Changes in 🟡 Biopharma Material Testing Ontology
- Maturity: 🟡 Provisional
New ontology in this release, review all classes: 🟡 Biopharma Material Testing Ontology
Added
Classes
| Construct | Definition |
|---|---|
CultureMediaFingerprinting | measurement process in which a culture medium is characterized by one or more analytical methods to generate a multivariate profile that can be used to assess identity or consistency |
MaterialConformanceSpecification | requirement specification that specifies tests and acceptance criteria for evaluating the acceptability of a material product, process intermediate material, raw material, or production consumable for a particular use |
MaterialConformanceTestingProcess | material testing process that evaluates a material product, process intermediate material, raw material, or production consumable against acceptance criteria specified by a material conformance specification |
MaterialHoldState | material state during which a material entity remains restricted from one or more specified uses or handling activities |
MaterialPerformanceTestingProcess | material testing process that evaluates a capability of the input material entity through its use in a specified process or its exposure to specified test conditions |
MaterialReleaseDispositionSpecification | material state specification that is a specified output of a material release process and specifies the post material state of the evaluated material entity with respect to a particular use |
MaterialReleaseProcess | planned process in which a material entity, together with relevant evidence, is assessed against specified requirements to determine whether, and under what conditions, the material entity may exit quarantine or another controlled hold and be made available for a particular use |
MaterialStabilityTestingProcess | material testing process that evaluates the capability of an input material entity to maintain one or more specified attributes or performance characteristics over time under specified conditions |
MaterialTestAssessment | information content entity that records the outcome of evaluating measurement results against a specified testing criterion |
MaterialTestingInformationContentEntity | information content entity that is the result of testing a material entity or one or more of its attributes against specified testing criteria |
MaterialTestingProcess | planned process that evaluates a material entity or one or more of its attributes against one or more specified testing criteria |
OutOfSpecificationAssessment | material test assessment that records that one or more measurement results do not meet the acceptance criteria specified by an applicable material conformance specification |
SpentCultureMediaAnalysis | measurement process in which one or more attributes of material samples containing spent culture medium are measured to characterize the extracellular medium during or following cell culture |