Cold chain system
- 1. COLD CHAIN SYSTEM Dr Preeti Solanki Assistant Professor Department of Community Medicine 16-03-2021 1
- 2. Definition • Cold chain is a system of storing and transporting vaccines at recommended temperatures from the point of manufacture to the point of use. 16-03-2021 2
- 3. Key elements 1. Personnel: to manage vaccine storage and distribution (vaccine and cold-chain handler at each cold-chain point) 2. Equipment: to store and transport vaccine and monitor temperature 3. Procedures: to ensure correct utilization of equipment and ensure vaccines are stored and transported safely. 16-03-2021 3
- 4. Personnel Vaccine and cold-chain handler: • At every ILR point, designate a senior male or female HW (pharmacist/staff nurse/ANM/LHV/MPW/health supervisor) as the VCCH. • He/she should be responsible for forecasting, indenting, receiving, storing and distributing vaccines and logistics, maintaining cold-chain equipment and related records. • They will require training or update of knowledge and skills in order to perform their roles effectively 16-03-2021 4
- 5. Equipment The NCCMIS (National Cold Chain Management Information System) website is the platform where all information on the cold chain equipment and management is being collated. 16-03-2021 5
- 6. Technical specifications of cold chain equipment 16-03-2021 6
- 7. Holdover time The time taken by the equipment to raise the inside cabinet temperature from its cut- off temperature to the maximum temperature limit of its recommended range. Example: In the case of ILR, if the temperature is 4°C, then the time taken to reach 8°C from 4°C will be the holdover time for that ILR. 16-03-2021 7
- 8. Holdover time of ILR depends on the following factors: • Ambient temperature – more the ambient temperature, less will be the holdover time. • Frequency of opening of lid and use of basket. • Quantity of vaccines kept inside with adequate space between the containers (equipment empty/loaded). • Condition of the ice pack lining (frozen/partially frozen/melted) inside electrical/non-electrical cold-chain equipment. 16-03-2021 8
- 9. ILR point or Cold Chain point • Located at a health centre (usually PHC/UHC/CHC) with an Ice Lined Refrigerator for storage of vaccines and a deep freezer for preparation of frozen ice packs. • The cold chain point must have a generator as power back up. • The function of the CCP point is to receive, store and further distribute vaccines, diluents and other logistics to another ILR point or directly to the session sites. 16-03-2021 9
- 10. Cold-chain room • Keep all electrical cold-chain equipment in a separate room with restricted entry to keep the vaccines and cold-chain equipment safe and secure. • During visits to the cold chain room and the weekly meetings, review the cold chain and vaccine distribution system of your centre. • Ensure proper display of all the cold chain related job aids and use them to refresh knowledge and skills 16-03-2021 10
- 11. Cold chain room 16-03-2021 11
- 12. Ice Lined Refrigerator • An ILR with a top-opening lid prevents loss of cold air during door opening and can keep vaccines safe with as little as 8 hours electricity supply in a 24-hour period. • An ILR maintains a cabinet temperature between +2°C and +8°C. • It is used to store UIP vaccines at the PHC and district levels. • ILRs are available in two sizes – large (for districts) and small (for PHCs). • Vaccines should never be kept on the floor of the ILR. 16-03-2021 12
- 13. Storing vaccines in ILR 16-03-2021 13
- 14. Fridge Tag • Digital thermometer • Fridge tag is designed for ILRs • Low and high temperature alarm indicator • 30 days temperature recorder (records max and min temperature every day) • Visual indicator of temperature range violation 16-03-2021 14
- 15. Do’s & Dont’s for ILR 16-03-2021 15
- 16. Deep freezer • Freezing ice packs in the DF maintains the cabinet temperature between -15°C and -25°C. • Unlike the ILR, the DF has little or limited holdover time, which is dependent on the number of frozen ice packs in it and the frequency of opening. • PHC level- DF is used only for preparation of ice packs. • District headquarters- storage of recommended vaccines such as OPV and preparation of ice packs. 16-03-2021 16
- 17. Do’s & Dont’s for DF 16-03-2021 17
- 18. Freezing ice packs in the deep freezer 16-03-2021 18
- 19. Brick layered ice packs in deep freezer 16-03-2021 19
- 20. Domestic refrigerators • Maintain a cabinet temperature between +2°C and +8°C with a holdover time of only 4 hours. • Not recommended for common use in the UIP. • However, they are used in urban dispensaries and by private practitioners in urban areas due to more assured power supply and non-availability of ILRs and DFs. The refrigerator if used must be: • Used exclusively for vaccines • No vaccine should be kept in the compartments of the freezer, chiller, door or basket of the refrigerator • Follow the guidelines to store vaccines on the shelves of the refrigerator in the same order as used for ILR. 16-03-2021 20
- 21. Vaccine van • Insulated van used for transport of vaccines in bulk. • Vaccines should be transported only in cold boxes with the desired number of conditioned ice packs. • These cold boxes should be loaded in the vaccine van immediately after packing with vaccines and unloaded at the destination as soon it is reached. • Vaccines should be removed from the cold boxes and placed in the ILR immediately after reaching the destination. 16-03-2021 21
