Cold Chains can Save Lives

The launch of the COVID-19 vaccination campaign in December 2020 led to great relief around the world and was greeted with hope after the virus had affected almost all aspects of life for most of the year. While public discourse focused on the lack of production capacity, another major challenge came into play: the safe transport and storage of vaccines at very low temperatures. Unfortunately, this issue is still highly topical in 2022. The summer wave combined with the extreme heat and an upcoming fourth vaccination in autumn continue to require increased vigilance and reliable refrigerated transport.

Despite the adverse conditions, Trane Technologies, with its strategic Thermo King® brand, and Danfoss have joined forces to play a critical role in maintaining the cold chain and delivering life-saving vaccines. Thermo King has long been a global leader in refrigerated transport and storage of food, medicines and other sensitive, perishable goods. This often involves the use of the powerful, adaptable SuperFreezer solution, which has been co-designed and built with Danfoss since 1996 to achieve ultra-low temperatures and optimal preservation.

The SuperFreezer is typically used for sea transport of sushi-grade tuna, but also for biopharmaceutical products such as blood plasma and other pharmaceutical agents, as well as biological samples. It ensures consistent temperature control, prevention of microbial decay and efficient storage and transport – even under challenging conditions such as high ambient temperatures, frequent door openings or long operating times.

The SuperFreezer is a cascade system with two refrigeration circuits, each with its own compressor, refrigerant and inline components, both controlled by a common advanced controller. Each SuperFreezer unit relies on Danfoss inline components such as expansion valves, solenoid valves, regulators, dehydrators, sight glasses, pressure switches, contractors, etc. to ensure smooth and reliable operation of the refrigerant and to maintain the correct cryogenic temperature.

The COVID-19 mRNA vaccines, with their unique ultra-cold temperature specifications – down to -70 degrees Celsius – are ideal for the SuperFreezer. However, the equipment had to be slightly modified to reach and maintain the extremely cold temperatures. Danfoss components played a crucial role in this process.

Many rural hospitals, doctors’ surgeries or clinics do not have access to suitable temperature-controlled storage facilities. Rural regions often do not have a suitable infrastructure to ensure the required cold chain. The situation is also particularly critical in third world countries, where vaccination rates are still far too low, even one and a half years after the first vaccines were approved.

To reduce the spoilage of life-saving vaccines, active refrigeration like the Thermo King SuperFreezer is the ideal solution. “To meet the demands of shipping and storing vaccines worldwide, we had to customise the units and produce them quickly,” says Francesco Incalza, president of Thermo King EMEA at Trane Technologies. “This meant we had to source additional components supplied by Danfoss in an extremely short time.”

Danfoss received its first component order from Thermo King in late 2020, and production was immediately up and running. As the components are manufactured in several factories around the world – in Denmark, Poland, China, Mexico and India – each factory had to follow the same strict production schedule to meet the demand for the SuperFreezer.

“The entire supply chain had to be accelerated,” said Carlos Zamudio, senior director of global accounts at Danfoss. “Instead of a normal eight-week process, production became a three- to four-week process,” Zamudio said. “The entire supply chain worked together to produce the parts needed for the SuperFreezer. All Danfoss factories worked together to supply Thermo King and subcontractors with parts.”

Initially, the factories had to source sufficient raw materials, which was a challenge due to shortages in the market. “We were able to leverage our relationships with our suppliers,” says Jason Pederson, Global Key Account Manager at Danfoss. “We made sure we had enough manpower to complete production. When total customer demand exceeded our production capacity by 25%, we prioritised the products we made for the SuperFreezers.”

“We were able to respond quickly,” says Zamudio. “Everyone understood the importance of what we were doing. Thermo King relied on us to deliver the components on time. Throughout the supply chain, many companies worked together to ensure the vaccines could be delivered and stored.”

“It was critical that there were no delays in production or shipping,” Incalza stressed. “The support of Danfoss was instrumental in ensuring that we were able to transport this critical cargo through all the countries in Europe and to many remote locations around the world. The fact that we were able to respond quickly and efficiently to a crisis of this magnitude is a testament to the strength of partnerships like this.”

After all components were airlifted to Thermo King, the SuperFreezers were quickly assembled and ready for their life-saving cargo – becoming a vital part of the first mass immunisation and pop-up clinics. Due to the urgency, Thermo King transported the parts by air freight from Danfoss’ manufacturing and distribution sites in Europe, North America and Asia Pacific to Thermo King in China.

The last two years have been challenging, but also educational. Thermo King has decades of experience and played a role in safeguarding past vaccines such the one used during the Ebola outbreak in West Africa, and over the past two years has accumulated a wealth of experience that is vital as infections and variant formations continue to rise. The Corona pandemic is unfortunately more topical than ever and society must prepare for further follow-up vaccinations. Here, a fast and safe vaccine distribution must be guaranteed to help overcome this pandemic once and for all.

