Pharmaceutical Cold Chain Management Best Practices

April 3, 2023

Pharmaceutical Transport

It’s one thing to transport everyday temperature-sensitive products like food and beverages, but pharmaceuticals are a whole other ball game. Cold chain pharma logistics is a complex and sensitive business and the risks of getting it wrong have a very real cost both to businesses and consumers.

The positive side to this level of responsibility is that the industry has developed its own best practices to help support transporters. If you’re in the business of transporting temperature-sensitive products, you’re not alone. There is a lot you can gain from modern-day thinking that will help you with pharmaceutical KPI (key performance indicator) setting.

The temperatures you need to know

The key to any cold chain is being clear on the temperature range requirements of the product that you are transporting. Though each product may require different control mechanisms, packaging, and transportation vehicles, some general ranges can be used as a guide.

The types of pharma shipments generally fall into three ranges: Ambient, Refrigerated, and Cryogenic:

Ambient: Controlled room temperature, 68°F to 77°F – Pills, capsules, tablets, etc.
Refrigerated: 35°F to 46°F – Vaccines like Polio, Measles, Tetanus, Hepatitis B, Smallpox, etc.; insulin, eye drops, etc.
Cryogenic: Below 32°F to -238°F – Tissue products, biosamples used in clinical trials, new cellular/gene therapies, and certain COVID vaccines.

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In cases where products need to be kept within ‘room’ temperature, like many pills and serums, temperatures that exceed 59°F and 86°F are generally allowed. Provided the spikes in temperature are not too severe and do not persist for extended periods (e.g. 24 hours).

What to look out for

Unlike other temperature-sensitive products, cold chain supply pharmaceuticals are often high-priority and very specialized. This means that transport distances and times are often much longer. This extension of the cold chain creates compounded challenges to cold chain logistics.

Consider how the COVID-19 pandemic impacted cold chain pharma logistics. The extreme demand for COVID vaccines created an unprecedented need for pharmaceutical cold chain solutions. Moreover, vaccines were created in limited parts of the world and needed to be distributed globally as quickly as possible.

This recent global event perfectly highlights the challenges faced by cold product transporters. Typical challenges include the following:

A lack of capacity in key areas of the cold chain
Delays along the journey that can impact temperature and expiry
Exposure to varying temperatures and climate environments as pharmaceutical products travel across the globe
Inadequate product packaging and cold storage solutions
A lack of transparency regarding the products’ temperature along the journey
A lack of skilled/knowledgeable personnel who can handle the products according to strict requirements

These are just a few of the many challenges faced by pharmaceutical companies and their cold chain transporters. Overcoming these challenges is a matter of planning, experience, having access to the right technologies, and following cold chain management best practices.

5 pharmaceutical cold chain management best practices

If you are serious about your pharmaceutical cold chain, you need to keep an eye on what is happening in the industry. Logistics and systems are becoming increasingly efficient and innovation is taking effect throughout the cold chain. Here are 5 cold chain management best practices to keep in mind:

Use technology to get oversight

Technology is part of every step of the cold chain, but it is also becoming an important factor throughout as well. While every stakeholder can do their best at their phase of the cold chain, you want oversight of the full chain to ensure that products are fit for consumption. Technological solutions like those offered by Varcode give you the information you need to make decisions and ensure quality. For example, Varcode’s Smart Tags will let you know exactly when products exceed temperature thresholds. Make sure you have the right technology in place to take the guesswork out of your logistics.

Align your logistics with regulations

You are not alone in your responsibility to deliver temperature-sensitive pharmaceutical products. The whole industry has regulations in place to protect you and the products you are responsible for. Regulations like those from IATA Temperature Control Regulations (TCR), the FDA, and the WHO (World Health Organization) Guidelines are a great place to start. These regulations are not there to make your cold chain pharma logistics more difficult but to ensure that you can deliver safely and according to quality standards.

Have robust storage and packaging processes

Temperature-sensitive pharmaceutical products are most vulnerable during the cold chain process, especially when being loaded and unloaded. It is when products are being taken from one environment to another that they can be mishandled or experience big temperature differences. It is at these critical junctures that you need to be sure about the cold chain storage for pharmaceutical products. Your storage facilities need to have reliable packaging and personnel that can handle packages with care.

Build in latency

All along the cold chain there are various ranges to adhere to: temperature ranges, time frames, and quantities of product. Across all ranges, it’s a good idea to build safety measures in case challenges arise. For example, if a product needs to be kept frozen, set the temperature nearer to the lower range or allow for extra transit time to any trip in case of a delay. This may mean you will spend more on cooling or have longer delivery times, but rather small, manageable costs than the loss of an entire load.

Know your products

Each product is different which means you cannot take a blanket approach to transporting temperature-sensitive pharmaceutical products. Before taking on a shipment, make sure you know the product's requirements for packaging, temperature, time to market, and even what types of transportation are ideal (refrigerated truck, shipping container, air freight, etc.). The better you understand your product, the more equipped you will be to transport it.

With these cold chain management best practices in mind and the various regulations to follow, you are well on your way to delivering temperature-sensitive pharmaceutical products safely.

How Varcode can help

Varcode provides the best cold chain wireless temperature monitoring solutions for pharmaceuticals and beyond. With Varcode’s Smart Data Solution (VSDS™) you get access to a range of intelligent tools including Smart Tags, Scanning Suite, and Management Suite. This solution gives you the data you need to take full control of your pharmaceutical cold chain monitoring and deliver on your pharmaceutical KPIs. You can get rich data about your products’ temperature throughout the cold chain journey in a beautiful, digital dashboard. Check out Varcode today to ensure that you are in the driver's seat when it comes to cold chain supply pharmaceuticals.