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Demystifying Medical-Grade Cold Storage: Part 1

Posted on Feb 13, 2024 by Brandon Russell

Pharmacy Cold Storage from Helmer Scientific

Many terms are used to designate and market cold storage equipment in the medical space. Phrases such as purpose-built, medical-grade, and CDC-compliant are often attached to equipment to position it as appropriate for clinical use. 

But what does it all actually mean, and how can you determine if a refrigerator or freezer is truly up to the task of storing critical medication, vaccines, and other temperature-sensitive materials in the clinical setting? 

In this three-part blog, we’ll discuss what performance standards, product features, and certifications decision makers can look for when choosing new or replacement refrigerators and freezers for their facilities. 

Let’s first dive into what performance metrics and quality standards can give you peace of mind and confidence that you’re making the right decision for your facility. 

Key Indicators of Performance and Quality 

A refrigerator or a freezer should get cold and stay cold, the end. It seems simple, doesn’t it?

However, unlike the milk or produce in your home refrigerator, temperature-sensitive materials must be stored at much tighter temperature bands and exposed to fewer fluctuations and deviations in temperature to maintain viability. 

Medical-grade equipment should be able to reach and maintain appropriate storage temperatures based on application. For refrigerated vaccines and medications, the temperature band is generally between 2°C and 8°C. For frozen vaccines and medications, the temperature band is between -35°C and -15°C depending on the material. 

There are a few data points you can ask for to determine if a refrigerator or freezer meets your application need: 

  • Temperature Uniformity: Does the refrigerator or freezer reach and maintain a uniform temperature throughout the cabinet? Has the manufacturer completed and provided temperature mapping studies to validate units do not have hot or cold spots that put your inventory at risk? 
  • Temperature Stability: Does the refrigerator or freezer limit temperature deviations from the setpoint, avoiding rapid and significant changes in temperature? Can the manufacturer validate its claims? 
  • Temperature Recovery: Refrigerators and freezers are accessed much more frequently than standard units. This requires the units to recover quickly and safely to the unit’s setpoint after the unit is accessed. Manufacturers should be able to provide you with data that shows how quickly a unit recovers to setpoint after a quick door opening, say 10 seconds to access inventory, and longer door openings, up to 3 minutes or so, which is not uncommon during loading and inventory activities. 
  • Accelerated Life Testing: Medical-grade equipment is an investment, and it’s one worth making. When you make an investment, whether it’s one unit or an entire new fleet, you expect it to last. While warranties are one thing, it’s smart to ask manufacturers what accelerated life testing has been done to the units to ensure they will continue to perform as intended after 1, 3, or even 10 years of service. And, as with the points above, ask for the data. Manufacturers who have invested the time and resources into this type of quality and reliability effort should be happy to share it with you. 
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There is a trend in all the recommendations listed above: data. Validated, verifiable data to substantiate performance and reliability claims should be readily available for equipment used in precision applications. This is especially true when it comes to storing such sensitive materials as medication and vaccines. 

Helmer Scientific has an in-house research and development team dedicated to providing world-class medical-grade cold storage. If you’d like to learn more about the performance specifications of Helmer equipment and see the data behind it, check out our website. 

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Brandon Russell

Written by Brandon Russell

Brandon Russell is a senior marketing manager, covering the vaccine and pharmacy segments. He has more than five years of marketing experience.

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