Iec 61512 3 2008

3.1.3 process procedure chart a graphical representation of equipment-independent recipes that is defined in this part of As defined in the recipe model of IEC 61512-1, a recipe is an e

Terms and definitions

For the purposes of this document, the terms and definitions given in IEC 61512-1,

IEC 61512-2 and IEC 60050-351, as well as the following, apply

3.1.1 equipment-independent recipe recipe type that defines general requirements for equipment but is not specifically tailored for a precise class or size of equipment

3.1.2 master recipe transform component part of a master recipe that is used in the transformation of an equipment-independent recipe into a complete master recipe

LICENSED TO MECON Limited - RANCHI/BANGALORE FOR INTERNAL USE AT THIS LOCATION ONLY, SUPPLIED BY BOOK SUPPLY BUREAU.

3.1.3 process procedure chart a graphical representation of equipment-independent recipes that is defined in this part of

3.1.4 product family a set of produced materials that are related by manufacturing process or business policy

3.1.5 product grades collections of similarly produced materials with variations in properties.

Abbreviation

Recipe types

As defined in the recipe model of IEC 61512-1, a recipe is an entity that contains the minimum set of information that uniquely defines the manufacturing requirements for a specific product

Recipes provide a way to describe products and how those products are produced

IEC 61512-1 defines four types of recipes: general, site, master, and control recipes General and site recipes outline the equipment-independent processing requirements for producing a specific product, while master and control recipes detail the specific actions needed with particular equipment to manufacture a batch of that product.

Additional information on the four recipe types is defined in IEC 61512-1.

General and site recipe description

Manufacturing information

General and site recipes serve as essential resources for creating process cell-specific master recipes, focusing on manufacturing information independent of specific equipment They outline the necessary materials, equipment requirements, and both chemical and physical transformations needed for product manufacturing.

Multiple site definitions

General and site recipes establish processing requirements applicable to various process cells and can be utilized across multiple areas and sites As illustrated in Figure 1, these recipes may also facilitate the sharing of product-manufacturing information among different enterprises.

One general recipe per produced material, maintained at the enterprise level

For example, 1 000 company-wide products

One site recipe per site and produced material, maintained at the site for local materials, language, or segment of production

For example, 10 000 site recipes for 10 sites

One master recipe per process cell and produced material

For example, 50 000 master recipes for

One control recipe per batch

For example, 1 000 000 batches per year

Describes the custom options and formula values for one specific batch of product

Process cell Process cell Process cell

There are generally fewer general and site recipes in a manufacturing enterprise than master recipes

A small specialty chemical company can manage around 1,000 general recipes and 10,000 site-specific recipes across 10 production sites, with an estimated 50,000 master recipes based on an average of 5 process cells per site In contrast, larger companies may handle thousands of products and millions of master recipes, where a single modification to a general recipe can lead to adjustments in hundreds of master recipes.

Expansion and collapsing of the recipe type hierarchy

The general and site recipe hierarchy can be expanded or collapsed to meet an enterprise’s needs

A company may possess only general recipes rather than site-specific ones Alternatively, it can incorporate an additional tier of equipment-independent recipes beneath the site recipe, tailored to specific areas within the site.

Equipment-independent recipes

Equipment-independent recipe subtypes

General and site recipes are subtypes of a general class of equipment-independent recipes

They have the same structure, information, and display, but they differ by their use within a company, based on company policies.

Activities of equipment-independent recipes

Companies can implement equipment-independent recipes in various ways Two prevalent methods include using these recipes as inputs for trial or pilot plant production, and generating equipment-independent recipes as outcomes from such production processes.

These approaches are defined for product manufacturing; they do not necessarily apply to

MECON Limited is licensed for internal use in Ranchi and Bangalore, as supplied by the Book Supply Bureau The concepts discussed are not only applicable to research and development (R&D) but can also provide benefits across various other areas of the enterprise.

In the examples, the recipes are identified as general recipes, but they can be any type of equipment-independent recipe

The creation of equipment-independent recipes is usually an iterative process, involving continuous feedback loops during the development cycle For clarity, these multiple feedback loops are not illustrated in Figures 2 and 3.

Input to trial or pilot production

Figure 2 illustrates the activities associated with the generation and use of equipment- independent recipes as an input to trial or pilot plant production

A company creates equipment-independent recipes that define trial or pilot plant operations These recipes are then transformed into master recipes tailored to the pilot plant's equipment layout, allowing for the scaling up and validation of the process.

Convert and validate in trial facility

Figure 2 – Pilot plant creation of equipment-independent recipe

Output from trial or pilot production

An effective approach for developing equipment-independent recipes involves creating such recipes following the scale-up and verification of processes in a trial or pilot facility This method culminates in a final equipment-independent recipe, which is typically based on the final trial master recipe that serves as the process description.

Using a formal, equipment-independent structure for process descriptions can enhance clarity In certain situations, it may be beneficial to apply this same structure as input for the pilot plant, even if it is not explicitly labeled as a recipe.

Convert and validate in trial facility

Figure 3 – Equipment-independent recipe from pilot plant development

Control of equipment-independent recipes

Equipment-independent recipes are crucial as they embody a company's valuable and proprietary intellectual capital Therefore, it is essential to manage these recipes through formal procedures and implement adequate safeguards for change control.

Equipment-independent recipe definition

An equipment-independent recipe defines a single set of processing requirements for the production of an intended material or materials

EXAMPLE The produced material may be products, co-products, and by-products.

Equipment-independent recipe variants

An equipment-independent recipe for a produced material can have several variants, each outlining different synthesis paths or alternative formula materials These variants are documented in distinct equipment-independent recipes To clarify the connections between these multiple variant recipes, an identification method is typically employed.

