Cold chain

The temperature-controlled supply chain that keeps a product within its required range from manufacture through storage and transport to use, whether refrigerated, frozen or cryogenic. For cell therapy products the chain often runs at cryogenic temperatures in vapor-phase liquid nitrogen dry shippers, from collection of starting material to the treatment site. A temperature excursion during storage or transport must be assessed before the product is used, and the procedure for doing so, including who decides, should exist before the first shipment.