Cold Chain Management for Vaccines PDF

HALIZA KATAS (PhD) Faculty of Pharmacy UKM  Vaccines Vaccines are produced from the same microorganisms or toxins that cause disease, Three main substances are used for the production of vaccines: – LIVE microorganisms, e.g., weakened measles and polio vir...

HALIZA KATAS (PhD) Faculty of Pharmacy UKM  Vaccines Vaccines are produced from the same microorganisms or toxins that cause disease, Three main substances are used for the production of vaccines: – LIVE microorganisms, e.g., weakened measles and polio viruses or tuberculosis bacteria; – KILLED microorganisms, e.g., pertussis microorganisms used in DPT production; and – TOXOIDS, e.g., inactivated toxins such as tetanus toxoid and diphtheria toxoid. In addition, some vaccines are produced using genetic engineering technologies, e.g. recombinant DNA Hepatitis B vaccine. Introduction [TSD] Definition: ( aim : to maintain potency – The system of transporting, storing and distributing vaccines in a potent state at the recommended temperature from the point of manufacture to the point of use – a system of people and equipment which ensures that the correct quantity of potent vaccine reaches the peoples who need it from the point of production need proper equipment *  Cold Chain The essential components of a cold chain include: 1. Personnel responsible for vaccine distribution 2. Appropriate equipment to store and transport vaccines 3. Appropriate transport facilities all the time 4. Maintenance of equipment working property - 5. Monitoring **Competent personnel and efficient procedures are a vitally important part of the cold chain system Cold Chain System Cold Chain System REMEMBER: Even the most expensive and sophisticated equipment will not ensure an effective cold chain if not correctly used and managed by health personnel  Cold Chain System Vaccine handling occurs mainly at four levels and at each level different members of the health team are responsible for the maintenance of cold chain Level Institution Team Member Central Level [national] Epidemiological Unit Epidemiologist Regional District Level Medical DPDHS, OIC/RMSD,RE, Supplies Division MO(MCH) (RMSD) Divisional Office of the MOH, PHNS, SPHM Level Medical Officer of Health Health Facility Immunization Clinic MOH, PHNS, SPHM, PHM, Level Nursing Officers and Pharmacists in Hospitals ☒ itjust tell it involved diff people at diff level C.one team]  Equipment The basic cold chain equipment includes: – For vaccine storage : Refrigerators, Freezers, and Cold-rooms. – For vaccine transport: Cold boxes, Vaccine carriers, Day-carriers and Thermos flasks. – For cold chain monitoring: Thermometers, Cold Chain Monitors, Vaccine Vial Monitors and Freeze Watch Monitors – Vehicles * depends on level , eg vaccine : storage in central > district  Vaccine stability All vaccines are sensitive biological substances that progressively lose their potency This loss of potency is much faster when the vaccine is exposed to temperatures outside the recommended storage range. Any loss of potency is permanent and irreversible. The correct temperature is the most ← important factor in maintaining the potency of vaccines.  Vaccine stability Live oral polio vaccine (OPV) Most sensitive Measles (Lyophilized) * Pertussis and Mumps (Lyophilized) Hepatitis B HEAT Adsorbed Diphtheria-Pertussis-Tetanus vaccine (DPT) Adsorbed Diphtheria-Tetanus vaccine (DT, Td) BCG (Lyophilized) * Least sensitive Tetanus Toxoid (TT) * Note: These vaccines become much more heat sensitive after they have been reconstituted with diluent.  Vaccine stability Vaccines susceptible to damage by freezing Table 1: Sensitivity of vaccines to freezing Vaccines damaged by Vaccines unaffected by freezing freezing DPT BCG * DT OPV Td Measles * TT Mumps Hepatitis B Note: Vaccines freeze at temperatures just below zero. BCG and measles vaccines must not be frozen after reconstitution diluent for any vaccine must never be frozen.  Vaccine stability Range Vaccine HepB Hib (liquid) DTP, DTP-HepB, DTP-Hib, DTP-HepB+Hib, FREEZE DT Td TT, Hib lyophilised  ①heat ✓ Vaccine stability C. ②freeing / ur ⑤ light Several vaccines are also highly sensitive to strong light, sun light, ultraviolet and fluorescent neon lights Need to be kept in the dark as far as possible. These vaccines must never be exposed to sunlight, and are given some protection by being supplied in vials of dark brown glass to reduce the penetration of light. @ amberglass Any loss of potency due to light is also permanent and irreversible. Examples: – Lyophilized and reconstituted BCG, Measles, MMR, Varicella, Rotavirus, Human Papilloma Virus, most DTaP containing vaccines  Vaccine stability Damage due to successive exposures to heat or