Having reliable cold storage capabilities are critical for clinical labs to store samples safely and with confidence.
By Wilfredo Marin
Clinical diagnostic samples are precious, irreplaceable cargo. Cold storage is key to keeping them safe and viable, enabling end users to save lives and make medical breakthroughs. Deviation from required conditions, whether it be from poor management or equipment failure, would put these invaluable specimens at risk.
The following are general considerations lab managers and administrators should keep in mind when buying the equipment that protects their precious samples.
Energy Use and Environmental Sustainability
Cold storage units are a necessity, but they can use up a lot of energy and may use refrigerants that can harm our surroundings. This means cold storage can negatively impact both the environment and the organization’s bottom line. Choose a partner that participates in global programs focused on efficiency and sustainability of lab products, such as the ACT Environmental Impact Factor Label program. The program provides a virtual label that gives each product an environmental impact score based on its manufacturing practices, energy and water use, and end-of-life disposal. A cold storage partner should also support objectives of the U.S. Environmental Protection Agency’s Significant New Alternatives Policy, the European Union’s F-Gas compliance, and other worldwide standards.
In the real world, clinical personnel are in and out of cold storage units multiple times per day to grab what they need from inside—which could cause temperature fluctuations and jeopardize the remaining samples. To prevent sample damage, cold storage units may lock users out until they’ve stabilized back to a safe temperature. However, long recovery times are frustrating and can put important work on hold. A cold storage unit’s recovery time should be a main consideration for any lab manager choosing new equipment.
Cold Storage User Accessibility
Like any industry, clinical labs experience employee turnover. One recent study[i] found the median three-year average turnover rate for clinical lab staff was 16.2%. When an employee leaves, the institutional knowledge they’ve accumulated may also leave with them. That can leave remaining workers scrambling to decode how to properly use the cold storage their samples depend on. When choosing cold storage equipment, administrators should look at ease of use so there’s less of a disruption if a primary user finds a new job elsewhere.
Cold Storage Warning Systems and Remote Monitoring
Deviations in cold storage conditions can be devastating, so the sooner any fluctuation is identified, the better. In-lab warning systems and remote monitoring capabilities can give everyone peace of mind that their samples are safe and secure. Simple warnings visible from a distance, like green and red lights on the outside of the unit, can alert even non-technical users to a potential problem. And remote monitoring can give users a range of data on everything from temperature and energy consumption to door access and predictive failure analytics—even when they are off site. The equipment can continuously tell users their samples are safe.
How the Equipment Will Be Used now—and in the Future
Lab personnel needs change and evolve over time, so cold storage equipment purchases must be made with an eye to the future. A bad purchase typically stems from not considering the intended use of the unit for its lifespan. Too-empty freezers can become messy and disorganized, but freezer overcrowding can also be a problem when accessing samples. A good partner will not only ensure the cold storage equipment runs as it should and meets regulatory requirements but will also learn about your current needs and how you can scale for increased volume. The right partner will be there through all stages of the lab’s growth, making sure samples are organized and accessible at any stage or capacity.
Choosing the Right Cold Storage for the Job
Choosing the equipment that keeps samples safe, therefore, is critical. Below is an overview of the cold storage requirements and best practices for specific diagnostic samples, such as blood, tissue, and cells.
Cold Storage Origins: Blood Banks
The first “blood depot”[ii] —the precursor to modern blood banks—dates back to 1917, when soldiers stored blood using sawdust and ice during World War I. Over the past 100+ years, the technology used to preserve whole blood, platelets and plasma has evolved into the modern refrigerators of today, which can maintain consistent, reliable temperatures for days or months. The American Red Cross estimates[iii] 13.6 million units of whole blood and red blood cells are collected each year, but volumes vary. When selecting cold storage solutions for blood samples, administrators should consider variable volumes and also transportability, in case their supply be needed in an emergency or a national disaster. They should choose equipment that can ensure the traceability of every sample and meet standards set by organizations like AABB, the American National Red Cross and the Food and Drug Administration.
Biobanks and Biorepositories
Biobanks store a variety of specimens, everything from biofluids and human tissue to fungi, seeds, and viruses. Each sample type has different required storage conditions and requires a range of cold storage equipment. Some need refrigeration, while others need the ultra-low temperature freezer at -80°C or even cryogenic storage. Biobanks need to choose equipment that can guarantee sample integrity at any temperature. International standards, like the ISO20387 biobank standard[iv], ensure quality control requirements for biological material and data collection. Accommodating sample volume and overall increased demand of biobank capacity—driven by the development of regenerative medicine that could treat conditions like cancer or Alzheimer’s disease—are other considerations biobanks must consider when selecting a storage partner.
Cold Storage for Cell and Gene Therapy Applications
The samples modified using cell and gene therapy technologies can deliver life-saving results once delivered to the patients who need them. And the work done in these labs is growing in demand: researchers expect the industry will grow[v] 30% between 2019 and 2025. But tackling diseases through cell and gene therapy isn’t possible without reliable cold storage of the samples these cures are built from. This is a highly regulated environment, and cold storage equipment that provides enhanced data traceability to support audit requirements, 21 CFR part 11 compliance and GMP needs, will become critical as the industry grows.
Regardless of the setting or sample type, it’s clear that cold storage is integral to the safety of specimens. Investing in the right equipment should not be taken lightly. There’s a lot to consider when choosing an equipment partner.
Capacity to Innovate
Though cold storage techniques may seem passive, there is always room for equipment to evolve and meet the needs of the end users and changing regulations. A good cold storage equipment partner listens to the frontline users and works to improve their experience. They will also keep an ear to the ground for upcoming regulations, so they can stay ahead of any changes and influence them before they’re set in stone. In other words, the right partner will be customer-led and science-focused.
Whether it’s storing blood, tissue, materials for gene therapy or anything in between, all clinical lab personnel deserve to have confidence in how their clinical diagnostic samples are stored. Keeping all of these considerations when choosing your cold storage partner can make all the difference.
About the Author
Wilfredo Marin, MS, is a senior product application specialist with Thermo Fisher Scientific, where he provides biobanking and cryopreservation expertise to colleagues and customers. Marin has innovative workflow solutions that utilize high-quality biospecimens at the highest levels of investigation. During his previous 15 years in academic research laboratories, he has contributed to projects investigating sleep neuroanatomy, genome editing in animal models, cancer stem cells, and managing a pediatric rare-disease biobank. He’s authored several publications and has volunteered for several biobanking committees and presentations for the organization’s annual meetings.
[i] “Laboratory Staff Turnover: A College Of American Pathologists Q-Probes Study of 23 Clinical Laboratories” https://pubmed.ncbi.nlm.nih.gov/31313958/
[ii] “The Blood Depot” Proto Magazine, https://protomag.com/technology/blood-depot/
[iii] “Importance of the blood supply” American Red Cross https://www.redcrossblood.org/donate-blood/how-to-donate/how-blood-donations-help/blood-needs-blood-supply.html
[iv] “ISO 20387: 2018 Biotechnology — Biobanking — General Requirements for Biobanking” https://www.iso.org/standard/67888.html
[v] “The Rise Of Gene & Cell Therapy And The Resulting Need For In-House Production Facilities: A Guide” Cell & Gene, https://www.cellandgene.com/doc/the-rise-of-gene-cell-therapy-and-the-resulting-need-for-in-house-production-facilities-a-guide-0001