Storage and Handling

This chapter provides an overview of best practice guidance

for storage and handling. CDC’s Vaccine Storage and Handling
Toolkit, http://www.cdc.gov/vaccines/recs/storage/toolkit/
storage-handling-toolkit.pdf, contains comprehensive
information on best practices and recommendations.
Manufacturers’ product information and package inserts
include the most current information about the storage
and handling of specific vaccines. Refer to CDC’s Storage
and Handling webpage for links to these and other resources, 5
http://www.cdc.gov/vaccines/recs/storage/default.htm.
Participants in the Vaccines for Children (VFC) program or
those who have any vaccines purchased with public funds
should consult their state or local immunization program
for specifics because some program requirements may differ
from the information contained in the Vaccine Storage and
Handling Toolkit.

Vaccine Storage and Handling

There are few immunization issues more important than
the appropriate storage and handling of vaccines. Vaccine- Vaccine Storage and Handling
preventable disease rates have decreased in part because ●●Vaccine-preventable disease
of proper storage and handling of vaccines. Exposure of rates decreased in part
vaccines to temperatures outside the recommended ranges because of proper storage
can decrease their potency and reduce the effectiveness and handling
and protection they provide. Storage and handling errors ●● Storage and handling errors
can cost thousands of dollars in wasted vaccine and
revaccination. Errors can also result in the loss of patient
■■ decrease potency and
confidence when repeat doses are required. It is better to reduce effectiveness and
not vaccinate than to administer a dose of vaccine that has protection
been mishandled. Vaccine management, including proper ■■ cost thousands of dollars
storage and handling procedures, is the basis on which good in wasted vaccine and
immunization practices are built. revaccination
■■ loss of patient confidence
Vaccines must be stored properly from the time they are
manufactured until they are administered. Assuring vaccine ●● It is better to not vaccinate
quality and maintaining the cold chain is a shared responsi- than to administer a dose
bility among manufacturers, distributors, public health staff, of vaccine that has been
and health-care providers. A proper cold chain is a tempera- mishandled
ture-controlled supply chain that includes all equipment and
procedures used in the transport and storage and handling
Cold Chain
of vaccines from the time of manufacture to administration
(a temperature-controlled
of the vaccine. By following a few simple steps and imple- supply chain)
menting best storage and handling practices, providers can
●● Vaccines must be stored
ensure that patients will get the full benefit of vaccines they
properly from the time they
receive.
are manufactured until they
are administered
Storage and Handling Plans
Every facility should have detailed written protocols for ●● Shared responsibility among
routine and emergency vaccine storage and handling manufacturers, distributors,
and they should be updated annually. These policies and public health staff, and
procedures should be available in writing as a reference for healthcare providers
all staff members and easily accessible.

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 Storage and Handling
A routine storage and handling plan provides guidelines for
Vaccine Storage daily activities, such as:
and Handling Plans
●● Develop and maintain written
ROUTINE plan for:
• Ordering and accepting vaccine deliveries

■■ ordering and accepting • Storing and handling vaccines

vaccine deliveries
• Managing inventory
5 storing and handling
•
■■

vaccines Managing potentially compromised vaccines

■■ managing inventory Every facility should also have an emergency vaccine retrieval
■■ managing potentially and storage plan. The plan should identify a back-up
compromised vaccines location where the vaccines can be stored. Considerations
when choosing this site include appropriate storage units,
●● Develop and maintain written
temperature monitoring capability, and a back-up generator
EMERGENCY vaccine retrieval
that can maintain power to the vaccine storage units.
and storage plan
Potential back-up locations might include a local hospital,
■■ back-up storage location pharmacy, long-term care facility, or the Red Cross.
with appropriate storage
units, temperature There should be an adequate supply of packing materials
monitoring capability, and and portable refrigerators and freezers or qualified
back-up generator that containers and packouts on hand to accommodate the
can maintain power to the facility’s largest annual vaccine inventory (e.g., flu season).
vaccine storage units A refrigerated truck may be needed to move large inventories
■■ adequate supply of of vaccine.
packing materials and Power outages or natural disasters are not the only events
portable refrigerators that can compromise vaccine. Forgotten vials of vaccine left
and freezers or qualified out on the counter or doses of vaccine stored at improper
containers and packouts, temperatures due to a storage unit failure are other
or refrigerated truck examples of how vaccines can be potentially compromised.
Protocols after an event will vary depending on individual
Staff Training and Education state or agency policies. Contact the local or state health
●● Assign responsibilities to a department immunization program (hereafter referred to as
primary vaccine coordinator “immunization program”), vaccine manufacturer(s), or both
for appropriate actions or guidelines that should be followed
●● Designate at least one for all potentially compromised vaccines. Do not discard
alternate (back-up) vaccine vaccines unless directed to by the immunization program
coordinator and/or the manufacturer.

