COLD CHAIN MANAGEMENT

Transcription

1 COLD CHAIN MANAGEMENT FOR COLD CHAIN HANDLERS PREETAM KUMAR PATRO COLD CHAIN CONSULTANT UNICEF PATNA

2 1. INTRODUCTION The COLD CHAIN is the combination of people and equipment with the task of insuring that the vaccines are kept in an ideal environment and temperature to preserve their quality during their transportation from the site of their production to the site of their and storage, or application. An immunization program s ability to provide vaccination services to all members of the target population depends on attention to detail, and nowhere this more necessary than in cold chain and logistics. Ensuring that vaccines, supplies, and staff arrive on time and when they are needed requires an integrated system of equipment, people, policies and procedures. This integrated system is called cold chain. The cold chain consist of a series of storage and transport links, all designed to keep vaccines within an acceptable range until it reaches the user. 2. DEFINITION A system of storing and transporting the vaccines at recommended temperatures from the point of manufacture to the point of use. From the above definition, the five most important aspects emerge: Transportation of vaccine Storage of Vaccine Recommended temperature Point of manufacture Point of use 3. ELEMENTS OF COLD CHAIN The essential elements of cold chain are: PERSONNEL to organize and manage vaccine distribution. EQUIPMENT for storage and transport of vaccine. TRANSPORT facilities MAINTENANCE OF EQUIPMENT MONITORING Vaccines are sensitive to heat and freezing and must be kept at the correct temperature from the time they are manufactured until they are used.

3 4. SENSITIVITY OF VACCINES ORDER OF SENSITIVITY OF VACCINES TO HEAT BCG (after reconstitution) OPV Measles (Before & after reconstitution) DPT DT BCG (before reconstitution) DT, TT, Hep B, JE DAMAGED SENSITIVITY TO FREEZING Hepatitis B DPT DT TT Hepatitis B, DPT, DT and TT vaccines lose their potency if frozen. There is also a risk of adverse events if frozen vaccines are administered. Therefore, always store T Series vaccines (DPT, DT, TT) and Hepatitis B vaccines between +2 Deg C and + 8 Deg C. NO HARM BCG ( Before reconstitution) MEASLES (Before reconstitution) OPV HEAT & LIGHT SENSITIVE VACCINES - BCG - OPV - Measles All vaccines are damaged by temperatures more than + 8 Deg C, whether they are exposed to a lot of heat in a short time (e.g., as a result of keeping vaccine in a closed vehicle in the sun) or a small amount of heat over a long period (e.g., as a result of the frequent opening of lid of ILR) Reconstituted BCG, measles and JE vaccines are most sensitive to heat and light. Since these live vaccines do not contain preservatives, there is a risk of contamination leading to toxic shock syndrome and therefore, they should not be used after 4 hours of reconstitution.

4 BCG and Measles vaccines are also light-sensitive, which is why they are supplied in amber-coloured vials. Therefore, they need to be kept away from light. PROTECT ALL VACCINES FROM DIRECT SUNLIGHT 5. CFC AND CFC FREE EQUIPMENT In the 1980 s, it was discovered that the thin layer of OZONE in the earths atmosphere was vulnerable to damage to chlorofluorocarbons (CFCs) resulting in harmful ultra violet radiation emanating from the sun. In the industrialized world, total phase out of most categories of OZONE DEPLETING SUBSTANCES (ODS) was achieved by the end of Developing countries are to phase out equipment with ODS by the year 2010 as per the Montreal protocol. CFCs are used in Air conditioning, Refrigeration and other products. In the cold chain equipment, Walk-in-freezer (WIF), Walk-in-cooler (WIC), Deep freezer (DF), and Ice Lined Refrigerators (ILR) are using CFC and CFC Free Refrigerants. Common CFC refrigerant: R12.(Used in the old DF & ILR) Common CFC Free refrigerant: R134a (Presently used in all new DF & ILR) Sticker available on all new equipment I AM CFC FREE 6. COLD CHAIN EQUIPMENT 6.1 WALK-IN-FREEZER (WIF) ELECTRICAL EQUIPMENT The Walk-in-freezer is a pre-fabricated and pre-painted modular Polyurethane (PUF) insulated panels with two identical Refrigeration units and are available in two sizes 32 Cu Mt and 15.5 Cu Mt. These are connected with standby generator sets with automatic start and stop facilities. These are also provided with a temperature meter and alarm system. Two Walk-in-freezers is installed at the State Vaccine Stores at Patna and one is installed at the Regional Vaccine Stores at Purnea. Stores bulk quantity of OPV and freezes ICE packs. Storage temperature: - 20 Deg C Storage capacity: Lakh doses.

