Glossary Terms (Simple List)
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System, Closed
A “closed” system is sterilized-in-place or sterilized while closed prior to using a validated procedure, is pressure and/or vacuum tight to some pre-defined leak rate maintained through the length of the campaign, can be utilized for its intended purpose without breach to the integrity of the system, can be adapted for fluid transfers in and/or out while maintaining asepsis, is connectable to other closed systems while maintaining integrity of all closed systems (e.g., Rapid Transfer Port, steamed connection, etc.), is safe guarded from any loss of integrity by scheduled preventative maintenance and utilizes sterilizing filters for sterilization of process streams which are integrity tested and traceable to each product lot. (TR28)
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System, Open
A system which fails to meet one or more of the criteria which define a closed system. (TR28)
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Tailgate Sample
Representative and random samples of the lot taken by the manufacturer during the packing process for the use of incoming inspection purposes. (TR76)
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Tailing
Deviation from first-order death kinetics in a microbial population observed when the logarithm of the number of survivors is plotted against time. The “tail” of the survivor curve represents organisms surviving for times in excess of those that would be predicted from first-order kinetics. (TR51)
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Taints
Taints are unpleasant odors and tastes due to low levels of organic compounds of natural or human-derived origin in food, beverages and drug products. Taints arise from an external source as opposed to off-odors or off-flavors from internal changes to a product (i.e., microbial spoilage). (TR55)
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Tangential Flow Filtration
Filtration in which the product stream is introduced parallel to the membrane surface and flows in a direction perpendicular to the filtrate flow. (Synonym:cross-flow filtration) (TR15)
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Tangential or Cross Flow Filtration (TFF or CFF)
Filtration in which a fluid (feed) stream runs tangential to a membrane. A pressure differential causes some fluid to pass through the membrane. (TR41)
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Target Criteria
Numerical limits, ranges, or other suitable measures of target performance levels of an analytical method that indicate suitable performance for intended use. For a method entering qualification, this is a target performance criterion that, when assessed, indicates that the method is qualified for its intended purpose. (TR57-2)