Changes in 🟢 Targets Limits Ranges Ontology

Maturity: 🟢 Released

New ontology in this release, review all classes: 🟢 Targets Limits Ranges Ontology

Added

Classes

Construct	Definition
`AcceptanceLimitValueExpression`	limit value expression beyond which an acceptance criterion is not satisfied
`ActionLimitValueExpression`	limit value expression beyond which action is required to address a departure from normal operating conditions and prevent or mitigate potential impact on process performance or product quality
`AlertLimitValueExpression`	limit value expression beyond which an early warning of potential drift from normal operating conditions is triggered, prompting closer monitoring or investigation
`ControlLimitValueExpression`	limit value expression that is a statistical or operational threshold beyond which a process is considered to be out of control
`InitialControlLimitValueExpression`	control limit established from limited process data or process knowledge and applicable only until sufficient information is available to establish statistically justified control limits
`LimitValueExpression`	value expression that is the specified boundary value for a particular entity
`LongTermControlLimitValueExpression`	control limit established from statistically sufficient process data and used for routine monitoring and evaluation of stable long-term process performance
`RangeValueExpression`	value expression that is an interval for values of a particular entity
`SpecificationLimitValueExpression`	acceptance limit value expression that is part of a specification
`TargetRangeValueExpression`	range value expression that prescribes a preferred interval for a quality attribute, material attribute, performance indicator, or process parameter at a particular time point or during a particular time interval of some planned process
`TargetValueExpression`	value expression which is a prescribed value that a quality attribute, material attribute, performance indicator, or process parameter should have at a particular time point or during a particular time interval of some planned process

Object Properties

Construct	Definition
`isLimitValueExpressionOfAtSomeTime`	relation from a limit value expression to an entity indicating that the limit value expression contains a value that marks a boundary of a value region relevant to the entity
`isLowerSideLimitValueExpressionOfAtSomeTime`	relation from a limit value expression to an entity indicating that the limit value expression contains a value that marks a lower-side boundary of a value region relevant to the entity with respect to an ordering in the relevant value space
`isUpperSideLimitValueExpressionOfAtSomeTime`	relation from a limit value expression to an entity indicating that the limit value expression contains a value that marks an upper-side boundary of a value region relevant to the entity with respect to an ordering in the relevant value space

Changed

Classes

`NormalOperatingRangeValueExpression`

IRI: https://spec.industrialontologies.org/ontology/construct/NormalOperatingRangeValueExpression

Annotations

isDefinedBy = “https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter”
explanatoryNote = “NOR is the span within which process is designed to function under typical conditions. This range is distinct from the broader ranges, which may include values associated with abnormal operation or alarm conditions. When a process parameter remains within the normal operating range, no alarm is expected to trigger, as the process parameter is considered to be under control.”
firstOrderLogicAxiom = “NormalOperatingRangeValueExpression(x) → ValueExpression(x) ∧ ∃y (ProcessParameterSpecification(y) ∧ continuantPartOfAtAllTimes(x, y)) ∧ ∃z (SetpointValueExpression(z) ∧ hasContinuantPartAtAllTimes(x, z))”
naturalLanguageDefinition = “value expression that is a range around a set point within which a particular process parameter is expected to vary during normal operation of a process process and that lies within the proven acceptable range for that parameter”@en-US
semiFormalNaturalLanguageAxiom = “if x is a ‘normal operating range value expression’ then x is a ‘value expression’ and x is a ‘continuant part of at all times’ some ‘process parameter specification’ and x ‘has continuant part at all times’ some ‘setpoint value expression’”

isDefinedBy = “https://spec.industrialontologies.org/ontology/biopharma/TargetsLimitsRanges/”
explanatoryNote = “NOR is the span within which a process parameter is expected to vary during normal operation. This range is distinct from broader ranges, which may include values associated with abnormal operation or alarm conditions. When a process parameter remains within its normal operating range, it is considered to be operating within its expected region of normal variability.”
firstOrderLogicAxiom = “NormalOperatingRangeValueExpression(x) → RangeValueExpression(x) ∧ ∃z (SetpointValueExpression(z) ∧ hasContinuantPartAtAllTimes(x, z))”
naturalLanguageDefinition = “range value expression that is an interval around a setpoint within which a particular process parameter is expected to vary during normal operation of a process and that lies within the proven acceptable range for that parameter”@en-US
semiFormalNaturalLanguageAxiom = “if x is a ‘normal operating range value expression’ then x is a ‘range value expression’ and x ‘has continuant part at all times’ some ‘setpoint value expression’”

Parents

ValueExpression (https://spec.industrialontologies.org/ontology/construct/ValueExpression)

RangeValueExpression (https://spec.industrialontologies.org/ontology/construct/RangeValueExpression)

Axioms

SubClassOf: bfo:continuant_part_of_at_all_times some constr:ProcessParameterSpecification
SubClassOf: constr:ValueExpression

SubClassOf: constr:RangeValueExpression

Was Defined By

Moved from BiopharmaParameter (https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/) on 2026-07-10T12:41:00

`ProvenAcceptableRangeValueExpression`

IRI: https://spec.industrialontologies.org/ontology/construct/ProvenAcceptableRangeValueExpression

