Cold Chain Vaccine

7/27/2019 Cold Chain Vaccine

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Core Topic 8Storage and handling of

vaccine


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Learning Outcome

To follow correct procedures

for storage and handling of

vaccines

Immunisation Department, Centre for Infections


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Learning Objectives

Describe the cold chain and the importance of its maintenance

Specify minimum/maximum temperatures for vaccine storage

Describe the effects of temperature on potency and efficacy of

vaccine

Describe the requirements for the correct ordering, delivery andstorage of vaccines in the workplace

Identify vaccines sensitive to light heat and freezing

Know how to manage breakdowns in the cold chain, where

to dispose of damaged vaccine, who to inform and what action totake

Explain how to audit current management of cold chain within their

practice area.



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Cold Chain

The cold chain is the system oftransporting and storing vaccines

within the safe temperature range of2C to 8C. For frozen vaccines theoptimum temperature is -15C orlower. In addition, protection fromlight is a necessary condition forsome 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)



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Cold chain system Immunization program are

widely recognized as one ofthe most effective types ofhealth interventions.

However, for manycountries, the delivery ofsafe injection practices andquality vaccines is asignificant challenge.

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

challenge.


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The cold chain systemVaccines are sensitive biological substances that,with time, lose their potency, especially whenexposed 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, vaccinesneed to be distributed, stored and administeredat recommended temperatures


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The cold chain systemThe cold chain system ismeans of deliveringeffective vaccinationsinchildren.

The common elements ofall cold chain systems area series of storage andtransport links through anetwork of :

fridges, freezers and

cold boxes

that keep vaccines atasafe temperaturethroughout their journey.


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Typical cold chain system

As shown in the

diagram, atypical coldchain systembegins whenvaccine ismanufacturedand ends with

the childbeingimmunized.


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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

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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.



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Why is the cold chain important?

2. Assurance/confidence in potent product andvaccine programmes

Professional responsibility Confident the vaccines you give will be effective

Public Health responsibility Public confidence in immunisation programmes



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important?

3. Ensuring maximum benefit from

immunisations

Responsibility not to waste scarce

NHS resources

Reduce wastage from errors



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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 alicensed product

Responsibility/ liability rests with immunisation

provider and PCT.



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Vaccine Stability

Sensitivity to HEAT

BCG

Varicella

MMR

MenC

Hepatitis B

DT and/oraP/IPV/HIB

Sensitivity to COLD

HepB andcombination

DTand/or

aP/IPV/HIBInfluenza

MenC

*MMR

*Varicella*BCG

(*Freeze dried)


LEAST

SENSITIVE

MOSTSENSITIVE


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Light Sensitive

Sensitive to strong light, sunlight,ultraviolet, fluorescents (neon)

BCG

MMR

Varicella

Meningococcal C ConjugateMost DTaP containing vaccines


Vaccines should

always be stored

in their original

packaging until

point of use to

protect them from

light


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Vaccine Storage

Use a dedicated vaccine fridge

Safeguard electricity supply

No more than 50% full

Place vaccines in clearlylabelled plastic mesh baskets

Group vaccines by type(Paediatric, Adult, Adolescent)

Defrost/calibrate fridgeregularly

Ensure back up facilities areavailable in the event of fridgefailing


X No food o r medica l

specimens

X Do not p lace fr idge in

direct sunl igh t or near heat

source

X Do not remov e vaccines

f rom original boxes unt i l

ready to us e

X Do not store vaccines in

fr idge doors or in sol id

plast ic trays/con tainerswith in the fr idge

X Keep v accines away from

fr idge wal ls and cold air

vents

Picture taken from www.medisave.co.uk


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Temperature Monitoring

Use max/min thermometer

Probe should be placed in thecentre of fridge

Temperature should be

recorded at least once a day

Reset daily

Calibrate as recommended

Take immediate action if

temperature is outsiderecommended range



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Sample refrigerator temperature recordchart

Immunisation Department, Centre for InfectionsAvai lable at: http:/ /www 2.cdc.gov/nip/ isd/ immto olki t /cont ent/vacstorage/ logs.htm


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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



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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 middleshelves

Diluents next to the vaccines with which they were

supplied

Arrange the boxes of vaccine in stacks between whichthe air can move.