light is CUMULATIVE. – each time a vaccine is exposed to incorrect temperature or strong light its potency will decrease. All vaccines lose potency gradually, even at correct temperature. – Therefore the expiry ⇐date marked on a vial or packet of vaccine must be strictly observed even *duration not too long usually , short  Vaccine storage Recommended vaccine storage temperatures/times for different levels of the cold chain Vaccine National Regional District Health Facilities Maximum up to 6 months up to 3 months up to 1 month up to 1 month Storage time OPV -15 to -25⁰C -15 to -25⁰C -15 to -25⁰C 0 to + 8⁰C ☐ Measles Mumps DPT -15 to -25⁰C -15 to -25⁰C 0 to + 8⁰C -15 to -25⁰C -15 to -25⁰C 0 to + 8⁰C -15 to -25⁰C -15 to -25⁰C 0 to + 8⁰C 0 to + 8⁰C 0 to + 8⁰C 0 to + 8⁰C Hep B 0 to + 8⁰C 0 to + 8⁰C 0 to + 8⁰C 0 to + 8⁰C DT 0 to + 8⁰C 0 to + 8⁰C 0 to + 8⁰C 0 to + 8⁰C Td 0 to + 8⁰C 0 to + 8⁰C 0 to + 8⁰C 0 to + 8⁰C TT 0 to + 8⁰C 0 to + 8⁰C 0 to + 8⁰C 0 to + 8⁰C BCG 0 to + 8⁰C 0 to + 8⁰C 0 to + 8⁰C 0 to + 8⁰C  Vaccine storage At the national level – keep vaccines for a maximum of 6 months : – store OPV, Measles, and Mumps vaccines at -15 to - 25⁰ C; – store Hepatitis B, DPT, DT, Td, TT and BCG at 0 to +8⁰ C – send vaccines to regions in insulated containers at 0 to +8o C. At the regional level – keep your vaccines for a maximum of 3 months : – store OPV, Measles, and Mumps vaccines at -15 to - 25⁰ C; – store Hepatitis B, DPT, DT, Td, TT and BCG at 0 to +8⁰ C – send vaccines to districts in insulated containers at 0 to +8⁰ C.  Vaccine storage At the district level – keep vaccines for a maximum of 1 month – store OPV, Measles, and Mumps vaccines at -15 to -25 ⁰C, if possible; – store Hepatitis B, DPT, DT, Td, TT and BCG at 0 to +8 ⁰C – send vaccines to health facilities in insulated containers at 0 to +8 ⁰C. At the health facility level – keep all vaccines for a maximum of 1 month – store all vaccines at 0 to +8 ⁰C.  Equipment There are different vaccine storage conditions appropriate to each level of the cold chain. – Each level requires different storage equipment ° of vaccine to be stored, depending on the quantity the duration 0 of storage and the temperature necessary. All equipment must be able to keep vaccines safely whatever the outside temperature There are also different types of equipment designed for transporting vaccines between the various levels of the cold chain, and for use during immunization sessions.  Equipment The cold chain involves two complementary aspects: 1) the set chain represented by the walk-in cold rooms, deep freezers and refrigerators 2) the mobile chain represented by isothermic boxes and vaccine carriers Cold chain equipment commonly used in office practice including domestic refrigerators, cold boxes and vaccine carriers  Equipment Level Refrigerator type Central Level Cold rooms, Freezer room, ice pack freezer District Level Large top-opening refrigerator/freezer, “Ice-lined“ refrigerator, cold rooms, ice pack freezer Health Facility two-compartment refrigerators/freezers, small Level top-opening freezers ff I Divisional Level small “ice-lined” refrigerators, upright household with area blackout - many fluctuations - frottageout power  Equipment Equipment Functions Walk in cold rooms (WIC) and They are used for bulk storage of vaccines at the Walk- in freezers (WIF) manufacturer site, or at major distribution points. They have two cooling units and standby generator sets, and are fitted with temperature recorders and alarm systems. Deep freezers They are used for long term storage of OPV/ Measles/MMR vaccines. They are also used for making ice-packs for use in outreach programs Ice lined refrigerators (ILR) They are used where the power supply is intermittent. Most of the space is taken up by water which is frozen when electricity is available. Appropriate temperatures can be maintained for several hours. Do: 1.Place vaccine in breathable plastic mesh baskets and clearly label baskets by type of vaccine (A) 2.Keep baskets 5 to 8 cm from walls and other baskets (B) 3.Keep vaccine in their original boxes until you are ready to use them (C) 4.Keep vaccines with shorter expiration dates to the front of the shelf/basket (D) 5.Keep temperature between 2 and 8 degrees C (aim for 5 degrees C) (E) 6.Check and log temperature twice a day (F) Do Not: 7.Store food or drink in refrigerator – only vaccine in vaccine storage unit (G) 8.Place vaccine in solid plastic trays or containers (H) 9.Store vials out of their original individual packaging (I) 10.Place vaccine in drawers or on floor of refrigerator (J) 11.Open door more than necessary (K) Ice-lined refrigerator  Domestic Refrigerator The main compartment should have a temperature of 2 to 8⁰C, and the freezer compartment should maintain a temperature of -5 to -15⁰C. * → easy to maintain temp A double door refrigerator should be used - The doors should close snugly Free of leakages of water and coolant Quiet Auto defrost and auto door closure. A voltage stabilizer A good well calibrated thermometer – The thermometer should be placed in both the freezer and the main compartment in the center and away from the walls, door, air vent or frozen packs and never in the door.  ( distinct / health facilities] Domestic Refrigerator A refrigerator in a MOH office should be able to hold: – A one month supply of vaccines and diluents; and – A one month stock of vaccines and diluents as a buffer stock; and – Diluents next to the vaccines with which they were supplied ; and – Frozen ice packs or bottles of water in the bottom of the refrigerator to keep it cool during power failures; and As – Nothing in half the total space available to allow air to circulate around the vaccines and diluents as to keep them cool ; and rputinfont * – Keep Open and unopened vials that have been taken out of the refrigerator in a special two boxes in the main section labeled ‘Returned Unopened Vials ’ and ‘Returned Opened Vials’. Use these vials first in the next session. Domestic Refrigerator These unfrozen (chilled water) ice-packs help to keep the refrigerator cold during a power failure. They should always be stored vertically to avoid possible leaks. Do: 1.Place vaccine in breathable plastic mesh baskets and clearly label baskets by type of vaccine (A) 2.Keep baskets 5 to 8 cm from walls and other baskets (B) 3.Keep vaccine in their original boxes until you are ready to use them (C) 4.Keep vaccines with shorter expiration dates to the front of the shelf/basket (D) 5.Store full water bottles on empty shelves and on the door (E) 6.Place temperature probe/vial in the middle of the refrigeration unit (F) 7.Keep temperature between 2 and 8 degrees ⁰C (aim for 5 degrees C) (G) 8.Check and log temperature twice a day (H) Do Not: 9.Store food or drink in refrigerator – only vaccine in vaccine storage unit (I) 10.Place vaccine in solid plastic trays or containers (J) 11.Store vials out of their original individual packaging (K) 12.Place vaccine in veggie bins, drawers or on floor of refrigerator (L) 13.Open door more than necessary (M) 14.Store vaccine in doors or freezer compartment (N) 15.Use manual or cyclic defrost refrigerators  Domestic Refrigerator Oral Polio (OPV), Measles Rubella (MR),Measles, Rubella and BCG vaccine should be kept in the coldest part of the refrigerator, or in the freezer as freezing does not damage them. Hepatitis B, DPT, DT, TT, IPV and JE should stored in the warmest part of the refrigerator where the temperature will most consistently stay between + 2 °C to + 8 °C. It is very important to make sure that none of the above killed vaccines should be exposed to sub zero temperatures, or not to store in the door or the vegetable compartment of the refrigerator. The arrangement of the stocks should be such that those with a shorter expiry date are easily accessible for use before those with longer expiry dates. This will ensure that the newly received vaccine will be used after those received earlier. Baffle tray: should be kept empty. No vaccines should be stored in the door.  Vaccine transportation msisey carriers > ☐box / Vaccine Cold – These are used for transport of vaccines. – The cold box is designed for: Collection and transport of large quantities of vaccine at temperatures between 0º to +8º C; - Storage of vaccine during maintenance periods, e.g. when cleaning or defrosting a refrigerator or freezer; and Emergency storage of vaccine, e.g., during breakdowns of cold chain equipment, power failures, and similar situations. Vaccine transportation Cold Box Vaccine carriers  Cold Box/Vaccine Carrier They should have frozen ice packs lining the sides. in cold box / vaccine carrier ① use conditioned icepack ⑧ hen intervening a ada /layer ✗ u to prevent injury Arranging ice packs in a vaccine carrier ③ thermometer - to monitor  Cold Box/Vaccine Carrier biarkan kat hear 30 mins , ( then shake idengar air → and... To prevent cold injury conditioned icepacks should be = used rather than frozen packs. Pack killed vaccines (e.g. DPT, DT, aTd, TT , JE and Hepatitis B ) in a plastic container before place inside the vaccine carrier  Cold Box/Vaccine Carrier The vaccine pack should not be placed in direct contact with the icepacks but should have an intervening layer - of plastic/ bubble wrap/styroform peanuts. A thermometer should be placed in the cold box/ vaccine carrier for recording temperatures. For keeping vaccines for longer durations the walls of the thermocol box should be 2 inches thick and have a