COLD CHAIN GUIDELINE Edition 2 FSU-MSF-H 2002

Transcription

1 COLD CHAIN GUIDELINE Edition 2 FSU-MSF-H 2002

2 Cold Chain guideline 2002 FSU-MSF page 2

3 Table of Content 1. Immunity and vaccines...6 Immunity...6 A bit of theory on immunization...6 Why Immunize?...7 What Immunizations, When And Whom To Immunize..8 EPI...8 Immunization campaigns Vaccines properties What Vaccines Are Made Of Are vaccines ready-to-use? What Damages Vaccines Heat, Sunlight And Freezing Chemicals, Disinfectants, Detergents, Soap Temperature Types of vaccines Inactivated or killed vaccines Live vaccines The Cold Chain Temperature zones The future The fast chain Various cooling systems Freezing capacity Is a solar fridge a good choice? Transport & Storage Transport Why ice? The cold box The properties How to choose a cold box? Filling the cold box Maintenance Transport conditions Storage Storage at different levels Refrigerating and freezing When things go wrong Cold Chain guideline 2002 FSU-MSF page 3

4 How to choose a fridge or freezer? Operation and maintenance of absorption fridges. 36 General Kerosene Gas Winterization Of The Cold Chain How to assess a cold chain Cold room How to assess a Cold store or cold room Temperature surveillance The tools The thermometer The cold chain monitor card Vaccine vial monitor The freeze indicator In practice EPI Immunization campaign: the preparation Campaign Committee Estimation of the target population size Define the immunization strategy Criteria to launch a mass immunisation campaign 57 Constraints Target population Priorities Where to start? Fixed or mobile? Register or not? Resources needed Vaccine needs Equipment needs Cold chain supplies Calculating cold storage space requirements Calculating Ice Pack and freezing requirements.. 62 Practical tips Safe injections Immunization records Staff needs Cold Chain guideline 2002 FSU-MSF page 4

5 Budget Organization of the campaign Logistic organization Duration Location Organization of the site Organization of immunization sessions Mobilization of the local community Monitoring and evaluation: Waste management Evaluation of the intervention Evaluation of the case management Evaluation of the immunization program Report of the epidemic and intervention Annexes Do s and don ts for a fridge Multilingual names of diseases/vaccines The WHO multi-dose vial policy PEP The shake test The"Tiny TTM", a mini size data logger Main Vaccines Tally Sheet Normal age distribution in a developing country Estimation of freezing capacity for a campaign Immunization & Cold Chain Glossary Cold Chain guideline 2002 FSU-MSF page 5

6 1. Immunity and vaccines Immunity If you have had measles, you cannot catch it again. You have become immune to measles. When you have an infection, your body learns to make antibodies against the micro-organism (virus or bacteria) that causes the infection. The antibodies kill 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 many infections by its mother's antibodies. These come from the mother's blood and cross the placenta into the baby's body before birth. There are also antibodies in breast milk, especially in colostrum (the first breast milk), which help to protect a baby against diarrhoea and other infections. At birth, the baby begins to make its own antibodies. Childhood diseases can be prevented by immunization. To immunize a person, you give a vaccine - that is, a weakened or killed form of the same micro-organism which causes the disease. The vaccine encourages the child's/person's body produce antibodies, but will not cause the disease. The child/person becomes immune, without becoming ill. Vaccines are given by injection or by mouth. A bit of theory on immunization The various recommendations for immunizing infants, children and adults against diseases are based on medical knowledge, the availability of safe Cold Chain guideline 2002 FSU-MSF page 6

7 vaccines, other scientific knowledge, and on judgments by public health officials and doctors. Each vaccine has benefits and risks associated with its use, and no vaccine is completely safe or completely effective. Vaccines are beneficial because they prevent disease infection and the various results of that infection, which may be mild symptoms such as a body rash, or more serious problems such as paralysis or death. Depending on the vaccine the benefits may vary from partial protection to complete protection against the disease or its effects. The risks associated with vaccine usage range from common, trivial, and inconvenient side effects, such as mild swelling or low grade fever, to on rare occasions severe, and life-threatening conditions. The decision to use a vaccine is based on the benefits, costs and risks associated with the vaccine. For each vaccine, recommendations are developed for its use, and these describe who should receive it, when they should receive it, and how the vaccine should be administered. These vaccine recommendations are developed to apply to large populations, but the recommendations may vary for specific individuals or even between countries. Finally, the relative balance of benefits and risks may change as diseases are controlled or eradicated. For example, because smallpox has been eradicated throughout the world, the risk of side effects associated with the smallpox vaccine now exceeds the risk of smallpox; consequently, smallpox vaccinations are no longer routinely given to the public. Why Immunize? It s effective Immunization is one of the most effective ways to prevent disease. Because immunizing children has proven to be so effective at preventing disease, in 1974 the World Health Organisation (WHO) launched the Expanded Program on Immunization (EPI). In 1974 less than 5% of the world's children were immunized against the initial six target diseases-diphtheria, tetanus, whooping cough, polio, measles and tuberculosis-during their first year of life. By 1990, almost 80% of the 130 million children born each year were immunized before their first birthday. Within two decades, the EPI was preventing the deaths of at least 3 million children a year. In addition, at least fewer children were blinded, crippled, mentally retarded or otherwise disabled Cold Chain guideline 2002 FSU-MSF page 7

8 In the United States the widespread use of vaccines has reduced the peak-level incidence of disease by at least 95%. The vaccination series consists of 2-5 doses of each of 5 vaccines. Most vaccines protect 90% or more of the individuals vaccinated. In addition, most vaccines when used widely in communities indirectly protect other persons as well, including those too young for vaccination and those with legitimate medical contraindications to vaccination. This goes for anywhere in the world. It saves lives Experience in the United States in recent years has illustrated both the effectiveness of immunization and the tragic consequences of failure to vaccinate properly. Before the measles vaccine was approved in 1963, an average of over 500,000 cases of measles was reported each year, killing 400 to 500 people annually. By 1983, in the United States the number of cases of measles reported had dropped to a record low of 1,497. However, a resurgence of measles between 1989 and 1991 (over 55,000 cases of measles, including 132 reported deaths) occurred primarily among unvaccinated 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 vaccinate children on time at months of age. It saves money In addition to lessening the human suffering brought about by disease, immunization is cost-effective. It is estimated that every $1 spent on vaccinations for measles, mumps, and rubella represents a potential savings of many more dollars in treatment costs. The measles outbreak of caused over 44,000 days of hospitalization. Studies suggest that each 1,000 cases results in $3-4 million in direct medical treatment costs. What Immunizations, When And Whom To Immunize EPI Which vaccinations against what diseases? Cold Chain guideline 2002 FSU-MSF page 8

9 The Target Diseases The EPI program aims at immunizing all children against the six diseases before their first birthday. These diseases are very serious, and can kill or disable many children - even though other children survive and become immune. These six diseases are: Poliomyelitis Measles Diphtheria Pertussis (whooping cough) Tetanus Tuberculosis (TB). All but tetanus (lockjaw) are contagious and can be transmitted from an infected person to an uninfected person. These vaccinations are necessary for a child to be adequately protected against serious childhood diseases that can lead to death: TB, infection of the lungs, highly contagious, and/or any other organ, which can cause death if untreated. Diphtheria, an 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; Pertussis (whooping cough), which is highly contagious and causes severe coughing and occurs mostly in children under 5 years of age; Polio, which causes paralysis and death; Measles, which is highly contagious, causes a rash, high fever and possibly death. When to vaccinate The basic schedule recommended by WHO (World Health Organisation), which differs substantially from the schedule used in the US and other countries in the western hemisphere, in the framework of the EPI (Expanded Program on Immunization) is as follows: Cold Chain guideline 2002 FSU-MSF page 9

10 Age Birth Vaccine BCG + oral Polio 6 weeks DTP + oral Polio 10 weeks DTP + oral Polio 14 weeks DTP + oral Polio 9 months Measles >15 years Tetanus The recommended ages are not absolute, so if need be, all recommended vaccines can be given simultaneously. Other vaccines (like MMR (Mumps Measles Rubella) are either skipped or added (like Hepatitis B and Hib (Haemophilus Influenza type b)) to the schedule when the MOH (Ministry Of Health) of governments can afford them. Immunization campaigns Besides the EPI, immunization is also used as a tool to stop or prevent the spread of an epidemic. In that case people are only immunized against one specific disease. Measles, meningitis and yellow fever are well-known mass immunization campaigns. Other vaccines you may encounter when working in MSF projects: Hepatitis A Typhoid fever Rabies Japanese encephalitis Cold Chain guideline 2002 FSU-MSF page 10

11 2. Vaccines properties What Vaccines Are Made Of Manufacturers make vaccines from micro-organisms similar to the ones that cause disease, or from the toxins (poisons) that bacteria produce. The micro-organisms or toxins have been changed so they cannot harm people. Are vaccines ready-to-use? Yes, some are! The vaccines that come as a liquid are ready-to-use. Other vaccines are preserved much better in a lyophilized (or freeze-dried) state, and need to be reconstituted at the vaccination site. The latter come in two vials: one for the lyophilized vaccine, the other containing the diluent (saline solution). Reconstituted vaccines are very unstable and have to be discarded if not used directly. What Damages Vaccines All vaccines are sensitive biological substances that progressively lose their potency (i.e. their ability to give protection against disease). This loss of potency is much faster when the vaccine is exposed to temperatures outside the recommended storage range. Once vaccine potency has been lost, returning the vaccine to correct storage condition cannot restore it. Any loss of potency is permanent and irreversible. Thus, storage of vaccines at the correct recommended temperature conditions is vitally important in order that full vaccine potency is retained up to the moment of administration. Although all vaccines are heat-sensitive, some are far more sensitive than others. For more detailed information see annex 8.7. In addition to being temperature-sensitive, several vaccines are also highly sensitive to strong light, and thus need to be kept in the dark as much as possible. BCG and Measles are those most affected and exposure to sunlight must be avoided. They are given some protection by being supplied in vials of dark brown glass to reduce the penetration of light. This alone will not prevent light damage however and great care must be taken to protect them during Cold Chain guideline 2002 FSU-MSF page 11