5 6.2 WALK-IN-COOLER (WIC) The Walk-in-cooler is a pre-fabricated and pre-painted modular Polyurethane (PUF) insulated panels with two identical Refrigeration units and are available in two sizes 32 Cu Mt and 15.5 Cu Mt. These are connected with standby generator sets with automatic start and stop facilities. These are also provided with a temperature meter and alarm system. These are used for storage of large quantities of vaccines at the State and Regional levels. In Bihar, these are located at the State stores at Patna and the Regional Vaccine stores at Purnea, Bhagalpur, Aurangabad, Saran, Motihari, Muzaffarpur and Darbhanga. Stores bulk quantity of DPT, DT, TT, BCG, Measles, Hep-B, etc. Storage temperature: + 2 to + 8 Deg,C Storage capacity: 12 to 15 Lakh doses. 6.3 DEEP FREEZERS (DF) Under the immunization program, Deep freezers have been supplied with the top opening lid. Deep freezers maintain a cabinet temperature between 15 Deg C to 25 Deg C and store OPV (at District level only) and prepare ice packs. Deep freezers should be used at PHC level only to freeze ice packs. CAPACITY: 300,286,140 & 116 Litres IDEAL TEMPERATURE: - 15 TO 25 Deg C HOLD OVER TIME: 18 Hours at 43 Deg C : 22 Hours at 32 Deg C

6 ICE PACK FREEZING CAPACITY: Litres freezes 40 packs every 24 hours Litres freezes 38 packs every 24 hours Litres freezes 25 packs every 24 hours Litres freezes 20 packs every 24 hours ICE PACK STORAGE CAPACITY - 300/286 Litres 200/180 icepacks - 140/116 Litres - 90/80 icepacks VACCINE STORAGE 286 / 300 Litres: 1, 00,000 1, 80,000 doses DEEP FREEZER DIFFERENT MAKE Indian Anand - Shakti - Krishna - Blue Star Imported - Vestfrost - Electrolux - Haier DEEP FREEZER - MODELS VESTFROST CFC SB 140 SB 300 MF 140 /142 MF 300 / 302 VESTFROST CFC FREE MF 114/144 MF 304 MF 314 HAIER CFC FREE - HBD HBD Correct method to freeze icepacks in Deep freezer:

7 KEEP THERMOMETER INSIDE THE CABINET AND MAINTAIN BETWEEN 15 TO 25 DEG C. MONITOR THE TEMPERATURE MORNING AND EVENING BASIC SAFETY TIPS - Do not allow anyone to climb or sit on the freezer. - Always unplug the freezer before cleaning or making repairs. - Do not damage the power cord by rolling the freezer over it or loosening joints by pulling or jerking on the cord. Damaged power cord should be replaced by a qualified electrician to avoid any electrical hazards. - Do not cut or remove the earthing wire from the power cord DEEP FREEZER OPERATION VESTFROST Connect the plug of the voltage stabilizer to the wall socket. Output from the stabilizer will go to the freezer after a delay of about 3 minutes. When the power is available to the freezer, the GREEN main indicator lamp on the control panel will glow. As soon as the inside temperature is above - 15 Deg C, the RED lamp will glow. This RED lamp will go off as when the temperature will come below 15 Deg C When the freezer is running, the outside cabinet will be warm. This indicates that the cooling action is there inside. Always keep a layer of frozen ice packs in the freezer. This will help prolonging the hold-over time during power failure. Defrost periodically Keep the equipment locked and open it only when necessary.