Multiple equipment-independent recipes can be utilized to produce wood-based glue, with variations depending on the season and tree species While all recipes aim for the same final product, they can be distinguished by their specific variants.

Source of scheduling information

Equipment-independent and site recipes serve as essential tools for corporate scheduling and planning A site recipe outlines all necessary processing materials for producing a product or its components at a specific location Additionally, it includes vital information about the resources needed for production, aiding in effective resource and production scheduling.

Equipment-independent recipes, especially site recipes, serve as valuable resources for scheduling and planning They include essential details such as the materials needed to produce a product or its components, as well as the resources necessary for the manufacturing process.

In cases where site recipes are not used (e.g., all sites use the same general recipe), then for purposes of scheduling, the general recipe can be considered a site recipe

Master recipes are needed for detailed scheduling of process cells and units, because these schedules require knowledge of the specific equipment required.

Equipment-independent recipes and business information

Recipes are essential for product production, as outlined in IEC 62264-1 General and site recipes provide equipment-independent guidelines, while master and control recipes offer equipment-specific instructions for production processes.

Because a site recipe can be defined for many process cells, with different structures, it is often used as a basis for site planning information, as specified in IEC 62264-1

There is an overlap of the information contained in a site recipe and the Bill Of Materials

(BOM) used in business systems to manage and schedule materials This overlap is identified as a manufacturing bill in IEC 62264-1, and is made up of the site recipes’ process inputs

The site recipe can be the source of information for the manufacturing bill See Figure 4

The information in a site recipe and the Bill Of Resources (BOR) used in business systems for production scheduling exhibits a significant overlap, characterized by both process and product elements.

Segments in IEC 62264-1 and can correspond to the site recipe’s process stages and process operations

Production routing may be defined as the process stage or process operation sequence

Manufacturing bill defined as the recipe’s process inputs

All information required to produce a product, at a given site

All materials required to produce a product at a given site, including materials not related to production

All resources, identified by scheduling, required to produce a product at a given site, including information not related to production (for example material order lead times)

Figure 4 – Site recipe, BOM, and BOR information overlaps

Equipment-independent recipes for capability comparison

Equipment-independent recipes enable the comparison of product-manufacturing specifications with equipment capabilities By utilizing generalized equipment and process requirements, these recipes can be aligned with the definitions of site or process cell equipment capabilities This alignment helps identify suitable manufacturing locations for the product, determine which components can be produced, and assess any additional equipment capabilities needed for production.

Equipment-independent recipes as facility design specifications

Equipment-independent recipes play a crucial role in facility design specifications While these recipes may not be directly applicable as specifications in their original form, they provide essential information needed for creating a formal, clear, and standardized facility specification.

Equipment-independent recipes play a crucial role in facility design by formally outlining processing and equipment requirements They facilitate the definition of material flows between units and process cells, ensuring efficient operations These recipes specify the materials to be handled and establish precise ratios of material amounts, including expected yields compared to raw materials Additionally, they can incorporate product-dependent processing times based on chemistry rather than equipment size When combined with anticipated production schedules as defined in IEC 62264-1, these recipes help determine equipment capacities effectively.

General recipes

Enterprise-wide definition

A general recipe defines the manufacturing requirements for a specific product or range of product It is independent of the actual site or equipment that could be actually used to

MECON Limited, located in Ranchi and Bangalore, is licensed for internal use only, as supplied by the Book Supply Bureau A general recipe serves as the technical specification outlining the process for manufacturing a product.

A general recipe is an enterprise-wide guideline that forms the foundation for site and master recipes, developed by experts in chemistry and processing It outlines the necessary raw materials, their quantities, and the required processing steps, including the order of operations Additionally, it specifies essential processing capabilities, such as heating or cooling, and general equipment requirements, like glass-lined reactors While it does not mandate specific equipment, it does identify authorized types of equipment when critical to the described process.

The general recipe is universally applicable across the enterprise, detailing the manufacturing requirements for specific materials in a way that all production sites can utilize Additionally, it provides essential input for corporate production planning and standard costing.

Purpose of a general recipe

A general recipe is a corporate guideline that outlines the necessary processes to produce a consistent product across various manufacturing locations Differences among these sites may include plant configurations, raw materials, and levels of automation Typically, a general recipe is established only after a master recipe for the product has been validated at one or more sites.

A comprehensive recipe must extend beyond mere laboratory experience; it should align with the company's established manufacturing capabilities and undergo testing in a production setting prior to final approval.

General recipe information

General recipes are essential for defining manufacturing processes and are typically created during the scale-up verification at pilot plants They reference a company's core manufacturing capabilities and involve both process and product development These recipes serve as a clear communication tool for processing requirements across various manufacturing locations.

Figure 5 – General recipes in a typical development function

Product development establishes the product and its specifications, detailing the methods for production, even at a laboratory scale This process leads to a fundamental understanding of the unique chemistry and processing needs associated with the product.

Product development can result in equipment requirements that are described in enough detail to define the type of equipment needed

Process development is essential for defining the manufacturing processes necessary to produce a product that meets its specifications It considers the existing basic manufacturing process definitions and identifies any additional processes required, establishing the new process requirements as needed.

EXAMPLE 1 New chemistry may require new process actions, such as ultraviolet light driven reactions

EXAMPLE 2 A new form of packaging may require a new process action, such as the addition of a sterilization in a form, fill, and seal action.

Site recipes

Site-specific recipes

A site recipe is a specialized recipe tailored to a specific location, integrating both site-specific details and general recipe information It accounts for variations such as the local language and differences in available raw materials, while not being tied to a specific set of processing equipment.

