A cold-chain is a temperature-controlled supply- and distribution-chain. A continuous chain is a series of storage and distribution events that keep a product within the range of a certain temperature. This helps prevent spoilage of materials and extends their usefulness on the market. Food, chemicals and prescribed medications are common examples of products that would need to be part of this chain.
pillsThe greatest application of this chemical procedure involves produce and pharmaceuticals. Two to eight degrees Celsius is a common temperature range for this procedure; however, a more specific level is used depending upon the exact type of product being kept. For food, other parameters must be met; carbon dioxide, oxygen and humidity must be controlled to prevent spoilage.
The cold-chain management process is regulated. It is an extension of the Good Manufacturing Process which all medicines and organic processes are required to abide by via different authoritative health bodies. Because of this, the management and distribution process must be monitored and approved to be sure that the product is not negatively altered or affected.
The basic premise of cold-chain management involves analyzing, measuring, controlling, documenting and validating. Subsequent qualifications create a state of validation. This is accomplished by creating and seeing out a “component qualification” on the ingredients or packaging list. After this, an “operational qualification” that shows the entire process performed to the extreme is necessary. A demonstration that what occurs is applicable to real life and within the boundaries of what was demonstrated completes the management process.
The most recent major misnomer in the field is that three successful events is equivalent to one proper validation. However, the whole process of watching the distribution is only an assurance that the process has actually been validated. If there are any outliers or anomalies, the process can’t be considered to be validated as anomalies are invalidating criteria. From a mathematical perspective, the process would require 30 different validating points to show everything is under control.
Cold-chains must be analyzed and controlled. The carriers and data analyzers can augment the shipping process. These people have the technical skill to coordinate with airlines to find and show real-time status, which can create internet printouts and electronic information.
The use of refrigerated trucks, cars, and other containers is very common. Shipping is usually done in insulated containers and other specific packaging. Temperature records are kept and monitored in real-time inside of the truck. Documenting the process is a must; the chain of custody cannot be contaminated. Delays in the process often occur at customs when paperwork contains errors or incomplete points.
It is further imperative to create a system whereby everything is documented – both internally and externally. The transactions and information exchanged between parties must be kept in check and recorded; this allows the entire supply chain to be tracked. All of these processes would monitor the status of machines and equipment across the supply chain. Temperature ranges and history, custody chain, and errors and involved parties would all be monitored and recorded. This prevents or at least minimizes food and drug spoilage; vaccines also are viable and safe up to and including the point of reaching the consumer.