msf cold chain guidelines en

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AN INTRODUCTION TO THE

COLD CHAIN

VERSION 1.1

1999


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PREFACE

This guideline is a supplement to the MSF Holland Logistic Guideline,published in Amsterdam. It deals with Cold Chain Management.You are kindly invited to send all your comments and recommendations aboutthe contents and set-up of this guideline to the Field Support Unit,Amsterdam.

1999 Field Support Unit

AmsterdamJune 1999

Other Guidelines published by the FSU

A practical Format Guide for Logistic Reporting - Co-days EditionCommunication Guideline - 2nd EditionDrug Purchase Policy- 1st EditionEnergy Guideline - 1st EditionLogadmin Kit - 2.0 for Windows 3.1xLogadmin Kit - 3.0 for Windows NTLogistic Management of Drug Distribution Programmes - 2nd EditionLogistics in Perspective - Workshop EditionMonitoring & Evaluating Logistics - 2nd EditionOrder Management - 5th edition

Satellite Voice/Data or Inmarsat Mini-M - Revised 2nd

EditionStock & Warehouse Management - 4th EditionTransport & Freight Management - 4th Edition


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TABLE OF CONTENTS

1. Vaccines And How To Look After Them............................................51.1 Immunity............................................................................51.2 The Six Target Diseases...........................................................51.3 What Vaccines Are Made Of......................................................61.4 What Damages Vaccines..........................................................7

1.4.1 Heat, Sunlight And Freezing................................................71.4.2 Chemicals - Disinfectants, Antiseptics, Spirit, Detergents And Soap 7

1.5 Temperature.......................................................................81.6 The Live Vaccines.................................................................8

1.6.1 Polio Vaccine..................................................................81.6.2 Measles Vaccine..............................................................91.6.3 Bcg Vaccine...................................................................9

1.7 The Killed Vaccines..............................................................101.7.1 Diphtheria Toxoid...........................................................101.7.2 Pertussis Vaccine............................................................101.7.3 Tetanus Toxoid..............................................................101.7.4 Damages......................................................................11

1.8 The Cold Chain...................................................................12

1.9 In A Refrigerator.................................................................121.10 Checking The Temperature...................................................13

2. Waste Disposal........................................................................163. Vaccine Storage And Handling Checklist..........................................174. Main Vaccines.........................................................................18

4.1 Calculating Vaccine Requirements...........................................194.1.1 EPI (Expanded Programme on Immunisation)...........................194.1.2 Vaccination Campaigns....................................................20

4.2 Calculating Parenteral Supplies (I.E. Syringes And needles)............214.3 Calculating Cold Storage Space Requirements..............................224.4 Calculating Ice Pack Requirements...........................................224.5 MSF Vaccination Kit..............................................................23

5. Winterisation Of The Cold Chain ...............................................245.1 Introduction.......................................................................24

5.1.1 Vaccines......................................................................245.1.2 Refrigerators.................................................................245.1.3 Power Cuts...................................................................25

6. The WHO (World Health Organisation) Policy ...................................277. Colour Coding Of Vaccine Vials ..................................................29

8. A Mini Size Data Logger.............................................................309. A Bit Of Theory On (US Oriented) Immunisation................................31


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9.1 Why Immunize?...................................................................319.2 What Immunisations, When And Whom To Immunise......................32

10. Recommended Immunization Schedule.........................................34

11. Introduction To The MSF PEP (Post Exposure Profylaxis) Guideline........3511.1 Risk Of Health Care Workers For Infection With HIV, HBV and HVC....3512. How It Works......................................................................37

12.1 Refrigeration....................................................................3712.1.1 Compression System ......................................................3712.1.2 Absorption System ........................................................3812.1.3 Refrigerants ................................................................3812.1.4 Refrigerants And The Environment ....................................39

13. Immunisation & Cold Chain Glossary............................................41


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1.Vaccines And How To Look After Them...

1.1 ImmunityIf you have had measles, you cannot have it again. You have become immuneto measles.When you have an infection, your body learns to make antibodies against themicro-organism (virus or bacteria) that causes the infection. The antibodieskill the organism and prevent it from growing again .The antibodies work only against that particular infection, not against others.

For the first few months of its life, a baby is protected against manyinfections by its mother's antibodies.These come from the mother's blood and cross the placenta into the baby'sbody before birth.There are also antibodies in breast milk, especially in colostrum (the firstbreast milk), which help to protect a baby against diarrhoea and otherinfections.At birth the baby begins to make its own antibodies.

1.2 The Six Target DiseasesThere are six important diseases that are very serious, and which can kill ordisable many children - even though other children survive and becomeimmune. These six diseases are:

Poliomyelitis

Measles

Diphtheria

Pertussis (whooping cough) Tetanus

Tuberculosis (TB).

They can be prevented by immunisation.

To immunise a person, you give a vaccine - that is, a weakened or killedform of the same micro-organism which causes the disease.The vaccine makes the child's/person's body produce antibodies, but will notcause the disease.

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The child/person becomes immune, without becoming ill.Vaccines are given by injection or by mouth.

The Expanded Programme on Immunisation aims to immunise all childrenagainst these six diseases before theirfirst birthday.

In 1974, when the Expanded Programme on Immunisation (EPI) waslaunched by the World Health Organisation (WHO), less than 5% of theworlds children were immunised against the initial six target diseasesdiphtheria, tetanus, whooping cough, polio, measles and tuberculosisduring their first year of life.By 1990 almost 80% of the 130 million children born each year were

immunised before their first birthday.Within two decades the EPI was preventing the deaths of at least 3 millionchildren a year. In addition, at least 750.00 fewer children were blinded,crippled, mentally retarded or otherwise disabled.

Other vaccines you may encounter when working in MSFs projects:

Hepatitis A

Hepatitis B

Yellow fever Typhoid fever

Rabies

Meningococcal meningitis

Japanese encephalitis

1.3 What Vaccines Are Made Of

Manufacturers make vaccines from micro-organisms similar to the ones thatcause disease, or from the toxins (poisons) that bacteria produce.But the micro-organisms or toxins must be changed so that they cannot harmpeople.

Manufacturers can use:

KILLED micro-organisms, pertussis in DPT (=Diphtheria Pertussis Tetanusvaccine) see: 1.7 The killed vaccines

LIVE micro-organisms that are attenuated, that is made weak (measles,polio and tuberculosis).

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TOXOIDS, which are inactivated harmless toxins (tetanus toxoid: TT anddiphtheria toxoid: DT)

1.4 What Damages VaccinesYou can easily damage vaccines if you do not look after them carefully.If a vaccine is in good condition, and able to make a child immune, it isPOTENT .If a vaccine is damaged, and not able to make a child immune, then it hasLOST ITS POTENCY.All vaccines lose their potency after a certain time, even with good care.

Vaccines have an EXPIRY DATE printed on the label. After that date, the

vaccine has lost much or all of its potency, even if it has been looked aftercarefully.

1.4.1 Heat, Sunlight And Freezing

Heat and sunlight damage all vaccines - but especially polio, measles andBCG (=TB vaccine).

Freezing damages DPT, tetanus toxoid, Japanese encephalitis, and

hepatitis vaccines.

The safest thing to do is to keep ALL vaccines at the correct lowtemperature and out of sunlight.If a vaccine is damaged by heat, sunlight or freezing, you cannot make itpotent again. It does not help to put the vaccine back at the correcttemperature or in the dark after the damage is done.Discard the vaccine, destroy it by incineration and bury the remains.

1.4.2 Chemicals - Disinfectants, Antiseptics, Spirit, Detergents And Soap

Disinfectants and antiseptics will kill unwanted micro-organisms.We use spirit, detergents and soap to clean. These chemicals can damagevaccines. If you clean or sterilise instruments in a chemical, some of thechemical may remain on the instruments.If there is any chemical on a syringe or needle, it can damage a vaccine.To sterilise immunisation equipment, one must use HEAT (steam or boilingwater).

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If syringes and needles have been in contact with disinfectants, antiseptics,spirit, detergent or soap, WASH THEM VERY THOROUGHLY and sterilise themwith steam or boiling water before use.

1.5 Temperature

Water changes into ice at zero degrees centigrade (0C).Eutectic icepacks have a different colour: green or blue (they are not filledwith water but with a special liquid) and may be still liquid at -4C. This isdangerous for DTP vaccine, which is not to be frozen. Do not use theseicepacks!

