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Cold Chain for Beginners

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Cold Chain is a term used to characterize temperature-controlled storage, distribution and transportation. The term can be misleading since it does not refer to “cold” temperatures in particular. Products that are sensitive to temperature variations, whether they be perishables such as fruits and vegetables or more sophisticated drugs and medical devices, are included in the term “cold chain”. However, cold chain is often more narrowly used in reference to temperature and time-sensitive high value healthcare products.

A growing number of cold chain conferences are being organized around the world, mainly in response to tighter regulations and growing global markets for temperature-sensitive products. Logistics experts, healthcare manufacturers, packaging providers, regulators and consultants often forget that the general public may not be all that knowledgeable about the topic.
 
Cold chain management uses its own terminology. Several temperature ranges are specified in the relevant literature, the most common being controlled-room temperature or CRT (often defined from 15oC to 25oC), but also cool (from 8oC to 15oC), cold or refrigerated (from 2oC to 8oC), frozen (around -10oC) and cryogenic (around -150oC). There is, however, no general or universal glossary that is commonly accepted by all regulatory agencies. One of the leading regulatory agencies, the International Air Transport Association (IATA), encourages customers to display a special sticker, the IATA thermal label, to indicate cold chain shipments that may require special handling.
 
Brief excursions outside of desired temperature ranges are typically allowed for a well-defined time and temperature extent but remain product specific. Healthcare shippers do place temperature data loggers in packaging materials to record temperatures during shipping. In practice these data loggers record temperature data at various frequencies or time intervals that vary from one shipment to another. Healthcare products can be irreversibly affected by exposure to a given temperature spike for a short period of time, experiencing biological degradation, physical phase changes, crystallization, or chemical reactions.
 
Since FedEx is in full control of its cold chain processes without involvement of external service providers, FedEx is able to see where and in which mode of transport shipments are at all times. Several solutions are offered to customers to reduce the risk of product spoilage, often resulting from unexpected events such as customs clearance delays or bad weather.

SenseAware, a multi-sensor device powered by a FedEx platform for data and device management, can monitor temperatures in near-real time. When bundled with Priority Alert, actions such as addition of dry ice or replacement of gel packs are even possible whenever SenseAware alarms become active while shipments are in transit within the FedEx global network. Moreover, FedEx has put several processes in place to control and stabilize temperatures, such as implementation of default temperature settings for its long-haul flights and use of refrigerated trucks. Reported temperature excursions are investigated internally to understand their origins, document issues, take corrective actions, and further optimize the FedEx cold chain network.

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