Vaccine Storage, Handling 2016

Vaccine
Storage & Handling

Toolkit June 2016
Storageans
Pl
U.S. Department of Health and Human Services

Centers for Disease Control and Prevention
Table of Contents
Tips for Using the Toolkit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Description of Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Where to Find Additional CDC Vaccine Storage and Handling Information. . . . 6
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Important Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Vaccine Cold Chain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

When the Cold Chain Fails. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Elements for an Effective and Reliable Cold Chain. . . . . . . . . . . . . . . . . . . . . . . . . . 10
Staff. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Staff Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Vaccine Coordinator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Vaccine Storage and Temperature Monitoring Equipment. . . . . . . . 13

Storage Units (Refrigerators and Freezers) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Temperature Monitoring Equipment (Digital Data Loggers) . . . . . . . . . . . . . . . . . 15
Storage Unit Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Storage Unit Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Temperature Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Stabilizing Temperatures in New and Repaired Units. . . . . . . . . . . . . . . . . . . 20
Organizing and Storing Vaccine in Storage Units . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Storing Vaccine in a Refrigerated Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Storing Vaccine in a Freezer Unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Avoid Placing Other Items in Vaccine Storage Units. . . . . . . . . . . . . . . . . . . . 24
Placement of Temperature Monitoring Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Monitoring Vaccine Temperature and Vaccine Storage Equipment. . . . . . . . . . . 25
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Table of Contents
Monitor and Record Storage Unit Temperature . . . . . . . . . . . . . . . . . . . . . . . 25
Out-of-range Temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Regular Maintenance of Vaccine Storage Units and Temperature

Monitoring Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Storage Unit Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Temperature Monitoring Device Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . 29
Troubleshooting Equipment Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Adjusting Storage Unit Temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Repeated Alarm Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Temperature Monitoring Device Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Vaccine Inventory Management, Transport, and Preparation . . . . . 32

Vaccine Deliveries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Scheduling and Receiving Deliveries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Unpacking Deliveries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Vaccine Inventory Accounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Expiration Dates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Stock Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Tally Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Stock Rotation and Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Stock Counts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Vaccine Ordering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Vaccine Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Vaccine Transport to Off-site or Satellite Facilities. . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Transport of Refrigerated Vaccines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Transport of Diluents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Emergency Transport. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
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Table of Contents
Preparing Vaccine for Administration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Single-dose Vials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Manufacturer-filled Syringes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Reconstitution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Predrawing Vaccines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Emergency Vaccine Storage, Handling, and Transport

Preparations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Emergency Backup Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Backup Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Generators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Alternative Vaccine Storage Facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
If an Alternative Vaccine Storage Facility is Not Available. . . . . . . . . . . . . . . 43
Accessing Your Building After Hours. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Power Outages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Monitoring Unit Temperature during a Power Outage . . . . . . . . . . . . . . . . . 44
Vaccine Transport Containers and Materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Coolant Materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Emergency Vaccine Packing and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Packing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Transport of Diluents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Transport of Varicella-containing (Frozen) Vaccines. . . . . . . . . . . . . . . . . . . . 48
Transport of Multidose Vials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Temperature Monitoring During Transport. . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
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Table of Contents
Vaccine Storage and Handling Standard Operating

Procedures (SOPs). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Storage and Handling SOP Sections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Routine Storage and Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Emergency Storage, Handling, and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Additional Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Glossary of Key Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Vaccine Storage and Handling SOP Worksheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Vaccine Manufacturer/Distributor Contact List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Fahrenheit to Celsius and Celsius to Fahrenheit Conversion . . . . . . . . . . . . . . . . . . . . . . 66
Sample Stock Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Stock Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Sample Tally Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Tally Sheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Vaccine Storage Rules Poster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Warning Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Transport Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
5
Tips for Using the Toolkit
Description of Icons
This list shows the symbols you will see throughout the toolkit:
Icon Description
CDC recommendation that applies to anyone who handles and
stores vaccine. It is particularly relevant to VFC providers or
other health care providers who receive vaccines purchased
with public funds.
Best practice
Take immediate action!
Print warning! A printed version of this toolkit may not be the most up-to-date
version. Always refer to the online version www.cdc.gov/vaccines/hcp/admin/
storage/toolkit/storage-handling-toolkit.pdf to verify you have the most
current information.
Where to Find Additional CDC Vaccine Storage and Handling Information

• Vaccine storage and handling home page: www.cdc.gov/vaccines/recs/storage/default.
htm (sign up for notifications about updates)
• Educational webinars and netconferences for health care providers: www.cdc.gov/vaccines/
ed/courses.html
• Contact information for state/local immunization programs: www.cdc.gov/vaccines/imz-
managers/awardee-imz-websites.html
• E-mail specific questions to CDC: [email protected]
6
Introduction
The Centers for Disease Control and Prevention (CDC)

Vaccine Storage and Handling Toolkit (referred to
Morbidity and Mortality Weekly Report
throughout this document as “the toolkit”) brings Recommendations and Reports / Vol. 60 / No. 2 January 28, 2011
together best practices from Advisory Committee on General Recommendations on Immunization

Immunization Practices (ACIP) recommendations*, Recommendations of the Advisory Committee
on Immunization Practices (ACIP)
product information from vaccine manufacturers,
and scientific studies. Implementing these best
practices and recommendations will help protect your
patients, safeguard your vaccine supply, and avoid
the unnecessary costs of revaccination and replacing
expensive vaccines.
Proper vaccine storage and handling has been an

important factor in preventing and eradicating many
common vaccine-preventable diseases. Yet, each year, Continuing Education Examination available at http://www.cdc.gov/mmwr/cme/conted.html
storage and handling errors result in revaccination U.S. Department of Health and Human Services
of many patients and significant financial loss due to

wasted vaccine. Failure to store and handle vaccines
properly can reduce vaccine potency, resulting in
inadequate immune responses in patients and poor protection against disease. Patients can lose
confidence in vaccines and providers if they have to be revaccinated because the vaccines they
received may have been compromised.
This toolkit provides information and resources to assist you in properly storing and handling
your vaccine supply, including information on:
• Storage and temperature monitoring equipment and setup

• Vaccine organization and storage
• Vaccine temperature and storage equipment monitoring
• Vaccine inventory management, transport, and preparation
• Emergency storage, handling, and transport
• Vaccine storage and handling standard operating procedure development
This toolkit reflects an adjustment in CDC’s guidance on the Fahrenheit temperature range
for storing refrigerated vaccines. The new recommended Fahrenheit temperature range is
between 36° F and 46°F (previously between 35° F and 46° F). The Celsius temperature range
(between 2° C and 8° C) remains unchanged, as stated in all manufacturer package inserts for
routinely recommended vaccines.
7
Introduction
Important Notes
If you are a Vaccines for Children (VFC) provider or receive other vaccines purchased with public
funds, you should consult with your state or local immunization program (referred to throughout
this document as “immunization program”)* to ensure you are meeting all mandatory storage
and handling requirements for your state, since there may be requirements that are specific or
tailored to your jurisdiction. This toolkit provides general background information for many of the
VFC storage and handling requirements and illustrates best practices essential to safeguarding
public vaccine supply that can ultimately protect individuals from vaccine-preventable diseases.
For specific, detailed storage and handling protocols for individual vaccines, always refer to the
manufacturers’ product information and package inserts*, or contact the manufacturer directly.
*ACIP Recommendations: www.cdc.gov/mmwr/preview/mmwrhtml/rr6002a1.htm?

Immunization programs: www.cdc.gov/vaccines/imz-managers/awardee-imz-websites.html
Manufacturers’ package inserts: www.immunize.org/packageinserts/
Disclaimer: This document provides best practices and CDC recommendations on storage, handling and transport of
vaccines and diluents. Use of trade names and commercial sources in this toolkit is for identification only, and does not
imply endorsement by the U.S. Department of Health and Human Services (DHHS), the U.S. Public Health Service (PHS),
or the Centers for Disease Control and Prevention (CDC). Photographs from non-federal organizations are provided
solely as a service to our users. These photographs do not constitute an endorsement of these organizations by CDC or
the federal government and none should be inferred.
8
Vaccine Cold Chain
The vaccine cold chain is a temperature-controlled environment used to maintain and

distribute vaccines in optimal condition. The cold chain begins with the cold storage unit at
the manufacturing plant, extends through transport of vaccines to the distributor and delivery
to and storage at the provider facility, and ends with administration of vaccine to the patient.
Appropriate storage and handling conditions must be maintained at every link in the cold chain.
When the Cold Chain Fails

Cold chain flow chart
Too much exposure to heat, cold, or light
at any step in the cold chain can damage
vaccines, resulting in loss of vaccine Manufacturer Vaccine
potency. Once lost, potency cannot be responsibility manufacturing
restored. Each time vaccines are exposed
to improper conditions, potency is reduced
further. Eventually, if the cold chain is not
properly maintained, potency will be lost
completely, and vaccines will be useless.
Manufacturer/distributor Vaccine
responsibility distribution
While exposure to any inappropriate

conditions can affect potency of refrigerated
vaccines, a single exposure to freezing
Provider Vaccine arrival
temperatures (0° C [32° F] or colder) will
responsibility at provider
destroy some. Liquid vaccines that contain facility
an aluminum adjuvant can permanently
lose potency when exposed to freezing
temperatures.
Vaccine
storage
and handling
Vaccine appearance is not a reliable at provider
facility
indicator that vaccines have been stored
in appropriate conditions. For example,
inactivated vaccines, even when exposed
to freezing temperatures, may not appear Vaccine
frozen, giving no indication of reduced or administration
lost potency.
9
Vaccine Cold Chain
Results of a cold chain failure can

be costly.1,2,3 ACIP’s General
Recommendations on Immunization
state, “Vaccine exposed to inappropriate Can you spot
temperatures that is inadvertently the difference?
administered generally should be
repeated.”4 Inappropriate storage can
mean extra doses for patients, increased
costs for providers, and damage to public Properly stored Improperly stored
vaccine vaccine
confidence in vaccines. More importantly, Full potency Diminished potency
patients who refuse revaccination Vaccine appearance is NOT a reliable indicator that vaccines
have been stored in appropriate conditions.
can remain unprotected from serious,
vaccine-preventable diseases.
Elements for an Effective and Reliable Cold Chain

An effective cold chain relies on three main elements:
• A well-trained staff
• Reliable storage and temperature monitoring equipment
• Accurate vaccine inventory management
These are the three main concepts upon which this toolkit is organized.
1. Department of Health and Human Services, Office of Inspector General.Vaccines for Children Program: Vulnerabilities in
Vaccine Management, June 2012, oig.hhs.gov/oei/reports/oei-04-10-00430.asp.
2. Gazmararian JA, Oster NV, Green DC, Schuessler L, Howell K, et al.Vaccine storage practices in primary care physician offices:
assessment and intervention.Am J Prev Med 2002;23(4):246–53.
3. Bell KN, Hogue CJR, Manning C, Kendal AP.Risk factors for improper vaccine storage and handling in private provider offices.
Pediatrics 2001;107(6):1–5.
4. Centers for Disease Control and Prevention.General Recommendations on Immunization: Recommendations of the Advisory
Committee on Immunization Practices and the American Academy of Family Physicians.MMWR 2011;60(No.RR-2):17–19.
Available from URL: www.cdc.gov/mmwr/preview/mmwrhtml/rr6002a1.htm.
10
Staff
Vaccine storage and handling practices are only as effective and successful as the staff that
implements them. A well-trained staff, familiar with key storage and handling principles, is critical
to ensuring the potency of your vaccine supply and the safety of your patients. Knowledgeable
staff can also save your practice significant costs of wasted vaccine and prevent loss of credibility
among patients who must be revaccinated due to a storage and handling error.
Staff Training
All staff members who receive deliveries and/or handle or administer vaccines should be familiar
with storage and handling policies and procedures at your facility. Keep standard operating
procedures (SOPs) for storage and handling near storage units and make sure staff knows where
to find them.
CDC recommends that storage and handling training should be done:
• As part of new employee orientation

• Annually as a refresher for all staff involved in immunization activities
• Whenever new vaccines are added to inventory
• Whenever recommendations are updated
It is recommended that you record names of trainings, dates, and participants. If you are a
VFC provider, this is required. Contact your immunization program* for any additional state
requirements if you are a VFC provider or have other vaccines purchased with public funds.
CDC offers an online training module, “You Call the Shots: Vaccine Storage and Handling,”*
and many immunization programs* and professional organizations also offer training resources
for vaccine storage and handling.
Designate a person to be the primary vaccine coordinator for your facility.

