Cold chain is a three-fold concept, involving certain aspects that can be co-related to science, technology, and process development. In terms of science, cold chain industry requires the understanding of chemical and biological processes associated with the product. This technology usually relies on physical methods to ensure desirable temperature conditions for perishable products throughout the supply chain. Further, the cold chain storage process involves the cold chain storage, cold chain transportation, and monitoring temperature controlled packaging products.
In the absence of suitable temperature controlled packaging solutions, the products packaged, such as vaccines, biologics, cell and gene therapies might get exposed to extreme ambient temperatures. Therefore, the pharmaceutical, biotech, food and chemical industries usually rely on cold chain packaging for the transportation of their products. Temperature controlled packaging system is a complex process and hence is designed in order to ensure ideal temperature (cold and frozen) for such temperature-sensitive products. Additionally, these temperature controlled packaging systems offer several other benefits for pharmaceutical, food and agricultural products, such as, reduction in loss accounting for damaged products and maintenance of the product quality.
Further, it is worth highlighting that these solutions are extensively being used for the distribution of seafood, healthcare products, pharmaceutical products, and meat due to their temperature sensitivity.
Historical Timeline of Cold Chain
The food and pharma cold chain industries are impacted in practically every way by the goal to maintain quality of temperature controlled packaging products at desired (low) temperatures. Therefore, the cold chain industry was introduced as an emerging solution. An uninterrupted cold chain industry, however, was unheard for thousands of years.
A major requirement of cold chain industry is to have a network of refrigerated production, cold chain storage, and distribution activities, together with related equipment and logistics. The concept of temperature controlled packaging initiated in 1817 in England, when the first commercial cardboard box was developed. Further advancements in this domain were observed in the late 1800’s, with the introduction of temperature controlled packaging equipment such as the vacuum flask which minimizes heat transfer and hence, controls temperature. Thereafter, during mid-20th century, the cold chain industry witnessed a major breakthrough in the pharmaceutical and medical sector owing to the need to transport temperature controlled packaging.
Further, considering the rising demand for cold chain storage, specialized freight forwarders have demonstrated active engagement in this domain, leading to significant improvements in the supply chain for such products.
Subsequently, the 21st century witnessed major advancements in this domain. Specifically, in the last five years, the implementation of real-time monitoring has largely impacted the adoption of traditional methodologies in cold chain industry. It is worth highlighting, in 2021, TempAid, a cold chain industry offering temperature controlled packaging products, announced the introduction of the first biodegradable shipping container.
Cold Chain Solutions for Pharmaceutical Industry
Over the years, cold chain industry has established its foothold across various sectors, including agriculture, food and beverage, dairy, pharmaceutical and healthcare industry. Various cold chain solutions such as, refrigerants, ice packs, refrigerators, containers, shippers, data loggers, sensors and indicators are currently being used in the pharmaceutical sector. These solutions are required for the maintenance and monitoring of specific requirements of the product in transit, such as temperature, humidity, shock, and light. Cold chain temperature controlled packaging solutions for pharmaceuticals in transit can broadly be categorized into two sections, packaging and monitoring. Brief descriptions of the aforementioned categories have been provided in the subsequent sections.
Types of Cold Chain Packaging Solutions: Containers and Shippers
Based on the source of energy used for the maintenance of temperature controlled packaging solution, cold chain containers / equipment are primarily classified into active, passive, and insulated cold chain solutions. Further details on these solutions have been provided in the subsequent sections.
Active Cold Chain Packaging Solutions
Active cold chain temperature controlled packaging solutions include active thermal systems that are dependent on mechanical or electrical systems for energy generation. These systems do not incorporate any phase change materials (PCM), such as water, dry ice, gel-packs, or liquid nitrogen. Alternatively, they may be equipped with a thermostat control to maintain appropriate product temperature. Active cold chain containers can be further classified into two sub-categories, based on the source of energy, namely compression refrigerators / freezers and absorption refrigerators / freezers.
Passive Cold Chain Packaging Solutions
Once the system has attained the specified temperature, passive systems / methods can be used to ensure easy storage and transportation of products. It is worth mentioning that these containers are developed using thermal systems, which are insulated with polystyrene, polyurethane or vacuum insulated panels and comprised of PCMs which aid in temperature control.
Insulated Cold Chain Packaging Solutions
Unlike active and passive containers which are primarily used for cooling / cold chain storage of temperature controlled packaging products, insulated packaging containers are used to ship these products. These containers are available in a single use, as well as reusable format. Additionally, they are equipped with sensors / data loggers to monitor and document the product’s temperature throughout the process.
Cold Chain Monitoring Solutions: Data Loggers
Cold chain monitoring involves the use of internet of things (IoT) technology for the continuous monitoring of temperature controlled packaging products, such as pharmaceuticals, biologics, food, and drinks that are transported in a cold chain. Effective cold chain monitoring enables businesses and their transportation partners to access and keep track of real-time data to:
Immediately detect temperature related problems.
Track and trace all the cold chain temperature controlled packaging products using a single technology platform.
Enhance predictive maintenance, remote monitoring, compliance, and fleet management by incorporating the sensor data with supply chain.
In pharma cold chain, monitoring solutions for pharmaceuticals in transit can broadly be classified into two sections: data loggers and indicators. Brief descriptions of the aforementioned classifications have been provided in the subsequent sections.
Data loggers are electronic equipment that monitor and log parameters, such as temperature, humidity, shock and light for analysis. It consists of a sensor that collects the information and a chip that stores it. Subsequently, the information stored in the data logger is transferred to a computer for analysis, either in real-time or after the shipment is completed.
Temperature indicators are cold monitoring tools which can process signals from temperature sensors and display them on the screen. They are the installation tools which provide information about the temperature shifts, quality and safety of the products.
Current Challenges and Future Perspectives
The concept of cold chain industry has garnered significant attention and is emerging at a significant pace owing to the growing demand for better cold chain storage and cold chain transportation facilities. However, it is difficult to move cold chain shipments through supply networks due to their sensitivity to temperature changes. Various challenges associated with cold chain transportation have been mentioned below:
Safety risks associated with fluctuating temperature of temperature controlled packaging products, such as perishable food and biologics.
Inadequate packaging can lead to prolonged exposure of the product to warm temperatures, which may result in degradation of perishables.
Microbial contamination due to poorly maintained freezers and fridges. Constant monitoring is required to minimize the microbial harborage and build up.
Despite the numerous challenges associated with the management of cold chain transportation, the advantages of deploying cold chain temperature controlled packaging solutions are believed to outweigh the associated risks. This can be primarily attributed to the fact that these solutions aid in maintaining product efficacy and integrity at different stages of the supply chain in cold chain industry. Moreover, over the last couple of years, stakeholders have been focused on the development of advanced tools and techniques for monitoring and tracking purposes, particularly real-time monitoring technologies, such as IoT, RFID and blockchain. Additionally, connected cold chain temperature controlled packaging solutions have been observed to offer various advantages over conventional methodologies, including automation across several steps and elimination of human handling errors.
In the near future, connected cold chain temperature controlled packaging solutions are likely to play an important role in overcoming many of the challenges (such as tracking / tracing and delivery time restrictions) that are associated with temperature controlled packaging products, thereby, minimizing the chances of product spoilage and saving additional costs. , Further, we believe that with increasing awareness related to inherent benefits of the cold chain industry, for instance, improved product life, it is likely to be adopted by majority of the drug developers in the foreseen future. The subsequent chapters provide additional details on the current landscape of cold chain packaging product providers and technologies / equipment that are currently being used for such operations and various other aspects of the market.