8 Ensure the thermometer is kept in the freezer and the temperature is recorded twice daily. Do not sit on the freezer as this will damage the lid and the hinges. HAIER Connect the plug of the voltage stabilizer to the wall socket. Output from the stabilizer will go to the freezer after a delay of about 3 minutes. Put on the power switch (yellow colour) which is located on the front panel. The yellow lamp will glow to indicate that the power is on. The thermostat which is located on the front panel is set on position 6. This position should be kept for at least 24 hours. After 24 hours of operation, thermostat setting should be adjusted to position 1 to 4 and temperature must be between 15C and 20C. When the temperature inside the freezer is stable, ice packs can be loaded. When frost on the freezer walls is over 6 mm thick, the freezer need to be defrosted. To defrost, first turn off the switch for 4 hours. Unplug the freezer from the electrical outlet. Empty the freezer of all icepacks. Keep the lid open. Open the drain plug located at the front of the freezer. To reduce the freezing time for icepacks, the following steps should be taken: - When vaccine carriers are brought back to the District or PHC from the field (session sites) in the evening, the courier/anm should be advised to remove the ice pack from the vaccine carrier and put the cool ice pack (which still remains cold) in a cold box kept separately for this purpose. - The temperature of all such ice packs which return back from the session sites will be much cooler (since they were conditioned and given in the morning )than those which are kept outside. - These cool ice packs should be kept in the method illustrated above. Since the ice packs were partially cooler than the ones which were kept outside, such ice packs would take lesser amount of time to freeze. Due to this reason, larger amount of ice packs could be frozen in a day. All such ice packs which are frozen can be removed and kept in a separate cold box from which, they may be used for dispatch with vaccines (after conditioning) - While distributing ice packs in the morning along with vaccines, ice packs should be removed from one side of the Deep freezer from beginning from the top to bottom. This should be done in rotation and all ice packs kept at different levels should be removed while providing the same to Couriers / ANM in the morning while preparing to dispatch vaccines.(usually, icepacks located at the top are generally removed and the ones at the bottom continue to be kept at the same location. After a period of time, due to excessive freezing and water dripping, these ice packs cannot be removed.) It should be ensured that water which collects at the bottom portion inside the Deep freezer is removed. Water can be collected with a cloth or sponge whenever found in the Deep freezer. This will avoid rusting of the bottom portion and will increase the life of the equipment.

9 6.4 ICE LINED REFRIGERATOR (ILR) Under the immunization program, Ice Lined Refrigerators (ILR) has been supplied with the top opening lid: ILRs are to maintain a cabinet temperature between +2 to + 8 Deg C and are used to store vaccines at District and PHC level. ILRs are so designed with an ice bank (Icepack lining) which keeps the internal temperature at a safe level despite electricity failure. The figure given below indicates the correct placement of vaccines in the baskets of an ILR. Keep thermometer hanging on the baskets and maintain temperature between +2 to + 8 Deg C (monitor morning and evening) RIGHT WAY OF KEEPING VACCINES IN ILR Keep all vaccines in baskets. Avoid placing vaccines at the bottom of ILR. Leave space between the vaccine boxes. Place the thermometer in the centre of the ILR.

10 Diluent/freeze sensitive/closer expiry date vaccine on top. Heat sensitive/further expiry date vaccines in the bottom of the basket. CAPACITY: 300,200,140 & 70 litres IDEAL TEMPERATURE: + 2 to + 8 Deg C HOLD OVER TIME: 62 Hours at 43 Deg C : 78 Hours at 32 Deg C VACCINE STORAGE CAPACITY: (Mixed antigen) litres stores doses litres stores doses litres stores doses - 70 litres stores doses ILR DIFFERENT MAKE IMPORTED - VESTFROST - HAIER ILR MODELS VESTFROST - CFC MK 140 /142 MK 300 / 302 VESTFROST CFC FREE MF 114/144 MF 304 MF 314 HAIER CFC FREE - HBC HBC ILR OPERATION Connect the plug of the voltage stabilizer to the wall socket. Output from the stabilizer will go to the freezer after a delay of about 2 minutes. When the power is available to the freezer, the GREEN main indicator lamp on the control panel will glow. When the ILR is running, the outside cabinet will be warm. This indicates that the cooling action is there inside. Vaccines can be stored inside as soon as the temperature is between 2 Deg C to 8 Deg C. Keep the equipment locked and open it only when necessary.