Appoint a second staff member to serve as an alternate in the absence of the primary coordinator.
*Immunization programs: www.cdc.gov/vaccines/imz-managers/awardee-imz-websites.html

You Call the Shots: Vaccine Storage and Handling module: www2a.cdc.gov/nip/isd/ycts/mod1/courses/sh/ce.asp
11
Staff
Vaccine Coordinator
Designate a person to be the primary vaccine coordinator for your facility. This
person will be responsible for ensuring all vaccines are stored and handled correctly. Appoint
a second staff member to serve as an alternate in the absence of the primary coordinator (this
is particularly important in case of after-hour emergencies). Both coordinators should be fully
trained in routine and emergency policies and procedures.
Coordinator responsibilities include:
• Ordering vaccines
• Overseeing proper receipt and storage of vaccine deliveries
• Documenting vaccine inventory information
• Organizing vaccines within storage units
• Setting up temperature monitoring devices
• Reading and recording storage unit temperatures a minimum of 2 times each workday
• Reading and recording minimum/maximum temperatures from a digital data logger 1
time each workday, preferably each morning
• Reviewing and analyzing temperature data at least weekly for any shifts in temperature
trends
• Rotating stock at least weekly so vaccines with the earliest expiration dates are used first
• Removing expired vaccine from storage units
• Responding to out-of-range temperatures (temperature excursion)
• Maintaining all documentation, such as inventory and temperature logs
• Ensuring staff is properly trained
• Monitoring operation of storage equipment and systems
• Overseeing proper vaccine transport (when necessary)
• Overseeing emergency preparations
––Tracking inclement weather conditions†
––Ensuring appropriate handling of vaccines during a disaster or power outage‡
†The National Oceanic and Atmospheric Administration (NOAA) provides up-to-date information on U.S. weather conditions:
www.weather.gov/
www.goes.noaa.gov/
‡
The Federal Emergency Management Agency (FEMA) offers a wide range of information on disaster preparedness:
www.fema.gov/
The Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) offers information
concerning the storage and use of temperature-sensitive biological products that have been involved in a temporary electrical
power failure or flood conditions:
www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ProductSecurity/ucm147243.htm
12
Vaccine Storage and Temperature Monitoring Equipment
Proper Vaccine Storage Temperatures
Refrigerated vaccines should be stored at temperatures between 2° C and 8° C (36° F and 46°
F). The thermostat should be set at midrange to achieve a temperature of about 5° C (40° F),
which will decrease the likelihood of temperature excursions.
Vaccines stored in the freezer should maintain temperatures between -50° C and -15° C (-58°
F and +5° F). The thermostat should be at the factory-set or midpoint temperature setting to
assure appropriate frozen storage temperatures.
This toolkit reflects an adjustment in CDC’s guidance on the Fahrenheit temperature range for storing refrigerated
vaccines. The new recommended Fahrenheit temperature range is between 36° F and 46° F (previously between 35° F and
46° F). The Celsius temperature range (between 2° C and 8° C) remains unchanged, as stated in all manufacturer package
inserts for routinely recommended vaccines.
Think of your storage and monitoring equipment as an insurance policy to protect your patients
from inadvertent administration of compromised vaccine, and your facility against costs of
revaccination, replacement of expensive vaccines, and loss of patient confidence in your practice.
For the best protection, your facility needs appropriate equipment that is set up correctly and
maintained and repaired as needed.
To fully ensure the safety of vaccines, the following

equipment is recommended:
• Stand-alone refrigerator(s) with enough space to

accommodate your maximum inventory without crowding
Refrigerator
• Stand-alone freezer(s) with enough space to accommodate Store vaccines
your maximum
inventory without between
crowding
• Digital data logger
Freezer 2°C and 8°C
(DDL) with a current Store vaccines (36°F and 46°F)
and valid Certificate
of Calibration Testing between
(also known as a
Report of Calibration) -50°C and -15°C
for each unit and at (-58°F and +5°F)
least one backup in
case of a broken or
malfunctioning device.
Stand-alone freezer Stand-alone refrigerator
13
Transport situations also require special equipment, such as emergency transport containers
and additional digital data loggers for each container (if there are more containers than storage
units).
Storage Units (Refrigerators and Freezers)

Refrigerators and freezers typically used for vaccine
storage are available in different grades (household and
purpose-built) and types (stand-alone and combination
FREEZER
refrigerator/freezer).
Purpose-built units are sometimes referred to as

“pharmaceutical grade” and are designed specifically for
storage of biologics. These units often have:
Refrigerated
• Microprocessor-based temperature control with a
digital temperature sensor (thermocouple, resistance vaccines
temperature detector [RTD], or thermistor)
• Fan-forced air circulation, with powerful fans or
multiple cool air vents inside the unit that promote
ONLY
uniform temperature and fast temperature recovery
CDC makes the following recommendations for

vaccine storage units:
• Use purpose-built units designed to either

refrigerate or freeze (can be compact, under-the
counter-style or large units).
• If a purpose-built unit is not available, use a stand-
alone household unit.
• If you must use a household-grade combination Household combination refrigerator/freezer
refrigerator/freezer unit, only use the
refrigerator compartment for storing vaccines.
These units have cold spots and temperature
fluctuations, and air circulating from the freezer
could expose refrigerated vaccines to freezing
temperatures. Use a separate stand-alone
freezer to store frozen vaccines.
• Do not store any vaccine in a dormitory-
style or bar-style combined refrigerator/
freezer unit under any circumstances.
Do not store any vaccine in a dormitory-style
These units have a single exterior door and an or bar-style combined refrigerator/freezer unit
evaporator plate/cooling coil, usually located in under any circumstances.
14
an icemaker/freezer compartment. These units have been shown to pose a significant risk of
freezing vaccines, even when used for temporary storage. (Note: Not all small storage units
are dormitory- or bar-style units. Compact purpose-built units for biologics can be used to
store vaccines.)
• Make sure the storage unit has enough space to store the largest inventory you might have
at the busiest point in the year (e.g., flu season) without crowding.
• Remove any deli, fruit, and vegetable drawers from refrigerator units. This provides extra
space for water bottles to help maintain stable temperatures and prevents use of the
drawers for storing food, beverages, or vaccines.
• Use safeguards to ensure the doors of the unit remain closed (for example, self-closing door
hinges, door alarms, door locks, etc.).
Temperature Monitoring Equipment

(Digital Data Loggers)
An accurate temperature history that reflects actual
vaccine temperatures is critical for protecting your
vaccines. Every vaccine storage unit must have a
temperature monitoring device, and investing in
reliable devices is less expensive than replacing
vaccines wasted due to inaccurate temperature
readings.
CDC recommends the use of a continuous

monitoring and recording digital data logger
(DDL) with a current and valid Certificate of
Calibration Testing (also known as a Report
of Calibration), set at a minimum recording
interval of at least every 30 minutes. Unlike a
simple minimum/maximum thermometer, which Digital data loggers
only shows the warmest and coldest temperatures
reached in a unit, continuous monitoring and recording DDLs provide detailed information on
all temperatures recorded at preset intervals. Many DDLs use a buffered temperature probe,
which is the most accurate way to measure actual vaccine temperatures. Temperatures measured
by a buffered probe match vaccine temperatures more closely than those measured by standard
thermometers, which tend instead to reflect air temperature. DDLs provide the most accurate
storage unit temperature information, including details on how long a unit has been operating
outside the recommended temperature range (referred to as a temperature excursion).
15
Your facility should have a DDL for:
• Each vaccine storage unit

• Each emergency transport unit (this is particularly important if there are more transport units
than storage units)
• At least one backup DDL in case a primary device malfunctions or is out for calibration
testing (make sure the backup device has a different calibration testing schedule than the
primary device so it is available when the primary device is being tested)
CDC recommends DDLs with the following characteristics:
• Detachable probe in a thermal buffered material (e.g., glycol, glass beads, sand, Teflon®)†
• Alarm for out-of-range temperatures
• Low-battery indicator‡
• Current, minimum, and maximum temperature indicator§
• Recommended uncertainty of +/-0.5° C (+/-1° F)
• Logging interval (or reading rate) that can be programmed by the user
Temperature data from a DDL can be downloaded to a computer using special software or
retrieved from a website. The software or website may also allow you to set the frequency of
temperature readings. Reviewing DDL data is critical for vaccine safety, so it is important to
decide whether independent software or a website program will work best for your facility.
CDC recommends that a DDL’s current and valid Certificate of Calibration Testing (Report of
Calibration) should include:
• Model/device name or number

• Serial number
• Date of calibration (report or issue date)
• Confirmation that the instrument passed testing (or instrument in tolerance)
• Recommended uncertainty of +/-0.5° C (+/-1° F) or less
If you need to determine if a Certificate of Calibration Testing or Report of Calibration was issued
by an appropriate entity, check to see if the certificate indicates one or more of the following
items about calibration testing:
• Conforms to International Organization for Standardization (ISO)/International

Electrotechnical Commission (IEC) 17025 international standards for calibration testing and
traceability
• Performed by a laboratory accredited by International Laboratory Accreditation Cooperation
(ILAC) Mutual Recognition Arrangement (MRA) signatory body
––A list of ILAC/MRA signatories may be found at
ILAC.org/ILAC-MRA-and-signatories/
16
• Traceable to the standards maintained by the National Institute of Standards and Technology
(NIST)
• Meets specifications and testing requirements for the American Society for Testing and
Materials (ASTM) Standard E2877 Tolerance Class F (< +/-.5° C or < +/-1° F) or better
• Refers to another acceptable accuracy validation method, such as comparison to other
traceable reference standards or tests at thermometric fixed points
Certain types of temperature monitoring devices have significant limitations and should
not be used to measure temperatures in a vaccine storage unit. These devices can be
difficult to read and, because they only show

the temperature at the exact time they are read,
may fail to detect temperatures outside the
recommended range.
Specifically, CDC does not recommend the

following temperature monitoring devices:
• Alcohol or mercury thermometers, even if

placed in a fluid-filled biosafe liquid vial
• Bi-metal stem temperature monitoring devices
• Food temperature monitoring devices
• Chart recorders
• Infrared temperature monitoring devices
• Temperature monitoring devices that do
not have a current and valid Certificate of CDC does NOT recommend these temperature
Calibration Testing monitoring devices
Devices sold in hardware and appliance stores are generally designed to monitor temperatures
for household food storage. They are not calibrated and not accurate enough to ensure vaccines
are stored within the correct temperature range. Using these devices can pose a significant risk of
damaging expensive vaccines.
†Probes that are permanently imbedded 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.
§Battery changes may affect temperature accuracy and may warrant checking against a known calibrated temperature device.
Check with the device’s manufacturer for specific information on battery changes.
17
Storage Unit Setup

Storage Unit Placement
Good air circulation around the outside of the storage unit is important. Place storage units in a
well-ventilated room, leaving space between the unit, ceiling, and any wall. Nothing should block
the cover of the motor compartment. The unit should be firm and level, with the bottom of the unit
above the floor. Make sure the unit door opens and closes smoothly and fits squarely against the
body of the unit. Studies find that most units work best when placed in an area with standard indoor
room temperatures, usually considered to be between 20° C and 25° C (68° F and 77° F). Check the
manufacturer-supplied owner’s manual for additional guidance on placement and spacing.
Power Supply
Take the following precautions to protect the storage unit’s

power supply:
• Plug in only one storage unit per electrical outlet to

avoid creating a fire hazard or triggering a safety switch
that would turn off power.
• Use a safety-lock plug or an outlet cover to prevent the
unit from being unplugged.
• Post “DO NOT UNPLUG” warning signs at outlets and on
storage units to alert staff, custodians, electricians, and
other workers not to unplug units.
• Label fuses and circuit breakers to alert people not to
turn off power to storage units. Labels should include
immediate steps to take if power is interrupted. If your
building is owned by a third party and you do not have
access to circuit breakers, work with your building manager.
Avoid using power outlets that can be tripped or switched

off, including:
• Built-in circuit switches (may have reset buttons)

• Outlets that can be activated by a wall switch
• Multi-outlet power strips
If the entire storage unit is impacted by out-of-range

temperatures because of a power outage or unit malfunction,
refer to your facility’s emergency storage and handling SOPs.
18
Temperature Ranges
Refrigerators should maintain temperatures between 2° C and 8° C (36° F and 46° F).† The
thermostat should be set at midrange to achieve a temperature of about 5° C (40° F), which will
decrease the likelihood of temperature excursions.
Freezers should maintain temperatures between -50° C and -15° C (-58° F and +5° F). The
thermostat should be set at the factory-set or midpoint temperature to assure appropriate frozen
storage temperatures.
19
Consult the owner’s manual for instructions on how to operate the thermostat. Thermostats are
marked in various ways, and in general, show levels of coldness rather than temperatures. The
only way to know the temperature where vaccines are stored is to measure and monitor it with a
continuous monitoring and recording digital data logger (DDL). Each unit should have its own
temperature monitoring device.
†
This toolkit reflects an adjustment in CDC’s guidance on the Fahrenheit temperature range for storing refrigerated vaccines.
The new recommended Fahrenheit temperature range is between 36° F and 46° F (previously between 35° F and 46° F). The
Celsius temperature range (between 2° C and 8° C) remains unchanged, as stated in all manufacturer package inserts for
routinely recommended vaccines.
Stabilizing Temperatures in New and Repaired Units
It may take 2 to 7 days to stabilize the temperature in a newly installed or repaired refrigerator or
2 to 3 days for a freezer. Before using a unit to store vaccines, check and record temperatures a
minimum of 2 times each workday for 2 to 7 days.
If you are using a household combination refrigerator/freezer, do not use the freezer
compartment to store vaccines. To maintain proper temperatures in the refrigerator, leave the
freezer on at the factory-set or midpoint temperature setting. Water bottles should also be
placed in the refrigerator to help maintain the correct temperature range and reduce the risk of
freezing vaccines.
Organizing and Storing Vaccine in Storage Units

Following recommended guidelines and best practices for placement of vaccines in a
storage unit will help to prevent conditions that could reduce vaccine potency or cause vaccine
failure.
Always refer to manufacturers’ product information/package inserts for the most up-
to-date storage and handling recommendations for specific vaccines and diluents.
Storing Vaccine in a Refrigerated Unit
All vaccines except varicella-containing vaccines (varicella, zoster, and MMRV) should be stored
in a refrigerator between 2° C and 8° C (36° F and 46° F), with a desired target temperature of 5°
C (40° F). Measles, mumps, and rubella (MMR) vaccine may be stored in either a refrigerator or
freezer. Some diluents must be refrigerated, while others may be stored in the refrigerator or at
room temperature (no warmer than 25° C [77° F]).†
20
Best practices for storing vaccine and diluent in a refrigerated unit include:
• Always store vaccines in their original packaging with lids closed until ready for
administration. This protects them from light and provides additional thermal protection/
stability. Never store loose vials or manufacturer-filled syringes outside of their
packaging. This increases the risk of administration errors, exposes vaccine to light, and
makes it more difficult to track expiration dates and manage inventory.
• Place water bottles on the top shelf and floor and in the door racks. ‡§ Putting water
bottles in the unit can help maintain stable temperatures caused by frequently opening
and closing unit doors or a power failure. It can also prevent vaccines from being stored in
areas where there is a greater risk of out-of-range temperatures (such as the top shelf, floor,
and door). Place water bottles carefully so they cannot dislodge, preventing the door from
closing securely or weighing the door down so the seals are not tight. Label all water bottles,
“DO NOT DRINK.”
• Whenever possible, store diluent with the corresponding refrigerated vaccine:
––Diluents for Pentacel (DTaP-IPV/Hib) and Menveo (meningococcal conjugate vaccine)
contain antigen and must be stored with their corresponding (freeze-dried) vaccine.
––Some diluents can be stored at room temperature (no warmer than 25° C [77° F]).
Water bottles on unit floor Water bottles in unit door

21
• Store each type of vaccine or diluent in a separate container.

