Glossary Terms (Simple List)
-
Chromatography
The passage of a solute (mobile phase) through resin (stationary phase) to achieve purification of substances based on the chemical, physical, and biological properties of the molecules involved. (TR14)
-
Chromatography Resin
Material used to interact with the process stream in order to purify the target protein. Chromatography resin usually consists of porous particles within a defined particle size range that are insoluble in the process stream (e.g., ceramic beads, agarose). (TR14)
-
Clarification
The removal of solid particulates from a liquid through filtration, sedimentation, centrifugation or other means. (TR45)
-
Class I Recall
A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. (TR55)
-
Class II Recall
A situation in which use of or exposure to a violative product or may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequence is remote.(TR55)
-
Class III Recall
A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.(TR55)
-
Clean
Having product residues, process residues, and environmental contaminants removed to an acceptable level. (TR29) (TR49)
The implementation of procedures to render an area, piece of equipment, system, or object free of adulterants and contaminants. (TR 70)
-
Clean Hold Time
The time from the end of the cleaning process until the equipment is used again (which may be product manufacture, autoclaving, or a steam in place (SIP) cycle). (TR29)
-
Clean in Place (CIP)
The process of rinsing or washing of process components, as installed without removal, in order to remove or eliminate any contaminants. (TR45)
-
Clean Water Flux
A baseline filter flow measurement performed with clean water or a buffer, at a specified transmembrane pressure and temperature. (TR15)