Let’s face it, the role of laboratory grade refrigeration and freezers isn’t exactly the conversation clinical stakeholders thought they’d be having. In what might seem like an overnight response, those immersed in the clinical space are grasping the significance and urgency of laboratory grade refrigeration and freezers. Due the pandemic, laboratory grade refrigeration is now a trending topic. Much of the spotlight is on ultra-low freezers because of the new COVID-19 vaccine storage requirements.
As clinics, laboratories, hospitals, and pharmacies prepared to deliver COVID-19 vaccines to thousands of people each day, many wondered if they could pull this off logistically. Stakeholders scrambled to figure out up-to-the-minute cold-chain logistics and how to house large quantities of delivered vaccines. Adding to the already difficult situation, they realized the storage requirements for the two COVID-19 vaccine offerings required two vastly different vaccine freezer temperatures for safe keeping: -70°C for Pfizer and -25°C for Moderna.
COVID-19 Forced an Increased Need for Additional Ultra-Low Freezers
The urgent direction from the government to get the vaccine out to as many as possible forced clinical operations to analyze their current cold-storage situation. They needed to implement the set of guidance parameters issued by the CDC to the letter. This translated to a surge in ultra-low freezer acquisitions.
“We ordered them and are waiting for them to come,” said Lisa Polinsky, assistant vice president of pharmacy services for Lifebridge Health, which operates Sinai Hospital in North Baltimore, Northwest Hospital in Randallstown and Carroll Hospital in Westminster. "These types of freezers aren’t something used all that often.”
ULT freezers are uniquely designed to meet the delicate temperature variances required to safely house mRNA-based vaccines. Prior to the onset of coronavirus this level of technology wasn’t common for local pharmacies and smaller clinics.
Ultra-Low Freezers Are Designed for a Unique Purpose
To put it simply, these freezers are built to operate at temperatures ranging from below -40°C. It is designed to house a specific class of biospecimens and biological products that require extremely low temperatures in order to remain viable. It is important to note these ULT freezers house high dollar amount products, making them indispensable. What matters most in a ULT freezer?
It may seem like a no-brainer to expect your high-end purchase to work without any glitches. However, many stakeholders understand that reliability translates to a sample that still has its integrity intact. In laymen’s terms – How do we keep the sample useable over a designated span of time? Moreover, what factors contribute to the overall reliability of any laboratory grade refrigerator/freezer?
The answer is that reliability for any laboratory-grade vaccine freezer is defined by its ability to limit temperature interruptions. This can be as simple as an applied methodology incorporated to maintain the desired temperature, even with constant door opening and closing.
A news report indicates a clinic in Tennessee used an unapproved freezer resulting in the loss of 5,000 doses. This is said to be one of the largest incidences of COVID-19 vaccine spoilage seen this year.
Easy Defrosting System
There isn’t any getting around the need to defrost a ULT due to the fact it draws in humid, moist air into it every single time the door is opened. However, it can at least be a simple process. Much of this is determined in the make and model of your unit as well as its condition.
Most ULT units are housing volatile lifesaving materials. A disruption in temperature could render the vaccines unusable. Unfortunately, power failures do occur. Sometimes, they can just be a minor blip on and off situation, or in other cases several hours and heaven forbid days. Some of the higher end units feature alarms designed to integrate seamlessly with remote temperature monitoring technology.
Consistent temperature monitoring is easy when you have convenient tools to help. Many elite vaccine freezer models have controls on the outside of the unit eliminating the need to open the freezer or refrigerator door. Digital temperature loggers are a requirement in most cases.
Size matters. In smaller clinical settings, a model with a smaller footprint may work best. This is where doing your homework counts. Consider the various samples that need housing. Understand the various temperature requirements and assess the need for capacity based upon that assessment. Most cold-storage retailers will feature models designed to fit under counter, chest size, or even those that meet certain height requirements.
It may get easy to become overwhelmed when comparing models and prices. Many are mistaken in that they assume higher priced models are superior or larger. This is not an accurate assumption. Some of the largest laboratory grade refrigeration and freezer units offer almost 70 cu. Of storage space.
Laboratory managers work on avenues to reduce this cost by choosing models with vacuum insulated walls which allow for more space in the unit and those that have the HFC type refrigerants. Other cost-saving features include units with expanded insulation and variable speed recirculation. The neat thing is that many institutions incentivize laboratories for purchasing qualified energy friendly equipment making it an attractive option.
The Challenges Associated with Ultra-Low Temperature Requirements
Laboratory grade ULT freezers are an essential investment towards public health and safety efforts. It is easy to see how they are going to be a mainstay around the globe. The clinical research community is homing in on the new ability to produce mRNA-based solutions for not only vaccines but many other chronic conditions.
We can expect more of the same type of fragility associated with similarly fashioned biological products that will be in large-scale production in the future. This means that most medical institutions will need to have a plan to house them and require ULT freezers. A PR firm released a statistic indicating the post-covid ultra-freezer purchase surge will total $750M by the year 2031.
This dramatic statistic puts the vaccine freezer need into perspective especially because many of the biological products will have varying temperature requirements. One vaccine product may require temperatures in the -50°C range versus other samples that may require temps at or below -20°C.
On a global scale, it may be difficult for third-world countries and other remote locations to arrange for a solid cold-storage plan. Several factors come into play such as the ability to provide a consistent power source to the cold-storage unit. The vaccines cannot tolerate even the slightest temperature disruption.
“It’s not an unknown logistical issue," said Benjamin, pointing to lack of refrigeration and other infrastructure in developing countries. "Having said that, the big issue is not how to move vaccines across the country by major shippers. It is how to move it from them to pharmacies, retail clinics, doctors' offices, etc., and maintain the ultra-cold environment.”
These are just a few of the many obstacles that will need to be figured out. The coronavirus keeps evolving into more deadly strains and we are already seeing the need for boosters and/or annual covid-19 vaccines for optimizing public safety. Though the task seems daunting to arrange for cold-storage transportation and housing, strategic partnering with large humanitarian outfits such as UNICEF are being forged.
Vaccine Freezer Clinical Applications
Ultra-low freezers are a staple in clinical laboratories, blood banks, biorepositories, and privatized research facilities. As indicated throughout this article, ultra-low freezers are required for storing a variety of biological samples, medicines, and vaccines. They are also used a great deal in the scope of medical procedures to help maintain the integrity of vital organs during implantation or delicate lifesaving surgeries.
Considerations for vaccine freezers differ greatly by industry making the choices somewhat of an individualized nature. The options for purchasing ULT freezers today are exciting due to such rapid expansion in the clinical space towards vaccine development. Many of the cold-storage units sold today are built for expanded functionality and offer units that come equipped with clear glass doors, heavy duty security locking systems, alarms, and enhanced temperature monitoring.
Because of the pandemic, we believe the most critical element relevant to any unit selection boils down to temperature. It is necessary to determine which models meets the vaccine temperature requirements set forth by the FDA and CDC. The team at K2 Scientific offers personalized customer service in addition to competitive pricing. Most importantly, we have a clear understanding of the temperature requirements for both the Pfizer and Moderna COVID-19 vaccine.
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