11 6.4.5 SHAKE TEST To determine if a vaccine was frozen or not at any time, a SHAKE TEST must be done. T Series vaccines (DPT, DT and TT) Typhoid and hepatitis B vaccines can be damaged due to freezing. By performing the SHAKE TEST, it can be found if the vaccine has been frozen. - The vaccine vial that is suspected to be frozen may be taken and marked. Take a vaccine vial of the same type, same manufacturer, same batch number as the suspect vaccine vial you want to test. - Shake both vials so that the sediments, if any are completely mixed into the vial. Wait for 30 minutes. - Look at the vaccine inside the two vials. - If the vaccine is not uniformly mixed or the sediments are still found settled at the bottom, the vaccine was frozen. SHAKE TEST IS NOT TO BE PERFORMED FOR OPV, MEASLES & BCG VACCINES CORRECT STORAGE AND USE OF DILUENTS Only use the diluents supplied and packed by the manufacturer with the vaccine, since the diluents is specifically designed for the needs of that vaccine. Store the diluents, between +2 Deg C to +8 Deg C in the ILR. If there are constraints of space, then store diluents outside the cold chain. However, remember to cool diluents for at least 24 hours before use to ensure that vaccines and diluents are at +2 Deg C to + 8 Deg C when being reconstituted. Otherwise, it can lead to thermal shock i.e. the death of some or all the essential live organisms in the vaccine. Store the diluents and the droppers with the vaccines in the vaccine carrier during transportation. Diluents should not come in direct contact with the ice pack. Do not keep in the cold chain, any vials that are expired, frozen or with VVMs beyond the discard point, as they may be confused with those containing potent vaccines. Keep them in the red bag for disinfection and disposal.

12 6.5 INSTALLATION OF NEW DEEP FREEZER & ILR On arrival of the equipment, ensure that there is no damage during unloading. The packing case containing the equipment should be stored vertically (Arrow and symbol showing right side normally mentioned on the box. Unpack the wooden crate / card board box and be careful not to damage the equipment with the tools while opening the box. In case of any sign of damage to parts or the equipment, do not start the equipment and report the matter to a trained Technician and / or report the matter to the Cold Chain Officer. Prior to installation of the equipment, you must ensure the following is available: - Room is available with proper ventilation. - Proper wiring with a 16 Amp 3 pin power plug socket is available. - Dedicated earthing is available. - Voltage stabilizer is available. After the above is made available, the equipment may be installed as under: - The equipment should be installed on the floor, preferably on wooden blocks leaving a space under the equipment. - A minimum of 20 cm space should be kept on all the sides of the equipment for good air circulation. A distance of at least 50 cms should be maintained towards the equipment grill side (which accommodates the compressor and parts) - Connect the main cord wires of the Deep freezer of ILR with the voltage stabilizer in the connector as mentioned on the stabilizer as (E) (N) (L). - Connect the voltage stabilizer plug with the Main Power plug. - Ensure that the equipment runs for 24 hours before placing vaccines in them. 6.6 PREVENTIVE MAINTENANCE All equipment needs to be maintained to reduce the likelihood of failure. There is need to identify what action is required to be taken on a regular basis to ensure that that the equipment is maintained and kept clean. It is required to take action at all Vaccine stores to ensure that all equipment is maintained well. Deep freezer/ilr Check daily - If the exterior is clean. - Temperature is within the prescribed limits - The door is shut and sealed Check weekly - frost is more than 0.5cm, defrost immediately Check monthly - If equipment is defrosted and cleaned, if required, adjust thermostat.