• Attach labels to shelves and containers to clearly identify where each type of vaccine and
diluent is stored. If diluent is stored separately from the corresponding vaccine, label the
container where it is stored.
• Store vaccines and diluents with similar packaging or names (e.g., DTaP and Tdap or Hib
and HepB) or with both pediatric and adult formulations on different shelves to minimize
the risk of administration errors. Make sure to label the formulation “pediatric” or “adult,” if
applicable.
• Place vaccines and diluents in the center of the unit, 2 to 3 inches away from walls, ceiling,
floor, and door. Avoid storing vaccines and diluents in any part of the unit that may not
provide stable temperatures or sufficient air flow, such as directly under cooling vents, in
drawers, or in shelves on the door.` The instability of temperatures and air flow in these areas
may expose them to inappropriate storage temperatures.
Recommended vaccine storage locations in the refrigerator

Household combination Pharmaceutical Stand-alone freezerless
NO vaccine directly under Avoid storage on top shelf near cooling vent. Likely
cooling vent = 2°C to 5°C colder location to exceed max allowed temp during outages.
and only MMR on the top shelf.
Top
Main
Bottom
No storage in crisper This can be an area Can be 1°C to 2°C

drawers: fill floor space of caution in some colder than main
with water bottles. pharmaceutical units. refrigerator space.
Best storage practice—place vaccines in center refrigerator space, contained in original packaging,
inside designated storage trays positioned 2 to 3 inches from refrigerator walls.
22
• Do not store vaccines in deli, fruit, or vegetable drawers, or in the door. Temperatures in
these areas are not stable and can differ from those inside the main part of the unit.
• Arrange vaccines and diluents in rows, allowing space between rows to promote air
circulation. This helps each vaccine and diluent maintain a consistent temperature.
• Place vaccines and diluents with the earliest expiration dates in front of those with later
expiration dates.
• Do not pack a storage unit too tightly. This can restrict air circulation and impact vaccine
temperature.
Storing Vaccine in a Freezer Unit
Varicella-containing vaccines (varicella, zoster, and MMRV) should always be stored in a freezer
unit between 50° C and -15° C (-58° F and +5° F) until reconstitution and administration. Measles,
mumps, and rubella (MMR) vaccine can be stored in either a refrigerator or a freezer. Never store
any diluent in the freezer.
Best practices for storing vaccine in a freezer unit include:
• Always store vaccines in their original packaging with lids closed until ready for
administration. This protects them from light and provides additional thermal protection/
stability. Never store loose vials or manufacturer-filled syringes outside of their
packaging. This increases the risk of administration errors, exposes vaccine to light, and
makes it more difficult to track expiration dates and manage inventory.
• Place water bottles against the walls, in the back, on the floor, and in the door racks.
Putting water bottles in the unit can help maintain stable temperatures caused by frequently
opening and closing unit doors or a power failure. It can also prevent vaccines from being
stored in areas where there is a greater risk of out-of-range temperatures (such as the floor
and door). Place water bottles carefully so they cannot dislodge, preventing the door from
closing securely or weighing the door down so the seals are not tight. Label all water bottles,
“DO NOT DRINK.”
• Store each type of vaccine in a separate container.
• Attach labels to shelves and containers to clearly identify where each type of vaccine is
stored.
• Store vaccines with similar packaging or names (e.g., VAR and HZV) or with both pediatric
and adult formulations on different shelves to minimize the risk of administration errors.
Make sure to label the formulation “pediatric” or “adult,” if applicable.
• Place vaccines in the center of the unit, 2 to 3 inches away from walls, ceiling, floor, and door.
Avoid storing vaccines in any part of the unit that may not provide stable temperatures or
sufficient air flow, such as directly under cooling vents or shelves on the door. The instability
of temperatures and air flow in these areas may expose them to inappropriate storage
temperatures.
23
• Arrange vaccines in rows, allowing space between rows to promote air circulation. This helps
each vaccine maintain a consistent temperature.
• Place vaccines with the earliest expiration dates in front of those with later expiration dates.
• Do not pack a storage unit too tightly. This can restrict air circulation and impact vaccine
temperature.
Avoid Placing Other Items in Vaccine Storage Units
If possible, no items other than vaccines, diluents, and water bottles should be placed or
stored in the units.
Food and beverages should never be stored

in the unit with vaccines. Doing so can lead
to frequent opening of the door to access food,
putting vaccines at risk of temperature fluctuations
and excessive light exposure. It can also result in
spills and contamination.
If other medications and biological products Do NOT store food or beverages inside a
vaccine refrigerator or freezer.
must be stored in the same unit as vaccines,
never store these products in the same
container with vaccines. Always store them below
vaccines and on a different shelf. This prevents
contamination and reduces the likelihood of
medication errors.
†More information about storage of specific diluents can be found

at www.immunize.org/catg.d/p3040.pdf.
‡Some refrigerator units, particularly pharmaceutical-grade units,
may have specific guidance about the use of water bottles. Check
the manufacturer’s guidance for your unit.
§Avoid storing vaccines on the top shelf. If the top shelf must be
used, place water bottles close to the vent and only store MMR
vaccines on this shelf.
If other medications/biologics are stored in same

unit with vaccines, store on a lower shelf.
24
Placement of Temperature Monitoring Device

To help ensure vaccines are stored at appropriate temperatures, it is important to follow
recommended best practices for placement of a digital data logger (DDL) in a storage unit.
• Place the buffered probe of the DDL in the center of the unit with the vaccines
surrounding it. A device placed near the walls, floor, vent, ceiling, or door may indicate
temperatures that are colder or warmer than the actual vaccine temperature. This may not be
true for pharmaceutical units because air flow and temperature are better regulated. Refer to
your owner’s manual for instructions on temperature monitoring device placement.
• Place the DDL’s active digital display outside the unit so temperatures can be read
without opening the door and disturbing the probe. The DDL should be set to measure
temperatures at least every 30 minutes.
Monitoring Vaccine Temperature and Vaccine Storage Equipment

Monitoring vaccine storage equipment and temperature is a daily responsibility to ensure the
safety of your vaccine supply and your patients. Implementing routine monitoring activities can
help you identify out-of-range temperatures quickly and take immediate action to correct them,
preventing loss of vaccines and the potential need for revaccination of patients.
Monitor and Record Storage Unit Temperature
CDC recommends on a twice daily basis:
• Check and record storage unit temperature readings each workday—in the morning
when you arrive and in the evening before leaving. This should be done even if there is a
temperature alarm or a DDL temperature monitoring device. A temperature monitoring log
sheet† should be placed on each storage unit door (or nearby), and the following information
should be recorded:
––Temperature
––Date
––Time
––Initials of person recording the data
If a reading is missed, leave a blank entry in

the log.
The twice-daily checks provide an

opportunity to inspect the storage unit,
reorganize any misplaced vaccines, and
remove any expired vaccines.
25
Check unit doors throughout the day and always at the end of the day to ensure they are
tightly closed. A door left open not only affects temperature in the unit, but can also expose
vaccines to light, putting them at risk of reduced potency.
CDC recommends on a weekly basis:
• Review storage unit temperature readings and review continuous DDL software or website
information for changes in temperature trends that might require action (adjusting unit
temperature or repairing/replacing storage or temperature monitoring equipment).
• File this information so it can be analyzed for long-term trends and/or recurring problems.
Temperature data should be kept for 3 years (unless state statutes or rules require a longer
period).
If there appears to be any fluctuation in temperature, troubleshoot the problem based on

additional information provided in this toolkit, manufacturer manuals, and/or your office
storage and handling SOPs.
Out-of-range Temperatures
Out-of-range storage temperatures or inappropriate conditions for any vaccine require

immediate action. Any temperature reading outside ranges recommended in the manufacturers’
package inserts* is considered a temperature excursion. In general, manufacturers analyze
information about the magnitude of the temperature excursion and the total amount of time
that temperatures were out of range, as well as information about the vaccine in question, to
determine whether a vaccine is likely to be viable.
If there is any question about whether vaccines may have been exposed to a temperature
excursion because the unit became too cold or too
hot, CDC recommends the following steps:
1. Any staff member who hears an alarm or
notices a temperature excursion on the
DDL should notify the primary or alternate
vaccine coordinator immediately or report
the problem to their supervisor.
2. Label exposed vaccines, “DO NOT USE,” and
place them in a separate container apart
from other vaccines in the storage unit (do
not discard these vaccines).
3. The vaccine coordinator, supervisor, or if Label exposed vaccines, “DO NOT USE,” and place
them in a separate container apart from other
necessary, the person reporting the problem vaccines in the storage unit.
should begin to document the event:†
26
a. Date and time of the temperature excursion

b. Storage unit temperature and room temperature, if available (including minimum/
maximum temperatures during the time of the event, if available)
c. Name of the person completing the report
d. Description of the event:‡
• General description (i.e., what happened)
• If using a DDL, determine the length of time vaccine may have been affected
• Inventory of affected vaccines
• List items in the unit (including water bottles) other than vaccines
• Any problems with the storage unit and/or affected vaccines before the event
• Other relevant information
4. Contact your immunization program* and/or vaccine manufacturer(s) per your SOPs for
further guidance on whether to use affected vaccines and for information about whether
patients will need to be recalled for revaccination.§ Be prepared to provide documentation
of the event (e.g., temperature log data) to ensure you receive the best guidance.
5. Implement your facility SOPs to adjust unit temperature to the appropriate range. At
a minimum, check the temperature monitoring device to make sure it is appropriately
placed in the center of the vaccines.
6. Complete your documentation of the event, including:
a. Action taken
i. What you did with vaccine and the time
ii. Whom you have contacted and instructions received
iii. What you have done to prevent a similar future event
b. Results
i. What happened to affected vaccines
ii. Other comments
If you are a VFC provider or have other vaccines purchased with public funds, contact your
immunization program* about required actions and special instructions or forms to be
completed in the event of a temperature excursion.
Never allow vaccines to remain in a nonfunctioning unit for an extended period of time. If you
believe the unit has failed, begin to implement your emergency vaccine SOPs.
*Manufacturers’ package inserts: www.immunize.org/packageinserts/

†The Immunization Action Coalition has developed a Temperature Monitoring Log (www.immunize.org/handouts/
temperature-logs.asp) and a Vaccine Storage Troubleshooting Record (www.immunize.org/catg.d/p3041.pdf) to support
these activities.
‡Responses from vaccine manufacturers to events depend on information given by the provider to the manufacturer. If different
information about the same event is provided to the same manufacturer, this can lead to different recommendations on
whether vaccine can be used or whether patients need to be revaccinated. In addition, each event is unique, and manufacturer
recommendations based on existing stability data cannot be applied to future events that may appear to be similar.
§In the General Recommendations on Immunization, ACIP recommends “vaccine exposed to inappropriate temperatures that is
inadvertently administered generally should be repeated.”
27
Regular Maintenance of Vaccine Storage Units and Temperature