12 use. As with loss of potency due to heat, any loss of potency due to light is also permanent and irreversible. Note that all losses of potency are CUMULATIVE, that is, each time a vaccine is exposed to incorrect temperature or strong light its potency will decrease. Since the vaccine may have already been exposed previously, any new exposure, however small, will increase the damage to the vaccine. It is therefore vitally important to know the CORRECT storage conditions for each vaccine, and to ensure that each is always kept at the recommended conditions. 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 after carefully. Heat, Sunlight And Freezing Heat and sunlight damage all vaccines - but especially polio, measles and BCG (=TB vaccine). Freezing damages: DPT, tetanus toxoid, Hepatitis and Hib B vaccines. When you are certain the vaccine has been damaged: discard the vaccine, destroy it by incineration and bury the remains. Chemicals, Disinfectants, Detergents, Soap Disinfectants and antiseptics will kill unwanted micro-organisms. We use spirit, detergents and soap to clean. These chemicals can damage vaccines. If you clean or sterilize instruments in a chemical, some of the chemical may remain on the instruments. If there is any chemical on a syringe or needle, it can damage a vaccine. To sterilize immunization equipment, you must use HEAT (steam or boiling water). If syringes and needles have been in contact with disinfectants, antiseptics, spirit, detergent or soap, WASH THEM VERY THOROUGHLY and sterilize them with steam (pressure cooker or autoclave) before use Cold Chain guideline 2002 FSU-MSF page 12

13 Temperature The correct temperature to store vaccines in a health center is between +2 C and +8 C, which in the tropics can only be found in a refrigerator. There is a safety margin, so don t throw away your vaccines when the temperature has been lower than 2 but not lower than 0 C or higher than 8 but not higher than 12 C for longer than a week. When in doubt consult your technical/medical dept, or local UNICEF expert. Types of vaccines There are two types of vaccines in common use: Inactivated or killed vaccines, and vaccines made from live organisms: Inactivated or killed vaccines Are sub-divided into three categories: Inactivated whole bacterial vaccines e.g. pertussis (whooping cough) vaccine Inactivated whole virus vaccines e.g. injected poliomyelitis vaccine and hepatitis A vaccine Sub-component vaccines may be based on bacterial toxins that have been rendered harmless (toxoids) as in the case of diphtheria, some forms of pertussis (whooping cough), and tetanus vaccines, or consist of polysaccharide complex (sugar) molecules, which are attached to protein molecules to improve the immune stimulatory effect. Good examples of these so-called conjugate vaccines are the Haemophilus influenzae Type b (Hib) vaccine; the meningococcal C vaccine and the pneumococcal conjugate vaccine. Sub-unit viral vaccines include influenza and hepatitis B Cold Chain guideline 2002 FSU-MSF page 13

14 The Killed Vaccines DPT Vaccine DPT vaccine contains diphtheria toxoid, pertussis vaccine and tetanus toxoid. It s referred to as "triple vaccine". They are given by injection and come in liquid form. Diphtheria Toxoid This is the "D" part of DPT vaccine. Diphtheria is caused by bacteria, which produce a toxin. The vaccine is a toxoid, that is, inactivated diphtheria toxin. The vaccine is heat-sensitive, although to a lesser extent than OPV and measles, but is immediately destroyed by freezing. The temperature to freeze the vaccine is approximately 3 C, so storage temperatures should never be less than 0 C to allow a margin for safety. To check if freezing has damaged a vaccine: see annex 8.5. When DPT is at rest the liquid is clear, with white sediment forming at the bottom of the vial. Shaking of the vial makes the vaccine a white, uniformly turbid liquid, with no granules. Pertussis Vaccine This is the "P" part of DPT vaccine. The microorganisms 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. Therefore, the pertussis vaccine is the most easily damaged part of DPT. It is the limiting factor for the "triple vaccine". 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. Freezing damages Tetanus toxoid. It is also damaged by heat, but more slowly than the other vaccines. DPT and tetanus toxoid are both liquid vaccines, which you give by injection Cold Chain guideline 2002 FSU-MSF page 14

15 Meningitis A+C There are different bacteria causing meningitis: they are catagorized by serogroup.this is the bivalent meningococcal serogroup A and C vaccine. Meningitis vaccines against other serogroups (W-135 and Y) exist as well. Unfortunately there is no vaccine available for serogroup B with clearly demonstrated efficacy and safety. Three years protection is expected from a single dose. Meningitis A+C comes as a dry powder in a vial. The vaccine is not damaged by freezing and can be frozen, thawed and refrozen without damage. The diluent however, must not be frozen. Before you can use it, you must reconstitute the dry vaccine with the diluent. Reconstituted vaccine loses its potency more quickly. Although the diluent does contain a preservative, you must use the reconstituted vaccine in only one immunization session and discard the vial directly afterwards. Live vaccines Vaccines made from live organisms, which have been modified or "attenuated"(= weakened) so that they stimulate the production of the appropriate antibodies without causing the disease. Examples of live bacterial vaccines are the BCG (Bacillus Calmette- Guérin) vaccine, which is used against tuberculosis and the more recent oral vaccine against typhoid fever. Live virus vaccines include those against yellow fever, oral poliomyelitis (Sabin), measles, mumps and rubella. New multivalent vaccines may include several different sub-components, often allowing combined protection against different diseases and reducing the number of immunizations. Polio Vaccine The micro-organism, which causes polio, is a virus. The vaccine that most countries use is made from a live attenuated 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 Cold Chain guideline 2002 FSU-MSF page 15

16 Polio vaccine is given ORALLY: put two drops of vaccine straight from the bottle into the child's mouth. Oral polio vaccine (OPV) is damaged very quickly by heat. It is more easily damaged by heat than other vaccines. However, freezing does not damage OPV - it can be frozen and refrozen without harm. Some countries use a KILLED VIRUS polio vaccine, which you give by injection (IPV= injectable polio vaccine). Freezing will damage this vaccine. Measles Vaccine The 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 is freeze-dried. To use the vaccine, you must mix the dry vaccine with diluent water for injection (= reconstituting the vaccine). Measles vaccine is easily damaged by heat. The dry vaccine stays potent for a long time if you keep it cold. Freezing does not damage the dry vaccine - it can be thawed and refrozen without harm. Reconstituted vaccine loses its potency very quickly, even if it is cold. It must be used within 6 hours or till the end of the immunization session whichever comes sooner and discarded. BCG Vaccine BCG vaccine protects against tuberculosis (TB). It is made from a special weak but living kind of mycobacterium, BCG is a LIVE BACTERIAL VACCINE. BCG is freeze-dried, like measles vaccine. BCG comes as a dry powder in the container/vial. Before you can use BCG, you must reconstitute the dry vaccine with diluent Cold Chain guideline 2002 FSU-MSF page 16

17 BCG is damaged most easily by sunlight. The containers are usually made of dark glass. Heat damages BCG, but not as quickly as it damages measles and polio vaccines. The dry vaccine stays potent for a long time if you keep it cold. The vaccine is not damaged by freezing and can be frozen, thawed and refrozen without damage. The diluent however, must never be frozen. In practice however, BCG vaccine is not normally stored in the frozen state. Reconstituted vaccine loses its potency more quickly. Because the diluent does not contain a preservative, bacteria might grow in it. You must use it within 6 hours or in the same immunization session, whichever comes sooner, and discard it. Yellow fever Yellow fever vaccine is safe and highly effective. Yellow fever vaccine is a live attenuated viral vaccine. A single dose confers long-lived immunity lasting 10 years or more. The vaccine comes as a lump of dry material at the bottom of a vial. It is freeze-dried. The dry vaccine stays potent for a long time if you keep it cold. The vaccine is not damaged by freezing and can be frozen, thawed and refrozen without damage. The diluent however, must never be frozen. The reconstituted vaccine loses its potency more quickly. Because the diluent does not contain a preservative, bacteria might grow in it. You must use it within 6 hours or in the same immunization session, whichever comes sooner, and discard it Cold Chain guideline 2002 FSU-MSF page 17

18 3. The Cold Chain As you know now, vaccines are damaged by heat and by freezing. The correct temperature to store vaccines in a health center is between +2 C and +8 C, which in the tropics can only be found in a refrigerator. Vaccines 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 the manufacturer to the end user are together called: THE COLD CHAIN. Before vaccines reach the health center they must be: collected quickly from the airport; stored at the correct low temperature in the refrigerator at the Central Store, the Regional Store and the District Store; kept cold during transport from one store to another. Only then vaccines arrive at your health center in good condition Cold Chain guideline 2002 FSU-MSF page 18

19 After vaccines reach the health center: they have to be kept at the correct temperature in the refrigerator. they have to be carried to the immunization session in a vaccine carrier 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 same temperature as the vaccine, to prevent killing the live vaccine by heat shock. Some vaccines are more vulnerable than others: as stated in chapter 2, Oral Polio is the first one to loose its potency when exposed to heat whereas Tetanus Toxoid can be used with some precaution without any cooling, so without a cold chain altogether! If we talk about freezing exposure, Hep B is the first one to be damaged at approx. -0.5ºC. See for more information the table in annex 8.7 Main vaccines. Temperature zones Most cold chain equipment was designed for tropical or hot conditions. As more projects opened in the more moderate or even cold climates, the temperature zones concept was introduced. All equipment will have a temperature label : hot (0 43 C), moderate (0-32 C) or cold (-5 C C). All equipment in this guideline carries the label hot. The future The rules of the cold chain are strict and based on a worst-case scenario. In some cases the rules are far too strict to the extent that they can slow down a rapid mass vaccination campaign. This goes especially for Meningitis where a fast reaction after an outbreak is essential where the vaccine itself is very stable. In the near future most vaccines will have a temperature monitoring device, a so-called VVM, a Vaccine Vial Monitor (see chapter 5 for a detailed Cold Chain guideline 2002 FSU-MSF page 19

