]> Recipe Ontology This module contains terms and relations for describing the hierarchical and temporally sequenced operations and actions which comprise the recipe. Module contents also describes the evolution and maturation of the recipe over time as it is transformed from a general recipe (not specific for a site) to a specific instance recipe associated with a batch. 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 NIIMBL BD-1 Ontology Group http://opensource.org/licenses/MIT NIIMBL Recipe Ontology

batch run batch process batch run process A single 2,000-liter fed-batch CHO culture carried out according to a production recipe, starting with inoculation and ending with harvest on Day 14; A single batch run of the PVC resin production process carried out according to a defined recipe, resulting in the production of Granular PVC Grade PQ5.

ISA-88 Part 1

BatchRun(x) → ManufacturingProcess(x) ∧ ∃y (hasParticipantAtSomeTime(x, y) ∧ PieceOfEquipment(y)) ∧ ∃z (prescribedBy(x, z) ∧ Recipe(z))

true

manufacturing process that leads to the production of finite quantities of material by subjecting quantities of input materials to an ordered set of processing activities over a finite period of time using one or more pieces of equipment

This term is expected to remain primitive due to the lack of sufficient ontological constructs for representing both finite material quantities and the ordered execution of process steps.

if x is a 'batch run', then x is a 'manufacturing process', x 'has participant at some time' some 'piece of equipment', and x is 'prescribed by' some 'recipe'

batch run identification batch run identifier The identifier "BR-2025-07-001" designates a batch run of monoclonal antibody production in July 2025; The identifier "MFG-BCH-0815" designates a GMP manufacturing batch run for a recombinant protein on August 15th; The identifier "CellRun_Alpha_003" designates a batch run for CHO cell culture during upstream process development; The identifier "BATCH-0921-Pilot" designates a pilot-scale batch run of a gene therapy vector formulation executed in September 2021

The identifier "Lot-57B" designates the output material (lot) produced during a batch run, not the batch run itself. This example fails the definition because the identifier refers to a material product (e.g., a lot of vials or bulk drug substance), not to the process instance (the batch run) that generated it.

BatchRunIdentification(x) ↔ Identifier(x) ∧ ∃b(BatchRun(b) ∧ designates(x, b))

identifier for a batch run

every instance of a 'batch run identification' is exactly an instance of an 'identifier' that 'designates' some 'batch run'

control recipe Control recipe ‘CR-PVC-20250623-01’, derived from the ‘MR-PVC-SUSP-HOU-Cell2-V3’ Master Recipe that employs the ‘Granular PVC Grade PQ5 production procedure Houston’ Recipe Procedure, which comprises the following sequence of Unit Procedures: ‘Vinyl chloride monomer polymerization unit procedure’, ‘Water Separation unit procedure’, and ‘Drying unit procedure’. This recipe procedure is to be carried out in the following equipment units of the ‘Granular PVC production cell 001’ Process Cell: Reactor JR-102; Centrifuge C-301; VCM Recovery Unit VRU-1; Deionized water tank WTK-101; Low pressure steam supply system; Chilled Water Circuit; and Spray Dryer SD-02. This Recipe Procedure will transform 2220 lb. of the ‘Vinyl Chloride Monomer’ raw material into 985 kg of ‘Granular PVC Grade PQ5’ product, employing the following Consumables: Deionized Water (1060 Gallons), Suspension Agent Polyvinyl Alcohol (CAS No.9002-89-5), by Wacker Chemie AG (11.5 lb.), Benzoyl Peroxide Initiator (CAS No. 94-36-0), by Arzo Nobel (2.25 lb.), Sodium Bicarbonate (CAS No. 144-55-8), by Church & Dwight Co (1.18 lb.).

https://www.plcacademy.com/isa-88-s88-batch-control-explained/

A control recipe may be derived from a master recipe. However, this is not always the case such as in a process development. In that scenario a control recipe is created before a master recipe.

LA1: ControlRecipe(x) → Recipe(x) ∧ ∃y∃z (hasContinuantPartAtAllTimes(x, y) ∧ Identifier(y) ∧ designates(y, z) ∧ PieceOfEquipment(z))

LA2: Recipe(x) ∧ ∃y (isConcretizedByAtSomeTime(x, y) ∧ BatchRun(y)) → ControlRecipe(x)

true

recipe that prescribes particular pieces of equipment and specific lots or inventoried materials to be used in some batch runs

There are currently insufficient constructs to create a set of mutually necessary and sufficient conditions.

