
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 48: Moist Heat Sterilizer Systems (1)
- TR 57: Analytical Method Validation (1)
- TR 61: Steam in Place (1)
- TR 64: Temp Controlled Systems Qualification (1)
- TR 3: Validation: Dry Heat (1)
- TR 14: Validation: Protein Purification Chromatography (1)
- TR 15: Validation: TFF in Biopharmaceuticals (1)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 39: Cold Chain (1)
- TR 42: Validation: Protein Manufacturing (1)
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Darcy Permeability
The constant of proportionality of the material as defined by Darcy’s Law. (TR45)
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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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Pressure Shock
An unanticipated rapid increase in fluid flow. [Synonym: Hydraulic Shock] (TR45)
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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 (Forward Pressure Shock)
Rapid increase in forward fluid flow that may dislodge particulates. (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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Screening Studies
Studies used to select a particular type and grade of filter media. (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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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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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)