Monitoring Devices
Storage units and temperature monitoring devices need regular maintenance to ensure proper
operation, maintain required temperatures, and extend the useful life of the equipment. Check
the manufacturer’s product information for cleaning instructions and recommended maintenance
schedules. Document maintenance tasks and repairs as indicated in your storage and handling
SOPs.
Storage Unit Maintenance
The following routine maintenance tasks are recommended for all storage units:
• Check storage unit door seals regularly for signs of wear and tear. Seals should not be torn
or brittle, and there should be no gaps between the seals and the body of the unit when the
door is closed. If seals need to be replaced, contact a repair technician immediately.
• Check door hinges and adjust so that the door opens and closes smoothly and fits squarely
against the body of the unit.
• Clean unit coils and motor. Dust and dirt buildup can affect transfer of heat from the coils
and prevent the unit from working efficiently.
• Clean inside of units to discourage bacterial and fungal growth. Cleaning must be done
quickly to minimize the risk of the temperature going
out of range.
• Defrost manual-defrost freezers when the frost
exceeds either 1 cm or the manufacturer’s suggested
limit. Follow the manufacturer’s instructions. While
defrosting, store vaccines temporarily in another unit
with appropriate freezer temperatures.
Unit doors pose a particular risk to maintaining appropriate

internal temperatures of vaccine storage units. A door that
is not sealed properly or that is left open unnecessarily
not only affects the temperature in a unit, it also
Refrigerator coils
exposes vaccines to light, which can reduce potency of
some vaccines. Leaving the door open can cause the thermostat to respond to warmer room
temperatures, and the unit will work harder to maintain the correct temperature inside. The unit
will continue to adjust its output of cool air, and the temperature may become very cold in some
parts of the unit, possibly freezing refrigerated vaccine. Using an open-door alarm and a self-
closing door may be helpful.
28
If your facility has a backup generator, it should be tested quarterly and serviced annually (check
the manufacturer’s guidance for testing procedures and maintenance schedules).
Temperature Monitoring Device Maintenance
Because all temperature monitoring devices experience “drift” over time that affects their
accuracy, calibration testing should be done every 1 to 2 years or according to the manufacturer’s
suggested timeline.†
If calibration testing indicates your temperature monitoring device is no longer accurate within
+/-.5° C (+/-1° F), it should be replaced. Adjustments to correct accuracy of the device are not
recommended. You may prefer to replace the device rather than submitting it for calibration
testing. Any new temperature data logger must have a current and valid Certificate of Calibration
Testing (also known as Report of Calibration).
†Providers who receive VFC vaccines or other vaccines purchased with public funds should consult their state or local
immunization program (www.cdc.gov/vaccines/imz-managers/awardee-imz-websites.html) about the required time
frame for calibration testing.
Troubleshooting Equipment Problems

Adjusting Storage Unit Temperatures
Storage unit temperatures will likely need to be adjusted over time. In some situations,
thermostats may need to be reset in summer and winter, depending on room temperature.
• Thermostat adjustments should only be
made by the primary or alternate vaccine
coordinator, based on information from
digital data loggers and temperature
monitoring logs.
• Post a warning sign on all storage units
stating, “Do NOT adjust temperature
controls. Notify (name of vaccine
coordinator) if adjustments are necessary.”
• Temperature adjustments should not be
done during a busy clinic day when the
unit door is being frequently opened and Thermostat adjustments should only be made by the primary or
alternate vaccine coordinator, based on information from digital
closed. data loggers and temperature monitoring logs.
29
Remember that temperatures within any storage unit will vary at least slightly, even with normal
use. Therefore, before making any adjustment:
• Confirm the unit is securely plugged into a power source.

• Check the temperature inside the storage unit.
• Wait 30 minutes, without opening the door, to allow the temperature to stabilize, and check
it again to verify the thermostat should be adjusted. If you believe there could be an issue
with your monitoring device, use your backup device to confirm the temperature.
If you confirm that an adjustment is needed:
• Refer to the owner’s manual for detailed instructions.

• Turn the thermostat knob slowly to avoid going outside the correct temperature range, and
make a small adjustment toward a warmer or colder setting as necessary.
• Allow the temperature inside the unit to stabilize for 30 minutes without opening the door.
• Recheck the temperature.
• Repeat these steps as needed until the temperature has stabilized at around 5° C (40° F) for a
refrigerator or between -50° C and -15° C (-58° F and +5° F) for a freezer.
• Consider placing additional water bottles in the unit to help improve temperature stability.
If you are using a combination storage unit, please note that adjustments to the freezer
temperature can adversely affect the refrigerator compartment temperature, possibly resulting in
frozen refrigerated vaccines.
Do not leave vaccines in a storage unit that does not maintain temperatures within the
recommended range. If you are unable to stabilize the temperature in your unit within the
required range, or temperatures in the unit are consistently at the extreme high or low end of the
range, your vaccine supply is at high risk. Use your emergency storage, handling, and transport
SOPs to identify an alternative unit with appropriate temperatures and sufficient storage space
until the primary unit can be repaired or replaced.
Repeated Alarm Alerts
If the temperature alarm goes off repeatedly, do not disconnect the alarm until you have
determined and addressed the cause. Do basic checks of the unit door, power supply, and
thermostat settings. If the alarm continues to trigger or the temperature remains out of range,
transfer vaccines to a backup unit as directed by your emergency storage and handling SOPs. A
repair technician should check your equipment to determine the need for repair or replacement.
30
Temperature Monitoring Device Equipment
Mishandling a temperature monitoring device can affect its accuracy. CDC recommends that
if a DDL is dropped, hit against the side of a storage unit, or potentially damaged in any other
way, its accuracy should be checked against another calibrated temperature monitoring device. If
there is any question about accuracy, the device should be sent for calibration testing or replaced.
It is common with some devices to see a slight variation in temperature from one reading to
another, even when the unit thermostat is set at a particular temperature. Temperatures within
any storage unit will vary at least slightly, even with normal use. If you observe no fluctuation in
your temperature monitoring device, the device may be faulty and may need calibration testing
or replacement.
Contact your immunization program* for resources on checking the accuracy of your
temperature monitoring device.
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Vaccine Inventory Management, Transport, and Preparation
Vaccines are expensive, so it’s important to make sure they are unpacked and stored correctly,
and to account for every dose received and used by your facility, whether administered, wasted,
compromised, expired, or transferred. Keeping accurate records to assist you in ordering and
rotating stock on a regular basis will ensure that your facility has available the vaccines your
patients need.
Vaccine Deliveries
Scheduling and Receiving Deliveries
All staff members who might receive vaccine deliveries must be aware of the importance of
maintaining the cold chain. They should be trained to immediately notify the vaccine coordinator
or alternate when deliveries arrive so that vaccines are checked in and stored quickly.
The person arranging for deliveries should know which staff member will be available to receive
them, considering holidays, vacations, and any changes in the facility’s hours of operation. Ideally,
the vaccine coordinator or alternate should be available to receive deliveries.
Never leave a vaccine shipping container unpacked and unattended. If vaccines and diluents
inside get too warm, they cannot be used. Be sure all staff members know that vaccine deliveries
require immediate attention.
Unpacking Deliveries
Vaccines and diluents must be carefully unpacked, stored at recommended

temperatures, and documented immediately after they arrive. Do not place an unopened
and/or unpacked shipment box in a vaccine storage unit.
When unpacking deliveries:
• Examine the shipping container and vaccines for signs of physical damage.
• Check the contents against the packing list to be sure they match.
––For varicella-containing (frozen) vaccines, the packing list will show the maximum time
vaccines can be in transit based on shipment date.
• If the shipment includes lyophilized (freeze-dried) vaccines, make sure they came with the
correct type and quantity of diluents. (Diluents for varicella-containing [frozen] vaccines are
stored in a separate compartment in the lid of the shipping container and should be stored
separately in the refrigerator.)
• Check both vaccine and diluent expiration dates to ensure you have not received any expired
or soon-to-expire products.
32
• Check the cold chain monitor (CCM) for any indication of a temperature excursion during
transit. CCMs are stored in a separate compartment of the shipping container (a CCM may not
be included when vaccines are shipped directly from the manufacturer). Note: CCMs are for
one-time use and should be thrown away after being checked.
If there are discrepancies between the contents and the packing list or other concerns about
the contents, immediately notify the vaccine manufacturer. If you are a VFC provider or receive
other vaccines purchased with public funds, contact your immunization program*.
Vaccine Inventory Accounting

Expiration Dates
Understanding expiration dates is a key component of managing your vaccine inventory. Vaccine
and diluent expiration dates indicate when the product must be discarded if it has not been used.
These dates are printed on vials, manufacturer-filled syringes, and packages.
When the expiration date has only a month and year, the product may be used up to and
including the last day of that month. If a day is included with the month and year, the
product may only be used through the end of that day.
Vaccine expiration date: Vaccine expiration date:

08/16/17 08/17
Note: Use through Note: Use through
August 16, 2017. August 31, 2017.
Do NOT use on or after Do NOT use on or after
August 17, 2017. September 1, 2017.
Vaccine may be used up to and including the expiration date.
Be aware of instances when vaccines expire before the expiration date on the label.
Sometimes vaccines must be used before the expiration date—by an earlier date known as the
“beyond use date” (BUD). The BUD is calculated based on the date the vial is first entered and
33
the storage information in the package insert. The BUD replaces the expiration date and should
be noted on the label along with the initials of the person making the change. Examples include:
• Reconstituted vaccines have a limited time frame for use once the vaccine is mixed
with a diluent. This time frame or BUD is noted in the package insert. For example, if the
package insert states that the reconstituted vaccine must be used within 30 minutes, it
must be discarded if not used by that time. This time frame might only apply as long as the
reconstituted vaccine is still in the vial—not after it is drawn into a syringe—so check the
package insert carefully.
• Multidose vials might have a specified time frame for use once they have been entered with
a needle. For example, the package insert may state that the vaccine must be discarded 28
days after it is entered. If the vial is entered on 06/01/2017, the BUD is 06/29/2017. The vaccine
should not be used after the BUD.
Manufacturer-shortened expiration dates may apply when vaccine is exposed to inappropriate

storage conditions. The manufacturer might determine that the vaccine can still be used, but will
expire on an earlier date than the date on the label.
Stock Record
A stock record helps you keep track of your vaccine inventory. These records can be in paper
or electronic form, or part of an immunization information system (IIS) with the capacity to
manage vaccine inventory. Many state and local programs that have an IIS with vaccine inventory
accounting functions will require VFC providers to use the IIS to track their inventory. The stock
record should be updated weekly.
You should account for and document every dose of vaccine on a stock record, including:
• Date of delivery (and initials of the person who unpacked the delivery)
• Vaccine and diluent name and manufacturer
• Number and expiration date for each lot (including expiration dates based on beyond use
date guidance in the product information)
• Number of doses received
• Condition of each vaccine and diluent upon arrival (i.e., did vaccine arrive in good condition
at the proper temperature?)
• Cold chain monitor (CCM) reading if a CCM is included in the shipping container (and actions
taken if the monitor was triggered, signaling a possible temperature excursion)
• Number of doses used (i.e., administered, wasted, compromised, expired, or transferred [and
destination])
• Balance of remaining doses after subtracting the amount used
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If you receive multiple doses of the same vaccine in the same presentation from the same lot
with the same expiration date, you can document these doses as one entry on the stock record.
Indicate the total number of doses received, regardless of how many vials or syringes the doses
came in. For example, if you receive 10 single-dose vials of the same vaccine with the same lot
number and expiration date, you can make a single entry on the stock record, noting that 10
doses were received.
Doses of diluents that come with lyophilized (freeze-dried) vaccines should be documented on a
separate stock record. Quantities of vaccines and their corresponding diluents should be equal at
all times.
Tally Sheets
Use tally sheets to help you keep your stock record up to date. Place tally sheets outside the
storage unit door (or another easily accessible location), and have staff use tick marks to keep
a count of every dose removed from the unit (with columns for those administered, wasted,
compromised, expired, or transferred).
At least weekly, add up the dose counts on the tally sheet and transfer that information to the
stock record.
Stock Rotation and Removal
Vaccine stock should be rotated and checked for expired doses regularly.
The vaccine coordinator (or other designated person) should rotate vaccine and diluent stock at
least once a week, as well as each time your facility receives a vaccine delivery. Arrange stock in
the storage unit so that for each vaccine type, doses with the earliest expiration dates are placed
in front of those with later expiration dates.
Check expiration dates on vaccines and diluents at least once a week, and immediately
remove any expired vaccines and diluents to avoid inadvertently administering them. Be sure
to document expired doses on the tally sheet and stock record. If expired vaccines were purchased
with public funds, contact your immunization program* to find out if they can be returned.
Stock Counts
At least once a month and before placing any vaccine order, count all vaccine and diluent doses
to make sure the number of doses in the storage unit matches the number of doses documented
in the stock record. Always check expiration dates while counting stock and remove any expired
doses immediately.
35
If the numbers do not match, enter the correct number based on your count on a separate line
below the old balance. Make a note next to the new entry indicating that your count confirmed the
new balance and sign it. Use the corrected balance for calculating stock quantities in the future.
At the end of each month, determine the total number of vaccine and diluent doses used during
the month and the amount of stock still available. At the end of each year, use your stock record
to determine the number of doses received for the year and add up your monthly dose counts to
get a total number of doses used. This information will help you determine your facility’s needs
and guide you in ordering in an effort to minimize future waste and reduce the need for transfer
and transport of vaccines.
Vaccine Ordering
The information in your stock record will help you determine the type and amount of vaccine
your facility should stock to meet the needs of your patients. Make sure you are only ordering the
vaccines and presentations that are appropriate for the ages and types of patients your facility
serves.
CDC recommends that providers should order and stock only enough vaccine to meet
patient needs.† Storing a larger volume than your facility needs can increase the risk of wasting
vaccines if they expire before they can be used or they are compromised in some way (e.g., due to
mechanical failure of a storage unit).
Most facilities should also reorder based on patient needs after doing a stock count. Vaccine
orders usually arrive within 1 to 2 weeks, but keep in mind there could be delays. If possible, avoid
placing last-minute or rush orders to prevent the risk of running out of vaccines.
† An adequate supply of vaccine for most providers or facilities would typically be enough to last 60 days, with a reordering
threshold of 30 days.
Vaccine Disposal
Medical waste disposal requirements are set by state environmental agencies. Contact your
immunization program* or state environmental agency for guidance to ensure your facility’s
vaccine disposal procedures (and any related documentation) comply with state and federal
regulations.
General disposal guidelines for:
• Vaccine doses that have expired or been compromised—contact your immunization

program* and/or the vaccine manufacturer. Sometimes unused vaccine and diluent doses,
36
unopened vials, expired vials, and potentially compromised vaccine may be returned for
credit, even if they must be discarded.
• Open vials and broken vials and syringes, as well as manufacturer-filled syringes that
have been activated and vaccine predrawn by providers—these cannot be returned and
should be discarded according to your state requirements.
• Empty vaccine vials—most are not considered hazardous or pharmaceutical waste
and do not require disposal in a biomedical waste container.† However, check your state
requirements before disposal.
† While vials are not usually considered hazardous or pharmaceutical waste, an empty RV dispensing tube or oral applicator is
considered medical waste and should be disposed of in a medical waste container.
Vaccine Transport to Off-site or Satellite Facilities