20 description). The VVM is an indicator on each vial that tells you if the vaccine is still potent (if the expiry date has not passed). The VVM allows you to soften the strict cold chain rules, as the vaccinator at the end of the cold chain can tell by looking at the VVM if the vaccine can still be used. VVM are now present on almost all oral polio vaccines. The strict rules of the cold chain did produce some other problems: the cold chain is often too cold. So cold that it damages the most cold sensitive vaccine: Hep B. It is suggested that as many Hep B vaccines are damaged by cold as by heat exposure. There is no clear-cut solution for the low temperature problem. The fast chain In a vaccination campaign or a NID (National Immunization Day) the turnover of the vaccines is higher. Consequently, if sent through a poor functioning or even without a- cold chain, heat exposure will not be extended, and vaccines can still be used safely at the vaccination site. There are preconditions: the vaccine should not be within 6 months of their expiry date; you are sure about the quality of cold storage up to the moment of reception of the vaccine, either by importing it yourself or by an assessment of the cold store or cold chain from the supplying party; appropriate training of the end users is guaranteed; the expiry date of the vaccines should be changed. The new expiry date will be the current date + the maximum time (for the average local temperature) outside of the cold chain Cold Chain guideline 2002 FSU-MSF page 20

21 If the Fast chain conditions (page 20) are met, the following table applies and can be used for planning purposes, even for vaccines carrying a VVM. Note that for vials with a VVM- the VVM reading overrules any of the indications mentioned below. Vaccine can be used at max 37 C outside of the cold chain for maximum can be used at max 25 C outside of the cold chain for maximum When kept cool can be used after reconstitution for maximum At 37 C can be user after reconstitution for maximum ORAL POLIO do not use outside n.a. MEASLES 14 days 3 months 6 hours not allowed MENINGITIS A+C 14 days 1 month one session 6 hours YELLOW FEVER 7 days 1 month 6 hours 1 hour TETANUS 2 month 6 months n.a. DPT 14 days 3 months n.a. DPT POLIO do not use outside n.a. JAPANESE 3 months 6 months one session 6 hours ENCEPHALITIS IPV=INACTIVATED do not use outside n.a. POLIO VACCINE HEPATITIS A 7 days 3 months n.a. HEPATITIS B 7 days 3 months n.a. HIB=HAEMOPHILUS 3 months 1 year 6 hours 6 hours INFLUENZA TYPE B MUMPS 14 days 3 months one session 6 hours RUBELLA 14 days 3 months one session 6 hours RABIES 1 month 3 months one session 6 hours BCG 14 days 3 months 6 hours 1 hour Cold Chain guideline 2002 FSU-MSF page 21

22 Various cooling systems There a numerous types of refrigerators and freezers. MSF selected a few models for the average intervention (see chapter 6: the MSF fridges); for more information check the Product Information Sheets (PIS 2000 edition, published by the WHO ref: WHO/V&B/00.13) We can subdivide the refrigerators into two categories: by cooling system ice lined or not Cooling system There are two cooling systems used in our fridges: the so-called absorption system and the compression system. The absorption system Pro s: can run on several energy sources: electricity, butane/propane, kerosene Con s: low cold yield, labor intensive maintenance, difficult to repair. An absorption fridge is only a good choice for locations where no reliable power supply is available. The first choice for fuel or energy is gas: considerable lower maintenance and problems compared to the kerosene version. The last resort is kerosene. For more information on how to maintain a kerosene fridge, see chapter 4. The compression system Pro s: high cold yield, easy to maintain, easy to repair. Con s: needs relative reliable electrical power supply. A compression fridge is the preferred choice if you have a relatively reliable electricity supply. Icelined or not? An icelined fridge is what it says: a fridge with a lining of ice in the interior. As ice has a good cooling capacity, the so-called holdover time of this type of fridge is far superior to a normal type of fridge (hold-over time: the time the temperature in the fridge stays below 8ºC without electricity). An icelined fridge will always be a compression type needing electricity. Cold Chain guideline 2002 FSU-MSF 22

23 A good quality ice lined fridge or iceliner will stay cold enough for vaccine storage with as little as 8 hours of electricity/24 hours at 43ºC. At a lower average ambient temperatures 32 C, our standard icelined fridge -the Vestfrost MK/MF4010(=MKMF074)- a minimum of 6 hours of electricity supply is needed. If your electricity supply is not sufficient for an iceliner, your choice of fridge will be the absorption one. Freezing capacity A compression freezer is in practice- the only freezer available. It needs a reliable electricity supply. For storage purposes, choose a freezer on the basis of its storage volume. For freezing icepacks choose the freezer on the basis of its freezing capacity (indicated in no of Kg/24 hours). Check out all details of fridges and freezers in chapter 4. You can find a calculation example in Is a solar fridge a good choice? Solar fridges are expensive and only a good choice for a stable long term or remote environment. Appropriate training should accompany any solar system implementation. Ask for advise from your support department before buying. Cold Chain guideline 2002 FSU-MSF 23

24 4. Transport & Storage Transport Why ice? Ice (in the form of ice packs) is necessary to transport the cold: A classic ice pack Water can also be liquid at a temperature of Oº C. When it is solid at this temperature it is ice. In this graph, the energy supplied by the change from water to ice (or vice versa) is represented: Cold Chain guideline 2002 FSU-MSF 24

25 You can see from the graph that the ice pack generates maximum cold energy when it is thawing. Let s look at an example When transported in a cold box an ice pack gives off 10 Kcal each day. If it is therefore perfectly frozen to start with (even at Oº C) it will keep the vaccines cold for 9 days. If however it is liquid (even at Oº C) it will only keep the same vaccines cold for 1 day. Conclusion It is very important to freeze an ice pack properly. All the water in the icepacks should be transformed into ice Eutectic mixture ice packs are marketed for camping and pic-nic. They are not suitable for vaccines. There are Glycol mixtures (often colored green or blue) with a freezing point below Oº C (as in car radiators). These are dangerous for vaccines (like DTP Cold Chain guideline 2002 FSU-MSF 25

26 and Hep b) because they create a lower temperature when thawing and can still be liquid at - 5º C. Do not use these icepacks! Use only icepacks filled with water! In a mass-vaccination campaign huge amounts of ice are needed to send all cold boxes to the field. The freezing capacity for the icepacks is in such a case is often too low. In such a case one can use wet ice from a local ice factory. Danger warning for wet ice: If the septum of a vial of vaccine or diluant has been immersed in the melted water from the wet ice, the vial should be discarded! Take care to pack all vials carefully in a watertight container if you have to use wet ice! The rubber stopper is called the septum Cold Chain guideline 2002 FSU-MSF 26

27 The cold box The various models Cold boxes and cold bags can be subdivided in to The isothermal boxes The cold box The vaccine carrier The isothermal bag In each category we find many models that must satisfy certain well-defined requirements like cold life and others (weight, price, strength, color, size...) Isothermal boxes They are used by producers to ship their vaccines around the world. In the case of large-scale vaccination programs, they must conform to certain standards. Generally they consist of a polystyrene box inserted in a cardboard box for transport of large quantities of vaccines in favorable circumstances (e.g. in an airplane). They have a very limited cold life (often with a maximum of 4 days). Avoid unfavorable conditions (long delay at customs, long transit, shocks) or inform the transporting agency to take measures. Make sure the shipment is stored properly in the cold store at the airport of arrival (or transit). Cold boxes These will be used in the distribution of the vaccines inside the country. There are many models, from the picnic style box to the luxury type. The Electrolux RCW 25 (see picture on page 32) is the MSF standard, and by far the best there is. Vaccine carriers Cold Chain guideline 2002 FSU-MSF 27

28 These are small cold boxes used to keep the vaccine cold for short transport, or to store vaccines temporary just before use in a campaign (to prevent frequent openings of the cold box). There are many types. The MSF standard is the Thermos Note: the ice-packs for the RCW25 Cold box do not fit in the Thermos vaccine carrier! Isothermal bags These are used by MSF to transport small quantities of vaccines and/or to temporary store pre-filled syringes. Take care that the vaccines are not in direct contact with the ice pack. The properties Let s have a look at some requirements we just mentioned. Cold life This refers to the number of hours the temperature inside the box stays below +8º C. This depends on the ambient temperature, the number of times the box is opened and for how long, the number and temperature of the ice packs used, but also on the quality of the box, how well it closes and insulates. Other requirements Don t forget the weight of the empty box and the ice packs in case you would have to carry it by foot or by donkey. Whenever possible don t put the box in the sun, of course. Cold Chain guideline 2002 FSU-MSF 28

29 All these criteria must be considered when selecting a cold box. How to choose a cold box? Vaccine Specifics transport Device Cold box Electrolux RCW 25 Vaccine carrier Thermos Ice packs (0.6 L) set of ice packs (0.6 L) provided weight: 17.5 kg 4 ice packs (0.3 L) provided weight: 1.8 kg only for RCW25 Volume/storage capacity Vaccine storage period = Holdover time * Price level 22 L 156 hrs $ L 33 hrs $ 25 $ 30 * Without opening, ambient temp. 43 C Cold Chain guideline 2002 FSU-MSF 29

30 Filling the cold box FIRST POSSIBILITY Some vaccines will be irreversibly damaged when frozen (DTP, DT, Td, TT, Hep A and Hep B, Hib) a) Put the ice packs out in the air (never in the sun) until their temperature reaches 0 ºC, which is no longer dangerous for the above mentioned vaccines. How do you know when they have reached 0 ºC: If the ice pack has a temperature indicator, it must change from yellow (danger) to red. When this happens, don t wait any longer. When the ice pack has no temperature indicator, wait until the frost on the surface (and only the frost) melts. You can recognize this by the moist or droplets that appear on the surface of the ice pack. b) Line the cold box with ice packs. c) Put a LCD thermometer inside. d) Place the vaccines which may be frozen (Measles, Polio, Yellow fever, ect.) at the bottom. This is the coldest part of this type of cold box because the cold air accumulates at the bottom. Cold Chain guideline 2002 FSU-MSF 30

31 e) Make sure that any remaining space is filled with packing material to avoid damage on transport. Let Icepacks reach 0 ºC before using them in the cold box SECOND Avoid POSSIBILITY freeze sensitive vaccines to touch the icepacks SECOND POSSIBILITY Put vaccines that may be frozen at the bottom If all vaccines to be shipped in the cold box may be frozen (Measles, Polio, Yellow fever, Meningitis, etcetera), do not wait, but proceed with packing directly. The solvents that come with some of these vaccines can be transported in the same cold box; they will not freeze or be damaged. Arrival Check the temperature of the cold box directly on arrival. Take care to read the LCD thermometer very quickly after the opening of the box, as it rises very quickly due to the contact with the ambient temperature. When the temperature reading is O.K., put the vaccines directly in the fridge (remember: earliest expiry date first out!) or store the cold box in the coolest place, depending on the local conditions. Return If you return by airplane, you could empty the ice packs to lower the weight. Return the box with the same number of ice packs and the thermometer it was sent with. If you have more cold boxes, it is recommended to number them (and even the ice packs), but especially to make the people who will transport and receive the boxes aware of their responsibility. Maintenance When putting away the cold box or vaccine carrier for some time, clean it with water and soap and dry it thoroughly afterwards. Cold Chain guideline 2002 FSU-MSF 31