Vaccine Logistics System with storage in container design

Once an effective COVID19 vaccine is available in the required quantities and is to be delivered to the vaccination centres, a specific logistical task also needs to be addressed: Some vaccines must be transported at a temperature of at least -70C to -80C and stored on site at the vaccination centre. L&R Kältetechnik has developed a safe, flexible and economical concept for this demanding type of deep-freeze storage: a deep-freeze storage system that is installed in an industrial container.

L&R has extensive experience with the deep-freeze storage of sensitive pharmaceutical active ingredients and products. Vaccine serums, blood plasma, stem cells, bone marrow and biomedical materials are among the stored goods that are kept in the walk-in L&R deep-freeze storages at temperatures down to -110°C. Such storage is in use at many pharmaceutical manufacturers – among other reasons also because they are more reliable, efficient and energy-saving than laboratory freezers.

Based on this experience, L&R has now developed a solution with which millions of vaccine doses can be stored at -80C. The basic idea: a storage cell (pictured) -80°C, with a pre-cooling room at -20°C, is installed in an industrial container with corresponding redundant, multi-stage refrigeration technology in order to guarantee a storage option that is suitable for pharmaceuticals.

Two highly efficient refrigeration systems are installed in 20′ or 40′ containers, each of which ensures a permanent temperature level below -70C. The systems are air-cooled, so only one mains connection is required for operation. They have a redundant design so that if one refrigerating circuit fails, the second circuit can automatically take over the cooling. An optional emergency power supply or nitrogen emergency cooling offers an even higher level of safety.

The interior equipment of the cryogenic storage is adapted to user requirements. Pallet storage spaces are possible as well as shelves and/or drawers for different product sizes. Optionally, the interior can be manufactured with a stainless steel floor according to cleanroom standards. The highly effective insulation ensures a low heat transfer coefficient. This increases the temperature holding time and reduces the energy requirement. The deep-freeze containers are optionally supplied with FDA approval for materials in contact with the product. Via the touch panel of the Siemens PLC, the user can control the system comfortably, and visualize the process. Remote maintenance is possible as well as GPS positioning of the container.

In the construction of this deep-freeze storage system, attention was not only paid to maximum safety and high energy efficiency: the worldwide availability of the components also played a role. Burkhard Rüßmann, general manager of L&R Kältetechnik, told us: “When the vaccine production starts, the logistics must be available all the way up to the vaccination centres – not only in Germany. That’s why we have made sure that our production is scalable over a wide range.”

The container design is the basis for the high-quality systems to be set up with very little effort exactly where the vaccination is carried out. And it offers another advantage: Over the rest of their lifetime, the mobile deep-freeze stores can afterwards be used at other locations and for other tasks.

Vaccine Transport Protection

Temperature-controlled transport specialist Thermo King is ready to meet the challenge of storing COVID-19 vaccines, which are likely to require extreme conditions beyond anything previously needed in the industry. Paul Hamblin hears about the plans.

Pharmaceutical companies in final-stage clinical trials for COVID vaccines anticipate they will require strict temperature controls to safeguard their products – indeed, down to temperatures as low as -70 degrees Celsius. That requirement caught a lot of people in the industry off guard, says Jessica Poliner, VP Marine, Rail and Air for Thermo King, by Trane Technologies. “It’s because it’s about maintaining the temperature the vaccines need to be transported and stored at,” she explains from her office in Brussels. “It’s different than more usual vaccines, which are usually kept at 2-8 degrees Celsius. The stability profile of the potential COVID vaccines is much more uncertain, and so that certainly leaves more room for degrading, whether through human error or storage problems. It is maintaining that set point that is essential for the vaccine profile.”

Safe vaccine storage is an area that’s vital to get right, because according to the World Health Organization (WHO), nearly 20 percent of temperature sensitive health care products are damaged during transport, and 25 percent of vaccines reach their destination in a degraded state due to breaks in the cold chain.

Jessica Poliner says that she and her team have spent a lot of time talking to their customers, whether pharma companies, logistics firms, or forwarders, to look at potential solutions for something the whole world is waiting for. It is from these discussions that the temperature requirements became clear. “Everybody’s trying to put together their blueprints of what this will look like. With the Thermo King brand, we have the ability to transport, from road transportation to air cargo. What we’ve added to the mix is a storage solution as well, so that we can offer both transport and storage for vaccines at a very wide range from -70 degrees Celsius to +30 degrees Celsius.”

