Home
|
About IAC
|
Contact
|
A-Z Index
|
Donate
|
Shop
|
SUBSCRIBE
Immunization Action Coalition
IAC Home
|
Ask the Experts
|
Topic Index
|
Storage and Handling

Ask the Experts: Topics

Storage and Handling

Make a Donation Ask the Experts Home
Administering Vaccines
-- Vaccine Administration Errors
Billing and Reimbursement
Documenting Vaccination
Precautions and Contraindications
Scheduling Vaccines
Storage and Handling
-- Vaccine Storage Units
-- Temperature Monitoring & Controls
-- Troubleshooting & Follow-Up
-- Vaccine Viability & Expiration
-- Resources
Vaccine Recommendations
Vaccine Safety
 
More Ask the Experts
What's New
Question of the Week
Vaccine Index
View All
 
Storage and Handling
Vaccine Storage Units Vaccine Viability and Expiration
Temperature Monitoring and Controls Resources
Troubleshooting and Follow-up  
Vaccine Storage Units
When is a "dormitory style" refrigerator considered adequate for storing vaccines?
Never! Dormitory-style (bar-style) units pose a significant risk of freezing vaccine even when used only for temporary storage. During testing, dormitory-style refrigerators demonstrated consistently unacceptable performance, regardless of where the vaccine was placed inside the unit. The use of dormitory-style refrigerators is specifically prohibited for storage of VFC vaccines or other vaccines purchased with public funds.
We have a small office with limited space for a vaccine storage unit. If dormitory-style refrigerators are no longer an option, what can we use?
A "dormitory-style" refrigerator is a small combination refrigerator/freezer unit that is outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside an icemaker compartment (freezer) within the refrigerator. This type of unit has severe temperature control and stability issues. However, compact "purpose built" or "pharmacy grade" refrigerators and freezers that have been engineered to maintain even temperatures throughout the unit are available, and these are ideal for use in small offices. In general, the unit must be large enough to store the year's largest vaccine inventory without crowding and to store water bottles (in a refrigerator) and frozen coolant packs (in a freezer) to stabilize the temperatures and minimize fluctuations.
Our office is committed to assuring appropriate storage for our vaccines. Do we need a stand-alone refrigerator and freezer, or is a combination unit adequate?
Stand-alone units that only refrigerate or only freeze are recommended by CDC. Combination refrigerator/freezer units are less capable of simultaneously maintaining proper storage temperatures in both compartments. If a combination refrigerator/freezer must be used, only refrigerated vaccines should be stored in the unit, and a separate stand-alone freezer should be used for frozen vaccines. Stand-alone units can vary in size from compact, under-the-counter (not dormitory) style to large, stand-alone, pharmaceutical grade units.
 
There is a vent in our combination refrigerator/freezer that brings in cold air from the freezer. Vaccines stored near this vent are colder to the touch. Could this be a problem?
Yes. Vaccines that are stored in the refrigerator portion of a combination refrigerator/freezer should be moved away from the vent located in the refrigerator compartment. The cold air from the freezer is circulated into the refrigerator compartment to cool it, which can cause your vaccines to freeze. Inactivated vaccines must be kept between 35° and 46°F (between 2° and 8°C) and not frozen.
Since I am no longer storing frozen vaccines in the freezer portion of my combination refrigerator/freezer, should I just turn off the freezer portion of the unit?
No. If you turn off the freezer portion of a combination refrigerator/freezer, the refrigerated compartment will not maintain the proper temperature.
We have a large quantity of vaccines, and space is always an issue. Since you cannot put vaccines in the vegetable bins, can we remove them and then put vaccines in that space?
Vaccines should not be stored in vegetable bins or the space occupied by vegetable bins. This area is commonly closer to the motor of the unit and the temperature is different from that in the body of the refrigerator. We recommend that you remove the vegetable bins and put bottles of water in that space to help maintain a constant temperature in your refrigerator. Vaccines should be placed in the center of the refrigerator, away from the walls and floor of the unit in open containers so air can circulate around the vaccines. You also do not want the top shelf in the refrigerator to be too close to the vent that comes from the freezer because this can expose your vaccines to freezing temperatures.
 
