Cold Chain Logistics: Keeping Product Safe and Effective 

Cold chain logistics accounts for a complex process to move temperature-sensitive goods through the supply chain. Many industries are affected and any challenge within the process can lead to a loss in product.

With global food losses totaling over $750B a year and with more than $5.65B in pharmaceutical clinical trial losses due to ineffective product, a temperature-controlled supply chain must hold up from manufacturing to delivery.

Let’s take a deep dive into keeping product safe and effective in this complex world of cold chain logistics.


What is a cold chain?

Cold chain refers to the management of the temperature of perishable products to maintain quality and safety from the point of origin through the distribution chain and to the consumer or patient. The cold chain is especially critical within the healthcare and life sciences supply chain.

According to the Institute for Human Data Science, more than $35B is lost annually within the biopharma industry due to failure in temperature control. Challenges within cold chain logistics have led to a high rate of damage claims, shipping delays, increased quality standards, and higher costs.

Cold Chains are vital in transport for the following segments:

What is cold chain logistics?

Cold chain logistics is the transport of temperature-controlled goods. It impacts every stage of the supply chain – from procurement to transport, storage, and transport to the end customer. Because cold chain logistics covers the entire span of maintaining a temperature range from manufacturing to delivery, there are several high risks involved to consider:

  1. Equipment Malfunction – power outages, insulation failure, poor circulation, insufficient reserves, limited fuel, limited back-up energy or coolant source
  2. Lack of Standards and Infrastructure – flexibility in processes, inadequate temperature-controlled warehouses, limited storage facilities, lack of temperature monitoring
  3. Distribution/Delivery – packaging failure, breakdowns in remote locations, product left on docks
  4. Human Error – insufficient training, non-compliance, inefficient use of equipment, bad paperwork

What are the main elements in the cold chain?

When 4 very important pieces come together within the cold chain system, the product remains safe and effective: temperature-controlled storage, temperature-controlled transport, trained personnel, and operational procedures.

Temperature-controlled storage includes specialized refrigerated facilities that maintain products at their appropriate temperature until they’re shipped for distribution or delivery.

Temperature-controlled transport refers to customized packaging with thermal management properties utilizing phase change materials, dry ice, liquid nitrogen, gel packs, or a combination of these, to maintain a temperature range. When paired with temperature and humidity monitoring devices, digital data can be captured to ensure product stayed compliant. This data can then be stored for compliance purposes and analyzed for future shipping trends.

Trained personnel understand the complexity of handling products that require cold transport. Far beyond just understanding, they are diligent in following the outlined operational processes and recording the necessary data for overall quality management in the cold chain process.

Operational procedures are created to minimize risk during day-to-day operations. Plans for unexpected incidents allow for trained personnel to save temperature sensitive product while it moves within the storage or transport phases.

    Why is the cold chain important?

    Cold chain plays a big part in a product’s lifecycle, as it guarantees usability after storage and transportation. Using a supply chain that is critically focused on thermal management and monitoring requires an extensive amount of planning, but when done right, reduces waste and safety concerns.

    Supply chains in the pharmaceutical industry are especially reliant on cold chain operations. If we take a look at the vaccine cold chain alone, stakeholders must monitor and maintain a vaccine’s optimal internal temperature from release to administration to the patient. Failing to maintain their target internal temperature could result in degradation, loss of potency, waste of product and money, or the need to re-immunize patients.

    Proper handling, described by the CDC, is a shared responsibility by the manufacturers, distributors, public health staff, and health care providers.

    How is a cold chain different from a supply chain?

    A standard supply chain consists of moving product from one location to another. The cold chain is similar in form, but relies on temperature control and typically has higher risks associated. It’s sometimes referred to as the “Cold Supply Chain”.

    Maintaining temperature to guarantee product integrity lives at the heart of the Cold Supply Chain. Things like thermally managed containers, extensive shipping plans and last mile protocols, temperature monitoring, and overall compliance with the FDA, FSMA, WHO, and more regulatory groups, come into play to ensure a product’s quality is maintained.

    Because a cold chain requires a higher level of end-to-end control, there are typically a number of integrations that come into play throughout the process. This could include the utilization of a 3PL (3rd Party Logistics) provider, source loading provider, and software that tracks time and temperature as product moves from manufacturing to delivery.

    What is the “last mile” in cold chain logistics?

