SIST EN 61512-1:2001

SLOVENSKI STANDARD
01-april-2001
Batch control - Part 1: Models and terminology
Batch control -- Part 1: Models and terminology
Chargenorientierte Fahrweise -- Teil 1: Modelle und Terminologie
Contrôle-commande des processus de fabrication par lots -- Partie 1: Modèles et
terminologie
Ta slovenski standard je istoveten z: EN 61512-1:1999
ICS:
01.040.25 Izdelavna tehnika (Slovarji) Manufacturing engineering
(Vocabularies)
25.040.40 Merjenje in krmiljenje Industrial process
industrijskih postopkov measurement and control
35.240.50 Uporabniške rešitve IT v IT applications in industry
industriji
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.





NORME
CEI
INTERNATIONALE
IEC
61512-1
INTERNATIONAL
Première édition
STANDARD
First edition
1997-08
Contrôle-commande des processus
de fabrication par lots –
Partie 1:
Modèles et terminologie
Batch control –
Part 1:
Models and terminology
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61512-1  IEC:1997 – 3 –
CONTENTS
Page
FOREWORD . 9
INTRODUCTION . 11
Clause
1 Scope. 13
2 Normative references. 13
3 Definitions . 13
4 Batch processes and equipment . 23
4.1 Processes, batches and batch processes . 23
4.1.1 Continuous processes . 23
4.1.2 Discrete parts manufacturing processes . 23
4.1.3 Batch processes . 23
4.2 Physical model. 27
4.2.1 Enterprise level. 31
4.2.2 Site level . 31
4.2.3 Area level . 31
4.2.4 Process cell level . 31
4.2.5 Unit level. 33
4.2.6 Equipment module level . 33
4.2.7 Control module level . 33
4.3 Process cell classification. 35
4.3.1 Classification by number of products. 35
4.3.2 Classification by physical structure . 35
5 Batch control concepts. 39
5.1 Structure for batch control. 41
5.1.1 Basic control. 41
5.1.2 Procedural control. 41
5.1.3 Coordination control . 45
5.2 Equipment entities . 47
5.2.1 Procedural control model/physical model/process model relationship. 47
5.2.2 Equipment control in equipment entities. 47
5.2.3 Structuring of equipment entities. 55
5.3 Recipes. 57
5.3.1 Recipe types . 57
5.3.2 Recipe contents . 63
5.3.3 Control recipe procedure/equipment control relationship. 73
5.3.4 Recipe transportability. 89
5.4 Production plans and schedules. 91

61512-1  IEC:1997 – 5 –
Clause Page
5.5 Production information . 93
5.5.1 Batch-specific information . 93
5.5.2 Common (non-batch specific) batch information. 95
5.5.3 Batch history. 95
5.5.4 Batch reports. 95
5.6 Allocation and arbitration. 97
5.6.1 Allocation. 97
5.6.2 Arbitration. 99
5.7 Modes and states. 99
5.7.1 Modes. 99
5.7.2 States. 103
5.8 Exception handling. 109
6 Batch control activities and functions . 111
6.1 Management activities . 111
6.1.1 Control activity model . 111
6.1.2 Information handling . 115
6.1.3 Process and control engineering. 119
6.2 Recipe management. 121
6.2.1 Manage general recipes . 121
6.2.2 Define general recipe procedural elements. 123
6.2.3 Manage site recipes. 125
6.2.4 Manage master recipes. 125
6.2.5 Define master recipe procedural elements . 127
6.3 Production planning and scheduling . 129
6.4 Production information management. 129
6.4.1 Receiving and storing batch history information. 131
6.4.2 Manipulating historical data. 137
6.4.3 Producing batch reports. 137
6.5 Process management. 141
6.5.1 Manage batches . 143
6.5.2 Manage process cell resources. 147
6.5.3 Collect batch and process cell information. 149
6.6 Unit supervision . 149
6.6.1 Acquire and execute procedural elements . 151
6.6.2 Manage unit resources . 153
6.6.3 Collect batch and unit information . 153
6.7 Process control . 155
6.7.1 Execute equipment phases . 157
6.7.2 Execute basic control . 159
6.7.3 Collect data. 159
6.8 Personnel and environmental protection. 161