Can we store vaccine in the same unit where we store employees' lunches?
No, don't use the same unit. Frequent opening of the refrigerator door to retrieve food items can adversely affect the internal temperature of the unit and potentially damage the vaccines.
Is it okay to store medications and other biologic products in the same unit as vaccines?
CDC's Vaccine Storage and Handling Toolkit states "If possible, other medications and biologic products should not be stored inside the vaccine storage unit. If there is no other choice, these products should be stored below the vaccines on a different shelf. This prevents contamination of the vaccines should the other products spill and reduces the likelihood of medication errors."
Temperature Monitoring & Controls Back to top
What type of thermometers should be used for measuring temperatures in a vaccine storage unit? What type of thermometers should NOT be used for this purpose?
CDC recommends that vaccines be monitored using a thermometer that provides continuous monitoring information with an active display. The thermometer should be digital and have a probe placed in a glycol-filled bottle. It should include an alarm for out-of-range temperature and have a low battery indicator. The thermometer should be capable of showing both the current temperature and the minimum and maximum temperatures since the last reading. If the thermometer is a data logger with a min/max display, it should have a reset button. The unit should be capable of accuracy within +/- 0.5°C (+/- 1°F).
Thermometers that are NOT recommended for monitoring vaccine temperatures are fluid-filled biosafe liquid thermometers, bi-metal stem thermometers, food thermometers, household mercury thermometers, and infrared (sometimes called laser or non-contact) thermometers. These types of thermometers can be difficult to read and only indicate the temperature at the precise time they are read. Although chart recorders are not routinely recommended, these paper-based loggers may be the only option for continuous temperature monitoring in facilities that do not have access to a computer. Finally, thermometers that are not calibrated are not recommended.
More detailed information on thermometer selection is available in the CDC Vaccine Storage and Handling Toolkit, found at www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf.
What is a digital data logger?
Digital data loggers are electronic devices that may be programmed to record temperatures at intervals throughout the day. Currently, CDC recommends that the logger be set to measure the temperature every 15 minutes. Digital data loggers come in a variety of shapes, sizes, and styles, and typically are battery operated. Some models have an alarm that can be set to ring at a specified temperature. Digital data loggers are used with special software that is installed on a computer. To review the temperature history, the user must download data from the thermometer to a computer on a regular basis, at least weekly.
What is a certified calibrated thermometer?
CDC recommends that you use only a calibrated thermometer with a Certificate of Traceability and Calibration Testing (also known as a Report of Calibration). This certificate provides the thermometer's level of accuracy compared to a recognized standard. This certificate comes with the thermometer when it is purchased, and it is different than the manufacturer's warranty. While all thermometers are calibrated during manufacturing, certified calibrated thermometers undergo a second individual calibration against a reference standard from an accredited testing laboratory. Additional information on this topic is available in the ACIP's "General Recommendations on Immunization" (see www.cdc.gov/mmwr/pdf/rr/rr6002.pdf) and in CDC's Vaccine Storage and Handling Toolkit (see www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf).
Why does the thermometer probe need to be suspended in glycol? Won't it work just as well if it is measuring air temperature?
Glycol-encased probes provide a more accurate reading of actual vaccine vial temperatures when placed in the same area where the vaccine is stored. Vaccines are more thermostable than air because they are fluid-filled and thus have a larger thermal mass. Standard probes that measure air temperature can fluctuate with the defrost cycles of the unit, frequent opening and closing the door on busy workdays, air circulation patterns, etc. This could lead someone to inaccurately interpret changes in air temperature to mean that the vaccine temperature was out of range.
How long should we monitor the temperature in a new refrigerator before storing vaccines in it?
CDC recommends you allow one week of twice daily refrigerator and freezer temperature recordings, including minimum/maximum temperatures daily (preferably in the morning) to make sure temperatures are within the appropriate ranges before using the units to store vaccines. See CDC's "Vaccine Storage & Handling Toolkit" for useful information on vaccine storage and handling at www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf.
How often should temperatures be checked and recorded on our vaccine storage unit's log?
It is important that you check and record the temperatures of both the refrigerator and freezer units at the beginning and end of the workday. In addition, CDC recommends that the minimum/maximum temperatures be recorded daily, preferably in the morning. You also should record the room temperature on your log. These readings should occur regardless of whether there is a temperature alarm, a digital data logger thermometer, or a chart recorder thermometer. This provides assurance that the equipment is working correctly and, if an alarm system should fail or a response process is not correctly followed, the issue will be identified quickly. Immediate corrective action can then be taken that may save vaccines.
Why should I record the temperature of the room where the vaccine storage unit is located?
If the vaccine cold chain is broken, the ambient room temperature is useful information in helping determine how to handle the compromised vaccine. Do not remove the calibrated thermometer from the refrigerator or freezer to measure the room temperature. A standard household thermometer in the room is fine for this purpose.
How long do we need to keep our refrigerator/freezer temperature tracking logs?