    The “last mile” is simply the delivery of a shipment to its destination. Timing of the delivery along with the correct personnel and cold storage space are critical for maintaining product quality. Things as small as congestion in the delivery area or parking difficulties could cause hurdles in maintaining the integrity of the product.

    The final transfer of goods (moving product from the truck, onto the dock, and finally to storage) must be precise. The entire cold chain process must take temperature tolerance into consideration and guarantee the product is maintained to the last mile.

    Cold Chain Standards and Regulations

    While each country has unique entities that regulate Cold Chain Standards, understanding the regulations in the US provides insight into the level of scrutiny of this process. In the US, several federal regulators that come into play when talking about cold chain logistics include US Customs, the International Air Transport Association (IATA), the Transportation Security Administration (TSA), the Federal Drug and Food Administration (FDA), the Department of Transportation (DOT) and others.

    These groups define requirements to ensure products are shipped and arrive safely. For pharmaceutical and life science products, this would be administration or use. For food and beverage products this would mean consumption. Each regulator has their own requirements for different products in relation to temperature, timing, and packaging standards.

    Some regulatory considerations outlined by these regulators include:

    • Temperature requirements
    • Transportation
    • Stability
    • Packaging
    • Monitoring
    • Recalls

      Temperature Standards for Cold Chain Logistics

      Many perishable or temperature-sensitive products categorize themselves into a general category range:

      • (-28 °C to -30 °C) Deep freeze — seafood, meat exports
      • (-16 °C to -20 °C) Frozen — meat, some product
      • (2 °C to 4 °C) Chill — fruits, vegetables, fresh meat, certain dairy products
      • (2 °C to 8 °C) Pharma — medicines, vaccines.
      • (12 °C to 14 °C) Cool-chain — fresh produce, processed food, over-the-counter drugs

      Transportation and packaging options in the cold chain industry are becoming more flexible, providing confidence to brand owners to developer global supply chains.

      For more information about temperature standards, be sure to check out our guide to temperature regulation for every industry.

        What is cold chain monitoring?

        Cold chain monitoring utilizes an Internet of Things (IoT) strategy to track temperature-sensitive product as it moves through the cold chain.

        Benefits include:

        1. Full audit trail of product for compliance and quality purposes
        2. Quick detection of possible temperature issues within the supply chain
        3. Predictive maintenance and analytics for future temperature trends

        Cold chain monitoring can consist of color-changing indicators (set temperature tolerance based on product testing), electronic data loggers, or a mix of the two. Typical applications lead to indicators at the product-level and data loggers at the box or skid-level for complete temperature visibility.

        How does thermal management assist with cold chain logistics?

        With proper thermal management comes the ability to manage or control temperature and manipulate thermal properties of an object or its environment. Thermal packaging solutions utilize phase change materials in panel, gel pack, or various other forms to maintain stable temperature and protect the product it surrounds. When combined with ice, dry ice, or liquid nitrogen, products can maintain temperature longer or reach heightened temperature ranges. 

        Thermal management trends like sustainability add to complexity with a vast number of temperature-sensitive products moving through the cold chain every day. Smaller, compostable solutions are critical for in-home deliveries to reduce waste once the package is opened.

        Not many products moving through the cold chain travel through the same shipping channels, have the same product specifications, and the same end users. Custom, key-turn packaging options create a flexible solution for every need.

        The Impact of Cold Chain Shipping



        Specialization and complex planning allow for the transportation of cold chain goods in global trade. It enables wide distribution from single, large manufacturers but comes with hurdles based on time in transit and a wide range of environmental measures.


        Regional cold chain distribution supports production and economies of scale. This could involve the use of cold storage facilities servicing local grocery store or specialized healthcare divisions exchanging temperature-sensitive products.



        Timely distribution to the final consumer. This may include perishables or medications that may become unsafe when specified temperature thresholds are met.

        The Benefit of Data within the Cold Chain

        Brands can save thousands of dollars when they partner with the right logistics partner or solutions provider. Refrigeration and proper transportation equipment to maintain a temperature controlled environment can quickly become expensive.

        Taking a step back and truly understanding the specifications of the product being shipped, their temperature tolerances, the shipping lanes, expected delivery dates, and expected weather throughout the journey of the product allows for extensive planning and future trend analysis.

        Using automation and data science to assess, measure, and predict gives better accuracy. Paying for expansive shipping methods or hefty packaging may be unwarranted for certain cold chain products.

        Companies must consider a number of factors to save costs without compromising product quality and speed to market.