Lesson #1: Glossary of Terms & Definitions
Active Thermal Shipper: thermal shipper which employs thermostatic controls to maintain proper temperature, in combination with an energy source and mechanical/electrical cooling/heating.
Ambient Product: product which does not require cold chain packaging since it can be exposed to any extreme environmental temperature.
Brick: rigid gel pack which maintains its shape both when frozen and thawed.
Controlled Room Temperature (CRT) Product: as per USP <1079>, a product which can be exposed from 20 to 25ºC, with allowable excursions from 15 to 30ºC
Chemical Temperature Monitor: an analog temperature monitor which relies on a chemical reaction to provide an indication of temperature exposure.
Component Qualification (CQ): First step in the qualification process for cold chain packaging where packaging component specifications are determined. Equivalent to Installation Qualification (IQ) for the validation process.
Digital Temperature Monitor: a temperature monitor, battery operated with silicon circuitry which provides a high accuracy means of recording temperatures. May or may not record time history temperatures.
Environmental Chamber: a test device used in cold chain packaging qualifications which can simulate extreme environmental conditions of temperature and humidity.
Flexible Gel Pack: Gel packs which contain the phase change material (PCM) by means of flexible film. Typically manufactured with Vertical Form Fill Seal equipment.
Gel Pack: a container of phase change material (PCM) where its contents have high enough viscosity to prevent leakage and enhance the rigidity of the container.
Heat of Fusion/Latent Heat: the amount of energy required to melt or freeze a material.
Hybrid Thermal Shipper: thermal shipper which employs thermostatic controls to maintain proper temperature, in combination with phase change material (PCM).
IATA: International Air Transport Association
ISTA: International Safe Transit Association
JIT: Just In Time inventory management
Kraft: a sulphate wood pulp paper
LD3 & LD9: designation for containers capable of holding one to four U.S. sized pallets respectively
Mechanical Temperature Monitor: a temperature monitor which provides a record of temperature by means of a mechanical temperature sensor, such as a bimetallic strip thermometer.
NIST: National Institute of Standards and Technology, a standards setting government agency (such as for temperature measurements)
Operation Qualification (OQ): second step in the cold chain qualification process involving the laboratory testing of a cold chain system against simulated extreme conditions to provide evidence of performance.
Passive Thermal Shipper: a thermal shipper which uses phase change material in combination with insulation to maintain proper product temperatures.
Phase Change Material (PCM): a substance which is employed for cold chain packaging because of the inherent ability of matter to maintain a specific phase change temperature during the phase transition of said matter from one physical state to another, such as from solid (frozen) to liquid; matter is able to maintain a specific temperature because the temperature of the matter itself does not change during this transition. Water is the most common PCM, with a phase transition temperature of 0ºC or 32ºF.
Phase Change Temperature: temperature at which a substance will change from one physical state to another, such as from solid sate (frozen) to liquid, or such as from liquid to gas.
Performance Qualification (PQ): Third step in the qualification process, whereby testing takes place in the field instead of the laboratory (as in the OQ), to further verify assumptions and performance characteristics established during OQ.
Qualification: a process of providing evidence of performance which provides a moderate degree of assurance of reliability and performance capability.
Refrigerated Product: a produc which, as defined by USP <1079> must be stored between 2 to 8ºC.
Rigid Gel Pack: a gel pack which will maintain its shape regardless of the physical state of the Phase Change Material (PCM) within it because of the rigidity of the containment packaging. A blowmolded bottle is a typical packaging form for a rigid gel pack.
Specific Heat: the amount of energy necessary to raise or lower the temperature of one unit of mass of a substance one unit of temperature.
Thermal Shipper: a shipping system capable of maintaining a specified temperature, for a specified payload for a specified time period.
Universal Packout: a type of packout which is unchaged througout the year for a given shipping system, including quantity, positioning and conditioning temperatures for all components.
Validation: a process of providing evidence of performance which provides a very high degree of assurance of reliability and performance capability. Typically the degree of assurance is measured in standard deviations, as 3 sigma or 99.9% reliability / process capability.
WHO: World Health Organization
XPS: Extruded Polystyrene