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Choosing a Refrigerator and Freezer1. 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-+8Cor -20C

3. Ice pack freezing capacity, how many icepacks should be frozen per24 hours 23


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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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Conti..


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What to do when a vaccine refrigerator is outof 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 freeze-

sensitive 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. 26


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All the vaccines should be stored in thebasket provided with the refrigerator

1. Measles,BCG and OPV in the bottom only2. Freeze-sensitive vaccines (Penta, TT) in the top

only.


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Different Types ofRefrigerators/Freezers

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ILR Mk 074Solar Powered

De

e

p

Chest freezer


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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 plateMust 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 monitoringequipment: 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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Dial type Thermometer

Type of Vaccine Thermometer

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Bar type Thermometer

(r ead safety zone as 20to 80C & not as 00to 80)

Type of Vaccine Thermometer

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Maintaining cold boxes and vaccinecarriers

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 thelid 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. 38


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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 ofthe cold box or carrier. Vials may be kept in

their boxes or packed without them, depending

on how many vials you need.39


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Cold Chain & Vaccine Management Training

Cold box and Vaccine Carriers

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Vaccine carrier with vaccine vials in foam pad

Cold box


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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 vehiclethat 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


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Ice packs

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0.4 liters 0.6 liters


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Vaccines sensitive to heat

OPV

Measles

BCG

TTPentavalent

Most sensitive

Least sensitiv


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Vaccines sensitive to cold

Pentavalent

TT

Most sensitive

Least sensitive


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VaccinesNational Provincial District Facility

6 months 3 months 2 months 1 month

OPV -15C to -25C

BCG

Measles

Penta

TTNote:

1.BCG and Measles can be stored and transported at +2C to +8C. It is not

2.Diluent vials must never be frozen, they must be stored and transported at

+2C to + 8C when packed together with the vaccine.

Level/Max stock in months

+ 2C to + 8C

harmful to store them at minus temperature but it is unnecessary.

Recommended Storage Temperature for Vaccines

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A vaccine vial monitor (VVM) is a label containing a heat-

sensitive material which is placed on a vaccine vial to register

cumulative heat

exposure over time.

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What is a vaccine vial monitor?


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VVM (Vaccine Vial Monitor)

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R di V i Vi l M it


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Reading a Vaccine Vial Monitor

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S d ti t h l l ft


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Some recommendations at each level after

the assessment:

1. Provision of Freeze tag for all freeze sensitive

vaccines.2. Completing of cold chain monitor at federal,

provincial and district level

3. Observe strictly vaccine ordering and stock keeping4. Designate & train cold chain staff at all levels

5. Observe Multi dose vial policy

6. Perform Ice pack conditioning for freeze sensitive

vaccines

7. Adapt an effective vaccine distribution system

8. Monitor stock and expiry datesImmunisation Department, Centre for Infections


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Vaccine and Cold Chain Monitoring Devices

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Cold Chain Equipment

The recommended

equipment typically used

for vaccine storage are :

cold rooms,

refrigerators and

freezers.

For transporting vaccines

equipment such as

cold boxes, vaccine carriers and

international containers

are commonly used.

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.


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Cold chain equipment

for transporting vaccine

Coldbox

Vaccine carrier

Ice

bags


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Cold chain equipment

For vaccine storage

Cold room

refrigerators

Freezer


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Controlling and monitoring temperatures

There are different typesof monitoring devices formeasuring, controllingand recording storagetemperature of vaccines.

Refrigerators, freezersand cold boxes normallyhave thermometers thatmeasure the internaltemperature.

