Core Topic 8

Storage and handling of vaccine

Learning Outcome
To

follow correct procedures for storage and handling of vaccines

Immunisation Department, Centre for Infections

Learning Objectives
Describe Specify

the cold chain and the importance of its maintenance the effects of temperature on potency and efficacy of

minimum/maximum temperatures for vaccine storage

Describe

vaccine
Describe Identify Know

the requirements for the correct ordering, delivery and storage of vaccines in the workplace vaccines sensitive to light heat and freezing how to manage breakdowns in the cold chain, where

to dispose of damaged vaccine, who to inform and what action to take how to audit current management of cold chain within their practice area.
Immunisation Department, Centre for Infections

Explain

Cold Chain
The cold chain is the system of transporting and storing vaccines within the safe temperature range of 2C to 8C. For frozen vaccines the optimum temperature is -15C or lower. In addition, protection from light is a necessary condition for some vaccines.
(Nayda C., Kempe A., Miller N. Keep it Cool: the Vaccine Cold Chain. Guidelines for Immunisation Providers on Maintaining the Cold Chain. Second edition. Commonwealth of Australia 2001 )

Immunisation Department, Centre for Infections

Immunization program are widely recognized as one of the most effective types of health interventions. However, for many countries, the delivery of safe injection practices and quality vaccines is a significant challenge.

Cold chain system

The cold chain system, when implemented properly, can help overcome this challenge.

The cold chain system

Vaccines are sensitive biological substances that,
with time, lose their potency, especially when exposed to heat, sunlight or fluorescent light and, in some cases, when cold. Once potency has been lost, it cant be restored. To provide protection against disease, vaccines need to be distributed, stored and administered at recommended temperatures

The cold chain system

The cold chain system is means of delivering effective vaccinations in children. The common elements of all cold chain systems are a series of storage and transport links through a network of :
fridges, freezers and cold boxes

that keep vaccines at a safe temperature throughout their journey.

Typical cold chain system

As shown in the diagram, a typical cold chain system begins when vaccine is manufactured and ends with the child being immunized.

How long is the cold chain?

Manufacturer to airport; cold storage at airport Transport at the correct temperature from airport to storage in central, regional and district stores and in health centers Transported at the correct temperature to outreach sites Kept at correct temperature during immunization sessions

Why is the cold chain important?

1.

Vaccines are:

Biological products
lose potency with time Process irreversible and accelerated if proper storage conditions are not adhered to.

Immunisation Department, Centre for Infections

Why is the cold chain important?

2. Assurance/confidence in potent product and vaccine programmes Professional responsibility

Confident the vaccines you give will be effective

Public Health responsibility

Public confidence in immunisation programmes

Immunisation Department, Centre for Infections

Why is the cold chain important?

3. Ensuring maximum benefit from immunisations Responsibility not to waste scarce NHS resources

Reduce wastage from errors

Immunisation Department, Centre for Infections

Why is the cold chain important?

4.Compliance with Manufacturer

Any vaccine that has not been stored at a temperature of 2-8C as per its licensing conditions is no longer a licensed product
Responsibility/ liability rests with immunisation provider and PCT.

Immunisation Department, Centre for Infections

Vaccine Stability

Sensitivity to HEAT

MOST SENSITIVE

Sensitivity to COLD

BCG Varicella MMR MenC Hepatitis B DT and/or aP/IPV/HIB

HepB and combination DTand/or aP/IPV/HIB Influenza MenC *MMR *Varicella *BCG (*Freeze dried)

Immunisation Department, Centre for Infections

LEAST SENSITIVE

Light Sensitive
Sensitive to strong light, sunlight, ultraviolet, fluorescents (neon)
BCG MMR Varicella Meningococcal C Conjugate Most DTaP containing vaccines

Vaccines should always be stored in their original packaging until point of use to protect them from light

Immunisation Department, Centre for Infections

Vaccine Storage
X No food or medical specimens

Use a dedicated vaccine fridge

Safeguard electricity supply No more than 50% full Place vaccines in clearly labelled plastic mesh baskets Group vaccines by type (Paediatric, Adult, Adolescent) Defrost/calibrate fridge regularly Ensure back up facilities are available in the event of fridge failing

X Do not place fridge in direct sunlight or near heat source

X Do not remove vaccines from original boxes until ready to use X Do not store vaccines in fridge doors or in solid plastic trays/containers within the fridge X Keep vaccines away from fridge walls and cold air vents

