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.
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.
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”.
The number of hours the temperature inside a passive cold chain container stays below +20º C.
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.
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).
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.
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”
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 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.
Vaccines that come as a liquid and are ready to use in the person.
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 Preparation||The 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 Equipment||Specialized instruments that remotely monitor and log data on cold chain facilities, including ongoing inside/outside temperatures, and temperature events.|
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.