Glossary Terms (Simple List)
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Shipping Container
A standardized reusable metal box used for safe, efficient and secure storage and movement of materials and products within a global containerized intermodal freight transport system. Intermodal implies that the container can be moved from one mode of transport to another without unloading and reloading. They are the main type of equipment used in intermodal transport, particularly when one of the modes of transportation is by ship. They can also be referred to as ISO containers because the dimensions have been defined by ISO. Other types of transportation containers can include truck trailers. (TR55)
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Shipping Documentation
Documents that have been written for a particular shipment; for example, CMR (Convention Relative au Contract de Transport International de Marchandises par la Route), BOL (Bill of Lading) and/or AWB (airway bill). (TR58)
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Shipping Lane
An established route of transportation between a specific point of origin to a specific destination. More defined routes will consistently use the same combination and types of transportation vehicles and transfer procedures, but this may not be observed through all shipping lanes throughout the last mile. (TR46)
Lane described by origin, transportation node(s) and destination in combination with the used transport mode(s) (truck, aircraft, etc.). (TR58)
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Sieving
Size-exclusion filtration occurs when a particle is too large to pass through the filter medium and is retained on the surface or within the depth of the filter. (TR45)
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Sieving Coefficient (S0)
The ratio of the filtrate concentration of component i (Ci,f) to the bulk or feed concentration of component i (Ci,b) as in the following equation: S = Ci,f/Ci,b Where S = 1 for a freely passing solute, typically a low molecular weight solute S = 0 for a solute that is fully retained by the membrane [Synonym: transmission; product transmission] (TR15)
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Signal Detection Theory
A means to quantify the ability to discern between signal and noise. According to the theory, there are a number of determiners of how a detecting system will detect a signal, and where its threshold levels will be. The theory can explain how changing the threshold will affect the ability to discern, often exposing how adapted the system is to the task, purpose or goal at which it is aimed. (TR55)
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Significant Body of Information
A significant body of information on the stability of the drug product is likely to exist after 5 years of commercial experience for new molecular entities, or 3 years of commercial experience for new dosage forms (TR38)
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Similar
Having a general likeness. (TR38)
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Single Plan True AQL
The quality of product for which the percent of lots expected to be accepted (Pa) is 95.0. These values are found in Tables X-A-1 to X-R-1 in ANSI/ASQ Z1.4-2003. (TR43)
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Single-Use Component (SUC)
An individual part designed to perform a particular function when assembled into a single-use system. (TR66)