61512-1  IEC:1997 – 7 –
Figures Page
1 Process model (entity-relationship diagram). 27
2 Physical model . 29
3 Single-path structure. 35
4 Multiple-path structure. 37
5 Network structure . 39
6 Procedural control model. 43
7 Procedural control/equipment mapping to achieve process functionality. 49
8 Recipe types. 59
9 General recipe procedure. 67
10 Master recipe procedure. 69
11 Procedural element relationships in the site recipe and master recipe . 71
12 Control recipe procedure/equipment control separation. 75
13 Control recipe procedure example with unit procedures, operations and phases . 79
14 Control recipe procedure example with unit procedures and operations. 81
15 Control recipe procedure example with unit procedures . 83
16 Control recipe procedure example with only a procedure . 85
17 Control recipe procedure/equipment control collapsibility examples. 89
18 State transition diagram for example states for procedural elements. 109
19 Management activity model . 113
20 Simultaneous definition/selection of procedural elements and equipment entities. 119
21 Recipe management . 123
22 Process management . 143
23 Unit supervision. 151
24 Process control . 157
Tables
1 Possible implementations of example modes. 101
2 State transition matrix for example states for procedural elements. 107
Annexes
A Model philosophy. 163
B Bibliography . 177

61512-1  IEC:1997 – 9 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
_________
BATCH CONTROL −
Part 1: Models and terminology
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization
for Standardization (ISO) in accordance with conditions determined by agreement between the two
organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical reports or guides and they are accepted by the National Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61512-1 has been prepared by subcommittee 65A: System aspects,
of IEC technical committee 65: Industrial-process measurement and control.
IEC 61512 consists of the following parts, under the general title Batch control:
– Part 1: Models and terminology;
– Part 2: Data structures and guidelines for languages.
The text of this standard is based on the following documents:
FDIS Report on voting
65A/217/FDIS 65A/238/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
Annex A forms an integral part of this standard.
Annex B is for information only.

61512-1  IEC:1997 – 11 –
INTRODUCTION
The models and terminology defined in this part of IEC 61512
– emphasize good practices for the design and operation of batch manufacturing plants;
– can be used to improve control of batch manufacturing plants; and
– can be applied regardless of the degree of automation.
Specifically, this standard provides a standard terminology and a consistent set of concepts
and models for batch manufacturing plants and batch control that will improve communications
between all parties involved; and that will
– reduce the user's time to reach full production levels for new products;
– enable vendors to supply appropriate tools for implementing batch control;
– enable users to better identify their needs;
– make recipe development straightforward enough to be accomplished without the
services of a control systems engineer;
– reduce the cost of automating batch processes; and
– reduce life-cycle engineering efforts.
It is not the intent of this standard to
– suggest that there is only one way to implement or apply batch control;
– force users to abandon their current way of dealing with their batch processes; or
– restrict development in the area of batch control.
The models presented in this standard are presumed to be complete as indicated. However,
they may be collapsed and expanded as described below. The unit and the control module
levels may not be omitted from the physical model. The master recipe and the control recipe
may not be omitted from the recipe-type model. Specific rules for collapsing and expanding
these models are not covered in this standard.
– Collapsing: elements in the models may be omitted as long as the model remains
consistent, and the functions of the element removed are taken into account.
– Expanding: elements may be added to the modules. When they are added between
related elements, the integrity of the original relationship should be maintained.