Annotations

isDefinedBy = “https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter”
explanatoryNote = “The PAR is established based on process development and validation activities, and it is typically narrower than the full instrument span. It defines the boundaries for making saleable product, and excursions outside this range are considered process deviations that may require investigation and corrective action.”
firstOrderLogicAxiom = “ProvenAcceptableRangeValueExpression(x) → ValueExpression(x) ∧ ∃y (ProcessParameterSpecification(y) ∧ continuantPartOfAtAllTimes(x, y))”
naturalLanguageDefinition = “value expression range that has been validated through testing or documented experience and that is a prescribed range within which a single process parameter may vary without adversely affecting product quality, assuming all other process parameters are held constant at their target values”@en-US
semiFormalNaturalLanguageAxiom = “if x is a ‘proven acceptable range value expression’ then x is a ‘value expression’ and x is a ‘continuant part of at all times’ some ‘process parameter specification’”

isDefinedBy = “https://spec.industrialontologies.org/ontology/biopharma/TargetsLimitsRanges/”
explanatoryNote = “The PAR is established based on process development and validation activities and is typically narrower than the full instrument operating span. It defines the demonstrated boundaries for acceptable operation of the process parameter, and excursions outside this range may be treated as process deviations requiring assessment, investigation, or corrective action.”
firstOrderLogicAxiom = “ProvenAcceptableRangeValueExpression(x) → RangeValueExpression(x)”
naturalLanguageDefinition = “range value expression that has been validated through testing or documented experience and that is a prescribed interval within which a single process parameter may vary without adversely affecting product quality, assuming all other process parameters are held constant at their target values”@en-US
semiFormalNaturalLanguageAxiom = “if x is a ‘proven acceptable range value expression’ then x is a ‘range value expression’”

Parents

ValueExpression (https://spec.industrialontologies.org/ontology/construct/ValueExpression)

RangeValueExpression (https://spec.industrialontologies.org/ontology/construct/RangeValueExpression)

Axioms

SubClassOf: bfo:continuant_part_of_at_all_times some constr:ProcessParameterSpecification
SubClassOf: constr:ValueExpression

SubClassOf: constr:RangeValueExpression

Was Defined By

Moved from BiopharmaParameter (https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/) on 2026-07-10T12:41:00

`SetpointValueExpression`

IRI: https://spec.industrialontologies.org/ontology/construct/SetpointValueExpression

Annotations

isDefinedBy = “https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter”
example = “for a residential dwelling temperature control process, the set point might be 72 degrees Fahrenheit during the day and 68 degrees Fahrenheit during the day; 250 rpm as the setpoint for agitation speed in a formulation tank; 20 minutes as the setpoint for residence time in the protein purification chromatography step”
explanatoryNote = “The setpoint represents the value of a physical condition that a control system aims to achieve and maintain. The set point is used by the control system as a reference for comparison against the actual measured value of the process parameter. Specifically, a control system performs regulation by actuating one or more final control devices to modify process parameters, thereby driving the process variable toward the set point. Representation of this control behavior will be included in a future version of the ontology”
firstOrderLogicAxiom = “SetpointValueExpression(x) → ValueExpression(x) ∧ ∃y (ProcessParameterSpecification(y) ∧ continuantPartOfAtAllTimes(x, y))”
naturalLanguageDefinition = “value expression which is a prescribed value that a process parameter should have at a particular time point or during a particular time interval of some planned process”@en-US
semiFormalNaturalLanguageAxiom = “if x is a ‘setpoint value expression’ then x is a ‘value expression’ and x is a ‘continuant part of at all times’ some ‘process parameter specification’”

isDefinedBy = “https://spec.industrialontologies.org/ontology/biopharma/TargetsLimitsRanges/”
example = “for a residential dwelling temperature control process, the setpoint might be 72 degrees Fahrenheit during the day and 68 degrees Fahrenheit during the night; 250 rpm as the setpoint for agitation speed in a formulation tank; 20 minutes as the setpoint for residence time in the protein purification chromatography step”
explanatoryNote = “A setpoint is a prescribed target for a process parameter. It may be used by an automated control system, supervisory system, recipe, or operator as a reference for regulating or evaluating the realized process parameter. In a closed-loop control system, the measured process variable is compared with the setpoint and the resulting difference may be used to determine control action.”
firstOrderLogicAxiom = “SetpointValueExpression(x) → TargetValueExpression(x)”
naturalLanguageDefinition = “target value expression which is a prescribed value that a process parameter should have at a particular time point or during a particular time interval of some planned process”@en-US
semiFormalNaturalLanguageAxiom = “if x is a ‘setpoint value expression’ then x is a ‘target value expression’”

Parents

ValueExpression (https://spec.industrialontologies.org/ontology/construct/ValueExpression)

TargetValueExpression (https://spec.industrialontologies.org/ontology/construct/TargetValueExpression)

Axioms

SubClassOf: bfo:continuant_part_of_at_all_times some constr:ProcessParameterSpecification
SubClassOf: constr:ValueExpression

SubClassOf: constr:TargetValueExpression

Was Defined By

Moved from BiopharmaParameter (https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/) on 2026-07-10T12:41:00