Staff Training and Education

Assign a primary vaccine coordinator who is responsible
for ensuring that vaccines are stored and handled correctly
at each facility. Designate at least one alternate (back-up)
vaccine coordinator who can perform these responsibilities
in the absence of the primary coordinator. These responsi-
bilities include, but are not limited to, the following tasks:

• Ordering vaccines

• Overseeing proper receipt and storage of vaccine

deliveries

64
• Organizing vaccines within the storage unit(s)
 Storage and Handling
• Temperature monitoring of the storage unit(s) (i.e.,
current temperature at least 2 times each workday). Training and Education
Staff who
•
●●

Recording temperature readings on a log ■■ handle or administer

• Daily physical inspection of the storage unit(s) vaccines

deliver or accept vaccine
•
■■

Rotating stock so that vaccines closest to their expiration shipments

dates will be used first
■■ have access to vaccine 5
• Monitoring expiration dates and ensuring that expired
vaccines and diluents are removed from the storage ●●
storage unit(s)
Provide training and
unit(s) and not administered to patients continuing education when

• Responding to potential temperature excursions

■■ new or temporary staff
are oriented

• Overseeing proper vaccine transport ■■ new vaccines are stocked

• Maintaining all appropriate vaccine storage and

handling documentation, including temperature-
■■ changes to storage and
handling guidelines occur
excursion responses

• Maintaining storage equipment and maintenance

records

• Maintaining proper documentation for the VFC program

in participating facilities

• Ensuring that designated staff is adequately trained

A physician partner or member of management should be

directly involved with the clinical staff that is responsible
for vaccine storage and handling. Management staff should
have a clear understanding of the vaccine replacement costs
and clinical implications of mismanaged vaccines.

All personnel who handle or administer vaccines should

be familiar with the storage and handling policies and
procedures for their facility. This includes not only those
who administer vaccines, but also anyone who delivers or
accepts vaccine shipments and anyone who has access to
the unit(s) where vaccines are stored. Vaccine storage and
handling training should be provided to all new personnel
who handle or administer vaccines, including temporary
staff. Continuing education for staff is essential when new
vaccines are stocked and when there are any changes to the
storage and handling guidelines for a particular vaccine.
CDC has a free web-based storage and handling module as
part of the online training tool, “You Call the Shots,” at http://
www.cdc.gov/vaccines/ed/youcalltheshots.htm. Continuing
education credit for a variety of healthcare professionals and
a certificate of completion are available. Many immuniza-
tion programs and professional organizations also offer
vaccine storage and handling training programs.

65
 Storage and Handling
Receiving and Unpacking Vaccine Deliveries
Proper vaccine storage and handling is important from the
Vaccine Deliveries moment the vaccine arrives at the facility. All office staff
●● Notify vaccine coordinator should be trained to notify the vaccine coordinator or the
or alternate (back-up) alternate (back-up) coordinator when a vaccine delivery
coordinator when delivery has arrived. This is extremely important for receptionists or
arrives other front desk staff since they may be the first to know
that vaccines have been delivered. Avoid having other people
5 ●● Avoid having people accept
deliveries who may not accept deliveries who may not understand the importance
understand the importance of storage at appropriate temperatures. The vaccine
of storage at appropriate coordinator should request delivery during office hours and
temperatures upon arrival update vaccine orders to reflect any period of time the office
will be closed, such as holidays or scheduled vacation time.
●● Examine vaccine deliveries
■■ container Examine deliveries right away and store vaccines at the
proper temperatures immediately upon arrival. Examine
■■ contents
the shipping container and its contents for any evidence of
■■ shipping temperature damage during shipment. Cross check the contents with
monitors/indicators the packing slip to be sure they match. Check heat and cold
●● If there are concerns, label temperature monitors/indicators if either are included in the
vaccines “Do NOT Use,” store shipping container following instructions on the monitors
under appropriate conditions, for reading and reporting. If a monitor indicates a possible
separate from other vaccines temperature excursion during shipping, the monitor reading
should be documented for future reference. Report the
●● Consult immunization
reading to the distributor within the required timeframe if
program, distributor, and/or
VFC vaccines or other vaccines purchased with public funds
vaccine manufacturer
are involved. Vaccines sent directly by the manufacturer are
for guidance
in specially designed boxes and may not contain heat or cold
temperature monitors.

Allowable shipping time varies among distributors and

manufacturers and is dependent on the type of container
and packout. Determine if shipping time was within
allowable limits noted on shipping insert or container. If the
shipping time was more than the allowable limit or there
are any discrepancies with the packing slip or concerns
about the contents, immediately notify the primary vaccine
coordinator (or the alternate [back-up] coordinator). If
neither is available, notify a supervisor immediately. Label
the vaccines “Do NOT Use” and store the vaccines under
appropriate conditions separate from other vaccines.
Then, according to your facility’s procedures, contact your
immunization program, the distributor, and/or vaccine
manufacturer(s) for guidance.

Record the contents of each container on an inventory log

(stock record). This log should include the name of each
vaccine, the number of doses for each vaccine received, the
date it was received, the condition of the vaccines upon
arrival, the names of the vaccine manufacturers, the lot
numbers, the expiration dates for each vaccine, and any
action taken regarding questionable vaccines.