32 Check proper closing and check if the seal is intact periodically. Transport conditions Obviously the time of transport must be considerably less than the cold life of the cold box. The quality of modern cold boxes is general sufficient for this. Unexpected events such as technical breakdowns, human error or carelessness often cause delay. It is therefore necessary: not to compromise on the number of ice packs (which you may want to do because the distance is short, for instance). to place your cold box in the vehicle as follows: - In the shadow (black out car windows, cover with canvas or something in open boat or pickup), - away from warm spots to tie the box down firmly. Be sure of your means of transport: preventive maintenance is key here! Take extra care of reliability and maintenance when you would have to rent vehicles. Be sure of your transport agent, especially if this is a private person or firm don t forget to explain him how sensitive your material is, involve him in your problem. Make sure that the information on the arrival of the vaccines has been received at the other end. Cold Chain guideline 2002 FSU-MSF 32

33 Use this sticker or the tape if you send cold item with a third party! Storage Storage at different levels Vaccine storage temperatures are different depending on the stage of the cold chain. In order to guarantee potent vaccines up to the end of the expiry date, follow this table: Vaccine oral polio central storage with electricity: up to 6 months deep frozen (-15 C) regional storage with electricity: up to 3 months district and health center storage: up to 1 month yellow fever measles meningitis BCG IPV DTP Hep A and B Hib frozen or 2-8 C 2-8 C Cold Chain guideline 2002 FSU-MSF 33

34 Refrigerating and freezing Vaccines stay in good condition in a refrigerator (or freezer when applicable) provided that the refrigerator is correctly loaded and used ; the temperature is checked and found O.K. twice a day the refrigerator and/or freezer are defrosted regularly. Check out the do s and don ts for fridges in Annex 8.1. When things go wrong There is a safety margin, so don t throw away your vaccines when the temperature has been out of range: for a fridge lower than 2 but not lower than 0 C or higher than 8 but not higher than 12 C for maximum one week. For a freezer holding oral polio: higher than -15 C but lower than 5 C for maximum one week. When in doubt or when the cold chain was broken for a longer period and/or at higher temperatures, consult your technical/medical dept, or local UNICEF expert. Cold Chain guideline 2002 FSU-MSF 34

35 How to choose a fridge or freezer? For EPI project components you should adapt the existing cold chain materials; for campaign components, the following table applies: Model Refrig/freezer Vestfrost MK/MF 4010 (=MKMF074 ) chest type Refrig/freezer Sibir V170 EG cabinet type Refrig/freezer Sibir V170 EK cabinet type Refrigerator Vestfrost MK 114 chest type Refrigerator Vestfrost MK 204 chest type Refrigerator Vestfrost MK 304 chest type Power supply AC* min. req. 8 hrs per 24hrs EG* EK* AC min. req. 8 hrs per 24hrs AC min. req. 8 hrs per 24hrs AC min. req. 8 hrs per 24hrs Storage capacity 10 dose vials 40 L (fridge only) 55 L (fridge only) 55 L (fridge only) Ice produced (amb. = 43 C) per 24 hrs 10 Kg (only with AC 24 hrs/day) 3.6 Kg 3 hrs 2.8 Kg 3 hrs 72 L n.a. 34 hrs 120 L n.a. 34 hrs 190 L n.a. 36 hrs holdover time during power cut (amb. = 43 C) 40 hrs Cold Chain guideline 2002 FSU-MSF 35

36 Freezer Vestfrost MF 114 chest type AC min. req. 8 hrs per 24hrs 111 L 17 Kg (only with AC 24 hrs/day) 13 hrs Freezer Vestfrost MF 214 chest type AC min. req. 8 hrs per 24hrs 192 L 22 Kg (only with AC 24 hrs/day) 16 hrs Freezer Vestfrost MF 314 chest type AC min. req. 8 hrs per 24hrs 264 L 32 Kg (only with AC 24 hrs/day) 18 hrs * AC = alternating current 220 V/ 50 Hz EK = electricity or kerosene EG = electricity or gas Note: If the AC supply is of very poor quality (average voltage below 190 Volts, frequent power cuts or high voltage spikes), install a voltage regulator with time-delay in the electricity supply. Operation and maintenance of absorption fridges General The absorption fridge is an old design, but an accurately made piece of equipment. As there have been people injured and even killed by a fridge catching fire, local purchase of this type of a fridge is restricted to a Sibir or an Electrolux. Absorption refrigerators use a heat source to function: this can be produced by kerosene, gas or electricity. The ones on kerosene are known for their problems: they need constant attention. Unfortunately they are the most widespread type in the bush because kerosene is available almost everywhere (lamps, burners...) Cold Chain guideline 2002 FSU-MSF 36

37 Absorption refrigerators on gas are very reliable but gas is sometimes hard to come by, forbidden to transport by airplane, rare delivery in isolated areas, higher demand than supply... You should always have one or more bottles extra, with a minimum of three in circulation. Gas refrigerator => More reliable and less maintenance Gas => Transport and availability problem An absorption fridge can be used on electricity as well, but this should only be used as an exception as the cooling system is very inefficient compared to the normal electrical fridge. An absorption fridge should be leveled for proper functioning! Some fridges will have an internal leveling devise like this one: An absorption fridge needs good ventilation: not too much (avoid draft) and not too little (keep a minimum distance from the wall of 20 cm). Cold Chain guideline 2002 FSU-MSF 37

38 Kerosene Fuel There are several qualities of kerosene: Lamp kerosene (kerosene oil in British, kerosene in American, petrole in French). The best kind is airplane kerosene (jet-a-1) because it has no impurities, unlike lamp oil that often contains water. To prevent problems, the best quality kerosene should be used. Filter it anyways with tightly woven cloth. If you have water in the kerosene, it can be filtered out through a chamois (a very slow process though!). Be careful when using barrels: water will accumulate on the bottom: always take fuel at least 10 cm above this level; filter the remaining fuel through a good filter before use (or use it in lamps). Never use petrol (gasoline) or diesel (gas oil). Cold Chain guideline 2002 FSU-MSF 38

39 The use 1. Light the burner with a match, after (depending on the model) having taken out the reservoir, moved the tightening ring over the burner upwards. Take care: the glass is very fragile. 2. Having replaced everything, make sure glass and chimney are tightly connected, as functioning will be impaired otherwise. 3. Regulating the temperature is done by regulating the height of the flame, to be done in successive stages. Cold Chain guideline 2002 FSU-MSF 39

40 There are two main types of burner: -Burner with cylindrical wick: flame must be blue without yellow spikes. This is often very difficult to achieve, just try to get the flame as blue as possible; the more yellow you see the more soot is produced and the more frequently you have to clean the flue. - Burner with flat wick (Kosmos 8), flame must be yellow without smoke, the higher the flame (without smoke or yellow sparks), the lower the inside temperature. Regulation Contrary to gas refrigerators, kerosene refrigerators are not regulated by thermostat, that is, they are even more sensitive to temperature variations such as between day and night, summer and winter. When the cold season approaches the flame is put lower. Cold Chain guideline 2002 FSU-MSF 40

41 In a project where day and night temperatures differ greatly, set the temperature near the maximum (+ 8 C) to avoid freezing of vaccines during the night, a problem you should not underestimate. Maintenance (on kerosene) Check (and correct if needed) the flame twice a day (when checking the temperature) Clean the flue and baffle each time you fill the tank (every week); prevent soot falling down on the tank: put a cloth underneath! baffle Cold Chain guideline 2002 FSU-MSF 41

42 baffle wire condenser fins extension clean the dust from the condenser fins every month flue trim the wick when you cannot get a blue flame anymore (for the blue flame types); renew the wick when needed clean the tank and burner completely once a year Wicks and glasses A wick normally lasts 2 months and a glass little longer if no precautions are taken (waiting 10 minutes after switching fridge off before lifting the glass). So you need at least two spare glasses and several wicks. After you replaced a wick, allow it to soak in the kerosene for at least 15 minutes before lighting it. Cold Chain guideline 2002 FSU-MSF 42

43 Gas Absorption fridges on gas are the most reliable because of their heat source gas under pressure is a more stable heat source than kerosene. Remarks about gas: - this is often a mixture of butane and propane and comes usually in 27 kilo steel bottles with a 13 kg gas content. - pressurized gas can present a safety risk. Often, gas fridges are placed in centers where there are a lot of children. Make sure that no gas can escape: check connections, hoses and gaskets regularly. Allow for a good ventilation around gas bottles and fridges. Do not smoke near gas fridges. If gas escapes, don't panic: close off the source and ventilate the room. Gas can only explode when it is highly concentrated. Maintenance (on gas) clean the dust from the condenser fins every month Winterization Of The Cold Chain Or how to treat your cold chain when ambient temperature drops below zero. Introduction The necessity of a cold chain in winter is obvious: to prevent vaccines from getting spoiled i.e. frozen! You ll 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. Vaccines The safe temperature range to store all vaccines is between 2 and 8 C. This is valid during summer and winter. In summer the problem of keeping Cold Chain guideline 2002 FSU-MSF 43

