Glossary

Direct comparison of the properties of, for example, the similar biotherapeutic product with the reference biotherapeutic product in the same study.

The amount of heat that must be added to convert a unit of mass of a solid into a liquid at its melting-point temperature, or the amount of heat that must be removed to convert a unit of mass of a liquid into a solid at its freezing-point temperature.

A transportable, powered appliance moveable by multiple people for short periods, intended primarily for temporary and/or long-term vaccine storage and transport by powered vehicle. All appliances must be designated by the legal manufacturer as one of three appliance types: lightweight, medium-weight, or heavy-weight.

The time in hours during which all points in the vaccine compartment remain between +2°C and +8°C, at the maximum ambient temperature of the temperature zone for which the appliance is rated, after the appliance has initially cooled and stabilized, the power supply has been subsequently disconnected and no other power sources are actively cooling the device. 

Hot zone appliances and units must maintain specified internal storage temperatures while operating at a steady +43°C ambient temperature and over a +43°C/+25°C day/night test cycling temperature range.

Hot zone units must maintain specified internal storage temperatures while operating at a steady +50°C ambient temperature and over a+50°C/+25°C day/night cycling temperature range.