Cold chain
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Cold chain is the term used to refer to a temperature-controlled supply chain. An unbroken cold chain is composed of an uninterrupted series of storage and distribution activities which maintain a given temperature range. Cold chains are common in, for example, the food and pharmaceutical industries. A common temperature range for a cold chain in such industries is 2 to 8 °C.
This is particularly important in the supply of vaccines to distant clinics in hot countries with poorly-developed transport networks. Disruption of a cold chain due to war may produce consequences similar to the Smallpox outbreaks in the Philippines during the Spanish-American war.
Traditionally all historical stability data developed for vaccines was based on the temperature range of 2-8 C. With the recent development of biological products by former vaccine developers, biologics has fallen into the same category of storage at 2-8 C due to the nature of the products and the lack of testing these expensive products at wider storage conditions.
Traditionally the industry as a whole believed that the cold chain process could not be Validated, but that is a myth. With the proper understanding of the entire process, this process is completely Validateable. Please see PDA Technical Report # 39 for a rough summary of how this process can be Vailidated.
