Vaccine Storage and Handling Guidance

Updated March 2020

Vaccine Storage and Ha​​ndling


Guidance for vaccine storage and monitoring is developed by experts at the Centers for Disease Control and Prevention. State Vaccine for Children (VFC) programs require that participating practices implement this guidance as a minimum. They may also choose to require stricter criteria for their programs. The CDC guidance is intended to keep vaccines stored safely, so that they are not exposed to temperatures at which they could lose potency and become ineffective.

Vaccine manufacturers offer product-specific information, including:

    • At what temperature the vaccine should be stored.

    • How to store and use a diluent to reconstitute a vaccine (if needed).

    • When to discard a vaccine.

Updates

In January 2020, the CDC updated their Vaccine Storage and Handling Toolkit. The following describes the main changes made:

  • The 2020 Toolkit includes monitoring instructions for temperature monitoring devices (TMD) that do not read min/max temperatures:

    • TMD without min/max temperatures should be checked a minimum of two times per day, at the start and end of the workday.

    • Record: min/maximum temperature, date, time, name of person who checked and recorded the temperature, any actions taken if a temperature excursion occurred. Leave a blank entry in the log if a reading is missed.

  • The 2020 Toolkit states that defrosting manual-defrost freezers should occur "when the frost exceeds either 1 cm or the manufacturer's suggested limit."

  • CDC clarified storage unit temperatures:

    • Refrigerator temperature should measure between 2°C and 8°C (34°F and 46°F)

    • Although vaccines can be correctly stored anywhere within the aforementioned temperature range, storage unit temperatures should still aim midpoint of 5°C to avoid temperature excursions.

  • If Beyond Use Date (BUD) is not indicated on a vaccine, the expiration date provided by the manufacturer should be used.

  • New definitions:

    • Portable vaccine storage unit:
      "a type of powered refrigerator or freezer unit specifically designed for use during vaccine transport. These are passive units that require a power source to function. Please note that some active units are 'qualified' to maintain desired temperatures for a set amount of time in the event of a power loss."

    • Qualified container and pack out:
      "a type of container and supplies specifically designed for use when packing vaccines for transport. They are passive containers that do not require a power source and are 'qualified' through laboratory testing under controlled conditions to ensure they achieve and maintain desired temperatures for a set amount of time."

Guidance

  • The CDC Vaccine Storage and Handling Toolkit offers recommendations that are good for all offices, but serves as minimum requirements for VFC providers. Main points include:

    • Using a temperature buffered probe rather than measuring ambient air temperatures.

    • Using Digital Dataloggers (DDLs) as TMDs to continuously monitor vaccines that will be administered to children in the VFC program. This applies to:

      • Each vaccine storage unit

      • Each transport unit (emergency or non-emergency)

      • Have at least one backup TMD in case a primary device breaks or malfunctions.

    • Assessing and recording minimum and maximum temperatures at the start of each clinic day.

    • Maintaining primary and back-up DDLs that meet CDC requirements, which include having:

      • Detachable probe that best reflects vaccine temperatures (e.g., a probe buffered with glycol, glass beads, sand, or Teflon®)†

      • Alarm for out-of-range temperatures

      • Low-battery indicator†

      • Current, minimum, and maximum temperature display‡

      • Recommended uncertainty of +/-0 .5° C (+/-1° F)

      • Logging interval (or reading rate) that can be programmed by the user to measure and record temperatures at least every 30 minutes

      • A current and valid Certificate of Calibration Testing. This should include:

        • Model/device name or number

        • Serial number

        • Date of calibration (report or issue date)

        • Confirmation that the instrument passed testing (or instrument is in tolerance)

        • Recommended uncertainty of +/-0 .5° C (+/-1° F) or less

    • Using a stand-alone refrigerator and stand-alone freezer units suitable for vaccine storage rather than combination (refrigerator + freezer) or other units not designed for storing vaccines.

    • Discontinuing use of dorm-style or bar-style refrigerator/freezers for ANY vaccine storage, even temporary.

    • Weekly review of vaccine expiration dates and rotation of vaccine stock.

* Probes that are permanently embedded in a buffer are acceptable as long as the temperature monitoring system for the entire unit can be calibration-tested. † Since these devices are typically battery-operated, have a supply of extra batteries on hand.

  • The AAP Immunization Training Guide also contains tips for storing and monitoring your vaccines, including:

    • Refrigerator temperature should measure between 2°C and 8°C.

    • Freezer temperature should measure -15°C to -50°C

    • Vaccines meant to be stored in the refrigerator should never be frozen.

    • Temperatures of the refrigerator and freezer should be checked at least twice each day and documented on a temperature log. The maximum and minimum temperatures reached each day should also be recorded on this log.  

Education:

  • CDC eLearn: Immunization: You Call the Shots-Module Ten-Storage and Handling—2020
    This module is the tenth in a series titled Immunization: You Call the Shots and focuses on storage and handling requirements for vaccines. The series is designed to provide key immunization knowledge in a very basic step-by-step manner. It presents practice-oriented content about immunization. It does not discuss the denser more complex material regarding epidemiology, disease transmission, etc

  • Keys to Storing and Handling Your Vaccine Supply
    Keys to Storing and Handling Your Vaccine Supply is presented as a web-on-demand video
    Description: This video is designed to decrease vaccine storage and handling errors by demonstrating recommended best practices and addressing frequently asked questions (FAQs) 

Resources:


 Resources

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