44 especially Oral Polio Vaccine cold enough is bugging you, while in winter to guard DPT, DT,TT, Hib, Hep A and Hep B from freezing will be your main concern. Refrigerators Thermostat(s) control the inside temperature of the fridge. When ambient temperature goes up, the thermostat has to be adjusted to a higher setting to prevent the inside of the fridge to become too warm. When the ambient temperature drops, you must adjust the thermostat to a lower setting. When you fail to do this, the temperature in the fridge may become dangerously low; even below 0 C: DPT, DT,TT, Hib, Hep A and Hep B vaccines will be spoiled when this happens. When the temperature inside the fridge is lower than 2 C and you cannot adjust the thermostat to a lower setting because it is already on Minimum, it is better to switch off the refrigerator. From then on you must keep a close watch on the temperature inside the fridge and switch it on as soon as the inside temperature starts to rise above 8 C. IN FACT YOU ARE NOW PLAYING THE ROLE OF THE THERMOSTAT. This extra work is only acceptable for a short period of time. When the ambient temperature is very low for a long time, e.g. lower than 10 C, it is better to take the DT, DPT, TT, Td (=diphtheria tetanus booster for adults) and HEP B out of the fridge and put them in a cold box and keep the box 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 temperature inside your health facility will drop below zero, you should put the cold-box in a safe room where it never freezes, for example a basement. You ll have to fill all empty space in the cold box with unfrozen icepacks to prevent the inside temperature from changing too quickly. Put a thermometer inside and take readings every day. Leave BCG and Measles in the main compartment of your still switched on refrigerator and keep OPV in the freezer (compartment). Cold Chain guideline 2002 FSU-MSF 44

45 When the ambient temperature rises above 15 C you should bring the vaccines from the cold box back to the refrigerator. The accompanying temperature monitor card should be filled out correctly. Power Cuts In wintertime electricity supply is often bad, power outages may occur and continue for hours up to several days. With a power outage the inside temperature of the refrigerator will rise slowly. When you have an ice lined refrigerator or many frozen icepacks in the freezing compartment, the inside temperature will almost remain constant as long as the water in the icepacks is frozen. ONLY WHEN ALL THE ICE IN THE ICEPACKS IS MELTED, THE INSIDE TEMPERATURE OF YOUR REFRIGERATOR WILL RISE QUICKLY! Therefore fill all empty space in the freezer with icepacks or make sure that the ice lining is complete. In addition you have to put plastic bottles with water in the main compartment or at the bottom of the fridge to increase your cold mass. It goes without saying that it is even more important not to open the fridge door 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 inside fridge temperature instantly with an adjustment of the thermostat. You should read from your temperature monitor chart over several days if the average inside temperature is too high or too low, and adjust your thermostat accordingly. Be very conservative when adjusting your refrigerator. Do not yank the thermostat to a higher level (colder) in an otherwise well functioning fridge when you put a fresh batch of vaccines in, you ll run the risk of freezing them. Keep a very close eye on the inside temperature during power outages. When the temperature becomes too high, even while you took all the necessary Cold Chain guideline 2002 FSU-MSF 45

46 precautions, prepare to move your vaccines to a refrigerator in an area where they do have electrical power. With icepacks from that fridge/freezer, you can transport your vaccines to the working fridge. Take care of a good registration of the type and number of doses of vaccines you are bringing to your neighbours fridge. For the cold countries, Vestfrost builds an ice-lined refrigerator/freezer (type: MK/MF074 =4010) with a heating element inside to prevent the inners of the fridge to freeze. This internal thermostate has a knob that has numbers 1 to 7 on it. To the contrary of what you might expect, you have to turn the knob of the inner thermostat point at a LOWER number to make the fridge COLDER. To make the fridge WARMER turn the knob to a HIGHER number. As you may understand, some extensive fiddling with both thermostats is necessary to get (and keep) the inners of the fridge at the right temperature. Follow the manufacturers instructions. How to assess a cold chain For a start, it goes without saying that you have to check the procedures and their implementation To have an idea of the functioning of a cold chain, you can use the following tools: the vaccine cold chain monitor card; an electronic data logger like the tiny TTM. The vaccine cold chain monitor card: send it either alone (in a small box with the sticker: vaccines, keep cold ) or accompanying vaccines from the starting point to the lowest distribution or storage level. Even without filling out the card, it gives you the end result: no blue windows should appear when everything goes according to the cold rules. If one or more windows are blue, you will have to do a more detailed check on that part of the cold chain. Cold Chain guideline 2002 FSU-MSF 46

47 The electronic data logger is sent in the same way as the monitor card. It will give you more detailed information on when (and from when you will know where!) possible problems in the cold chain occurred. Cold room A cold store is a place where a large cold storage space is available; it can consist of a number of fridges and freezers in one place. As the fridges and freezers produce heat at the condenser, the room has to be kept relatively cool and should be air-conditioned in a hot or tropical climate. A cold room is a room where the temperature is controlled between 2 and 8ºC, it is a huge fridge in fact. Next to this cold room, there will be a smaller room for the freezers. A cold room should have a recording thermometer. The large amount of vaccines a cold store or room contains makes a back-up generator a must (in case of a power failure). Most cold stores and/or rooms are run by the MOH in the (provincial) capital. How to assess a Cold store or cold room Checklist: Are the tasks clearly defined (who is responsible for the servicing of the generator and cooling equipment, who is responsible for opening the cold room/store, who for giving out vaccines)? Are the vaccines properly stored? Are the vaccines properly dispatched (First expiry First out)? Are temperature records kept (from the recording thermometer)? Is the emergency generator well serviced and operational? Cold Chain guideline 2002 FSU-MSF 47

48 5. Temperature surveillance Temperature surveillance is indispensable for the evaluation of vaccine validity. Temperature must be checked at all stages of the cold chain, e.g. during transport and storage. Temperature surveillance demands rigorous organization and strict planning on the part of the cold chain personnel. The tools The thermometer The stop watch card The cold chain monitor card The VVM The freeze indicator The above-mentioned tools can be subdivided into two groups: 1. The tools that measure the temperature on the spot; readings still have to be interpreted; 2. The tools that accumulate temperature data and indicate an end result Group 1: tools that measure the temperature on the spot The thermometer Different types are used like the LCD type, the glass type and the min-max type It must indicate the temperature of the vaccine or of the air right next to it: - The thermometer must be as close as possible to the vaccines. - The temperature must be measured after a stabilization period between the temperature of the vaccines and that of the air around them (some 20 minutes). Cold Chain guideline 2002 FSU-MSF 48

49 Thermometer in the door If possible, read the temperature while you have to open the door anyhow to get or put back your vaccines. Temperature registers Don't forget that a temperature reading (except for the min-max type) only applies to a given moment. You cannot draw conclusions about vaccine validity and the state of the cold chain from a single reading. Hence you must keep a temperature register (Logadmin kit form 4S) with twice daily measurements (morning and evening) in order to be able to react and act immediately if the temperature increases or decreases abnormally. It is on the basis of this register that you will be able to detect malfunctions that may necessitate adjustment of the equipment, or repairs. This person must of course have been trained and motivated to fill out the form, interpret and take action when needed. Experience shows that even with trained and motivated staff the temperature data recorded are not too reliable. A better tool for monitoring the cold in your fridge is the so-called Stopwatch card. The LCD thermometer will be mainly used for cold boxes in transit; it reacts very quickly when taken out of the cold to read. Cold Chain guideline 2002 FSU-MSF 49

50 The LCD thermometer The min-max thermometer is in-between the two groups of temperature surveillance tools: it does record the temperature over time. That is to say only the minimum and the maximum. It does not register how long these temperatures did exist however. The minimum reading gives enough information to act if need be; the maximum reading does not as you do not know how long the high temperature expose did last. Reset the min-max thermometer every time you write down its readings. Group 2. The tools that accumulate temperature data and indicate an end result Stop watch card The Stopwatch card indicates the temperature in the fridge outside of the recommended range (so under 0 C and over 8 C) over time. It consists of a MonitorMark indicator that turns irreversibly blue from the left to the right when exposed for a certain time to heat above 8 C. It reacts exactly like a vaccine reacts to heat: the vaccine looses potency which you cannot see, but the card shows the heat/time expose by turning blue; for a limited exposure only the A window turns blue, progressing to the C window. The D mark indicates a high temperature exposure only, not related to the time of exposure. Cold Chain guideline 2002 FSU-MSF 50

51 Besides the heat exposure indicator, it also holds a freeze indicator, registering dangerously low temperatures. The freeze indicator has been specially designed for the protection of the adsorbed vaccines that once being frozen- loose their effectiveness and possibly creating abscesses when used. Check the Stopwatch card every day. If a window has turned completely blue, note on the back of the card the date and the window concerned (e.g. A, B or C). Take appropriate corrective action if needed. If the freeze watch has burst and spilled its ink on the blotting paper the adsorbed vaccines might have been damaged; check them with the shake test if needed. Replace the Stopwatch card once a year. The cold chain monitor card The cold chain monitor card consists (just like the one on the stop watch card) of a MonitorMark indicator that turn irreversibly blue from the left to the right when exposed for a certain time to heat above 8 C. It reacts exactly like a vaccine reacts to heat: the vaccine loses potency which you cannot see, but the card shows the heat/time expose by turning blue; for a limited exposure only the A window turns blue, progressing to the C window. The D mark indicates exposure to a high temperature for a limited period of two hours. The monitor card is used to register/record and detects all heat damage to the vaccines. Its function: - It indicates the validity of the vaccines. - It registers how well the cold chain functions (from the beginning to end). A monitor card is only a reliable indicator for the potency of a vaccine if it has accompanied the vaccine from its point of origin: a monitor card should be activated at the factory. A monitor card is (or at least should be) sent from the factory with every batch of 3,000 doses. Cold Chain guideline 2002 FSU-MSF 51

52 When the vaccines arrive from the factory in the central cold store, they will be distributed to regional cold stores and further on to district cold stores. So a batch of 3000 doses of vaccines that came with one monitor card, will be split up in small shipments, and maybe only one dose out of 20 will end up in the field locations accompanied by a monitor card. Adding monitor cards in a later stage of the cold chain is tricky, as the history of the vaccines from the factory to the point of addition of the card is not taken into account. The monitor card must be filled out at every transport: on dispatch and on arrival at the next location. Even with extensive training, the monitor card remains difficult to fill out, interpret and take action when needed. They are expensive as well (approx. 2.5US$/pc) For more information and/or training modules, refer to your support department. The monitor card enables you to find out at which point along the cold chain mistakes have been made, and to correct them. Cold Chain guideline 2002 FSU-MSF 52