66
 Storage and Handling
Vaccine Storage and Temperature
Monitoring Equipment
These items should be selected carefully, used properly,
maintained regularly (including professionally serviced
when needed), and monitored consistently to ensure the
recommended temperatures are maintained. This chapter
provides only general guidelines for equipment. Providers Freezers and Refrigerators
Stand-alone units that only
should consult their immunization program, particularly
providers of VFC vaccines or other vaccines purchased with
●●

freeze or refrigerate
5
public funds, for any specific storage equipment require- ■■ can vary in size from
ments. compact, counter-top or
under-the-counter to large,
Keep a logbook for each piece of vaccine storage equipment.
pharmaceutical grade
The serial number of each piece of equipment, the date each
piece of equipment was installed, the dates of any routine ■■ maintain required
maintenance tasks (such as cleaning), the dates of any temperatures better
repairs or service, and the contact information of the service than combination units,
provider should be recorded. A logbook is also an ideal particularly the freezer
place to keep the instructions that came with the equipment. section of these units
●● If existing equipment is a
Freezers and Refrigerators household, combination
Using proper vaccine storage units can help prevent costly refrigerator/freezer
vaccine losses and the inadvertent administration of ■■ only use refrigerator for
compromised vaccines. CDC recommends stand-alone units, vaccine storage
meaning self-contained units that either freeze or refrigerate,
and are suitable for vaccine storage. These units can vary in
■■ use a stand-alone freezer
size, from compact, counter-top or under-the-counter style for frozen vaccines
to large, pharmaceutical grade units. Studies demonstrated ■■ applies to both temporary
that stand-alone units maintain the required temperatures and long-term storage
better than combination units, particularly the freezer ●● Able to maintain required
section of household, combination units. temperature range
throughout year
If existing equipment is a household, combination refrig-
erator/freezer, CDC recommends using only the refrigerator ●● Dedicated to storage
compartment for refrigerated vaccines. Use a separate of biologics
stand-alone freezer to store frozen vaccines. Research found ●● Large enough to hold year’s
that freezers in household combination units cannot hold largest vaccine inventory
proper storage temperatures for frozen vaccines particularly without crowding (including
during defrost cycles. This applies to both temporary and flu vaccine)
long-term storage.
●● If stand-alone freezer is
Any freezer or refrigerator used for vaccine storage must be manual defrost, must defrost
able to maintain the required temperature range throughout regularly and have another
the year. The unit should be dedicated to the storage of storage unit that maintains
biologics and must be large enough to hold inventory a appropriate temperatures
provider might have at the busiest point in the year without for temporary storage during
crowding (including flu vaccine). There should also be defrosting
enough room to store water bottles in the refrigerator and ●● Frost-free or automatic
frozen water bottles in the freezer to stabilize the tempera- defrost cycle may be
tures and help maintain temperature longer in a power preferred
outage.

67
 Storage and Handling
If your stand-alone freezer is manual defrost, you must
Storage Unit Placement defrost regularly and have another storage unit that
●● Promote good air circulation maintains appropriate temperatures for temporary storage
around storage unit of the vaccine while defrosting. A frost-free unit with an
■■ place in well-ventilated room automatic defrost cycle may be preferred if regular manual
defrosting cannot be assured.
■■ allow for space on all sides
and top Good air circulation around a vaccine storage unit is
5 ■■ allow at least 4 inches essential for proper cooling functions. A storage unit should
between storage unit and be in a well-ventilated room with space around the sides
a wall and top and at least 4 inches between the unit and a wall.
Nothing should block the cover of the motor compartment
■■ do not block motor cover
and the unit should be level and stand firmly with at least 1
■■ ensure unit stands level to 2 inches between the bottom of the unit and the floor.
with at least 1 to 2 inches
between bottom of unit CDC does not recommend storage of any vaccine in
and floor a dormitory-style or bar-style, combined refrigerator/
freezer unit under any circumstances, even temporarily.
A dormitory-style refrigerator is defined as a small
Dormitory-style Refrigerator combination freezer/refrigerator unit with one exterior
●● Small combination freezer/ door and an evaporator plate (cooling coil), which is
refrigerator unit with one usually located inside an icemaker compartment within the
external door and an refrigerator. These units have exhibited severe temperature
evaporator plate (cooling control and stability issues throughout the entire storage
coil), which is usually area. Dormitory-or bar-style units pose a significant risk of
located inside an icemaker freezing vaccines, even when used for temporary storage.
compartment (freezer) within The use of this type of unit is prohibited for storage of VFC
the refrigerator vaccines or other vaccines purchased with public funds.
●● NOT recommended for
vaccine storage under Temperature Monitoring Devices
any circumstances, even Temperature Monitoring is a critical part of good
temporarily storage and handling practice. CDC recommends using
●● Prohibited for storage of VFC only a calibrated digital data logger with a current and
vaccines or other vaccines valid certificate of calibration testing (also known as a
purchased with public funds Report of Calibration). This certificate informs the user
of a temperature monitoring device’s level of accuracy
●● NOT recommended for compared to a recognized standard. Calibrated temperature
vaccine storage under monitoring devices are required for providers who receive
any circumstances, even VFC vaccines or other vaccines purchased with public funds.
temporarily
All temperature monitoring devices, through normal use,
drift over time, which affects their accuracy. Because of this,
temperature monitoring devices should undergo periodic
calibration testing. Testing should be performed every 1 to
2 years from the last testing date or according to the manu-
facturer’s suggested timeline. CDC recommends that testing
meets standards defined in the Vaccine Storage and Handling
Toolkit. If calibration testing indicates that your temperature
monitoring device is no longer accurate, it should be
replaced. Immunization programs are often excellent
resources for information on temperature monitoring
devices.