61512-1  IEC:1997 – 13 –
BATCH CONTROL −−
Part 1: Models and terminology
1 Scope
This part of IEC 61512 on batch control defines reference models for batch control as used
in the process industries and terminology that helps explain the relationships between these
models and terms. This standard may not apply to all batch control applications.
2 Normative references
The following normative documents contain provisions, which through reference in this text,
constitute provisions of this part of IEC 61512. At the time of publication, the editions
indicated were valid. All normative documents are subject to revision, and parties to
agreements based on this part of IEC 61512 are encouraged to investigate the possibility of
applying the most recent editions of the normative documents indicated below. Members of
IEC and ISO maintain registers of currently valid International Standards.
IEC 60848: 1988, Preparation of function charts for control systems
NOTE – Structures defined in IEC 60848 may be useful in the definition of procedural control and, in particular,
in the definition of a phase.
IEC 60902: 1987, Industrial-process measurement and control – Terms and definitions
3 Definitions
For the purpose of this part of IEC 61512, the following definitions apply. Definitions found in
IEC 60902 were used as a basis for definitions in this part of IEC 61512. Where necessary,
the specific connotation of terms used in batch control was included.
3.1 allocation: A form of coordination control that assigns a resource to a batch or unit.
NOTE – An allocation can be for the entire resource or for portions of a resource.
3.2 arbitration: A form of coordination control that determines how a resource should be
allocated when there are more requests for the resource than can be accommodated at one
time.
3.3 area: A component of a batch manufacturing site that is identified by physical,
geographical, or logical segmentation within the site.
NOTE – An area may contain process cells, units, equipment modules, and control modules.
3.4 basic control: Control that is dedicated to establishing and maintaining a specific state
of equipment or process condition.
NOTE – Basic control may include regulatory control, interlocking, monitoring, exception handling, and discrete
or sequential control.
61512-1  IEC:1997 – 15 –
3.5 batch
(1) The material that is being produced or that has been produced by a single
execution of a batch process.
(2) An entity that represents the production of a material at any point in the
process.
NOTE – Batch means both the material made by and during the process and also an entity that represents the
production of that material. Batch is used as an abstract contraction of the words "the production of a batch."
3.6 batch control: Control activities and control functions that provide a means to process
finite quantities of input materials by subjecting them to an ordered set of processing
activities over a finite period of time using one or more pieces of equipment.
3.7 batch process: A 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.
3.8 batch schedule: A list of batches to be produced in a specific process cell.
NOTE – The batch schedule typically contains such information as what to produce, how much to produce, when
or in what order the batches are needed, and what equipment to use.
3.9 common resource: A resource that can provide services to more than one requester.
NOTE – Common resources are identified as either exclusive-use resources or shared-use resources (see 3.22
and 3.54).
3.10 control module: The lowest level grouping of equipment in the physical model that
can carry out basic control.
NOTE – This term applies to both the physical equipment and the equipment entity.
3.11 control recipe: A type of recipe which, through its execution, defines the manufacture
of a single batch of a specific product.
3.12 coordination control: A type of control that directs, initiates, and/or modifies the
execution of procedural control and the utilization of equipment entities.
3.13 enterprise: An organization that coordinates the operation of one or more sites.
3.14 equipment control: The equipment-specific functionality that provides the actual
control capability for an equipment entity, including procedural, basic and coordination
control, and that is not part of the recipe.
3.15 equipment entity: A collection of physical processing and control equipment and
equipment control grouped together to perform a certain control function or set of control
functions.
3.16 equipment module: A functional group of equipment that can carry out a finite number
of specific minor processing activities.
NOTES
1 An equipment module is typically centered around a piece of process equipment (a weigh tank, a process
heater, a scrubber, etc.). This term applies to both the physical equipment and the equipment entity.
2 Examples of minor process activities are dosing and weighing.
3.17 equipment operation: An operation that is part of equipment control.

61512-1  IEC:1997 – 17 –
3.18 equipment phase: A phase that is part of equipment control.
3.19 equipment procedure: A procedure that is part of equipment control.
3.20 equipment unit procedure: A unit procedure that is part of equipment control.
3.21 exception handling: Those functions that deal with plant or process contingencies
and other events which occur outside the normal or desired behaviour of batch control.
3.22 exclusive-use resource: A common resource that only one user can use at any given
time.
3.23 formula: A category of recipe information that includes process inputs, process
parameters and process outputs.
3.24 general recipe: A type of recipe that expresses equipment and site-independent
processing requirements.
3.25 header: Information about the purpose, source and version of the recipe such as
recipe and product identification, creator, and issue date.
3.26 ID: A unique identifier for batches, lots, operators, technicians, and raw materials.
3.27 line; train: See definition for train.
3.28 lot: A unique amount of material having a set of common traits.
NOTE – Some examples of common traits are material source, the master recipe used to produce the material
and distinct physical properties.
3.29 master recipe: A type of recipe that accounts for equipment capabilities and may
include process cell-specific information.
3.30 mode: The manner in which the transition of sequential functions are carried out within
a procedural element or the accessibility for manipulating the states of equipment entities
manually or by other types of control.
3.31 operation: A procedural element defining an independent processing activity
consisting of the algorithm necessary for the initiation, organization and control of phases.
3.32 path; stream: The order of equipment within a process cell that is used, or is
expected to be used, in the production of a specific batch.
3.33 personnel and environmental protection: The control activity that
– prevents events from occurring that would cause the process to react in a manner that
would jeopardize personnel safety and/or harm the environment; and/or
– takes additional measures, such as starting standby equipment, to prevent an abnormal
condition from proceeding to a more undesirable state that would jeopardize personnel
safety and/or harm the environment.