A site recipe is tailored from a general recipe to address specific conditions and requirements at a manufacturing location, ensuring it includes the necessary details for long-term production scheduling Alternatively, it can also be developed independently, without relying on a general recipe.

Site recipe definition

A site recipe mirrors the structure of a traditional recipe, yet it is specifically customized for each target location Additionally, the site recipe can be adapted to accommodate the local language.

When creating a site-specific recipe, it is essential to consider the local language, measurement units (such as Imperial or metric), and the availability of raw materials The site recipe may only encompass a portion of the overall process outlined in the general recipe that is executed at the location.

A single product may involve intermediate materials produced at one location and subsequently transported to another for final processing In this scenario, the recipe for each site is tailored to include only the specific components of the overall recipe necessary for the processing at that particular site.

Site recipes are commonly utilized to establish local variations in both the recipe production process and presentation These variations can encompass factors such as ingredient substitutions, cooking techniques, and serving styles.

Utilizing alternate raw materials is essential for optimizing production processes When a product, defined by a general recipe, is manufactured at multiple locations, each site may have a specific recipe that outlines only the relevant portion of the manufacturing process Additionally, site recipes serve to establish a genealogy link at the site level to the master recipes, ensuring consistency and traceability in production.

Site recipes are essential for materials produced and consumed locally, serving multiple purposes such as site-costing and providing manufacturing specifications that align with equipment capabilities They also offer critical information regarding production requirements, material needs, and material ratios necessary for designing an efficient production facility.

Site recipe policies

Site recipes are not always used Their use is determined by a company's policy If site recipes are used, then a company should define a policy for control of the recipes

A policy can be established where a site creates its own unique recipes that remain exclusive to that site, without sharing them with other sites or corporate management Alternatively, a site may only access recipes specifically generated for it, without ever receiving general recipes.

EXAMPLE 2 A policy would allow sites to generate site recipes based on copies of approved general recipes.

Product families and product grades

Product definition

IEC 61512-1 defines "product" as the output of a process cell, with the final product's definition established at the enterprise level This definition often considers factors beyond just the production processes.

EXAMPLE A product may be defined by packaging, brand name, or delivery form

The definition of a final or finished “product” is beyond the scope of this part of IEC 61512

The terms "product family" and "product grade" are essential classifications that apply to both process cell outputs and final products.

Product families

Sets of produced materials that are related by manufacturing process or business policy are sometimes identified as product families

Product family definitions can be categorized in several ways: a) as a group of materials produced through the same manufacturing process; b) as materials made using identical equipment; c) as items that share manufacturing processes but differ in packaging methods; and d) as collections defined by business rules, such as demand forecasting, rather than by manufacturing criteria.

Product grades

Product grades are collections of similarly produced materials with variations in properties

Typical implementations of product grades use multiple recipes that all use the same procedure, but have different formula values In this situation, there is one recipe per product grade

In some cases, a single recipe can also produce product grades In this situation, process variability or material property variations produce a range of products that match various product quality specifications

Recipe information

Equipment-independent recipes, including general and site recipes, must include essential information similar to that found in master and control recipes This information encompasses a header, formula, procedure, equipment requirements, and any additional details as specified.

Recipe life cycle states

Equipment-independent recipes shall have an associated life cycle state The state information is used to define the current state of the recipe definition

The minimum set of equipment-independent recipe life cycle states that shall be supported is defined in Table 7

To ensure consistency in the life cycle states of equipment-independent recipes, it is essential to associate these states with the life cycle states of referenced elements, including process actions, equipment requirements, and materials Implementing a robust policy and administrative process is crucial for maintaining this alignment.

EXAMPLE If the state of a referenced material becomes “Withdrawn,” then the state of all recipes referencing the material becomes “Withdrawn.”

Recipe header

The header in an equipment-independent recipe contains essential administrative information, including recipe identification, product identification, version number, product family, product grade, originator, and life cycle state.

Recipe formula

The formula represents a type of equipment-independent recipe information that encompasses process inputs, parameters, and outputs It specifies the materials or resources involved, along with their respective quantities.

Materials used in equipment-independent recipes shall be identified by material definitions or material classes as defined IEC 62264-1 Equipment-independent recipes do not use material lot definitions (see IEC 62264-1)

Material definitions and material class definitions should be maintained in a material definition library to ensure that only valid material definitions are used in equipment-independent recipes

A material definition must be linked to a specific state, which is essential for determining the life cycle status of both the material definition itself and the equipment-independent recipes that utilize it.

The minimum set of material definition and material class states that shall be supported are defined in Table 7.

Recipe procedure

Process model

The procedural part of an equipment-independent recipe is defined according to the process model described in IEC 61512-1

Process hierarchy

An equipment-independent recipe procedure outlines a process consisting of multiple stages, each made up of various operations, which in turn are composed of specific actions This hierarchical structure is visually represented in Figure 6.

Procedure A procedure defines a process that is made up of an ordered set of one or more process stages

A pocess stage is made up of an ordered set of one or more process operations

A pocess operation is made up of an ordered set of one or more process actions

Figure 6 – Equipment-independent recipe procedure definition

A procedure is made up of process stages; the process stages are made up of process operations, which in turn are made up of process actions

The distinction between the procedure definitions in a master recipe and an equipment-independent recipe is crucial A master recipe outlines process-oriented tasks tailored to specific equipment within a process cell, reflecting the organization of that equipment In contrast, an equipment-independent recipe emphasizes the sequence of material processing and the nature of the required processing, regardless of the equipment used.