LA1: if x is a 'control recipe', then x is a 'recipe' and ' has continuant part at all times' some 'identifier' that 'designates' some 'piece of equipment'

LA2: if x is a 'recipe' that 'is concretized by at some time' some 'batch run', then x is a 'control recipe'

1) Only control recipes are executed (bfo: concretized by) a batch run. Other recipe types serve only to prescribe the process at various levels of abstraction. They themselves are not executed (concretized by) the batch run. Therefore, if a recipe is concretized in a batch run, this is a sufficient condition to classify it as a control recipe. 2) A control recipe explicitly specifies the actual equipment used in the batch run, including the unique identifiers of that equipment. In contrast, other types of recipes typically define only the required capabilities or categories of equipment (e.g., “a mixing vessel” or “a bioreactor class”). This is formally expressed using the axiom 'has continuant part at all times' some (identifier and (designates some 'piece of equipment')). Users should include an identifier as a continuant part of the control recipe, where the identifier designates a specific individual piece of equipment (a particular equipment instance), not merely an equipment type (class).

general recipe General Recipe ‘GR-PVC-SUSP-V1’, which employs the Recipe Process ‘PVC granular resin production process’ that comprises the following sequence of process stages ‘Vinyl chloride monomer polymerization stage’, ‘Water Separation stage’, and ‘Drying stage’, to transform the raw material Vinyl Chloride Monomer (1000 kg) into ~980 kg of PVC granular resin, employing the following Consumables: Deionized Water (4000 L), Suspension Agent (e.g., Polyvinyl Alcohol/ Methylcellulose/Hydroxypropyl Methylcellulose 5 kg), Benzoyl Peroxide (1 kg), Buffer (e.g., Sodium Bicarbonate/Sodium Carbonate - 0.5 kg).

https://www.plcacademy.com/isa-88-s88-batch-control-explained/

GeneralRecipe(x) → Recipe(x) ∧ ¬∃y (prescribesPlannedProcessLocation(x, y) ∧ PhysicalSite(y))

true

recipe that is independent of equipment and physical site

This term is expected to remain primitive, as expressing its independence from equipment or physical site would require the use of negation, which is generally avoided in ontological definitions.

if x is a 'general recipe', then x is a 'recipe' and x does not 'prescribe planned process location' some 'physical site'

if x is a general recipe, then x is a recipe

master recipe Master Recipe ‘MR-PVC-SUSP-HOU-Cell2-V3’ that employs the ‘Granular PVC Grade PQ5 production procedure Houston’ Recipe Procedure, which comprises the following sequence of Unit Procedures: ‘Vinyl chloride monomer polymerization unit procedure’, ‘Water Separation unit procedure’, and ‘Drying unit procedure’. This recipe procedure can be carried out in the ‘Granular PVC production cell 001’ Process Cell, composed of: a) Reactors JR-101/JR-102/JR-103/JR-104 (Stainless steel, 1,000-gallon, rated 100 psia, mechanical agitator, with temperature and pressure control systems, nitrogen purge system, pressure relief system with a Rupture disc); b) Centrifuges C-301/C-302 (Basket type, 600 lb. batch); c) VCM Recovery Unit VRU-1/VRU-2; d) Deionized water tanks WTK-101/WTK-103; e) Low pressure steam supply system; f) Chilled Water Circuit; g) Spray Dryers SD-02/SD-04. This Recipe Procedure will transform 2220 lb. of the ‘Vinyl Chloride Monomer’ raw material into 985 kg of ‘Granular PVC Grade PQ5’ product, employing the following Consumables: Deionized Water (1060 Gallons), Suspension Agent Polyvinyl Alcohol (CAS No.9002-89-5), by Wacker Chemie AG (11.5 lb.), Benzoyl Peroxide Initiator (CAS No. 94-36-0), by Arzo Nobel (2.25 lb.), Sodium Bicarbonate (CAS No. 144-55-8), by Church & Dwight Co (1.18 lb.).

https://www.plcacademy.com/isa-88-s88-batch-control-explained/

A master recipe may still specify multiple choices of equipment while the control recipe specify the exact piece to equipment to be used in a particular batch run.

MasterRecipe(x) → Recipe(x)

true

recipe that prescribes some equipment families, types, or sets of alternative pieces of equipment or process cell information that specifies the composition of equipment families, types, or sets of alternative piece of equipment and types of materials or cataloged items

There are insufficient constucts currently available to axiomatically capture all the possible entites that a master recipe may prescribe

if x is a 'master recipe' then x is a 'recipe'

recipe control recipe;general recipe;master recipe; site recipe

https://www.plcacademy.com/isa-88-s88-batch-control-explained/

A recipe contains an essential and comprehensive set of information required to uniquely define the manufacturing requirements for a specific product or process intermediate. This information typically includes: Product identification and version, List of raw materials and their quantities, Equipment requirements, Process parameters (e.g., temperatures, pressures, speeds), Step-by-step production instructions, Quality control specifications, Safety precautions, Packaging and labeling instructions.