Picture taken from www.medisave.co.uk

Immunisation Department, Centre for Infections

Temperature Monitoring

Use max/min thermometer Probe should be placed in the centre of fridge Temperature should be recorded at least once a day Reset daily Calibrate as recommended Take immediate action if temperature is outside recommended range

Immunisation Department, Centre for Infections

Sample refrigerator temperature record chart

Immunisation Department, Centre for Infections

Available at: http://www2.cdc.gov/nip/isd/immtoolkit/content/vacstorage/logs.htm

Storage temperature

Never exceed 8C or fall below 2C

Aim for 5C
Aim to maintain vaccine fridge as close as possible to 5C as this gives a safety margin of + or 3c

Immunisation Department, Centre for Infections

Loading Vaccine Refrigerators

Put vaccines and diluents on the top and middle shelves of the main section OPV and measles vaccine on the top shelf BCG, Pentavalent and TT vaccines on the middle shelves Diluents next to the vaccines with which they were supplied Arrange the boxes of vaccine in stacks between which the air can move.
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Choosing a Refrigerator and Freezer

1. Temperature Zone, the average temperature during the hottest/coldest months should be taken as criteria for the determination of the zones. There are three temperature zones for which cold chain refrigerators and freezers will be classified: Hot zone, 0C to +43C Temperate zone, 0C to + 32C Cold zone, -5C to +32C

2. Vaccine storage capacity, how much vaccines must be stored at 0-+8C

or -20C

3. Ice pack freezing capacity, how many icepacks should be frozen per
24 hours
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Conti..

4. Power source, electricity, kerosene or bottled gas. Is supply Continuous or not 5. Holdover time, How many hours will the vaccine remain below 10C 6. Reliability, Repair facilities and spare parts are available 7. Price, Which refrigerator meets requirements at the lowest cost

8. Training, Are the users and those in charge of maintenance of equipment properly trained

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What to do when a vaccine refrigerator is out of order

If your vaccine refrigerator stops working, first protect the vaccines and then repair the refrigerator.

Protecting the vaccines

Move the vaccines to another place until the refrigerator is repaired. If you think that the problem will last only a short time, you may use a cold box or vaccine carrier lined with conditioned ice-packs for temporary storage. For a longer duration, use another refrigerator. Always keep a freezer indicator with the freezesensitive vaccines to monitor eventual freezing.
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Restoring the refrigerator to working order

Check the power, gas or kerosene supply. If there is no power, make other arrangements (e.g. store the vaccine in a household refrigerator) until power is restored. If there is no gas or kerosene, get it as soon as possible. If a lack of power, gas or kerosene is not the problem, repair the refrigerator or report to your repair technician or supervisor. Record the breakdown on the daily temperature recording chart. Note: Concerning the routine maintenance and the servicing of refrigerators, WHO technical manuals exist for each kind of refrigerator.
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All the vaccines should be stored in the basket provided with the refrigerator
1. Measles,BCG and OPV in the bottom only

2.
only.

Freeze-sensitive vaccines (Penta, TT) in the top

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Different Types of Refrigerators/Freezers

D Chest freezer e e p ILR Mk 074

Solar Powered

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General rules about refrigerators

Opening the refrigerator door raises the temperature. Before you open the door, plan what you are going to do.

When you open the door, do what you have to do

quickly and close the door as soon as possible. Try not to open the refrigerator door more than three times a day.
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Storage Principles
Vaccines must not be kept:
In the door compartments of domestic refrigerators
In the salad trays at the bottom of the refrigerator In contact with the evaporator plate

Must not be confused with other heat sensitive pharmaceuticals Diluents must be stored at the same temperature

at the point of use. This prevents damage to the potency of the vaccine
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Contingency Plans

Each

facility should have a contingency plan for power

failures and these must be visible placed on the fridge It must be include an alternative storage area/place and it must be adequate

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Walk-in Type Cold Room

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Combination Walk-in Type Cold/Freezer Room

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Cold chain monitoring equipment: thermometers

Health centre staff use dial thermometers, as recommended by WHO to monitor the temperature of refrigerators, cold boxes and cooler boxes. Max-min thermometers are not recommended as training is required

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Type of Vaccine Thermometer

Dial type Thermometer

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Type of Vaccine Thermometer

Bar type Thermometer (read safety zone as 20 to 80 C & not as 00 to 80)

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Maintaining cold boxes and vaccine carriers

Vaccine carriers and cold boxes must be well dried after their use. If they are left wet with their lids closed, they will become mouldy. Mould may affect the seal of the cold boxes and vaccine carriers. If possible, store cold boxes and vaccine carriers with the lid open, when not being used.

