Changes in 🟢 Biopharma Monitoring And Control Ontology

Maturity: 🟢 Released

Added

Classes

Construct	Definition
`AliquotingProcess`	material sampling process in which a homogeneous material entity is subdivided into multiple portions of defined amount, each portion representing the composition of the source
`AtlineMonitoringProcess`	monitoring process consisting of one or more measurement processes that are preceded by a material sampling process, in which material representing the entity of interest is collected from a process stream or in-process material and transferred to analytical equipment located within the same physical area
`InlineMonitoringProcess`	monitoring process consisting of one or more measurement processes that use sensors or probes integrated with the process equipment to measure an attribute without material removal or diversion before measurement
`MaterialAliquot`	material entity that is the specified output of some aliquoting process
`MaterialProductQualityPlan`	material quality plan that prescribes the processes needed to ensure that a material product meets the required quality objectives
`MaterialSamplingPlan`	plan specification that prescribes how, when and how often material samples are to be taken
`MaterialSamplingProcess`	planned process of selecting and collecting a limited amount or number of some material entity in a manner which ensures it is representative of the input material entity
`OfflineMonitoringProcess`	monitoring process consisting of one or more measurement processes that are preceded by a material sampling process, in which material representing the entity of interest is collected from a process stream or in-process material and analyzed in a separate analytical area
`OnlineMonitoringProcess`	monitoring process consisting of one or more measurement processes that are preceded by or temporally overlapped by a material sampling process, in which material representing the entity of interest is collected from a process stream or in-process material and measured using analytical equipment connected to the process equipment
`RetentionSampleRole`	role that is held by a material sample set aside for future testing, examination, identification, or investigation

Object Properties

Construct	Definition
`hasMonitoredAttribute`	relation from a monitoring process to a specifically dependent continuant, temporal region, process profile, or process characteristic that is measured or observed during the monitoring process

Removed

Classes

Construct	Definition
`SamplePlan`	plan specification that prescribes how, when and how often samples are to be taken during a particular process
`SamplingProcess`	planned process of selecting and collecting a limited amount or number of some material entity in a manner which ensures it is representative of the input material entity

Changed

Classes

`ControlStrategy`

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

Annotations

example = “A control strategy for sterile filling includes gravimetric sensors to monitor and regulate fill volume (process parameter), cleanroom environmental monitoring to monitor particulate levels and temperature (quality attributes), and automated rejection of out-of-spec units. The process performance indicator is fill volume deviation rate, calculated as the percentage of vials outside volume targets; A control strategy for fed-batch cell culture includes specifying a gas controller to regulate dissolved oxygen (process parameter), a pH control loop to maintain pH within range (process parameter), and monitoring of cell viability over time as a process performance indicator. It also specifies that the glycosylation profile and aggregate levels as critical quality attributes and their periodic monitoring throughout the culture using off-line analysis”
naturalLanguageDefinition = “plan specification consisting of one or more specifications of methods and technologies that prescribe the monitoring or regulation of process parameters, quality attributes, and process performance indicators associated with a particular process and its resulting material product”@en-US

example = “a control strategy for sterile filling that specifies filling-pump speed, line speed, and stopper-placement settings as process parameters; fill-volume and container-closure-integrity specifications as quality attribute specifications; and viable and nonviable particle monitoring, room pressure differential, and cleanroom temperature as facility and environmental controls; A control strategy for fed-batch cell culture includes specifying a gas controller to regulate dissolved oxygen (process parameter), a pH control loop to maintain pH within range (process parameter), and monitoring of cell viability over time as a process performance indicator. It also specifies the glycosylation profile and aggregate levels as critical quality attributes and prescribes their periodic monitoring throughout the culture using off-line analysis.”
naturalLanguageDefinition = “plan specification consisting of one or more specifications of methods and technologies that prescribe the monitoring or regulation of process parameters, quality attributes, or process performance indicators of a particular process and its resulting material product”@en-US

`MaterialQualityPlan`

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

Annotations

example = “A material quality plan for particular chromatography resin prescribes synthesis process controls, intermediate and final QC testing, and release criteria to ensure the resin meets defined binding capacity, particle size distribution, and metal impurity limits. It includes in-process monitoring of pH and temperature during functionalization, validated leachables testing, and visual inspection.”
explanatoryNote = “1) At least one process prescribed by some part of the quality plan has to be a measurement process 2) The processes embedded in the quality plan typically include testing, inspection, characterization”
firstOrderLogicAxiom = “MaterialQualityPlan(x) → PlanSpecification(x) ∧ ∃a(PlanSpecification(a) ∧ ∃m(MeasurementProcess(m) ∧ prescribes(a, m)) ∧ hasContinuantPartAtAllTimes(x, a)) ∧ ∃q(QualityAttributeSpecification(q) ∧ hasContinuantPartAtAllTimes(x, q)) ∧ ∃p(PlannedProcess(p) ∧ (∃pp(ProductProductionProcess(pp) ∧ (precededBy(p, pp) ∨ occurrentPartOf(p, pp) ∨ isTemporallyOverlappedBy(p, pp))) ∧ prescribes(x, p)))”
naturalLanguageDefinition = “planned specification that prescribes the processes needed to ensure that a material product meets the required quality objectives”@en-US
semiFormalNaturalLanguageAxiom = “if x is a ‘material quality plan’, then x is a ‘plan specification’ that ‘has continuant part at all times’ some ‘plan specification’ a that ‘prescribes’ some ‘measurement process’, and ‘has continuant part at all times’ some ‘quality attribute specification’, and ‘prescribes’ some ‘planned process’ p that either ‘precedes’, is an ‘occurrent part of’, or ‘is temporally overlapped by’ some ‘product production process’”