The correct temperature to store vaccines in a health centre is between +2C

and +8C, which in the tropics can only be found in a refrigerator.There is a safety margin, so dont throw away your vaccines when thetemperature has been lower than 2 but not lower than 0C or higher than 8but not higher than 12 for longer than a week. When in doubt consult yourtechnical/medical dept, or local UNICEF expert.

1.6 The Live Vaccines

Polio

Measles BCG

1.6.1 Polio Vaccine

The micro-organism which causes polio is a virus.The vaccine that most countries use is made from a LIVE ATTENUATED (=weakened) VIRUS.Polio vaccine is a clear pink or pale orange liquid. It comes in a special small

bottle with a dropper cap to give measured drops of polio vaccine.

Polio vaccine is given ORALLY: Put two drops of vaccine straight from thebottle into the child's mouth.

Oral polio vaccine (OPV) is damaged very quickly by heat. It is more easilydamaged by heat than other vaccines.But OPV is not damaged by freezing - it can be frozen and refrozen withoutdamage.

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Some countries use a KILLED VIRUS polio vaccine which you give by injection(IPV= injectable polio vaccine).

1.6.2 Measles VaccineThe micro-organism that causes measles is a virus.Measles vaccine is made from LIVE ATTENUATED VIRUS.The vaccine comes as a lump of dry material at the bottom of a vial. It isfreeze-dried.To use the vaccine, you must mix the dry vaccine with diluent water forinjection(= reconstituting the vaccine).You give the reconstituted vaccine by injection.

Measles vaccine is easily damaged by heat.The dry vaccine stays potent for a long time if you keep it cold.The dry vaccine is not damaged by freezing - it can be frozen and refrozenwithout damage.

Reconstituted vaccine loses its potency very quickly, even if it is cold. It mustbe used it in the same immunisation session or discarded.

1.6.3 Bcg Vaccine

BCG vaccine protects against tuberculosis (TB).It is made from a special weak but living kind of mycobacterium,(called B acillus C almette G urin).

BCG is a LIVE BACTERIAL VACCINE.

BCG is freeze-dried, like measles vaccine. BCG comes as a dry powder in thecontainer/vial.Before you can use BCG, you must reconstitute the dry vaccine with diluent

water.You inject reconstituted BCG into the top layers of the skin = intradermal.

BCG is damaged most easily by sunlight. The containers are usually made ofdark glass.

Heat damages BCG, but not as quickly as it damages measles and poliovaccines.

The dry vaccine stays potent for a long time if you keep it cold.

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Dry vaccine is not damaged by freezing - it can be frozen and refrozenwithout damage.Reconstituted vaccine loses its potency more quickly.Because the diluent does not contain a preservative, bacteria may grow in it.

You must use it in the same immunisation session, or discard it.

1.7 The Killed Vaccines

Diphtheria

Pertussis

Tetanus

Dpt Vaccine

DPT vaccine contains diphtheria toxoid, pertussis vaccine and tetanus toxoid.Its referred to as "triple vaccine".

1.7.1 Diphtheria Toxoid

This is the "D" part of DPT vaccine.

Diphtheria is caused by bacteria which produce a toxin. The vaccine is atoxoid, that is, inactivated diphtheria toxin.

Diphtheria toxoid is damaged by freezing. It is also damaged by heat, but notas quickly as the live vaccines.

1.7.2 Pertussis Vaccine

This is the P part of DPT vaccine.

The micro-organisms that cause pertussis (or whooping cough) are bacteria.The vaccine is made from KILLED BACTERIA. Pertussis vaccine is damaged by

heat, about as quickly as BCG. So the pertussis vaccine is the most easilydamaged part of DPT. The limiting factor for the "triple vaccine".

1.7.3 Tetanus Toxoid

This is the "T" part of DPT vaccine. It is also available as a separate vaccine

TT, given to pregnant women to prevent neo-natal tetanus.Tetanus is caused by bacteria, which produce a toxin. The vaccine is a toxoid,

that is, inactivated tetanus toxin.

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Tetanus toxoid is damaged by freezing. It is also damaged by heat, but moreslowly than the other vaccines.DPT and tetanus toxoid are both liquid vaccines which you give by injection.

1.7.4 Damages

To check if DPT or TT has been damaged by freezing:

When DPT and TT vaccines have been standing, the liquid is clear, andthere is a white sediment at the bottom.

If you tip the container, the sediment moves easily.

If you shake the container, the vaccine goes cloudy. The cloudiness is very

smooth and not granular. The sediment begins to fall to the bottom againvery slowly.

DPT and TT vaccines are damaged most easily by freezing.

If you see DPT or TT vaccine when frozen solid, you know that it is damaged.But you may not see the vaccine until after it has thawed or melted and hasbecome liquid again.To find out if a liquid vaccine has been frozen and damaged some time

before, you must do a simple test.

The Shake TestCompare the vaccine that you suspect has been frozen and thawed withvaccine from the same manufacturer that YOU are SURE was never frozen.

Shake the vials of vaccine;

Inspect the contents carefully;

Leave the vaccines to stand side by side for 15-30 minutes for the

sediment to settle. Inspect the contents carefully on granular particles again.

Check the properties of the liquid in the vials:

smooth and cloudy not smooth

starting to clear you can see granular particles

no sediment thick sediment

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VACCINE NEVER FROZEN VACCINE FROZEN AND THAWED

USE THIS VACCINE DO NOT USE THIS VACCINE

1.8 The Cold ChainVaccines must stay cold all the way from the manufacturer to the end user =child/adult.

The equipment and the people that keep vaccines cold from themanufacturer to the end user are together called: THE COLD CHAIN.

Before vaccines reach the health centre they must be:

Collected quickly from the airport;

Stored at the correct low temperature in the refrigerator at theCentral Store, the Regional Store and the District Store;

Kept cold during transport from one store to another. Only thenvaccines arrives at your health centre in good condition.

After vaccines reach the health centre:

They have to be kept at the correct temperature in the refrigerator.

They have to be carried to the immunisation session in a vaccinecarrier with ice.

They have to be put on ice (icepack) while vaccinating.

Diluents do not have to be stored in the refrigerator.

At the time of reconstitution diluents need to have the sametemperature as the vaccine, to prevent killing the live vaccine byheat shock.

1.9 In A RefrigeratorOne can keep vaccines in good condition in a refrigerator for two months; butyou must make sure that the refrigerator works at the correct temperature.To make sure that the refrigerator works well you must:

Load and use the refrigerator correctly;

Check the temperature twice daily and defrost the refrigerator regularly.

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Parts of a refrigeratorA refrigerator has two compartments: the main compartment and thefreezer.

The main compartment is where you store vaccines. The temperature in thiscompartment should be between +2C and +8C.

The freezer compartment is used to freeze icepacks.The temperatures in this compartment should remain below -10C.A thermostat is used to regulate and control the temperature in therefrigerator.

The knob in the main compartment serves to adjust the thermostat.The knob usually has numbers 1 to 6 or 1 to 7 on it and an arrow to showwhich number is in use.To make the refrigerator COLDER, turn the knob so that the arrow points to aHIGHER number.To make the refrigerator WARMER, turn the knob so that the arrow points toa LOWER number.

1.10 Checking The Temperature

To check the temperature of the main compartment, make sure you have:

A thermometer (max/min); keep it in the main compartment;

A stopwatch momitor card;

A chart to record temperatures; put it on top of the refrigerator or on theoutside of the door;

One person who is in charge of the refrigerator. That person checks andrecords the temperature. But everyone who uses vaccines must knowwhat the chart means.

Dos:

Check the temperature in the main compartment twice every day - whenyou arrive for work and when you leave.

You should be able to recognise if the temperature is too high or too lowand you should know what to do about it.

Stand the vaccines on ice (icepack) while vaccinating.

Donts

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Do NOT put any food or drink in the vaccine refrigerator.Food and drinks can make the inside of the refrigerator too warm.

Do NOT put any vaccine in the door shelves. The door is the warmest placein the refrigerator.

Do NOT keep "EXPIRED" vaccines in the refrigerator. PARTLY USED vaccine you may keep and use (see WHO guideline on use

of open vials - page 14), are always the vaccines that do not have to bereconstituted. For example: OPV (oral polio vaccine), DTP, TT, HepatitisB, Hepatitis A.

All diluted vaccines will have to be thrown away at the end of avaccination session. If you have to keep them to show as an example, keepthem somewhere else, outside the refrigerator. Mark them clearly.