53 If the monitor card indicates (after several heat excesses) that the vaccines must be tested, first consult a vaccination or cold chain specialist. In the meantime, keep your vaccines cold. - If you have only a few doses, you must throw them away. - If a large quantity (> doses) is concerned, label the vaccines and return them (through the cold chain) to the producer. Conclusions There are many publications about the monitor card. Still, a lot of people don't quite understand how it works. It will be replaced little by little by the VVM (see below). Vaccine vial monitor A vaccine vial monitor (VVM) is a label made of heat sensitive material, which is placed on a vaccine vial to register cumulative heat exposure over time. The combined effects of time and temperature cause the monitor to change color, gradually and irreversibly. A direct relationship exists between the rate of color change and temperature: The lower the temperature, the slower the color change, The higher the temperature, the faster the color 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 a product label or attached to the cap of the vaccine vial. The inner square is made of heat sensitive material, which is light at the starting point and becomes darker with exposure to heat. The discard point is reached when the color of the inner square matches or is darker than the outer circle. To date the vaccine vial monitor is only used with OPV (oral polio vaccine), planning is to have VVMs on Measles and DTP in the near future. Cold Chain guideline 2002 FSU-MSF 53

54 The VVM or Vaccine Vial Monitor says The square is lighter than the circle. If the expiry date is not passed, use the vaccine! The square is lighter than the circle. If the expiry date is not passed, use the vaccine! The square matches the circle. Discard the vaccine! The square is darker than the circle. Discard the vaccine! The freeze indicator Contrary to MonitorMark indicator they register dangerous low temperatures. They have been specially designed for the protection of adsorbed vaccines. It is a small ampoule, filled with dark blue liquid, which breaks when it is being frozen (below 0 C for more than one hour). The liquid spreads on a blotting paper and irreversible indicates that the temperature inside the fridge has been below 0 C (dark blue color). Note that the old version of the freeze watch had red colored ink only freezing at 4.5 C. Cold Chain guideline 2002 FSU-MSF 54

55 They too should be as close as possible to the vaccine in question to be a perfect witness of its possible freezing. During transportation and storage, they may be inserted into the boxes containing the vaccines. What are the main causes of freezing? Direct contact between the vaccines and the ice packs in the cold box. Bad adjustment of the refrigerator (during cold night for example). Cold Chain guideline 2002 FSU-MSF 55

56 6. In practice EPI As EPI requires a long-term approach, the only MSF action in EPI will consist of support to an EPI program run by another body. Seek advice from your support department and medco for more information. Immunization campaign: the preparation Campaign Committee When MSF is asked by the MOH to assist fighting an epidemic, a committee will be created for the organization of the vaccination campaign; involving national Ministry of Health, UNICEF, health agencies, local EPI representatives and community leaders to organize the plan of action and to divide the different tasks. The national EPI (Expanded Program of Immunization) of the country should be involved from the beginning. Estimation of the target population size - Determine the age group for vaccination. Campaigns should be targeted to age groups identified through analysis of epidemiological data on disease cases and should include all children in these age groups, irrespective of previous immunizations. - Calculate, if possible, the number of people to be immunized for each village, town district or camp section. The population between 6 and 59 months: about 16 % of the population, the population between 6 months and 15 years: about 35 to 45 % of the population - If age determination proves to be difficult, remember that children < 100 cm in height can be considered < 60 months old. Determine the geographic area in which to vaccinate. Cold Chain guideline 2002 FSU-MSF 56

57 - Review the map where the disease cases have been reported. - Mark the location of hospitals, health centers, reception areas for new arrivals and other gathering places (churches, mosques, markets, school etc.). - Identify the routes for access to vaccination sites and calculate the distance and travel times between various destinations. Define the immunization strategy To be efficient, a mass immunisation campaign must be carried out as early and as quickly as possible during the course of the outbreak. Criteria to launch a mass immunisation campaign Thresholds and delays If delayed (i.e. 5 weeks after the epidemic threshold has been crossed), an immunisation campaign has a limited impact. Still, despite lower results at this stage, a large number of cases can be avoided in densely populated areas. Constraints Expected delays before implementation. The optimal duration to prepare an emergency vaccination campaign ranges from 1 to 2 weeks. Expected rainy season The spread of meningitis tends to stop as soon as the rains start. This can have a major effect on the epidemic and thus on the vaccination campaign. Other constraints Accessibility (transport and road networks, required time to reach specific places, etc.) and particular events that can affect the impact of a vaccination campaign: holidays, religious events, elections, etc. Target population The age group with the highest age specific attack rate will be the target of the vaccination campaign. The disease specific default age group is suggested in the VVC calculation sheet on the diskette. Cold Chain guideline 2002 FSU-MSF 57

58 In some circumstances, it may be difficult to exclude persons outside of the specified age group. The decision will take into consideration country's financial constraints, available stocks of vaccines and current policy. The objective of a campaign is 100% coverage of the target population. Priorities Urban and rural zones are to be studied separately. Areas of high population density and population gathering represent a higher risk of transmission. Vaccination will be first organised in cities or camps of 8,000 inhabitants or more, as the risk of transmission is 2 to 4 times higher when population is larger. Places where the threshold has been crossed most recently will have priority. Where to start? Start vaccination in densely populated area s like camps or urban settings: it will result in a high coverage in a short period. In urban settings, a mass immunisation campaign is the best approach. High and quick coverage rates can be obtained, since access is easy and logistic is simple. Fixed or mobile? Maintain one or several fixed centres (according to the town size) for 8 to 10 days, for further vaccination; this aims at reaching persons who might have been absent during the campaign. Do not forget vaccination in other gathering areas, such as hospitals, schools, jails, military barracks, pilgrimage areas. In rural areas, the strategy might differ and combine several approaches. Mobile vaccination teams: when villages are scattered, it is wiser to avoid any population gathering in order to limit the transmission risk. The mobile teams go from place to place which will require extensive logistical resources. Start in the village/area where cases have been first declared, in order to avoid panic reactions with needless population movements. Cold Chain guideline 2002 FSU-MSF 58

59 Register or not? Using a vaccination card for each person requires a larger team: for 1 vaccinator at least 2 additional persons are needed for registration. This can slow down the speed of the operation. You should only use vaccination cards when there is a clear plan for research or evaluation based on the data on the card. Giving a vaccination card with only a MSF stamp (specifying the vaccination!) can be helpful to motivate people to be vaccinated. You should always keep a record of the number of persons vaccinated per age group using a Tally sheet (see annex 8.8) Resources needed Needs evaluation process - Do an assessment of MOH capacity for material resources such as vaccines, vaccination material, cold chain equipment and transport/fuel, personnel and salaries/per Diem, - Investigate if other agencies are present to support MOH (UNICEF etc.), - Investigate locally available transport resources (e.g. vehicles to be rented), - Do an inventory of MSF materials available in the field. MSF should consider supplying vaccine, cold chain material, transport, incentive for national staff, etc. when MOH and Unicef are not able to provide sufficient resources. Vaccine needs Calculation of vaccine needs: - Obtain the figures for the target population size - Set an immunization coverage figure as a goal. If not stated otherwise, the aim should be to reach 100 % of the target population. - Correct the calculation during the campaign if the actual population figures differ from the official ones. - Estimate the vaccine wastage. In an immunization campaign, a loss of 15% can be expected. In other words, 85 % of the vaccines will effectively be used. -To immunize 85 people, 100 doses should be available; Cold Chain guideline 2002 FSU-MSF 59

60 -to immunize 100 people, 117 doses should be available. So for every vaccine to be administered, 1.17 doses should be ordered - On top of this, add 25 % for the reserve stock. For example (a measles vaccination) -Total population people -Target population 6 months to 15 years (x 0.45) people -Coverage aims 100 % (x 1) people -Number of doses to give (x 1) doses -No. of doses including wastage (x 1.17) doses -No. of doses including reserve (x 1.25) doses In an epidemic situation, all the vaccines will be required at the same time. An order would therefore be made for doses, which are vials of 10 doses each. The VVC (Vaccine Volume Caluculator on the diskette) does the calculation for you! Always order vaccines in number of doses and mention the preferred vial size. Because of market constraints, you will sometimes recieve different vial sizes. Where should vaccines be ordered? - Vaccines can either be obtained locally through UNICEF or the MOH. Do check their cold storage conditions and the vaccines origin. - The MSF procurement department; they will make an urgent order to the manufacturer. Equipment needs Injection material: Single use equipment: one auto-disable syringe for each injection + 10%. The vaccines that need to be reconsituted need an additional 10 ml syringe and 18 g needle for every vial: # of vials to be reconstituted + 10% Advantage of single use equipment: - No time lost with sterilizing equipment - No risk of cross infection - Easy to use Cold Chain guideline 2002 FSU-MSF 60

61 Disadvantage: - Appropriate disposal of used material must be ensured, and will be a challenge, considering the (daily) volume. - The equipment occupies a lot of storage space. - High cost The preferred choice of single-use material calls for a very well organized system for the appropriate disposal of syringes and needles. For more information read the part on waste management (page 70). The use of a Jet Injector like IM-O-JET or Pedo-Jet is not recommended. The risk of transmission of blood-borne viruses, such as Hepatitis-B and HIV, cannot totally be ruled out. A new type of needless jet injector is in the making, which does not have the disadvantage of blood-borne transmission. Cold chain supplies A basic immunization kit has been developed by MSF for epidemics. Each kit contains material for vaccinating 10,000 people with 5 teams (see the MSF Guide of Kits). This kit is composed of cold chain and logistic equipment and contains disposable and reusable material. - The kit allows for the immunization of 10,000 people, by 5 teams, depending on the situation: fixed sites and or mobile teams - Only disposable material is used. - It enables rapid installation of a cold chain and/or reinforcement of existing structures - The immunization kit does not include vaccines, nor fuel for the generator. - Calculations need to be made for requested storage capacity. Calculating cold storage space requirements Rules of thumb: The amount of cold chain space required for e.g doses of OPV (oral polio vaccine) is 1 (one) liter. Every 500 doses of other vaccines requires 1 liter of storage space (excluding the diluent if applicable; 500 doses diluent take up 1 liter). Cold Chain guideline 2002 FSU-MSF 61

