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 73: Prefilled Syringe User Requirements for Biotech Applications (2)
- TR 14: Validation: Protein Purification Chromatography (2)
- TR 15: Validation: TFF in Biopharmaceuticals (2)
- TR 26: Sterilizing Filtration of Liquids (2)
- TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (2)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 62: Manual Aseptic Processes (1)
- TR 66: Single-Use Systems (1)
- TR 22: Aseptic Process Simulation (1)
- TR 41: Virus Filtration (1)
- TR 45: Depth 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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Elastomer
Thermoplastic material formulation (that may or may not contain rubber/natural latex) derived from elastic polymer; often used interchangeably with the term “rubber.” (TR73)
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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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Leachable
A chemical component that migrates from a contact surface into a drug product or process fluid during storage or normal use conditions. The term leachable is often erroneously used to describe an extractable. (TR14) (TR26) Leachables are organic and inorganic chemical entities that migrate from a packaging/delivery system, packaging component, or packaging material of construction into an associated drug product under normal conditions of storage and use or during accelerated drug product stability studies. Leachables are typically a subset of extractables or are derived from extractables. (TR54-4) Chemical substances that are leached, from product-contact or non-product-contact materials, under typical process conditions and detected in final dosage. Leachables may be a subset of extractables, and can include their reaction or breakdown products. (TR66) Organic or inorganic chemical entity that migrates from pharmaceutical container closure system components into a drug product formulation. (TR73)
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Mandrel
Specialized filling needles on certain BFS machines which also act to form the container. (TR77)
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Parison
The “tube” of polymer extruded by the BFS machine from which the containers are formed. (TR77)
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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)