Glossary Terms (Simple List)
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Pressure Shock (Forward Pressure Shock)
Rapid increase in forward fluid flow that may dislodge particulates. (TR45)
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Presterilization Bioburden
Number of viable organisms present on or in product prior to exposure to the sterilization process. (TR30)
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Pre-Vacuum Process
A sterilization process in which air is removed from the chamber using a vacuum pump or other mechanical system before the exposure phase begins. This method is particularly suited to load items that can trap air such as tubing, filters and filling machine assemblies. (TR01)
A process in which air is removed by applying a vacuum (i.e., negative pressure) or pulses of vacuum to precondition the system prior to the exposure phase. (TR61)
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Preventative Action
Action to eliminate the cause of a potential non-conformity or other undesirable potential situation. NOTE: Preventative action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence. (TR54)
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Primary (Gold-Standard) Reference Standard
Substance shown by extensive analytical testing to be authentic, representative material; can be
1) obtained from an officially recognized source,
2) prepared by independent synthesis,
3) obtained from existing production material, or
4) prepared by further purification of existing product material; is representative of the production process, so distinct reference materials for product-related substances, product-related impurities, and process-related impurities may need to be established. (TR57-2) -
Primary Contact Surfaces
All process surfaces that have a direct influence on the quality of the drug substance being manufactured, including surfaces processing equipment, storage containers, and of processing aids during manufacturing operations. (TR54-4)
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Primary Pack
Packaging that protects the inoculated carrier from damage and contamination without preventing penetration of the sterilizing agent(s). (TR51)
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Primary Packaging Component
A component that is (or may be) in direct contact with the dosage form. Some examples of primary components are glass vials, syringe barrels, bottles, rubber closures, and container or closure liners. (TR39)
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Primer
A short synthetic single-stranded nucleic acid complementary to a specific sequence of a target gene, DNA or RNA. It usually serves to initiate the de novo synthesis of nucleic acid from a template. (TR50)
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Probabilistic Leak Test Method
A method that is the converse of a deterministic leak test method, being stochastic in nature. Probabilistic tests rely on a series of sequential and/or simultaneous events, each associated with random outcomes described by probability distributions. (TR86)