Local Planning Efforts for COVID-19 Vaccine Distribution

In our last blog post, we pointed out some of the daunting challenges associated with “Operation Warp Speed” (OWS) because certain COVID-19 vaccine candidates will require storage at -80°C, while other doses may need to be frozen from -40°C to -20°C. Perhaps the most significant OWS obstacle now falls to local/regional COVID preparedness teams to plan for vaccine “last mile” distribution and administration. “Last mile” is a general term used within the cold chain space to indicate the connection from a regional repository to the end patient recipient. The responsibility sits with thousands of local health systems, clinical sites and pharmacies to plan local vaccine inoculation, where the side task of now needing to maintain the ultra-low temperature (ULT) cold chain may be the most difficult aspect of guaranteeing safe and effective doses. That is because most local facilities, processes and organizations providing vaccines for patients around the world have never had to prepare for a task of this magnitude, let alone at this temperature range!

Last Mile Vaccine Cold Storage Challenges
This lack of local preparedness is evidenced by the recent list of questions submitted by the National Governors Association to the Trump administration, which focuses on pressing issues related COVID-19 vaccine distribution, administration and cold chain at the regional and municipal level. This letter expresses specific concerns about dry ice shortages and handling issues, as well as the limited availability of ULT storage equipment in health care systems. In fact, health care facilities and pharmacies that will need to store and administer COVID-19 vaccines rarely have access to ULT freezers. Traditional ULTs have tended to be too expensive, bulky and noisy for clinical environments, with most requiring dedicated power supply to remain operative.

Local leaders will also be challenged to get vaccines from central state repositories to remote or immobile communities, such as rural populations, extended care facilities, nursing homes, etc., without breaking the ULT cold chain. Vaccine distribution partnerships with large pharmacy chains or health systems will only work if patients can and will drive to them. Finally, large pharmacy chains are not consistently available across all geographies and one size may not fit all.

Cold Storage Solutions for Local COVID Preparedness
To maintain vaccine efficacy, health care facilities and pharmacies have the option of deploying ULT freezers designed for remote and portable use in limited spaces. Stirling Ultracold’s ULT25NEU portable freezer and SU105UE undercounter model are ideal for local vaccine administrators who will suddenly find themselves needing remote and on-site ultra-low storage of frozen vaccine doses. These compact, lightweight units deliver the same performance and reliability as full-size ULTs and can be easily moved throughout clinical sites and plugged into any outlet worldwide, avoiding the need for building rewiring or HVAC modifications.

Depending on which vaccine candidates release, cold storage requirements of -20°C to -80°C must be available, and Stirling Ultracold freezers are the ONLY units available to cover that range and will help local leaders cover their bases.

Stirling ULT freezers are also available with SenseAnywhere remote cloud-based monitoring for these critical vaccine doses. With precise temperature setpoint control and the ability to log vaccine temperatures, point-of-care facilities and pharmacies can also maintain a reliable audit trail on site.

With the limited availability, life span and temperature control of dry ice cooling, portable and compact ULT storage will become a critical linchpin for local delivery of safe and effective vaccines to the public.

A Local Health System Leading the Way
The North Dakota Department of Health recently took notice of the unique temperature range and compact ULT models offered by Stirling Ultracold as they finalized their COVID preparedness programs. They’ve since decided to purchase multiple ULT25NEU portable freezers to distribute these vaccines from their central warehouses within their population. The ULT25NEU portable units are capable of transporting smaller batches of vaccines to local clinics and storing them for multi-dose waves. All the while, these ULT freezers hold doses at optimal temperatures until the vaccine is ready to be administered. With this last mile solution, North Dakota DOH now has the potential to become the model for many other more-remote communities across the United States.

Learn how to lead the way in COVID preparedness for your area. C-19_Vaccination-Administration_Local-Planning-Guide_Stirling_Ultracold

Three Cold Chain Obstacles to Rapid COVID-19 Vaccine Distribution

By Dusty Tenney, CEOAs of this blog posting, more than 30 COVID-19 vaccine candidates are in development worldwide in a historic pandemic response. In the United States alone, the “Operation Warp Speed” (OWS) collaboration driven by the federal government and 18 biopharmaceutical companies, intends to deliver 300 million vaccine doses by early 2021.

Standing in their way is this stark reality: more than 50% of vaccines may be wasted every year because of temperature control, logistics and shipment-related issues, according to the World Health Organization.

Given the urgent global need for a COVID-19 vaccine, manufacturers, third-party logistics (3PL) providers and distribution centers must overcome three significant challenges that could threaten rapid vaccine deployment and availability. Our recent white paper, Meeting the Challenges of Rapid COVID-19 Vaccine Cold Chain Deployment on an Unprecedented Scale, explains in detail how 3PL and pharma distribution organizations must ramp up ultra-low temperature (ULT) cold chain capacity in order to safely store and deliver vaccines. Here are key points and insights from the white paper that can help meet the cold chain requirements of accelerated vaccine deployment.