KEEP THE DOOR CLOSED

Opening the door increases the temperature in the refrigerator. When youneed to open the door, plan what you will do first. Then open the door, dowhat you have to do, and close the door again quickly.

Do not open the door of an absorption refrigerator more than 2 or 3times a day.

An absorption refrigerator will only slowly replenish the cold lost by openingthe door. It has a low cold yield, i.e. slow cold production. (see also How itworks)

Vaccine vial monitorA vaccine vial monitor (VVM) is a label made of heat sensitive material whichis placed on a vaccine vial to register cumulative heat exposure over time.

The combined effects of time and temperature cause the monitor to change

colour, gradually and irreversibly. A direct relationship exists between therate of colour change and temperature:

The lower the temperature, the slower the colour change,

The higher the temperature, the faster the colour change

VVMs can be used on vaccine vials or ampoules.The VVM is a circle with a small square inside it. It can be printed on aproduct label or attached to the cap of the vaccine vial.

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The inner square is made of heat sensitive material which is light at thestarting point and becomes darker with exposure to heat.

The discard point is reached when the colour of the inner square matchesor is darker than the outer ring.

To date the vaccine vial monitor is only used with OPV (oral polio vaccine)

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2.Waste Disposal

To prevent re-use of injection material and vaccine vials, material should bedisposed of properly.

Handling used sharps Never strip the needle from a used syringe.

Never recap a used needle

Always place syringe and needle in a safe disposal box immediately afteruse.

Always supervise the transport & incineration of the syringes & needles in

the disposal box and maintain records of disposal and destruction.

MSF uses a 5 litre safety box for the collection of used sharps.The following formula may be used to estimate the number of litres of sharpswaste which will be generated in EPI or a vaccination campaign.

A = Estimation of used syringes: i.e. Total number of children to beimmunised in vaccination campaign.

B = Volume of used syringes A X 50/1000= Total volume in litres.C = Number of safety boxes required to hold sharps:For 5 litre boxes B / 5

For example: you plan to immunise 345.362 children.A = 345.362B = 345.362 x 50 / 1000 = 17268 litres of sharps wasteC = 17268 / 5 = 3454 rounded up = 3460 safety boxes of 5 litres.

In a regular EPI program you have to burn (in the safe disposal box) or buryyour used material. Crush the vials before you bury them.There is a risk that theyre being filled up with water and used again.

During a vaccination campaign the first choice is burning.The syringes have to be burnt with the safe disposal box.Try to find an incinerator, some health facilities or hospitals have them or usean oil drum.

Bury waste or the ashes on a depth of at least 1 (one) metre with 0.5 metreof soil on top.

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3.Vaccine Storage And Handling Checklist

Choose and train one person and one back-up to be responsible for thecold chain and cold storage. When applicable: install a lock/plug-guard on the electrical plug. Post

warning notices at both the plug and at the circuit-breaker. Use preferably a maximum/minimum thermometer to monitor

temperatures twice daily in both refrigerator and freezer. In the morningbefore work begins , check that the minimum temperature in therefrigerator is not below 2Celsius and the maximum is not above 8Celsius. Make sure the freezer maintains an average temperature of

-15 Celsius or below. In case of min/max thermometers reset them aftereach reading.

Do not open an absorption refrigerator (gas, kerosene) more than twotimes a day.

Do not store food or drinks in the refrigerator that is used for vaccinestorage.

Store icepacks in your freezer and bottled water at the bottom of therefrigerator to help maintain a stable temperature and prolong holdovertime.

Do not store vaccines in the refrigerator doors (the doors are the warmestplace in the fridge).

Store vaccines together by type and keep space between boxes for goodair circulation.

When you lack space: store Oral Polio Vaccine (OPV) in the freezer.

Earliest Expiry, First Out. Store vaccines with shorter expiration dates tothe front, longer expiration dates to the rear. (consequently overruling the"First In, First Out" principle).

Defrost the freezer compartment when the layer of ice exceeds 5millimetres.

The beginning and length of any breakdown should be carefully noted andmeasures taken to protect the vaccines.

When vaccines are out of the refrigerator, keep them cool with icepacks, donot let vaccines and diluents other than opv, measles, meningitis and yellow

fever come in direct contact with icepacks (keep some cardboard in between)and protect measles and BCG from UV light.

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4.Main Vaccines

VACCINE TYPE THERMO SENSITIVITY STABILITY

HEAT COLD

ORAL EPI Liquid +++ FreezingPOLIO no risk

MEASLES EPI Freeze-dried ++ Freezingno risk

MENINGOCOCCAL Freeze-dried + FreezingMENINGITIS no risk

BCG EPI Freeze-dried ++ Freezingno risk

YELLOW Freeze-dried + FreezingFEVER no risk

DPT EPI Toxoid ++ DestroyedDPT POLIO Liquid by freezing

JAPANESE Freeze dried ++ FreezingENCEPHALITIS no risk

IPV= EPI Liquid + DestroyedINJECTABLE by freezingPOLIO VACCINE

HEPATITIS A Liquid + Destroyedby freezing

HEPATITIS B Liquid + Destroyedby freezing

HAEMOPHILUS Liquid ++ UnknownINFLUENZA TYPE B = HIB

MUMPS Freeze dried ++ Freezing

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no risk

RUBELLA Freeze dried ++ Freezingno risk

RABIES Freeze dried + Freezingno risk

TETANUS EPI Toxoid + DestroyedTOXOID Liquid by freezing

!! STORE ALL VACCINES BETWEEN 2- 8C !!!! RECONSTITUTION AFFECTS STABILITY OF VACCINES !!

+ =Little sensitive to heat.+++ =Very sensitive to heat: minimise exposure to over 8C.

Names of childhood diseases/vaccines

Nederlands English Franais Portugues EspagnolDifterie Diphtheria Diphtrie Difteria DifteriaMazelen Measles Rougeole Sarampo Sarampin

Bof Mumps Oreillons Caxumba,Parotidite,

Papeira

Parotiditis,Paperas

Rode hond Rubella,Germanmeasles

Rubole Rubela Rubeola

Kinkhoest Whooping cough,Pertussis

Coqueluche Tosse convulsaCoqueluche

Tosferina,Tosconvulsina

Gele koorts Yellow fever Fivre jaune Febra Amarela Fiebra AmarillaRabis Rabies Rage Raiva RabiaPolio Polio Polio Poliomielite,

Paralisia infantilPoliomielitis,

Parlises infantilTetanus Tetanus,

LockjawTtanos Ttano Ttanos

4.1 Calculating Vaccine Requirements

4.1.1 EPI (Expanded Programme on Immunisation)

In routine EPI vaccination programs:

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Total number of doses (all antigens1) to be administered in the supply period+ reserve stock of 25% or 2 weeks consumption (depends on the length of yoursupply period) which ever is the greater.

Supply intervals:The selected supply interval will influence the (cost) effectiveness of theprogramme. Too short an interval may increase the cost and create anunrealistic administrative burden. Too long an interval may put vaccine at riskand result in too much vaccine in the pipeline.

Supply interval for clinics/health centres will depend on:

reliability/cost of delivery/collection;

speed of delivery; reliability of suppliers (including depots);

reliability of refrigeration at the clinics;

reliability of management at the clinics;

value of vaccine stored;

Indicative supply intervals for different levels:

Province Sub-province Clinic

3 months 1 month 1 month

The following guide to calculate your vaccine requirements goes for massimmunisation campaigns; large amounts of people covered, in contrast withthe earlier mentioned EPI, which is the regular day to day immunisationroutine in a health centre or clinic.

4.1.2 Vaccination Campaigns

The formula for calculating vaccine requirements is:

Number of doses = target population x wastage multiplier + reserve stock.

In case of a vaccination campaign, a wastage multiplier of 1.17 (which isapproximately 15% wastage) should be used, augmented by 25% reserve stock.

1 All EPI vaccines

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For subsequent orders of vaccines, the wastage multiplier and reserve stockcan be adjusted (usually downwards) based on wastage calculations done atvaccination sites.

During vaccination campaigns high quantity dose vials (2050) should be used.To estimate the number of vials required divide the number of doses neededby 20-50 and round up.

Always make an international order in # of doses, state the preferred vialsize. Vials come in different volumes = different doses per vial.

