Vaccine Storage and HandlingWilliam L. Atkinson, MD, MPH

National Immunization Program

North Carolina Immunization ConferenceGreensboro, NC18 August 2005

Effect of Temperature on Vaccines

• Live vaccines– tolerate freezing–deteriorate rapidly after removal

from freezer

• Inactivated vaccines–damaged by exposure to freezing

temperatures– tolerate short time out of

refrigeration

Vaccine Storage and HandlingGuidelines

• Develop and maintain detailed written protocol

• Assign responsibilities to one person

• Designate a back-up person

• Provide training on vaccine storage and handling

Vaccine Shipments• Examine shipment on arrival• Crosscheck contents with packing slip• Check vaccine expiration dates• Examine contents for damage• Was shipping time <48 hours?• Is there evidence of excessive heat or cold

exposure?

Vaccine Inventory Log

• Name of each vaccine• Number of doses of each vaccine

received• Date received• Condition upon arrival• Vaccine manufacturers• Lot numbers• Expiration dates for each vaccine

Vaccine Storage Requirements

• Maintain required temperature range throughout the year

• Separate doors for refrigerator and freezer• Large enough to hold year’s largest vaccine

inventory• Dedicated to biologics (no food or

beverages!)• Dorm-style refrigerators should NOT be used

to store varicella vaccine or LAIV

Temperature Monitoring

• Separate thermometer for refrigerator and freezer compartments

• Use good quality calibrated thermometer (biosafe liquid, continuous graphic, or minimum/maximum)

• Manually check temperatures twice a day even if using continuous graphic thermometer

Temperature Monitoring

• Use temperature log for both refrigerator and freezer compartments

• Check and record the temperatures twice a day

• Keep temperature logs for at least 3 years

• Take immediate action when the temperature is outside the recommended range

Recommended Temperatures

Refrigerator

35o - 46oF

or

2o - 8oCAverage 40oF (5oC)

Freezer

<+5oF

or

<-15oC(varicella & LAIV)

Preventive Measures

• Use a plug guard or safety-lock plug

• Post a warning sign above the plug and on the refrigerator

• Label fuses and circuit breakers

• Install a temperature alarm

Preventive Measures• Remove vegetable bins and replace

with bottles of water to stabilize refrigerator temperature

• Keep extra cold packs or blue ice in the freezer

• Never store vaccines in the door of the refrigerator or freezer

Multi-dose Vials

• Contain a bacteriostatic

• Good until expiration date unless contaminated

Single-dose Vials

• Do NOT contain a bacteriostatic

• Once opened use or discard within 24 hours

After reconstitution use within:

• 30 minutes – varicella, ActHIB

• 8 hours – MMR

• 24 hours - PedvaxHIB

Unreconstituted Varicella Vaccine

• Can store at refrigerator temperature for 72 hours, then discard if not used

• Do NOT refreeze

LAIV Storage and Handling• Must be stored at <5o F (-15o C) to

maintain expiration dates• Can be stored in a standard frost-

free freezer• Manufacturer-supplied freezer

box no longer required• May be stored at refrigerator

temperature for 60 hours – cannot be refrozen

Vaccine Handling• Open only one vial at a time• Store vaccine vials separate from

other medications or biologics• Do NOT store food/beverages in

refrigerator or freezer with vaccines• Keep MMR, varicella and yellow fever

vaccines in their box until ready to use

Prefilling Syringes

• Increased risk for administration errors

• Increased vaccine wastage• Risk of inappropriate vaccine storage

conditions• Bacterial growth in vaccines that do

not contain a preservative• Reduced vaccine potency

Preparing for a Mass Clinic• Administer only one type of vaccine• Separate vaccine administration stations

by vaccine type • Transport the vaccine to the clinic in the

manufacturer-supplied packaging at the recommended temperature

• Use an insulated barrier (such as bubble wrap) between the vaccine and the cold or frozen packs

• A single layer of towel over ice is NOT adequate protection

Prefilling Syringes at aMass Clinic

• Upon arrival draw up <1 vial or 10 doses• Replenish supply throughout the day• Monitor patient flow to avoid drawing up

unnecessary doses

• Discard any syringes other than those filled by the manufacturer at the end of the clinic day

Vaccine Inventory Control

• Conduct a monthly vaccine inventory• Avoid stocking excessive vaccine supplies• Include diluents in the stock control

procedure• Monitor expiration dates• Rotate stock to avoid waste from expiration• Expired vaccine and diluent should never be

used• Limit access to authorized personnel only

Top Ten Vaccine Storage and Handling Errors

10. Only one person in the office is responsible for vaccine

9. Vaccine stored in the wrong part of the refrigerator

8. No emergency plans for a power outage or natural disaster

7. Discarding multi-dose vials after they are opened for 30 days

6. Leaving the refrigerator/freezer door open overnight

5. Storing varicella vaccine in a dorm-style refrigerator

4. Recording temperatures once per day

3. Recording temperatures for only the refrigerator or freezer

2. Throwing away temperature logs at the end of every month or year

Top Ten Vaccine Storage and Handling Errors

Top Ten Vaccine Storage and Handling Errors

1. Documenting out of range temperatures on vaccine temperature logs and NOT taking action!

When There is a Problem with your Refrigerator or Freezer

• Notify your supervisor- immediately!

• Adjust the thermostat

• Check the unit for problems

• Document the date, time, temperature, problem, and what you did to correct

• Recheck the temperature q2h

• If still out of range, call for help

• Move vaccine to alternate site

National Immunization Program

• Hotline 800.CDC.INFO

• Email nipinfo@cdc.gov

• Website www.cdc.gov/nip*

*order S&H Toolkit CD from online publication system