68
 Storage and Handling
Several types of temperature monitoring devices are
available. CDC recommends digital data loggers with the
following characteristics: a digital display easily readable
from outside the unit; a detachable probe in a buffered
material, which more closely reflects vaccine temperatures
rather than air temperature in the unit; an alarm for out-of-
range temperatures; current and minimum and maximum
temprature accuracy within +/-1°F (+/-.5°C); a low battery
indicator; memory that stores at least 4000 readings; and
Temperature Monitoring Devices
5
user programmable logging interval. CDC recommends a
back-up digital data logger for each vaccine storage unit. ●●Use only calibrated
Staff should be trained and understand how to set up, read temperature monitoring
and analyze temperature data provided by the data logger. devices with a certificate of
calibration testing (Report
Temperature monitoring device placement within the unit of Calibration) from an
is just as important as device selection. Place the buffered accredited laboratory
probe with the vaccines. This should be in the middle, center ■■ required for providers who
of the storage unit away from walls, ceiling, cooling vents, receive VFC vaccines or
door, floor, and back of the unit. Prior to storing vaccines vaccines purchased with
in a unit, allow the unit temperature to stabilize for a week public funds
before placing vaccines in the unit. CDC recommends using
●● Calibration testing every 1 to
a digital data logger to monitor the temperature in the
2 years from last calibration
storage unit prior to storage of vaccines.
testing date or according to
Temperature Monitoring the manufacturer’s suggested
timeline
Regular temperature monitoring is key to proper cold chain
management. Store frozen vaccines (Varicella, MMRV, and
Digital Data Logger
Zoster) in a freezer between -58°F and +5°F (-50°C and
Characteristics
-15°C). Store all other routinely recommended vaccines in
a refrigerator between 35°F and 46°F (2°C and 8°C). The ●● Digital temperature display
desired average refrigerator vaccine storage temperature is outside storage unit
40°F (5°C). Exposure to temperatures outside these ranges ●● Detachable probe in a
may result in reduced vaccine potency and increased risk of buffered material
vaccine-preventable diseases. ●● Alarm
CDC recommends reviewing and recording temperatures in ●● Current and minimum and
both the freezer and refrigerator units at least 2 times each maximum temperatures
workday, in the morning and before leaving at the end of the ●● Accuracy within +/-1°F
workday. (+/-.5°C )
This best practice recommendation applies to all vaccine ●● Low battery indicator
storage units, regardless of whether or not there is a ●● Measures current and daily
temperature alarm, or a digital data logger that continu- minimum and maximum
ously records temperatures in the unit. These readings will temperatures in the unit
provide a better indication of any problems with the storage ●● Memory for storing at least
unit’s function. 4,000 readings
Reviewing and recording temperatures also provides an ●● Uses programmable
opportunity to visually inspect the storage unit, reorganize logging interval
the vaccines when necessary (e.g., moving vaccine away

69
 Storage and Handling
from walls or cold air vents), identify vaccines and diluents
Recommended Temperatures with short expiration dates, remove any expired vaccines
●● Freezer and diluents, and provide a timely response to temperature
■■ between -58°F and +5°F excursions.
(between -50°C and -15°C)
Post a temperature log on each storage unit door or nearby
●● Refrigerator in a readily accessible and visible location. In addition, if
■■ between 35°F and 46°F using a device that enables download of temperature data,
5 (between 2°C and 8°C) review and store data at least once every week and reset the
device before returning to storage unit monitoring.
■■ average: 40°F (5°C)
CDC recommends maintaining an ongoing file of
Temperature Monitoring temperature data, including hard copies and downloaded
data for at least 3 years or according to individual state
●● Review and record
record retention requirements. As the storage unit ages,
temperatures in both freezer
recurring temperature variances or problems can be tracked
and refrigerator units 2 times
and documented. This data can be important when
each day, once in the morning
evaluating the need for a new storage unit or if there is a
and once before leaving at the
potential need to recall and revaccinate patients because of
end of the workday
improperly stored vaccine.
●● Post temperature log on the
door of each storage unit Twice daily temperature monitoring may not be accom-
●● If using a continuous plished when a provider’s office is closed. A digital data
temperature monitor, logger that stores data and/or can be accessed remotely
download temperature data can provide information on storage temperatures while the
and review weekly office is closed and help assure that timely corrective action
can be taken if temperatures go out of range. Providers
●● Keep temperature logs (hard should determine how they are to be notified in the event of
copies and downloaded an emergency (e.g., a power outage) during hours when the
data) 3 years or according facility is not open.
to individual state record
retention requirements Equally important to temperature monitoring is taking
timely corrective action when there is a temperature
excursion. If it is discovered that stored vaccines have been
Temperature Excursion
exposed to temperatures outside the recommended ranges,
●● If stored vaccines have been these vaccines should remain properly stored, but separated
exposed to temperatures from other vaccine supplies and marked “Do NOT Use” until
outside recommended ranges guidance can be obtained. Protocols after an event will vary
■■ store the vaccines properly depending on individual state or agency policies. Contact
your immunization program, vaccine manufacturer(s), or
■■ separate from other vaccine
both for guidance.
supplies
■■ mark “Do NOT Use”
■■ contact immunization Vaccine and Diluent Placement and Labeling
program, vaccine Vaccines should be stored in the center of the unit as this is
manufacturer(s), or both the area where appropriate temperatures are typically most
for guidance stable. A storage unit should be big enough so that vaccines
can be placed in the part of the unit best able to maintain
the constant, required temperature away from the walls,
coils, cooling vents, ceiling, door, floor and back of the
unit. Vaccines and diluents should be kept in their original
packaging with the lids on until ready for administration
and stacked in rows with vaccine and diluent of the same

