
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.
(Please select "All" to restart a filtered Search)
Refine Results
Filter By Technical Report Number
- TR 26: Sterilizing Filtration of Liquids (7)
- TR 61: Steam in Place (2)
- TR 69: Bioburden/Biofilm Management (2)
- TR 13: Environmental Monitoring (2)
- TR 14: Validation: Protein Purification Chromatography (2)
- TR 22: Aseptic Process Simulation (2)
- TR 47: Virus Spikes/Virus Clearance (1)
- TR 51: Biological Indicators (1)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 62: Manual Aseptic Processes (1)
- TR 66: Single-Use Systems (1)
- TR 67: Objectionable Microorganisms (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (1)
- TR 15: Validation: TFF in Biopharmaceuticals (1)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (1)
- TR 41: Virus Filtration (1)
- TR 43: Glass Defects (1)
Filter By Technical Report Keyword
Filter By Technical Report Category
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)
Source:
Capsule
A self-contained filter device. (TR45)
Source:
Chemical Compatibility
The relative stability of filter materials and/or filter assembly components when exposed to process fluids and process parameters. (TR45)
Source:
Clarification
The removal of solid particulates from a liquid through filtration, sedimentation, centrifugation or other means. (TR45)
Source:
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)
Source:
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)
Source:
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)
Source:
Fermentation Broth
The fluid and all constituents in a fermentation vessel prior to separation. (TR45)
Source:
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)
Source:
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)
Source:
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)
Source:
Microorganism
A microbe; a free-living organism too small to be seen by the naked eye. (TR45) (TR26)
Source:
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)
Source:
Particulate
Relating to, or occurring in the form of particles. (TR45) (TR26)
Source:
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)
Source:
Scalability Studies
Studies used to assess sizing for the appropriate performance of filter media at increased process volumes. (TR45)
Source:
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)