PlanSpecification(x) ∧ ∃y (prescribes(x, y) ∧ BatchRun(y)) ∧ ∃z ((RecipeProcedure(z) ∨ RecipeProcess(z)) ∧ hasContinuantPartAtAllTimes(x, z)) → Recipe(x)

true

plan specification that prescribes some batch runs for a specific product or process intermediate

There are currently insufficient constructs available to create a set of necesary and sufficient conditions. In particular recipe structural elements like the header are missing

if x is a 'plan specification' that 'prescribes' some 'batch run' and 'has continuant part at all times' some 'recipe procedure' or 'recipe process' then x is a 'recipe'

recipe creation process A member of the ‘Polymer Process Development Team’ of the ‘StarChemicals’ company, creates the ‘GR-PVC-SUSP-V1’ General Recipe, which employs the Recipe Process ‘PVC granular resin production process’ that comprises the following sequence of process stages ‘Vinyl chloride monomer polymerization stage’, ‘Water Separation stage’, and ‘Drying stage’, to transform the Vinyl Chloride Monomer (1000 kg) raw material into ~980 kg of PVC granular resin product, employing the following Consumables: Deionized Water (4000 L), Suspension Agent (e.g., Polyvinyl Alcohol/ Methylcellulose/Hydroxypropyl Methylcellulose 5 kg), Benzoyl Peroxide (1 kg), Buffer (e.g., Sodium Bicarbonate/Sodium Carbonate - 0.5 kg).

ISA-88 Part 1

A recipe creation process may proceed de novo, based on domain knowledge of the product or process, without reuse of existing recipe structures. Alternatively, it may involve the reuse or adaptation of one or more existing recipes, or of their process or procedural elements, in which case it is classified as a recipe derivation process.

RecipeCreationProcess(x) ↔ PlannedProcess(x) ∧ ∃a(Agent(a) ∧ hasParticipantAtSomeTime(x, a)) ∧ ∃r(Recipe(r) ∧ hasSpecifiedOutput(x, r))

planned process in which some agent creates a recipe

every instance of 'recipe creation process' is defined as exactly an instance of 'planned process' that 'has participant at some time' some 'agent', and 'has specified output' some 'recipe'.

recipe derivation process A member of the ‘Houston Process Engineering Department’, of the ‘StarChemicals Americas’ company, derives the ‘SR-PVC-SUSP-HOU-V5’ Site Recipe from the ‘GR-PVC-SUSP-V1’ General Recipe. It employs the Recipe Process ‘PVC granular resin production process Houston’, which comprises the following sequence of process stages ‘Vinyl chloride monomer polymerization stage’, ‘Water Separation stage’, and ‘Spray Drying stage’, to transform the Vinyl Chloride Monomer (2200 lb) raw material into ~980 kg of PVC granular resin product, employing the following Consumables: Deionized Water (1057 Gallons), Suspension Agent Polyvinyl Alcohol (CAS No.9002-89-5), by Wacker Chemie AG (11 lbs or target value), Benzoyl Peroxide Initiator (CAS No. 94-36-0), by Arzo Nobel (2.2 lbs or target value), Sodium Bicarbonate (CAS No. 144-55-8), by Church & Dwight Co (1.1 lbs. or target value).

ISA-88 Part 1

This process involves reusing, adapting, or recombining parts of existing recipe structures to generate a new recipe that may reflect different production contexts, equipment capabilities, regulatory constraints, or product variations. Derivation may occur at the level of entire recipes or at the level of subcomponents such as recipe procedures, unit procedures, or process stages.

RecipeDerivationProcess(x) ↔ RecipeCreationProcess(x) ∧ ∃i((Recipe(i) ∨ RecipeProceduralElement(i) ∨ RecipeProcessElement(i)) ∧ hasInput(x, i))

recipe creation process in which a new recipe is created based on one or more existing recipes, recipe process elements, or recipe procedural elements

every instance of 'recipe derivation process' is defined as exactly an instance of 'recipe creation process' that 'has input' some 'recipe', 'recipe procedural element', or 'recipe process element'

recipe element creation process A member of the ‘Polymer Process Development Team’ of the ‘StarChemicals’ company, creates the ‘Vinyl chloride monomer polymerization stage’ process stage. It comprises the following sequence of process operations: ‘Setup process operation’, followed by a ‘Charge water, additives and monomer process operation’, followed by a ‘Polymerization process operation’, finishing with a ‘Post-polymerization process operation’.

