going from a solid to a liquid phase provides extended temperature protection). The materials are designed for use in Pelican Biothermal’s Credo Cube parcels, which feature vacuum panels for insulation, and the PCMs contained within a TIC (thermal isolation chamber) arrangement of coolant panels that interlock on all sides of the parcel. The Credo Cube (originally designed for the military’s need for on-the-battlefield medications) is said to maintain specified temperature, depending on ambient conditions, for up to 168 hours (seven days), and for payloads ranging from 2-96 liters.
This “universal” (all seasons) packout “offers operational ease of use year round and high performance in any thermal conditions,” according to Kevin Lawler, Pelican BioThermal VP, sales. The Credo Cube can also be provided with one PCM for CRT shipments with a defined shipping lane (such that either only high or low temperatures are experienced). The company has also just posted a white paper on CRT shipping options including the Series 22.
In recent years, Pelican has expanded a reuse program for the Credo shippers called the Asset Management Solution; to that end, the company has just announced the opening of two service centers, in Puerto Rico and Belgium, additions to existing centers in the US and Asia. Now, the shipping containers can be leased or rented, as opposed to single use and then disposal.