Pressure
Force applied per unit area, usually expressed as psi, mbar, kPa or kg/cm2. (TR45) (TR26)
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Pressure Shock (Backward Pressure Shock)
Rapid backward fluid flow that may result in filter rupture. (TR45)
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Pressure Shock
An unanticipated rapid increase in fluid flow. [Synonym: Hydraulic Shock] (TR45)
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Pressure Shock (Forward Pressure Shock)
Rapid increase in forward fluid flow that may dislodge particulates. (TR45)
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Volatile
Evaporates easily; converts easily from a liquid form to gas. (TR45) (TR26)
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Void Volume
See Porosity. (TR45)
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Water for Injection (WFI)
Water purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms and contains no added substances. (TR45)
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Yield, Theoretical
The quantity that would be produced at any appropriate phase of production, based upon the quantity of material to be used, in the absence of any loss or error in actual production. (TR45)
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Yield, Expected
The quantity of material or the percentage of theoretical yield anticipated at any appropriate phase of production based on previous laboratory, pilot scale or manufacturing data. (TR45)
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Turbidity
Finely dispersed particles causing cloudiness or haziness in water or other fluid. Turbidity may be measured using a nephelometer. (TR45)
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Standard Pressure
A pressure of 1 atmosphere (14.70 psi or 760 mm of mercury) to which measurements of quantities dependent on pressure are often referred. (TR45)
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Surfactant
A soluble compound that reduces the surface tension of a liquid or reduces interfacial tension between two liquids (causing formation or micelles) or between a liquid and a solid. [Synonym:Wetting Agent] (TR45) (TR26)
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Recovery
The mass of desired solute in the final product solution (either permeate or retentate, depending on the process), divided by the mass of the desired solute in the initial feed solution, expressed as a percentage. [Synonym: yield] (TR15) (TR45) A measure of the amount of analyte carried through the entire sample preparation and assay procedure and expressed as a percentage of the nominal concentration. (TR57)
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Rejection
The ability of a filter to exclude solutes or particulate matter from passing through. (TR45)
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Retention Efficiency
The percentage of particles of a specific size that are removed by a filter. (TR45)
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Retention Rating
The means by which a filter manufacturer defines the ability of a filter to retain specific-sized particles. (TR45)
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Scalability Studies
Studies used to assess sizing for the appropriate performance of filter media at increased process volumes. (TR45)
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Screening Studies
Studies used to select a particular type and grade of filter media. (TR45)
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Sieving
Size-exclusion filtration occurs when a particle is too large to pass through the filter medium and is retained on the surface or within the depth of the filter. (TR45)
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Sanitization
Reduction of microbial contaminants to safe levels as judged by public health requirements for the specific country. (TR13) A significant reduction in bioburden, achieved in chromatography by the use of bactericidal agents, such as sodium hydroxide (NaOH), hydrochloric acid (HCl), ethanol (EtOH), and isopropanol (IPA). (TR14) The process of reducing microbial levels by treatment at less than defined sterilizing conditions. Typically water at 80 °C or a chemical treatment is used to perform sanitization of process components. (TR45) A process that reduces the number of viable microorganisms to a defined level. (TR61) (TR69)
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Particulate
Relating to, or occurring in the form of particles. (TR45) (TR26)
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Performance Qualification (PQ)
Documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications. (TR3) (TR14) (TR45) (TR42) (TR48) (TR61) (TR64)
Transport tests of product or representative product that is conducted during actual transportation or distribution. (TR39)
Documented evidence that provides a high degree of assurance that the equipment and/or system functions accurately and consistently according to predetermined specifications in its operating environment. (TR54-5)
Documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications (17). (TR60-3)
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Particle
Any discrete unit of material structure; a discernible mass having an observable length, width, thickness, size and shape. (TR45) (TR26)
Foreign material which is unintended and either removable from the surface of a primary packaging component or freely moving within a filled and sealed pharmaceutical dosage form. The term particle is used interchangeably with “particulate” and “particulate matter” without any intended difference in meaning. (TR85)
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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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Limulus Amebocyte Lysate (LAL) Test
Endotoxin detection and quantitation can be accomplished at high sensitivity and specificity using reagents manufactured from Limulus Amebocyte Lysate, a biological reagent prepared from horseshoe crabs and offered in a variety of formulations. (TR45)
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Media
The part of the filter through which fluid passes that retains particles during filtration. (TR45)
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Lenticular Filters
A filter made up of a series of biconvex cells that are stacked on top of one another with rings between them to prevent bypass between the cells. End-caps are then placed at the top and bottom of the assembly and are held in place with a central core. [Synonyms: Lenticular Cartridge, Modules, Filter Elements, Filter Devices] (TR45)