ISA-88 Part 1

RecipeElementCreationProcess(x) ↔ PlannedProcess(x) ∧ ∃a(Agent(a) ∧ hasParticipantAtSomeTime(x,a)) ∧ ∃o((RecipeProceduralElement(o) ∨ RecipeProcessElement(o)) ∧ hasSpecifiedOutput(x,o))

planned process in which some agent creates a recipe process element or recipe procedural element

every instance of a 'recipe element creation process' is exactly an instance of a 'planned process' that 'has participant at some time' some 'agent' and 'has specified output' some 'recipe procedural element' or 'recipe process element'

recipe element derivation process A member of the ‘Houston Process Engineering Department’, of the ‘StarChemicals Americas’ company, derives the ‘Vinyl chloride monomer polymerization Unit Procedure, from the ‘Vinyl chloride monomer polymerization stage’ process stage. This Unit Procedure, which can take place in any of these Jacketed Reactors JR-101/JR-102/JR-103/JR-104, comprises the following sequence of recipe operations: ‘Setup process operation’, followed by a ‘Charge water, additives and monomer process operation’, followed by a ‘Polymerization process operation’, finishing with a ‘Post-polymerization process operation’.

ISA-88 Part 1

RecipeElementDerivationProcess(x) ↔ RecipeElementCreationProcess(x) ∧ ((∃i((RecipeProceduralElement(i) ∨ RecipeProcessElement(i)) ∧ hasInput(x,i)) ∧ ∃o(RecipeProceduralElement(o) ∧ hasSpecifiedOutput(x,o))) ∨ (∃i(RecipeProcessElement(i) ∧ hasInput(x,i)) ∧ ∃o(RecipeProcessElement(o) ∧ hasSpecifiedOutput(x,o))))

recipe element creation process in which either a new recipe procedural element is created based on one or more existing recipe procedural elements or recipe process elements, or in which a new recipe process element is created based on one or more recipe process elements

every instance of 'recipe element derivation process' is exactly a 'recipe element creation process' that either has input some 'recipe procedural element' or 'recipe process element' and has specified output some 'recipe procedural element', or has input some 'recipe process element' and has specified output some 'recipe process element'

The two equivalent class axioms for recipe element creation process reflect different possibilities for how recipe elements can be derived. One axiom allows for the creation of a 'recipe procedural element' from either a 'recipe process element' or another 'recipe procedural element', while the other focuses specifically on the creation of one 'recipe process element' from another. This supports modeling different derivation scenarios across recipe abstraction layers.

recipe operation unit operation A ‘Setup operation’, which is part of a ‘‘Vinyl chloride monomer polymerization unit procedure’ and that can take place in jacketed reactor JR-101/JR-102/JR-103, has the following set of recipe phases: ‘Inspect reactor cleaning conditions phase’, ‘Test agitation system phase’, ‘Calibrate temperature control system phase’, ‘Test pressure relief system phase’, and ‘Prepare Nitrogen purge system phase’.

1) From ISA-88 (1995) Part 1 Section 3, a procedural element defining an independent processing activity consisting of the algorithm necessary for the initiation, organization, and control of phases. 2)From ISA-88 (2010) Part 1 Section 5.1, an operation is an ordered set of phases that defines a major processing sequence that takes the material being processed from one state to another, usually involving a chemical, physical, biologoical change

RecipeOperation(x) → RecipeProceduralElement(x) ∧ ∀y (hasContinuantPartAtSomeTime(x, y) → ¬(RecipeProcedure(y) ∨ RecipeUnitProcedure(y))) ∧ ∀z (hasProperContinuantPartAtSomeTime(x, z) → ¬RecipeOperation(z))

RecipeOperation(x) ↔ RecipeProceduralElement(x) ∧ ∃p(RecipePhase(p) ∧ hasContinuantPartAtAllTimes(x, p)) ∧ ∃u(RecipeUnitProcedure(u) ∧ continuantPartOfAtAllTimes(x, u)) ∧ ∃z(PhysicalUnit(z) ∧ (∃y(InformationContentEntity(y) ∧ hasContinuantPartAtAllTimes(x, y) ∧ (denotes(y, z) ∨ ∃c(ManufacturingCapability(c) ∧ capabilityOf(c, z) ∧ prescribes(y, c)) ∨ prescribes(y, z)))))

recipe procedural element that has a partially ordered set of recipe phases as its part and that prescribes one or more alternative physical units with compatible capabilities

if x is a 'recipe operation', then x is a 'recipe procedural element', x 'has continuant part at some time' only entities that are not a 'recipe procedure' or 'recipe unit procedure', and x 'has proper continuant part at some time' only entities that are not a 'recipe operation

every instance of 'recipe operation' is exactly a 'recipe procedural element' that 'has continuant part at all times' some 'recipe phase', is a' continuant part at all times' some 'recipe unit procedure', and has 'continuant part at all times' some 'information content entity' that either 'denotes' a 'physical unit' or 'prescribes' either the 'physical unit' or a 'manufacturing capability' that is a 'capability of' a 'physical unit'

recipe phase ‘Calibrate temperature control system’, ‘Feed fresh media’, ‘Test pressure relief system’, ‘Sample bioreaction mixture’.

