Glossary Terms (Simple List)
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Microbial Enumeration
Compendial test for microbial counts using the plate-count, membrane-filtration or most probable number methods described in USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumerations Tests. (TR67)
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Microbial Identification
The determination of the genus, and species when possible, to which a laboratory or manufacturing isolate belongs. (TR13)
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Microbiological Examination Tests
The compendial tests for microbial enumeration and absence of specified microorganisms as found in USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumerations Tests and USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. (TR67)
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Microbiological Identification
Biochemical characterization of isolated colonies to determine the isolate genus and, where feasible and appropriate, the species. (TR22)
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Micro-condensation
The formation of very fine layers of condensation often invisible to the naked eye. (TR51)
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Microdosing Studies
Studies designed to speed up the development of promising drugs by establishing early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. May include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent’s pharmacokinetics and pharmacodynamics. A Microdosing study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. (TR56)
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Microfiltration (MF)
Pressure-driven, membrane-based separation process in which particles and dissolved macromolecules (typically 0.1 &mum or larger) are retained. (TR15)
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Microorganism
A microbe; a free-living organism too small to be seen by the naked eye. (TR45) (TR26)
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Microorganism of Concern
A bacterium, yeast, or mold that, due to it prominence in product recalls, infection outbreaks, nosocomial infections, and the clinical literature, results in a multifactor risk assessment to determine whether the microorganism is objectionable if it is present in a specific nonsterile product. (TR67)
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Microprocessor
One of the five major components of a TCU, the unit interfaces with temperature sensors in the discharge and return air and adjusts the output rate of active cooling or heating to achieve the setpoint temperature. (TR64)