EXAMPLE Some materials have to be operated on independently before they are joined, because the materials react or mix to form different materials or unique compounds.

Ideal procedure for manufacture

An effective product manufacturing procedure is defined by the sequence of process stages, operations, and actions While exception logic or conditions are typically not included in the procedure definition, they can be detailed in the additional information of the recipe.

Process stage

A process stage refers to a distinct segment of a process that functions autonomously, leading to a predetermined series of chemical or physical transformations in the material being processed It is essential to clearly identify the resources or materials as process inputs and outputs in a recipe When a process output from one stage serves as an input for another, it is termed a process intermediate and does not require additional identification Additionally, process stages can produce multiple outputs or intermediates.

Process operation

Process operations are key activities that lead to chemical or physical changes in materials, defined without specifying the exact equipment configuration They are categorized based on chemical or physical factors and serve several purposes: they provide a natural organizational structure for major processing steps, help identify operation boundaries for master recipes, and determine equipment requirements for actions within the operation Additionally, process operations are expected to function sequentially on the materials defined at each process stage.

Process action

A process action is a minor processing activity, such as grind, cool, heat, delay, test or mix

Many actions are simply the addition of material, removal of material, addition of energy, or removal of energy

Even the simple addition of a material can be performed through different types of process actions

EXAMPLE The addition rate could be fixed or could be controlled by a process variable such as a pressure, temperature, or pH

Companies may have unique processing capabilities defined by specific actions like separation or packaging Additionally, certain industry-specific actions, such as catalytic conversions or changes in property states, play a crucial role in these processes.

Process actions in operations are expected to function on specified materials in a predetermined order This order can involve either serial or parallel sequences and may include multiple branching paths.

Definition of equipment requirements

Process elements are not tied to specific equipment; however, they can establish requirements for the target equipment or production environment This is particularly important when the characteristics of the equipment or environment affect the chemistry or physics of the production process.

In the production of chemicals for color photography film, nickel contamination in process vessels or pipes can lead to fogging of the film Therefore, it is essential to ensure that all vessel and pipe linings are free of nickel to maintain the quality of the final product.

EXAMPLE 2 A material may be shear sensitive, and there could be an equipment constraint specifying that any target equipment has low shear properties.

Process stage guidelines

This section assists in recognizing the stages of a process by highlighting their defining characteristics It serves as a guideline for identifying these stages rather than presenting strict rules.

5.5.8.2 Process-related guidelines a) A process stage usually describes a major physical or chemical function in a manufacturing process, such as grinding, mixing, chemical synthesizing, fermenting, and packaging

NOTE 1 This may even be considered the primary characteristic used in defining a process stage

MECON Limited is licensed for internal use at the Ranchi and Bangalore locations, with materials supplied by the Book Supply Bureau Additionally, a single process stage may result in the production of multiple materials.

A process stage that involves separation can yield several primary materials and is typically linked to a significant transformation of the material This stage can be recognized as a method to carry out a specific named chemical reaction.

NOTE 2 A chemical reaction may be a secondary defining characteristic, but it does have a meaning for chemists who have to interpret general recipes d) Materials shall be operated on independently

NOTE 3 Materials in separate stages can be assumed to be independent (not reacting) with the other materials until the materials are combined through specific process actions e) Materials can be operated on asynchronously

NOTE 4 Intermediate materials may be pre-made and stored for later use f) There are common chemical or physical properties required for the target equipment

NOTE 5 Equipment requirements can be applied to an entire stage This means that any target equipment, for any of the process actions and any intermediate material movement system, meet the equipment requirements

5.5.8.3 Non-process related definitions a) Different parts of the processing described in the equipment-independent recipe can eventually be carried out in more than one process cell, requiring the intermediate material to cross cell boundaries with possible intermediate storage

NOTE 1 The process stage provides a convenient organizational structure for splitting a general recipe into smaller parts

NOTE 2 A process stage defines processing that will likely be implemented in a single process cell b) Different parts of the equipment-independent recipe can possibly be carried out on different sites, requiring the intermediate material to be transported between sites

NOTE 3 Part of the definition of a site recipe is as the subset of a general recipe that can be implemented on a site Process stages provide a convenient organization structure for splitting a general recipe into multiple site recipes One or more stages can then be implemented on each site, and intermediate materials may be shipped between sites c) An intermediate material may have to be separately inventoried

NOTE 4 Intermediate materials possibly have a unique cost, or value, to the company and possibly have to be identified and inventoried for tax or accounting purposes Many intermediates can also be final products and are either sold or used based on customer demand

NOTE 5 Process stage boundaries can be used to identify inventoried intermediates d) Intermediate materials can be purchased instead of produced, so that part of the equipment-independent recipe would not need to be transformed into a segment of a master recipe

NOTE 6 Process stage boundaries can be used to identify intermediates that can be obtained locally instead of being produced e) The same intermediate materials can be used in multiple products or general recipes f) The production of intermediate materials is often separately planned and scheduled

NOTE 7 If the production of intermediates takes significant time, or uses constrained resources, then process stages can be used to identify process breakpoints to balance workload on capacity-constrained equipment.

Process operation guidelines

Process operations consist of distinct stages that facilitate the transformation of a batch through chemical or physical changes These operations are fundamentally linked to traditional chemical engineering unit operations, highlighting their importance in the overall processing framework.

This subclause assists in recognizing process operations by highlighting their identifying characteristics It serves as a guideline for identifying these operations rather than establishing strict rules.

