Professional Documents
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Randy Dwiggins, PE
Principal Engineer, NNE Pharmaplan Chairman, ISA-88 & IEC-61512
Agenda
Introduction to ISA-88 Batch Processes Process Model Physical Model Equipment Entity Model Types of Control Recipes Modes & States Control Activity Model Project Execution
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Other parts detail specific aspects, mainly of interest to developers ISA-88 now refers to both the standard (was S88) and the committee (was SP88)
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ISA88 defines an integrated approach with multiple implementation options and interpretations to fit different needs
Vendor recommendations may be polarized biased on a particular philosophy used in their product design
Must understand ISA88 models and functions that are not visible to users to fully grasp software and develop compliant specifications
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Agenda
Introduction to ISA-88 Batch Processes Process Model Physical Model Equipment Entity Model Types of Control Recipes Modes & States Control Activity Model Project Execution
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Updated
Process Process Process Operation Operation Operation Specifies the order to process one or more Process Process Process Action Action Action
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Process Stage: a part of a process that usually operates independently from other process stages and that usually results in a planned sequence of chemical or physical changes in the material being processed
EXAMPLES - Typical process stages in the PVC process might be: Polymerize, Recover VCM, Dry PVC
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Process Action: a minor processing task that may be combined with other minor processing activities to make up a process operation
EXAMPLES - Typical process actions for the react process operation might be: Add Catalyst, Add VCM, Heat
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Agenda
Introduction to ISA-88 Batch Processes Process Model Physical Model Equipment Entity Model Types of Control Recipes Modes & States Control Activity Model Project Execution
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2010 Update
Site Site
Contains zero or more
Area Area
Contains one or more
Unit
Contains zero or more
Unit
Contains zero or more Contains zero or more
Updated
Note: One or more control modules must be present somewhere in the process cell.
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Area: a component of a manufacturing site that is identified by physical, geographical, operational, or logical segmentation within the site
NOTE An area may contain process cells, units, equipment modules, and control modules. Enterprise, Site, and Area levels are not used in ISA-88, except respectively as the organizational levels at which General and Site Recipes exist and for consistency with ISA-95 Enterprise-Control System Integration.
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Control Part
Contains zero or more
Physical Part
Control Part
Contains zero or more
Note: One or more control module entities must be present somewhere in the process cell entity.
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Physical Equipment
Equipment Entity
Equipment Control
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Equipment modules may be engineered around processing equipment such as a heating/cooling system, an agitator, or auxiliary equipment such as a dosing system
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Exclusive-use Resource: a common resource that only one user can use at any given time
EXAMPLE: A shared weigh tank that can be used by only one reactor at a time is an example of an exclusive-use resource.
Shared-use Resource: a common resource that can be used by more than one user at a time
EXAMPLE: A process heater and a raw material distribution system which are capable of serving more than one unit at a time are examples of shared-use resources.
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It is usually centered on a relatively independent major piece of processing equipment, such as a mixing tank or reactor.
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Agenda
Introduction to ISA-88 Batch Processes Process Model Physical Model Equipment Entity Model Types of Control Recipes Modes & States Control Activity Model Project Execution
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Procedure Specifies the execution order of one or more Process Process Unit Stage Stage Procedure Specifies the execution order of one or more Process Process Operation Operation Operation Specifies the execution order of one or more Process Process Action Phase Action
Procedural Control Model: a hierarchical model which depicts the orchestration of procedural elements to carry out process-oriented tasks
Procedural Element: a building block for procedural control that is defined by the procedural control model
Functionality at each level of the Procedural Control Model is analogous to the Process Model
Procedural Control is not supported in Control Modules
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Procedure(s)
Process Cell(s)
Process Stage
Unit Procedure(s)
Unit(s)
Process Operation
Operation(s) *Units may support Unit Procedure, Operation, and Phase level procedural elements.
Process Action
Phase(s)
Equipment Module(s)
Control Module(s)
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(See Figure 2)
(See Figure 9)
(See Figure 3)
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Unit Procedure: a strategy for carrying out a major processing task within a unit to accomplish all or part of a process stage typically through the initiation, organization, and control of operations.
This level of procedural control may only execute in a Unit No more than one Unit Procedure may be active at a time in a Unit
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Phase: the lowest level procedural element in the procedural control model that is intended to accomplish all or part of a process action
This level of procedural control may execute in a Unit or in an Equipment Module It is common for multiple Phases to be active simultaneously in a Unit No more than one Phase may be active at a time in an Equipment Module
The Procedural Model is collapsible, permitting any level(s) of the hierarchy to be omitted except the Procedure level.