“Transport” has a different meaning than “shipping,” which usually involves a professional
carrier and a longer distance and time period for moving vaccines between locations. Transport
involves the movement of vaccine over a short time frame and distance between providers. The
time needed to transport should be fewer than 8 hours and vaccine should be placed in a stable
storage unit as quickly as possible. CDC does not recommend any shipment of vaccines from
your vaccine supply or any routine transport of vaccines.
Vaccines should only be transported when absolutely necessary (e.g., for a mass
immunization clinic, in an emergency, or to ensure vaccines that are about to expire† can be
used rather than wasted). Frozen varicella-containing vaccines should never be transported
except in an emergency.
CDC does not recommend reshipping vaccines after receiving them from a commercial distributor
or manufacturer because doing so would put the cold chain, and ultimately, the viability of the
vaccines, at risk.
Transport of Refrigerated Vaccines
Vaccines that will be used at an off-site or satellite facility should be delivered directly
to that facility. If that is not possible, transport of vaccines should be done using a portable
vaccine refrigerator with a temperature monitoring device placed with the vaccines. If this is
not available, qualified containers and pack-outs can be used with a temperature monitoring
device. If you must transport vaccines, transport only what is needed for the workday. The total
time for transport and workday should be a maximum of 8 hours. If you must transport vaccines
in non-commercial vehicles, use the passenger compartment—not the trunk.
37
Immediately upon arrival at an off-site/satellite facility, vaccines should be stored in an

appropriate storage unit with a temperature monitoring device, and temperatures should be read
and recorded a minimum of 2 times during the workday.
If vaccines cannot be stored in an on-site storage unit, they should be kept in the portable
vaccine refrigerator during an off-site clinic:
• Place a temperature monitoring device (preferably with a probe in a thermal buffer) as

close as possible to the vaccines, and read and record temperatures at least hourly.
• Keep the container closed as much as possible.
• Remove only 1 multidose vial or 10 doses at a time for preparation and administration by
each person administering vaccines.
Transport of Diluents
Transport diluents with their corresponding vaccines to ensure there are always equal
amounts of vaccines and diluents for reconstitution. Follow the manufacturer’s guidance for
specific temperature requirements.
Diluents that contain antigen (e.g., DTaP-IPV diluent used with Hib lyophilized vaccine and
MenCWY diluent used with MenA lyophilized vaccine) should be transported with the
corresponding vaccines at refrigerator temperature.
If diluents that are stored at room temperature (68°F to 77°F or 20°C to 25°C) are going to be
transported with refrigerated vaccines, they should be refrigerated in advance for as long as
possible so they do not raise the container temperature when placed with refrigerated vaccines.
If you have concerns about vaccines or diluents that may have been compromised (exposed to
inappropriate conditions or temperatures or handled improperly), label them “DO NOT USE” and
store them in appropriate refrigerated conditions (set apart from other vaccines). Immediately
contact your immunization program* or vaccine manufacturer(s) for guidance. Do not discard
the vaccines or diluents unless directed to do so by the immunization program or manufacturer.
Emergency Transport
CDC recommends all vaccine providers have emergency plans and SOPs for transporting
vaccines. Portable vaccine refrigerators are recommended when vaccines must be transported.
Qualified containers and pack-outs can be used in an emergency. See the section on Emergency
Vaccine Storage, Handling, and Transport Preparations for more information related to
emergency transport.
Packing Vaccines for Transport during Emergencies: www.cdc.gov/vaccines/hcp/admin/storage/downloads/emergency-transport.pdf
†If you are a VFC provider, or have other vaccines purchased with public funds, and must transfer vaccine to another facility so it can be used
before it expires, contact your immunization program* (www.cdc.gov/vaccines/imz-managers/awardee-imz-websites.html) for guidance
on vaccine transport.
38
Preparing Vaccine for Administration

Vaccine preparation is the final step in the cold chain
before administration. Handling vaccines with care is equally
as important as storing them properly.
• Vaccines should be prepared in a designated area away

from any space where potentially contaminated items are
placed.
• Only prepare vaccines when you are ready to
administer them. Always check expiration dates and
confirm that you have selected the correct vaccine.
• Only administer vaccines you have prepared. This
is a quality control and patient safety issue and a best
practice standard of medication administration. If vaccine
is drawn up by one person but administered by another,
the person administering the vaccine cannot be sure
what is in the syringe and whether it is safe.
Single-dose Vials
A single-dose vial (SDV) contains ONE dose and should be used ONE time for ONE patient.
Do not combine leftover vaccine from one SDV with another to obtain a dose.
Single-dose vials do not contain a preservative to help prevent the growth of microorganisms.
There have been outbreaks of infections caused by pooling contents and/or storing contents for
future use.
Do not open an SDV until ready to use. Before you remove the protective cap, always check
the vial to make sure you have the correct vaccine. Once you remove the cap, you must use the
vaccine because it may not be possible to determine if the rubber seal has been punctured.
Discard any unused SDVs without a protective cap at the end of the workday.
Single-dose vials are meant for one-time use only. Once unsealed, discard vial at end of the workday.
39
Multidose Vials
A multidose vial (MDV) contains more than one dose of vaccine. Because MDVs typically contain
a preservative to help prevent the growth of microorganisms, they can be entered or punctured
more than once. Only the number of doses indicated in the manufacturer’s package insert should
be withdrawn from the vial. After the maximum number of doses has been withdrawn, the vial
should be discarded, even if there is residual and the expiration date has not been reached.
MDVs can be used until the expiration date printed on the vial unless the vaccine is contaminated
or compromised in some way or there is a beyond use date (BUD) noted in the package insert.
Never use partial doses from two or more vials to obtain a dose of vaccine.
Manufacturer-filled Syringes
A manufacturer-filled syringe (MFS) is prepared and sealed under

sterile conditions by the manufacturer. Do not activate an MFS
(i.e., remove the syringe cap or attach the needle) until ready
to use. MFSs do not contain a preservative to help prevent the
growth of microorganisms. Once the sterile seal has been broken,
the vaccine should be used or discarded at the end of the workday.
Reconstitution Manufacturer-filled syringes
Lyophilized (freeze-dried) vaccines may be in the form of a powder or pellet that must be mixed
with a liquid (diluent) in a process known as “reconstitution” before being administered.
Liquid diluents vary in volume and composition, and are specifically designed to meet volume,
pH (acid/alkaline balance), and chemical requirements of their corresponding vaccine. Some
diluents contain antigen (e.g., DTaP-IPV).
Diluents are not interchangeable unless specified by the manufacturer (e.g., those for MMR,
varicella, zoster, and MMRV). Even if the diluent is composed of sterile water or saline, use only the
diluent supplied with the vaccine to reconstitute
it. Never use a stock vial of sterile water or
normal saline to reconstitute vaccines.
Never administer vaccine reconstituted with

the wrong diluent. If the vaccine has already + =
been administered, contact your immunization
program* and/or vaccine manufacturer for
guidance on revaccination.
Always check expiration dates on both diluents

Diluent + lyophilized powder = Reconstituted vaccine
and vaccines before reconstituting them.
40
Predrawing Vaccines
CDC recommends drawing up vaccines only at the time of administration. Once vaccines
are inside syringes, it is difficult to tell them apart, which can lead to administration errors.
Predrawing can also result in vaccine waste if more is drawn up than is needed.
General-use syringes are designed for immediate administration—not for storage. Contamination
and growth of microorganisms can occur in syringes with predrawn vaccine that does not contain
a preservative. In addition, vaccine components may interact with polymers in a plastic syringe
over time, potentially reducing vaccine potency.
Vaccine manufacturers do not recommend predrawing vaccines in advance of influenza

vaccination clinics because no data exist on the stability of vaccines stored in general-use
syringes that have been filled by providers.
As an alternative to predrawing vaccines, CDC recommends using manufacturer-filled

syringes for large immunization clinics.
If vaccine must be predrawn:
• Set up a separate administration station for each vaccine type to prevent medication errors.
• Do not draw up vaccines before arriving at the clinic site. Drawing up doses hours or
even days before a clinic is not acceptable.
• Each person administering vaccines should draw up no more than one MDV, or 10 doses, at
one time.
• Monitor patient flow to avoid drawing up unnecessary doses.
• Discard any remaining vaccine in predrawn syringes at the end of the workday.
• Do not predraw reconstituted vaccine into a syringe until you are ready to administer it. If
not used within 30 minutes of being reconstituted, follow manufacturer guidance for storage
conditions and time limits. A manufacturer may specify that an unused reconstituted vaccine
can only be stored in the vial for the indicated time.
• Never transfer predrawn reconstituted vaccine back into a vial for storage.
41
Emergency Vaccine Storage, Handling, and Transport Preparations
Emergencies usually happen without warning. Various situations—equipment failures, power

outages, severe weather conditions, or natural disasters—may compromise vaccine storage
conditions. Vaccines should never be allowed to remain in a nonfunctioning unit for an
extended period of time. Therefore, making preparations in advance to retrieve and/or protect
vaccines as quickly as possible during a potentially compromising situation could save your
facility costly vaccine loss.
Emergency Backup Options

Backup Equipment
No piece of vaccine storage equipment is infallible. At some point, equipment will fail because of
a power outage, breakdown, or normal wear and tear.
At a minimum, every facility should have:
• Backup digital data logger(s)

• Spare batteries
• Flashlights (in case of a power outage)
• Vaccine transport containers and materials
Your facility may also choose to have a backup storage unit so that vaccine may not have to be
packed and/or moved to an alternative storage facility if the primary storage equipment fails.
Generators
An on-site generator can prevent having to transport vaccine

to an alternative storage facility during a power outage. Keep
sufficient fuel on hand to continuously run the generator for at
least 72 hours.
Alternative Vaccine Storage Facility

Backup generator
Even if you have backup equipment or a generator, you should
establish a working agreement with at least one alternative storage facility with a backup
generator where vaccines can be appropriately stored and monitored in an emergency. Hospitals,
long-term care facilities, state depots, the Red Cross, fire stations, packing plants, and commercial
pharmacies are some of the facilities that may be able to assist you.
42
Establish at least one alternate storage facility where vaccines can be appropriately stored and monitored.
This facility should have a backup generator.
An agreement with an alternative facility should allow you to store vaccines when:
• Severe weather conditions are expected. If there is reasonable cause to believe weather
circumstances might impact your facility, implement emergency procedures in advance of
the event.
• Equipment fails or power cannot be restored before the storage unit temperature rises above
the recommended range.
Always make sure you can have 24-hour access to the alternative facility.
If an Alternative Vaccine Storage Facility is Not Available
If you cannot find an alternative vaccine storage facility with a backup generator within a
reasonable distance, or if you cannot reach your alternative facility, you can use qualified
containers and pack-outs* to store vaccines temporarily and safely at your facility. Always place
a temperature monitoring device with the vaccines. Temporary storage containers should remain
closed, and vaccines should only be stored for as long as the qualified containers and pack-outs
are validated to maintain proper storage temperatures.
*Packing Vaccines for Transport during Emergencies: www.cdc.gov/vaccines/hcp/admin/storage/downloads/emergency-

transport.pdf
43
Accessing Your Building After Hours
An emergency situation can arise outside of business hours, and having a relationship with your
facility’s building manager and/or security staff can be essential to protecting your vaccines. Meet
with the manager and/or security personnel regularly and always introduce them to new staff
members. Your storage and handling SOPs should have written instructions for accessing your
vaccine storage units when the building is closed.
Provide anyone who needs access to vaccine storage units during an emergency with written
instructions, a building diagram/map, and locations of:
• Spare batteries
• Flashlights
• Keys
• Locks
• Circuit breakers
• Packing materials
Keep information on after-hours building access and security procedures (including alarm codes)
with the SOPs, and also make sure relevant staff members (and building management and
security staff, if appropriate) have copies of this information available at home.
Power Outages
During a power outage, never open the storage unit door until power is restored or
it is determined that vaccines need to be packed in separate storage containers and/or
transported to an alternative storage facility.
Monitoring Unit Temperature during a Power Outage
Units with Outside Temperature Monitoring Devices
If you can monitor the temperature of the storage unit from the outside without opening the
door, take the following steps:
• Record room temperature (if possible) and the temperature inside the unit as soon as the
power goes out.
• Record minimum and maximum temperatures reached inside the unit during the outage.
• If temperatures have fallen outside of the recommended range, follow your procedures for
out-of-range temperatures/excursions.
44
• If you are unsure how long the power interruption will last, or you determine power will
not be restored in time to maintain proper temperatures inside the unit, implement your
emergency vaccine storage, handling, and transport procedures.
Units without Outside Temperature Monitoring Devices
If you cannot monitor the temperature inside the unit without opening the door, wait until the
power is restored, then take the following steps:
• Record the room temperature (if possible) and the temperature inside the unit.
• If using a digital data logger, document the length of time power was off and the minimum
and maximum temperatures during that period.
• If temperatures inside the unit have already fallen outside of the recommended range, follow
your procedures for out-of-range temperatures/excursions.
• If you are unsure how long the power interruption will last, or you determine power will
not be restored in time to maintain proper temperatures inside the unit, implement your
emergency vaccine storage, handling, and transport procedures.
The Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration
(FDA) offers general guidance concerning storage and use of temperature-sensitive biological
products that have been involved in temporary electrical power failure or flood conditions,
Impact of Severe Weather Conditions on Biological Products.†
†Impact of Severe Weather Conditions on Biological Products: www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/

