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What is the cold chain, what products are transported in a cold chain, and how is it regulated?

A supply chain that is kept under strict temperature controls is called a cold chain. This regulated temperature-controlled system consists of both processes and a network of refrigerated warehouses, refrigerators and freezers, cold stores, and cold boxes organized and maintained to keep products within a consistent temperature range throughout development, transport, storage, and distribution from manufacture to the point of use.

A cold chain includes the interaction between the product, origin/destination, and distribution:

  • Starting with the product that requires specific temperature conditions, these conditions dictate its mode of transport and packaging.
  • Knowing the product’s origin and destination of manufacture and consumption enables you to know how long it will take to get to the destination and how long a temperature must be kept stable.
  • The distribution infrastructure and method dictate the type of packaging and transportation type required, including reefers, trucks, and warehousing facilities.

For vaccinations, specifically, there is ultralow (-70 degrees C) for the Ebola and Pfizer–BioNTech’s COVID-19 vaccine, frozen requiring -20 degrees C, and the refrigerated chain, 2 to 2°C (36 to 46°F). Most flu vaccinations only require refrigeration. Several products and manufacturers have their own specific time and temperature ranges they require based on the tolerances of the particular product being shipped.

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Why Is A Regulated Cold Chain Critical?

According to the Produce Marketing Association (PMA), about 40 percent of all foods are refrigerated at some point1.

Some products, such as pharmaceuticals, cheese, chocolate, wine, chemicals, film, meats, seafood, and frozen foods, must be kept at a consistent, uninterrupted temperature to preserve, extend the shelf life of products, and in some cases, protect the integrity of these products. Proper cold storage, in particular, is vital to prevent quantifiable and qualitative losses.

Products That Need To Be Regulated

A cold supply chain is standard in both the food and pharmaceutical industries and many chemical shipments.

  • Produce and other foods – Food contamination is a very real and dangerous prospect. If the safety risk is unknown or has not been reported, any food consumed may cause foodborne illnesses that can have a substantial social cost. The International Institute of Refrigeration (IIR) estimates foodborne illnesses may cost more than $50 billion annually in the United States alone and more than 120,000 hospitalizations and 3,000 deaths.
  • Vaccines – From drug stores to distant clinics, hospitals, and people’s homes, the cold chain is utilized to provide life-saving vaccines worldwide. If it were not for the cold chain, vaccines such as the Covid-10 vaccine would not reach their destination intact.

How Is The Cold Chain Validated?

Cold chain distribution requires set processes that must be followed based on global regulatory bodies such as the WHO. Good Manufacturing Processes (GMP) are guidelines that provide minimum requirements manufacturers must meet to ensure products are consistently high quality from one batch to the other. These GMPs must be validated to ensure no negative impact on the drug substance’s safety, efficacy, or quality is compromised.

GMP environments require that these are tested and validated during the entire manufacture, storage, and distribution process. This is done using testing techniques and tools such as tested data loggers and recorders.

Cold chain packaging includes several elements, including insulated containers, gel packs, and corrugate. These components help keep goods stay at the right temperature, whether in storage, shipment, handling, or during the last mile (end of delivery route).

Once validated, qualified cold chain packaging is used to hold the temperature of a product for extended periods to ensure that when not in a temperature-controlled vehicle or warehouse, the product is still kept consistent. Well-designed cold chain packaging reduces void fill, insulates against temperature changes, and minimizes freight cost, allowing you to reduce the overall cost of your product to the end-user.

Tempaid Cold Chain Packaging

Our deep understanding of compliance, manufacturing requirements, and shipping conditions allows us to evaluate, qualify and validate your packaging to assure temperature stability and reduce your total cost of ownership for shipments

TempAid’s fully qualified packaging solutions are designed to:

  • Provide a robust solution that prevents errors caused by incorrect pack-out configurations or errors.
  • Support stringent testing guidelines surpassing both Canadian and US regulations for temperature consistency and hold-time requirements.
  • Maximize the effectiveness of low-temperature profiles across the United States and Canada
  • Provide sustainable packaging options that are recyclable, compostable, and reusable to provide an environmentally friendly alternative to standard, single-use containers.

As the cold chain packaging division of Rapid Aid, TempAid manufactures a complete line of cold chain solutions designed for optimal temperature stability in the food, pharmaceutical, and laboratory sectors.

As a part of the Rapid Aid brand, the company has been delivering solutions to the market since 1975. The company has the capacity and manufacturing capability to deliver hundreds of millions of units per year. Contact us for more information.


1. https://www.pma.com/content/articles/2015/05/cold-chain-defined

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