Obstacle: The approved storage temperatures for the different COVID-19 vaccines are still somewhat unknown.

Certain COVID-19 vaccine candidates will require -80°C storage, while others may allow for warmer frozen storage ranging from -40°C to -20°C. How will your organization ensure it’s prepared to meet the storage requirements of any one of the viable vaccine candidates?

Solution
Expand capacity throughout the cold chain with ULT freezers designed to provide the widest temperature range. Stirling Ultracold offers the ONLY commercially available freezer models that can safely maintain temperature setpoints from -86°C to -20°C. These units meet the cold storage efficacy requirements of the majority of COVID-19 vaccine candidates, regardless of which are ultimately approved.

 

Obstacle: Few distribution facilities are designed for high-volume ULT vaccine storage.

Quick answers are needed to questions about the heat ULTs generate, how to fit them into limited floor space, as well as their power demands and potentially high energy costs. How will warehouses and distribution centers overcome these facility infrastructural obstacles when ramping up ULT freezer capacity for high-volume COVID-19 vaccine storage?

Solution
Increase ULT storage capacity with freezers that require less space, energy and infrastructure to operate over a wider range of ambient conditions and voltages. ENERGY STAR®-certified units can significantly reduce electricity usage and costs as well as the associated heat output and operating carbon footprint. Stirling ULT freezers produce less heat than standard compressor-based models and operate reliably in warmer conditions. This reduces the HVAC load and enables your organization to avoid expensive and time-consuming modifications to existing facilities. Other infrastructural obstacles can be eliminated globally by choosing Stirling ULT technology, which uses 110V-240V universal power to operate anywhere in the world without electrical modifications.

 

Obstacle: The vaccine cold chain must be unbroken throughout on-site storage, bulk loading and transportation.

Before COVID-19 vaccine doses can be administered to billions of patients, they must be transported and safely stored along the journeys from manufacturing facilities to 3PLs, distribution centers and health systems throughout the world. How will your organization maintain ultra-low temperatures along the entire way, from end-to-end?

Solution
Combine active and passive cooling technologies to ensure vaccine efficacy and eliminate cold chain gaps in transit. Active cooling technologies include stationary ULT freezers and shipping containers with built-in refrigeration powered by plug-in and/or battery backups. Passive cooling options include dry ice, vacuum-insulated panels (VIPs) and containers using phase-change materials (PCMs) that must be “charged” via active cooling prior to transport.

Temperature trackers or monitoring devices can be used with cloud-based monitoring platforms to enable a continuous cold chain of custody through all stages of the vaccine distribution process. Likewise, Stirling Ultracold freezers can be easily enabled for connectivity, monitoring and integration with existing BMS/BAS platforms.

 

Are you prepared to keep frozen COVID-19 vaccines safe and effective?

Scaling up cold chain deployment to manufacture and distribute COVID-19 vaccine doses is daunting. Nonetheless, vaccine manufacturers, 3PLs and distribution centers can prepare now before vaccine candidates are fully approved. ULT freezers are available that can enable your organization to avoid risking vaccine efficacy while also minimizing the infrastructural and financial challenges that lie ahead.

Download our complete Vaccine Cold Chain White Paper

VWR Recognizes Stirling as 2017 Supplier of the Year for Equipment, Instruments, and Chromatography

It’s been less than a year since announcing our new distribution agreement with VWR, the leading global independent provider of product and service solutions to laboratory and production customers. That’s why we were so honored to recently receive VWR’s coveted Supplier of the Year Award for Equipment, Instruments, and Chromatography. Being recognized among so many well-regarded suppliers at VWR’s recent 2018 Americas Sales Conference demonstrates just how successful this great relationship has become in a short time!

These VWR awards recognize supplier accomplishments and excellence in operations, sales support and customer service. “Throughout the year, our suppliers collaborate with our Sales organization to ensure we provide innovative and customized solutions to meet our customers’ needs,” said Mark McLoughlin, EVP, Americas for VWR, part of Avantor. “We are very pleased to recognize Stirling Ultracold for the products and service they provide to our customers.”

Read our Press Release Announcement >>

Our Undercounter ULT Freezer: Convenient, Compliant Personal Storage

When you don’t have enough room for a full-size ULT freezer in your lab or clinical space, Stirling Ultracold offers a smaller version of our upright freezer with the same award-winning Stirling engine technology: our SU105UE (105) undercounter ULT freezer. The 105 is a personal and lockable ULT freezer that is ideal for placing under or near your bench in the lab. This stackable model uses the revolutionary free-piston Stirling engine technology found in our SU780XLE Upright Freezer, offering a highly reliable ULT storage solution with only two moving parts, no oil and no compressors. We’ve packed convenience and reliability into one ULT freezer.