Knocks and sunlight can cause cracks in the walls and lids of cold boxes and vaccine carriers. If this happens the vaccines inside will be exposed to heat. If a cold box or vaccine carrier wall has a small crack you may be able to repair it with adhesive tape until you can get an undamaged one.
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Packing a cooler box

1. Take all the frozen ice packs you need from the freezer and condition them. 2. Put ice packs against each of the four sides of the cold box or vaccine carrier. 3. Take all the vaccines and diluent you need from the main section of the refrigerator and close the door. 4. Put the vaccines and diluent in the middle of the cold box or carrier. Vials may be kept in their boxes or packed without them, depending on how many vials you need.
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Cold box and Vaccine Carriers

Cold box

Vaccine carrier with vaccine vials in foam pad

Cold Chain & Vaccine Management Training

41

Keeping things cool in the field

Keep the lid tightly on the vaccine carrier in transit. Keep cold boxes and vaccine carriers in the shade. Do not leave a cold box or vaccine carrier in a vehicle

that is standing in the sun. Take it out of the vehicle

and put it in the shade.

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Ice packs

Ice packs are flat, square plastic bottles that can be filled with water and frozen. The required number in a particular cold box or vaccine carrier varies. Every health centre should have two sets of ice packs, one being frozen while the other is in use. Condition the ice packs before use

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Ice packs

0.4 liters

0.6 liters

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Vaccines sensitive to heat

OPV Measles BCG TT Pentavalent
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Most sensitive

Least sensitive

Vaccines sensitive to cold

Pentavalent

Most sensitive

TT

Least sensitive
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Recommended Storage Temperature for Vaccines

Vaccines OPV BCG Measles Penta TT Level/Max stock in months
National 6 months
-15C to -25C

Provincial 3 months

District 2 months

Facility 1 month

+ 2C to + 8C

Note: 1.BCG and Measles can be stored and transported at +2C to +8C. It is not harmful to store them at minus temperature but it is unnecessary. 2.Diluent vials must never be frozen, they must be stored and transported at +2C to + 8C when packed together with the vaccine.

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What is a vaccine vial monitor?

A vaccine vial monitor (VVM) is a label containing a heatsensitive material which is placed on a vaccine vial to register cumulative heat exposure over time.

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VVM (Vaccine Vial Monitor)

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Reading a Vaccine Vial Monitor

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Some recommendations at each level after the assessment: 1. Provision of Freeze tag for all freeze sensitive vaccines
2. 3. 4. 5. 6.

Completing of cold chain monitor at federal, provincial and district level

Observe strictly vaccine ordering and stock keeping Designate & train cold chain staff at all levels Observe Multi dose vial policy Perform Ice pack conditioning for freeze sensitive vaccines 7. Adapt an effective vaccine distribution system 8. Monitor stock and expiry dates

Immunisation Department, Centre for Infections

Vaccine and Cold Chain Monitoring Devices

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Cold Chain Equipment

All cold chain equipment has to comply with a set of performance standards defined by the WHO EPI program and United Nations Childrens Fund (UNICEF), or national policy.

The recommended equipment typically used for vaccine storage are :

For transporting vaccines equipment such as cold boxes,

cold rooms,

vaccine carriers and

international containers are commonly used.

refrigerators and
freezers.

Cold chain equipment

for transporting vaccine

Cold box Ice bags

Vaccine carrier

Cold chain equipment

For vaccine storage

refrigerators

Freezer

Cold room

Controlling and monitoring temperatures

There are different types of monitoring devices for measuring, controlling and recording storage temperature of vaccines. Refrigerators, freezers and cold boxes normally have thermometers that measure the internal temperature. Most refrigerators and freezers are fitted with an adjustable thermostat to control and correct storage temperature.