13 Cold Boxes and Vaccine Carriers After every use - Keep latches open and free from load and tension. - Clean with detergent and dry. - Examine inside and outside surface for cracks. - Check that the rubber seal around the lid is not broken (if so, replace immediately) - Hinges and locks are lubricated with machine oil. 6.7 VOLTAGE STABILIZER A voltage stabilizer function along with the equipment is to reduce the range of voltage fluctuations in the main voltage. The main features of the voltage stabilizer are: An essential safe guard of 1 KVA capacity connected to all Deep freezers and ILR s to combat unstable electric supply voltage. Incorporates: High & Low voltage cut off with 3 6 minute time delay. Input voltage: volts CONECTIVITY - 1 KVA to single 300 Litres unit. - 1 KVA to two small 140 Litres units. - 1 KVA single 214 / 300 Litres RIGHT CONNECTION WITH VOLTAGE STABILIZER INDIAN MAKE DEEP FREEZER & ILR GREEN COLOR WIRE EARTH RED COLOR WIRE PHASE (LINE) BLACK COLOR WIRE NEUTRAL VESTFROST MAKE DEEP FREEZER & ILR GREEN & YELLOW COLOR WIRE EARTH BROWN COLOR WIRE PHASE (LINE) BLUE COLOR WIRE NEUTRAL

14 7. POWER POWER SUPPLY FOR EQUIPMENT ELECTRICAL SUPPLY: Ideally 220 +/-10volts. Ensure there is no loose wiring. Ensure equipment is connected with voltage stabilizer. Earthing is properly done. Proper electrical wiring is essential with good quality accessories should be installed For the proper functioning of the equipment, it is essential to provide proper electrical wiring and fittings at the cold chain room. 7.2 SPECIFICATIONS FOR WIRING & EARTHING Specifications for proper electrical wiring, fittings and earthing for Deep freezer and ILRs are as below: 3 X 4 sqmm wire of Anchor / Havells make through PVC conduit pipe. DP Main switch of 32 Amp to be fixed on 8 X 6 size board. Miniature circuit breaker (MCB) of 16 Amp of Anchor / Havells make. 32 Amp Changeover switch of Havells / Anchor make for generator / mains. 5 in 1 Power plug of 16 Amp of Anchor / Havells make. Dedicated earthing is required of 3mm thick Copper wire and copper plate to be buried below ground level of at least 20 feet through GI pipe with thick copper plate, charcoal, salt and should be checked with MAGOR. 7.3 GENERATOR Run generator once a week. Diesel Tank is kept + 5 litres reserve stock. Change-over switch is provided. Generator is serviced periodically. In case of out-sourced generator, it should be ensured that the throttle is set at the correct RPM which will ensure proper voltage output. In case the voltage output is less than 200 Volts, the throttle should be adjusted (with a help of a Technician). The Deep freezer and ILR will not function in case the voltage is less than 180/200 volts. It should be ensured that the equipment is properly serviced failing which, there will be a fluctuation in the voltage which will hamper the working of the cold chain equipment.

15 8. NON-ELECTRICAL EQUIPMENT 8.1 COLD BOX A cold box is an insulated container that can be lined with ice-packs to keep vaccines and diluents cold during transportation and /or short period storage. Cold boxes are mainly used for transportation of vaccines. In emergency, they can be used to store vaccines and frozen Ice-packs. DPT, DT and TT vaccines should not be placed in direct contact with frozen ice packs and should be surrounded by OPV vials. In case OPV vials are not being sent with the T Series vaccines, conditioned ice packs should be sent. Vaccines should be carried after placing the icepacks as follows: - Place conditioned icepacks at the bottom and sides of the cold box before loading the vaccines in cardboard cartons or polythene bags. - It is desirable to keep a thermometer inside the cold box. - Do not use frozen ice packs in the Cold Box. - Do not place DPT, DT, Hep B and TT vials in direct contact with conditioned ice packs. - After placing the required quantity of vials, place two rows of ice packs above and securely close the lid - Do not remove the rubber seal of the Cold Box. - Do not place any weight or other cold boxes on the lid. Cold boxes are used to collect and transport vaccine supplies from State to Regional Vaccine Stores and or District Vaccine Stores and or to PHC. In case of TYPE: Insulated boxes of 20 litres & 5 litres capacity. USAGE: Stores & transports vaccines. Also stores Ice packs. CAPACITY: 20 litres = 6000 doses or 300 vials approx. with Ice packs 5 litres = 1500 doses or 75 vials approx. with icepacks HOLD OVER TIME : 20 litres = 5 days : 5 litres = 3 days While transporting vaccines, icepacks should be placed on the floor and sides. Place the vaccines and diluents in between the space of Ice packs. Place the cardboard/packing material in between the vaccines and the Ice packs to prevent freezing of the vaccines and then place two layers of Ice-packs after keeping the packing material on top of the vaccines and close the lid and secure the latch of the cold box. After using the cold box, ensure that they are clean and dry. Do not tamper with the rubber seal. If this not available, replace the same. The cold box should not be used in case the rubber seal (gasket) is not available. Lubricate the hinges and locks routinely.

