Glossary Terms (Simple List)
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Particle
Any discrete unit of material structure; a discernible mass having an observable length, width, thickness, size and shape. (TR45) (TR26)
Foreign material which is unintended and either removable from the surface of a primary packaging component or freely moving within a filled and sealed pharmaceutical dosage form. The term particle is used interchangeably with “particulate” and “particulate matter” without any intended difference in meaning. (TR85)
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Particles/Particulate (Extrinsic Particles)
Particles that are not part of the formulation but are foreign and unexpected. Examples of extrinsic particles include fibers (e.g., cellulous), clothing fragments, hair, foreign rubber (including degraded/reverted rubber of the same formulation), metal, plastic, and paint. Materials such as foreign rubber, metal, and plastic are defined as extrinsic in cases where the specific material identified is not a material of construction and therefore not considered part of the rubber formulation.(TR76)
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Particles/Particulate (Inherent Particles)
Particles that are expected from the drug formulation, and therefore not included as a category in this Lexicon.(TR76)
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Particles/Particulate (Intrinsic Particles)
Particles that arise from sources related to the materials of construction of the component. Examples of intrinsic particle materials include elastomeric particles of the same formulation or ingredients from elastomer for elastomeric components. (TR76)
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Particulate
Relating to, or occurring in the form of particles. (TR45) (TR26)
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Particulate Load
The total quantity of particles in solution as tested per qualified method. (TR76)
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Particulate Matter
Particulate matter consists of mobile, randomly-sourced, extraneous substances, other than gas bubbles, that cannot be quantitated by chemical analysis due to the small amount of material that it represents and its heterogeneous composition. (TR79)
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Passaging
Propogation of a seed stock by serial sub-culturing. (TR51)
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Passive Holdover
The length of time that the temperature remains within the acceptable range when power is lost. (TR64)
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Passive System
Systems without active temperature control. Refrigerants may be, for example, gel packs, dry ice, water, and/or ice. Examples include insulated containers, packouts and cool boxes/containers. (TR58)
Systems without active temperature control (e.g., insulated containers with or without refrigerants). (TR39)