example = “A material quality plan for a particular chromatography resin prescribes synthesis process controls, intermediate and final QC testing, and release criteria to ensure the resin meets defined binding capacity; A material quality plan for incoming acetaminophen API prescribes supplier approval, receipt inspection, quarantine, CoA review, identity and composite QC testing, release criteria, status labeling, and batch documentation to ensure suitability before tablet production.”
firstOrderLogicAxiom = “MaterialQualityPlan(x) → PlanSpecification(x)”
naturalLanguageDefinition = “plan specification that prescribes the processes needed to ensure that a raw material, process intermediate material, material product, or production consumable meets the required quality objectives”@en-US
semiFormalNaturalLanguageAxiom = “if x is a ‘material quality plan’ then x is a ‘plan specification’”

Axioms

SubClassOf: bfo:has_continuant_part_at_all_times some (constr:PlanSpecification and constr:prescribes some constr:MeasurementProcess)
SubClassOf: bfo:has_continuant_part_at_all_times some constr:QualityAttributeSpecification
SubClassOf: constr:prescribes some (constr:PlannedProcess and (bfo:preceded_by some constr:ProductProductionProcess or bfo:occurrent_part_of some constr:ProductProductionProcess or constr:isTemporallyOverlappedBy some constr:ProductProductionProcess))

`MaterialSample`

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

Annotations

example = “A 10 mL aliquot of bioreactor culture collected during mid-log phase for cell viability analysis; a pre-filled vial of harvested supernatant taken from a chromatography pool for impurity testing; a powder sample taken from the middle of a drum of API to test for uniformity of composition; a tablet randomly selected from a production batch during compression for hardness testing”
firstOrderLogicDefinition = “MaterialSample(x) ↔ MaterialEntity(x) ∧ ∃s(SamplingProcess(s) ∧ isSpecifiedOutputOf(x, s))”
naturalLanguageDefinition = “material entity that is the specified output of a sampling proces”@en-US
semiFormalNaturalLanguageDefinition = “every instance of ‘material sample’ is defined as exactly an instance of ‘material entity’ that ‘is specified output of’ some ‘sampling process’”

example = “a 10 mL portion of bioreactor culture collected during mid-log phase for cell-viability analysis; a portion of harvested supernatant contained in a labeled vial and taken from a chromatography pool for impurity testing; a powder portion taken from the middle of an API drum for composition-uniformity testing; a tablet selected from a production batch during compression for hardness testing”
firstOrderLogicDefinition = “MaterialSample(x) ↔ MaterialEntity(x) ∧ ∃s (MaterialSamplingProcess(s) ∧ isSpecifiedOutputOf(x, s))”
naturalLanguageDefinition = “material entity that is the specified output of a material sampling process”@en-US
semiFormalNaturalLanguageDefinition = “every instance of ‘material sample’ is exactly an instance of ‘material entity’ that ‘is specified output of’ some ‘material sampling process’”

Axioms

EquivalentTo: bfo:material_entity and constr:isSpecifiedOutputOf some constr:SamplingProcess

EquivalentTo: bfo:material_entity and constr:isSpecifiedOutputOf some constr:MaterialSamplingProcess

`MonitoringProcess`

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

Annotations

example = “UV absorbance and conductivity monitoring during column loading; continous monitoring of temperature and humidity in a clean room; Tablet weight is measured in-line every 30 minutes during compression using an integrated balance; During a fed-batch cell culture process, at-line nutrient monitoring is performed using a Nova BioProfile® FLEX analyzer to measure glucose, lactate, glutamine, and ammonia levels; Flow rate is continuously monitored during tangential flow filtration to ensure consistent membrane performance”
explanatoryNote = “1)Each monitoring process is an execution of a monitoring plan that prescribes it 2) In case a monitoring process is responsible for monitoring the attribute/parameter/indicator in multiple processes (e.g., multiple unit operations) it is a part of the ‘larger process’ which has the ‘occurrent part’ the unit operations and it does not imply that it is an occurrent part of the unit operations themselves”.”

example = “UV absorbance and conductivity monitoring during column loading; continuous monitoring of temperature and humidity in a clean room; tablet weight monitoring every 30 minutes during compression using an automated tablet-testing system; During a fed-batch cell culture process, at-line nutrient monitoring is performed using a Nova BioProfile® FLEX analyzer to measure glucose, lactate, glutamine, and ammonia levels; Flow rate is continuously monitored during tangential flow filtration to ensure consistent membrane performance”
explanatoryNote = “1) Each monitoring process is an execution of a monitoring plan that prescribes it 2) If a monitoring process monitors an attribute, parameter, or indicator across multiple process parts, it should be modeled as part of the larger planned process that has those process parts as occurrent parts. This does not imply that the monitoring process is an occurrent part of each monitored process part individually. For example, a decontamination process may include mixing, heating, and adsorption as process parts. If one temperature monitoring process monitors temperature across the decontamination process, then the monitoring process is an occurrent part of the decontamination process. It is not automatically an occurrent part of each of the mixing, heating, and adsorption processes. If temperature is monitored only during heating, then the monitoring process may be modeled as an occurrent part of the heating process.”