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    WHO/EPI/LHIS/98.02

    O riginal: English

    Distribution: G eneral

    Safe vaccine handling, cold chain and

    immunizations

    A manual for the N ewly Independent States

    GLOBAL PROGRAMME FOR VACCINES AND IM MUNIZATION

    EXPANDED PROGRAMME ON IMMUNIZATION

    World Health Organization, Geneva, 1998

    Produced in collaboration with Basics, USAID and UNICEF

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    Based on the C old Chain Training Manual for H ealth Workers prepared in Bishkek,

    Kyrgyzstan in 1992/93 by health officials and staff, with the assistance of the USAID/REACH

    Project, incorporating original materials from WH O and additional materials from U N IC EF and

    USAID/BASICS.

    Thanks to all of the WH O , UN IC EF, and USAID/BASIC S staff and consultants who gave theirtime, hard work, and expertise in the development of this manual. Special thanks to the

    Ministries of H ealth in Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, and

    Uzbekistan, as well as the WH O Steering Committee representatives, for their cooperation,

    dedication, and support in reviewing, finalizing and field testing this manual.

    Through the cooperation of the staff and counterparts of the Ministries of H ealth and t heir

    affiliates, WH O , UN IC EF, and the U SAID /BASIC S project have been active in their t echnical

    support to improve and strengthen the immunization programmes and cold chain systems in the

    N IS. Thanks to WH O for their collaboration and guidance with the government and the

    Ministries of H ealth in the development of immunization policy, funds in support of vaccine

    prophylaxis, training of specialists and support for national immunization programs. Thanks toUN IC EF for its work with the governments of the N IS in the procurement of vaccines from

    WH O pre-qualified manufacturers and in procurement o f equipment such as cold rooms, cold

    boxes, refrigerators and freezers to upgrade the cold chain systems. Thanks to USAID/BASICS

    for their assistance with the Ministries of H ealth in immunization policy development and

    reform, assessments and trainings in cold chain logistics and management, and immunization

    system strengthening.

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    Table of contents

    Preface ......................................................................................................................................................v

    1. Immunity and vaccines .....................................................................................................................1

    1.1 Immunity ......................................................................................................................................1

    1.2 Target diseases..............................................................................................................................1

    1.3 H ow are vaccines made? .............................................................................................................2

    1.4 Vaccine stability ...........................................................................................................................2

    1.5 Correct administration of vaccines ............................................................................................3

    1.6 Policy on use of opened vials of vaccine....................................................................................6

    2. The cold chain system ........................................................................................................................8

    2.1 Vaccine storage.............................................................................................................................92.2 Vaccine potency .........................................................................................................................11

    2.3 Vaccine stock quantities ............................................................................................................11

    2.4 Vaccine stock records ................................................................................................................14

    2.5 Vaccine arrival report ................................................................................................................15

    3. Cold chain equipment and its use .................................................................................................16

    3.1 Equipment for vaccine transportation .....................................................................................17

    3.2 Equipment for vaccine storage .................................................................................................24

    4. Maintenance of cold chain equipment .........................................................................................36

    4.1 Installation ..................................................................................................................................36

    4.2 Defrosting...................................................................................................................................37

    4.3 Cleaning ......................................................................................................................................37

    4.4 Safety requirements ...................................................................................................................38

    5. Control and monitoring of temperatures ...................................................................................39

    5.1 Thermometers ............................................................................................................................39

    5.2 Temperature record sheets ........................................................................................................40

    5.3 Refrigerator or freezer thermostats.......................................................................................... 40

    5.4 Cold chain monitor card ...........................................................................................................41

    5.5 Vaccine vial monitor ..................................................................................................................44

    5.6 DT & TT vaccine shipping indicators .....................................................................................47

    5.7 FreezeWatch indicator ..............................................................................................................485.8 Stop!Watch indicato r.................................................................................................................48

    5.9 Vaccine shake test ......................................................................................................................49

    6. The cold chain during immunization sessions...............................................................................3

    6.1 At the beginning of the working day ......................................................................................... 3

    6.2 During immunization sessions at fixed health facilities...........................................................3

    6.3 At the end of the working day:...................................................................................................4

    6.4 During out reach immunization sessions ...................................................................................5

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    7. Syringes, needles and sterilisation...................................................................................................6

    7.1 Injection equipment.....................................................................................................................6

    7.2 Sterility and sterilisation of reusable equipment .......................................................................8

    7.3 Confirming complete sterilizat ion .............................................................................................9

    8. Breakdowns and emergencies ...........................................................................................................4

    8.1 Technical faults in the refrigerator .............................................................................................4

    8.2 Plan for cold chain emergencies .................................................................................................7

    Annex 1: Vial size and doses/ vial for EPI vaccines......................................................................11

    Annex 2: Vaccine stock record ........................................................................................................12

    Annex 3: Vaccine arrival report ......................................................................................................13

    Annex 4A: Monthly temperature recording sheet (sample).........................................................15

    Annex 4B: Annual temperature recording sheet (sample) ...........................................................16

    Annex 5A: Adverse events following immunization .....................................................................17

    Annex 5B: AEFI case-invest igation report form ..........................................................................18

    Annex 6: N ational

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