Glossary Terms (Simple List)
-
Sterilizer System Suitability Evaluations
Physical evaluations (e.g., chamber integrity or air removal) conducted on a scheduled frequency to demonstrate ongoing control of the sterilizer system. (TR30)
-
Sterilizing Grade Filter
A filter intended for terminal processing of sterile liquids that has been tested under worst-case actual processing conditions for the ability to retain a minimum challenge of 107 cells of Brevundimonas diminuta per cm2 of filter area. (TR41)
A filter that reproducibly removes all test microorganisms from the process stream, producing a sterile effluent. (TR75)
A filter that reproducibly removes test microorganisms from the process stream, producing a sterile filtrate. (TR26)
-
Stirred-Cell Filtration
A surrogate for tangential flow filtration where shear is achieved by rapidly stirring the solution immediately adjacent to the membrane. Typically the stirring is accomplished by mechanical means, such as through the use of a stir bar or impeller. (TR15)
-
Storage
The retention of pharmaceutical products in a location such as a warehouse; the storing of pharmaceutical products up until their point of use. (TR53)
-
Storage Solution
A solution typically selected to control bioburden during column storage. (TR14)
-
Storage Temperature
The temperature range listed on the medicinal product label specified for long term storage. (TR39)
-
Store
A store is a temperature-controlled and / or temperature- monitored warehouse, chamber, or cabinet where pharmaceutical products are stored. (TR58)
-
Strain
A specific isolate of a species that is maintained in pure culture and is serotypically, genotypically, or chemotaxonomically characterized to differentiate it from other strains of the same species. The strain is representative of the species and provides a reference for the species based on its historic isolation, characterization, and deposition in recognized culture collections. (TR13)
-
Stress Studies (Degradation Pathway Studies)
Studies undertaken to elucidate the intrinsic stability of the drug substance and/or drug product; part of the development strategy and normally carried out under more severe conditions (e.g., high or low pH or oxidation levels, or shaking) than those used for accelerated testing. (TR57-2)
-
Stringer
A continuous, longitudinal, solid or notched beam-component of a pallet used to support deck components, often identified by location as the outside or center stringer. (TR55)