What is Cold Chain?

A temperature-controlled supply chain is known as a cold chain. It involves science, technology, and a process logistically managed from the point of origin through to the consumer. This is done to protect quality and safety of perishable products and the end users. Products from the pharmaceutical, biopharmaceutical, food, beverage, and floral industries rely on the cold chain. Some chemicals also need the cold chain. To protect the integrity of these and other temperature-sensitive items and the safety of consumers, organizations around the world play a part in setting specific guidelines and regulations. The cold chain is a necessary yet challenging system. All involved are responsible for its management.

cold chain process perishable food tomatoes

Why is the cold chain important?

The cold chain ensures that perishable products are safe and of high quality when they reach the end user. Failure to keep product at the correct temperatures can result in textural degradation, discoloring, bruising, and microbial growth.1 The end goal is a satisfied customer, more product demand, reduced company losses and public health safety. The cold chain also contributes positively to the world economy and workforce. The global cold chain market size is estimated to reach USD 447.50 billion by 2025.2

Read about reducing supply chain risk with cold chain monitoring

The foundation of a cold chain system

The cold chain system is a series of actions that combine the knowledge of science, innovative equipment and technology, and a consistent and documented process to keep products safe along their journey from origin to the end user. The cold chain system first requires knowledge of chemical and biological perishable products. It includes equipment and technology such as refrigerators, monitoring devices, packaging, trucks, and more to ensure required temperature conditions are met from end to end. It is a process of preparing, storing, transporting and monitoring temperature-sensitive items. Logistics are put into place to manage the cold chain. Together, these provide a system that, when uninterrupted, retains the integrity of temperature-sensitive item and safety for the end user.

Read about effective temperature monitoring throughout the Cold Chain Process

Types of products requiring a cold chain

Products that need to be in a cold chain process include pharmaceutical drugs, vaccines, biopharmaceuticals, perishable foods such as ice cream, fresh fruit and vegetables, meat, and certain chemicals. The temperature is dictated by the specific temperature range needed to maintain integrity of the product being shipped. About 70 percent of the food consumed in the US is handled by the cold chain process yet 25 percent of all food products transported in the cold chain are wasted each year due to integrity breaches leading to fluctuations in temperature and product degradation.3

Read how temperaturing monitoring plays an important role in food safety from farm to fork

How regulations play a role

Specific compliance requirements for establishing an effective cold chain structure and governance strategy are based upon a combination of regulatory requirements defined by the corresponding regulatory body such as the Federal Drug Administration (FDA), European Medicines Agency (EMA), World Health Organization (WHO), Health Canada, etc.3 However, industry best practice guidance organizations such as the International Safe Transit Association (ISTA), United States Pharmacopeia (USP) and International Air Transport Association (IATA) offer important, practical information on the details and considerations required.

pharmaceutical cold chain

See a list of key Regulatkions for Cold Chain

Who is responsible for managing the cold chain?

Each sector of the cold chain, from the point at which product is harvested or manufactured to the point at which it is sold, shares responsibility. If one area of the cold chain is broken, then all suffer leading to a dissatisfied or possibly sickened customer.

Summary

The cold chain is a regulated supply chain used to protect the integrity of temperature-sensitive items and protect consumers. Such products requiring a cold chain include meats, cheeses, wines, fruits, vegetables, pharmaceutical drugs, vaccines, and chemicals. The end goal for using a cold chain system is a satisfied customer, more product demand, reduced company losses, and public health safety.

1. Global Cold Chain Alliance, About the Cold Chain, https://www.gcca.org/about/about-cold-chain, Accessed, March 3, 2020.
2. Product PMA Research, Cold Chain Defined, https://www.pma.com/content/articles/2015/05/cold-chain-defined, Accessed February 27, 2020.
3. Bikash Chatterjee, Managing Cold Chain Distribution Across the Global Supply Chain: Trends and Regulations, Pharmaceutical Outsourcing, https://www.pharmoutsourcing.com/Featured-Articles/189297-Managing-Cold-Chain-Distribution-Across-the-Global-Supply-Chain-Trends-and-Regulations/, Accessed March 2, 2020.