IGEM:IMPERIAL/2007/Cell By Date
Cell by Date
Motivations
A 'cold chain' refers to the temperature maintenance of the supply chain of sensitive products. Cold chains are
A break in the cold could compromise the efficacy and integrity of an entire product batch, resulting in direct consequences to the consumer.
Traditionally, the temperature range of a cold chain is between +2ºC to +8ºC - 'potentially hazardous' foods are defined by the Food Standards Agency as the
“Cold Chain Maintenance” is a term defined as the materials, equipment and procedures used to maintain temperatures between +2ºC to +8ºC while in transit throughout the distribution and storage process for vaccines
A cold chain is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. Cold chains are common in the food and pharmaceutical industries and also some chemical shipments. One common temperature range for a cold chain in pharmaceutical industries is 2 to 8 °C. but the specific temperature (and time at temperature) tolerances depend on the actual product being shipped.
This is important in the supply of vaccines to distant clinics in hot climates served by 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 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 products at wider storage conditions.
Traditionally the industry believed that the cold chain process could not be validated. With the proper understanding of the entire process, this process is validateable. Please see PDA Technical Report # 39 for a rough summary of how this process can be validated.
