Glossary Terms (Simple List)
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Pore-Size Distribution
The range of pore sizes in a filter used to determine the filter’s average pore size. (TR15)
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Porosimetry (Gas-Liquid and Liquid-Liquid)
An analytical technique used to determine various quantifiable aspects of a material’s porous nature, such as pore diameter, total pore volume, surface area, and bulk and absolute densities. (TR41)
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Porosity
The ratio of void volume to bulk volume of the filter media. (TR26)
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Porosity (Synonym:Void volume)
The percentage of a membrane’s volume that is occupied by pores. (TR15)
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Porous/Hard Goods Load (P/HG)
A porous/hard goods load consists of items in which the bioburden is inactivated through direct contact with saturated steam. Porous/ hard goods load items include: filters, stoppers, tubing (hoses), mops, garments, stoppers, cleaning equipment, or machine change parts. (TR01)
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Positive Control
A test article used to assess the performance of an assay in the known presence of a targeted microorganism or nucleic acid. A positive control is used to monitor the performance of assay routinely and during validation. For culture-based assays, a live mycoplasma preparation must be used to show that the assay was run properly. NAT positive controls use a nucleic acid with the target sequence of interest. (TR50)
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Positive Control Filter Membrane (Penetration Control)
A control filter membrane with a larger pore size rating than the test filter and used to demonstrate the penetrative ability of the test microorganism. Penetration of this filter by at least one CFU is required to validate a test. (TR75)
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Positive Unit
Unit filled in an aseptic processing simulation that exhibits detectable microbial growth after incubation. (TR22) (TR62)
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Post-fill Inspection
Inspection of glass containers after product filling. (TR43)
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Potency
The measure of the biological activity using a suitably quantitative biological assay, based on the attribute of the product that is linked to the relevant biological properties. (TR57)
An expression of the activity of a secondary calibration standard to relate units of weight (ng/ vial or ng/mL) to units of activity (EU/ng) in a preparation.(TR82)