ISA-88 Part 1

1) ISA 88 Part 1 Section 3: The lowest level of procedural element in the procedural control model. 2) ISA 88 Part 1 Section 5: The smallest element of procedural control that can accomplish a process-oriented task is a phase. A phase may be subdivided into smaller parts. 3) Specifics about how phase may be subdivided can be found in other standards like MTP which contains a lot equipment and action specific information. According to ISA88 a recipe phase points to an equipment phase. This interaction will be explored in the future.

RecipePhase(x) → RecipeProceduralElement(x) ∧ ∀y (hasContinuantPartAtSomeTime(x, y) → ¬(RecipeOperation(y) ∨ RecipeProcedure(y) ∨ RecipeUnitProcedure(y))) ∧ ∀z (hasProperContinuantPartAtSomeTime(x, z) → ¬RecipeProceduralElement(z))

true

recipe procedural element that has no other recipe procedural element as its proper part and that prescribes one or more alternative physical units or equipment modules with compatible capabilities

This term is expected to remain primitive, as expressing that it has no other procedural elements as parts requires the use of negation, which is generally avoided in ontological definitions.

if x is a 'recipe phase', then x is a 'recipe procedural element', x 'has continuant part at some time' only entities that are not a 'recipe operation', 'recipe procedure', or 'recipe unit procedure', and x 'has proper continuant part at some time' only entities that are not a 'recipe procedural element'

recipe procedural element recipe operation; recipe phase; recipe procedure; recipe unit procedure

1) From ISA-88 (1995) part 1 section 3, a building block for procedural control that is defined by the procedural control model. 2) From ISA-88 (2010) part 1 section 5, a procedural element is any part of a recipe or control strategy that defines a set of activities or actions, potentially including decision logic, which guides the execution of a manufacturing process.

RecipeProceduralElement(x) → PlanSpecification(x) ∧ ∀y(continuantPartOfAtSomeTime(x, y) → ¬(GeneralRecipe(y) ∨ RecipeProcessElement(y) ∨ SiteRecipe(y))) ∧ ∃z (prescribes(x, z) ∧ PlannedProcess(z) ∧ ∃w (occurrentPartOf(z, w) ∧ BatchRun(w)))

true

plan specification that prescribes some planned process that is part of a batch run and is equipment specific or manufacturing capability specific

This term is expected to remain primitive, as it is challenging to define a set of OWL-compatible necessary and sufficient conditions that in all cases reliably distinguish a recipe procedural element from a recipe process element.

if x is a 'recipe procedural element', then x is a 'plan specification', x is not a continuant part at any time of a 'general recipe', 'recipe process element', or 'site recipe', and x 'prescribes' some 'planned process' that is an 'occurrent part of' some 'batch run'

1) A recipe procedural element must not be included in general recipes, site recipes, or recipe process elements, as it is intended to represent equipment-specific or manufacturing capability-specific instructions. This restriction is formally captured by the axiom: 'continuant part of at some time' only (not ('general recipe' or 'recipe process element' or 'site recipe')). 2) While a recipe procedural element may be included in one or more control recipes or master recipes, there is no axiomatic requirement for such inclusion, allowing for flexible reuse and recombination across different contexts. When associating a recipe procedural element with a control or master recipe, the 'continuant part of at some time' relation (or an appropriate subproperty) should be used.

recipe procedure A ‘PVC granular resin production recipe procedure’, which comprises the following unit procedures: a ‘Vinyl chloride monomer polymerization unit procedure’, a ‘Water Separation unit procedure’, and a ‘Drying unit procedure’. This recipe procedure can be carried out in Process Cell ‘Granular PVC production cell 001’, composed of a) Reactor JR-101/JR-102/JR-103/JR-104 (Stainless steel, 1,000-gallon, rated 100 psia, mechanical agitator, with temperature and pressure control systems, nitrogen purge system, pressure relief system with a Rupture disc); b) Centrifuge C-301/C-302 (Basket type, 600 lb. batch); c) VCM Recovery Unit VRU-1/VRU-2; d) Deionized water tank WTK-101/WTK-103; e) Low pressure steam supply system; f) Chilled Water Circuit, g) Spray Dryer SD-02/SD-04.