5.5.9.2 Process-related guidelines a) A process operation can be identified with some physical or chemical change in the material The change is typically not reversible b) There can be different equipment requirements needed within a stage; the equipment requirements can be associated with process operations c) Process operations can be used to separate process actions that work together to perform a basic function d) Process operation boundaries can occur at natural breakpoints in production, when the material being created has readily identifiable characteristics e) Process operation boundaries can occur where there are test points or decision points in related master recipes Test points and decision points are often associated with delays while tests are run The process operation provides a convenient boundary for test points f) Common process operations can be defined and used in multiple recipes

5.5.9.3 Non-process-related guidelines a) Process operations can be defined to simplify transformation of an equipment- independent recipe to master recipes The process operations can be used to define the boundaries of master recipe unit procedures or operations This can be information used by people generating master recipes, or information used by automated conversion facilities b) Process operations can be defined because activity-based cost accounting needs finer granularity than is provided by process stages c) Process operations can be defined as a boundary condition so that the resultant target equipment can be reconfigured between master recipe operations.

Process action guidelines

This subclause aids in the identification of process actions It focuses on the identifying characteristics of process actions and is meant to provide guidelines for identifying process actions

To ensure the use of widely accepted and understood process action definitions in equipment-independent recipes, it is essential to maintain a process action library This library serves as a collection of available process action definitions, rather than implying a specific storage or management system.

To create a coherent recipe, it is essential to establish the fundamental building blocks, particularly the process actions, independent of equipment If these building blocks are not clearly defined, including their intentions and necessary parameters, the recipe author may resort to creating nonstandard actions This can lead to confusion regarding the author's true intentions and the expected functionality of the parameters within the process Consequently, variations may arise between different recipes and authors, undermining consistency and clarity.

Process actions are established during the creation of a recipe, utilizing pre-defined building blocks that simplify recipe construction and standardize processes This standardization enhances the understanding of process intent for those responsible for operating the equipment To effectively implement equipment-independent recipes, it is essential to have a clearly defined and documented set of process actions that serve as the foundation for all recipes.

Process actions within the process action library are linked to a specific state, which is crucial for defining the life cycle state of both the process action definition and the equipment-independent recipes that utilize the process action.

The minimum set of process action states that shall be supported is defined in Table 7

Process actions in the process action library shall have the minimum set of properties defined in Table 1

Unique identification Used to identify the specific process action and version of the process action

Functional description Used to describe the intent of the action

State Used to define the life cycle state of the process action definition

Parameters Used to optionally parameterize each specific use of the process action in a recipe.

Process action types

Process actions can significantly change the processing environment, which is characterized by factors such as temperature, pressure, and mixing state To establish this environment, one can choose between a non-persistent or a persistent model Regardless of the selected model, it is crucial to clearly communicate it to those responsible for interpreting the equipment-independent recipe to create master recipes.

The non-persistent model characterizes process actions that shape the environment solely during their active state This approach necessitates a mechanism to record the concurrent execution of these process actions.

EXAMPLE A process operation is shown in Figure 7 in graphical format The process actions of HEAT and MIX run in parallel to the CHARGE, WAIT, CHARGE, and TEST actions

Figure 7 – Non-persistent process actions

The persistent model defines process actions that set the environmental conditions that are maintained until altered by another process action or external command

In the process operation outlined in Table 2, heating and mixing occur during the CHARGE, WAIT, CHARGE, and TEST actions The "MIX ON" action initiates mixing, which persists until "MIX OFF" is activated, while "HEAT ON" begins heating and continues until "HEAT OFF" is reached.

Table 2 – Persistent process action table format example

Sequence order Sequence path Process operation or process action Material

There are process actions that add materials These can be parameterized and there can be different actions depending on how the material is to be added

EXAMPLE Table 3 lists some example process actions for material addition

Table 3 – Material addition process action examples

Process action name Functional description Parameters

Charge Add the specified material There is no rate constraint on the material addition Usually used where there is no expected chemical reaction

Material to add Amount to add

ChargeAtRate Add the specified material at the specified rate and tolerance Usually used when mixing is required or too fast a rate will cause an undesired chemical reaction

Material to add Amount to add Percent per minute

To maintain the desired temperature of the produced material, it is essential to add the specified material, which may involve either heating or cooling capabilities This process is typically necessary during exothermic or endothermic chemical reactions.

Material to add Amount to add Maximum temperature Minimum temperature Temperature tolerance

There are process actions that remove materials from the process These can be parameterized and there can be different actions depending on how the material is to be removed

EXAMPLE Table 4 lists some example process actions for material removal

Table 4 – Material removal process action examples

Dry Dry the material to remove any water or other safely evaporated materials Material to remove

Expected amount removed minimum temperature

Evaporate solvent Remove a solvent through evaporation The solvent is to be retained and not dispersed into the atmosphere

Expected amount removed evaporation temperature

Filter solids Remove solids Material to remove

There are process actions that add energy to the process These can be parameterized and there can be different actions depending on how the material is to be heated

EXAMPLE Table 5 lists some example process actions for energy addition

Table 5 – Energy addition process action examples

Heat Induce energy to flow into the material

Heat profile Control the rate at which energy is added to the material There can be one or many sets of parameters for different profiles

Rate to heat Holding temperature Holding time

There are process actions that remove energy from the process These can be parameterized and there can be different actions depending on how the heat is removed

EXAMPLE Table 6 lists some example process actions for energy removal

Table 6 – Energy removal process action examples

Cool Induce energy to flow out of the material Final temperature

Cool profile Control the rate at which energy is removed from the material There can be one or many sets of parameters for different profiles

Rate to cool Holding temperature Holding time

Equipment requirements

Requirements of final manufacturing equipment

Equipment requirements outline the essential specifications for the manufacturing equipment needed to facilitate process activities, while also documenting key attributes necessary for this equipment.