Most refrigerators andfreezers are fitted with anadjustable thermostat tocontrol and correctstorage temperature.


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A designatedperson in chargeof cold chainequipment shouldread and recordstorage

temperature on arecord sheet atleast twice daily oraccording to policy


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Controlling and monitoring

temperatures A Cold Chain Monitor card

(CCM) approved by theWHO is always packagedwith each consignment ofvaccine supplied byUNICEF.

All CCMs have temperature-sensitive indicators thatmonitor heat exposurethroughout the entire journeyof vaccine, frommanufacturer to health

facility.

This indicator changesirreversibly from white toblue if exposed totemperatures higher than +10and +34C to monitorconditions in transit and instorage.


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FreezeWatchindicators are CCMs

used to monitorstorage conditions ofcold-sensitivevaccines.

Stop! Watches

comprise of CCM andFreezeWatch devicesto monitor high andlow storagetemperatures in arefrigerator.


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A Vaccine Vial Monitor (VVM) is alabel

on a vaccine vial that is marked by acircle with a small square inside.

A heat-sensitive material on the labelregisters cumulative heat exposure ofeach individual vaccine vial overtime.

When the inner square matches or isdarker than the outer circle, itindicates that the vaccine has lost itspotency and must be discarded.

VVMs are NOT substitutes for expirydates.

Vaccines must never be used aftertheir expiry dates.

VV

M


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Keeping vaccines in the domestic

refrigerator at health center

1. The refrigerator must be placed in the coolestplace away from direct sunlight with adequate

air circulation around it (1215 inches awayfrom the wall)

2. It must be kept locked and opened only whennecessary

3. It must be defrosted regularly

4. Its temperature must be recorded twice daily5. Both monitor and thermometer are placed in

the refrigerator, while temperature chart isstuck on the outer-surface of the refrigeratordoor

Arrangement of vaccines in the refrigerator


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g g

MMR


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Shake test

Shake test should beperformed on a sample of

vaccine vial in question andon the sample of the samebatch/manufacture whichis known to have beenfrozen.

The two vials should beshaken vigorously for fewminutes, and observed forthe rate of sedimentation

DPT, DT, dT, TT

These vaccines are damaged

by freezing


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Ordering and Deli er


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Ordering and Delivery

Named trained designated person and deputy who haveoverallresponsibility for ordering, receipt and care of vaccines.

Responsibilities include:

Ensuring cold chain has been maintained during transport andmanaging 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



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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 preventdirect 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



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What to do if there has been aCold 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 soughtfrom the vaccine manufacturer

Written procedure for the disposal of vaccines by incineration should be

available locally



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Post administration

Treat as Serious Untoward Incident

Inform Practice Manager/Line Manager/PCT of the

incident

Suspend all immunisation clinics until resolved



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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



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Useful resources


Poster and plug stickers available to

order from DH publications orderline

(www.dh.gov.uk)

Chapter 3&4 Green Book: Storage,

distribution and disposal of vaccines

and Immunisation Procedures

CDC Vaccine Storage and Handling Toolkithttp://www2a.cdc.gov/vaccines/ed/shtoolkit/

WHO. Temperature sensitivity of vaccines.

August 2006. http://www.who.int/vaccines-

documents/DocsPDF06/847.pdf
http://www2a.cdc.gov/vaccines/ed/shtoolkit/http://www2a.cdc.gov/vaccines/ed/shtoolkit/http://images.google.co.uk/imgres?imgurl=http://img.dailymail.co.uk/i/pix/2008/01_01/plug0201_468x542.jpg&imgrefurl=http://www.dailymail.co.uk/pages/live/articles/technology/technology.html?in_page_id=1965&in_article_id=505613&h=542&w=468&sz=19&hl=en&start=74&tbnid=1QYLsw1YNZzncM:&tbnh=132&tbnw=114&prev=/images?q=plug&start=60&gbv=2&ndsp=20&hl=en&sa=N


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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)

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Cold Chain Vaccine

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