ISA-88 Part 1

1) ISA-88 Part 1 Section 3: The part of a recipe that defines the strategy for producing a batch. 2) ISA-88 Part 1 Section 5: The procedure is the highest level in the hierarchy and defines the strategy for carrying out a major processing action such as making a batch. It is defined in terms of an ordered set of unit procedures.

RecipeProcedure(x) → RecipeProceduralElement(x) ∧ ∀y (hasProperContinuantPartAtSomeTime(x, y) → ¬RecipeProcedure(y))

RecipeProcedure(x) ↔ RecipeProceduralElement(x) ∧ ∃c,y,z (ProcessCell(c) ∧ InformationContentEntity(y) ∧ (denotes(y,c) ∨ (prescribes(y,c) ∨ ∃m(prescribes(y,m) ∧ ManufacturingCapability(m) ∧ capabilityOf(m,c)))) ∧ hasContinuantPartAtAllTimes(x,y) ∧ RecipeUnitProcedure(z) ∧ hasContinuantPartAtAllTimes(x,z))

recipe procedural element that has a partially ordered set of recipe unit procedures as its part and that prescribes one or more alternative process cells with compatible capabilities

if x is a 'recipe procedure', then x is a 'recipe procedural element', and x 'has proper continuant part at some time' only entities that are not a 'recipe procedure'

every instance of a 'recipe procedure' is a 'recipe procedural element' that has continuant part at all times' some 'recipe unit procedure' and that 'has continuant part at all times' some 'information content entity' that either 'denotes' or 'prescribes' a 'process cell' or a 'manufacturing capability' that is the 'capability of' the 'process cell'

recipe process A ‘PVC granular resin production process’, which comprises a ‘Vinyl chloride monomer polymerization stage’, a ‘Water Separation stage’, and a ‘Drying stage’

ISA-88 Part 1

The definition given in ISA-88 Part 1 Sections 3 and 4 — "a sequence of chemical, physical, or biological activities for the conversion, transport, or storage of material or energy" — more accurately corresponds to the planned process that the recipe process prescribes. IOF follows the BFO distinction between plans and processes; accordingly, the natural language definition provided here focuses on the recipe structure — specifically, the partial ordering of its constituent elements. This reflects the recipe as a plan specification rather than describing the execution it prescribes. The ISA definition has been retained here for reference and traceability to the source specification.

RecipeProcess(x) → RecipeProcessElement(x) ∧ ∃y (hasContinuantPartAtAllTimes(x, y) ∧ RecipeProcessStage(y)) ∧ ∀z (hasProperContinuantPartAtSomeTime(x, z) → ¬RecipeProcess(z))

true

recipe process element that has a partially ordered set of recipe process stages as its part

There are currently insufficient constructs to represent a partially ordered set.

if x is a 'recipe process', then x is a 'recipe process element', x 'has continuant part at all times' some 'recipe process stage', and x 'has proper continuant part at some time' only entities that are not a 'recipe process

recipe process action ‘Calibrate temperature control system’, ‘Feed fresh media’, ‘Test pressure relief system’, ‘Sample bioreaction mixture’

ISA 88 Part 1 Section 3 and 4: Minor processing activities that are combined to make up a process operation.

RecipeProcessAction(x) → RecipeProcessElement(x) ∧ ∀y (hasContinuantPartAtSomeTime(x, y) → ¬(RecipeProcess(y) ∨ RecipeProcessOperation(y) ∨ RecipeProcessStage(y))) ∧ ∀z (hasProperContinuantPartAtAllTimes(x, z) → ¬RecipeProcessAction(z))

true

recipe process element that has no other recipe process element as its proper part

This term is expected to remain primitive, as expressing that it has no other recipe process elements as parts requires the use of negation, which is generally avoided in ontological definitions.

if x is a 'recipe process action', then x is a 'recipe process element', x 'has continuant part at some time' only entities that are not a 'recipe process', 'recipe process operation', or 'recipe process stage', and x 'has proper continuant part at all times' only entities that are not a 'recipe process action'

recipe process element recipe process, recipe process action, recipe process operation, recipe process stage

