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 22: Aseptic Process Simulation (2)
- TR 48: Moist Heat Sterilizer Systems (1)
- TR 50: Alt. Methods Mycoplasma Testing (1)
- TR 51: Biological Indicators (1)
- TR 62: Manual Aseptic Processes (1)
- TR 69: Bioburden/Biofilm Management (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 71: Emerging Methods for Virus Detection (1)
- TR 3: Validation: Dry Heat (1)
- TR 13: Environmental Monitoring (1)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (1)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (1)
- TR 28: Process Simulation for Bulk API (1)
- TR 41: Virus Filtration (1)
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Eductor
A device that produces vacuum by means of the Venturi effect. [Synonym: Aspirator, ejector pump] (TR48)
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Endogenous Virus
A virus that pre-exists in the genome of the cell substrate. (TR71)
A virus that integrates into the genome of the cell substrate. (TR83)
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Endogenous Virus-Like Particles – (e.g., Type C endogenous retroviruses)
Virus-like entity whose genetic material is stably integrated into the germ line of an organism or cell line. Cell lines (notably CHO) may constitutively produce virus-like particles, which are typically noninfectious but still of safety concern. Model retroviruses are generally used as surrogates to measure virus-like particle clearance. (TR41)
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Endospore
A type of spore formed intracellularly by some bacterial genera. (TR51)
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Endotoxin Indicator (EI) for Depyrogenation
An article challenged with a vial of endotoxin (or a carrier spiked with endotoxin) designed for use in depyrogenation studies. The endotoxin (a purified lipopolysaccaride) is validated for use in or on an endotoxin indicator. The carrier is made from a material appropriate for the intended depyrogenation processes to which it will be subjected. The endotoxin on a carrier is added at a concentration sufficient to allow recovery of a minimum of 1000 USP endotoxin units/carrier. The endotoxin indicator would allow for accurate indication of at least a 3-log reduction in USP endotoxin units during depyrogenation process challenges. (TR3)
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Endpoint PCR
A classical PCR method based on repeated cycling of the reaction mixture between two or three temperatures (denaturing, annealing, and extension) with detection of the amplified product after reaction completion (e.g., by agarose gel electrophoresis). (TR50)
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Environmental Control Parameters
Conditions and corresponding measurements as associated with facilities and equipment used in the control of a manufacturing area that may impact the identity, strength, quality, or purity of a product. Among such parameters are airflow rates and patterns, pressure differentials, materials and personnel flow, temperature and relative humidity, as well as nonviable and viable particulates. (TR13)
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Environmental Flora (isolates)
Microorganisms associated with a processing environment. (TR22)
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Environmental Monitoring (EM)
Describes the processes and activities that need to take place to characterize and monitor the quality of the environment. (TR70)
Monitoring for nonviable particulates and/or microorganisms where the result meets or exceeds the alert and/or action level or limit. (TR88)
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Environmental Monitoring Program
Defined documented program which describes the routine particulate and microbiological monitoring of processing and manufacturing areas, and includes a corrective action plan when action levels are exceeded. It includes assessment of environmental air, surfaces and personnel. (TR22) (TR28) (TR62)
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Extracellular Polymeric Substance (EPS)
Product of microbial growth, particularly in biofilms, composed of polysaccharides, lipids, proteins, and nucleic acids; produced by bacteria and fungi; is an important mediator of microbial attachment to surfaces and biofilm formation. (TR69)