Example of a vaccine requirement calculation:

Total population in a province/refugee camp: 123,233Target population (0-59months) 17% of total populationVaccine wastage multiplier = 1.17Vial size: 20 dose vials

123,233 x 0.17 x 1.17 (+25%) = 32162.32

32162.32 / 20 = 1608.11 = 1610 vials needed

4.2 Calculating Parenteral Supplies (I.E. Syringes Andneedles)(parenteral = the route to administer drugs not through the alimentary canalbut rather per injection)

In addition to vaccines, EPI and vaccination campaigns require the followingparenteral equipment:5 ml syringes + 18g x 1,5(1,20 mm x 40 mm) needles (pink) forreconstitution

2 ml syringes + 23g x 1(0,60mm x 25 mm) needles (blue) for administering0.5 ml autodestruct syringes with needleBCG syringe with needle

Calculating quantities per order cycle:2 ml syringes: # of doses to be administered + 10% (minus stock on hand or inpipeline)0.5 ml autodestruct syringes: # of doses to be administered + 10% 23 g needles: # of doses to be administered, excluding BCG, + 10%

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5 ml syringes: # of vials to be reconstituted + 10% 18 g needles: # of vials to be reconstituted + 10%

BCG syringes/needles: # of doses of BCG to be administered + 10%

4.3 Calculating Cold Storage Space RequirementsGeneral guidelines for calculating vaccine storage requirements:

the amount of cold chain space required for e.g. 1000 doses of OPV (oralpolio vaccine) is 1 (one) litre.

every 500 doses of other vaccines requires 1 litre of storage space.

in a non-refugee situation, storage space at the most peripheral level isusually sufficient.

the most serious problems of inadequate space occur at the regional,provincial or district level.

temporary arrangements, such as the use of commercial freeze/coldrooms for vaccine storage or ice making, must be made in those areas

with insufficient refrigerator or freezer space.

4.4 Calculating Ice Pack Requirements

Number of ice packs needed = number of vaccination sites x {the number ofice packs in the cold box + (number of ice packs used on the table x numberof vaccinators per site)}.The number of packs will be adjusted after the first day, depending on

ambient temperature.

You can use the ice pack as long as there is ice in the pack: the temperaturewill then be 0C !

When all ice is melted the temperature of the pack will rise quickly!

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4.5 MSF Vaccination KitMSFs vaccination kit contains all the necessary cold chain equipment(refrigerators freezers, cold boxes, vaccine carriers), medical (syringes,needles, cotton, etc.), logistical and stationary equipment to vaccinate10.000 people with 5 teams.See for a detailed description your purple Guide of kits and emergencyitems.Only the vaccine youll have to order separately.

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5.Winterisation Of The Cold Chain

Or how to treat your cold chain when ambient temperature drops belowzero.

5.1 IntroductionThe necessity of a cold chain in winter is obvious: to prevent vaccines fromgetting spoiled. During winter youll have to deal with two problems:

1. Irregular power supply and in some countries power outages that may last

for days.2. Very low ambient temperatures.

5.1.1 Vaccines

The safe temperature range to store all vaccines is between 2 and 8C. Thisis valid during summer and winter. In summer the problem of keepingespecially Oral Polio Vaccine cold enough is bugging you, while in winter toguard DPT, DT ,TT and Hepatitis B from freezing will be your main concern.

5.1.2 Refrigerators

Thermostat(s) control the inside temperature of the fridge. When ambienttemperature goes up, the thermostat has to be adjusted to a higher setting toprevent the inside of the fridge to become too warm.When the ambient temperature drops, you must adjust the thermostat to alower setting. When you fail to do this, the temperature in the fridge maybecome dangerously low; even below 0C: DPT, DT, TT and Hepatitis Bvaccines will be spoiled when this happens.

When the temperature inside the fridge is lower than 2C and you cannotadjust the thermostat to a lower setting because it is already on Minimum ,it is better to switch off the refrigerator.From than on you must keep a close watch on the temperature inside thefridge and switch it on as soon as the inside temperature starts to rise above8C.

IN FACT YOU ARE NOW PLAYING THE ROLE OF THE THERMOSTAT.

This extra work is only acceptable for a short period of time.

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When the ambient temperature is very low for a long time, e.g. lower than10C, it is better to take the DT, DPT, TT, Td (=diphtheria tetanus booster foradults) and HEP B out of the fridge and put them in a cold box and keep thebox in a safe unheated room. When you leave those vaccines in the fridge you

run the risk of freezing them. When you are afraid that the temperatureinside your health facility will drop below zero, you should put the coldbox ina safe room where it never freezes, for example a basement.

Youll have to fill all empty space in the coldbox with unfrozen icepacks toprevent the inside temperature from changing too quickly. Put athermometer inside and take readings every day.Leave BCG and Measles in the main compartment of your still switched onrefrigerator and keep OPV in the freezer (compartment).

When the ambient temperature rises above 15C you should bring thevaccines from the cold box back to the refrigerator. The accompanyingtemperature monitor card should be filled out correctly.

5.1.3 Power Cuts

In wintertime electricity supply is often bad, power outages may occur andcontinue for hours up to several days. With a power outage the insidetemperature of the refrigerator will rise slowly. When you have an icelined

refrigerator or many frozen icepacks in the freezing compartment, the insidetemperature will almost remain constant as long as the water in the icepacksis frozen.

ONLY WHEN ALL THE ICE IN THE ICEPACKS IS MELTED, THE INSIDETEMPERATURE OF YOUR REFRIGERATOR WILL RISE QUICKLY !

Therefor fill all empty space in the freezer with icepacks or make sure thatthe icelining is complete. In addition you have to put plastic bottles with

water in the main compartment or at the bottom of the fridge to increaseyour cold mass.

It goes without saying that it is even more important not to open the fridgedoor except to take out vaccines or record temperature.

Never put unfrozen (= warm) icepacks in the freezer during power cuts.With irregular electrical power supply, it is difficult to regulate the insidefridge temperature instantly with an adjustment of the thermostat. Youshould read from your temperature monitor chart over several days if the

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average inside temperature is too high or too low, and adjust your thermostat accordingly.Keep during power outages a very close look at the inside temperature. Whenthe temperature becomes too high, even while you took all the necessary

precautions; prepare to move your vaccines to a refrigerator in an area wherethey do have electrical power.With icepacks from that fridge/freezer, you can transport your vaccines tothe working fridge. Take care of a good registration of the type and numberof doses of vaccines you are bringing to your neighbours fridge.

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6.The WHO (World Health Organisation) Policy

(on the use of opened vials of vaccine in subsequent immunisation sessions)

This policy aims at cutting vaccine wastage by 30% and save $ 40.000.000globally.WHO revised its policy, in the sense that certain vaccines may be usedinsubsequent immunisation sessions on the condition that:

vaccines meet WHO standards for potency and temperature stability, andare packed according to ISO standards and contain the appropriateconcentration of preservative (=supplied by UNICEF);

sterile injection procedures are adhered to;

the expiry date is not passed;

the vaccine vial does not leave the health centre;

The vaccines in question are:OPV, DTP, TT, DT and Hepatitis B.

Be aware that:

Reconstituted vaccines like measles, yellow fever, meningitis and BCG do notcontain preservatives and must be discardedat the end of each immunisationsession.Death due to toxic shock syndrome has resulted when reconstituted live virusvaccines which were kept reconstitutedin stock were injected.

This WHO policy is linked to the introduction of vials which are supplied witha vaccine vial monitor.Vaccine vial monitors (time/temperature indicators) will show if vials of OPV(Oral Polio Vaccine) have been exposed to unacceptable high temperatures.

Every vial has its own monitor.

We expect in the coming years a change to vaccine vial monitors suppliedwith the various vaccines.Measles vaccine will be supplied with VVMs following the successful

introduction on Oral Polio.UNICEF supplies OPV with these monitors, as part of the vials label.

When you get OPV with vaccine vial monitors in your project, you can usethem in subsequent immunisation sessions.

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You may use opened vials of DTP, DT, TT and Hep B in subsequentimmunisation sessions, even when they do not carry vaccine vial monitors.National and expat staff have to be trained to work according to this policy.

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7.Colour Coding Of Vaccine Vials

Vaccine vials have often been confused with other vaccines, and on occasionwith other pharmaceuticals. Even in MSF this mistake occurred. Suchconfusions can have tragic consequences. Manufacturers have had their owncolour codes to distinguish their products from one another, but these colourshave often conflicted with the colours used by other manufacturers.

UNICEF has requested all vaccine suppliers to conform to a standard colour. Itis hoped that by standardisation of colour codes vaccines will be more easilyidentified.

