Glossary Terms (Simple List)
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Leak Test
See System Integrity Test. (TR61)
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Length
The measure of the distance along its longest axis. Light obscuration (LO). Analytical technique measuring the size and quantity of subvisible particles. (TR85)
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Lenticular Filters
A filter made up of a series of biconvex cells that are stacked on top of one another with rings between them to prevent bypass between the cells. End-caps are then placed at the top and bottom of the assembly and are held in place with a central core. [Synonyms: Lenticular Cartridge, Modules, Filter Elements, Filter Devices] (TR45)
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Life Supporting or Life Sustaining Drug
Life supporting or life sustaining is used to describe a product that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function that is important to the continuation of human life. (TR68)
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Lifecycle
All phases in the life of a product from the initial development through marketing until the product’s discontinuation. (TR54) (TR60)
All phases in the life of a product, from the initial development through marketing until the product is discontinued. (TR60-2)
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Ligand
A functional molecule (small molecule or protein) coupled to the chromatography resin that selectively interacts with the target protein, impurities, or other molecules from the process stream. (TR14)
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Limit
A value for a residue above which a cleaning process would not be acceptable. (TR29) A value for a residue above which a cleaning validation protocol would fail. (TR49)
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Limit of Detection (LOD)
The lowest concentration of microorganisms in a test sample that can be detected, but not necessarily quantified, under the stated experimental conditions. (TR33)
The lowest amount of analyte in a sample that can be distinguished from the absence of analyte. (TR41)
The lowest concentration of analyte that can be unambiguously detected in a sample. For qualitative and for quantitative NAT methods, this value is conventionally expressed as a 95% positive cut-off value, representing the target concentration detected in 95% of repeated tests using a certain assay. (TR50)
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Limit of Quantification
The lowest number of microorganisms in a test sample that can be enumerated with acceptable accuracy and precision under the stated experimental conditions. (TR33)
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Limit Sample
An actual physical unit that is agreed to between the drug manufacturer and the glass manufacturer that defines the approximate maximum degree of acceptability for a specified non-conformance. Creation of limit samples between the user and the manufacturer is optional. (TR43)