The pharmaceutical cold chain is a complex and effective process for all pharmaceutical manufacturing and commercialization activities. The main goal is to improve product quality by reducing contamination of raw materials and personnel during production, and maximize throughput of finished product for maximum profit through optimized use of resources. As a result, pharmaceutical manufacturing companies invest extensively in improving processes, products, infrastructure, and security. However, as this type of activity evolves, it becomes increasingly important to have a solid understanding of the chain management procedures and their interrelated dynamics. This paper aims to make this task more manageable through an extended analysis of key features of this complex process. Click here for more
How to Know Understanding the Pharmaceutical Cold Chain
The cold chain refers to all steps that occur between the discovery of a new pharmaceutical agent and its first application in a new therapeutic or life-saving product. The major drivers of this process are temperature, real-time temperature, batch number, sanitation practices, availability of ingredients, and contamination avoidance strategies. The cold chain functions through several distinct processes, such as kinetic energy (potential energy) and adsorption to create temperature gradients for drugs and vaccines. As a final step, real-time temperature monitoring is used to monitor all steps to determine whether temperatures have reached or will reach theirthermodynamic maximum. Based on these parameters, planned temperature-controlled temperature profiles are established, monitored, and adjusted as needed to maintain real-time temperatures within specific physiological ranges for all phases of production and processing.
While temperature-controlled environments have been shown to increase efficiencies across a wide range of industries, such as biotechnological and diagnostic sites, there is still debate as to whether temperature-controlled environments improve manufacturing productivity. A number of factors, including product cycle times and the speed of access to low temperature ingredients, affect the efficiency of the pharmaceutical cold chain. In addition, the increased cost of raw ingredients and increased cost of production for pharmaceuticals may impact the relationship between pharmaceuticals’ ability to affordably increase production to meet demand, and keep costs down.