Glossary Terms (Simple List)
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Beta Glucans [(1?3)-ß-D-glucans] (BG)
Homopolymers of glucose connected by (1→3)-β-D- glycosidic linkages. (TR45)
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Bias
A systematic difference in a method that manifests itself as a deviation of the method mean from an expected value. (TR57)
Total systematic error, in contrast to random error. Measurement centered on the true result is said to be unbiased or have no systematic error. The distance between the center of a large (infinite) number of measurements and the correct value is the bias. (TR 57-2)
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Bioanalytical Test Method
A method used to assess the presence of analytes (chemical or biological) in biological samples (e.g., serum, plasma, etc.). (TR57)
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Bioassay
Analysis (as of a drug) to quantify the biological activity(ies) of one or more components by determining its capacity for producing an expected biological activity. (TR57)
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Bioburden
The total number of microorganisms per unit of material prior to sterilization. (TR13)
Total number of viable microorganisms on or in a health care product prior to sterilization. (TR22)(TR61)(TR62)
A population of viable microorganisms in a fluid prior to sterilizing filtration. (TR26)
A measure of the contaminating organisms found in or on a given amount of material before it undergoes a sterilization process. (TR45) (TR70)
The number of detectable microorganisms (bacteria and fungi) with which an object is contaminated. It is measured in CFU (colony forming units). (TR47)
The number of viable, contaminating microorganisms present on a product immediately prior to decontamination. (TR51)
Viable microbial contaminants associated with personnel manufacturing environments (air and surfaces), equipment, product packaging, raw materials (including water), in-process materials, and finished products. (TR 67) (TR 69)
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Biocide
Chemical substance that has been proven to kill specific microorganisms common in the pharmaceutical manufacturing environment. (TR 69)
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Biofilm
Microbially derived sessile community characterized by cells that are irreversibly attached to a substratum, interface, or each other; are embedded in a matrix of extracellular polymeric substances (EPSs) that they produce; and exhibit an altered phenotype with respect to growth rate and gene transcription. (TR 69)
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Biofouling (or Biological Fouling)
Accumulation and subsequent deleterious effects of biological contaminants on engineered products or processes (TR 69)
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Biological Active Substance
Manufactured biological active substances and medicinal products involving biological processes and materials, such as cultivation of cells or extraction from living organisms. (TR56)
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Biological Activity
Property that describes the specific ability or capacity of a product to achieve a defined biological effect. (TR57)