Glossary Terms (Simple List)
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SUS Interchangeability
Functionally equivalent substitution of an alternative SUS, for an existing SUS design providing a contingency or process improvement with equivalent process performance and product quality. The end user is responsible to evaluate and determine if appropriate quality requirements are met for their application. (TR66)
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Suspensions
A suspension is a biphasic preparation consisting of solid particles dispersed throughout a liquid phase. Some suspensions are prepared and ready for use, and others are prepared as solid mixtures intended for reconstitution with an appropriate vehicle just before use. (TR79)
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Syncytial Forming Units (SfU)
A clumping of fused neighboring cells (syncytia) caused by viral infection when viral fusion proteins are transported to the surface of the infected cells and cause the host cell membrane to fuse with neighboring cells. The number of syncytia is directly correlated to the number of infectious virus particles. (TR47)
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Syringeability
The qualities required for delivery of the syringe contents at a given injection rate via a needle of a predetermined gauge and length that enables optimal injection conditions for the drug product, taking into account the product’s physical properties, flow rate, injection force, and needle gauge. (TR73)
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System D-value
D-value of a BI when measured in a specified gas generator/separative enclosure combination operating within a defined sporicidal vapor-phase decontamination cycle. (TR51)
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System Integrity Test
Any test designed to detect leaks or other breaches in system integrity that might compromise operator safety or system sterility (or sanitary status). [Synonym: leak test.] (TR61)
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System Integrity Test (Mass Flow Integrity Test)
A system integrity test that measures the mass flow needed to maintain a given pressure. (TR61)
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System Integrity Test (System Pressure Hold Test)
A system integrity test in which the system is pressurized to a predetermined level with filter sterilized compressed air or other compressed gas, after which the system is isolated and the amount of pressure loss over time is measured. (TR61)
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System Integrity Test (System Vacuum Hold Test)
A system integrity test in which the system under test is evacuated to a predetermined setpoint and the system is isolated from the external environment. The decay in vacuum level over time is measured. (TR61)
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System Suitability Evaluations
Physical evaluations (e.g., chamber integrity or air removal) conducted on a scheduled frequency to demonstrate ongoing control of the sterilizer system. (TR01)