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 47: Virus Spikes/Virus Clearance (6)
- TR 41: Virus Filtration (2)
- TR 69: Bioburden/Biofilm Management (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (1)
- TR 79: Particulate Matter Control in Difficult to Inspect Parenterals (1)
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Vapor Phase Hydrogen Peroxide (VPHP)
A disinfection system in which 35% hydrogen peroxide is changed to a vapor phase and used for bioburden reduction of a chamber or items in a chamber. (TR70)
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Viable
Alive and able to be cultured in the laboratory. (TR69)
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Virus
A simple, potentially pathogenic organism composed of a single type of nucleic acid (DNA or RNA) encased in a protein shell (called a capsid) and, in some cases, a lipid membrane (called an envelope). Viruses are incapable of independent replication and therefore must infect a host cell in order to propagate. (TR41)
Obligate, intercellular, replicating, infectious agents that are potentially pathogenic, possessing only a single type of nucleic acid (either RNA or DNA). They use the host cells for propagation as they are unable to grow independently, for example by binary fission, and multiplying their genomic material. (TR47) (TR83)
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Virus (Endogenous Virus
Viral entity whose genome is part of the germ line of the species of origin of the cell line and can be produced in culture by cell lines from these species. (TR47)
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Virus (Non-specific Model Virus)
A virus used for characterization of viral clearance of the process when the purpose is to characterize the capacity of the manufacturing process to remove and/or inactivate viruses in general, i.e., to characterize the robustness of the purification process. (TR47)
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Virus (Relevant Virus)
A virus used in process evaluation studies that either is the virus, or of the same species as a virus known to or possible to contaminate the cell substrate or any other reagents or materials used in the production process. (TR47)
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Virus Production Lot
A virus preparation that is used directly in a clearance study. It can be crude or purified. Typically a large volume is produced, tested and qualified. This volume is divided into multiple aliquots for individual clearance studies. (TR47)
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Virus Removal
Physical separation of virus particles from the intended product. (TR41)
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Virus Seed
An initial virus stock produced after a new virus is introduced into a laboratory. Its purpose is to create a Master Virus Bank. (MVB) (TR47)
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Visible Particle Range
Particulate matter sized above the visible particle 70% probability of detection threshold are considered in the visible range, typically >100-150 μm. (TR79)