ProductSecurity/ucm147243.htm
Vaccine Transport Containers and Materials

For the safe transport and storage of vaccines, proper supplies are essential. Your facility should
have a sufficient supply of materials needed for emergency vaccine transport of your largest
annual inventory.
Appropriate materials include:
• Portable vaccine refrigerator/freezer units† (recommended)

• Hard-sided insulated or Styrofoam™†
• Coolant materials: frozen 16.9- or 8-ounce water bottles that can be conditioned or 4° C to 5° C
phase change materials (PCMs)
• Insulating materials such as bubble wrap or corrugated cardboard—enough to form two
layers per container
• Digital data logger for each container
45
Do not use soft-sided coolers. Most commercially available soft-sided coolers are poorly insulated
and likely to be affected by room or outdoor temperatures.
Coolant Materials
Frozen water bottles can be used as coolant packs if they are properly conditioned, which
should take only a few minutes:
• Hold the bottles under running tap water or submerge them in a sink filled with tap water
until you can easily see a layer of water forming near the surface of the plastic.
• Once the ice block inside the bottle can spin freely, the bottle is ready to be used for packing.
The inner block of ice will continue to melt while maintaining a constant temperature in the
cooler.
• Use appropriate insulating materials, such as bubble wrap, to protect vaccines from direct
contact with the water bottles.
Phase change materials (PCMs) at 4° C –5° C (39° F –41° F) can also be purchased to maintain
proper temperatures. Follow the manufacturer’s instructions for use to reduce the risk of freezing
vaccines during transport.
Do not use frozen gel packs or coolant packs from vaccine shipments to pack refrigerated
vaccines. Even if they are conditioned or appear to be “sweating,” they can still freeze vaccines.
†If these items are not available, the manufacturer’s original shipping boxes may be used for emergency transport.
Emergency Vaccine Packing and Transport

Improper packing for transport is as risky for vaccines as a failed storage unit. To help make sure
your vaccines arrive safely, follow your facility’s emergency retrieval and transport SOPs. These
should include, at a minimum, the following procedures and protocols:
Packing
• If possible, suspend vaccination activities before the onset of emergency conditions to allow
more time for packing and transport.
• Contact the alternative vaccine storage facility before packing any vaccine to confirm their
generator is working and they can accept your vaccines for storage.
• Take an inventory of your vaccines and record actions taken to protect the vaccines. Be sure
to note whether there were water bottles in the unit at the time of the event.
46
• Open unit doors only when absolutely necessary and only after completing all preparations
for packing and moving vaccines.
• Use appropriate materials for packing. CDC has compiled recommendations on the methods
and materials to use for emergency vaccine transport, Packing Vaccines for Transport
during Emergencies.*
Transport
• Identify primary and backup vehicles and drivers in advance.
• Consider renting a refrigerated truck if you have a large quantity of vaccines or need to
transport vaccines an extended distance.
• If using a noncommercial vehicle, only transport vaccines inside the passenger compartment
(not in the trunk).
• Move transport containers directly to a preheated or precooled vehicle.
• Avoid leaving containers in areas where they are exposed to direct sunlight.
• Check vaccine temperature upon arrival at the alternative vaccine storage facility, and store
vaccines at recommended temperatures immediately.
• Check with your immunization program* for additional guidance and resources on
emergency transport of vaccines, particularly in major emergencies.
Transport of Diluents
Transport diluents with their corresponding vaccines to ensure there are always equal
amounts of vaccines and diluents for reconstitution. Follow the manufacturer’s guidance for
specific temperature requirements.
Diluents that contain antigen (e.g., DTaP-IPV diluent used with Hib lyophilized vaccine and
MenCWY diluent used with MenA lyophilized vaccine) should be transported with the
corresponding vaccines at refrigerator temperature.
If diluents that are stored at room temperature (68°F to 77°F or 20°C to 25°C ) are going to be
transported with refrigerated vaccines, they should be refrigerated in advance for as long as
possible so they do not raise the container temperature when placed with refrigerated vaccines.
Place an insulating barrier (e.g., bubble wrap) between the diluents and conditioned water bottles
or phase change materials.
Never freeze diluents, not even during transport.
47
Transport of Varicella-containing (Frozen) Vaccines
The manufacturer does not recommend transporting frozen vaccines (varicella, zoster,
MMRV).
If these vaccines must be transported during an emergency, CDC recommends using a

portable vaccine freezer unit (available for rent in some areas) or qualified container and pack-out
that maintains temperatures between -50° C and -15° C (-58° F and +5° F).
Follow these steps for transporting frozen vaccines:
• Place a calibrated temperature monitoring device (preferably with a buffered probe) in the
container as close as possible to the vaccines.
• Record the time vaccines are removed from the storage unit and placed in the container, the
temperature during transport, and the time at the end of transport when vaccines are placed
in a stable storage unit.
• Immediately upon arrival at the destination, place vaccines in a freezer at a temperature
range between -50° C and -15° C (-58° F and +5° F). Any stand-alone freezer that maintains
these temperatures is acceptable.
Do not use dry ice, even for temporary storage. Dry ice might expose the vaccines to
temperatures colder than -50° C (-58° F).
If necessary, varicella-containing vaccines that have not been reconstituted may be transported
at refrigerator temperatures between 2° C and 8° C (36° F and 46° F). Varicella-containing vaccines
can be refrigerated for up to 72 continuous hours before reconstitution. Transported varicella-
containing vaccines cannot be put back in the freezer. They must be used or discarded.
Transport of Multidose Vials
If absolutely necessary, a partially used vial may be transported to or from an off-site/satellite

facility operated by the same provider, as long as the cold chain is properly maintained. However,
a partially used vial cannot be transferred from one provider to another or across state
lines.
48
Temperature Monitoring During Transport
Use a digital data logger for continuous temperature monitoring and recording while
transporting vaccines:
• The digital data logger should have an accuracy of +/-.5° C (+/-1° F).
• Place liquid or solid buffered probe material in a sealed vial directly with the vaccines.
• Keep the data logger display on top of vaccines so you can easily see the temperatures.
CDC does not recommend using cold chain monitors during transport since they provide
limited data on temperature excursions that may occur.
If you have concerns about vaccines or diluents that may have been compromised (exposed to
inappropriate conditions or temperatures or handled improperly), label them “DO NOT USE” and
store them in appropriate refrigerated conditions (set apart from other vaccines). Immediately
contact your immunization program* or vaccine manufacturer(s) for guidance. Do not
discard the vaccines or diluents unless directed to do so by the immunization program or
manufacturer.
*Packing Vaccines for Transport during Emergencies: www.cdc.gov/vaccines/hcp/admin/storage/downloads/emergency-

transport.pdf
49
Vaccine Storage and Handling Standard Operating Procedures (SOPs)
Clearly written, detailed, and up-to-date storage and handling standard operating
procedures (SOPs) will help your facility stay organized, serve as a reference and training
tool, and assure proper vaccine management. Without SOPs, there is no way to be
sure proper procedures will be followed or that problems will be identified, reported, or
corrected. SOPs should also provide guidance for emergency situations such as equipment
malfunctions, power failures, or natural disasters. SOPs are a critical component in
protecting your vaccine supply and, ultimately, your patients.
If you have multiple facilities, the details of your SOPs may differ depending on local
policies.
Storage and Handling SOP Sections

Storage and handling SOPs should be reviewed and updated annually and should
contain plans and information for three major areas (Vaccine Storage and Handling SOP
Worksheet):
• General information—includes contact information for vaccine manufacturers, equipment

service providers, and important facility staff, as well as job descriptions, regularly used
forms, and staff training requirements
• Routine storage and handling—includes all routine aspects of vaccine inventory
management, from ordering to monitoring storage conditions
• Emergency vaccine storage, handling, and transport—outlines steps to be taken in the event
of equipment malfunctions, power failures, natural disasters, or other emergencies that
might compromise vaccine storage conditions
General Information†
General information should include:
• Contact information for:

––Primary vaccine coordinator
––Alternate vaccine coordinator
––Additional staff to assist in emergencies
––Immunization program*
––Vaccine manufacturers
––Refrigerator and freezer maintenance and repair companies
––Temperature monitoring device (DDL) companies
––Utility/power company
50
––Vaccine storage unit alarm company (if applicable)

––Generator repair company (if applicable)
––Sources for qualified containers and pack-outs and calibrated temperature monitoring
devices
• Descriptions of roles and responsibilities of primary and alternate vaccine coordinators
• Information for each storage unit, including serial number, links to equipment websites,
installation dates, and routine maintenance and repair records
• Samples of all vaccine-related forms used in your facility
• Protocols for staff education and training
Routine Storage and Handling†

Routine storage and handling information
should include protocols for:
• Ordering and accepting vaccine deliveries

• Receiving and unpacking deliveries
• Managing inventory
• Storage requirements for each vaccine and
diluent in your inventory (package inserts*)
• Placing vaccines and diluents in storage
units
• Handling vaccines prior to administration
• Disposing of vaccines and supplies Each facility should have routine and emergency plans.
• Monitoring storage unit and temperature
• Maintaining storage equipment and temperature monitoring devices
• Responding to storage and handling problems
• Transporting vaccines to off-site/satellite facilities
Emergency Storage, Handling, and Transport†‡§††

Because emergencies can happen at any time, it is important that in addition to facility
staff, custodians, security officers, and/or building managers are aware of the emergency
plan and know how to notify appropriate staff about any problems with vaccine storage
equipment or power outages.
Copies of the emergency SOPs should be stored with the emergency supplies, kept with
vaccine coordinator staff at their homes, and shared with others as appropriate, such as
security officers or building managers.
51
Emergency storage, handling, and transport information should include:

• A primary and alternate staff contact for each type of emergency (e.g., power outage,
weather conditions, equipment failure), as well as designated drivers for transporting
vaccines and transport vehicle information (contact information should be reviewed
quarterly)
• Name and address of alternative vaccine storage facility, names and numbers of contact
persons, and 24-hour access information for facility
• Names and numbers for companies or private drivers to transport vaccines to alternative
vaccine storage facilities
• Sources of qualified containers and pack-outs and calibrated temperature monitoring
devices
• Vaccine storage unit specifications, including brand name, model number, serial number, and
maintenance and repair company contact information
• A facility floor diagram showing the locations of important elements, including doors,
flashlights, spare batteries, keys, locks, circuit breakers, and packing materials
• Protocols for:
––Monitoring vaccines during a power outage
––Packing vaccines and diluents for emergency transport
––Transporting vaccines to and from an alternative vaccine storage facility
––Assessing whether vaccine can be used after an emergency
––Accessing your building and facility after hours
If you are a VFC provider or have other vaccine purchased with public funds, contact your
immunization program* for guidance regarding routine and emergency SOPs.

