Interruptions to the cold chain create problems such as spoilage, changes in the appearance, taste, or smell of a product, growth of harmful bacteria, or lost potency. Preventing any interruption of the cold chain is one of the main responsibilities of a logistics manager. Let’s look at some of the significant cold chain challenges you may have to face, and how you can keep issues at bay.

REGULATIONS

Regulations for the cold chain are ever-changing and complex, which is why they are one of the major challenges faced today. If your cold chain is worldwide, it can be more complicated as there is no one entity to regulate on a global scale. Each region has its own regulations, compliance mandates, and enforcement agencies. Some examples of these are:

U.S. Food and Drug Administration (FDA)

In the U.S., the federal regulatory agency for food and pharmaceuticals is the FDA. 

Most cold chain food regulations come from the FDA’s Food Safety Modernization Act (FSMA) of 2017. This regulation covers the cleanliness and function of equipment, protocols set in place for transportation, employee training on the proper handling of food in cold chains, and records of all FSMA compliance.

When it comes to pharmaceutical products, many regulations affect the cold chain. Some of those include:

• 21 CFR 203.32
  • Addresses the need for maintaining drugs under stable conditions and meeting manufacturer’s specifications.
  • 21 CFR 211.150
    • Provides guidance on the written procedures for managing expirations and a reliable system for identifying the distribution of drug samples in the event of a recall.
  • 21 CFR 203.36
    • Outlines the responsibilities of manufacturers and authorized distributors.
  • 21 CFR 205.50
    • Minimum requirements for storage and handling of prescription drugs and maintenance of distribution records

Canadian Food and Drugs Act

In Canada, the regulatory authority is the Government of Canada. The Canadian Food and Drugs Act was passed in 1920 and revised in 1985. It regards the production, import, export, and transport across provinces for food, drugs, and cosmetics including products like soap and toothpaste. It ensures products are safe, ingredients disclosed, and drugs are effective. 

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

Many other countries, refer to ICH guidelines gathering data on a product’s safety and efficacy to establish a cold chain strategy. ICH brings together many regulatory authorities to discuss data and establish those guidelines. Gathered data is used to consider the duration of temperature excursions that can occur across distribution channels. 

Regulations can be complex and demanding at times, but they all have the same goals of retaining the safety, quality, transparency, and efficacy of cold chain commodities. The biggest key to keeping compliance with cold chain regulations is increasing end-to-end visibility in your cold chain. Keeping proper documentation of data throughout your supply chain can seem difficult but modern technology like a transportation management system (TMS), can simplify this cold chain challenge. Current technology applications like GPS tracking, ELD data, Internet of Things (IoT), and a TMS can give you advanced analytics and reporting that would otherwise be comprised of manual processes. Not only does technology offer you savings in time but of human error as many processes become automated. 

SUSTAINABILITY

Another significant cold chain challenge is the increasing spotlight on sustainability. The distribution and transportation of temperature-controlled products have shown to be major causes of greenhouse gas emissions. In comparison to other supply chain transportation, cold chain transport consumes 20 percent more fuel than other heavy vehicle types due to the refrigeration equipment. The biggest issue facing sustainability is the high-power consumption or combustion of fossil fuels necessary to power the cold chain’s cooling systems. 

There are also growing issues and increasing regulations on refrigerant gases used in cooling systems like hydrofluorocarbons (HFCs) as they are responsible for high greenhouse gas emissions. In 2015, the European Union set strict limits on the production and sale of high global warming potential HFC refrigerants. In the U.S., the Manufacturing Act of 2019 was passed which established a timeline of phasing down the use of HFCs by 2036. 

Because of the increasing pressure of sustainability and its regulations enacted on the cold chain, many large food and pharmaceutical companies have plans in place to reduce their carbon emissions. In 2015, more than 150 businesses in the U.S. signed the Business Act on Climate Pledge which launched for private sector businesses to express their support on international action on climate change. Also, in 2015, the Paris Agreement was created, signed by 195 countries at the United Nations climate change summit. This agreement aims to reduce greenhouse gas emissions to prevent the planet from warming by more than 2 degrees Celsius. 

Being sustainable in the cold chain is also something you can be recognized for now with awards such as the Supply & Demand Chain Executive Green Supply Chain Award or the Council of Supply Chain Management Professionals’ Supply Chain Sustainability Award. Some ways to consider in adding sustainability to your cold chain is improving your cold chain management to reduce waste and your carbon footprint or considering alternative transportation modes like intermodal versus truckload when shipping your products. While you’re working on improving sustainability in your cold chain, make sure the providers you work with are equally interested in sustainability as well. Here at Trinity, we are proud of our sustainability efforts and to be recognized as a SDCE Green Supply Chain Award winner and as a Food Logistics’ Top Green Provider. 

