Keeping Clinical Samples Cold

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 Keeping Clinical Samples Cold

An expert-led tour of questions to consider and features to expect

A wide range of clinical samples must be kept cold. The type of sample, though, determines the best method of cold storage. Here, an expert walks readers through the steps that lead to the best purchase.

According to Alex Esmon—senior product manager, cold storage, at Thermo Fisher Scientific (Waltham, MA)—the most important question that a lab manager should ask when purchasing cold storage for clinical applications is: What are the storage requirements for the items being stored? For example, a clinical facility might need to store vaccines, patient medications, nourishment, and so on. “If you start there and follow the recommendations of the guidance bodies, such as the U.S. Centers  for Disease Control and Prevention or the World Health Organization, the rest will fall in line,” he says. “A follow-up question might be: Are there  any considerations for accreditation and qualification audits, by bodies such as the Joint Commission on Accreditation of Healthcare Organizations or the College of American Pathologists?”

Once a lab manager collects the requirements for a specific cold-storage unit, the next step is making sure that the solution keeps samples as safe as necessary. “This may include the purchase of extra cold-storage units, an independent monitoring system, back-up generators, and/or other facility considerations,” Esmon explains. “An independent monitoring system is an important piece of the quality management system.”

Getting specific

Beyond the general considerations, a lab manager needs to get specific about particular needs. Esmon provides a helpful list:

  • How much storage space do you need?
  • Are there physical or dimensional constraints that will limit the size of product that you can purchase and move through the facility?
  • What is the desired operating temperature or temperature range?
  • Will the instrument need to be qualified before it is released for use?
  • If qualification is required, what are the acceptance limits (e.g., ± 10 °C)?
  • Do you have existing protocols for testing or will you require help or assistance to create them?
  • How will the contents be managed?
  • What is the use case and frequency of access to the product? For example, how many door openings will you experience per day?
  • Do you use a system-wide independent monitoring system?
  • Have you considered HVAC needs to ensure airflow and humidity management?
  • Do you have voltage-specific requirements?
  • Do you have a service support system in place?

That’s a sizable list, but one worth considering. “Taking the time up front to help clearly define your application and understand the specific requirements is an essential step in providing the right solution for your needs,” Esmon notes.

Features worth finding

Improving the safety of samples also comes with some benefits to lab personnel. “The clinical space can be a noisy and cramped place to try and work,” as Esmon points out. “Recent advances in refrigeration technology enable clinicians to have the option for products that are much quieter than the previous generation, use much less energy, and put out less heat into the ambient environment.” As a result, clinical lab personnel working around cold-storage units gain a more pleasant experience. The workspace is more comfortable in many ways—just from putting in modern cold-storage units.

Advances in technology also provide other options for a lab manager to consider. For example, Esmon mentions that “new technologies and advances in solid-state cooling mean that units can have increased storage capacities in the same footprint as older technologies.”

ImageScientists and clinicians use cold-storage devices for many kinds of clinical samples, as well as medications. (Image courtesy of Thermo Fisher Scientific.)

For example, the Thermo Scientific −80 Benchtop Freezer provides 28 liters of capacity in a footprint that is just 640 × 781 millimeters—roughly the footprint taken up by about half a dozen shoeboxes. That unit includes industrial-grade hermetically sealed refrigeration compressors and 102-millimeter thick foamed-in-place insulation.

LABRepCo (Horsham, PA) makes benchtop and portable options. As stated in product literature: “From their integrated alarms and locks and rugged construction, to simple operation and effortless maintenance, these portable freezers are ideal for everyday lab use or field transporting within the research, pharmaceutical, clinical and lab animal sciences areas, as well as any other time and temperature sensitive applications.”

Meandering around the market

Even when considering only cold storage for clinical applications, many options exist. For example, Helmer Scientific (Noblesville, IN) makes a range of blood-bank refrigerators. Some of them fit under a counter and others stand upright, including various numbers of doors and even a pass-through option.

Sometimes, a small system is not what an application requires. When a clinical facility calls for lots of cold storage, cold-room units from U.K.-based CRS Pharma Solutions might be just the answer. According to the company, it “offers a range of modular cold room cold storage units that are ideal for use in the pharmaceutical industry.” For some applications, modularity is the key, which allows a company to create the space that it needs for cold storage. So, CRS makes its units in various shapes and sizes. In addition, the temperature can be controlled in steps of ±0.05 °C across a range of−40 to +60 °C. Beyond the range of size options, units from CRS offer time-sensitive solutions, as well. The company points out that its units can quickly “be delivered and installed on site.”

With room-size cold storage, care needs to be taken to ensure uniform temperature. For that, CRS uses forced-air circulation. That provides a consistent environment, one that has been used to store vaccines, diagnostic kits, and more since 1996. Part of the confidence in these cold rooms comes from the use of redundant systems that provide backup when needed.

Keep it in order

The range of cold-storage options for clinical applications gives a lab manager opportunities and challenges. It’s not a simple task to select the best solution, but Esmon’s lists and suggestions provide a good place to start. After that, a lab manager needs to focus on the features that make the biggest impact on the application at hand.

In thinking about how this technology has changed, Esmon says, “The result of these advances in cold-storage products delivers an improved experience and interaction with refrigeration equipment.” He adds, “Make sure you are investigating these advances in refrigeration as you are making your buying decisions.” Only then can a lab manager know what to look for to fill a specific cold-storage need.

Mike May is a freelance writer and editor living in Texas. He can be reached at [email protected]

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