- 22. Cold box • Insulated box used for transportation and emergency storage of vaccines and ice packs. • It is available in two sizes, large and small. • It is used to: • Collect and transport large quantities of vaccines; • Store vaccines for transfer up to 5 days, if necessary for outreach sessions or when there is a power cut; • Store vaccines in case of breakdown of ILR, as a contingency measure; • Used for storing frozen ice packs, e.g. during emergencies and before campaigns. 16-03-2021 22
- 23. Packing a cold box 1. Place conditioned ice packs at the bottom and sides of the cold box. 2. Load the vaccines in cardboard cartons or polythene bags. 3. Never place freeze-sensitive vaccines in direct contact with the ice packs. 4. Surround them with OPV/BCG/JE vaccines. 5. Keep a thermometer in the cold box. 6. Place two rows of conditioned ice packs above the vaccine vials. 7. Place a plastic sheet to cover the ice packs kept on top to ensure full holdover time. 8. Securely close the lid of the cold box. 16-03-2021 23
- 24. Ice packs • Ice packs are plastic containers filled with water. • These are hard frozen in the deep freezer. • They are placed inside a vaccine carrier and cold box to improve and maintain the holdover time. • They are also used in ILRs as inside lining to improve and maintain holdover time during electricity failure. • About 20–25 ice packs (8–10 kg of ice) and 35–40 ice packs (12–14 kg of ice) can be frozen in one day in small and large deep freezers, respectively. • Standard ice packs used in UIP for cold box and vaccine carrier are of 0.4 litre capacity 16-03-2021 24
- 25. Do’s & Dont’s for Ice packs 16-03-2021 25
- 26. • Conditioning of ice packs prevents freezing of vaccines (freeze-sensitive vaccines such as Hep B and T series) during transportation. • Freeze-sensitive vaccines can be damaged if they come in direct contact with the frozen ice packs. Conditioning of ice packs 16-03-2021 26
- 27. 16-03-2021 27
- 28. Placement of vaccines at Routine immunization session site 16-03-2021 28
- 29. Checking vaccines for heat damage • Vaccine Vial Monitor (VVM) is a label containing a heat-sensitive material to record cumulative heat exposure over time. • The combined effect of time and temperature causes the inner square of the VVM to darken gradually and irreversibly. • Before opening a vial, check the status of the VVM. • If the VVM shows change in colour to the end point, then discard the vaccines. 16-03-2021 29
- 30. 16-03-2021 30
- 31. Checking vaccines for cold damage (freezing) • Conduct the shake test if you suspect that a large number of vials at the cold-chain point could have been frozen. • DPT, TT, IPV, HepB and penta vaccines lose their potency if frozen. • Moreover, the risk of adverse events following immunization (AEFIs) such as sterile abscesses may increase. 16-03-2021 31
- 32. 16-03-2021 32
- 33. 16-03-2021 34
- 34. Vaccine carrier • It is an insulated box used for carrying vaccines (16–20 vials) and diluents from the PHC/ cold- chain point to session sites and to bring back the open vials (under the open vial policy) from the session sites to the cold-chain point on the same day after the session for storage and subsequent use. • Vaccine carrier (with 4 conditioned ice packs) maintains the inside temperature between +2°C and +8°C for 12 hours, if not opened frequently. 16-03-2021 35
- 35. 16-03-2021 36
- 36. Do’s & Dont’s for vaccine carrier 16-03-2021 37
- 37. Open vial policy • Implementation of open vial policy allows reuse of partially used multidose vials of applicable vaccines under UIP in subsequent session (both fixed and outreach} upto four weeks (28 days) subject to meeting certain conditions and thus reduce vaccine wastage. 16-03-2021 39
- 38. Electronic Vaccine Intelligence Network (eVIN) • India’s solution for ensuring effective management of the immunization supply chain. 16-03-2021 40 Three crucial questions Where are my vaccines? Are they available in adequate quantities? Are they being stored in appropriate conditions?
- 39. • Conceptualized and piloted by the Immunisation Technical Support Unit (ITSU), MoHFW. • Three components: 1. Processes 2. Technology 3. Human resources 16-03-2021 41
- 40. How do cold-chain handlers interact with eVIN? • Interaction 1: eVIN’s registers • Interaction 2: eVIN’s technology • Interaction 3: Training of cold-chain handlers and VCCMs 16-03-2021 42
- 41. eVIN’s Registers 1. Vaccine Distribution Register • The number of doses distributed and returned for each vaccine to each session site is recorded in this register. • At the end of the session day, cold-chain handlers calculate the net utilization for each vaccine (total distributed - total returned). 2. Vaccine Stock Register • At the end of a session day, the net utilisation for a vaccine is deducted from the day’s opening stock balance to create a closing balance. • In addition, important information such as batch number, expiry date, name of manufacturer and VVM status is recorded for every transaction. 16-03-2021 43
- 42. Interaction 2: eVIN’s technology • Mobile phone alerts are sent to cold-chain handlers in case storage temperatures or stock levels are too high or too low. 1. Mobile Logistics Management Information System (LMIS) application 2. Temperature loggers 16-03-2021 44