Glossary Terms (Simple List)
-
Ultrafiltration (UF)
A pressure-driven, membrane-based separation process in which a semipermeable membrane is used to retain high molecular weight solutes, while low molecular weight solutes are allowed to pass through the membrane. (TR15)
-
Ultrafiltration Membranes
Membranes that retain particles whose sizes are measured by molecular weight, with retention ranges from 1,000 to 1,000,000 (Daltons). (TR41)
-
Unidirectional Air Flow Hood (UAFH)
A cabinet designed to protect materials from operator and environmental contamination. Also referred to as laminar air flow hood. (TR62)
-
Unit Operation
A discrete step or manipulation in a manufacturing process where process and operating parameters are defined to achieve a specific process objective. [Synonym: process step] (TR74)(TR14)
-
Unwanted Event or Condition
Lack of sterility assurance or an unacceptable level of endotoxin that could result in harm to the patient. (TR44)
-
Upstream
The influent side of the filter. (TR45) (TR26)
-
User Requirements
Requirements defined by the end user that provide the basis for the development of the equipment specification. They combine the product, process, regulatory, and business needs of a manufacturing system. (TR54-5)
-
Validation
A documented program that provides a high level of scientific assurance that a manufacturing process will reliably produce acceptable product. The proof of validation is obtained through rational experimental design and the evaluation of data, preferably beginning from the process development phase and continuing through the commercial production phase. (TR01)
A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria. (TR26) (TR57) (TR70) (TR74)
Documented testing, performed under highly controlled conditions, which demonstrates that a process consistently produces a result that meets predetermined acceptance a result that meets predetermined acceptance criteria. Used to test processes, methods, and systems for which conditions can be controlled in the real world (i.e., after completion of testing, when the process is in use). Transportation processes can be qualified but not validated; in the real world, it is not possible to exert control over all parameters that could affect the transportation process (e.g., weather, customs, traffic delays, mechanical failures, etc.). (TR58)
A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria. (Note: Validation is a lifecycle program which may include development and qualification activities for one or more elements/systems that form a process.) (TR54-5)
A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria (17). (TR60-3)
-
Validation Reference Standards
Reference standard preparations used for method validations. (TR50)