16 8.2 VACCINE CARRIER Vaccine carriers are normally of 1.7 litres capacity. They are used for carrying vaccines and diluents from PHCs to session sites. It should be ensured that all unused vaccines which are returned from session sites to the PHC the same day in the cold chain. These returned unused vaccines should be kept in a box which should be labeled Returned unused in the ILR.These unused vaccines can be used in subsequent sessions. Do not keep used vials in the cold chain. TYPE: Insulated boxes used for carrying small quantities of vaccine. CAPACITY: Vials with 4 Icepacks HOLD OVER TIME: About 24 hours. ICE PACKS: A maximum of 4 frozen packs. NEVER STORE VACCINES IN VACCINE CARRIERS LAYOUT OF VACCINES Direct contact of frozen ice packs spoils the vaccine. Give carton spacers / surround vaccine by OPV vials. Place vaccines & diluents in cartons or polythene bags to ensure labels are protected. 8.3 ICE PACKS Ice packs are plastic containers filled with water. These are frozen in Deep freezer and when placed in Cold boxes and vaccine carriers, help increase the holdover time. TYPE: Water filled HDPE containers. WATER FILL: Do not fill 100%. Leave 10mm room for expansion as water freezes. USAGE: Lowers temperature range for safe vaccine storage. Placed inside lining of ILR to improve & maintain holdover time during electrical failure. BEST FROZEN: In WIF, DF & Ice factories PREPARE ICE-PACK FOR FREEZING Fill the ice-pack with water to mark. Check water level before every use. Do not add salt to this water. Fit the stopper and screw on the cap. Make sure the ice-pack does not leak. Wipe the ice-pack dry and place in the freezer ICE PACK FREEZING Ice Packs to be frozen ROCK solid. Freezing is faster & uniform if gap / breathing space is left between ice packs. Ice packs are best frozen in Deep freezers. Large DF freezes 42 packs / 24 hours. Small DF freezes packs / 24 hours

17 8.3.3 CONDITIONING OF ICE PACKS When icepacks are removed from a Deep freezer, they are normally at -25 Deg C temperature. This ice pack need to be kept at room temperature for long enough to allow the temperature of ice at the core of the icepack to rise to rise to 0 Deg C. This process is called conditioning. An ice pack is adequately conditioned as soon as beads of water cover its surface and the sound of water is heard on shaking it. Done to prevent freezing of the cold sensitive vaccines ( Hep B & T series vaccines) Freezing of vaccine can take place during storage ( In ILR) or during transport ( Cold box, vaccine carrier) Freeze sensitive vaccines can be damaged if comes in direct contact with the frozen ice packs Conditioning of ice packs prevents freezing of vaccine during transport. On the session day, place frozen ice-packs in the open. Allow ice-packs to sweat at room temperature for some time (5-15 minute) Check if an ice-pack has been conditioned by shaking it and listening for water UNCONDITIONED ICE-PACKS MAY DAMAGE FRREZE SENSITIVE VACCINES HOW TO PACK THE VACCINE CARRIER Pack four conditioned ice packs into the vaccine carrier along the sides. Take the required amount of vaccines plus one vial of diluent (only diluents which are kept at 2-8 Deg C.) for every BCG & Measles vial and place in a plastic bag. Place the plastic bag in the centre away from the ice packs. This will prevent labels from peeling off from the vials. The vials of DPT, DT, TT and Hep.B should not be placed in direct contact with frozen ice packs. The dropper for OPV should also be placed inside the vaccine carrier in the plastic bag. Collect vaccines in the carrier on the session day. Do not drop or sit or leave the vaccine carrier in the sunlight Close the lid securely. 9. THERMOMETER Place a functional thermometer in every cold chain equipment. Do not take it out of the equipment or hold for long. Read it where it is placed.