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Agenda
Introduction to ISA-88 Batch Processes Process Model Physical Model Equipment Entity Model Types of Control Recipes Modes & States Control Activity Model Project Execution
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may be transformed into Master Recipe includes Process cell-specific batch processing information
is the basis for Control Recipe includes Specific batch processing information pertaining to a unique batch
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Master Recipe: a type of recipe that accounts for equipment capabilities and may include process cell-specific information Control Recipe: a type of recipe which, through its execution, defines the manufacture of a single batch of a specific product
Only Control Recipes are directly used to control batches. Each is created from a Master Recipe and modified as the batch executes. Consequently, both Master and Control Recipes are required levels in the model; the others are not.
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Equipment Requirements: Equipment requirements constrain the choice of the equipment that will eventually be used to implement a specific part of the procedure. Recipe Procedure: The recipe procedure defines the strategy for carrying out a process. Recipe procedures are created graphically from building blocks Other Information: Other information is a category of recipe information that may contain batch processing support information not contained in other parts of the recipe. Examples include regulatory compliance information, materials and process safety information, process flow diagrams, and packaging/labeling information
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Recipe Procedure Specifies the execution order of one or more Process Process Recipe Unit Stage Stage Procedure Specifies the execution order of one or more Process Process Recipe Operation Operation Operation Specifies the execution order of one or more Process Process Recipe Action Action Phase References one Recipe supplies associated information as necessary Equipment Phase
Rather than orchestrate a set of subordinate recipe elements, any control recipe procedural element may instead link to a corresponding element in equipment control. In this way, the control recipe causes the equipment to operate and make batches. The figure to the left illustrates this link when the control recipe uses the full (un-collapsed) master recipe procedure model. The following slide depicts an example containing some of the other possible scenarios and illustrating the possibility of multiple simultaneous links.
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Engineered
Unit Procedure 1
Unit Procedure 2
Unit Procedure 3
Operation A
Operation B
Operation C
Equipment Operation
Phase 3
Equipment Phase
Phase 2
Equipment Phase
Phase 1
Equipment Phase
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Generic equipment modules are often designed with procedural control to make the phases commanding them either: (a) more reusable by removing variable equipment design details or (b) able to manipulate more equipment without growing too complex.
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Agenda
Introduction to ISA-88 Batch Processes Process Model Physical Model Equipment Entity Model Types of Control Recipes Modes & States Control Activity Model Project Execution
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Changes in this area that are reflected in the 2010 version of part 1 are
The section on exception handling was expanded to describe the role of procedural states A more expansive example procedural state model (shown on the subsequent slide) is suggested that is a superset of the old one and the PackML state model published in TR88.00.02 It is desired to standardize on the more expansive procedural state model (with collapsibility and expandability) in the future to facilitate interoperability and user understanding of the recipe-equipment link requirements
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Unit Supervision
Control Activity Model: a conceptual model identifying seven interdependent activities (several of which are subdivided into functions) that manage control definition, operation, and information for batch processes The global model for batch control, which is often neglected because its functionality is process and equipment neutral.
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Process Control: The control activity that includes the control functions needed to provide sequential, regulatory, and discrete control and to gather and display data.
The Process Control Activity is generally executed in Equipment Control.
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Agenda
Introduction to ISA-88 Batch Processes Process Model Physical Model Equipment Entity Model Types of Control Recipes Modes & States Control Activity Model Project Execution
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Project Execution:
Benefits even without Compliant Software
Issue Solved Communication of requirements is difficult Traditional functionally grouped PLC constructs with arbitrary interaction mechanisms are difficult to design, debug, validate, and maintain Customized manipulation of individual devices per product is very complex and generally prohibitive ISA-88 Resolution Use standard terminology and reference models to replace jargon and organize requirements Parse control into a hierarchy of clearly discernable and reusable equipment entities that fully implement equipment capabilities and procedural elements that capture all product-specific requirements Procedural elements define how equipment entities will be manipulated to execute all required processing actions
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Project Execution:
Additional Benefits with Compliant Software
Issue Solved Extensive custom programming required for a complete solution that fully utilizes equipment capabilities ISA-88 Resolution Batch software packages support much of the ISA-88 activity model (schedule and recipe management, procedure execution, exception handling, resource allocation, batch records) and FDA requirements
Programming procedures Recipes contain procedural elements that for each product/equipment can link high level commands to any combination suitably capable equipment entity No standard methods for operator interaction High performance and schedule risks; prohibitive to subsequently change Recipe systems provide embedded objects for operator interaction as required Reuse of procedural building blocks and equipment entity types reduces task duration and reliance on system experts
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Questions?
Thank you for your attention! Please feel free to contact me with any questions at:
Randy Dwiggins (908) 704-9041 RDwg@nnepharmaplan.com Website: www.nnepharmaplan.com
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