The term “cold chain” refers to the transportation of pharmaceutical products, active ingredients and biological items in controlled temperature environments. Some sectors where the cold chain mechanism can be used include research, diagnostics and so on. The main objective of using cold chain management during transportation of pharmaceutical goods is to keep the products within a specific temperature range, following the guidelines set in the GMP (Good Manufacturing Practice) by the FDA, as a result, decreasing the cost and increasing efficiency levels.
Specifically Pharma transport follows certain rules during temperature controlled transport. While controlling the temperature, the Mean Kinetic Temperature (MKT) formula is used. The medicines need to be kept between 2 and 8 degrees Celsius. Sometimes in the journey the temperature is allowed to drop to zero degrees and up to 15 degree during storage, shipping and distribution. However the MKT should not exceed 8 degrees.
Sometimes a breach of regulations regarding temperature happens in the cold chain logistics operation. In order to prevent the breach, Timestrip has developed a product named TimestripPlus. This device detects whether or not a product was exposed to a higher temperature during a delivery. Whenever the product is kept outside the specified range during temperature controlled transport, the liquid inside TimestripPlus keeps moving. The liquid stops moving as soon as the product is brought below 8 degrees Celsius. This difference between times can help to decide what actions are needed to be taken. If a person is not sure how long the drug was exposed to the extreme temperature, then one might have no choice other than to dispose of the item. By using TimestripPlus temperature sensitive labels, this problem can be avoided. Vaccine cold chain management is very important as well. There should be some kind of active and passive temperature control system while transporting vaccines.