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Integrity Test
Test to determine the functional performance of a membrane filter or container/closure system. (TR22) A nondestructive test used to predict the functional performance of a filter. (TR45) A nondestructive physical test that can be correlated to the bacterial retention capability of a filter/filter assembly. (TR26)
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Hydraulic Pressure
Pressure that results from forcing liquid through an orifice, pipe or other channel. (TR45)
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Gauge Pressure
The pressure measured by a pressure gauge. Typically expressed in units of psig, bar or kilopascal. (TR45) Gauge pressure is the difference between a given fluid pressure and that of the atmosphere. (TR26)
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Flow Decay Test
An experiment to determine flow rate and throughput of a filter type or combination of filters on a specific liquid, usually by using a small area filter, to determine the sizing of a filter system by extrapolation. (TR45)
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Fermentation Broth
The fluid and all constituents in a fermentation vessel prior to separation. (TR45)
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Extractable
A chemical component that is removed from a material by application of an artificial or exaggerated force (e.g., solvent, temperature, time). The term extractable is often erroneously used to describe a leachable. (TR14) (TR15) (TR26) (TR41) (TR45) Chemical substances that can be extracted from components of material process fluid contact surfaces by exertion of an exaggerated force (e.g., organic solvent, extreme elevated temperature, ionic strength, pH, contact time, etc.) Extractables may represent most but not all of the potential leachables that may be seen in process fluids. (TR66) Extractables are organic and inorganic chemical entities that can be released from a pharmaceutical packaging/delivery system, packaging component, or packaging material of construction under laboratory conditions. (TR54-4) Organic or inorganic chemical entity that is forced out of container closure system materials and components under laboratory experimental conditions. (TR73)
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Downstream Side (of Filter)
The effluent side of the process step (filter). (TR45) The filtrate or outlet side of the filter. (TR26)
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Deionized Water
Water treated by passing through both cation- and anion-exchange resin beds, or a mixed-resin bed to remove both positive and negative ions. (TR45)
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Depth Filter
A matrix of randomly distributed fibers creating a tortuous path with pores of undefined size and shape. A filter that removes particles by a combination of adsorption and size exclusion within its porous matrix rather than on its frontal surface. (TR45)
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Darcy Permeability
The constant of proportionality of the material as defined by Darcy’s Law. (TR45)
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Diffusion Flow Test
A test to determine the integrity of a filter. The test is based on the measurement of the diffusive (diffusional) flow of a gas through a wetted filter, along with any bulk flow of gas through open (unwetted) pores. Either the gas flow or the downstream liquid, displaced by the gas flow, may be measured. [Synonym: Forward Flow Test] (TR45)
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Differential Pressure
The difference in pressure between the upstream (feed or influent) and downstream (effluent) sides of the filter. (May be modified with the terms: applied, available differential pressure, clean differential pressure, dirty differential pressure, initial differential pressure, or maximum differential pressure). [Synonym: Delta P (Δ P), PSID, Pressure Drop] (TR45) (TR26)
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Colloid
A mixture with properties between those of a solution and a fine suspension. (TR45)
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Compatibility
Proof that no adverse interaction between the filter and the process fluid has occurred. (TR26) A term used in relation to the non-reactivity of filter materials with the substance to be filtered. (TR45)
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Clean in Place (CIP)
The process of rinsing or washing of process components, as installed without removal, in order to remove or eliminate any contaminants. (TR45)
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Clarification
The removal of solid particulates from a liquid through filtration, sedimentation, centrifugation or other means. (TR45)
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Chemical Compatibility
The relative stability of filter materials and/or filter assembly components when exposed to process fluids and process parameters. (TR45)
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Breakthrough Limited
A filtration operation resulting in a significant rise in filtrate turbidity accompanied by a small increase in differential pressure. This occurs when the adsorptive capacity of the filter is reached, resulting in the passage of particles smaller than the pore size of the filter that would normally be removed by adsorption. (TR45)
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Brevundimonas Diminuta (B. diminuta)
Small bacteria (0.3–0.4 &mum in diameter by 0.6–0.1 &mum long) used to challenge a sterilizing grade filter during validation testing. [Formerly Pseudomonas diminuta](TR45)
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Capsule
A self-contained filter device. (TR45)
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Cake
Solids deposited on the upstream side of filter media. (TR15) (TR45) (TR26)
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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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Batch Process
A process where there are no streams flowing into or out of a controlled volume, as opposed to a continuous process. In a batch filtration process, the feed solution is reduced in volume due to permeation of filtrate through the filter. There is no continuous addition of feed solution to the feed vessel. (TR45)
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