​What is a Calibration Certificate for Medical Refrigerators and Freezers?

​What is a Calibration Certificate for Medical Refrigerators and Freezers?

Jan 12th 2021

The storage of vaccines in medical refrigerators typically requires temperatures between 2°C and 8°C. Preserving the efficacy of vaccines requires that they are consistently stored within this temperature range. According to the National Institute of Standards and Technology (NIST), 35% of the worldwide vaccine supply is wasted due to transportation or storage at inappropriate temperatures.

Proper temperature monitoring is essential to protect sensitive and costly vaccines. Medical or lab refrigerators and freezers come equipped with digital controllers featuring sensitive temperature probes to monitor cabin temperature. Some controllers and probes have been calibrated to ensure that temperature readings are accurate. The National Institute of Standards and Technology NIST has set up standards to calibrate temperature measuring devices accurately.

Participation in the Center for Disease Control (CDC) Vaccines for Children Program (VFC) requires regular temperature reporting from a NIST calibrated thermometer. Filling this requirement typically occurs in one of two ways:

Calibrated Medical, Lab, Pharmacy Refrigerator or Freezer

Some Medical refrigerators and freezers feature digital controllers and probes that are NIST calibrated and come with a Certificate of Calibration. This Certificate, which can be for one or two years, serves as proof to the CDC that the temperatures being measured by the device are accurate.

Calibrated Data Logger or Thermal Recorder

A data logger is a small digital thermometer that is combined with an internal temperature probe. Prices for digital data loggers with a NIST calibration certificate can be as little as $20 up to $500, depending on the desired features. Some data loggers are WIFI or Bluetooth enabled and offer sophisticated, cloud-based reporting and notification software.

Installation of these external data loggers is reasonably straightforward. The data logger probe and buffer are placed inside the refrigerator cabinet next to the vaccines. A connecting wire runs through a data logger port opening on the side of the vaccine refrigerator and connects to the display. The display is mounted outside of the refrigerator for easy viewing. Most retailers sell pre-calibrated data loggers with a one- or two-year calibration certificate.

Recalibrating your temperature probe, thermal recorder, or vaccine refrigerator.

The big difference in choosing a calibrated medical, vaccine refrigerator, or a data logger is the ease of recalibration. To recalibrate a data logger, you ship it back to the seller or manufacturer and have them calibrate it and issue another calibration certificate. With vaccine refrigerators, a visit from a calibration specialist is required to calibrate the unit on-site. The cost to calibrate a data logger is about $100 plus shipping. To have a vaccine refrigerator calibrated at a medical office or pharmacy can cost $200 to $1500 or more.

Most medical vaccine refrigerators do not have NIST calibrated controllers. It is recommended that you add a data logger for VFC reporting and temperature alarms. This redundancy also provides you with dual reporting and is an added safeguard against product loss.

In some cases, the temperature reading on your vaccine refrigerator controller will be a few degrees different from your calibrated data logger. It is possible to adjust the temperature settings on your refrigerator or freezer to reduce or eliminate the two devices' temperature differential. Consult your vaccine refrigerator or freezer manufacturer or technical contact for instructions.

K2 Scientific offers industry-leading value in medical-grade vaccine, lab, pharmacy refrigerators, and freezers. K2 has several calibrated data loggers available. Contact K2 sales for more information about the best fit for your vaccine storage needs.