Colour coding will help identify vaccines but will not substitute for carefulidentification by health care and logistics staff.

Keep vaccines separated from other pharmaceuticals and always look at thelabel before using.

At any level in the supply line when you receive vaccines, dont take forgranted that all levels before you have checked the labels against the

order and packing list, so do it again.

The colours chosen are:

DPT YellowTT GreenDT LimeMeasles Orange/RedBCG Blue

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8.A Mini Size Data Logger

Cold Chain temperature monitorThe temperature monitor "Tiny TTM", has been developed by Remonsys Ltd,UK.It is battery-operated and small enough to fit inside a 35 mm plastic filmcontainer. It has a single, on-board thermistor sensor which covers atemperature range of -37C to +50C and is capable of monitoring up to 1800readings at varying time intervals.It has an accuracy of +/- 0.2C and the recording time interval can be setfrom 0.5 seconds up to 4.8 hours. The duration of the recording willdetermine when the memory is full-- for instance, with a 30 minute interval,

the memory will be full in 37 days.

The data stored can be quickly downloaded by a special cable to the serialport of a computer. It can then be displayed in nice graphs and saved underdifferent formats using software prepared for this purpose.

The small size and design of the "Tiny TTM" makes it a useful supervisory tooland an extremely powerful monitor.At the moment the "Tiny TTM" is being used in Azerbaijan, Sudan and Brazil in

cold chain programs.When your cold chain is not working properly and it is hard to put the fingeron the faulty spot, you can order a "Tiny TTM" to help in fault finding.The current cost is approximately UK 100 for the hardware (the data loggeritself) and UK 50 for the software and cable.

You can get one on loan from Logistics /Field Support Unit temporarily.

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9.A Bit Of Theory On (US Oriented) ImmunisationThe various recommendations for immunising infants, children and adults

against diseases are based on medical knowledge, the availability of safevaccines, other scientific knowledge, and on judgements by public healthofficials and doctors.Each vaccine has benefits and risks associated with its use, and no vaccine iscompletely safe or completely effective. Vaccines are beneficial becausethey prevent disease infection and the various results of that infection,which may be mild symptoms such as a body rash, or more serious problemssuch as paralysis or death. Depending on the vaccine the benefits may varyfrom partial protection to complete protection against the disease or itseffects.The risks associated with vaccine usage range from common, trivial,

and inconvenient side effects, such as mild swelling or low grade fever, to onrare occasions severe, and life-threatening conditions.The decision to use avaccine is based on the benefits, costs and risks associated with the vaccine.For each vaccine, recommendations are developed for its use, and thesedescribe who should receive it, when they should receive it, and how thevaccine should be given to a person. These vaccine recommendations aredeveloped to apply to large populations, but therecommendations mayvary for specific individuals or even between countries.Finally, the relativebalance of benefits and risks may change as diseases are controlled or

eradicated. For example, because smallpox has been eradicated throughoutthe world, the risk of side effects associated with the smallpox vaccine nowexceeds the risk of smallpox; consequently, smallpox vaccinations are nolonger routinely given to the general public.

9.1 Why Immunize?

Its effective

Immunisation is one of the most effective ways to prevent disease. Because

immunising children has proven to be so effective at preventing disease,immunisations against specific diseases are required by all 50 states and theDistrict of Columbia in the US for children entering day care and/or school.The widespread use of vaccines has reduced the peak-level incidence ofdisease in the United States by at least 95%. The vaccination series consists of2-5 doses of each of 5 vaccines.

Most vaccines protect 90% or more of the individuals vaccinated. Inaddition, most vaccines when used widely in communities indirectly

protect other persons as well, including those too young for vaccination

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and those with legitimate medical contraindications to vaccination. Thisgoes for anywhere in the world.

It saves lives

Experience in the United States in recent years has illustrated both theeffectiveness of immunisation and the tragic consequences of failure tovaccinate properly. Before the measles vaccine was approved in 1963, anaverage of over 500,000 cases of measles was reported each year, killing 400to 500 people annually. By 1983, in the United States the number of cases ofmeasles reported had dropped to a record low of l,497.However, a resurgence of measles between 1989 and 1991 (over 55,000 casesof measles, including 132 reported deaths) occurred primarily amongunvaccinated pre-school children. In 1990, 64 individuals died of measles,

the highest number in two decades.The biggest cause of the measles epidemic was the failure to vaccinatechildren on time at 12-15 months of age. It saves money

In addition to lessening the human suffering brought about by disease,immunisation is cost-effective. It is estimated that every $1 spent onvaccinations for measles, mumps, and rubella represents a potential savingsof many more dollars in treatment costs.The measles outbreak of 1989-1991 caused over 44,000 days ofhospitalisation. Studies suggest that each 1,000 cases results in $3-4 millionin direct medical treatment costs.

9.2 What Immunisations, When And Whom To Immunise

Which vaccinations against what diseases?Children should be vaccinatedagainst ten diseases: TB, diphtheria, tetanus, pertussis, polio, Haemophilusinfluenzae type b, measles, mumps, rubella and hepatitis B.

All but tetanus (lockjaw) are contagious and can be transmitted from aninfected person to an uninfected person.These vaccinations are necessaryfor a child to be adequately protected against ten serious childhooddiseases that can lead to death: TB, infection of the lungs, highly contagious, and/or any other organ,

which can cause death if untreated. Diphtheria, infection of the throat, mouth, and nose, which can cause

heart failure or paralysis if untreated; Tetanus (lockjaw), an infection that attacks the nervous system and kills 3

out of 10 infected people;

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Pertussis (whooping cough), which is highly contagious and causes severecoughing and occurs mostly in children under 5 years;

Polio, which causes paralysis and death; Measles, which is highly contagious, causes a rash and high fever and

during the measles epidemic of 1989-1991 hospitalised 19% of persons withmeasles;

Mumps, which causes fever, headache and inflammation of the salivaryglands; three of every ten infected people develop meningitis andinflammation of the covering of the brain and spinal cord;

Rubella, or "German measles", which causes fever and rash and causessevere birth defects when pregnant women are infected;

Haemophilus influenzae type b (Hib disease), which was contracted by oneout of every 200 children before the age of five before vaccines were

available, affects blood, joints, bones and the covering of the heart; Hibdisease was the most common cause of serious bacterial meningitis inchildren;

Hepatitis B, which causes cirrhosis of the liver and liver cancer.When to vaccinate?Adequate immunisation against these diseases requiresabout five visits to a health care provider during the first two years of life.Approximately 80% of the vaccines needed to fully immunise child should begiven at these five visits during the first two years of life.

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10. Recommended Immunization Schedule

These recommended ages are not absolute.All recommended vaccines can be given simultaneously.The basic schedule recommended by WHO (World Health Organisation), whichdiffers substantially from the schedule used in the US and other countries inthe western hemisphere, in the framework of the EPI (Expanded Programmeon Immunisation) is as follows:

Age Vaccine

Birth BCG + oral Polio

6 weeks DTP + oral Polio10 weeks DTP + oral Polio

14 weeks DTP + oral Polio

9 months Measles

>15 years Tetanus

All other vaccines are either skipped: like MMR (Mumps Measles Rubella) oradded like Hepatitis B and Hib (Haemophilus Influenza type b) to theschedule when the MOH (Ministry of health) of governments can afford them.

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11. Introduction To The MSF PEP (Post ExposureProfylaxis) Guideline

This subject is added as a reminder

This guideline should be in your project library, the chemoprophylaxis whichis described in it should be in your medical stock! {ask the medical officerwho acts as your GP (general practitioner)}

11.1 Risk Of Health Care Workers For Infection With HIV, HBVand HVC

MSF works in many countries with a high prevalence of humanimmunodeficiency virus (HIV) and Hepatitis B (HBV) which poses a certain riskto its field staff.MSF aims to provide adequate information and the best possible measures ofprotection towards all its field staff. The organisation will also providechemoprophylaxis for expatriates after percutaneous exposure to blood (PEB).

A recent retrospective study by CDC (Centers for Disease Control andPrevention -Atlanta USA) showed that a treatment of AZT (Zidovudine) can

have a protective effect up to 70 % (43 - 94) on transmission duringneedlestick incidents. With a triple treatment of Zidovudine, Lamivudine anda Protease-inhibitor this protective effect will be increased, but we areawaiting results of on-going studies.Following the recommendations, MSF has decided to make this prophylactictreatment available to expatriate staff in projects where there is anoccupational risk.

