Recommended Vaccine Temperature Ranges
The CDC requires vaccine refrigerators to maintain temperature ranges between 2° to 6°C (36° to 46°F), and vaccine freezers to maintain temperature ranges between -50° to -15°C (-58° to +5°F). The vaccine’s package insert may also be consulted for additional information. The appliance temperature should be checked every time the unit is accessed, and min/max temperatures recorded at the start of each day.
It is important for every facility that is administering vaccines, to maintain the temperature and storage guidelines, that are set out in the CDC’s Vaccine Storage and Handling Toolkit. Without utilizing these best practices, vaccines can become damaged or impotent. This can lead to patients being left un-vaccinated, as well as a great loss of time and money to replace the inventory.
Tips For Keeping Vaccine Temperatures At Optimal Ranges
1) Use A Purpose-built or Pharmaceutical Grade Refrigerator
2) Monitor Temperatures with a Digital Data Logger
A DDL should have the following features:
- A ‘buffered temperature probe’ as they measure the actual vaccine temperature. Alcohol or mercury thermometers will only measure the temperature of the air.
- An alarm for out-of-range temperatures
- Low-battery indicator
- Current, minimum, and maximum temperature display
- An accuracy reading of +/-0 .5°C (+/-1° F)
- Logging interval (or reading rate) that you can program to measure and record temperatures at least every 30 minutes
- Current and valid Certificate of Calibration Testing
3) Have A Procedure For Recording Temperature Excursions
Temperature excursions happen when a storage unit has a temperature reading outside the recommended ranges in the manufacturer's vaccine package inserts. The CDC recommends the following steps when a temperature excursion occurs:
- Label exposed vaccines, “DO NOT USE” and separate them from other vaccines, preferably in a separate container. Do not discard them
- Document the event and a description of what happened, including the following information:
- Date and time of the temperature excursion
- Storage unit temperature as well as room temperature, if available
- The length of time the vaccine may have been affected. If you are using a DDL, it will provide you with the data you need.
- How many vaccines were affected?
- Other items in the storage unit other than the vaccines
- Any problems with the storage unit and/or affected vaccines before the event
- Other relevant information
- Readjust the unit temperature to its suitable range and ensure that the TMD is correctly placed in the center of the vaccines.
- Contact your immunization program and/or vaccine manufacturer for guidance on dealing with the affected vaccines. This guidance should include whether to recall patients for revaccination
4) Implement an Emergency Transport Plan
Even with a generator or battery backup system in place, the cold storage appliance could still fail, leaving the vaccines vulnerable to a rise in temperature. To guard against this, an Emergency Transport Plan should be put in place. This will involve packing up the vaccines in a ‘qualified’ container per CDC packing guidelines and transporting them to another facility. The alternative storage facility should be contacted before leaving to ensure the storage space is available, and temperatures monitored on the way with a TMD (temperature monitoring device).
5) Protect your Vaccines with a Backup Power Source
Learn More About Battery Backup Power
To answer even more of your questions and find additional solutions to problems that could affect your medical facility or laboratory, check out these other articles from the Medi-Products blog and the Medi-Products Learning Center:
What Are the NSF456 Vaccine Storage Standards? Are You Compliant?
Meeting Recommended Standards and Requirements and for VFC, CDC and NSF456