62 Calculating Ice Pack and freezing requirements Number of ice packs needed = number of vaccination sites x {the number of ice packs in the cold box + (number of ice packs used on the table x number of vaccinators per site)}, see annex The number of ice packs will be adjusted after the first day, depending on ambient temperature. The average ice pack holds 0.6 L of water. Check the available freezing capacity (indicated in no of Kg/24 hours). There is often a shortage of freezing capacity. Check out all details of freezers in chapter 4. Note: temporary arrangements, such as the use of commercial freeze/cold rooms for vaccine storage or ice making, must be made in those areas with insufficient refrigerator or freezer space. Practical tips Refrigerators must be turned on 24 to 48 hours before receiving the vaccines (to reach 2 to 8 C). Order twice the required number of ice packs, to allow for turnover. Start to freeze them several days in advance. Ice production is one of the big problems in immunization campaigns. Local businesses may be able to assist (butcher, ice cream manufacturers, fish wholesaler). To make sure diluent and vaccine have matching temperatures, prepare your vaccines + diluents the night before the vaccination day and store them with ice packs in the RCW 25 cold box. Thus diluents and vaccines will have the same temperature the next morning when you begin vaccinating. Safe injections To limit the risk of infections and cross infections you should: Always use auto-disable syringes. Never re-cap the needle after injection: dispose in a safe container directly. Always use good quality vaccines: adhere to the opened vial policy and respect the time limit for using reconstituted vaccines. Always transport and store vaccines and diluents in a safe and clean manner. Always supply latex gloves for the vaccinators Always supply heavy duty leather gloves for the ones handling waste Cold Chain guideline 2002 FSU-MSF 62

63 Immunization records If you would decide to use vaccination cards, make sure they are printed/ copied before the campaign starts. All daily records to be compiled into weekly statistics. Weekly compilation of immunization records. Staff needs National staff Various staff from the health sector can work in an immunization campaign. Teachers can be very helpful with organizing the registration. Structure and functions of an immunization team: Role Qualifications Number Tasks needed of staff Supervisor Health professional 1 Supervision of the team, training, etc. Recorder Literacy (e.g. teacher) 5 Registration of immunization cards Vaccinator Nurse/ Health worker 2 Cleans skin with water and Vaccinates Assistant Vaccinator Health worker 4 Preparation of vaccines and syringes Recorder Literate person 2 Recording of data / tally sheets Guard Community member 4-6 Maintain order, crowd control, information to the community, outreach during the campaign Logistician /Driver Mechanic, driver 1 Transport of team and material, cold chain, food supplies. * Staff should be specifically trained or have refresher training before the start of the campaign. * A job description should be given to each member. Cold Chain guideline 2002 FSU-MSF 63

64 * Practice run should be done before the campaign, involving the entire team and all equipment supplies. * Daily rates of pay will need to be set before the campaign, depending on the country and the situation. Cold Chain guideline 2002 FSU-MSF 64

65 International (expat) staff The need for international staff is determined by the following factors: - Workload of the international team (already) present. - Size of the target population - Extension and severity of the outbreak - Functioning and capacity of the existing health system If necessary, the existing team can be increased with a number of medical staff for organization/supervision of the treatment facilities and/or the immunization campaign. In addition, extra logistical staff is often required for the organization/ set up of facilities/vaccination points and establishment/maintenance of cold chain For the international staff, job descriptions should be made before the campaign. Budget With the calculation of the information given for the resources needed, a proposal should be written with clear objectives and activities. A budget needs to be calculated which should include: - Cost of staff (national/ international) - Cost of medical material (vaccine, equipment, cold chain) kit - Cost of logistic equipment (ropes, plastic etc.) - Cost of administrative material (vaccination cards, tally sheets, education material) - Cost of food for staff - Cost of communication equipment - Cost of transport, fuel Cold Chain guideline 2002 FSU-MSF 65

66 Organization of the campaign Logistic organization Overall planning and organization of a mass immunization campaign has to be a concerted action of logistics and medical staff. You ll have to discuss: - Preparation of the vaccination sites. - Material needs - Cold chain organization and monitoring - Storage capacity and stock management - Organization of staff and payment - Planning of transport (vehicles, drivers, fuel) - Waste disposal system - Budget control Duration The campaign needs to be conducted as quickly as possible, in order to minimize disease spreading. The organization will depend on what (extra) activities will be carried out (EPI, MUAC, Gentian Violet marking). Using auto-disable syringes prepared in advance by two assistants, one health worker can vaccinate about 175 people/hour or 1200 people a day. Location Depending on the context (rural area, urban area, or refugee camp), the vaccination team may use health centers, schools, churches, places of worship or even the shade of a tree to carry out immunization sessions. * The vaccination site must be accessible for all. * The waiting area should be spacious, in line and under shade. * The area actually needed for the immunization session needs to be clearly sealed off (as with rope if in an open area). * Two separate pass ways or doors (entry and exit) are essential to avoid confusion. * The area where the assistants fill the syringes should be relatively quiet but still accessible for the vaccinators. * Choose the immunization sites near to densely populated areas. Cold Chain guideline 2002 FSU-MSF 66

67 Organization of the site In this emergency setting, each staff member has a specific role to play in both the organization and function of the immunization site. Schematic drawing of an immunization site set-up a 4 4 4a meters 1 and 2 1. Triage zone, age check 4a.Syringe preparation posts 2. Information about immunization 5. Recording posts: Tallying (and cards) 3. Preparation of immunization cards 6. Vitamin A distribution and/or 4. Vaccination posts Gentian Violet marking 7. Supply area The area must be cordoned off when located in an open area. Use rope to mark the different zones within the site (children with mothers, men, boys) Queues must be well organized, with only one person entering the vaccination site at a time Cold Chain guideline 2002 FSU-MSF 67

68 Organization of immunization sessions Area Location Equipment Personnel Tasks Waiting Spacious & under Awning for shade Community Maintain order shade: like a school, church Drinking water, Latrines volunteers Triage After waiting area Rope, poles, boundary net Community volunteers Check ages and immunization status Registration Vaccination After triage. Large area needed After registration area Large area to accommodate queues After vaccination area Tables & chairs, registration books, Immunization cards Plastic covers, date stamps. Tables & chairs Vaccine carriers, cold boxes, ice packs Injection material, trays Water & soap Table & chair Vitamin A, Gentian Violet Literate persons e.g. teachers Health workers trained to immunize. Assistants Fill out immunization cards (date, name, age) Reconstitution of vaccine. Preparation of syringes. Vaccination (0.5 ml SQ or IM) Distribution Vitamin A Health assistant Distribute vitamin A Mark with Gentian Violet Recording Just before exit Tables & chairs Literate person Fill out data record sheets Data record sheets E.g. teacher according to age group Date stamps Stamp immunization cards Direct people towards exit Practical: prepare the site and all the equipment the day before: At the entry door, organize waiting lines with sufficient ropes/boundary nets. Narrow so that people enter one by one. Get some drinking water for waiting people; Prepare 100 syringes before you start Burn the sharps containers on the spot, and bury the remains. Cold Chain guideline 2002 FSU-MSF 68

69 Mobilization of the local community The effect of the immunization campaign will depend on: - the level of awareness and motivation among the local population; - the standard of organization. An information committee should be formed to mobilize the local community to increase the effectiveness of the intervention. This committee could include: - local authorities; - district representatives; - health officials; - police officials; - religious leaders; - school leaders. Information can be transmitted by the radio, TV, megaphone, posters, by district heads, health workers in the clinics, religious leaders, schoolteachers, and town criers. The information given should include: - a description of the disease and its complications; - the importance of early detection of cases and referral; - the benefits of immunization; - the age groups to be vaccinated; - the location and time of the sessions; - the advice to bring the immunization (EPI) cards to the session; - the assurance that there will be sufficient vaccines for the target population. Information on the campaign should start some days before the start of the campaign and during the immunization sessions in the area operating. Monitoring and evaluation: During the campaign at the end of each day a meeting should be held with the various key-players (logistics, team supervisors) to: Cold Chain guideline 2002 FSU-MSF 69

70 - review the outreach activities, coverage in the different areas and community mobilization; - check the functioning of the cold chain, transport; - check the functioning of the different teams, staff and quality of work, tasks; - compile statistics of the day. Waste management The preferred choice of single-use material calls for a very well organized system for the appropriate disposal of syringes and needles, you will need: - sharps containers; - incinerators or old fuel barrels to burn material. Be sure to burn your material at the end of the day, preferably at the place of vaccination. Do not transport medical waste over long distances, do not store. Bury the remainders. Avoid the use of reusable injection equipment in an epidemic context as: - Much time is lost in cleaning and sterilizing the articles - Many sterilization cycles are needed per day - There is a risk of incomplete sterilization, given the time limit. 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 after use. Always supervise the transport & incineration of the syringes & needles in the disposal box. MSF uses a 15-litre safety box for the collection of used sharps in a mass vaccination campaign. The following formula may be used to estimate the number of liters of sharps waste, which will be generated. Cold Chain guideline 2002 FSU-MSF 70

71 A = Estimation of used syringes: i.e. Total number of children to be immunized in vaccination campaign. B = Volume of used syringes A X 50/1000= Total volume in liters. C = Number of safety boxes required to hold sharps: For 15 liter boxes B / 15 For example: you plan to immunize children. A = B = x 50/1 000 = liters of sharps waste C = / 15 = rounded up = safety boxes of 15 liters. In a regular EPI program, you have to stick to the national guidelines concerning waste management. If there are no national guidelines, refer to your support department. The syringes have to be burnt with the safe disposal box. Try to find an incinerator, some health facilities or hospitals might have one or use an oil drum. The disposal of sharps waste in developing countries will stay a compromise between safety- and environmental sound procedures for years to come. Luckily syringes do not contain chlorine anymore, so there is no risk anymore for dioxins and furans when slow burning. Bury waste or the ashes at a depth of at least 1 (one) meter with 0.5 meter of soil on top. Cold Chain guideline 2002 FSU-MSF 71

72 7. Evaluation of the intervention (for the campaign buffs among you loggies) Evaluation of the case management - Has the program achieved its desired impact in terms of reducing disease related morbidity and mortality? - Has the rate of disease complications and death declined since the program was implemented? Evaluation of the immunization program The evaluation should be based on routinely collected data and if necessary, on a survey of vaccination coverage. Routinely collected data Immunization coverage is obtained by comparing the numbers vaccinated with the size of the estimated target population. The validity of this method depends on the accuracy of the target population estimate and of the collected data. Routine monitoring takes the form of daily and weekly compilation sheets, based on the tally sheets. At the end of the campaign: - All collected data are compiled - The monitoring of morbidity and case fatality rates is continued - If necessary, a vaccination coverage survey is undertaken Further action is planned according to the results obtained. A further mass immunization campaign could be implemented if the coverage results are too low. Vaccination coverage survey This survey allows confirmation of the results obtained from routinely collected data. It needs not to be undertaken systematically after each Cold Chain guideline 2002 FSU-MSF 72