This document outlines possible risks and protection, describes the postexposure profylaxis (PEP) and related procedures and gives information on

handling possible incidents of infection.

It should be noted that this document will need regular updates related tofield experiences and latest research developments on the prophylactictreatment.Health care workers (HCWs) are a risk group for infection with HIV (humanimmunodeficiency virus), HBV (hepatitis B virus) and HVC (hepatitis C virus).The risk of transmission through occupational exposure by accidentalinoculation with infected blood or saliva are shown in the table below.

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Risk of transmission of bloodborne viruses tohealth care workers

Human Immunodeficiency Virus (HIV)

Percutaneous exposure: 0.3 % *Mucutaneous exposure: 0.05 %

Hepatitis B virus (HBV)Percutaneous exposure: 9-30 %

Hepatitis C virus (HCV)

Percutaneous exposure: 3-10 %

* Risk for HIV infection exceeds 0.3 % for percutaneous exposureinvolving a larger blood volume and /or higher HIV titre in blood. Aswell with the increased number of exposure events, negligence ofuniversal precautions and increased sero prevalence of population

Procedures that have been identified as high risk are: Surgical procedures; especially emergency procedures and major surgery

on areas anatomically difficult to approach. In studies it has beenestimated that percutaneous exposure happens in 2-6% of the surgicalprocedures.

Intravenous procedures (drips and blood taking); especially in emergencysituations.

Cleaning up after special procedures or routinely in all clinics; non-medicalcleaning personnel is exposed to large amounts of blood or to strayneedles.

Besides the occupational exposure, sexual transmission and transmissionthrough blood transfusion are an increased risk to HIV and other blood bornediseases.Further reading in the guideline.......

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12. How It Works

12.1 RefrigerationProcess of lowering the temperature in a given space and maintaining it.Storing perishable foods, pharmaceuticals, or other items under refrigerationis commonly known as cold storage. Such refrigeration checks both bacterialgrowth and adverse chemical reactions that occur in the normal atmosphere.

In mechanical refrigeration, constant cooling is achieved by the circulation of

a refrigerant in a closed system, in which it evaporates to a gas and thencondenses back again to a liquid in a continuous cycle. If no leakage occurs,the refrigerant lasts indefinitely throughout the entire life of the system. Allthat is required to maintain cooling is a constant supply of energy, or power,and a method of dissipating waste heat. The two main types of mechanicalrefrigeration system are the compression system, used in domestic units forlarge cold-storage applications and for most air conditioning; and theabsorption system, now employed largely for heat-operated air-conditioningunits and to a lesser extent used for heat-operated domestic units or thespecifically for vaccine storage built units.

12.1.1 Compression System

Compression systems employ four elements in the refrigeration cycle:compressor, condenser, expansion valve and evaporator. In the evaporatorthe refrigerant is vaporised and heat is absorbed from the space being cooledand its contents. The vapour is next drawn into a motor-driven compressorand raised to high pressure, which raises its temperature . The resultingsuperheated, high-pressure gas is then condensed to liquid in an air-cooled

condenser. From the condenser the liquid flows through an expansion valve,in which its pressure and temperature are reduced to the conditions that aremaintained in the evaporator.

Pros: high cold yield, easy to maintain, easy to repair.Cons: needs relative reliable electrical power supply.

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12.1.2 Absorption System

A few household/vaccine storage units, called gas/kero/electricrefrigerators, operate on the absorption principle. In such refrigerators astrong solution of ammonia in water is heated by a gas/kerosene flame or

electric heating element in a container called a generator, and the ammoniais driven off as a vapour, which passes into a condenser. Changed to a liquidstate in the condenser, the ammonia flows to the evaporator as in thecompression system. Instead of the gas being inducted into a compressor onexit from the evaporator, however, the ammonia gas is reabsorbed in thepartially cooled, weak solution returning from the generator, to form thestrong ammonia solution. This process of reabsorption occurs in a containercalled the absorber, from which the enriched liquid flows back to thegenerator to complete the cycle.

Absorption refrigeration is increasingly used in refrigeration units for comfortspace cooling (airco systems), for which purpose refrigerant temperatures of45 to 50 F (7.2 to 10 C) are suitable.

Pros: can run on several energy sources: electricity, butane/propane,kerosene, direct solar.Cons: low cold yield, labour intensive maintenance, difficult to repair.

12.1.3 Refrigerants

For every refrigerant there is a specific boiling or vaporisation temperatureassociated with each pressure, so that it is only necessary to control thepressure in the evaporator to obtain a desired temperature. A similarpressure-temperature relationship holds in the condenser. One of the mostwidely used refrigerants for many years was dichlorodifluoromethane, knownas Refrigerant-12. This synthetic chlorofluorocarbon (CFC) would vaporise at-6.7 C (20 F) under a pressure of 246.2 kPa (35.7 psi), and aftercompression to 909.2 kPa (131.9 psi) would condense at 37.8 C (100 F).In small domestic refrigerators used for food storage, the condenser heat is

dissipated into the kitchen or other room housing the refrigerator. With air-conditioning units the condenser heat must be dissipated out of doors ordirectly into cooling water.In a domestic refrigeration system the evaporator, called the freezer, isalways placed in an insulated space. In some cases this space constitutes thewhole refrigerator cabinet. The compressor is usually oversized, so that if itran continuously it would produce progressively lower temperatures. In orderto maintain the interior of the box within the desired temperature range, themotor driving the compressor is controlled by a thermostatic switch.

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A frozen-food freezer resembles the household refrigerator except that itscompressor and motor must be of sufficient size to handle the larger gasvolume of the refrigerant at its lower evaporator pressure. For example, tomaintain a temperature of -23.3 C (-10 F) an evaporator pressure of 132.3

kPa (19.2 psi) would be required with Refrigerant-12.

12.1.4 Refrigerants And The Environment

Refrigerant-12 and the related CFCs Refrigerant-11 and Refrigerant-22, werethe major compounds used in the cooling and insulation systems of homerefrigeration units. It has been found, however, that CFCs are posing a majorthreat to the global environment through their role in the destruction of theozone layer. In accordance with the Montreal Protocol, the manufacture of

CFCs ceased in the European Union by the end of 1994 and was scheduled toend in most other industrialised countries by the end of 1995. Therefrigeration industry is switching rapidly to alternatives that do not depletethe ozone layer. Like Refrigerant-134a which depletes the ozone layer just alittle bit and Refrigerant-600 (carbohydrate, flammable gas) which depletesthe ozone layer not at all.

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13. Immunisation & Cold Chain Glossary

Adjuvant An addition (auxiliary help) to the vaccine- Used inkilled vaccines, either viral or bacterial, such as DPT,DT,TT, Hep B and certain brands of Hib. vaccines

containing an adjuvant may not be used afterfreezing.Antibody Most infections leave a person protected for some

time against a second attack of the disease becausethe micro-organisms causing the infection havestimulated the body to produce antibodies.Antibodies are special proteins in the blood whichinhibit the organisms or toxins causing the disease.Those antibodies which inhibit the action of toxinsare called antitoxins. The sites of maximum antibody

formation are the Iymph nodes and spleen.Maternal antibodies Produced by the mother and transmitted to the

foetus through the placenta or colostrum (seepassive immunity).

Antigen A substance which, when introduced into the body,stimulates the production of antibodies. Viruses,bacteria, bacterial toxins, red blood cells, tissueextracts, pollens, dust and many other substancesmay act as antigens.

Antitoxin See antibody.Attack rate Cumulative incidence rate (%) start count frommoment of outbreak: see incidence

Booster dose The word "booster", which originated in colloquialspeech, means "reinforcing", "augmenting" or"supplementing". Some vaccines have to be givenseveral times at intervals of at least four weeks toachieve an adequate level of protection. These firstdoses of the vaccine [in the cases of DPT (diphtheria,pertussis and tetanus) and OPV (oral polio vaccine)

three doses are given] are called the primary series.It is advisable to give an additional dose (boosterdose) after some months or years to maintainadequate protection. For example, the primaryseries of tetanus toxoid in pregnant womencomprises two doses, the second being given fourweeks after the first. A third dose (booster)administered during a subsequent pregnancy or thefollowing year protects all babies born within a

period of at least five years.

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Catchment population The number of children served by the immunisationprogramme within the boundaries of the communityserved.

