Glossary Terms (Simple List)
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Bubble Point Test
A test to indicate the maximum pore size of a filter. The differential gas pressure at which a liquid (usually water) is pushed out of the largest pores and a steady stream of gas bubbles is detected from a previously wetted filter under specific test conditions. Used to test filter integrity with specific, validated, pressure values, wetting liquids and temperatures for specific pore-size (and type of ) filters. (TR26)
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Bulk Packaged Product
Consists of solid, liquid, or frozen product in a bulk container configuration such as a bag, tank, or drum. The product may be in these container configurations between process steps or prior to filling into vials, ampoules, cartridges, or syringes. (TR39)
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Cake
Solids deposited on the upstream side of filter media. (TR15) (TR45) (TR26)
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Calibration
The demonstration that an instrument or device produces results within specified limits when compared to those produced by a reference standard or a standard that is traceable to national or international standards, over an appropriate range of measurements (calibration range). (TR 1) (TR 30) (TR 48) (TR 61)
The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a reference or traceable standard over an appropriate range of measurements. (TR 54-5)
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Calibration Curve
The relationship between measured response values and analytical concentrations of a standard or reference material. (TR57)
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Calibration Tolerance
In metrology, the maximum permissible range around a specified value that applies to a properly functioning measuring instrument. [Synonym calibration uncertainty, error](TR48)
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Campaign
A series of consecutive production batches manufactured without intervening cleaning and sterilization. (TR13) (TR22) (TR62)
Processing of multiple lots or batches of the same product serially in the same equipment. (TR29) (TR49)
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Campaigning
Extending the period of time, or number of cycles a single-use system is operating in a closed process without breaking the sterile barrier processes. The end user is responsible to evaluate and determine if appropriate quality requirements are met for their application. (TR 66)
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Capsule
A self-contained filter device. (TR45)
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Capsule Filter
Compact, self-contained filter assembly. Generally, the whole assembly is disposable. (TR26) (TR41)