Glossary Terms (Simple List)
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Pre-Filter
Any filter placed upstream of the final filter. (TR26)
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Preliminary Hazard Analysis (PHA)
A tool of analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations and events that might cause harm, as well as to estimate their probability of occurrence for a given activity, facility, product or system (ICH Q9). (TR54) (TR54-2) (TR54-3) (TR54-4)
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Preliminary/Process Hazard Analysis (PHA)
A tool of analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations and events that might cause harm, as well as to estimate their probability of occurrence for a given activity, facility, product or system. (TR54-5)
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Preparation Record
An approved document that gives the detailed instructions for preparation of the Clinical Trial Materials (CTM). (TR63)
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Preparation Site
The location where extemporaneous preparations of Clinical Trial Materials (CTM) are made. (TR63)
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Pressure
Force applied per unit area, usually expressed as psi, mbar, kPa or kg/cm2. (TR45) (TR26)
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Pressure Decay Test
A leak test in which a container or system is pressurized with air to a preset level. After the pressure has stabilized, the decay in pressure over a preset test time is measured and evaluated to determine if a leak (defect) is present. (TR66)
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Pressure Hold Test (or Leak Test)
A test for leaks and gross defects in which the system is held at a defined pressure for a defined time. Failure is indicated by the observation of a steady stream of air bubbles downstream of the filter. (TR41)
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Pressure Shock
An unanticipated rapid increase in fluid flow. [Synonym: Hydraulic Shock] (TR45)
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Pressure Shock (Backward Pressure Shock)
Rapid backward fluid flow that may result in filter rupture. (TR45)