The spring PDA Pharmaceutical Cold Chain Management Conference (Bethesda, MD, March 23-24) brought the members of the Pharmaceutical Cold Chain Interest Group together with many of the leading vendors of packaging, services and solutions for managing temperature-controlled logistics. Here is a sampling of some of the more notable announcements:
Sensitech (Beverly, MA) has updated one of its dataloggers as the TempTale 4 USB. The single-use device is designed to record the temperature trail that a package experiences during shipment and transfer along a supply chain. Biopharma companies that want validatable reporting of a shipment will be able to download the data via a conventional (and integrated) USB cable; the data can then be transferred via e-mail or other communication, without the need to retrieve the datalogger itself. Reports are available either as an industry-standard PDF file, or a secure, encrypted data file using Sensitech’s .ttx format. The device has a resolution of 0.1°C or °F, and can record 16K data points.
Cold Chain Technologies (Holliston, MA) demonstrated its use of a full-blown computational fluid dynamics (CFD) program to analyze packaging performance. CFD is a fairly advanced type of modeling that analyzes the thermodynamics of virtual “blocks” of space in a designed environment—it has been used for, among other things the flow of air around airplane wings, or the movement of ingredients inside a boiling chemical reactor.
Conversely, most cold chain packaging design has been based on fairly simplified models of heat conduction. By using the CFD system of Maya HTT (Montreal, QE), Cold Chain Technologies believes that it can more accurately capture the thermodynamics of the interior of a package, including both heat conduction and heat convection effects. The company will begin offering its design services to biopharma companies that want to develop specialized containers for their products.
TCP Reliable (Edison, NJ) has repackaged its Phase 5 phase-change material as a blanket to make it a flexible wrapping for diverse product geometries. The phase-change material (which has been on the market in the form of gel packs) has the advantage of maintaining a temperature of 5°C, exactly in the middle of the common 2-8°C range that many products have—and which either wet ice or dry ice have trouble maintaining without freezing the product.
Cryoport (Lake Forest, CA), together with the FedEx organization, are offering the Express One-Way Shipper for products that need to be maintained in low ranges suited to liquid nitrogen. The unit has an insulated, steel bottle that is charged with liquid nitrogen to begin a shipment and can be delivered to a clinical office or lab for receiving the biosample. FedEx then handles the movement of the container back to its origin, and recycles the container for recharging. The customer does not need to maintain liquid nitrogen (or liquid carbon dioxide, a competing coolant), nor the cost or burden of managing the containers. PC