Glossary Terms (Simple List)
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Phase Change Material (PCM)
A physical material that stores and releases thermal energy when freezing or melting. A PCM releases energy when freezing [latent heat energy] and absorbs energy when melting. (TR46)
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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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Pilot Scale
The manufacturing of a drug substance by a procedure fully representative of and simulating that to be applied to a production-scale batch. (TR38)
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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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Planktonic (Free Floating)
Suspended in the bulk phase of a fluid as opposed to being attached to surfaces. (TR69)
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Planning Bill of Materials (BOM)
A complete list of the raw material (chemicals, media, powders, resin, etc.) and consumables/components (filters, bags, tubing, containers, etc.) that are required to manufacture the product. (TR65)
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Plant Utilities
Utilities include pharmaceutical-grade water systems, compressed gases, pharmaceutical-grade air systems, heating, ventilation and air conditioning systems, and space pressurization. (TR67)
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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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Plaque Purification
The process of extracting virus from a lawn of plaque for growth in cell culture. By performing several rounds of plaque purification a virus clone can be isolated. (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)