A Beginner’s Guide to The Cold Chain System for Pharmaceuticals

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In recent years, the number of new medications that have become available in the marketplace requires cold chain handling. This is because they are complex, temperature-sensitive products. In this article, we will look at what cold chain storage is in the pharmaceutical industry, how these perishable products are monitored in these environments, what cold storage transportation looks like, and review temperature-sensitive packaging.

Why Is The Cold Chain So Important?

According to Dickson, the pharmaceutical cold chain has grown in importance simply due to the increase in the production of temperature-sensitive medications. The US Food and Drug Administration (FDA) approves these products. Over half of the drugs cleared for use by the FDA in 2018 alone were given the classification of temperature-sensitive products. Each of them requires cold chain storage and transportation. The pandemic is an example of a global event that produced vaccines that require storage and transportation in low-temperature environments. 

For these products to remain safe for use upon receipt by the service provider administering them to a patient, they must be in a cold environment. Any exposure of vaccines to temperatures that are warmer than they should render the medications unusable. Spoiled medications lose their effectiveness and add to the cost of production. This is why significant investment went into infrastructure that could ensure the integrity of temperature-sensitive products is not compromised thus making the cold chain a key component.

What Is Cold Chain Storage In The Pharmaceutical Industry?

Cold chain storage depends on the temperature range required to maintain the integrity of the products in storage. Most cold chain products are refrigerated at temperatures between 2 and 8 degrees C. Other sensitive assets must be frozen between -15 and -25 degrees C. There are now an increasing number of advanced specialty therapy products that must be ultra-frozen in temperatures as low as -80 degrees C or cryogenic storage of as low as -196 degrees C. Fortunately, cold storage manufacturers have developed freezers that can reach the acceptable temperature range to keep these sensitive assets safe and manageable.

Monitoring and Tracking Cold Chain Environments 

Probably the most reliable tool available for the monitoring and tracking of cold chain environments is a device called a data logger. This portable instrument is battery-powered and contains an onboard data storage system and either sensors or external probes that measure environmental conditions ranging from temperature and humidity to pressure. These devices can send alerts should temperatures fall out of a set parameter for human intervention. The data collected can be downloaded for analysis to track the recorded temperatures and provide verifiable proof of compliance.

What is Cold Chain Transportation?

Cold chain transportation is far more than just refrigerated transport trucks. Logistics partners should have ultra-low temperature solutions for transporting these sensitive assets. These solutions will include cryogenic storage and the use of dry shippers. Dry shippers are sturdy, engineered cylindrical metal containers that sit inside of a rigid outer case. These tools implemented for transportation ensure that required temperature ranges are maintained at all times as the temperature-sensitive products move through the cold chain to their destination.

What is Temperature-Controlled Packaging?

Cold chain packaging solutions are vital because they ensure that temperature-sensitive products maintain their integrity and quality regardless of where they travel on a global scale. Solutions identified as passive packaging are effective in that they stabilize temperatures for extended periods providing the correct environment so that these products can be distributed to remote areas and still be protected. Challenges such as airport customs delays or extreme climates are two instances where sensitive assets must retain their integrity. Innovation keeps revealing new packaging solutions and a recent entry in the market, a passive packaging option, provides stable temperature protection for up to 168 hours for different temperature zones. The product does this with a construction design that incorporates a combination of honeycomb, and vacuum-insulated panels made from an advanced material.

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The Cost of Temperature-Controlled Packaging

Investment from pharmaceutical companies into the development of temperature-controlled packaging is only part of the equation. Global spending on cold chain logistics keeps climbing and all indications are pointing at a 25 percent increase in investment over the next three years. That translates to a total of close to $21.3 billion by the year 2025. For example, $17.5 billion went to the pharmaceutical cold chain in 2020. Roughly 30 percent of that, or $5 billion, was spent specifically on packaging costs, tracking tools, and monitoring devices such as data loggers. With the ongoing development of temperature-sensitive drugs, the demand for cold chain packaging will continue.

How Is This All Possible?

Partnerships between drug manufacturers and distribution operators are an important component of the cold chain. The connection permits these specialty items to be distributed on a global scale promptly. These innovative products improve patient outcomes and increase product success. For this to happen, an unbroken temperature chain, flawlessly executed from the site where the product is made to where it is needed, in a clinic, hospital, or wherever, must happen. Flexible and reliable supply chain strategies make it possible. As easy as it looks, many elements in place are key to the success of the pharmaceutical cold chain.

Final Thoughts

We live in a world where technology is sometimes spinning out of control. Within that evolutionary stage is innovation. In the pharmaceutical sector, many new drugs require low-temperature storage from where they are made to their final destination. This often includes international transportation in various modes presenting more challenges to the cold chain. The challenges are huge as are the rewards. 

The only way for these temperature-sensitive products to get to their destination and keep their integrity intact is through a series of steps known as the cold chain. The cold chain is a temperature-controlled environment that moves along with the products to ensure they remain stable. This requires attention to several details related to temperature. From having the correct refrigeration to monitors that watch the temperature, the cold chain is complete. Simply put, innovative methods, materials, and tools all play a part in the success of the pharmaceutical cold chain.

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