Glossary Terms (Simple List)
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Temperature Monitor
A unit that measures the prevailing temperature. Several types exist, including:
• Stationary monitors installed in (cold) storage warehouses or storage facilities;
• Mobile monitors that include:
• Chemical indicators that change color when exposed to temperature over time
• Electronic indicators that indicate temperature excursions, but provide little or no summary data
• Electronic or mechanical data loggers that record and store temperature data for retrieval after arrival
• Transmitting monitors that transmit near real-time data and excursion events using wireless/satellite interfaces and software for “logical analysis” of data. (TR58) -
Temperature Probe
A sensor (e.g., thermocouple or resistance temperature detector (RTD)) that has been specifically designed to measure temperature. Temperature probes may be control, resident, surface mounted, validation, mapping, or permanent. (TR61)
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Temperature Probe/Sensor
A generic term used to describe any type of temperature measuring device that works through contact with the material or atmosphere to be measured. [Synonyms: Load Probe, Heat Penetration Probe, Temperature Distribution Probe, Drain Probe] (TR48)
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Temperature Profile
Anticipated ambient temperature variation and duration to which product may be exposed during transportation. (TR39)
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Temperature Sensitive Products
Products whose quality may be adversely affected by temperature extremes (e.g., frozen, refrigerated, and certain controlled room temperature products). (TR39)
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Temperature-Controlled Distribution
Material handling and movement of goods from an origin site to a receiving site, where the goods are kept within a specified temperature range using active and/or passive systems. (TR58)
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Temperature-Controlled Ocean Container
An actively cooled metal box, most commonly 20 or 40 foot long which can be easily transferred between different modes of transportation, such as ships, trains and trucks. Sometimes it is called a reefer container or intermodal container. (TR58)
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Temperature-Controlled Ocean Container (Reefer, Intermodal Container)
An actively cooled metal box (commonly 20 or 40 ft long) that can be easily transferred between different modes of transportation, such as between ships, trains, and trucks. (TR64)
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Temperature-Controlled Truck or Trailer
A cargo box attached to a truck chasse or as a trailer pulled by a truck that is equipped with a temperature control unit (TCU) to provide active cooling or heating control inside the box. Refrigerated trucks or trailers are sometimes referred to as “reefers”. The temperature control units are typically powered by an integrated engine or gen-set and not the engine that is used to propel the truck. (TR58)
A cargo box attached to a truck chassis or consisting of a trailer pulled by a truck that is equipped with a TCU to provide active cooling or heating control inside the box (refrigerated trucks or trailers are sometimes referred to as “reefers”). (TR64)
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Terminal Sterilization
A process whereby product is sterilized within its sterile barrier system. (TR01
The application of a lethal agent to sealed, finished drug products for the purpose of achieving a predetermined sterility assurance level (SAL) of usually less than 10-6 (i.e., a probability of a nonsterile unit of less than one in a million). A process where the material is sterilized in its final packaged configuration. (TR13)