ISA-88 Part 1

RecipeProcessElement(x) → PlanSpecification(x) ∧ ¬∃y (continuantPartOfAtSomeTime(x, y) ∧ (ControlRecipe(y) ∨ MasterRecipe(y) ∨ RecipeProceduralElement(y))) ∧ ∃z∃w (prescribes(x, z) ∧ PlannedProcess(z) ∧ occurrentPartOf(z, w) ∧ BatchRun(w))

true

plan specification that prescribes some planned process that is part of a batch run and is equipment independent

if x is a 'recipe process element', then x is a 'plan specification', x is not a continuant part at any time of a 'control recipe', 'master recipe', or 'recipe procedural element', and x 'prescribes' some 'planned process' that is an 'occurrent part of' some 'batch run'

1) A recipe process element must not be included in control recipes or master recipes or recipe procedural element, as it is intended to represent equipment-independent. This restriction is formally captured by the axiom: 'continuant part of at some time' only (not ('control recipe' or 'master recipe')). 2) While a recipe process element may be included in one or more general recipes, site recipes, or other recipe process elements, there is no requirement for such inclusion, allowing for its reuse and composition in varying contexts. When associating a recipe process element with a higher-level recipe, the 'continuant part of at some time' relation (or an appropriate subproperty) should be used.

recipe process operation A ‘Setup process operation’, which is part of a ‘Vinyl chloride monomer polymerization stage’, has the following set of recipe process actions: ‘Inspect reactor cleaning conditions’, ‘Test agitation system’, ‘Calibrate temperature control system’, ‘Test pressure relief system’, and ‘Prepare Nitrogen purge system’.

ISA-88 Part 1

1) ISA Part 1 Section 3: A major processing activity that usually results in a chemical or physical change in the material being processed and that is defined without consideration of the actual target equipment configuration. 2) ISA Part 1 Section 4: Process operations represent major processing activities. A process operation usually results in a chemical or physical change in the material being processed.

RecipeProcessOperation(x) → RecipeProcessElement(x) ∧ ∃y (hasContinuantPartAtAllTimes(x, y) ∧ RecipeProcessAction(y)) ∧ ∀z (hasContinuantPartAtSomeTime(x, z) → ¬(RecipeProcess(z) ∨ RecipeProcessStage(z))) ∧ ∀w (hasProperContinuantPartAtSomeTime(x, w) → ¬RecipeProcessOperation(w))

true

recipe process element that has an partially ordered set of recipe process actions as its part

There are currently insufficient constructs to represent a partially ordered set.

if x is a 'recipe process operation', then x is a 'recipe process element', x 'has continuant part at all times' some 'recipe process action', x 'has continuant part at some time' only entities that are not a 'recipe process' or 'recipe process stage', and x 'has proper continuant part at some time' only entities that are not a 'recipe process operation'

recipe process stage A ‘Vinyl chloride monomer polymerization stage’, which comprises a ‘Setup process operation’, followed by a ‘Charge water, additives and monomer process operation’, followed by a ‘Polymerization process operation’, finishing with a ‘Post-polymerization process operation’.

ISA-88 Part 1

1) ISA-88 Part 1 Section 3: A part of a process that usually operates independently from other process stages and usually results in a planned sequence of chemical or physical changes in the material being processed. 2) ISA-88 Part 1 Section 4: The process consists of one or more process stages which are organized as an ordered set, which can be serial, parallel, or both. A process stage is a part of a process that usually operates independently from other process stages. It usually results in a planned sequence of chemical or physical changes in the material being processed

RecipeProcessStage(x) → RecipeProcessElement(x) ∧ ∃y (hasContinuantPartAtAllTimes(x, y) ∧ RecipeProcessOperation(y)) ∧ ∀z (hasContinuantPartAtSomeTime(x, z) → ¬RecipeProcess(z)) ∧ ∀w (hasProperContinuantPartAtSomeTime(x, w) → ¬RecipeProcessStage(w))

true

recipe process element that has an partially ordered set of recipe process operations as its part

There are currently insufficient constructs to represent a partially ordered set.

if x is a 'recipe process stage', then x is a 'recipe process element', x 'has continuant part at all times' some 'recipe process operation', x 'has continuant part at some time' only entities that are not a 'recipe process', and x 'has proper continuant part at some time' only entities that are not a 'recipe process stage'

recipe unit procedure A ‘Vinyl chloride monomer polymerization unit procedure’, which comprises the following recipe operations: ‘Setup operation’, followed by ‘Charge water, additives and monomer operation’, followed by a ‘Polymerization operation’, followed by a ‘Post-polymerization operation’. This unit procedure can be carried out in any of the Reactors JR-101/JR-102/JR-103/JR-104 (Stainless steel, 1,000-gallon, rated 100 psia, mechanical agitator, with temperature and pressure control systems, nitrogen purge system, pressure relief system with a Rupture disc)

ISA-88 Part 1

1) From ISA-88 Part 1 Section 3: A strategy for carrying out a contiguous process within a unit, consisting of contiguous operations and the algorithm necessary for the initiation, organization, and control of those operations. 2) From ISA-88 Part 1 Section 5: A unit procedure consists of an ordered set of operations that causes a contiguous production sequence to take place within a unit.