Equipment selection

Having equipment requirements in a recipe is crucial for selecting the appropriate equipment needed for product manufacturing This is particularly beneficial when automating the equipment selection process By outlining these requirements, one can effectively compare the characteristics and attributes of existing plant equipment to assess the suitability of the chosen equipment.

Constraining target equipment

Equipment requirements define the constraints to be placed on target equipment, usually where the constraints impact the chemical or physical processing of the material

EXAMPLE The chemistry of a process stage could require that the operations occur in glass-lined reactors and

Teflon-lined pipes, because materials being processed will interact with normal steel containers and pipes.

Managing equipment requirement definitions

To ensure the use of only available equipment requirement definitions in equipment-independent recipes, it is essential to maintain an equipment requirement library This library serves as a collection of these definitions, rather than implying a specific storage or management system.

The equipment requirement definitions in the library must be linked to a specific life cycle state This state information is essential for determining both the life cycle state of the equipment requirement definitions and the life cycle state of equipment-independent recipes that utilize these definitions.

The minimum set of equipment requirement definition life cycle states that shall be supported is defined in Table 7.

Other information

A general recipe is a container of production information required for manufacturing, including the process definition, material identification and amounts, material quality information, and references to test definitions and test standards

Equipment-independent recipes often include various supplementary information, such as spreadsheets outlining known process sensitivity models, comprehensive process models, and images of both successful and defective products along with potential failure causes Additionally, they reference test methods, specifications, and material data safety sheets, while also providing crucial health and safety information and packaging details.

Life cycle states

Life cycle states for equipment-independent recipes, process action definitions, equipment requirement definitions, material class, and material definitions are defined in Table 7

The life cycle states represent the common minimum set of states Companies may define additional states as required by business rules

Transitions between states are flexible and can vary based on business rules, allowing for direct movement between any two states For instance, it is possible to transition from Draft to Effective or from Withdrawn to Approved without following a specific sequence.

The term "Draft" signifies that the element's definition is still being developed or is open for review, but it is not yet ready for normal production use Additional "Draft" substates may indicate that the work is in progress and awaiting approval.

Approved Indicates that the element definition is complete and has been approved by all pertinent authorities

Released Indicates that the element definition has been approved and has been distributed, but it has not yet become effective

Effective Indicates that the element definition is available for use

Withdrawn Indicates that the element definition is no longer effective and is not available for use

6 Equipment-independent recipe object model

General

This clause outlines data models that define a collection of objects, attributes, and fundamental relationships, reflecting the concepts of Clause 4 and Clause 5 of IEC 61512 at a high level of abstraction These models are designed for use with interfaces to recipe management systems in a technology-agnostic way and do not focus on the internal architecture of these systems.

The intended use of these models is to provide a starting point for developing interface specifications for components that address any subset of this part of IEC 61512

When objects and relationships are represented through an interface, the interface must utilize the object names and relationships specified in this clause, aligning with the selected interface technology and its capabilities.

Modelling techniques

The models that are described in this clause are based on the Unified Modelling Language

(UML) per ISO/IEC 19501 (see Clause 2).

Object model

The object model for equipment-independent recipes is shown in Figure 8 The main elements are equipment-independent recipes, an equipment requirement library, and a material definition and class definition library

Equipment requirement library corresponds to has a type of

Process element library is made up of is made up of

Process operation Process action is made up of is made up of has is made up of

General recipe Site recipe Material definition is made up of

Material definition library corresponds to corresponds to

Process parameter Process input Process output

Percent input Percent output produces % of the output has a type of

Figure 8 – Equipment-independent recipe object model

Object relationships

The object model for equipment-independent recipe entities establishes key relationships: a general recipe and a site recipe are both types of equipment-independent recipes, with the latter being derivable from all or part of the former Additionally, an equipment-independent recipe includes a defined process procedure and may contain zero or more sets of supplementary information.

An equipment-independent recipe includes multiple process inputs, with at least one being a material, and one or more process outputs, also including at least one material It may contain zero or more process parameters A process procedure is composed of various process elements, which define any necessary equipment requirements Each process element can represent a process action, operation, or stage, and corresponds to a specific process element specification Additionally, a process element library consists of these process element specifications.

The equipment requirement library consists of various equipment requirement elements, with each requirement corresponding to a specific element These requirements can be defined and maintained based on equipment class properties as outlined in IEC 62264-2 Additionally, a process element may utilize a process input at varying percentages and can produce a process output with corresponding percentages Both process inputs and outputs are associated with material classes or definitions, which are organized within a material definition library composed of material library elements Furthermore, a process element can be interconnected with multiple other process elements through designated links.

Object model elements

Attributes

IEC 61512-2 defines the attributes for recipe entities The attributes defined in IEC 61512-2 for recipe entities apply to equipment-independent recipes The attributes defined in

IEC 61512-2 also apply to the objects in this part of IEC 61512

Each element definition shall have a unique identification consisting of an ID and a version number Each combination of ID and version number shall be unique

Element definitions typically include several key attributes: the current status indicating the life cycle state, author names or initials for identification, and the owner's name or initials to denote ownership Additionally, approver names or initials are included to identify those who approved the definition, along with the approval date marking the final approval time The issue date indicates when the definition was released, while the effective date specifies when it became active Lastly, the withdrawal date shows when the definition was withdrawn, and the replaces version notes which previous version was replaced upon the new definition's effectiveness.

Equipment-independent recipe

An equipment-independent recipe is a recipe entity (see IEC 61512-2:2001, Clause 4.3.1) that is a superclass of site and general recipes An equipment-independent recipe has a life cycle state

There may be other types of equipment-independent recipes used within a company, but those are outside the scope of this part of IEC 61512.

