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 41: Virus Filtration (6)
- TR 1: Validation: Moist Heat (4)
- TR 3: Validation: Dry Heat (4)
- TR 26: Sterilizing Filtration of Liquids (4)
- TR 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (4)
- TR 47: Virus Spikes/Virus Clearance (2)
- TR 48: Moist Heat Sterilizer Systems (2)
- TR 66: Single-Use Systems (2)
- TR 70: Cleaning/Disinfection Programs (2)
- TR 15: Validation: TFF in Biopharmaceuticals (2)
- TR 45: Depth Filtration (2)
- TR 50: Alt. Methods Mycoplasma Testing (1)
- TR 51: Biological Indicators (1)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 69: Bioburden/Biofilm Management (1)
- TR 13: Environmental Monitoring (1)
- TR 75: Mycoplasma Filter Rating Method (1)
- TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC) (1)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (1)
- TR 29: Validation: Cleaning (1)
- TR 30: Parametric Release (1)
- TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (1)
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Packaged Raw Material for Single-Use
Procurement of a product such as liquid or powder format culture media or buffer and that has been supplied in single-use technology. (TR66)
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Parametric Release
A sterility release system based upon effective control, monitoring, documentation, and batch records review of a validated sterilization process cycle in lieu of release procedures based upon end-product sterility testing. (TR01) (TR3) (TR13) A sterility release program based on effective control, monitoring and documentation of a validated sterile-product manufacturing process where sterility release is based on demonstrated achievement of critical operational parameters and performance attributes in lieu of end-product sterility testing. (TR30)
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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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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)
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Particles/Particulate (Extrinsic Particles)
Particles that are not part of the formulation but are foreign and unexpected. Examples of extrinsic particles include fibers (e.g., cellulous), clothing fragments, hair, foreign rubber (including degraded/reverted rubber of the same formulation), metal, plastic, and paint. Materials such as foreign rubber, metal, and plastic are defined as extrinsic in cases where the specific material identified is not a material of construction and therefore not considered part of the rubber formulation.(TR76)
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Particles/Particulate (Inherent Particles)
Particles that are expected from the drug formulation, and therefore not included as a category in this Lexicon.(TR76)
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Particles/Particulate (Intrinsic Particles)
Particles that arise from sources related to the materials of construction of the component. Examples of intrinsic particle materials include elastomeric particles of the same formulation or ingredients from elastomer for elastomeric components. (TR76)
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Particulate
Relating to, or occurring in the form of particles. (TR45) (TR26)
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Particulate Load
The total quantity of particles in solution as tested per qualified method. (TR76)
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Pathogen
Any microorganism which by direct interaction with (i.e., infection of) another organism causes disease in the organism (by convention, a multi-cellular organism). (TR51)
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Penetration Probe
A probe placed in contact with the load item or inside a container of liquid to measure the temperature of the load item or liquid. (TR01) A thermocouple placed in contact with the load item to measure the temperature of the load item. (TR3)
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Penicylinder
A small, ceramic carrier surface used to hold cultures of microorganisms. Used in antimicrobial effectiveness testing procedures. (TR70)
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Permeability
The degree to which a fluid will pass through a permeable substance under specified pressure and temperature conditions. (TR41) (TR26)
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Permeate
The fluid which passes through a membrane. (see also filtrate) (TR41)
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Physical Qualification
A component of performance qualification that demonstrates that predetermined physical requirements, including temperature distribution and heat penetration, are achieved consistently throughout the load. (TR01)(TR03)
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Piping and Instrumentation Diagram (P&ID)
A schematic diagram that shows the relational arrangement of piping, components, instruments, and equipment connections of the system. It also illustrates the control and functional relationship. (TR48)
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Plaque Forming Unit (PFU)
A measure of virus infectively based on formation of a region, or “plaque” of lysed cells within a monolayer culture caused by viruses that kill and disrupt their host cell. The number of plaques is directly correlated to the number of infectious virus particles. (TR47)
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Plasmid
An extra-chromosomal DNA molecule in bacteria which is capable of replicating independently of the host chromosomal DNA. Plasmids are often used as positive controls for NAT assays. (TR50)
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Polymerase Chain Reaction (PCR)
A technique widely used in molecular biology in which a DNA polymerase is used to amplify a piece of DNA by in vitro enzymatic replication. As PCR progresses, the DNA thus generated is itself used as a template for replication. This sets in motion a chain reaction in which the DNA template is exponentially amplified. This technique may be used to quantify virus. (TR41) (TR47)
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Pore
The channel(s)/path(s) in a membrane through which a fluid or a gas may pass. (TR41) (TR26)
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Pore-Size Distribution
The range of pore sizes in a filter used to determine the filter’s average pore size. (TR15)
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Porosimetry (Gas-Liquid and Liquid-Liquid)
An analytical technique used to determine various quantifiable aspects of a material’s porous nature, such as pore diameter, total pore volume, surface area, and bulk and absolute densities. (TR41)
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Porosity (Synonym:Void volume)
The percentage of a membrane’s volume that is occupied by pores. (TR15)
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Positive Control Filter Membrane (Penetration Control)
A control filter membrane with a larger pore size rating than the test filter and used to demonstrate the penetrative ability of the test microorganism. Penetration of this filter by at least one CFU is required to validate a test. (TR75)
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Pressure Decay Test
A leak test in which a container or system is pressurized with air to a preset level. After the pressure has stabilized, the decay in pressure over a preset test time is measured and evaluated to determine if a leak (defect) is present. (TR66)
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Pressure Hold Test (or Leak Test)
A test for leaks and gross defects in which the system is held at a defined pressure for a defined time. Failure is indicated by the observation of a steady stream of air bubbles downstream of the filter. (TR41)
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Primary Contact Surfaces
All process surfaces that have a direct influence on the quality of the drug substance being manufactured, including surfaces processing equipment, storage containers, and of processing aids during manufacturing operations. (TR54-4)
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Probability of a Non-Sterile Unit (PNSU)
The number that expresses the probability of occurrence of a non-sterile unit after exposure to a sterilization process. Within the pharmaceutical industry, a design end point better than or equal to the probability of one non-sterile unit in a million units is expected, i.e., PNSU ≤ 10–6. [Synonym: Steriliy Assurance Level (SAL)] (TR01)
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Process
A series of operations and/or actions used to produce a desired result. (TR38)
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Product Changeover
Procedural steps taken for switching from the manufacturing of one product to another product. (TR29)
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Proportional Control Valve
A device that is designed for precise positioning and continuous movement, typically in response to a varying analog signal. [Synonym: Modulating Valve] (TR48)
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Pyrogen
Any substance capable of eliciting a febrile (or fever) response upon injection or infection (as in endotoxin released in vivo by Gram-negative bacteria. (TR3) Fever-producing substance (TR69) A material that elicits a pyrogenic response (fever). (TR70)