]> Reference Ontology Candidates This ontology serves as a staging area for candidate constructs developed within the BMIC and proposed for inclusion in IOF reference ontologies such as IOF Core. The content represents cross-cutting concepts intended for broad reuse across industrial domains. Adlane Rebai, Millipore Sigma Ana Nikolov, OAGi Boonserm Kulvatunyou, NIST Cameron Gibbs, CrownPoint Technologies, LLC Gabriela Henning, NIST Jan Kemper, AstraZeneca Marie-Aude Coutouly, Millipore Sigma Melissa Weller, CrownPoint Technologies, LLC Milos Drobnjakovic, OAGi Stephen J. Granite, CrownPoint Technologies, LLC Stephen Kahmann, CrownPoint Technologies, LLC http://opensource.org/licenses/MIT NIIMBL Reference Ontology Candidates Copyright (c) 2022, 2023, 2024, 2025, 2026 Open Applications Group manufacturing capability the capability of a technician to perform aseptic connections during a formulation procedure;the capability of a mixing vessel to achieve uniform suspension of components during buffer preparation; the capability of a fill-finish robot to accurately dispense liquid into vials the capability of a chromatography system to analyze protein purity during analytical method development - realizable in quality control or R&D, not in manufacturing;the capability of a liquid handling robot to automate compound dispensing during a high-throughput screening (HTS) assay in a clinical trial biomarker study LA1: ManufacturingCapability(x) → Capability(x) ∧ ∃y((Agent(y) ∨ PieceOfEquipment(y)) ∧ capabilityOf(x, y)) ∧ ∀z(hasRealization(x, z) → (ManufacturingProcess(z) ∨ ∃p(ManufacturingProcess(p) ∧ occurrentPartOf(z, p)))) LA2: Capability(x) ∧ ∃y((Agent(y) ∨ PieceOfEquipment(y)) ∧ capabilityOf(x, y)) ∧ ∃z(hasRealization(x, z) ∧ (ManufacturingProcess(z) ∨ ∃p(ManufacturingProcess(p) ∧ occurrentPartOf(z, p)))) → ManufacturingCapability(x) true capability of an agent or a piece of equipment that is realizable in a manufacturing process or its part This class is expected to remain primitive as it is difficult to find a set of mutually necessary and sufficient set of conditions. LA1: if x is a 'manufacturing capability' then x is a 'capability' that is the 'capability of' some 'agent' or 'piece of equipment' and whenever some y 'realizes' x then y is a 'manufacturing process' or an 'occurrent part of' some 'manufacturing process' LA2: if x is a 'capability' and x is the 'capability of' some 'agent' or 'piece of equipment' and x 'has realization' in some 'manufacturing process' or in some 'occurrent part of' a 'manufacturing process', then x is a 'manufacturing capability' material use process When a customer drives a car off from the dealership after purchasing the car, a material use process has started. A container/lot of a chemical may be considered used when the seal is opened or when the first portion is taken out from the container. The portion taken out from the container is also subjected to another material use process. MaterialUseProcess(x) → PlannedProcess(x) ∧ ∃m∃p∃c(MaterialEntity(m) ∧ PlannedProcess(p) ∧ Capability(c) ∧ specificallyDependsOn(c, m) ∧ hasParticipantAtAllTimes(x, m) ∧ hasOccurrentPart(x, p) ∧ temporallyStartedBy(x, p) ∧ realizes(p, c)) true planned process that is a part of a material entity lifecyle and which starts with a realization of the capability of that material entity This term is expected to remain primitive because different kinds of material entities, use processes, and business practices may have different definitions of when a material use process starts. If x is a 'material use process', then x is a 'planned process' that 'has participant at all times' some 'material entity' m, and 'has as occurrent part' some 'planned process' p that both 'temporally starts' x and 'realizes' a 'capability' c that 'specifically depends on' m process intermediate material Merck KGaA Yoghurt held after fermentation and before finishing with flavorings and packaging; Cocoa paste stored after conching and before molding and packaging; Dried PVC resin stored before compounding with additives; Harvested cell culture fluid held before primary clarification; Protein A eluate stored before viral inactivation; Concentrated bulk drug substance stored before final formulation and filling Cocoa paste, which is produced by a Cocoa manufacturer, sold, and shipped in heated tanker trucks to other food companies; Dried PVC resin produced by Company ABC and sold in bags or big bags to other companies that manufacture PVC pipes, different PVC compounds, etc., ProcessIntermediateMaterial(x) ↔ MaterialEntity(x) ∧ ∃r(ProcessIntermediateMaterialRole(r) ∧ hasRole(x, r)) material entity which has the process intermediate material role every instance of 'process intermediate material' is defined as exactly an instance of 'material entity' that 'has role' some 'process intermediate material role' process intermediate material role Merck KGaA role of a yoghurt when held after fermentation for use in finishing and packaging; role of a cocoa paste when stored after conching for use in molding and cooling; role of a dried PVC resin when kept after drying for use in compounding; role of a harvested cell culture fluid when held after bioreactor harvest for use in clarification; role of a Protein A eluate when collected after chromatography for use in viral inactivation; role of a bulk drug substance when stored after purification for use in formulation and filling ProcessIntermediateMaterialRole(x) → (∀y (HasRealization(x, y) → ManufacturingProcess(y) ∧ ∃e (HasInput(y, e) ∧ MaterialEntity(e)))) ∧ (∃a (RoleOf(x, a) ∧ MaterialEntity(a) ∧ ∃b (IsInputOf(a, b) ∧ ManufacturingProcess(b)) ∧ ∃c (IsSpecifiedOutputOf(a, c) ∧ ManufacturingProcess(c))) ∨ ∃a (RoleOf(x, a) ∧ MaterialEntity(a) ∧ ∃d (IsSpecifiedOutputOf(a, d) ∧ ManufacturingProcess(d)) ∧ ∃s (PrescribedBy(a, s) ∧ InputSpecification(s) ∧ ∃p (ContinuantPartOfAtAllTimes(s, p) ∧ PlanSpecification(p) ∧ ∃m (Prescribes(p, m) ∧ ManufacturingProcess(m)))))) true role held by a material entity when it is an output of a manufacturing process and is input of a subsequent manufacturing process or planned to be an input of a subsequent manufacturing process There are insufficient constructs to define necessary and sufficient conditions. if x is a 'process intermediate material role' then x 'has realization' only in some 'manufacturing process' that 'has input' some 'material entity', and x is a 'role of' either a 'material entity' that 'is input of' some 'manufacturing process' and 'is specified output of' some 'manufacturing process', or a 'material entity' that 'is specified output of' some 'manufacturing process' and is 'prescribed by' some 'input specification' that is a 'continuant part of at all times' some 'plan specification' that 'prescribes' some 'manufacturing process' production consumable Merck KGaA Benzoyl Peroxide used as a free-radical initiator in vinyl chloride polymerization; Deionized water used as a suspension medium in PVC polymerization and partially lost through evaporation; High-speed steel drill bits used in drilling operations and consumed after 200–400 drilling cycles; Single-use bioreactor bag used for mammalian cell culture and discarded after use; sterile filter used for media sterilization and discarded after filtration; Disposable depth filter used in harvest clarification and discarded post-use; Water employed in the Steam Reforming Process of Methane. Steam reacts with Methane at very high temperature in the presence of a Ni catalyst to produce Hydrogen and a CO/CO2 mixture. Though steam is fed in excess to avoid the carbonization of the catalyst, and is partly lost, certain amount of it is converted into Hydrogen. Therefore, water plays a raw material role;Water inside a closed-loop cooling system circuit that is part of a chemical reaction process. Since it is a closed system, water is not lost through evaporation, and it does not need a chemical/biological treatment. In consequence, it does not need to be recovered. See the expanded definition under the corresponding role class. The term is formalized here as a defined class by referring to its corresponding role class and exists primarily for ontological modeling and implementation convenience. ProductionConsumable(x) ↔ Consumable(x) ∧ ∃r(ProductionConsumableRole(r) ∧ hasRole(x, r)) material entity which has the production consumable role every instance of 'production consumable' is defined as exactly an instance of 'consumable' that 'has role' some 'production consumable role' production consumable role Benzoyl Peroxide in the role of a consumable in the polymerization of vinyl chloride; Deionized water in the role of a consumable in PVC polymerization as a suspension medium; Sterile filter in the role of a consumable in media sterilization; Single-use bioreactor bag in the role of a consumable in mammalian cell culture; Disposable depth filter in the role of a consumable in harvest clarification http://purl.allotrope.org/voc/afo/REC/2022/03/afo 1. 'Used up' in this context means that either a) the material entity no longer exist at the end of the process or b) the material entity has reduced or lost capability as a result of the process. 2. In many cases, organizations monitor the number of hours or frequency with which such consumables are used. 3. Consumables includes resources that are typically not specified in recipes, not included in the bill of materials, and not lot-tracked. ProductionConsumableRole(x) → ConsumableRole(x) ∧ (∀y (hasRealization(x, y) → ∃z (occurrentPartOf(y, z) ∧ ProductProductionProcess(z)))) ∧ (∃a (roleOf(x, a) ∧ MaterialEntity(a) ∧ ∃b (prescribedBy(a, b) ∧ InputSpecification(b) ∧ ∃c (continuantPartOfAtAllTimes(b, c) ∧ PlanSpecification(c) ∧ ∃d (prescribes(c,d) ∧ ∃z (occurrentPartOf(d, z) ∧ ProductProductionProcess(z)))))) ∨ ∃a (roleOf(x, a) ∧ ((MaterialEntity(a) ∧ ∃e (isInputOf(a, e) ∧ ∃z (occurrentPartOf(e, z) ∧ ProductProductionProcess(z)))) ∨ (HasCapability(a, f) ∧ Capability(f) ∧ ∃g (hasRealization(f, g) ∧ ∃z (occurrentPartOf(g, z) ∧ ProductProductionProcess(z))))))) true consumable role held by a material entity when it is planned to be, or is partially or fully consumed in a process that is part of a product production process There are insufficient constructs to define necessary and sufficient conditions. Specifically constructs for representing partially consumed are missing if x is a 'production consumable role' then x is a 'consumable role' and x 'has realization' only in some 'occurrent part of' a 'product production process' and x is a 'role of' either a 'material entity' that is 'prescribed by' some 'input specification' that is a 'continuant part of at all times' some 'plan specification' that 'prescribes' some 'occurrent part of' a 'product production process', or a 'material entity' that 'is input of' some 'occurrent part of' a 'product production process', or a 'material entity' that 'has capability' some 'capability' that 'has realization' in some 'occurrent part of' a 'product production process'