73 campaign, but only when the accuracy of results is questionable. The survey indicates, at a given point of time, the proportion of the target population that has been vaccinated. It does not give information on the vaccine efficacy. The classical method uses a two-stage cluster sample (sample size of 210 children, in 30 clusters of seven children). This vaccination coverage survey may be coupled with a nutritional survey. Vaccine efficacy A study of vaccine efficacy should be undertaken if vaccine failures are suspected. For instance, if a measles outbreak should occur or continue, despite a high level of vaccination coverage (over 90 %), and in the absence of a significant population movement. This study assesses the field vaccine efficacy/effectiveness, which may differ from the theoretical vaccine efficacy of 85 % to 95 % when administered at over 9 months of age. If the field vaccine efficacy is well below the theoretical one, possible causes should be investigated as inadequate cold chain; poor immunization techniques or the vaccine schedule is not respected. Report of the epidemic and intervention A report should be issued, providing information on the evolution of the epidemic on - The context - The descriptive analysis - The surveillance (morbidity and CFR = case fatality rate) - The control of the epidemic - Case management (see specific guideline) - Vaccination campaign (see specific guideline) - Resources used - Staff (national, international, medical, logistics) - Material (vaccine wastage, cold chain) - Cost - Overall conclusion Cold Chain guideline 2002 FSU-MSF 73

74 8. Annexes 8.1 Do s and don ts for a fridge To check the temperature of the main compartment, make sure you have: a thermometer (max/min); keep it in the main compartment; a stopwatch monitor card; a chart to record temperatures; put it on top of the refrigerator or on the outside of the door; one person who is in charge of the refrigerator. That person checks and records the temperature. However, everyone who uses vaccines must know what the chart means. Don ts 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 place in the refrigerator. Do NOT put freeze sensitive vaccines like Hep-B at the coldest spot of the refrigerator: the coldest spot is for a cabinet type near the evaporator; for a chest type the coldest spot is found at the bottom; keep these vaccines away from there! Do NOT keep "EXPIRED" vaccines in the refrigerator. Do s Do defrost the freezing compartment when the built up ice exceeds 5 mm. Do allow air to circulate around the vaccines: leave some space between the boxes. First Expiry, First Out: store vaccines with closer expiry dates to the front, later expiry dates to the rear (consequently overruling the "First In, First Out" principle). Maintain your refrigerator: there is little to be done on a compression type but intensive maintenance for the kerosene absorption type. When applicable: install a lock/plug-guard on the electrical plug. Post warning notices at both the plug and at the circuit breaker. Cold Chain guideline 2002 FSU-MSF 74

75 Store icepacks in your freezer and bottled water at the bottom of the refrigerator to help maintain a stable temperature and prolong holdover time. Check and record the temperature in the main compartment twice a day - when you arrive for work and when you leave. KEEP THE DOOR CLOSED Opening the door increases the temperature in the refrigerator. When you need to open the door, plan what you will do first. Then open the door, do what you have to do, and close the door again quickly. Do not open the door of an ABSORPTION refrigerator more than 2 or 3 times a day. An absorption refrigerator will only very slowly replenish the cold lost by opening the door. Cold Chain guideline 2002 FSU-MSF 75

76 8.2 Multilingual names of diseases/vaccines Note on Terminology: the terminology for measles has been the source of some confusion. The proper English scientific term is rubeola, although the illness has commonly been referred to as 10-day measles, hard measles, red measles and morbilli. However, in Spanish, rubeola means German measles (rubella). Alternative Spanish terms are sarampión or morbilli for measles and sarampión alemán for rubella. see table below Nederlands English Français Português Español Difterie Diphtheria Diphtérie Difteria Difteria Mazelen Measles Rubeola Rougeole Sarampo Sarampión Morbilli Bof Mumps Oreillons Caxumba, Parotidite, Papeira Parotiditis, Paperas Rode hond Kinkhoest Gele koorts Rubella, German measles Whooping cough, Pertussis Yellow fever Rubéole Rubéola Rubéola Sarampión alemán Coqueluche Fièvre jaune Tosse convulsa Coqueluche Febra Amarela Tos ferina, Tos convulsiva Fiebre Amarilla Rabiës Rabies Rage Raiva Rabia Polio Polio Polio Poliomielite Paralisia infantil Poliomielites, Paralises infantil Tetanus Tetanus, Lockjaw Tétanos Tétano Tétano Cold Chain guideline 2002 FSU-MSF 76

77 8.3 The WHO multi-dose vial policy (On the use of opened vials of vaccine in subsequent immunization sessions) This policy aims at cutting vaccine wastage by 30% and save $ globally. WHO revised it s policy, in the sense that certain vaccines may be used in subsequent immunization sessions on the condition that: Vaccines are good quality and come from a reliable source; Sterile injection procedures are adhered to (amoungst others that the septum of the vial has not been immersed in water); The expiry date has not passed and the VVM (if present) indicates O.K; 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 not contain preservatives and must be discarded at the end of each immunization session. Death due to toxic shock syndrome has resulted when reconstituted live virus vaccines, which were kept reconstituted in stock, were injected. This WHO policy is linked to the introduction of vials, which are supplied with a vaccine vial monitor or VVM. We expect in the coming years most vaccines to be supplied with VVMs. When you get OPV with vaccine vial monitors in your project, you can use them in subsequent immunization sessions. You may use opened vials of DTP, DT, TT and Hep B in subsequent immunization sessions, even when they do not carry vaccine vial monitors. Keep the opened vials in a special box in de fridge so that you remember to use them first in the next session. National and expat staff has to be trained to work according to this policy. Cold Chain guideline 2002 FSU-MSF 77

78 8.4 PEP POST-EXPOSURE PROPHYLAXIS (PEP) FIRST AID IN CASE OF ACCIDENTAL EXPOSURE TO BLOOD This subject is added as a reminder The complete PEP guideline ("procedures to be followed in case of accidental exposure to blood") should be in your field library; the chemoprophylaxis, which is described in it, should be in your medical stock! Ask the medical officer who acts as your GP (general practitioner). This part only describes the first aid after an injury with a needle or any other sharp instrument contaminated with infected blood or other body fluids; First aid after an accident 1. Let the wound bleed, immediately wash the wound and surrounding skin witn water and soap and rinse. 2. Disinfect the wound and surrounding skin with: -povidone iodine 2.5 % (Betadine) during 5 minutes, or -a 0.4% chlorine solution (a 1/10 dilution of normal household bleach (or 12 chlorine)) during 10 minutes or -alcohol 70 % during 3 minutes. Note: Chlorhexidine cetrimide (HAC) is active against HIV, but inactive against Hep B; it is therefore not recommended for persons who are not vaccinated against Hep B. Cold Chain guideline 2002 FSU-MSF 78

79 8.5 The shake test Adsorbed vaccines (DPT, DT, Td, TT or hepatitis B) are easily damaged by freezing. If you see this vaccine when frozen solid, you know that it is damaged. But you may not have noticed that the vaccine has been frozen (e.g. overnight in a climate with cold nights) until after it has thawed or melted and has become liquid again. To find out if a liquid vaccine has been frozen and damaged some time before, there is a simple test: the Shake test. The shake test is designed to determine whether adsorbed vaccines (DPT, DT, Td, TT or hepatitis B) have been frozen. After freezing, the vaccine is no longer a uniform cloudy liquid, but tends to form flakes. Sedimentation occurs faster in a vaccine vial that has been frozen compared to a vaccine vial -from the same manufacturer- that was never frozen. The Shake test is most easily demonstrated using a vaccine vial that you personally froze and do not intend to use for immunization. This vial can be used as a "frozen control sample" to be compared with suspect vaccines. If the control vial shows much faster sedimentation than in the vial being tested, the vaccine in question is probably potent and may be used. If, however, the sedimentation rate is similar and contains flakes, the vial under test should not be used. It is important that the Shake test is done using both "tested' and "control" vaccine vials produced by the same manufacturer. The Shake Test Compare the vaccine that you suspect has been frozen and thawed with the frozen control sample. Shake the vials of vaccine vigorously; Leave the vaccines to stand side by side for 10-15minutes for the sediment to settle. Inspect the contents carefully for granular particles or flakes. Cold Chain guideline 2002 FSU-MSF 79

80 Check the properties of the liquid in the vials: smooth and cloudy starting to clear little sediment not smooth you can see granular particles or flakes thick sediment VACCINE NEVER FROZEN VACCINE FROZEN AND THAWED USE THIS VACCINE 2 DO NOT USE THIS VACCINE Cold Chain guideline 2002 FSU-MSF 80

81 8.6 The"Tiny TTM", a mini size data logger Cold Chain temperature monitor Remonsys Ltd, UK, has developed the temperature monitor "Tiny TTM". It is battery-operated and small enough to fit inside a 35 mm plastic film container. It has a single, on-board thermistor sensor which covers a temperature range of -37 C to +50 C and is capable of monitoring up to 1800 readings at varying time intervals. It has an accuracy of +/- 0.2 C and the recording time interval can be set from 0.5 seconds up to 4.8 hours. The duration of the recording will determine when the memory is full-- for instance, with a 30-minute interval, the memory will be full in 37 days. An interface cable to the serial port of a computer can quickly download the data stored (for the Toshiba 1730 computers without a serial port there might be problems). It can then be displayed in nice graphs and saved under different formats using software prepared for this purpose. The small size and design of the "Tiny TTM" makes it a useful supervisory tool and an extremely powerful monitor. At the moment, the "Tiny TTM" is being used in several cold chain projects around the world. When your cold chain is not working properly and it is hard to put the finger on the faulty spot, you can order a "Tiny TTM" to help with fault finding. The current cost is approximately 155 for the data logger and 16 for the cable. (Software is pre-installed on all laptop computers) You can get one on loan from Logistics /Field Support Unit temporarily. Cold Chain guideline 2002 FSU-MSF 81