18 Use it to monitor and record temperature at 10 am and 4pm every day. Take action to correct storage temperatures are outside the recommended ranges. Alcohol thermometers are more sensitive and accurate as they can record temperatures from 50 Deg to + 50 Deg C and can be used for ILR and Deep freezers. The upper portion (T with hook shape) of the Stem type thermometer is the plus temperature side (up to 0 Deg C) is for the reading for ILR. The safe temperature is marked in green. The lower portion of the thermometer is the minus side which is to be read in the Deep freezer. Replace the thermometer immediately if broken. 10. TEMPERATURE RECORDING The temperature of all electrical cold chain equipment (WIC, WIF, Deep freezer and ILR) should be recorded at least twice daily without exception. All Vaccines stores throughout the State have been provided with Temperature record book in which details of the equipment is mentioned. The name of the Centre, PHC, District and State should be filled in. The Make, Type/Model, Machine No and the date of installation should be written. As and when repairs are undertaken for the equipment, details must be mentioned in the section so provided in the book. Monitor temperature twice daily and record in Temperature logbook. OPV & MEASLES 15 to 20 Deg C. DPT,DT,TT, Hep B & BCG + 2 to + 8 Deg C The temperature record book contains the Do s and Don'ts for operation and maintenance of the electrical cold chain equipment. Temperature records must be filled in daily. The MOIC should check and sign the book. The temperature record book should be kept safely for future reference. 11. VACCINE VIAL MONITOR (VVM) The Vaccine Vial Monitor or VVM is a circular indicator printed directly on the vaccine vial or affixed on to the top of the vial or ampoule. The inner square of the VVM is made of heat sensitive material that is initially light in colour and becomes darker when exposed to heat over time. The combined effects of time and temperature cause the inner square of the VVM to darken gradually and irreversibly. By comparing the colour of the square to the reference ring, health workers can determine the extent to which the vaccine has been exposed to heat. The vaccine can be used as long as the colour of the inner square is lighter than that of the reference ring. Before opening a vial, check the status of the VVM. VVM ensures that the administered vaccine has not been damaged by heat.

19 The VVM does not directly measure vaccine potency but it gives information about the main factor that affects potency: heat exposure over a period of time. The VVM does not, however, measure exposure to freezing that contributes to degradation of freeze-sensitive vaccines. Reading the Stages of the VVM 1. The inner square is lighter than the outer circle. If the expiry date has not been passed: USE THE VACCINE 2. The inner square is still lighter than the outer circle. If the expiry date has not been passed: USE THE VACCINE. Discard Point 3. The colour of the inner square matches that of the outer circle: DO NOT USE THE VACCINE Beyond the discard Point 4. The colour of the inner square is darker than the outer circle; DO NOT USE THE VACCINE. POTENCY T Series (DPT, DT, and TT) & Hepatitis B lose potency when frozen. Discard frozen vaccine. BCG, OPV & Measles are sensitive to heat and lose potency fast. VVM Tool for monitoring OPV potency. Damage to vaccine cannot be reversed by re-freezing. Discard frozen vaccine. Note the manufacturer, batch no, date of expiry, VVM status before session. No Vaccine should be stored at Sub Centre level 12. PLANNING FOR EMERGENCIES As we are aware, vaccines should be maintained at the desired temperature at all times, However, at times, due to electricity failure, the electrical equipment like WIF, WIC, Deep freezer and ILRs cannot function. Due to the breakdown of electrical equipment, the vaccines cannot be stored at the desired temperature and therefore, alternative storage arrangements have to plan much in advance to take appropriate action during such an emergency. Alternative storage of the vaccines has to be finalized and information is available at the Vaccine stores. In case of emergency, measures should be taken to take appropriate action. Contingency plan should be prepared for the District headquarters and at PHC level.