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 Storage and Handling
type. Trays or uncovered containers/bins that allow for air
circulation can be used to organize the vaccines and diluents Vaccine and Diluent
within the storage unit. Do not store vaccines in unit doors Placement and Labeling
or in deli, vegetable, or fruit crisper drawers. Avoid storing ●● Store vaccines away from
vaccines on the refrigerator top shelf. If the top shelf must walls, coils, cooling vents, top
be used, place water bottles close to the vent and only store shelf, ceiling, door, floor, and
vaccines not sensitive to coldest temperatures (e.g., MMR). back of unit
Keep vaccines and diluents in
5
●●
Some diluents must be refrigerated and others may be
original packaging with lids
stored in the refrigerator or at room temperature. Always
on to protect from light
follow the manufacturer’s guidance in the product
information/package inserts. If possible, store diluent next ●● Stack in rows with same type
to the corresponding vaccine. Some of these diluents may of vaccine and diluent
contain vaccine antigen. Never store diluents in the freezer. ●● Use uncovered storage
containers to organize
There should be space between the vaccine and diluent vaccines and diluents
stacks or containers. This will help to avoid confusion
between products, provide for air circulation around and ●● Do not store vaccines in
through stacks for even cooling, and protect vaccines storage unit doors, on the
from unnecessary light exposure. Not only live attenuated top shelf, on the floor, or in
vaccines, but also some inactivated vaccines must be deli, vegetable or fruit crisper
protected from light. Information on light sensitivity can be drawers
found in the manufacturer’s product information/package ●● Store pediatric and adult
insert. vaccines on different shelves
●● Use labels with vaccine type,
Each vaccine and diluent stack or container should be
age, and gender indications or
clearly labeled. This can be accomplished by attaching
color coding
labels directly to the shelves on which vaccines and diluents
are stored or by placing labels on the containers. Store ●● Do not store sound-alike and
pediatric and adult vaccines on different shelves. Use color look-alike vaccines next to
coded labels that include the vaccine type, as well as age each other
and gender indications, if applicable. Having each vaccine ●● VFC vaccines and other
and diluent stack or container labeled helps decrease the vaccines purchased with
chance that someone will inadvertently administer the wrong public funds should be
vaccine or use the wrong diluent to reconstitute a vaccine. identified and stored
Vaccines that sound or look alike should not be stored next separately from vaccines
to each other, e.g., DTaP and Tdap. VFC vaccines and other purchased with private funds
vaccines purchased with public funds should be identified
and stored separately from vaccines purchased with private
funds.

Vaccine Storage Troubleshooting

To maintain the proper temperature ranges, the freezer and
refrigerator units must be in good working condition and
they must have power at all times. There are several things
that can be done to prevent problems.

Plug storage units directly into wall outlets. Do not use

power outlets with built-in circuit switches (they have little
red reset buttons), outlets that can be activated by a wall
switch, or multi-outlet power strips. These can be tripped
or switched off, resulting in loss of electricity to the storage

71
 Storage and Handling
unit. Plug only one storage unit into an outlet. This will help
Diluent Storage to prevent a safety switch from being triggered to turn off
●● Store diluent as directed power and reduce the risk of overloading the outlet which
in manufacturer’s product could be a fire hazard.
information
●● Store refrigerated diluent with Use plug guards or safety-lock plugs to prevent someone
corresponding vaccine (these from inadvertently unplugging the unit. A temperature
diluents may contain vaccine alarm system that will alert staff to after-hour temperature
5 antigen) excursions, particularly if large vaccine inventories are
maintained, may be helpful in assuring a timely response to
●● Never store diluents in storage problems. Label circuit breakers to alert custodians
the freezer and electricians not to unplug vaccine storage units or
●● Label diluent to avoid turn off the power. This can be done by posting a warning
inadvertent use of the wrong sign near the electrical outlet, on storage units, and at the
diluent when reconstituting circuit breaker box. Warning signs should include emergency
a vaccine contact information.