Manufacturers’ package inserts: www.immunize.org/packageinserts/
†Additional resources are available in Resources and from the Immunization Action Coalition (IAC): Clinical Resources – Storage
and Handling (www.immunize.org/clinic/storage-handling.asp) and Emergency Response Worksheet (www.immunize.org/
catg.d/p3051.pdf).
‡Contact your immunization program for details about specific state or local regulations impacting this activity.
§The Federal Emergency Management Agency (FEMA) offers a wide range of information on disaster preparedness: www.fema.gov/.
††The Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) offers information concerning
the storage and use of temperature-sensitive biological products that have been involved in a temporary electrical power failure or
flood conditions: www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ProductSecurity/ucm147243.htm.
52
Resources
Glossary of Key Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Additional References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Vaccine Storage and Handling SOP Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Vaccine Manufacturer/Distributor Contact List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Stock Record
Sample Stock Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Stock Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Tally Sheet
Sample Tally Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Tally Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Vaccine Storage Rules Poster. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Warning Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Do Not Adjust Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Refrigerator (English/Spanish). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Freezer (English/Spanish) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Do Not Stop Power to Circuit Breaker. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Do Not Unplug Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Refrigerator (English/Spanish). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Freezer (English/Spanish) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Transport Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Refrigerate Upon Arrival . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Freeze Upon Arrival. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Open Immediately. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Refrigerate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Freeze. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Fragile. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Perishable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
53
Resources
Glossary of Key Terms
Buffered temperature probe Temperature probe designed to prevent false readings by protecting
the thermometer from sudden changes in temperature that can occur
when opening a refrigerator door. A probe is “buffered” by immersing
it in a vial filled with liquid (e.g., glycol, ethanol, glycerin), loose media
(e.g., sand, glass beads), or a solid block of material (e.g., Teflon®,
aluminum).
Beyond use date (BUD) The date or time after which a vaccine should not be administered,
stored, or transported. The BUD should never exceed the
manufacturer’s original expiration date.
Calibration Professional measurement of the accuracy of a temperature

monitoring device’s readings against nationally accepted standards.
Cold chain monitor (CCM) Generally, a single-use device that monitors the temperature inside of
a vaccine shipping container.
Conditioned water bottles Frozen water bottles that have been submerged under lukewarm
water until the ice block inside can spin freely.
Diluent A diluting agent (e.g., a liquid) added to reconstitute lyophilized

vaccine before administration. Manufacturers of freeze-dried vaccine
also supply the matching diluents.
Dormitory-style (bar-style) A combination refrigerator/freezer unit with one exterior door and
storage unit an evaporator plate (cooling coil), which is usually located inside an
icemaker compartment (freezer) within the refrigerator. These units
have been shown to pose a significant risk of freezing vaccines, even
when used for temporary storage.
Fan-forced air circulation Technology using powerful fans or multiple cool air vents inside
the unit that promote uniform temperature and fast temperature
recovery.
Lyophilized Freeze-dried; usually referring to a vaccine that is freeze-dried into a

powder or wafer.
Minimum/maximum A vaccine storage unit’s coldest and warmest temperature readings

temperature during a set period of time.
54
Resources
Glossary of Key Terms
Phase change materials Engineered packing supplies that help control container temperatures
(PCM) during vaccine transport or shipping.
Potency A vaccine’s strength or effectiveness; in the context of this toolkit,

potency refers to a vaccine’s response to environmental conditions.
Presentation Type of packaging for a vaccine (e.g., single-dose vial, multidose vial,
manufacturer-filled syringe, etc.).
Qualified container and A type of container and supplies specifically designed for use
pack-out when packing vaccines for transport. They are “qualified” through
laboratory testing under controlled conditions to ensure they achieve
and maintain desired temperatures for a set amount of time.
Soon-to-expire products Products that will expire within the next month.
Temperature excursion Any temperature reading that is outside the recommended range for
vaccine storage as defined by the manufacturer’s package insert.
Tolerance Compliance with nationally accepted standards for the calibration

limits of temperature monitoring equipment. The equipment can
either be considered “in” or “out of” tolerance.
Traceability An unbroken chain of measurements and associated uncertainties.
Uncertainty The quantification of the doubt about the measurement result.
55
Resources
Additional References
General Vaccine Storage and Handling Information
• CDC Vaccine Storage and Handling home page

(www.cdc.gov/vaccines/recs/storage/default.htm)
• CDC Vaccine Price List
(www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/)
• National Institute of Standards and Technology (NIST) “Storage and Monitoring of Vaccines”
(www.nist.gov/pml/div685/grp01/vaccines.cfm)
• Advisory Committee on Immunization Practices Recommendations
(www.cdc.gov/vaccines/acip/recs/index.html)
• Contact Information for State/Local Immunization Programs
(www.cdc.gov/vaccines/imz-managers/awardee-imz-websites.html)
• Specific Immunization Questions: E-mail CDC at [email protected]
Vaccine Labels for Storage Units (can be printed and reproduced)
• Vaccine Label Examples

(www.cdc.gov/vaccines/hcp/admin/storage/guide/vaccine-storage-labels.pdf)
• 2016-2017 Influenza Vaccine Label Examples
(www.cdc.gov/vaccines/hcp/admin/storage/index.html)
Emergency Vaccine Storage and Handling Resources
• Packing Vaccines for Transport during Emergencies

(www.cdc.gov/vaccines/recs/storage/downloads/emergency-transport.pdf)
Immunization Action Coalition Resources
• Vaccine Manufacturers’ Package Inserts

(www.immunize.org/packageinserts/)
• Handouts: Clinic Resources on Storage and Handling
(www.immunize.org/handouts/vaccine-storage-handling.asp)
• Temperature Monitoring Log
(www.immunize.org/handouts/temperature-logs.asp)
• Vaccine Storage Troubleshooting Record
(http://www.immunize.org/catg.d/p3041.pdf)
• Emergency Response Worksheet
(www.immunize.org/catg.d/p3051.pdf)
• Vaccines with Diluents: How to Use Them
(www.immunize.org/catg.d/p3040.pdf)
• State Immunization Program websites
(www.immunize.org/states/)
56
Resources
Additional References
Emergency Management Resources
• The National Oceanic and Atmospheric Administration (NOAA) provides up-to-date information on
U.S. weather conditions:
www.weather.gov/
goes.noaa.gov/
• The Federal Emergency Management Agency (FEMA) offers a wide range of information on disaster
preparedness:
www.fema.gov/
• The Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA)
offers information concerning the storage and use of temperature-sensitive biological products that
have been involved in a temporary electrical power failure or flood conditions:
www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ProductsSecurity/ucm147243.htm
• International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement
Signatories:
ILAC.org/ILAC-MRA-and-signatories/
57
Resources
Vaccine Storage and Handling SOP Worksheet
Complete the following checklist and forms and store this information in an
easily accessible area near the vaccine storage unit.
Checklist of General Information

Up-to-date contact information
––Primary vaccine coordinator
––Alternate vaccine coordinator
––Additional staff to assist in emergencies
––Immunization program
––Vaccine manufacturers
––Refrigerator and freezer maintenance and repair companies
––Temperature monitoring device companies
––Utility/power company
––Vaccine storage unit alarm company (if applicable)
––Generator repair company (if applicable)
––Sources for qualified containers and pack-outs
Descriptions of the roles and responsibilities of the primary and alternate (backup) vaccine
coordinators
––Information for each storage unit, including serial number, links to equipment websites,
installation dates, and routine maintenance and repair records
––Samples of all vaccine-related forms used in your facility
––Protocols for staff education and training
Checklist for Routine Storage and Handling

Protocols for:
––Ordering and accepting vaccine deliveries
––Receiving and unpacking deliveries
––Managing inventory
––Storage requirements for each vaccine and diluent in your inventory (package inserts)
––Placing vaccines and diluents in storage units
––Handling vaccines prior to administration
––Disposing of vaccines and supplies
––Monitoring storage unit and temperature
––Maintaining storage equipment and temperature monitoring devices
––Responding to storage and handling problems
––Transporting vaccines to off-site/satellite facilities
58
Resources
Checklist of Emergency Vaccine Storage, Handling, and Transport
All contact information in General Information as well as up-to-date contact information for:
––Alternative vaccine storage facility(ies)
––Transportation of vaccines
Vaccine storage unit specifications (type, brand, model number, serial number)
Diagram of facility showing important elements, including doors, flashlights, packing materials,
batteries, circuit breakers
Protocols for:
––Monitoring vaccines during a power outage
––Packing vaccines and diluents for emergency transport
––Transporting vaccines to and from an alternative vaccine storage facility
––Assessing whether vaccine can be used after an emergency
––Accessing your building and facility after hours
Store emergency information with emergency supplies. Keep

copies in multiple off-site locations, including homes of the vaccine
coordinator staff, alternative storage facility(ies), and with the
building/facility manager and security office (if appropriate).
59
Resources
Staff Contact List
Telephone Numbers
Name Title E-mail Address
home/cell/other
Primary Vaccine Coordinator
Alternate Vaccine Coordinator
Emergency Staff Contact List*

Telephone Numbers
Name Title E-mail Address
home/cell/other
1.
2.
3.
4.
5.
6.
* List contacts in order of preference. Determine whether all or certain persons on the list should be contacted or if
the first person reached is sufficient. Include the primary and alternate vaccine coordinators on the list.
60
Resources
General Resources Contact List
Contact Person Telephone Numbers

Resources E-mail Address
Name/Title home/cell/other
Local Health Department
Immunization Program
State Health Department

Immunization Program
Vaccine Manufacturers
Refrigerator Repair
Company
Freezer Repair Company
Utility/Power Company
Temperature Monitoring
Device Company
Vaccine Storage Unit Alarm

Company (if applicable)
Generator Repair Company

(if applicable)
61
Resources
Alternate Vaccine Storage Facilities

Alternate Vaccine Storage
Contact Person Telephone Numbers
Facility E-mail Address
Name/Title home/cell/other
Name/Address
1.
2.
3.
4.
Transportation to Alternate Vaccine Storage Facilities
Emergency Resources Contact Person Telephone Numbers

E-mail Address
Name/Address Name/Title home/cell/other
Refrigeration Company
Refrigeration Company
(alternate)
Private Vehicle
Private Vehicle (alternate)
62
Resources
Packing Material Suppliers Contact List
Emergency Resources Contact Person Telephone Numbers

E-mail Address
Company Name Name/Title home/cell/other
Portable vaccine
refrigerator/ freezer units
Qualified containers and

pack-out materials
Qualified containers
and pack-out materials
(alternate)
Packing materials
Packing materials
(alternate)
Vaccine Storage Unit Specifications

Type of Unit (Refrigerator or
Brand Model Number Serial Number
Freezer)
1.
2.
3.
4.
5.
63
Resources
Vaccine Manufacturer/Distributor Contact List

Telephone
Manufacturer/Distributor Websites Products
Number/E-mail
ACAM2000 Sanofi Pasteur 800-822-2463
www.sanofipasteur.us/vaccines/ www.sanofipasteur.us/ Smallpox
ACAM2000 contact
bioCSL 888-435-8633 or 855-358-8966

IIV
www.seqirus-us.com/products.htm [email protected]

www.cdc.gov/ncidod/srp/drugs/drug- Distributor for anthrax
404-639-3670 vaccine adsorbed (AVA),
service.html
[email protected] diphtheria antitoxin,
www.cdc.gov/laboratory/drugservice/ smallpox vaccine
index.html
CSL Limited (Merck Distributor)

800-637-2590 IIV
www.merckvaccines.com/
Emergent BioDefense Operations Lansing,

877-246-8472 Anthrax vaccine adsorbed
Inc.
[email protected] (AVA)
www.biothrax.com/
DTaP, DTaP-HepB-IPV, DTaP-
866-475-8222 IPV, HepA, HepB, HepA-
GlaxoSmithKline (GSK) HepB, Hib, Hib- MenCY,
vaccine.service-center@gsk. 2vHPV, IIV, JE, MenB-4C,
www.gskvaccines.com/
com MenACWY-CRM, Rabies,
RV1, Tdap
Massachusetts Biological Labs

800-457-4626 Td
www.umassmed.edu/massbiologics/
877-633-4411
MedImmune
medicalinformation@ LAIV
www.medimmune.com/
medimmune.com
64
Resources
Vaccine Manufacturer/Distributor Contact List
Telephone
Manufacturer/Distributor Websites Products
Number/E-mail
HepA, HepB, Hib, Hib-
Merck & Co., Inc HepB, 4vHPV, 9vHPV, HZV,
877-829-6372
www.merckvaccines.com/ MMR, MMRV, PPSV23, RV5,
VAR
877-683-4732
Novartis
Vaccineinfo.us@novartis. IIV, JE, MCV4, Rabies
www.novartis.com/about-us/contact
com
PaxVax (800) 533-5899

Typhoid (oral)
www.paxvaxconnect.com/vivotif [email protected]
Pfizer/Wyeth
800-438-1985 MenB-FHbp, PCV13
pfizerpro.com/
Protein Sciences 800-488-7099

www.flublok.com/contact. IIV
www.flublok.com/professionals.html html
DT, DTaP, DTaP-IPV/Hib,

Sanofi Pasteur DTaP-IPV, Hib, IIV, IPV,
800-822-2463 MenACWY-D, MPSV4,
www.vaccineshoppe.com/ Rabies, Td, Tdap, TT,
Typhoid, YF
65
Resources
Fahrenheit to Celsius and Celsius to Fahrenheit Conversion
°F °C °F °C °F °C °C °F °C °F
-22 -30 21 -6.1 64 17.8 -30 -22 13 55.4