Undercounter Convenience and Space Savings- The light-weight (220 lbs./99 kg) SU105UE model is the right size for positioning under your workbench or nearby, with a surprising amount of storage space. It holds 72 two-inch boxes, making the most of its compact footprint. The quiet Stirling engine puts out much less heat than compressor-based models, providing a mixture of convenience and comfort to your work space. These benefits paired with quick and easy access allow you more time to focus on your research.

Stackable Flexibility- The SU105UE is stackable with full access to samples in an over / under configuration. This is particularly useful for placing ULT storage in labs with limited floor space, and for “staging” sample temperatures. With the widest temperature range in its class, the 105 can store biological materials from -86˚C up to -20˚C. This is ideal for clinical samples and biological drugs that must be warmed to a specific temperature in stages.

 

A “Temperature Stack” Case Study –

One example of the SU105UE’s stackable flexibility can be found at a research lab in Western Pennsylvania, where the team is taking advantage of the 105’s stackability, as well as its uniquely wide temperature range. This lab is working with a biologic drug that must be transitioned from  -80˚C to room temperature in two stages. With the range of -86˚C up to -20˚C, one of the freezers in the stack is used for the intermediate stage of the transition. Placing 105s in a stack offers a unique level of convenience and space-savings in this situation, with the flexibility to use the same freezer model at dissimilar temperatures ranges. This research team has seen improved efficiency and accuracy in the transition of these biologic materials to room temperature, while conserving precious floor space in their lab.

Secure Personalized Storage – The SU105UE model is the perfect size for personalized ULT storage. It gives you the freedom and control to organize your samples in a way that makes the most sense to you and your research. The 105 is also lockable to keep samples secure. Having a smaller lockable chamber is ideal for clinical use, where HIPAA patient privacy and access compliance standards are involved.

All the Advantages of Stirling Engine Technology – Like all of Stirling Ultracold freezers, the SU105UE can plug into any outlet worldwide, including 120V – 240V 50/60 hz. Consuming less than 4 kWh/day at -80°C, it saves energy and is environmentally friendly with 100% natural refrigerants. Because the 105’s advanced Stirling engine cooling system is inherently reliable, it comes with an industry-leading warranty that includes 7 years engine protection, with 2 years and labor cover parts coverage in the U.S. and Canada.

The SU105UE provides the perfect blend of safety, security and flexibility for your lab which will allow you to be more productive than ever.

ULT Technology That Advances Both Energy-Efficiency and System Reliability

Perhaps you’re aware of the free-piston Stirling engine that allows Stirling Ultracold ultra-low temperature (ULT) freezers to use less than a third the energy of legacy, compressor-based models. You may also know that this enabling technology, not only saves energy and associated operating costs, but uses 100% natural refrigerants that substantially reduce ozone-depleting and greenhouse gas emissions. However, you may not realize that the Stirling engine also advances the safety of biological samples with its inherent reliability advantages.

From the outset, Stirling Ultracold has believed that sustainable, energy-efficient ULT technology would present a very compelling choice for the research community, and we are pleased to see the recent efforts of some compressor-based ULT manufacturers to improve the efficiency of their cascade technologies.

However, it should be noted that energy efficiency was never our sole reason for bringing Stirling engine technology to laboratory cold storage. Improvements in ULT efficiency and sustainability, while important on their own merits, should always support or enhance the reliability of cooling systems that preserve valuable samples for research. The inherent reliability of the Stirling engine, while less understood, is vitally needed in our industry to further the safe preservation of biological specimens.

This innovation delivers several reliability advantages that address well-known failures associated with aging technologies used in most ULT freezers. To understand this, let’s first look at the basic differences between cascade-compressor and Stirling engine systems . . .

Unlike “cascade systems” with two compressors and cooling loops in a cascading arrangement, the Stirling engine uses a single reciprocating piston and a continuous, gravity driven thermosiphon to cool the cabinet interior. In contrast to standard cascade systems that regulate temperatures by switching compressors on and off, the Stirling engine’s linear motor system continuously modulates and adapts by controlling the motion of the free piston.

How Does the Stirling Engine Improve ULT System Reliability?
Below are several key design attributes and innovations that extend the operating life of the Stirling engine and address the common reasons why conventional ULT systems fail . . .

  • The advanced integral linear motor system has only two moving parts.
  • The moving parts never wear because gas bearings eliminate physical contact (friction) during motion
  • There is no oil to clog up the system or lubrication levels to maintain.
  • There are no valves to fail or maintain
  • 100% adaptive, continuous modulation regulates temperatures without stop-start cycles.
  • Electromechanical stress and amperage peaks from on-off surge currents have been eliminated.
  • Minimal preventive maintenance is required for reliable cooling operation.

If you would like a more in-depth understanding of how advanced ULT technology can reduce your energy consumption, while also improving reliability and sample safety, talk to your Stirling Ultracold representative or contact us at sales@stirlingultracold.com.