Place containers of water, labeled “Do NOT Drink,” in the

refrigerator to help stabilize the temperature in the unit.
Place water bottles where vaccines are not stored, such as
the door, top shelf, and on the floor of the storage unit.
The same principle applies to the freezer. Store frozen water
bottles in the freezer and the freezer door. Be careful that the
water bottles do not weigh down doors so much that the
seals are compromised and the doors do not close properly.
These measures will help keep the temperature stable with
frequent opening and closing of the storage unit.

In addition to temperature monitoring, a physical inspection

of storage units should be performed daily. An inspection
should include the following:

• Are the vaccines placed properly in the unit?

• Are the vaccines in their original packaging?

• Are vaccines being stored away from the walls, coils,

cooling vents, ceiling, and floor and not in the doors?

During a workday it is easy for vaccines to be shifted into an

area of the storage unit where the temperature may not be
appropriate or stable, such as against a wall, under a cold
air vent, or in the door. CDC recommends that vaccines be
kept in storage units dedicated only to vaccines. If other
biologic specimens, such as blood or urine, must be stored
in the same unit as vaccines, specimens should be stored
on a lower shelf. This is to ensure that if a specimen leaks,
the vaccines will not be contaminated. Food and beverages
should not be stored in a vaccine storage unit because
frequent opening of the unit can lead to temperature
instability.

While it is important to take measures to prevent problems,

equally important is taking immediate corrective action
when a problem does exist, for example, when the storage
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 Storage and Handling
unit temperature falls outside the recommended range. Staff
should know who to contact in case of a malfunction or Preventive Measures
disaster. ●● Plug unit directly into wall;
do NOT use multi-outlet
If you experience a power outage, immediately begin to power strip
implement your emergency plan. Depending on room ●● Do NOT use power outlets
temperature, storage temperatures may be maintained for
with built-in circuit switchers
only a very short period of time. If there is an extended
period of time before the situation can be corrected and ●● Do NOT use power outlets
that can be activated by a
5
there are no other storage units available on site, move the
vaccines to the back-up storage facility using the guidelines wall switch
in the emergency plan. ●● Plug only one unit into an
outlet

Vaccine and Diluent Inventory Control ●● Use a plug guard or

safety-lock plug
Conduct a vaccine inventory monthly to ensure adequate
supplies to meet demand. Include vaccine diluents in the ●● Install a temperature alarm
inventory. Determining factors for the amount of vaccine ●● Label circuit breakers and
and diluent ordered include: projected demand, storage electrical outlets
capacity, and current vaccine supply. Avoid overstocking ●● Post warning signs that
vaccine supplies, which could lead to vaccine wastage or
include emergency contact
having outdated vaccine on hand.
information
Check vaccine and diluent expiration dates a minimum of ●● Use water bottles in
weekly. Rotate stock so that vaccines and diluents with the refrigerator and frozen water
soonest expiration dates are used first to avoid waste from bottles in freezer to maintain
expiration. If the date on the label has a specific month, temperature
day, and year, the vaccine can be used through the end of ●● Perform daily inspection of
that day. If the expiration date on the label is a month and storage unit(s)
year, the vaccine can be used through the last day of that
month. A multidose vial of vaccine that has been stored ●● If other biologics must be
and handled properly and is normal in appearance can be stored in the same unit, store
used through the expiration date printed on the vial unless them BELOW the vaccines to
otherwise stated in the manufacturer’s product information. avoid contamination
Some vaccines should be used within a certain time frame ●● Never store food and
after the first time a needle is inserted (e.g., multidose vials), beverages in the same unit
after the vaccine is reconstituted (e.g., vaccines requiring with vaccines
reconstitution), or if the manufacturer deems it is necessary ●● Take immediate corrective
to shorten the expiration date. This time frame is called the action when there is a problem
“beyond use date” or BUD. The BUD is the date or time
after which the vaccine should not be used. It may not be
the same as the expiration date printed on the vial by the Vaccine and Diluent
manufacturer. The BUD varies among vaccines and can Inventory Control
be found in the package insert. Check the package insert ●● Conduct a monthly vaccine
to determine if the vaccine has a BUD, and for the correct and diluent inventory
time frame (e.g., days, hours) the vaccine can be stored ●● Order vaccine based on
once the vial has been entered or has been reconstituted.
Calculate the BUD using the time interval found in the ■■ projected demand
vaccine’s package insert. Label the vaccine with the correct ■■ storage capacity
beyond use date/time and your initials. Refer to the CDC’s
■■ current supply
Vaccine Inventory Management for specific vaccine product
information, including the beyond use dates at http://www. ●● Avoid overstocking
cdc.gov/vaccines/recs/storage/toolkit/storage-handling-

