Glossary Terms (Simple List)
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Kiln Drying (Wood Pallets)
A process of drying lumber in a dry kiln to a specified moisture content using the correct drying schedule (combination of dry- and wet-bulb temperature settings). Kiln-drying suffices as a heat treatment. This type of treatment is not ISPM certified and would not necessarily have an HT (heat-treated) stamp. However, this is a normal process for drying of lumber. (TR55)
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Kilopascal (kPa)
The International System of Units derived unit of pressure. (TR75)
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Knowledge Management
Systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes and components (ICH Q10). (TR54) (TR68) (TR54-5)
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Labeling
The process by which a label is affixed to a packaging component. (TR85)
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Laminar Flow
Type of fluid (gas or liquid) movement in which the fluid travels smoothly (in a nonturbulent way) or in regular paths. The velocity, pressure, and other flow properties at each point in the fluid remain constant. (TR69)
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Largest Daily Dose
Maximum daily dose of the next product to be produced in the equipment train. (TR70)
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Latent Virus
Latency is the ability of a virus to be dormant (latent) within a cell (for example, genetic episomes; provirus). Under certain conditions the virus may become active and produce particles. (TR71)
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LD50/LC50
Median lethal dose or median lethal concentration, of a toxin, radiation, or pathogen is the dose required to kill half the members of a tested population after specified test duration. LD50 figures are frequently used as a general indicator of a substance’s acute toxicity. (TR55)
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Leachable
A chemical component that migrates from a contact surface into a drug product or process fluid during storage or normal use conditions. The term leachable is often erroneously used to describe an extractable. (TR14) (TR26)
Leachables are organic and inorganic chemical entities that migrate from a packaging/delivery system, packaging component, or packaging material of construction into an associated drug product under normal conditions of storage and use or during accelerated drug product stability studies. Leachables are typically a subset of extractables or are derived from extractables. (TR54-4)
Chemical substances that are leached, from product-contact or non-product-contact materials, under typical process conditions and detected in final dosage. Leachables may be a subset of extractables, and can include their reaction or breakdown products. (TR66)
Organic or inorganic chemical entity that migrates from pharmaceutical container closure system components into a drug product formulation. (TR73)
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Leak Rate
Leak rate is the quantity of air leakage over time into the sterilizer chamber obtained while performing a chamber leak test. The leak rate should not exceed a level that will inhibit the sterilization process during air removal or vacuum drying stages. (TR03)