61512-1  IEC:1997 – 19 –
3.34 phase: The lowest level of procedural element in the procedural control model.
3.35 procedural control: Control that directs equipment-oriented actions to take place in
an ordered sequence in order to carry out some process-oriented task.
3.36 procedural element: A building block for procedural control that is defined by the
procedural control model.
3.37 procedure: The strategy for carrying out a process.
NOTE – In general, this refers to the strategy for making a batch within a process cell. It may also refer to a
process that does not result in the production of a product, such as a clean-in-place procedure.
3.38 process: A sequence of chemical, physical, or biological activities for the conversion,
transport or storage of material or energy.
3.39 process action: Minor processing activities that are combined to make up a process
operation.
NOTE – Process actions are the lowest level of processing activity within the process model.
3.40 process cell: A logical grouping of equipment that includes the equipment required for
production of one or more batches. It defines the span of logical control of one set of
process equipment within an area.
NOTE – This term applies to both the physical equipment and the equipment entity.
3.41 process control: The control activity that includes the control functions needed to
provide sequential, regulatory and discrete control, and to gather and display data.
3.42 process input: The identification and quantity of a raw material or other resource
required to make a product.
3.43 process management: The control activity that includes the control functions needed
to manage batch production within a process cell.
3.44 process operation: 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.
3.45 process output: An identification and quantity of material or energy expected to
result from one execution of a control recipe.
3.46 process parameter: Information that is needed to manufacture a material but does
not fall into the classification of process input or process output.
NOTE – Examples of process parameter information are temperature, pressure and time.
3.47 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.

61512-1  IEC:1997 – 21 –
3.48 recipe: The necessary set of information that uniquely defines the production
requirements for a specific product.
NOTE – There are four types of recipes defined in this standard: general, site, master and control.
3.49 recipe management: The control activity that includes the control functions needed to
create, store and maintain general, site and master recipes.
3.50 recipe operation: An operation that is part of a recipe procedure in a master or
control recipe.
3.51 recipe phase: A phase that is part of a recipe procedure in a master or control
recipe.
3.52 recipe procedure: The part of a recipe that defines the strategy for producing a
batch.
3.53 recipe unit procedure: A unit procedure that is part of a recipe procedure in a
master or control recipe.
3.54 shared-use resource: A common resource that can be used by more than one user at
a time.
3.55 site: A component of a batch manufacturing enterprise that is identified by physical,
geographical, or logical segmentation within the enterprise.
NOTE – A site may contain areas, process cells, units, equipment modules and control modules.
3.56 site recipe: A type of recipe that is site-specific.
NOTE – Site recipes may be derived from general recipes recognizing local constraints, such as language and
available raw materials.
3.57 state: The condition of an equipment entity or of a procedural element at a given time.
NOTE – The number of possible states and their names vary for equipment and for procedural elements.
3.58 stream; path: See definition for path.
3.59 train; line: A collection of one or more units and associated lower level equipment
groupings that has the ability to be used to make a batch of material.
3.60 unit: A collection of associated control modules and/or equipment modules and other
process equipment in which one or more major processing activities can be conducted.
NOTES
1 Units are presumed to operate on only one batch at a time. Units operate relatively independently of one
another.
2 This term applies to both the physical equipment and the equipment entity.
3 Examples of major processing activities are react, crystallize, and make a solution.