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 Storage and Handling
toolkit.pdf. Note on a vial any change from the original
Expiration Dates expiration date/time printed on it, along with your initials.
●● Monitor vaccine and diluent Never use expired vaccine or diluent and immediately remove
expiration dates at minimum, them from the storage unit.
weekly
●● Rotate stock so that vaccine Emergency or Off-Site/ Satellite Facility Transport
and diluent with soonest General guidance regarding transport is provided here and
expiration dates are used first in CDC’s Vaccine Storage and Handling Toolkit. Providers should
5 ●● If normal in appearance and also contact vaccine manufacturers and/or their immuniza-
stored and handled properly, tion program for guidance. Some immunization programs
product can be used may have vaccine packing and transport practices and
procedures for maintaining the cold chain in the field that
■■ through end of day are specific to their area.
indicated if expiration
date is mm/dd/yyyy (e.g., Vaccine manufacturers do not generally recommend or
12/15/2015 – use through provide guidance for transport of vaccines and CDC
12/15/2015) discourages regular transport. If possible, have vaccines
■■ through end of month delivered directly to the off-site/satellite facility. Each
indicated if expiration date transport increases the risk that vaccines will be exposed to
is mm/yyyy (e.g., 12/2015 – inappropriate storage conditions.
use through 12/31/2015)
Plan for emergencies by ensuring that you have proper
●● Multidose vials equipment to maintain the cold chain during transport.
■■ can be used through CDC recommends that if emergency transport of vaccines is
expiration date on vial necessary, it should be done using a qualified container and
unless otherwise stated in pack-out or portable refrigerator/freezer. Vaccine manufac-
manufacturer’s product turers do not recommend re-use of shipping containers and
information packing material for routine transport.
●● Reconstituted vaccine If vaccines must be transported to an off-site/satellite
■■ expiration date/time facility, the amount of vaccines transported should be
might change once limited to the amount needed for that workday, including
opened or reconstituted. transport and work time (maximum 8 hours). CDC
This is referred to as the recommends using a digital data logger with a current
Beyond Use Date (BUD) and valid certificate of calibration testing. CDC does not
and is provided in the recommend cold chain monitors (CCMs) since they do not
manufacturer’s product provide adequate data on excursions that may occur during
information transport.
●● Note any change in expiration
The facility’s standard operating procedure (SOP) should
date/time on vial
specify that:
Never use expired vaccine
•
●●

or diluent Vaccines are attended at all times during transport to

maintain the cold chain

• Vaccines are not placed in the vehicle trunk

• Vaccines are delivered directly to the facility

• Vaccines are promptly unpacked and placed in

appropriate storage units on arrival

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 Storage and Handling
A digital data logger with a current and valid certificate
of calibration testing is placed with the vaccines during Transport to Off-Site/
transport. Satellite Facilities
●● Not recommended by vaccine
Diluents should be transported with their corresponding manufacturers
vaccines to ensure that there are always equal numbers of ●● If possible, have vaccines
vaccine and diluent for reconstitution. Follow manufacturer delivered directly to the
guidance for specific temperature requirements. Diluents off-site/satellite facility
that contain antigen (e.g., DTaP-IPV diluent used with
Plan for emergencies by 5
Hib lyophilized vaccine) should be transported with their
●●

corresponding vaccines at refrigerator temperature. NEVER ensuring you have proper

transport any diluents at freezer temperature. Refer to equipment to maintain cold
CDC’s Vaccine Storage and Handling Toolkit, or your immuniza- chain during transport
tion program for guidance on vaccine and diluent transport. ●● If transport is necessary,
use a qualified container
Transporting Varicella-Containing Vaccines and pack-out or portable
to Off-Site/Satellite Facilities refrigerator/freezer
The vaccine manufacturer does not recommend transporting ●● Vaccine manufacturers do not
varicella-containing vaccines to off-site/satellite facilities. recommend re-use of shipping
Varicella-containing vaccines are fragile. If these vaccines containers and packing
must be transported to an off-site/satellite facility, CDC material for routine transport
recommends transport with a portable freezer unit that
maintains the temperature between -58°F and +5°F (-50°C
Transport of Varicella-containing
and -15°C). Portable freezers may be available for rent Vaccines to Off-Site/
in some places. If varicella-containing vaccines must be Satellite Facilities
transported and a portable freezer unit is not available, do
●● The manufacturer does not
not use dry ice.
recommend transporting
Varicella-containing vaccines may also be transported at varicella-containing vaccines to
refrigerator temperature between 35°F and 46°F, (2°C and off-site facilities
8°C) for up to 72 continuous hours prior to reconstitution ●● If vaccine must be transported,
using the guidelines in CDC’s Vaccine Storage and Handling use a portable freezer that
Toolkit. maintains the temperature
between -58oF and +5oF (-50oC
Having a patient pick up a dose of vaccine (e.g., zoster and -15oC)
vaccine) at a pharmacy and transporting it in a bag to a
●● Do NOT use dry ice
clinic for administration is not an acceptable transport
method for zoster vaccine or any other vaccine. ●● Varicella-containing vaccines
may be also transported
Monitoring Temperatures at Off-Site/ at refrigerator temperature
Satellite Facility between 35oF and 46oF
(2oC and 8oC), for up to 72
Vaccines should be placed in an appropriate storage unit(s)
continuous hours prior to
at the recommended temperature range(s) immediately
reconstitution
upon arrival at the alternate facility. CDC recommends
placing a digital data logger in the storage unit(s) with the ●● Must use the guideline in
vaccines. Read and document temperatures 2 times during CDC’s Vaccine Storage and
the workday. CDC does not recommend keeping vaccines in Handling Toolkit
a transport container unless it is a portable refrigerator or ●● Patient transport of vaccine
freezer unit. If vaccines must be kept in transport containers (e.g. zoster) from pharmacy
during an off-site clinic: to a clinic for administration
is not an acceptable transport
method for any vaccine

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 Storage and Handling
• Container(s) should remain closed as much as possible.

