Cold Chain is a Process
Cold chain management is also a process since it requires a series of tasks to manufacture, store, transport, and monitor temperature sensitive products along the entire supply chain. Thus, every single step in the supply chain requires adherence to a defined process – often called standard operating procedures (SOP). They include guidance for:
• Using the right equipment for packaging and monitoring
• Transporting products in time
• Avoiding exposure to extreme conditions
• Following the defined release process at destination
Cold Chain is a Science
Cold chain is a science that requires understanding the chemical and biological processes driving the degradation of perishable products. Pharmaceutical products are often well-protected in primary packages. Food is very sensitive to external influences. For example:
• Food: bacteria, gases, temperature, and humidity on degradation
• Pharmaceutical products: time and temperature on the product potency (stability budget)
History of Cold Chain Monitoring
Cold chain monitoring began in the food and brewing industries. Until the early 20th century, people harvested ice blocks to keep foodstuff cool during transport and storage. The invention of the General Electric Monitor Top refrigerator in 1927 was not only the kick-start for refrigerators and freezers, but also the beginning of temperature-controlled trucks and transport containers.
Although the first vaccination was developed in 1796, and insulin was first purified in 1922, most pharmaceutical products were still chemical products, which have not been considered sensitive to temperature until a few years ago. While the cold chain grew familiar to the food industry in the 1960s and 1970 s, the pharma industry started focusing on the cold chain in the 1990s, with fast-growing markets in insulin, blood products, and vaccines. Since these are all biological products (substance derived from a living organism), the focus of the pharma cold chain industry was technologies and processes for keeping products cold or refrigerated at 2-8°C. The main term used was, therefore, “cold chain technologies” and “cold chain management.”
In 2013, the EU Good Distribution Practices (GDP) guidelines changed the scope to include all pharmaceutical products and medical devices considered to be room temperature products or products that must be stored at the controlled room temperature (CRT), between 2-25°C or 15-25°C. Since then, the term used has shifted from “cold chain logistics” to “temperature controlled logistics” – particularly in expert discussions.
The Difference Between Food Cold Chain and Pharma Cold Chain
What are the commonalities and differences between the food and the pharma cold chain? Although both product types are sensitive to temperature, there are significant differences:
• Food products are often “open” and exposed to bacteria, chemicals, and humidity. They can be sensitive to various environmental parameters. The shelf life of food products vary widely from a few days to many years depending on the product and the temperature range (frozen, fresh, or controlled). Therefore, the lengths and complexity of the supply chain has a great variance. Most food products are much more sensitive to temperature than pharmaceuticals and therefore must have shorter supply chains.
For example, if freshly cut roses are produced in India, they must reach the consumer in Europe within seven days before they fade and lose their commercial value. They are highly sensitive to temperature, fading fast at temperatures above 10°C, and cannot be frozen.
• Pharmaceutical products (commercial) are packaged to protect the product from bacteria, chemicals, and humidity. Most commercial pharmaceutical products have a shelf life of 18–36 months. They are often less sensitive to temperature compared to food products. The big challenge with most pharmaceutical products is that the quality and level of degradation is not visible to the patient; you cannot see or smell if a vaccine has been frozen, has lost its potency, or has become harmful.