Temperature Monitoring for Safe Vaccines

Temperature Monitoring for Safe Vaccines

Aug 17, 2017

Temperature Monitoring for Safe Vaccines

The proper cold storage of vaccines is crucial to maintain the effectiveness of those vaccines. Vaccine quality is the responsibility of everyone who handles vaccines from the time it’s manufactured, through transit, to the time it’s administered to the patient. The CDC has strict cold chain requirements in order to ensure that vaccines are maintained and distributed in a temperature-controlled environment, ensuring optimal conditions.

Retail pharmacies main responsibility and primary concern in maintaining the cold chain, lies with the storage and handling of the vaccines while at their facility. The CDC lays out guidelines that were designed to ensure optimal conditions.

Refrigerated vaccines should be stored at temperatures between 2° C and 8° C (36° F and 46° F), with the thermostat set to about 5° C (40° F),which decreases the likelihood of temperature excursions. Vaccines that should be refrigerated include, Influenza (LAIV, IIV, RIV), Hep A, meningoccal containing, HepB, Rotavirus (RV1 and RV5), Human Papilloma Virus (HPV4 and HPV2).

Vaccines stored in the freezer should maintain temperatures between -50° C and -15° C (-58° F and +5° F), with the thermostat set at a midpoint between these temperatures, to assure appropriate frozen temperatures. Some vaccines that should be stored in freezer units include MMR, HZC, VAR, MMRV.


Digital Data Loggers

In order to protect stored vaccines, it’s critical to have accurate temperature history that reflects actual vaccine temperatures. CDC recommends the use of a continuous monitoring and recording digital data logger (DDL). The DDL should have a current and valid Certificate of Calibration Testing, and set to record temperatures at least every 30 minutes, at a minimum. Many DDLs use a buffered temperature probe, to match vaccine temperatures more closely than standard thermometers, which reflect air temperature.

Facilities should have a DDL for each vaccine storage unit and at least one backup DDL, in case the primary one malfunctions or is out for calibration testing. CDC recommend DDLs with the following characteristics:

  • Detachable probe in a thermal buffer material like glycol
  • Alarm for all out of range temperatures
  • Low battery indicator
  • Current, minimum, and maximum temperature display
  • User programmable logging interval
  • Time stamp for when measurement was taken

The CDC does not recommend using alcohol or mercury thermometers, bi-metal stem temperature monitoring devices, food temperature monitoring devices, chart recorders, infrared temperature monitoring devices, and temperature monitoring devices that do not have a current and valid Certification of Calibration Testing.

CDC recommends performing the following routine maintenance tasks for all storage units: Check storage unit door seals for sign of wear and tear, check door hinges and adjust so door opens and closes smoothly, clean coils and motor, clean inside of units, defrost freezer when frost exceeds 1 cm or follow the manufacturer’s instructions.Calibration testing of temperature monitoring device should be done every 1-2 years.

With CDC requirements becoming more strict, it’s now more important than ever to make sure that your pharmacy is up to date with the latest tools to ensure that you are in compliance. Don’t expend your resources on things that you can automate. Let E-Control Systems (ECS) help you with your cold storage monitoring at your facilities, so that you can comply with the CDC recommendations and requirements.

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