61512-1  IEC:1997 – 23 –
3.61 unit procedure: A strategy for carrying out a contiguous process within a unit. It
consists of contiguous operations and the algorithm necessary for the initiation, organization
and control of those operations.
3.62 unit recipe: The part of a control recipe that uniquely defines the contiguous
production requirements for a unit.
NOTE – The unit recipe contains the unit procedure and its related formula, header, equipment requirements
and other information.
3.63 unit supervision: The control activity that includes control functions needed to
supervise the unit and the unit's resources.
4 Batch processes and equipment
This clause provides an overview of batch processing and the batch manufacturing plant. The
models and terminology defined in this clause provide a foundation for understanding the
application of batch control to the batch manufacturing plant in clauses 5 and 6. Specifically,
this clause discusses batch processes, a physical model, and process cell classification.
4.1 Processes, batches and batch processes
A process is a sequence of chemical, physical or biological activities for the conversion,
transport or storage of material or energy. Industrial manufacturing processes can generally
be classified as continuous, discrete parts manufacturing or batch. How a process is
classified depends on whether the output from the process appears in a continuous flow
(continuous), in finite quantities of parts (discrete parts manufacturing), or in finite quantities
of material (batches). Although aspects of this standard may apply to discrete parts
manufacturing or continuous processes, this standard does not specifically address these
types of processes.
4.1.1 Continuous processes
In a continuous process, materials are passed in a continuous flow through processing
equipment. Once established in a steady operating state, the nature of the process is not
dependent on the length of time of operation. Start-ups, transitions and shutdowns do not
usually contribute to achieving the desired processing.
4.1.2 Discrete parts manufacturing processes
In a discrete parts manufacturing process, products are classified into production lots that
are based on common raw materials, production requirements and production histories. In a
discrete parts manufacturing process, a specified quantity of product moves as a unit (group
of parts) between workstations, and each part maintains its unique identity.
4.1.3 Batch processes
The batch processes addressed in this standard lead to the production of finite quantities of
material (batches) by subjecting quantities of input materials to a defined order of processing
actions using one or more pieces of equipment. The product produced by a batch process is
called a batch. Batch processes are discontinuous processes. Batch processes are neither
discrete nor continuous; however, they have characteristics of both.

61512-1  IEC:1997 – 25 –
The subdivisions of a batch process can be organized in a hierarchical fashion as shown in
figure 1. The example batch process used in the following subclauses is the production of
polyvinyl chloride by the polymerization of vinyl chloride monomer.
4.1.3.1 Process stages
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. Typical process stages in
the polyvinyl chloride process might be the following:
– polymerize: polymerize vinyl chloride monomer into polyvinyl chloride;
– recover: recover residual vinyl chloride monomer;
– dry: dry polyvinyl chloride.
4.1.3.2 Process operations
Each process stage consists of an ordered set of one or more process operations. Process
operations represent major processing activities. A process operation usually results in a
chemical or physical change in the material being processed. Typical process operations for
the polymerization of vinyl chloride monomer into polyvinyl chloride process stage might be
the following:
– prepare reactor: evacuate the reactor to remove oxygen;
– charge: add demineralized water and surfactants;
– react: add vinyl chloride monomer and catalyst, heat to 55 °C – 60 °C and hold at this
temperature until the reactor pressure decreases.