-21 -29.4 22 -5.6 65 18.3 -29 -20.2 14 57.2
-20 -28.9 23 -5 66 18.9 -28 -18.4 15 59
-19 -28.3 24 -4.4 67 19.4 -27 -16.6 16 60.8
-18 -27.8 25 -3.9 68 20 -26 -14.8 17 62.6
-17 -27.2 26 -3.3 69 20.6 -25 -13 18 64.4
-16 -26.7 27 -2.8 70 21.1 -24 -11.2 19 66.2
-15 -26.1 28 -2.2 71 21.7 -23 -9.4 20 68
-14 -25.6 29 -1.7 72 22.2 -22 -7.6 21 69.8
-13 -25 30 -1.1 73 22.8 -21 -5.8 22 71.6
-12 -24.4 31 -0.6 74 23.3 -20 -4 23 73.4
-11 -23.9 32 0 75 23.9 -19 -2.2 24 75.2
-10 -23.3 33 0.6 76 24.4 -18 -0.4 25 77
-9 -22.8 34 1.1 77 25 -17 1.4 26 78.8
-8 -22.2 35 1.7 78 25.6 -16 3.2 27 80.6
-7 -21.7 36 2.2 79 26.1 -15 5 28 82.4
-6 -21.1 37 2.8 80 26.7 -14 6.8 29 84.2
-5 -20.6 38 3.3 81 27.2 -13 8.6 30 86
-4 -20 39 3.9 82 27.8 -12 10.4 31 87.8
-3 -19.4 40 4.4 83 28.3 -11 12.2 32 89.6
-2 -18.9 41 5 84 28.9 -10 14 33 91.4
-1 -18.3 42 5.6 85 29.4 -9 15.8 34 93.2
0 -17.8 43 6.1 86 30 -8 17.6 35 95
1 -17.2 44 6.7 87 30.6 -7 19.4 36 96.8
2 -16.7 45 7.2 88 31.1 -6 21.2 37 98.6
3 -16.1 46 7.8 89 31.7 -5 23 38 100.4
4 -15.6 47 8.3 90 32.2 -4 24.8 39 102.2
5 -15 48 8.9 91 32.8 -3 26.6 40 104
6 -14.4 49 9.4 92 33.3 -2 28.4
7 -13.9 50 10 93 33.9 -1 30.2
8 -13.3 51 10.6 94 34.4 0 32
9 -12.8 52 11.1 95 35 1 33.8
10 -12.2 53 11.7 96 35.6 2 35.6
11 -11.7 54 12.2 97 36.1 3 37.4
12 -11.1 55 12.8 98 36.7 4 39.2
13 -10.6 56 13.3 99 37.2 5 41
14 -10 57 13.9 100 37.8 6 42.8
15 -9.4 58 14.4 101 38.3 7 44.6
16 -8.9 59 15 102 38.9 8 46.4
17 -8.3 60 15.6 103 39.4 9 48.2
18 -7.8 61 16.1 104 40 10 50
19 -7.2 62 16.7 11 51.8
20 -6.7 63 17.2 12 53.6
66
Stock Record
Instructions: Use the monthly stock record to document inventory from new vaccine/diluent shipments and track weekly accounts of doses used.
At the end of each month, count inventory in storage unit(s) and compare with recorded balance. If physical count and recorded balance are
different, record the actual (physical count) balance next to the previous recorded balance. Note the cause of the discrepancy or if it is unknown.
Start a new stock record every month, listing at the top the previous month’s balance as the new month’s starting balance.
Vaccine Type: PPSV23 Month and Year: August 2017
Date Person Arrival Vaccine Manufac- Vial Type Lot Expiration Expiration Doses Doses Balance
Received Receiving Condition or Diluent turer (SDV, Number Date Date After Received/ Used (Doses)
or Usage Shipment ** Name MDV, Reconstitu- Balance †
Tallied * MFS)*** tion Forward
08/02/17 BEGINNING BALANCE FOR THE MONTH 2 N/A 2
08/09/17 1 1
08/15/17 LST G PPSV23 Merck MDV 03958 02/15/18 N/A 5 3 3
08/23/17 1 2
08/29/17 0 2
Vaccine 2
* The initials of the person who unpacked and checked the vaccines/diluents upon arrival 7 5
Totals ††
G = vaccines/diluents arrived in good condition
** ? = condition of vaccines/diluents questionable and state and local health department Physical Stock Check
immunization program and vaccine manufacturer(s) contacted. Document details/outcome 2
(In Doses)
on reverse side of stock record.
SDV = Single-dose vial Difference (“Balance”
minus Physical Stock
Sample Stock Record

*** MDV = Multidose vial 0
MFS = Manufacturer-filled syringe Check)
Balance Carried
† Includes number of doses administered, wasted, unusable, expired, or transferred. Forward 2
(In Doses)
Resources
†† Enter the sum of “Total Doses Received/Balance Forward” minus “Total Doses Used.”
Some state or local health department immunization programs have developed their own stock record for immunization providers. Contact
program staff for information. If stock record are not available from your state or local health department or an Immunization Information
System (IIS), this stock record may be used.
67
Stock Record
Instructions: Use the monthly stock record to document inventory from new vaccine/diluent shipments and track weekly accounts of doses used.
At the end of each month, count inventory in storage unit(s) and compare with recorded balance. If physical count and recorded balance are different,
record the actual (physical count) balance next to the previous recorded balance. Note the cause of the discrepancy or if it is unknown. Start a new
stock record every month, listing at the top the previous month’s balance as the new month’s starting balance.
Vaccine Type: Month and Year:
Date Person Arrival Vaccine Manufac- Vial Type Lot Expiration Expiration Doses Doses Balance
Received Receiving Condition or Diluent turer (SDV, Number Date Date After Received/ Used (Doses)
or Usage Shipment ** Name MDV, Reconstitu- Balance †
Tallied * MFS)*** tion Forward
BEGINNING BALANCE FOR THE MONTH N/A
Vaccine
* The initials of the person who unpacked and checked the vaccines/diluents upon arrival
Totals ††
G = vaccines/diluents arrived in good condition
** ? = condition of vaccines/diluents questionable and state and local health department Physical Stock Check
immunization program and vaccine manufacturer(s) contacted. Document details/outcome (In Doses)
on reverse side of stock record.
SDV = Single-dose vial Difference (“Balance”
*** MDV = Multidose vial minus Physical Stock
MFS = Manufacturer-filled syringe Check)
Balance Carried
† Includes number of doses administered, wasted, unusable, expired, or transferred. Forward
(In Doses)
†† Enter the sum of “Total Doses Received/Balance Forward” minus “Total Doses Used.”
Some state or local health department immunization programs have developed their own stock record for immunization providers. Contact
program staff for information. If stock record are not available from your state or local health department or an Immunization Information System
(IIS), this stock record may be used.
Tally Sheet
Instructions: Place a copy of this sheet on or near the refrigerator and freezer doors. Record the week (by date or week number). Write the vaccine/
diluent names and indicate the storage location (refrigerator = R, freezer = F). Make a tick mark in the appropriate box for each dose of vaccine/
diluent removed from the unit (i.e., each dose administered, wasted, unusable, expired, or transferred). At the end of the week, add the tick marks
for each vaccine/diluent and update the totals on the appropriate stock record. File the completed tally sheet and replace with a new sheet.
Week: August 19-23, 2017 (Week 3)
Storage Vaccine or Diluent Name Doses Administered Doses Doses Doses Doses Total
Location Wasted Expired Unusable Transferred
(R or F) ** (Viable)
* ***
F VAR IIII III (8 ) I 9
R DTaP IIII IIII II (12 ) 12
R HepB IIII IIII II (12 ) 12
R IPV IIII IIII II (12 ) II 14
R HepA (pediatric) II (2 ) 2
R PPSV23 I (1 ) 1
( )
( )
( )
( )
( )
( )
( )
( )
R = Refrigerator
*
Sample Tally Sheet

F = Freezer
Some unusable doses (VFC vaccines or other vaccines purchased with public funds) may need to be returned to your state or local health
**
department immunization program.
Resources
*** Viable vaccine doses transferred to your state or local health department immunization program or another facility.
Some state or local health department immunization programs have developed their own tally sheets for immunization providers. Contact
program staff for information. If tally sheets are not available from your state or local health department or an Immunization Information System
69
(IIS), this tally sheets may be used.

Tally Sheet
Instructions: Place a copy of this sheet on or near the refrigerator and freezer doors. Record the week (by date or week number). Write the vaccine/
diluent names and indicate the storage location (refrigerator = R, freezer = F). Make a tick mark in the appropriate box for each dose of vaccine/diluent
removed from the unit (i.e., each dose administered, wasted, unusable, expired, or transferred). At the end of the week, add the tick marks for each
vaccine/diluent and update the totals on the appropriate stock record. File the completed tally sheet and replace with a new sheet.
Week:
Storage Vaccine or Diluent Name Doses Administered Doses Doses Doses Doses Total
Location (R Wasted Expired Unusable Transferred
or F) ** (Viable)
* ***
R = Refrigerator
*
F = Freezer
Some unusable doses (VFC vaccines or other vaccines purchased with public funds) may need to be returned to your state or local health
**
department immunization program.
*** Viable vaccine doses transferred to your state or local health department immunization program or another facility.
Some state or local health department immunization programs have developed their own tally sheets for immunization providers. Contact program
staff for information. If tally sheets are not available from your state or local health department or an Immunization Information System (IIS), this
tally sheets may be used.
PROTECT YOUR VACCINE
PROTECT YOUR PATIENTS
Handle
with Refrigerator
Care! Store vaccines

Vaccine Storage Rules
• Keep your storage units and

vaccines within the
between
appropriate temperature
ranges.
• Review and record refrigerator
2°C and 8°C
and freezer temperatures at (36°F and 46°F)
least 2 times each workday.
• Take immediate action if Freezer
temperatures are out of range.
Store vaccines between
• Keep vaccines in their original
packages. -50°C and -15°C
• Many vaccines should be (-58°F and +5°F)
protected from light (consult
manufacturer’s product
information).
• Keep VAR, HZV, and MMRV
frozen.
Resources
• Check expiration dates and
rotate your vaccine stock.
71
Resources
Warning Labels
Do Not Adjust Refrigerator Controls (English)
Do Not Adjust Refrigerator Controls (Spanish)
72
Resources
Do Not Adjust Freezer Controls (English)
Do Not Adjust Freezer Controls (Spanish)
73
Resources
Warning! Do Not Stop Power to Circuit Breaker (English)
74
Resources
Warning! Do Not Unplug Refrigerator (English)
Warning! Do Not Unplug Refrigerator (Spanish)
75
Resources
Warning! Do Not Unplug Freezer (English)
Warning! Do Not Unplug Freezer (Spanish)
76
Resources
Do Not Unplug Refrigerator (English)
Do Not Unplug Refrigerator (Spanish)
77
Resources
Do Not Unplug Freezer (English)
Do Not Unplug Freezer (Spanish)
78
Resources
Transport Labels
Refrigerate Upon Arrival
Freeze Upon Arrival
79
Resources
Open Immediately: Refrigerate Upon Receipt
Open Immediately: Freeze Upon Receipt
80
Resources
Fragile: Handle with Care
Fragile
81
Resources
Perishable—Rush
82

Vaccine Storage, Handling 2016

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Vaccine

Storage & Handling

U.S. Department of Health and Human Services

Tips for Using the Toolkit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Where to Find Additional CDC Vaccine Storage and Handling Information. . . . 6

Vaccine Cold Chain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Elements for an Effective and Reliable Cold Chain. . . . . . . . . . . . . . . . . . . . . . . . . . 10

Vaccine Storage and Temperature Monitoring Equipment. . . . . . . . 13

Temperature Monitoring Equipment (Digital Data Loggers) . . . . . . . . . . . . . . . . . 15

Storage Unit Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Storage Unit Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Stabilizing Temperatures in New and Repaired Units. . . . . . . . . . . . . . . . . . . 20

Organizing and Storing Vaccine in Storage Units . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Storing Vaccine in a Refrigerated Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Storing Vaccine in a Freezer Unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Avoid Placing Other Items in Vaccine Storage Units. . . . . . . . . . . . . . . . . . . . 24

Placement of Temperature Monitoring Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Monitoring Vaccine Temperature and Vaccine Storage Equipment. . . . . . . . . . . 25

Monitor and Record Storage Unit Temperature . . . . . . . . . . . . . . . . . . . . . . . 25

Regular Maintenance of Vaccine Storage Units and Temperature

Storage Unit Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Temperature Monitoring Device Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . 29

Troubleshooting Equipment Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Adjusting Storage Unit Temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Repeated Alarm Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Temperature Monitoring Device Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Vaccine Inventory Management, Transport, and Preparation . . . . . 32

Scheduling and Receiving Deliveries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Vaccine Inventory Accounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Stock Rotation and Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Vaccine Transport to Off-site or Satellite Facilities. . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Transport of Refrigerated Vaccines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Preparing Vaccine for Administration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Emergency Vaccine Storage, Handling, and Transport

Alternative Vaccine Storage Facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

If an Alternative Vaccine Storage Facility is Not Available. . . . . . . . . . . . . . . 43

Accessing Your Building After Hours. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Monitoring Unit Temperature during a Power Outage . . . . . . . . . . . . . . . . . 44

Vaccine Transport Containers and Materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Emergency Vaccine Packing and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Transport of Varicella-containing (Frozen) Vaccines. . . . . . . . . . . . . . . . . . . . 48

Transport of Multidose Vials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Temperature Monitoring During Transport. . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Vaccine Storage and Handling Standard Operating

Routine Storage and Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Emergency Storage, Handling, and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Glossary of Key Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Vaccine Storage and Handling SOP Worksheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Vaccine Manufacturer/Distributor Contact List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Fahrenheit to Celsius and Celsius to Fahrenheit Conversion . . . . . . . . . . . . . . . . . . . . . . 66

Sample Stock Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Sample Tally Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Vaccine Storage Rules Poster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Take immediate action!

Where to Find Additional CDC Vaccine Storage and Handling Information

The Centers for Disease Control and Prevention (CDC)

together best practices from Advisory Committee on General Recommendations on Immunization

Proper vaccine storage and handling has been an

of many patients and significant financial loss due to

• Storage and temperature monitoring equipment and setup