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Cold Box

Insulated containers that can be lined with coolant packs to keep vaccines and diluents cold during transportation and/or short period storage. Cold boxes are used to collect and transport vaccine supplies from one fixed vaccine store to another, and from vaccine stores to health facilities. They are sometimes also used to temporarily store vaccines when the refrigerator is out of order or being defrosted.[1]

Cold Chain

Equipment and practices used to ensure a constant temperature for a product that is not thermostable (such as vaccines, serums, tests, etc.), from the time it is manufactured until the time it is used. It also includes all the temperature monitoring equipment and routines.

Cold Life

The number of hours the temperature inside a passive cold chain container 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. Cold life tests are performed at +43º C. Do not confuse “Cold life” with “Cool life”.

Cool Life

The number of hours the temperature inside a passive cold chain container stays below +20º C.

Coolant Pack

Also referred as “ice packs”, are flat, square plastic bottles that are filled with water and cooled. They are used to keep vaccines cool inside the vaccine carrier or cold box.

Decommission

The process of planned removal of equipment from an active status and its storage in a secure and safe place until disposal.

Disposable Insulated Carton Box

Passive cold chain portable container used by producers to ship their vaccines around the world. Generally, they consist of a polystyrene box inserted in a cardboard box for transport of large quantities of vaccines in favorable favourable circumstances (e.g. in an airplane). They have a limited cold life (often with a maximum of 4 days).

Lot Release

The process of national regulatory authority evaluation of an individual lot of a licensed vaccine before giving approval for its release on to the market.

Summary Protocol

A document summarizing all manufacturing steps and test results for a lot of vaccine, which is certified and signed by the responsible person of the manufacturing company. Also called “lot summary protocol”

Vaccine Carrier

Small cold boxes, portable by one single person, used to keep the vaccine cold for short transport, or to store vaccines temporary just before vaccine administration. There are many types.

Expanded Programme on Immunization (EPI)

Global program initiated by WHO with the objectives to ensure immunization of all children against certain diseases (such as measles, rubella and tetanus) and to eradicate poliomyelitis, and to extend all new vaccine and preventative health interventions to children in all districts in the world.

WHO PQS

WHO audited and pre-qualified medical equipment based on Performance, Quality and Safety (PQS) requirements. The list of validated equipment is accessible online and used by several agencies as reference for procurement.

Ready-to-use Vaccine

Vaccines that come as a liquid and are ready to use in the person.

Reconstituted Vaccines

The vaccines that come 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).

Solar Direct-Drive (SDD)

Refrigeration technology for solar powered devices that avoids the batteries for energy storage.

Vaccine PreparationThe process of mixing freeze-dried vaccine with the diluent. Consider that vaccine produced by one manufacturer must never be used with diluent produced by another.
Sensing/Monitoring EquipmentSpecialized instruments that remotely monitor and log data on cold chain facilities, including ongoing inside/outside temperatures, and temperature events.

Introduction

Vaccines are made from micro-organisms similar to the ones that cause disease, or from the toxins that bacteria produce. Therefore, 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.

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The infrastructure should enable the cold store to function effectively. This includes the adequateness of the store building (the location and the construction standard) and the basic utilities, particularly the power supply feeding the active cold chain.

All the infrastructure should be of a satisfactory standard and correctly maintained through planned preventive maintenance. Emergency repairs should be exceptional and conducted in a timely manner.  There should exist reports on maintenance and repairs. Adequate supplies of spare parts, consumables and fuel should be available. If relying in an emergency generator, it should be also well serviced and operational.

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Capital costs are one-time costs incurred at the time of purchase. It includes: the costs of the equipment, recommended spare parts, in-country transport, installation kit, and installation laborlabour.

Operating expenses are the recurring costs over the useful life of the equipment. This includes cost of energy (electricity, gas, kerosene), maintenance, repairs and decommissioning plus the costs of operation and training of staff.

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A refrigerated (multimodal) container or reefer, is a shipping container equipped with an integrated refrigeration unit for the transportation of temperature-sensitive cargo. They rely on external electrical power provided from the ship, the quay or the trailer. This These type of containers is are suitable for large-scale shipments and when the journey requires changing modes of transport (i.e. road-sea-road). Normally , normally over long distances.

This type of shipment is Refrigerated containers are rarely used for vaccine transport. For long distances or inter-continental movements, vaccines are commonly air-shipped in cold storage containers, which are either actively powered or passively kept cold. Therefore, refrigerated multimodal containers are not advised for transportation of vaccines.

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Such vehicles are utilised for large-scale transport of vaccines from the manufacturer to primary/central stores and in certain context for bulk transport between primary/central stores and secondary stores. Refrigerated vehicles are commonly run by specialised logistics operators. Please review the checklist for contracting refrigerated vehicles in the road transport section of this guide. 

Still, the high cost of refrigerated vehicles and their tendency to suffer mechanical breakdowns, have prevented many developing countries from using this transport method for regular deliveries.[23] Additionally, when using a refrigerated vehicle in such contexts, it is recommended cold packing provisions to protect vaccines in case of vehicle breakdown.

