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by Rob Fusco AL


Proper Monitoring of Refrigerators and Freezers to Protect Valuable Biomedical Inventory


Understanding cold storage best practices can help laboratory managers ensure that their medical inventory is in compliance and that they have the documentation to prove it. Guidelines on proper cold chain management for immunobiologics are provided by the Centers for Disease Control and Prevention (CDC).1


The cold chain (see Figure 1) illustrates the importance


of keeping vaccines and other pharmaceuticals at a consistently cold tem- perature—from manufacturing through distribution and storage to end use. Proper storage of pharmaceuticals before they reach the consumer is critical, because any loss of potency during this period may influence safety and efficacy2


and compromise research results.


High and extreme low temperatures are factors that most often cause degradation. For example, a vaccine can survive higher temperatures for a short period of time and still be deemed safe, but its lifespan may be shortened. Refrigerated vaccines are more susceptible to damage


when temperatures dip below freezing. Refrigerators need to be care- fully monitored to ensure the samples are kept in appropriate and auditable environmental conditions. The storage environment needs to be temperature-mapped with relevant controls in place to avoid temperature extremes.


Although The Joint Commission, an independent, not-for-profit organiza- tion that accredits and certifies nearly 21,000 healthcare organizations and programs in the United States, does not specifically require temperature logs for freezers and refrigerators, it does stipulate that medication be stored according to the manufacturer’s recommendations and that facili- ties maintain and monitor equipment performance.3


Facilities must track


temperatures on a regular basis and note deviations from the required ranges for all stored drugs. A process must be implemented for disposing of medication that no longer meets the recommended temperature ranges.


According to the CDC’s Vaccine Storage and Handling Toolkit,4 thermom-


eters used to monitor vaccine temperature should be: • Digital if a remote monitoring system with a sensor is not being used


• Equipped with a remote probe and suitable for the temperature range of the application


• Submerged in glycol or glass beads • Calibrated with a Certificate of Traceability • Calibrated by an accredited laboratory.


Moreover, thermometers should be accurate to ±1 °F and include an external alarm system with a min/max display and reset button.


Refrigerators and freezers overview The CDC recommends standalone units that either refrigerate or freeze.


All drawers should be removable; units should stabilize temperature with water bottles and frozen coolant packs, and it should not be possible to unplug the units. Full-size and under-the-counter pharmaceutical-grade refrigerators are ideal. Dorm-style or bar-style units are not recommended for primary or temporary storage.


Figure 1 – Cold chain flow chart. AMERICAN LABORATORY 14


These three simple steps can protect vaccine supplies from temperature- related problems. They should be followed to correctly monitor all aspects of a cooling unit, whether it is an ultralow standard freezer or refrigeration unit. First, identify if the cooling unit is configured with a built-in alarm


JANUARY/FEBRUARY 2017


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