61512-1  IEC:1997 – 27 –
Process
consists of an
ordered set of
Process
stage
consists of an
ordered set of
Process
operation
consists of an
ordered set of
Process
action
NOTE – Annex A provides an explanation of the format and general associations used in creating the diagrams
in this international standard.
Figure 1 – Process model (entity-relationship diagram)
4.1.3.3 Process actions
Each process operation can be subdivided into an ordered set of one or more process
actions that carry out the processing required by the process operation. Process actions
describe minor processing activities that are combined to make up a process operation.
Typical process actions for the react process operation might be the following:
– add: add the required amount of catalyst to the reactor;
– add: add the required amount of vinyl chloride monomer to the reactor;
– heat: heat the reactor contents to 55 °C – 60 °C;
– hold: hold the reactor contents at 55 °C – 60 °C until the reactor pressure decreases.
4.2 Physical model
The following subclauses discuss a physical model that can be used to describe the physical
assets of an enterprise in terms of enterprises, sites, areas, process cells, units, equipment
modules and control modules.
61512-1  IEC:1997 – 29 –
The physical assets of an enterprise involved in batch manufacturing are usually organized in
a hierarchical fashion as described in figure 2. Lower level groupings are combined to form
higher levels in the hierarchy. In some cases, a grouping within one level may be
incorporated into another grouping at that same level.
The model has seven levels, starting at the top with an enterprise, a site and an area. These
three levels are frequently defined by business considerations and are not modelled further in
this standard. The three higher levels are part of the model to properly identify the
relationship of the lower level equipment to the manufacturing enterprise.
AAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
Entreprise
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
may contain
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
Site
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
may contain
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAA
AAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
Area
AAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
may contain
Process
cell
must contain
Unit
may contain
AAAAAAAAAAAAAAAAAAAA AAAAAAAA
Equipment
AAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
module
may
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
contain
may contain
AAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAA
Control
AAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAA
may
module
AAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAA
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NOTE – The boxes for the top three levels are shown with slashed lines to indicate that the criteria that are
used for configuring the boundaries of these three levels is often beyond the scope of batch control and this
standard. Therefore, criteria for configuring the boundaries of these three levels of the physical model will not be
discussed in this standard.
Figure 2 – Physical model
61512-1  IEC:1997 – 31 –
The lower four levels of this model refer to specific equipment types. An equipment type in
figure 2 is a collection of physical processing and control equipment grouped together for a
specific purpose. The lower levels in the model are specific to technically defined and
bounded groupings of equipment. The four lower equipment levels (process cells, units,
equipment modules and control modules) are defined by engineering activities (see 5.2.3 and
6.1.3). During these engineering activities, the equipment at lower levels is grouped together
to form a new higher level equipment grouping. This is done to simplify operation of that
equipment by treating it as a single larger piece of equipment. Once created, the equipment
cannot be split up except by re-engineering the equipment in that level.
4.2.1 Enterprise level
An enterprise is a collection of one or more sites. It may contain sites, areas, process cells,
units, equipment modules and control modules.
The enterprise is responsible for determining what products will be manufactured, at which
sites they will be manufactured, and in general how they will be manufactured.
There are many factors other than batch control that affect the boundaries of an enterprise.
Therefore, the criteria for configuring the boundaries of an enterprise are not covered in this
standard.
4.2.2 Site level
A site is a physical, geographical, or logical grouping determined by the enterprise. It may
contain areas, process cells, units, equipment modules and control modules.
The boundaries of a site are usually based on organizational or business criteria as opposed
to technical criteria. There are many factors other than batch control that affect these
boundaries. Therefore, the criteria for configuring the boundaries of a site are not covered in
this standard.
4.2.3 Area level
An area is a physical, geographical, or logical grouping determined by the site. It may
contain process cells, units, equipment modules and control modules.
The boundaries of an area are usually based on organizational or business criteria as
opposed to technical criteria. There are many factors other than batch control that affect
these boundaries. Therefore, the criteria for configuring the boundaries of an area are not
covered in this standard.
4.2.4 Process cell level
A process cell contains all of the units, equipment modules and control modules required to
make one or more batches.
Process control activities respond to a combination of control requirements using a variety of
methods and techniques. Requirements that cause physical control actions may include
responses to process conditions or to comply with administrative requirements.

61512-1  IEC:1997 – 33 –
A frequently recognized subdivision of a process cell is the train. A train is composed of all
units and other equipment that may be utilized by a specific batch. A batch does not always
use all the equipment in a train. Furthermore, more than one batch and more than one
product may use a train simultaneously. The order of equipment actually used or expected to
be used by a batch is called the path. Although a process cell may contain more than one
train, no train may contain equipment outside the boundaries of the process cell.
A process cell is a logical grouping of equipment that includes the equipment required for
production of one or more batches. It defines the span of logical control of one set of
process equipment within an area. The existence of the process cell allows for production
scheduling on a process cell basis, and also allows for process cell-wide control
...