Glossary Terms (Simple List)
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Plate-and-Frame
A membrane-module geometry, utilizing flat sheet membranes, in which membranes are stacked between supporting plates. (TR15) A device used to support filter sheets and provide inlet- and outlet-flow channels. It is composed of a series of filters sheets separated by alternating plates (outlets) and frames (inlets) that are compressed between two end-plates (heads) by either hydraulic or mechanical means. (TR45)
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Platform Manufacturing
Development of a production strategy for a new drug starting from manufacturing processes similar to those used to manufacture other drugs of the same type (the production for which there already exists considerable experience). (TR60)
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Platform-Based Method
Existing method based on the same basic principles and steps as a new method that is required and defined in the design/strategy phase; applies to multiple sample types and requires minimal changes or refinements based on specific product requirements. (TR57-2)
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Plunger
The combined components of the plunger rod and plunger stopper. (TR73)
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Plunger Rod
Portion of the plunger assembly which provides a thumb pad for depressing the plunger and is attached to the plunger stopper inside the syringe barrel. (TR73)
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Plunger Stopper (Piston, Stopper, Plunger, Gasket, Plug, Bung, Closure)
Elastomeric component, which acts as a seal to prevent product leakage and also as the portion of the syringe which forces the expulsion of the contents of the syringe when depressed. (TR73)
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Plunger Stopper-Barrel Interface
Circumferential contact points between the ribs of the plunger stopper and the inner diameter of the syringe barrel. (TR73)
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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
The size of the channel passages through the filter media. (TR41)