Tips for Vaccine Storage and Handling


January 2013 - Vol. 10 No. 1 - Page #8

Effective vaccine storage and handling is an important component of proper vaccine management. Several recent scientific studies on equipment used for vaccine storage, as well as an improved understanding of best practices, have prompted the Centers for Disease Control and Prevention (CDC) to provide updated guidance on proper vaccine storage and handling practices.

See the CDC’s November 2012 Vaccine Storage & Handling Toolkit at:
http://www.cdc.gov/vaccines/recs/storage/toolkit/default.htm


Use the correct equipment to properly protect vaccine integrity. To ensure that refrigerators and freezers are maintaining the appropriate temperatures for vaccine storage, each unit should have a calibrated thermometer. Read and document temperatures on each unit a minimum of twice daily, including recording the minimum and maximum temperatures once each day. The temperature data,  whether it is electronic or paper, must be retrievable for at least three years. 

Biosafe glycol-encased probes are preferred, as they more accurately replicate the actual vaccine temperature in vials and therefore give more accurate temperature readings. The CDC recommends: 

  • Continuous monitoring information with an active display
  • Digital thermometer with a probe in a glycol-filled bottle
  • Alarm function to indicate out-of-range temperatures
  • Reset button if data logger has a minimum/maximum display
  • Display current temperature, as well as minimum and maximum temperatures
  • Accurate to within +/-.5°C (+/-1°F)
  • Low battery indicator
  • Calibrated annually

Ensure you have a back-up temperature probe for each vaccine storage unit. The back-up probe should match the primary set up (ie, temperature probe in glycol). Establish a different calibration schedule for the back-up probe so that it is available when the primary probe is sent for calibration. The CDC does not recommend fluid-filled biosafe liquid thermometers, bi-metal stem thermometers, food thermometers, household mercury thermometers, chart recorders, infrared thermometers, and non-calibrated thermometers for vaccine monitoring.

Use digital data loggers with detachable, programmable probes for 24-hour monitoring. If a storage unit is operating outside the recommended temperature range (see Sidebar), digital data loggers with detachable, programmable probes provide information about the length of time the unit has been out of range. Simple minimum/maximum thermometers provide only the warmest and coldest temperatures reached during a 24-hour period. Additionally, many digital data logger thermometers have special software that allows users to set the frequency of the temperature readings, download data from the device, and calculate temperature averages, minimums, and maximums. In the event of a temperature excursion, this detailed and precise information allows vaccine manufacturers to make specific recommendations about the viability of vaccine exposed to temperatures outside recommended ranges. 

Store vaccines in stand-alone refrigerators/freezers, as these units provide a more stable temperature environment than a combination unit. The National Institute of Standards and Technology (NIST) tested household combination refrigerator/freezers and found the freezer section of these units was incapable of maintaining the correct frozen vaccine storage temperatures consistently, especially during defrost cycles. In addition, avoid using dormitory-style refrigerators as they have great fluctuations in temperature, providing a less stable environment compared with full-size refrigeration units. Where possible, CDC recommends pharmaceutical grade or purpose-built refrigerators/freezers. 


Place vaccines in the proper location within the refrigeration unit. Vaccines should be placed approximately two to three inches from the walls and stored in bins by vaccine. Because most vaccines are light sensitive, they should remain in their boxes within the bins until used. Vaccines should never be stored in door compartments or in the crisper areas of refrigerators. In fact, should non–commercial grade units be used, the CDC recommends removing the crisper drawers and storing water bottles in both the crisper area and the door compartments to help maintain consistent temperature. In addition, do not store vaccines directly under any air vents, and ensure that air vents are never blocked.

 

 

 

 

 

 


Temperature Excursion Checklist* 

 

 

1. Checklist for general power loss 

  • Contact utility company 
  • Determine if time to restoration is acceptable 
  • Activate alternate generator if available 

2. Checklist for presumed storage unit malfunction Disposition of Storage Unit If unit is too warm, too cold, too noisy, or stopped, check the following items:

  • Circuit breakers active
  • Unit plugged in 
  • Door closed 
  • Door seal adequate 
  • Assess location of thermometers for temperature reading 
  • Record all temperatures 
  • Space between vaccine for air to circulate 
  • Coils free of dust 
  • Temperature adjusted gradually if not set correctly (need to re-check temperatures and record every 30 minutes) 
  • Unit secured and level (if unit is noisy) 
  • Screws tightened (if unit is noisy) 
  • Technician called 

3. Disposition of vaccine (if power not restored or if temperature does not begin to recover) 

  • Vaccine marked “do not use” (refrigerated vaccines first) 
  • Check temperature of alternative storage unit 
  • Vaccine moved to alternate storage unit (refrigerated vaccines first) 
  • Use data collection tool to record temperature excursion 
  • State immunization program contacted 
  • Manufacturer contacted 
  • Resume use of vaccines determined to be usable and returned to unit 
  • Determine disposition of compromised vaccine: 
  • Publicly purchased vaccine (provided through the Vaccines for Children program) prepared for return to distributor. 
  • Privately purchased vaccine should be disposed of in consultation with the manufacturer or its representative. Replacement plans will vary. 
  • If insured against losses of this type, contact insurance representative. 

*Centers for Disease Control and Prevention Web site.  http://www.cdc.gov/vaccines/recs/storage/toolkit/default.htm  Accessed December 19, 2012.


Jennifer Karpinski is a senior editor at Pharmacy Purchasing & Products magazine. PP&P would like to thank the CDC for their assistance with this article.

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