20 Identify alternate storage arrangements for vaccines in the event of equipment breakdown or electricity failure of more than 24 hours. Alternative stores should be identified and checked to ensure that they are functional and have adequate space and are capable of maintaining vaccines at correct temperature. Alternative Storage arrangements for emergencies ILR - Store vaccines in cold boxes with conditioned icepacks. Place thermometer inside the cold box Or - transfer to nearby PHC or other vaccine storage facility. Deep freezer. - Freeze icepacks in domestic refrigerator/s or in commercial ice factory Or - collect required quantity of frozen icepacks from nearby PHC in cold boxes on session days. - At District level - Transfer OPV to available ILR or refrigerator Or - Store OPV in cold box lined with frozen icepacks or commercial ice in polythene bags Voltage stabilizer - Disconnect the stabilizer and obtain replacement immediately from float assemblies for District/ Replacement HQ and reconnect. This plan should also have the following information: - Telephone and mobile numbers of all important persons of the District and PHC should be available with all the vaccine stores staff, MOIC, DIO, and CS. This should also be displayed outside the stores and also in all the responsible officials record. - Information of nearby Cold storage. - Adequate quantity of Cold Boxes in case of emergency. - Transportation facilities to shift the vaccines. - Periodically check the generator and fuel status. - All staff needs to be trained to take the appropriate action for shifting the vaccines to alternative locations. - The persons at each location have to be identified and informed in advance to take urgent action in case of such emergencies. INFORMATION OF PERSONNEL District Health Officials. Cold chain staff Nearest Cold storage. Electricity Dept

21 Petrol pump Fire station Transporters Generator Mechanic Electrician Cold Chain equipment Technician. Taxi / Vehicle owner Local staff of WHO Local staff of UNICEF THE EMERGENCY PLAN FORMAT FOR THE DISTRICT IS ATTACHED AS PER ANNEXURE VACCINE STOCK MANAGEMENT It should be ensured that vaccine stocks at the Regional, District and PHC level are maintained at the desirable level at all times. It is essential to monitor stocks and maintain records of all stock movements. Since the target population at all levels is available, it is possible to estimate the requirement of vaccines and maintain the minimum quantity so as to ensure that all vaccines are available. Regular indenting after review of the stock level being maintained should be ensured. A minimum of 3 months requirement should be available at the District level and 1 month stock should be available at PHC. Vaccine stocks should be reviewed every week against the minimum stock levels fixed for each PHC. Estimates should always include the buffer stock or safety stock which is 25 % for vaccines and 10 % for syringes. The buffer stock serves as a cushion against emergencies or delay during transportation. Vaccines which are first to expire should be stored systematically. The EEFO (Earliest-Expiry-First-Out) is to be followed to the FIFO (First-In-First-Out) handling of vaccines at all levels (Regional, District & PHC level) Vaccines which are suitable for use should be kept in the cold chain. Vials which have been damaged due to freezing, expired, VVMs which are beyond the discard point should not be kept in the cold chain. For accounting purpose, such vaccines should be marked All vaccines should be kept under lock and key. MAINTENANCE OF VACCINE STOCK REGISTER The vaccine stock register which is being presently maintained at the District and PHC level has the provision to note the VVM status of the vaccines. This should be noted without exception. The stock of diluents should also be noted in the stock register. Stock entries should be made on a daily basis and constantly updated. 14. STORAGE OF OLD RECORDS

22 Old records available at the District level should be stacked neatly and kept preferably in the old record room. In case the room is not available for old records, the records may be kept in boxes or cupboard so as to avoid clutter and occupy space at the District Vaccine stores and the Vaccines stores of the PHC. 15. VACCINE VANS: Vaccine vans have been provided at the District level for transportation of vaccines in bulk from the State /Regional Vaccine Stores. Approximately 6 to 10 Lakhs mixed antigen can be transported at a time. Vaccine should be transported only in Cold Boxes with the desired quantity of conditioned icepacks.