Equipment requirement

An equipment requirement defines a constraint to be applied on target equipment.

Equipment requirement element

An equipment requirement element is an entry in an equipment requirement library that defines an allowable equipment requirement An equipment requirement element has a life cycle state

Equipment requirement library

An equipment requirement library is a collection of equipment requirement elements that is used in the construction of an equipment-independent recipe.

General recipe

A general recipe is a type of an equipment-independent recipe that is applied across an enterprise, company, or division See IEC 61512-2:2001, Clause 4.3.1.

Material definition

A material definition is defined using IEC 62264-1 It may also be a material class as defined in IEC 62264-1 A material definition has a life cycle state.

Material definition library

A material definition library contains material definitions or material classes that are used in the construction of an equipment-independent recipe

There may be additional material definitions in the material definition library that are not part of the BOM exchanged information defined in IEC 62264-1

A material solution consisting of 50% water and 50% caustic can be defined in the material definition library for use in recipes This solution can be prepared on-site, with only the individual components being listed rather than the final solution itself.

Bill Of Material corresponding to the recipe.

Other information

The recipe information includes essential support details not found elsewhere, such as regulatory compliance, materials and process safety data, process flow diagrams, and packaging and labeling information.

See IEC 61512-2:2001, Clause 4.3.2 for additional definitions.

Percent input

Percent input defines the percentage of a process input associated with a process element

Material balancing in a recipe may include a check that the sum of all percent inputs for each material is 100 %.

Percent output

Percent output defines the percentage of a process output associated with a process element

Material balancing in a recipe may include a check that the sum of all percent outputs for each material is 100 %.

Process procedure

A process procedure is a definition of the production process for an equipment-independent recipe It defines a procedure as a hierarchy of process elements.

Process action

A process action causes a physical change to a material within an equipment-independent recipe Process actions are the basic building blocks of a process procedure

Process element

A process element is a superclass of process stages, process operations, and process actions It is a modelling construct used to simplify the object model.

Process element library

A process element library is a collection of process element specifications that is used in the construction of an equipment-independent recipe.

Process element link

A process element link is a link between process elements, usually indicating either a material

(in a process or stage diagram) or an action dependency (in a process operation diagram).

Process element specification

A process element specification is an entry in a process element library that defines an allowable process element A process element specification has a life cycle state.

Process input

A process input defines a material that is used as an input in production of a product.

Process operation

A process operation is an ordered set of process actions.

Process output

A process output defines a material that is produced as a result of production of a product.

Process parameter

A process parameter defines non-material information that is associated with the recipe See

Process stage

A process stage is an ordered set of process operations.

Site recipe

A site recipe is type of an equipment-independent recipe that is applicable across a site See

Process procedure chart

An equipment-independent recipe shall be represented as a process procedure chart (PPC), showing the process input materials, process output materials, and intermediate materials

In the diagram notation, process stages are depicted as annotated rectangles, while process operations and actions can be illustrated either as rectangles in the diagram or as rows in the table notation.

Annotated lines connecting the annotated rectangles indicate intermediate materials

Annotated lines pointing to the annotated rectangles represent process inputs Annotated lines leading from the annotated rectangles represent process outputs

Figure 9 illustrates the stage representation of a sample equipment-independent recipe

NOTE The PPC notation is derived from the NAMUR 33 Guideline (see bibliography)

Stage, operation, or action representation

Process note: make sure that process temperature is maintained between ring expansion and hydrolysis Recipe annotation

Figure 9 – Example stage PPC for an equipment-independent recipe

This clause defines a method for graphical representation of equipment-independent recipes

The representation of the process is called a Process Procedure Chart (PPC) This clause also addresses requirements for representation of formula, equipment requirements, header and other information

The PPC language as defined in this part of IEC 61512 is designed to support recipes with complex processes (e.g., independent stages, parallel actions) that vary from one product to another.

Process procedure chart notation

Symbols and links

Process procedure charts illustrate the relationships between materials and actions necessary for producing one or more output materials These charts utilize a variety of symbols, which are connected by directed links to represent the sequence and dependencies of the elements involved.

Process procedure chart symbols

A process procedure chart is defined by a set of symbols for: a) Process stages, process operations, and process actions b) Process input materials c) Intermediate materials d) Process output materials e) Directed links f) Process annotations

NOTE Only the general representation of the symbols is imposed; dimensions and details (e.g., thickness of lines and font of characters) are left to each implementation

Each diagram shall have an indication of the level the diagram represents, procedure, process stage, or process operation

A process procedure chart visually outlines the steps involved in a recipe, independent of specific equipment, highlighting the various process stages and their interdependencies It details the operations within each process stage, showcasing their sequence, and further breaks down each operation into specific actions, emphasizing their order and sequencing.

An annotated rectangle is utilized to depict a process stage, operation, or action, with the fundamental symbol being a rectangle that contains the element name, as illustrated in Figure 10 This rectangle can also include annotations that provide supplementary information about the element.

Stage, operation, or action name

Stage, operation, or action representation

Figure 10 – Recipe process element symbols

An indication within a stage or process operation symbol signifies the presence of procedural elements, such as process operations or actions This indication must be placed in the lower left corner of the enclosing symbol and can be numeric, graphical, or a combination of both If a graphical figure is utilized, it should represent a step in the process.

MECON Limited is licensed for internal use at the Ranchi/Bangalore location, with materials supplied by the Book Supply Bureau Figure 11 depicts a content indication annotation that includes a distinctive graphical symbol along with a numerical count representing the underlying elements at the next lower level.

