Glossary Terms (Simple List)
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Evaporator
Component that transfers heat out of or into the CES (to control the area temperature). (TR64)
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Event Tree Analysis (ETA)
A systematic technique that employs forward logic to construct a graphical representation of consequences from an initiating event. (TR54)
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Excipient
A component of a drug formulation that has no active pharmacologic function. Excipients are commonly used in drug formulations as modulators of pH or osmolality for parenteral administration and as stabilizers for APIs. (TR54-4)
An ingredient added intentionally to the drug substance that should not have pharmacological properties in the quantity used. (TR57)
Inactive pharmaceutical ingredients in a product formulation that are responsible for the product’s manufacturability and physicochemical attributes. (TR67) (TR88)
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Exclusivity
The capacity of an assay not to detect microorganisms closely related to a target microorganism. (TR33)
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Excursion
A temperature or humidity deviation from conditions such as those specified by product labeling or shipping specifications. (TR53)
Measurement that exceeds an alert, concern, or action level/limit by either a discreet value or an increasing/decreasing trend. (TR69)
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Exotoxin
Lipopolysaccharides from the cell walls of bacteria, the most potent of which derive from Gram-negative organisms. When injected, they are known to cause a febrile, or fever-producing reaction that can cause severe patient reactions, and on occasion, can be fatal. (TR26) (TR44)
Pyrogenic lipopolysaccharide component of Gram-negative bacterial cell walls.(TR69)
The major constituent of the outer membrane of Gram-negative bacteria is composed of lipid A, the core polysaccharide, and the O-antigen polysaccharide; endotoxin is also known as lipopolysaccharide (LPS).(TR82)
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Exposure Phase
The phase of the sterilization cycle in which the appropriate parameters are maintained within defined ranges for the time (exposure time or dwell period) and temperature determined to be necessary to achieve the desired lethality. (TR1) (TR3) (TR30) (TR48) (TR61)
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Extemporaneous Preparation (EP)
A type of compounding whereby a drug or combination of drugs and/or excipients is prepared under the supervision of a pharmacist to create a customized medication dosage form in accordance with a clinical protocol. (TR63)
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Extended Producer Responsibility (EPR)
Refers to a legislative requirement that packaging manufacturers “take back” their packaging, or otherwise ensure (through a tax) that it is collected and properly disposed of. (TR46)
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Extracellular Polymeric Substance (EPS)
Product of microbial growth, particularly in biofilms, composed of polysaccharides, lipids, proteins, and nucleic acids; produced by bacteria and fungi; is an important mediator of microbial attachment to surfaces and biofilm formation. (TR69)