Cohort A well-defined group of people who have had acommon experience or exposure who are thenfollowed up for the incidence of new diseases orevents as in a cohort or prospective study. A group

of people born during a particular period or year iscalled a birth cohort.

Cold chain A system of people and equipment which ensuresthat heat sensitive pharmaceuticals such as vaccinesreach potent and in correct quantity the 'end users':women, children and men who need it. This meansthat the temperature of these items must bemaintained within a specified temperature rangefrom the time of manufacture till the moment ofadministering.

Cold life The amount of time it takes for the temperatureinside a refrigerator, cold box or vaccine carrier togo from -3C to +10C.

Control of disease A significant reduction in the number of new cases ofa disease resulting from activities carried out byhealth authorities to check its spread, so that it nolonger constitutes an important public healthproblem. These activities include case finding andtreatment, immunisation, reduction in contacts with

vectors and surveillance.Disinfection The state of being free from most pathogenic

organisms, or of rendering them inert.Droplet infection An infection transmitted through tiny drops such as

small particles of respiratory secretions which areexpelled by coughing, sneezing or speaking andsuspended in the air. Evaporation causes them toreduce into small particles which remain in the airfor a long time, and thus transmit the microbialdisease from one person another.

Endemic The constant presence of cases of a disease orinfectious agent within a given community or region.

Epidemic This is the situation in which the number of cases ofa disease in a community increases well above theusual level. The number of cases constituting anepidemic depends on the size and type of thecommunity, its previous experience of the diseaseand the nature of the infecting agent.

Eradication of a disease This is the situation in which no new cases occur

because of activities designed to eliminate the

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vectors or agents and to render all casesnon-infective. The transmission of the disease istherefore stopped. The term "elimination" ispreferred when the geographical area concerned islimited. "Eradication" is generally understood torefer to the global level. Smallpox is the only diseasethat has so far been eradicated from the world;

concerted international action led to itsdisappearance by 1977.

Evaporator A part of the refrigerator which makes therefrigerator cold (often the evaporator is thefreezing compartment).

Flocculation Granular particles (floccules) visible after certainfrozen vaccines are shaken. They might not alwaysbe easily seen by the naked eye, but will sedimentfaster than unfrozen vaccine does.

Gamma globulin This product is a concentrate of antibodies derivedfrom human or animal blood. It can be used toprevent or lessen the effects of measles, hepatitis,yellow fever, tetanus and mumps. Its use isrestricted by cost and by its limited protective effect(two to six months).

Immunity Immunity is the state of resistance of the body toagents foreign to it. Immunity does not necessarilymean complete lack of susceptibility; varyingdegrees of immunity are recognised (nil, partial or

complete) which result in susceptibility, latentinfection (or healthy carrier state) orinsusceptibility. Immunity may be natural, activelyacquired or passively acquired.

Active immunity Active immunity is acquired by contracting aninfection (natural active immunity) or byadministration of vaccines (bacterial, viral andtoxoidal) either singly or in suitable combination.The person who contracts the infection or isimmunised makes his/her own antibodies whichremain in the body for a long time. This is the mostdesirable form of immunity; it is lost very slowlyand, where appropriate, can be rapidly restored by abooster dose.

Passive immunity In the case of passive immunity, ready-madeantibodies are acquired by infection or injection(e.g., gamma globulin). Passive immunity istransmitted from mother to foetus through theplacenta or colostrum (first milk of the mother) e.g.

neonatal tetanus can be prevented by administering

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tetanus toxoid to the mother. Passively acquiredantibodies give short-term protection, usually lastingonly two to six months.

Herd immunity This is the situation in which susceptibles(non-immune subjects) are protected from a diseaseif a sufficient proportion of the community hasbecome immune either through natural infection or

through being immunised against that disease.Such protection is acquired because the probabilityof a susceptible coming into contact with the diseaseis greatly reduced. However, even when the level ofherd immunity in a community is very high,susceptibles who do come into contact with thedisease may obviously still contract it. The currentinterest in the concept of herd immunity is due to itsusefulness in immunisation programs for estimatingthe minimum coverage which would lead to thecontrol of a given disease in a given community (i.e.,a considerable reduction in the number of cases forlong periods) or even its elimination (i.e., thecomplete cessation of transmission of the disease).There is a relationship between the level of herdimmunity and the characteristics of the particularpopulation or community, the infectious bacteriumor virus, and social and environmental factors. Animportant determinant of the level of herd immunity

is the nature of the infecting agent, specifically itsmode of spread and the duration and degree ofcontagiousness. Since measles is the most contagiousof the EPI diseases, its control requires the highestlevel of herd immunity. Herd immunity is notapplicable to tetanus since the bacillus is notdirectly transmitted from person to person orthrough vectors, and tetanus infection does notconfer immunity. Other significant determiningfactors are population characteristics, including thesize, composition and density of the population, thebirth rate (i.e., the rate at which new susceptiblesenter the community), and mobility within thecommunity. A higher level of herd immunity isrequired in a densely populated urbanised area in adeveloping country or a high-birth-rate area than inscattered rural settlements or areas with low birthrates. There are thus no fixed levels of herdimmunity applicable to the EPI diseases, since these

depend on the mix of the various conditions relating

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to the population, the disease and the physical andsocial environment. The ideal is to have every childprotected by being fully immunised. In EPI programs,an 80% average rate is often taken as a workingminimal level for all the vaccines. Such a coveragerate might produce an adequate level of herdimmunity for most of the diseases, depending on the

various parameters described above, with theexception of measles, which probably requires wellover 90% coverage in most communities. Thepractical implication of the concept of herdimmunity in developing countries is thatimmunisation programs must achieve very highcoverage rates and incorporate a good system ofdisease surveillance to judge their effectiveness.This is the prerequisite if the vaccine-preventablediseases are to be controlled (and some possiblyeradicated).

Incidence The number of new cases of a health problem in adefined population during a given time period.Incidence is expressed as an absolute number (e.g.,30 cases). The incidence rate is a measure offrequency of new cases of a disease in a definedpopulation during a given time period, usually ayear. It is expressed as the number of new cases per1,000 or per 100,000 of the population.

Jet injector This is an apparatus which projects fluid in a thin,high-speed jet which has enough force to penetratethe skin without requiring the use of a needle.Models which are cocked by means of a foot pumpare used in mass programs. As many as 1,000 personsan hour can be immunised, although in practiceaverage figures are lower, due to difficulties inorganising immunisation sessions. Hand cockedmodels are also available, but are restricted tointradermal injections and generally intended foroffice use. Operators of jet injectors must be welltrained. In mass programs, reserve injectors and anadequate supply of spare parts are required. Themeasles, DPT, meningitis and yellow fever vaccinescan be administered by jet injector. At present Jetinjectors are not used because of their inherent riskof contamination with Hep B and HIV. Manufacturersare developing a jet injector without thecontamination risk. There should be a new jet

injector on the market in 1998.

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Lead time Is the difference between re-order and minimumstock. This is the time it takes from placing theorder to receiving the stock.

Maximum stock The amount of any vaccine, supplies or spare partswhich should be in a store at the start of a newsupply period.

Minimum stock This is the reasonable minimum stock level which

should always be available in the store, to meet anypotential calculated problem.

Parenteral Not through the alimentary canal but rather byinjection, sub-cutaneous, intra muscular, intraspinal, etc. (enteral = through the intestine, e.g.oral or per rectum)

Prevalence The number of all cases of a disease existing in adefined population at a specific point in time.Prevalence is expressed as number (e.g., 3,000cases). The prevalence rate is a measure of thefrequency of all cases of a disease existing in adefined population at a specific point in time. It isexpressed as the number of cases existing per 1,000or 100,000 of the population.

Re-order level Is minimum stock plus the quantity of stock requiredto cover the lead time necessary between orderingand delivering of the vaccines.

Replacement rate The frequency with which vaccine, supplies or spareparts must be replaced because they have worn out

or are depleted.Seroconversion Seroconversion studies assess the presence or

absence of specific antibodies in the blood ofchildren or adults following immunisation or naturalinfection. Such studies allow calculation of theproportion of the population who are seropositive(i.e., have protective antibodies against a giveninfectious disease) or seronegative (i.e., do notpossess such anti bodies).

Stability The ability to resist physical disintegration. Avaccine that is stable will maintain potency for alonger period of time than an unstable vaccine whenit is exposed to high temperatures, freezingtemperatures, or light.

Sterilised The state of being free from (living) micro-organisms.