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Vaccine manufacturers ship products by air using coolant-packs of various types and sizes containing various fill materials, including water, gel and PCM. It is a common practice to reuse these coolant packs recovered from international shipping containers. WHO discourages this practice as these packs do not necessarily perform in the same way as the water-packs. In addition, they are not designed for repeated use and may not be dimensionally compatible with most of the passive containers used for the in-country supply chain. The recommendation is that, after vaccine arrival, these packs are removed from the receiving vaccine store and recycled or disposed of according to the vaccine manufacturer’s recommendations and/or national waste management policies. [29]

Preparing

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Shipments

Conditioning Water-Packs

The temperature of coolant packs must be set according to the temperatures required by the vaccines to be shipped. There are two main possibilities: (1) the vaccines to be shipped in the cold box may be frozen (Measles, Polio, Yellow fever, Meningitis, etc.); (2) the vaccines to be shipped in the cold box will be irreversibly damaged when frozen (DTP, DT, Td, TT, Hep A and Hep B, Hib).

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For international/air shipments, a label must be affixed to the front surface of each package indicating type of vaccine, name of manufacturer, presentation, batch number, date of manufacture, date of expiry, quantity, and storage conditions. The manufacture date and expiry date on all labels should be written in full, not in a coded form (i.e. June 2017, not 06.17). In addition, required temperature conditions for transportation must be clearly visible on the outer carton, indicating clearly where recommended transportation temperatures differ from recommended storage temperatures.[30]

A “Vaccine Rush” Label must be affixed to each face of the vaccine package

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A “Do Not Freeze” label must be affixed to those packages (in each face) containing freeze-sensitive vaccines, droppers or diluents.

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An IATA Time and Temperature Sensitive Label (mandatory from 2012). The lower half of the label must never be left blank and must indicate the external transportation temperature range of the shipment - this can be hand written or printed onto the label.

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Labels must be written in a language appropriate to the country of destination.

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Ensure priority unloading. Remove product from the vehicle and check that the number of boxes matches the number of boxes shown in the packing list. If it does not, note it conveniently in the provided way billwaybill. Also indicate in the way bill waybill if the shipping boxes were received in good condition and if all necessary labels on the outside of the shipping boxes were present.

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Temperature monitoring devices and routines are used during every storage and during every transportation stage, until the vaccine is administered to the recipient. Depending on the supply chain level (central store, intermediary store or outreach and transportation container) different monitoring devices are used.

Monitoring

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Devices and

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Technologies

Devices for Cold Rooms and Freezer Rooms

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Example of these devices are:

TempTime LIMITmarker™Temptime FREEZEmarker®
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Progressive Type chemical indicators register multiple events in a cumulative way. Whenever the threshold temperature is exceeded the reaction is activated and the indicator starts to change. Further temperature violations increase the change process. The indicator for this type of device usually takes the form of a progressive colour change along a paper strip.

Cold Chain Monitor (CCM) Card

Paper-based temperature monitoring device which change colour irreversibly and at a constant rate. Indicator strips are attached to a card on which instructions for use are printed.

CCMs provide a warning when excessive heat exposure occurs during transport. They are used primarily to monitor the international shipment of freeze-dried vaccine consignments where dry ice is used. CCMs may also be appropriate for national vaccine shipments where the delivery takes several days.[35]

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Vaccine Vial Monitor (VVM):

Heat-sensitive label that gradually and irreversibly changes colour as the vaccine is exposed to heat. It warns the health worker when a vial should be discarded because the vaccine is likely to have been degraded by exposure to heat. For instructions on how to interpret VVM, refer to WHO How to Monitor Temperatures in the Vaccine Supply Chain

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Electronic Freeze Indicators [36] - used to check if vaccines are exposed to freezing temperatures during storage or transport. The alarm indicator is triggered and displayed (changing from a “√” to an “X”) if exposed to temperatures lower than -0.5 °C for a continuous period of 60 minutes. To avoid malicious manipulation, once the alert is triggered, the alert is irreversible. If this happens the device is no longer usable and should be discarded. Otherwise, the device can be used until the built-in battery expires. The intermittent “dot” icon confirms active monitoring.

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Electronic Shipping Indicators - more sophisticated devices that show if a product has been exposed to temperatures beyond the assigned alarm settings. They record the temperature at regular intervals during a certain period (normally not exceeding 20 days due to memory overflow). They have a digital display that reflects if the vaccine being shipped crossed the alarm thresholds.

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  • Identify the affected products, mark them and place them in quarantine to avoid its use temporarily. A quarantine area should be clearly marked for this purpose in one functioning cold chain equipment.
  • Write a cold chain breakdown report and send it to the relevant persons. It must be submitted as soon as possible. The report should include information about the products (name, manufacturer, batch number, expire date, quantity) and the details of the Cold chain rupture (temperature range, exposure time, source of the alert).
  • Wait for pharmacist recommendations. Even if some cold chain break occurred, the vaccine could be used under certain instructions. In case that the vaccine must be discarded, proceed according to the national regulation.

References

How to calculate vaccine volumes and cold chain capacity requirements, 2017, WHO/IVB

Procurement Guidelines, Compression System Refrigerators and Freezers, 2014, UNICEF

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Templates and Tools

TEMPLATE - Cold Chain Temperature Monitoring Chart

Full Template Package

Sites and Resources

References

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Sites and Resources

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[1] Procurement Guidelines, Vaccine Carriers and Cold Boxes, 2016, UNICEF

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