CDC recommends that refrigerator and freezer temperature logs be kept for at least 3 years. (See www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf, page 52.) The reasoning is that it is useful to be able to look back at the record to help determine if a unit is developing a problem.
Individual state Vaccines For Children (VFC) programs may have different requirements for retaining temperature logs. You should contact your state program for this information. Contact information for state immunization programs is available at www.immunize.org/coordinators.
We plan to keep our influenza vaccine in coolers when we travel to off-site vaccination events. How can we ensure the vaccine remains within the proper temperature range?
CDC does not recommend keeping vaccines in transport containers unless they are portable refrigerator or freezer units. If vaccines must be kept in transport containers during off-site clinics:
The containers should remain closed as much as possible.
  Only the amount of vaccine needed at one time should be removed for preparation and administration.
  A calibrated thermometer (preferably with a biosafe glycol-encased thermometer probe) should be placed as close as possible to the vaccines within the container.
The temperature inside the container should be read and documented at least hourly.
If you have concerns that vaccines or diluents may have been compromised (exposed to inappropriate conditions/temperatures or handled improperly), label them “DO NOT USE” and store them under appropriate conditions separated from other vaccine supplies. Then contact your immunization program and/or vaccine manufacturer for guidance. Do not discard the vaccines or diluents unless directed to by your immunization program and/or the manufacturer. For more information, see the Transporting Vaccine in an Emergency or to Off-Site Facilities section on pages 91–96 of CDC’s Vaccine Storage and Handling Toolkit at www.cdc.gov/vaccines/recs/storage/toolkit/storagehandling-toolkit.pdf. Additional information is available on IAC’s Vaccine Storage and Handling website at www.immunize.org/handouts/vaccine-storage-handling.asp.
Troubleshooting & Follow-Up Back to top
We are carefully logging our vaccine storage unit's temperatures each day. Is there anything else that could go wrong?
Congratulations on all your hard work! You would be surprised at the number of people who, just like you, do a careful job of recording temperatures, but then they fail to act on them when the temperatures go out of range. Always take immediate action when you notice an out-of-range temperature. You may need to move the vaccines temporarily to a more reliable storage unit and determine the source of the problem. It may be something quite fixable (e.g., excessive lint or dust on the coils), and you will be back in business after you determine that the temperature is back in range after a few hours. Above all, don't chart an out-of-range temperature and not act on it! IAC has created temperature recording logs and a troubleshooting record to document unacceptable vaccine storage events. These materials provide guidance on the appropriate steps to take in the event of a storage problem (see www.immunize.org/handouts/vaccine-storage-handling.asp).
One morning, our refrigerator thermometer registered 32° F. The vaccine didn't look frozen so we kept using it. Was this okay?
No. If you find that a vaccine has been exposed to an inappropriate temperature, determine the reason for the temperature alteration, mark the vaccine "Do Not Use," and contact the manufacturer or the state or local health department to determine if the vaccine can be used.
ACIP and CDC's Vaccine Storage and Handling Guide say that refrigerated vaccines should be stored between 35° and 46°F, but some vaccine package inserts list 36°–46°F as the proper range. Should I use 35°F or 36°F as the low boundary of the range?
On the Celsius scale, the appropriate storage range for refrigerated vaccines is between 2°C and 8°C. Because 2°C converts to 35.6°F, some manufacturers have rounded the Fahrenheit reading to 36°F. However, 35°F is still considered acceptable for storage of any refrigerated vaccine. Providers should make an effort to store vaccines toward the midpoint of the range (approximately 40°F or 5°C) rather than at either end of the scale.
What should I do if my thermometer indicates my refrigerated vaccine has been stored between 32° and 34°F? Since the vaccine wasn't "frozen," will it be OK to use? And what about people who received the vaccine before we discovered the temperature excursion—will we need to revaccinate them?
This is a complex question that requires case-by-case review. First, while you're assessing the situation, return the vaccine to proper storage temperatures and mark it "Do Not Use." Then, contact your state or local immunization program or the appropriate vaccine manufacturer(s) to discuss the potential usability of the vaccine. They will need to consider several variables related to vaccine storage conditions. For example, their guidance will be affected by the accuracy of the thermometer, whether the thermometer probe was in a liquid or was reading the temperature of the air, the type of vaccine involved, the length of time of the excursion, etc.
In general, if it can be reliably determined that the vaccine in question was not stored below 32°F and the manufacturer's stability data concurs, most immunization programs and vaccine manufacturers would not recommend wasting the vaccine or revaccinating recipients.
For an extended period, the temperature in the vaccine-storage refrigerator in our practice was too cold. We assume all the vaccines given during that period are considered invalid. How should we schedule the revaccinations?
If administered vaccine is found to be stored at an inappropriate temperature, the provider should contact the state health department to determine if the vaccine dose is invalid. If the vaccine dose is determined to be invalid, another dose should be given. This applies to both inactivated and live vaccines. If the damaged vaccine was a live virus vaccine (e.g., MMR, MMRV, VAR, or HZV), you should wait at least 4 weeks after the previous (damaged) dose was given before repeating it. If the damaged vaccine was an inactivated vaccine, you can give the repeat dose on the same day you gave the damaged dose or at any other time. If you prefer, you can perform serologic testing to check for immunity for certain vaccinations (e.g., measles, rubella, hepatitis A, diphtheria, varicella, and tetanus).
 
