Glossary Terms (Simple List)
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Control Valve
A device that modulates the flow of fluid (e.g., gas, steam, water) in a conduit in response to a signal from a process measurement control system. (TR48)
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Controlled Area
An area constructed and operated in such a manner that some attempt is made to control the introduction of potential contamination (an air supply approximating to Grade D may be appropriate), and the consequences of accidental release of living organisms. The level of control exercised should reflect the nature of the organism employed in the process. At a minimum, the area should be maintained at a pressure positive to the immediate external environment and allow for the efficient removal of small quantities of airborne contaminants. (TR13)
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Controlled Environmental Space (CES)
An area that is controlled by regulating temperature. (TR64)
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Controlled Room Temperature (CRT)
Defined by USP <1079> as the usual and customary working environment of 20 °C to 25 °C (68 - 77 F) that allows for deviations between 15 °C and 30 °C (59 - 86 F) based on stability data. (TR58)
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Convection
The transfer of heat by the circulation or movement of the heated liquid or gas. (TR3)
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Cool-Down Phase
The phase of a sterilization cycle that occurs after completion of the exposure phase. Parameters of a cool-down phase are typically defined in order to meet applicable user requirements for load cooling and drying. (TR01)
The phase of a sterilization cycle that occurs after completion of the exposure phase. [Synonym: post-conditioning phase, slow exhaust phase, drying phase, equalization phase] (TR48)
The phase of an SIP cycle that occurs after completion of the exposure phase. Parameters (e.g., time, temperature, pressure) of a cool-down phase are typically defined in order to meet applicable user requirements for system cooling and drying. (TR61)
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Corked or Cork Taint
A musty-moldy off-flavor or taste imparted to the wine primarily due to the presence of 2, Combination Products 6-trichloroanisole (2, Combination Products 6-TCA) produced by the fungalo-methylation of 2, Combination Products 6-tricholorophenol (TCP) associated with corks, wooden barrels, and construction materials in wineries. (TR55)
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Correction
Repair, rework, or adjustment relating to the disposition of an existing deviation. (TR88)
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Corrective Action
Actions taken to eliminate the cause of an existing (corrective) or potential (preventative) non-conformity to prevent its recurrence. (TR52)
Action to eliminate the cause of a detected non-conformity or other undesirable situation. (TR54)
A response taken to remediate the effect of an excursion or product failure. (TR13)
Action taken to eliminate the causes of an existing deviation or other undesirable situation to prevent recurrence. (TR88)
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Corrective Action and Preventative Action (CAPA)
Action to eliminate the cause of a detected nonconformity or other undesirable situation. NOTE: Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence. (TR 52) (TR 54-2) (TR 54-3) (TR 54-5)
A subsystem used to collect and analyze information, identify and investigate product and quality problems, and take appropriate and effective measures to prevent recurrence of the identified problem (8). (TR88)