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 14: Validation: Protein Purification Chromatography (2)
- TR 26: Sterilizing Filtration of Liquids (2)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 57: Analytical Method Validation (1)
- TR 66: Single-Use Systems (1)
- TR 69: Bioburden/Biofilm Management (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (1)
- TR 74: Reprocessing of Biopharmaceuticals (1)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (1)
- TR 41: Virus Filtration (1)
- TR 45: Depth Filtration (1)
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Composite Membrane
A membrane consisting of multiple layers. (TR15)
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Contaminant
Any adventitiously or externally introduced material(s) (e.g., chemical, biochemical, or microbial species) not intended to be part of the process. (TR14) (TR15) (TR70)
An undesired impurity of a chemical or microbiological nature that is introduced into a raw material, intermediate, or API (drug substance) during manufacture. (TR14) (TR15)
Any adventitiously introduced materials (e.g., chemical, biochemical, or microbial species) not intended to be part of the manufacturing process of the drug substance or drug product. (TR69) (TR74)
Any adventitiously introduced material (e.g., chemical, biochemical) or microorganisms including viruses not intended to be included in the manufacturing process of the drug substance or drug product. (TR83)
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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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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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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)