What should we do if a dose of expired vaccine is given to a patient?
The dose should be repeated. If the error was detected on the same clinic day, you can repeat the dose that day. If the error is detected more than one day later AND if the expired dose is a live virus vaccine, you must wait at least 28 days after the previous (expired) dose was given before repeating it. If the expired dose is not a live vaccine, the dose should be repeated as soon as possible. If you prefer, you can perform serologic testing to check for immunity for certain vaccinations (e.g., measles, rubella, hepatitis A, diphtheria, varicella, and tetanus).
Vaccine Viability and Expiration Back to top
What is a "temperature excursion"?
Any temperature reading outside the recommended range for vaccine storage is a temperature excursion. However, it is the total amount of time, or cumulative time, out of range that affects the viability of vaccine. Any time appropriate vaccine storage temperatures are in question, contact your state immunization program and/or the vaccine manufacturer for further guidance about whether or not a vaccine may be used.
How long is a vaccine viable if it has been stored in the refrigerator in a syringe?
Disposable syringes are meant for administration of immunobiologics, not for storage. CDC recommends that vaccines that have been drawn into syringes by the provider be discarded at the end of the clinic day. Manufacturer-filled syringes that have not been activated (i.e., have not had the needle guard removed or a needle attached) may be kept and used until their expiration date.
I've heard that multidose vaccine vials should be disposed of after being open for 30 days. Is this true?
No. Multidose vials of vaccine that do not require reconstitution may be used through the expiration date printed on the label or box as long as the vaccine is not contaminated.
When the expiration date of a vaccine indicates a month and year, does the vaccine expire on the first or last day of the month?
Vaccine may be used through the last day of the month indicated on the expiration date. After that, do not use it. Monitor your vaccine supply carefully so that vaccines do not expire.
Help! I'm confused about how to correctly interpret expiration dates on vaccines.
The expiration date is the date by which the vaccine should be used. Vaccines may be used up to and including this date unless otherwise stated in the manufacturer's product information. The expiration date is based on the assumption that the vaccine has been properly handled and that it has not become contaminated.
Some vaccines expire within a certain time after opening or after reconstitution. Multi-dose vials contain bacteriostatic agents that prevent the growth of bacteria and may be used until the expiration date printed on the vial unless they become contaminated. (One exception to this is that multi-dose vials of MPSV4 should be discarded if not used within 35 days after reconstitution, even if the expiration date printed on the vial by the manufacturer has not passed.) Single-dose vials and manufacturer-filled syringes do not contain bacteriostatic agents. Once the cap has been removed or the sterile seal has been broken on these vaccines, they should be administered. Lyophilized (freeze-dried) vaccine must be used within a specified time frame after it has been reconstituted. You may find IAC's educational piece titled Vaccines with Diluents: How to Use Them helpful. It's available at www.immunize.org/catg.d/p3040.pdf.
What should I do with expired vaccines?
First and foremost rotate your vaccine supply so expensive vaccine does not expire in your refrigerator. If you discover expired vaccine, remove it from the refrigerator or freezer so that it is not inadvertently given to a patient. Expired vaccines and diluents should NEVER be administered, even if it is only 1 day past the expiration date. Contact your immunization program, vaccine supplier, or vaccine manufacturer for specific policies about disposing expired vaccines.
Resources Back to top
Where can I get the most up-to-date information about vaccine storage and handling?
CDC has published a thorough Vaccine Storage and Handling Toolkit covering topics such as vaccine storage units, thermometers, and inventory management. The toolkit also contains troubleshooting guides to assist with vaccine storage unit or thermometer problems. This terrific resource is available online at www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf.
In addition, IAC maintains many free, downloadable materials at www.immunize.org/handouts/vaccine-storage-handling.asp.
Our clinic needs to buy new equipment to be in compliance with these updated recommendations. How do we know what are the best products to purchase?
Your best resource is your state immunization manager or Vaccines for Children (VFC) coordinator if you store VFC-funded vaccines. Contact information can be found here: www.immunize.org/coordinators. The California VFC program has also put together a handy resource about buying a new refrigerator (see http://eziz.org/assets/docs/IMM-940.pdf).
This page was reviewed on July 31, 2014
Immunization Action Coalition  •  2550 University Avenue West  •  Suite 415 North  •  Saint Paul, Minnesota  •  55114
tel 651-647-9009  •  fax 651-647-9131
 
This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 5U38IP000290) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.