PDA Technical Glossary
PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.
The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the PDA Technical Report Portal.
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- TR 45: Depth Filtration (5)
- TR 15: Validation: TFF in Biopharmaceuticals (3)
- TR 49: Validation: Cleaning Biotech (1)
- TR 57: Analytical Method Validation (1)
- TR 62: Manual Aseptic Processes (1)
- TR 14: Validation: Protein Purification Chromatography (1)
- TR 22: Aseptic Process Simulation (1)
- TR 26: Sterilizing Filtration of Liquids (1)
- TR 29: Validation: Cleaning (1)
- TR 41: Virus Filtration (1)
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Aseptic Processing Simulation (APS)
A means for establishing the capability of an aseptic process as performed using a growth medium. (TR22) (TR62)
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Compatibility (Filter)
The ability of a filter to be used with a particular process fluid without a change in the inherent properties of the filter. (TR41)
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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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Flow Rate
The volumetric rate of flow of a solution, expressed in units of volume per time (e.g., L/min or gal/day). (TR15) (TR26)
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Flow-through
Effluent that may contain the product that is not retained by chromatography resin during column loading. (TR14)
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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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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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Recovery Study
A laboratory study combining the sampling method and analytical method to determine the quantitative recovery of a specific residue for a defined surface. (TR29) A laboratory study combining the sampling method and analytical method to determine the quantitative recovery of a specific residue for a defined surface. (TR49)
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Rejection
The ability of a filter to exclude solutes or particulate matter from passing through. (TR45)
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Screening Studies
Studies used to select a particular type and grade of filter media. (TR45)
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Stirred-Cell Filtration
A surrogate for tangential flow filtration where shear is achieved by rapidly stirring the solution immediately adjacent to the membrane. Typically the stirring is accomplished by mechanical means, such as through the use of a stir bar or impeller. (TR15)