The requirement for ultra-low temperature isn’t new. “The neat piece with the -70 is that it’s actually a product we’ve used in the marine industry for over 20 years, originally developed to transport a premium grade sashimi tuna along some of the routes from the Mediterranean Sea to Japan and elsewhere. In the past few months we’ve worked to re-purpose that proven product into a solution for vaccine storage at that ultra low temperature of -70 degrees Celsius. So it’s really an exciting time for us to be able to tell a story about a product that we’ve sold a lot of in the past and
have a good experience with, but that’s not in essence being used for that purpose.”

Modifications to it have been relatively minor. “We make a refrigeration system and then put it into the container,” she explains. “We’re recommending a 10 or 20 foot container that has more insulation and some additional safety measures. Obviously if you are going into something at -70 degrees Celsius then safety and PPE are front of mind. But there really isn’t that much difference
to the product itself, which is partly the beauty of it.”

Of course it’s not clear when the solution will be required or in what volume, but Thermo King will be ready to support. “There’s so much uncertainty. Everybody’s been asked to scale, everybody’s been asked to move fast, and there’s still so much uncertainty with when, where and what storage temperature will be needed. Despite a few RFQs out (Request for Quotation), there are still a lot of question marks.”

So her team are having to think on their feet? “The key for us from a manufacturer standpoint is to make sure we have the product available. So, our cold storage product that goes to -70 degrees Celsius can be produced in 10 times the normal volume. That gives you a feel for how quickly we are trying to ramp up our supply.” The alternative used today for ultra-low transport is CO2 in the form of dry ice. This works well when in smaller volumes. “It requires manual intervention and control, so in essence, it’s a band-aid solution. Now volumes of vaccines to be transported and
stored are much higher, and that ‘market’ will look for solutions that are proven and safe, so this is where the Thermo King SuperFreezer makes the difference.”

Deep-freeze Transport and Storage for COVID-19-Vaccine

Germany’s MECOTEC Group has launched a complete–one-stop solution for the deep-freeze, transport, storage and distribution for COVID-19-Vaccines with its first Mobile Hybrid Container. The company claims it is the first hybrid container solution for ultra-cold transport and storage for vaccines.

  • – Transport and storage of up to 1,000,000 vaccination doses in one standard size container at temperatures down to -80°C / -112 °F possible
    – Active deep cooling technology ensures safe and controlled transport and storage without dry ice

Vaccine manufacturers, transport and storage providers are facing major challenges in the fight against the coronavirus, as many of these vaccines only retain their effectiveness at temperatures down to – 80°C / -112 °F according to the current state of science. In addition, very few medical facilities have space to store the vaccine in large quantities at constant minimum temperatures.

The MECOTEC from Germany has now launched a complete-one-stop-solution consisting of:
1. Deep-freeze cooling + 2. Transport + 3. Storage & distribution: Immediately after production, the vaccine is frozen on site in a kind of deep cold storage. The vaccines can then be loaded into a container and safely transported to the distribution station at constant minimum temperatures down to – 80°C/-112°F. On site at the distribution station, the transport container then functions as a storage and distribution center.

MECOTEC has already developed a mobile cold store solution as prototype, an industrial solution with which the vaccine can be frozen directly at the manufacturer’s facility. For this purpose, the cold store system is located near production, the machine container is set up outside the production building. Immediately after production, the vaccine is deeply frozen in the cold store. This cold store solution can be set up anywhere where the vaccine is available for deep cooling.

“The project knowledge that we have gained with the development of the prototype as well as our many years of experience in the field of cooling technology made it possible within a very short time to adapt this deep-freeze facility into a transport, storage and distribution container,“ explains Jan Hüneburg, Managing Director at COOLANT, the industrial division of MECOTEC.

“We are pleased that today we can present our Mobile Hybrid Container Solution for the transport and storage of Covid-19-Vaccines and thus make a contribution to a safe and fast supply of the vaccine for people worldwide,“ says the Managing Director of the MECOTEC Group, Enrico Klauer. “Since our system is based on an active deep freezing technology, it does not require dry ice for cooling which makes it also suitable for safe international air transport.”

The process for transport and storage of the COVID-19-Vaccines at constant minimum temperatures down to – 80°C/-112°F is as follows:
The Vaccine Veils are loaded into the mobile refrigerated container in transport packaging and insulation boxes and then transported to the distribution (vaccination) center while maintaining the deep-freezing temperatures down – 80°C / -112 °F. At the distribution center the veils can be taken out individually. The whole process, including the location and the temperature within the container can be monitored centrally.

The complete solution developed by the MECOTEC Group can be used worldwide. “It is our aim to get the vaccine to the people as soon as possible. Therefore we offer several options: Orders for container production can be placed at MECOTEC directly and at our worldwide sales offices. In addition we also offer licensed production,” says Klauer.

Subscribe

Get notified about New Episodes of our Podcast, New Magazine Issues and stay updated with our Weekly Newsletter.