Controlling and monitoring temperatures

A designated person in charge of cold chain equipment should read and record storage temperature on a record sheet at least twice daily or according to policy

Controlling and monitoring temperatures

A Cold Chain Monitor card (CCM) approved by the WHO is always packaged with each consignment of vaccine supplied by UNICEF. All CCMs have temperaturesensitive indicators that monitor heat exposure throughout the entire journey of vaccine, from manufacturer to health facility. This indicator changes irreversibly from white to blue if exposed to temperatures higher than +10 and +34C to monitor conditions in transit and in storage.

Controlling and monitoring temperatures

FreezeWatch indicators are CCMs used to monitor storage conditions of cold-sensitive vaccines. Stop! Watches comprise of CCM and FreezeWatch devices to monitor high and low storage temperatures in a refrigerator.

Controlling and monitoring temperatures

A Vaccine Vial Monitor (VVM) is a label on a vaccine vial that is marked by a circle with a small square inside. A heat-sensitive material on the label registers cumulative heat exposure of each individual vaccine vial over time. When the inner square matches or is darker than the outer circle, it indicates that the vaccine has lost its potency and must be discarded. VVMs are NOT substitutes for expiry dates. Vaccines must never be used after their expiry dates.

VV M

Keeping vaccines in the domestic refrigerator at health center

1. The refrigerator must be placed in the coolest place away from direct sunlight with adequate air circulation around it (12 15 inches away from the wall) 2. It must be kept locked and opened only when necessary 3. It must be defrosted regularly 4. Its temperature must be recorded twice daily 5. Both monitor and thermometer are placed in the refrigerator, while temperature chart is stuck on the outer-surface of the refrigerator door

Arrangement of vaccines in the refrigerator

MM R

Shake test

DPT, DT, dT, TT These vaccines are damaged by freezing

Shake test should be performed on a sample of vaccine vial in question and on the sample of the same batch/manufacture which is known to have been frozen.

The two vials should be shaken vigorously for few minutes, and observed for the rate of sedimentation

Ordering and Delivery

Named trained designated person and deputy who have overall responsibility for ordering, receipt and care of vaccines.

Responsibilities include:
Ensuring cold chain has been maintained during transport and managing receipt of vaccines directly into refrigeration Checking delivery for leakage, damage and discrepancies

Rotation of stock
Maintaining stock information system to keep track of orders, expiry dates and running total of vaccines Ensuring adequate supply/ Minimising over ordering or stockpiling

Immunisation Department, Centre for Infections

Cool Boxes and Transporting vaccines

Use a validated cool box and ice packs from recognised medical supply company Monitor maximum/minimum temperature, recording at regular intervals
Vaccines should be wrapped in bubble wrap or similar insulation material to prevent direct contact with ice packs Use insulating material to fill any spaces within the cool box Only take enough vaccine for particular session and minimise exposure of the vaccines to room temperatures

Immunisation Department, Centre for Infections

What to do if there has been a Cold Chain failure

Prior to administration
Any vaccine that has not been stored at a temperature of 2-8C as per its licensing conditions is no longer a licensed product

Where there is any doubt that cold chain has not been maintained, vaccines should not be used until further advice has been sought from the vaccine manufacturer
Written procedure for the disposal of vaccines by incineration should be available locally

Immunisation Department, Centre for Infections

Post administration

Treat as Serious Untoward Incident Inform Practice Manager/Line Manager/PCT of the incident Suspend all immunisation clinics until resolved

Immunisation Department, Centre for Infections

Best practice in Cold Chain compliance

Defined local policies should be in place and written in accordance with PGDs, SPCs, DH Green Book Regular audit of current practice Training

Local multidisciplinary support

Immunisation Department, Centre for Infections

Useful resources
Chapter 3&4 Green Book: Storage, distribution and disposal of vaccines and Immunisation Procedures

Poster and plug stickers available to order from DH publications orderline (www.dh.gov.uk)
CDC Vaccine Storage and Handling Toolkit
http://www2a.cdc.gov/vaccines/ed/shtoolkit/

WHO. Temperature sensitivity of vaccines. August 2006. http://www.who.int/vaccinesdocuments/DocsPDF06/847.pdf

Immunisation Department, Centre for Infections

Minimum slide set created by:

Immunisation Department, Centre for Infections,

Health Protection Agency

to assist teaching of the Core Curriculum for Immunisation Training
(see http://www.hpa.org.uk/infections/topics_az/vaccination/training_menu.htm)

Immunisation Department, Centre for Infections