snugly fitting lid Remember: In order to maintain the temperature in cold boxes and vaccine carriers: Keep them in the shade Keep their lids on  Control and monitoring of temperatures Maintaining correct temperatures during storage and transport of vaccines is a critical task Temperatures must be regularly measured and recorded in order to: – ensure storage of all vaccines at the correct temperature conditions, and – ensure the correct operation of your cold chain equipment. Monitoring of temperatures should be a routine activity, There are a number of different types of monitoring devices to help in measuring, controlling and recording storage temperatures: – Alcohol or mercury thermometer – Dial thermometer – Liquid-crystal thermometer – Recording thermometer  Cold chain monitor card A cold chain monitor card (CCM) is designed to follow the vaccines from the point of manufacturer to the end user Throughout the journey the CCM monitors the temperature and will keep a record of vaccine exposures that have been experienced  Macan panting * Cold chain monitor card Time-temperature exposure of CCM card Index Windows completely A AB ABC blue At a temperature of 3 days 8 days 14 days 12ºC At a temperature of 2 days 6 days 11days 21ºC If windows A, B, C and D are all white, use vaccines normally. If windows A only, A and B, or A, B and C are completely blue, but window D is still white it means that the vaccine has been exposed to a temperature above +10ºC but below 34ºC for the number of days as shown in the table above. Follow instructions on card before using the vaccines. If window D is blue it means that there has been a break in the cold chain of a temperature higher than 34ºC for a period of at least two hours. This would indicate a serious cold chain failure has occurred, and an immediate investigation is needed.  replacement *additional , Vaccine vial monitor *for irdi vaea not The vaccine vial monitor (VVM) is a new type of monitor device applied directly to each vaccine vial by the manufacturer. It enables the health worker to verify at the time of use, whether vaccine is in useable condition and has not lost its potency and efficacy due to temperature exposure. The VVM progressively changes colour with heat exposure, and gives a visual indication when exposure has occurred. VVMs are not a substitute for CCMs; they are an additional device to use in conjunction with other monitors.  Vaccine vial monitor Figure : (a) Vaccine Vial Monitors (VVMs) on the neck of an ampoule, or on the label or cap of a vaccine vial (Source: WHO, 2004). (b) A vial of liquid PCV10 vaccine (Synflorix) with the VVM on the cap (Photo: WHO).  Vaccine vial monitor The VVM has a heat sensitive square in a circular disk that registers a gradual and progressive color change with exposure to heat. The inner square is initially white, but becomes darker with exposure to heat. All the time the inner square is lighter than the surrounding disk, the vaccine is safe to use. If the inner square becomes of equal color or darker than the surrounding disk, the vaccine must NOT be used. NOTE: The VVM is not affected by freezing temperatures so it cannot give any information about freezing.  Vaccine shipping indicators This is another type of indicator, which travels with the vaccines from manufacturer to Central Store for DT, DPT and TT This indicator has a temperature sensitive dot that irreversibly change from silver-gray to black at temperatures above +48ºC  Freeze indicators Freeze indicators are devices used to monitor the exposure of vaccines to freezing. Freeze indicators are packed with batches of freeze-sensitive vaccines The most commonly used type of freeze indicator is the freeze-tag. This is an irreversible temperature indicator It consists of an electronic temperature measuring circuit with a liquid crystal o display (LCD). A small blinking dot of light in the corner of the display shows that the freeze-tag is functioning correctly. Freeze-tags showing: (a) ‘good status’ display; (b) ‘alarm status’ display.  FreezeWatch indicator The FreezeWatch indicator is an irreversible temperature indicator, which shows if vaccines have been exposed to temperatures below 0ºC. It consists of a white backing card with a small vial of o red liquid, all contained in a plastic casing. If the indicator is exposed to temperatures below 0ºC for more than one hour, the vial will burst and release the red liquid. The indicator is used to monitor the storage conditions of DPT, DT, Td, TT and Hep. B. vaccines that lose their potency if frozen.  man penny a# Shake test DPT, DT, aTd, TT, JE and Hepatitis B vaccines can be damaged by freezing. Shake test is used to determine whether vaccine has been frozen  Shake test brant Y¥