Figure 11 – Annotation for stage or operation elements

An indication within a stage or process operation symbol specifies the number of equipment requirements for that stage This indication is placed in the lower right corner of the enclosing symbol and can be numeric, graphical, or a combination of both When using a graphical figure, it must be represented by a clipboard symbol, as shown in Figure 12, which demonstrates an equipment requirement indication annotation that includes both a graphical symbol and a numerical count of requirements.

Annotations can provide essential information regarding processes, equipment, or other relevant details When a process annotation is utilized, it must be linked to either a specific object or the overarching process definition.

EXAMPLE Figure 13 illustrates an example process annotation that could be placed on a process definition diagram

Process note: make sure that process temperature is maintained between ring expansion and hydrolysis

Figure 13 – Example process annotation indication

A process input (as defined in IEC 61512-1) shall be represented by the symbol shown in

A process input symbol may be annotated with the identification of the consumed resource, material definition, or material class

A process input symbol can include annotations that specify the scaled or relative quantity of material, its properties, and details regarding its specific application, such as minimum and maximum lot sizes.

EXAMPLE Figure 15 illustrates a process input symbol with an optional material identification

Material ID ABC435 Nominal pH 6,3

Figure 15 – Process input symbol with material identification

In situations where numerous process inputs are needed, a single process input symbol can denote multiple materials The quantity of materials represented is specified within the process input symbol This annotation can also be applied to symbols for process intermediates and outputs.

Figure 16 – Sample process input symbol representing multiple materials

An identified process intermediate shall be represented by the symbol shown in Figure 17

An intermediate symbol can be labeled with the names of the produced and consumed resources, along with their material definitions or classes Additionally, it may include details about the scaled or relative quantity of the material, its properties, and specific usage information, such as minimum and maximum lot sizes.

For cases where large numbers of process intermediates are required, the process intermediate symbol may represent a list of materials

7.2.2.9 Unidentified intermediate or sequencing dependency

On a procedure and a process stage diagram, an unidentified process intermediate shall be represented as a line with an arrowhead, as shown in Figure 18

Figure 18 – Unidentified intermediate material symbol

A process output (as defined in IEC 61512-1) shall be represented by the symbol shown in

A process output symbol can include details such as the identification of the produced resource, material definition, or material class It may also indicate the scaled or relative amount of material, its properties, and specific usage information, including minimum and maximum lot sizes.

Figure 20 illustrates a process output symbol with an optional material identification and material property information

Material ID XGH435 Nominal pH 7,0 Color Yellow Density 1,35

Figure 20 – Process output symbol with material information

For cases where large numbers of process outputs are required, the process output symbol may represent a list of materials.

Link types

In a process operation diagram, the execution sequence is depicted by a line with an arrowhead connecting actions, as shown in Figure 21 This indicates that the action at the tail of the arrow must be completed before the action at the head begins.

Figure 21 – Order of execution symbol

In a process operation diagram, parallel actions are initiated by arrowheads that direct towards a double horizontal line, with each parallel sequence represented by a line extending from this double line It is essential that the action at the tail of the arrow is completed before the actions at the heads of the arrows commence.

Figure 22 – Start of parallel execution symbol

In a process operation diagram, parallel actions are represented by lines converging to a double horizontal line, with a single line emerging from it to signify the conclusion of parallel execution The tasks indicated by the arrows leading to the double horizontal line must be completed before the task at the arrow's head can commence.

Figure 23 – End of parallel execution

7.2.3.4 Start of optional parallel execution

In a process operation diagram, optional actions can be executed in parallel or in series, indicated by arrowheads pointing to a dashed double horizontal line with a right-pointing arrowhead Each possible parallel sequence is represented by a line extending from the double horizontal line The action at the tail of the arrow leading to the double horizontal line must be completed before the subsequent actions at the heads of the following arrows commence The optional parallel symbol is illustrated in Figure 24.

Figure 24 – Start of optional parallel execution symbol

Each path under the optional parallel symbol can function either as a standard parallel or in a series configuration, proceeding from left to right as depicted in the diagram.

Add 1 Add 2 Add 3 Add 4 Add 5 Add 6

Figure 25 – Alternate execution paths for optional parallel execution

7.2.3.5 End of optional parallel execution

In a process operation diagram, optional parallel actions are represented by lines that lead to a dashed double horizontal line with a right-pointing arrowhead, indicating the conclusion of optional parallel execution The actions connected to the arrows pointing towards the double horizontal line must be completed before the subsequent action, indicated by the head of the following arrow, begins The symbol for the end of optional parallel execution is clearly defined.

Figure 26 – End of optional parallel execution

Rules for valid PPCs

All of the elements in a PPC shall be connected

NOTE Valid PPCs only have a single network of material flows

Valid PPCs shall start with one or more process inputs

Valid PPCs shall end with one or more process outputs

Valid PPCs shall have no loops of material dependencies

A process output from a process element cannot serve as a direct input to the same or a prior element To facilitate recirculation, it is essential to utilize process inputs and outputs that identify the same resource or material.

A loop in a Production Process Control (PPC) indicates that a material required for production is also one of the outputs generated, creating a scenario without a clear starting point in the recipe In practice, this is often managed by incorporating a portion of one batch into the subsequent batch While the material definition remains consistent, the material lots typically differ This relationship is documented in a PPC by using the same material as both a process input and output.

Process hierarchy

Transform components

Transformation tasks

Transformation mapping

Tiêu đề	Batch control – Part 3: General and site recipe models and representation
Thể loại	International Standard
Năm xuất bản	2008
Thành phố	Geneva

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