• Calibrated temperature monitoring device(s) (preferably

with a buffered probe) should be placed as close as
possible to vaccines.

• The temperature(s) inside the containers(s) should be

read and documented at least hourly.
5
• Only the amount of vaccine needed at one time (no
more than 1 multidose vial or 10 doses) should be
removed for preparation and administration by each
vaccinator.

Vaccine Preparation
Most vaccines are supplied in single-dose vials or manufac-
Vaccine Preparation turer-filled syringes. These preparations do not contain a
●● Once the protective cap bacteriostatic (preservative) agent. Once a single-dose vial is
is removed, vaccine in opened, meaning that the protective cap has been removed,
single-dose vial should be it should be discarded at the end of the workday if not used.
used or discarded at end of The same is true for an activated manufacturer-filled syringe.
workday Removing the needle cap or attaching a needle activates
●● Once manufacturer-filled a manufacturer-filled syringe and breaks the sterile seal.
syringe is activated (remove Multidose vials contain a bacteriostatic (preservative) agent.
needle cap or attach needle) Once opened, a multidose vial may be used through the
sterile seal is broken and expiration date unless contaminated or the manufacturer’s
should be used or discarded product information specifies a different timeframe (BUD).
at end of workday
CDC recommends that providers draw up vaccine only at
●● Do not predraw vaccine the time of administration and not predraw vaccines. Filling
■■ increases risk for a syringe before it is needed increases the risk for administra-
administration errors tion errors. Once in the syringe, vaccines are difficult to
tell apart. Other problems associated with this practice
■■ wasted vaccine
are wasted vaccine, the risk of inappropriate temperature
■■ possible bacterial growth in conditions, resulting in potentially reduced vaccine potency,
vaccines that do not contain and possible bacterial contamination in vaccines that do not
a preservative contain a preservative, such as single-dose vials.
■■ administration syringes not
Syringes other than those filled by the manufacturer
designed for storage
should be used only for immediate administration and
●● Consider using manufacturer- not for vaccine storage. If for some reason, like a large flu
filled syringes for large clinic, more than one dose of a particular vaccine must be
immunization events because predrawn, draw up only a few syringes at one time (no more
they are designed for both than 10 doses or the contents of a single multidose vial).
storage and administration In accordance with best practice standards, these syringes
should be administered by the person who filled them.

As an alternative to predrawing vaccine, CDC recommends

using manufacturer-filled syringes for large immunization
events, such as community influenza clinics. These syringes
are designed for both storage and administration.

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 Storage and Handling
Vaccine Disposal
Unused vaccine and diluent doses may be returnable
under certain circumstances. Contact the vaccine supplier, Vaccine Disposal
which may be the immunization program or the vaccine ●● Consult immunization
manufacturer, for specific policies regarding the disposition program or vaccine
of returnable vaccine, unopened vials, expired vials, unused manufacturer regarding
doses, and potentially compromised vaccine due to inap- returnable vaccines
propriate storage conditions. ●● Refer to CDC’s Vaccine
Storage and Handling Toolkit for
5
In general, most empty vaccine vials are not considered comprehensive storage and
hazardous or pharmaceutical waste and do not require handling guidance.
disposal in a biomedical waste container. However, require-
ments for medical waste disposal are regulated by state
environmental agencies so you should contact your immuni-
zation program or state environmental agency to ensure that
your disposal procedures are in compliance with state and
federal regulations.

Acknowledgement
The editors thank Donna Weaver, Patricia Beckenhaupt,
and JoEllen Wolicki, National Center for Immunization
and Respiratory Diseases, CDC, for their contribution to
this chapter.

Selected References
Centers for Disease Control and Prevention (CDC). General
recommendations on immunization: recommendations of
the Advisory Committee on Immunization Practices. MMWR
2011;60(no. RR-2): 23-27. http://www.cdc.gov/vaccines/
pubs/ACIP-list.htm

CDC. Recommendations and Guidelines: Storage and

Handling: http://www.cdc.gov/vaccines/recs/storage/
default.htm

Food and Drug Administration (FDA): http://www.fda.

gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/
ucm093830.htm

Manufacturers’ Product Information: http://www.immunize.

org/packageinserts/

National Institute of Standards and Technology (NIST).

Thermal Analysis of Refrigeration Systems Used for Vaccine
Storage, 2009, Household, Dormitory-Style Refrigerators
and Data Loggers. http://www.nist.gov/manuscript-publica-
tion-search.cfm?pub_id=904574

Immunization Action Coalition Storage and Handling

Handouts: http://www.immunize.org/clinic/storage-
handling.asp

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