Toxoid Some bacteria cause illness by producing substances(toxins) which act at a distance from the site ofinfection. In neonatal tetanus, the umbilical cord is

usually the site of infection, but the toxin produces

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generalised effects on the muscles of the body.Toxoids are toxins modified by the application ofchemicals such as formaldehyde, which destroy theirability to cause disease without affecting theircapacity to produce antibodies. The diphtheria andtetanus vaccines are Toxoids.

Live attenuated

viral/bacterialvaccines Live vaccines contain live bacteria or viruses. These

organisms are treated in the laboratory to minimisetheir harmful effects while retaining their ability tostimulate the production of protective antibodies.Examples include BCG, oral polio (Sabin), measles,rubella, mumps and yellow fever vaccines. In theirliquid state, live vaccines may be inactivated by heator even by strong light. Vaccine stability can beimproved by freeze drying, a process in which thevaccine is reduced to a powder by freezing andremoving water vapour under vacuum. Freeze-driedvaccines are reconstituted before use with a diluent,commonly distilled water or saline. The diluentshould be at almost the same temperature as thevaccine i.e. between +2C and +8C at the time ofreconstitution, to prevent losing vaccine potency bythermal shock.

Inactivated

viral/bacterialvaccines Dead or killed vaccines are made from killed bacteria

or viruses. DPT vaccine contains dead pertussisbacteria and diphtheria and tetanus toxoids. Otherexamples are the cholera, typhoid, polio (Salk) andinfluenza vaccines. Killed vaccines are lessheat-sensitive than live vaccines.

Inactivatedbacterial toxins/toxoid vaccines Examples are the Diphtheria and Tetanus Toxoids.Vaccine efficacy This is a measure of the degree to which a vaccine

protects the members of the community in which itis used. A comparison is made between the attackrates (i.e., the number of cases occurring per 100 ofthe defined population) in those who have beenimmunised, as against the non-immunisedpopulation.Example:

Number immunised I

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Number not immunised UCases in the immunised population IcCases in the non-immunised population Uc

Vaccine efficacy (V.E.) = 1(Uc/U-Ic/I)/(Uc/U)

If I = 2,000 persons

U = 200 personsIc =15 casesUc =10 cases

then V.E. = (10/200-15/2,000)/(10/200)=0.85 or 85%

In practice, vaccines are never either whollyeffective or totally ineffective. Measles vaccine,administered correctly, is 80 to 95% effective.Studies on the clinical efficacy of vaccines provideuseful information. They can assure health careproviders that a vaccine is highly effective andcontribute to building confidence in vaccination. Ifefficacy is lower than expected, the vaccinemanagement and vaccine administration techniquesshould be carefully evaluated.

Vaccine potency The ability of a vaccine to protect from disease.A vaccine that has low potency will give lessprotection to the people who are immunised. A

vaccine that has high potency will give moreprotection to the people who are immunised.

Bibl: Universal child immunisation 1990/UnicefWho EPI guidelines

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Index

absorption refrigerator.......14, 17absorption system..................37Active immunity....................43adjuvant.............................41

Adjuvant.............................41ambient temperature....22, 24, 25antibodies..........5, 41, 43, 46, 47Antibodies...........................41Antigen...............................41antiseptics.........................7, 8Antiseptics............................7Antitoxin.............................41attack rate..........................47

Attack rate..........................41bacteria.........5, 6, 10, 41, 46, 47bacterial toxins................41, 47BCG 7, 8, 9, 10, 17, 18, 21, 22, 25,

27, 34, 47booster dose....................41, 43Booster dose........................41carbohydrate........................39Catchment population.............42CDC...................................35

CFC...................................38chlorofluorocarbon.................38cohort................................42Cohort................................42cold chain.........17, 22, 23, 24, 30Cold chain...........................42Cold life..............................42cold storage....................17, 37coldbox...............................25

Colour coding.......................29compression system...........37, 38Compression system...............37Control of disease..................42diarrhoea..............................5diluent water.........................9diphtheria. .6, 7, 10, 25, 32, 41, 47Diphtheria.......5, 6, 10, 19, 32, 47disinfectants..........................8Disinfectants..........................7

Disinfection.........................42doses..........20, 21, 22, 26, 31, 41Droplet infection...................42DTP vaccine...........................8

Endemic..............................42EPI.....6, 16, 18, 19, 20, 21, 34, 44epidemic....................32, 33, 42Eradication of a disease...........42evaporator.............37, 38, 39, 43Evaporator...........................43expiry date..........................27Flocculation.........................43freezer.. .13, 17, 22, 25, 26, 38, 39

freezing 7, 8, 9, 10, 11, 18, 19, 24,25, 41, 43, 46, 47Freezing......................7, 18, 19gamma globulin.....................43Gamma globulin....................43Haemophilus...............32, 33, 34health care workers................36Health care workers...............35Hepatitis A.......................6, 14Hepatitis B...6, 14, 24, 27, 33, 34,

35, 36herd immunity......................44Herd immunity......................44HIV...........................35, 36, 45icepacks............8, 13, 17, 25, 26immunity.............................43Immunity.........................5, 43inactivated.......................7, 10Inactivated..........................47

incidence..............31, 41, 42, 45Incidence............................45IPV.................................9, 18ISO standards........................27Japanese encephalitis...........6, 7jet injector..........................45Jet injector..........................45killed bacteria......................47lead time............................46Lead time............................46

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Live attenuated.....................47Maternal antibodies................41Maximum stock.....................46measles..5, 6, 7, 9, 17, 19, 27, 32,

33, 43, 44, 45, 47Measles 5, 8, 9, 19, 25, 27, 29, 33,

34, 48

meningitis..................27, 33, 45Meningococcal meningitis..........6minimum stock.....................46Minimum stock......................46MMR...................................34MOH...................................34monitor card........................25mumps......................32, 43, 47Mumps......................19, 33, 34OPV.........8, 14, 17, 22, 25, 27, 41parenteral...........................21Parenteral.......................21, 46passive immunity..............41, 43Passive immunity...................43pertussis............6, 10, 32, 41, 47Pertussis..............5, 6, 10, 19, 33polio. .6, 7, 8, 9, 14, 22, 32, 41, 47Polio.......8, 17, 19, 24, 27, 33, 34Poliomyelitis..........................5

post exposure profylaxis..........35potency..............7, 9, 10, 27, 46prevalence.................35, 36, 46Prevalence...........................46Rabies.............................6, 19refrigerants..........................38Refrigerants....................38, 39refrigerator. .8, 12, 13, 14, 17, 22,

24, 25, 26, 38, 39, 42, 43Refrigerator.........................12Replacement rate..................46rubella...........................32, 47Rubella......................19, 33, 34Seroconversion......................46stability.........................27, 47Stability..............................46sterile injection....................27Sterilised.............................46stopwatch momitor card..........13

supply intervals.....................20

Supply intervals.....................20temperature. .7, 8, 12, 13, 14, 17,

22, 24, 25, 26, 27, 30, 37, 38,39, 42, 47

Temperature.....................8, 13tetanus 6, 7, 10, 11, 25, 32, 41, 43,

44, 46, 47

Tetanus.5, 6, 10, 11, 19, 32, 34, 47thermometer..............13, 17, 25thermostat.................13, 24, 26Thermostat..........................24Tiny TTM.............................30toxins......................6, 7, 41, 46toxoid...............7, 10, 11, 44, 47Toxoid..................10, 18, 19, 46toxoid vaccines.....................47treatment costs.....................32TT vaccine...........................11tuberculosis........................6, 9Tuberculosis..........................5Typhoid fever.........................6Unicef................................48UV light..............................17vaccination campaign....16, 20, 21Vaccine efficacy...............47, 48vaccine potency....................47

Vaccine potency....................48vaccine requirements..............20vaccine vial monitor......14, 27, 28Vaccine vial monitor..........14, 27vaccines.6, 7, 8, 9, 10, 11, 12, 13,

14, 17, 19, 20, 21, 22, 24, 25,26, 27, 29, 31, 33, 34, 41, 42,43, 45, 46, 47, 48

Vaccines. .5, 6, 7, 8, 10, 12, 24, 31viral/bacterial......................47virus...........5, 8, 9, 27, 35, 36, 44Virus..................................36who.13, 31, 35, 42, 43, 44, 46, 47,

48WHO......................6, 14, 27, 34yellow fever...........27, 43, 45, 47Yellow fever.....................6, 19Zidovudine...........................35

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msf cold chain guidelines en

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