RecipeUnitProcedure(x) → RecipeProceduralElement(x) ∧ ∀y (hasContinuantPartAtSomeTime(x, y) → ¬RecipeProcedure(y)) ∧ ∀z (hasProperContinuantPartAtSomeTime(x, z) → ¬RecipeUnitProcedure(z))

RecipeUnitProcedure(x) ↔ RecipeProceduralElement(x) ∧ ∃o(RecipeOperation(o) ∧ hasContinuantPartAtAllTimes(x, o)) ∧ ∃z(PhysicalUnit(z) ∧ ∃y(InformationContentEntity(y) ∧ hasContinuantPartAtAllTimes(x, y) ∧ (denotes(y, z) ∨ prescribes(y, z) ∨ ∃c(ManufacturingCapability(c) ∧ capabilityOf(c, z) ∧ prescribes(y, c)))))

recipe procedural element that has a partially ordered set of recipe operations as its part and that prescribes one or more alternative physical units with compatible capabilities

if x is a 'recipe unit procedure', then x is a 'recipe procedural element', x 'has continuant part at some time' only entities that are not a 'recipe procedure', and x 'has proper continuant part at some time' only entities that are not a 'recipe unit procedure'

every instance of 'recipe unit procedure' is exactly a 'recipe procedural element' that 'has continuant part at all times' some 'recipe operation', and 'has continuant part at all times' some 'information content entity' that either 'denotes' a 'physical unit' or 'prescribes' either a 'physical unit' or a 'manufacturing capability' that is a 'capability of' a 'physical unit'

site recipe Site Recipe ‘SR-PVC-SUSP-HOU-V5’, which employs the ‘PVC granular resin production process Houston’ Recipe Process that comprises the following sequence of Process stages ‘Vinyl chloride monomer polymerization stage’, ‘Water Separation stage’, and ‘Spray Drying stage’, to transform the Vinyl Chloride Monomer (2200 lb. or target value) raw material into ~980 kg of PVC granular resin product, employing the following Consumables: Deionized Water (1057 Gallons or target value), Suspension Agent Polyvinyl Alcohol (CAS No.9002-89-5), by Wacker Chemie AG (11 lb. or target value), Benzoyl Peroxide Initiator (CAS No. 94-36-0), by Arzo Nobel (2.2 lb. or target value), Sodium Bicarbonate (CAS No. 144-55-8), by Church & Dwight Co (1.1 lb. or target value).

https://www.plcacademy.com/isa-88-s88-batch-control-explained/

Site recipes may be derived from general recipes recognizing site specific constraints, such as language and available raw materials.

LA1:SiteRecipe(x) → Recipe(x) ∧ ∃y (prescribesPlannedProcessLocation(x, y) ∧ PhysicalSite(y))

LA2: Recipe(x) ∧ ∃y (hasContinuantPartAtAllTimes(x, y) ∧ RecipeProcessElement(y)) ∧ ∃z (prescribesPlannedProcessLocation(x, z) ∧ PhysicalSite(z)) → SiteRecipe(x)

true

recipe that is physical site specific but equipment independent

This term is expected to remain primitive because, although a set of sufficient conditions can be defined (e.g., the inclusion of recipe process elements), these conditions are not universally necessary, as not all site recipes consistently include such elements

LA1: if x is a 'site recipe', then x is a 'recipe' and x 'prescribes planned process location' some 'physical site'

LA2: if x is a 'recipe' that 'has continuant part at all times' some 'recipe process element' and 'prescribes planned process location' some 'physical site', then x is a 'site recipe'

prescribed to precede The viral inactivation operation is prescribed to precede the protein A chromatography operation; The filter integrity test is prescribed to precede the sterile filtration unit procedure

This relation captures a prescriptive temporal ordering between two plan specifications. It is used to represent that, according to the structural constraints of a plan, one planned process is to precede another. This does not assert actual temporal precedence in an execution trace, but rather defines the intended order of execution.

relation between two plan specifications indicating that the planned process prescribed by the first must precede the planned process prescribed by the second in order to conform to the ordering constraints of the plan specification

prescribes planned process location A site recipe for monoclonal antibody production prescribes planned process location the Solna Biologics Manufacturing Site; A viral filtration operation prescribes planned process location the Sterile Filtration Area;

relation between a plan specification and a site or material entity indicating that a planned process prescribed by the plan specification should occur at that particular site or in the material entity