TEMPERATURE VARIANCES

Shipping temperature-sensitive items? Check out our Temperature Shipping Guide for temperature suggestions?

It’s one of the biggest and most common cold chain challenges: maintaining the required temperature of the product throughout the entire supply chain. Any temperature that is higher than the set temperature can affect a product’s quality. Not all products that get exposed to a temperature past their threshold will spoil right away, as it depends on how steep and frequent the exposure was. Once a product has begun to thaw, it is considered contaminated. Depending on the product and temperature, that window of time can be very short. There are many times during cold chain in which a product can be exposed to a temperature variance: during unloading and loading of the product, from poor packaging, handling, or broken equipment.

Loading and Unloading

As your product moves through the cold chain, it can get exposed to temperatures outside its set temp. Whenever loading and unloading your product, handling should be as quick as possible. Preventing prolonged exposure to temperature changes prevents having problems with quality. 

Poor packaging or handling

There are many different ways to package your cold chain freight so it can keep its cool. If it’s not done right or in mind of your transit time, your goods can spoil before arrival. When handled poorly, they can become damaged, causing lost product.

Equipment problems

One way the cold chain can be interrupted is when your equipment breaks down. Refrigeration equipment can malfunction due to damage, inadequate maintenance, or losing power. 

In cold storage, doors becoming damaged are one of the common challenges they face. When cold storage doors become damaged, they can’t maintain their specified temperatures.

Due to inadequate maintenance, there can be a buildup of condensation in coolers and freezers, causing slippery surfaces and unsafe conditions for workers, as well as a spoiled product. Another maintenance challenge is handling the growth of mold or mildew, which can happen with poorly maintained temperatures. Should this happen, the freezer will need to be cleaned thoroughly and inspected for any problems. 

Transportation Breaks Down

Vehicles can break down at any time. Any hold-up in your cold chain shipment could mean more than just a time delay, it can mean a spoiled product. Make sure you’re working with a qualified carrier who inspects their truck or other modes of freight before the journey begins.

Keeping track of the temperature throughout your cold chain is another way to combat having your products exposed to changes in temperature. Temperature monitoring systems are quickly replacing any manual processes of collecting temperature information, saving time, and preventing spoiled products. This also allows cold chain managers insight into their problem areas and being able to fix them.

Some of these temperature monitoring systems are RFID or wireless sensor network, thermal imaging, and temperature loggers. RFID or other wireless sensor networks are the most common in the cold chain. These sensors capture the location and temperature, communicating the information back to a database and allowing parameters like an estimated shelf life to be calculated. You’ll often find these in warehousing and cold storage. Thermal imaging is exactly what you think it is; imaging that is taken showing the different temperatures of everything in the photo. Thermal imaging uses a sensor to convert the radiation given off at different temperatures into a visible light picture. This is also often used in warehousing and cold storage. Lastly, temperature loggers are another type of sensor placed next to cargo in transportation. They can be set to record as frequently as every second, minute, or hour. Once removed, they can be plugged into a computer so the temperature data can be transferred and analyzed.

TEMPERATURE-CONTROLLED SHIPPING CAPACITY 

Another significant cold chain challenge is available capacity. Capacity is always a challenge for any industry, but even more so for the cold chain, especially right now. With freight in high demand across all industries and capacity slim, drivers can pick and choose what shipments they want to take based on (already) high rates. Reefer trailers are already limited with the increased demand on cold chain, but when rates for moving other high-demand commodities such as lumber or retail keep increasing, those drivers can choose to utilize their reefer trailer as a dry van to haul should those rates be better paying, further reducing cold chain capacity. Cold storage warehousing is seeing the strain as well because of the growing freight demand. More storage space is needed in the supply chain and new buildings are being built, but those currently in production or needing their building supplies (which are also in high demand), puts yet another strain on shipping capacity until that demand has decreased. With the cold chain demand increasing and available equipment and drivers doing quite the opposite, can the logistics sector keep up? Read more in our current whitepaper.

DON’T LET THE COLD CHAIN SCARE YOU

There is a lot of juggling to do when managing the cold chain. If even one ball is dropped, it can affect the whole cold chain. You can prepare as best as you can for these cold chain challenges, but sometimes it’s nice to know you have backup when you need it most.

Luckily here at Trinity, we’re experts in complex situations. In fact, I would say it’s our specialty. We’ve seen every possible problem there could be and are happy to help. By working with Trinity, you can gain access to the data you need to improve your performance and output, find equipment and capacity when you’re finding it difficult, and work with someone who understands current regulations, no matter the region or type of commodity you work with. We’re here to have your back regardless of what cold chain challenge comes your way.

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Author: Christine Morris