GUIDE

Introduction to

BATCH PROCESSING WITH S88

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Manufacturing Process Methods

Table of Contents
Discrete Process: A discrete manufacturing process involves
Manufacturing Process Methods 2 the production of individual parts that move from one station
to the next. The item gains value at each stop in the process.
At the end of the process each item retains its individual iden-
The S88 Standard 3 tity. Examples of applications using a discrete manufacturing
process are disposable razor blades, micro-chips, box knives,
furniture, light bulbs, and staplers.
Benefits of a Good S88 Design 4 Continuous Process: A continuous process involves the con-
tinuous flow of a material through the manufacturing equip-
ment. The amount of product produced depends directly how
Diagram Nomenclature 5 long the equipment is turned on. The process will produce a
consistent product no matter how long the operation may run.
Gasoline and oil refinery processes are prime examples of a
Process Example 7
continuous process.
Batch Process: A batch process produces a finite quantity
Recipe Model 8 of material using an ordered set of activities over a finite pe-
riod of time. Where a continuous process may run for days
or weeks a batch process will consistently require the same
Master and Control Recipe Procedures 10 amount of time to produce the same amount of material. The
finite amount of material produced at the end of the process is
referred to as a batch.
Physical Model 14
Batch processes are not discrete. That is to say that when
batch is complete you cannot easily separate the individual
Linking Recipes to Equipment 18 parts of the batch. For example if you have a box of batteries
you can separate the individual batteries from one another.
However, if you have a batch of ice cream you could separate
Case Study Link 20 the individual containers, but the ice cream inside the boxes
are part of the same batch. You could not distinguish one box
from the next.
What’s Next 20 Examples of batch processes include special chemical man-
ufacturing, the production of pharmaceuticals, and the manu-
facturing of food products.

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The S88 Standard

S88 is a standard created by a committee in an effort to resolve the lack of a universal model re-
garding batch control, and the difficulties engineers were experiencing in creating an effective batch
control system.

The standard was originally created in 1995 by the SP88 committee and updated in 2010 to include
the following parts:

• ANSI/ISA-S88.01-2010 Batch Control Part 1: Models and Terminology

• ANSI/ISA S88.00.02.2001 Batch Control Part 2: Data Structures and Guidelines for Languages

• ANSI/ISA S88.00.03 Batch Control Part 3: General and site recipe models and representation

• ANSI/ISA S88.00.04 Batch Control Part 4: Batch Production Records

The S88 standard provides a design philosophy to manufacturing processes. Using S88 enables
system designers to simplify changes to the process, reuse program modules, significantly decrease
time to market, simplify documentation and validation activities, and lower the cost of automating
your process.

Separation of Recipe and Equipment

The standard essentially separates the equipment from recipes. Engineers would traditionally
program the recipe or steps required to create a specific product with the code to control each
piece of equipment. As a result if a new ingredient was needed in the process a large number
of man-hours would be required to make the necessary changes to the program.
Incorporating recipe and equipment logic also creates a problem with other parts of the pro-
gram. For example if a new ingredient is added to recipe A how does that affect recipe B. S88
moves the recipe logic to a higher level in the architecture and isolates it from the logic needed
to run the equipment.
When a new ingredient is added only the steps in the recipe need to be changed, and the pro-
gram that controls the equipment is left alone.

Common Terms and Definitions

S88 defines a common set of terms and definitions used for the various parts of a process.
The standard breaks the equipment model down into the following modules: Enterprise, Site,
Area, Process Cell, Unit, Equipment Module, and Control Module.
The recipe module is broken down into the following modules: General Recipe, Site Recipe,
Master Recipe, and Control Recipe.
The control recipe can be broken down further into the following: Procedure, Unit Procedure,
and Phase.

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Benefits of a Good S88 Design

Improve Recovery from Abnormal Events

S88 provides guidelines on how to recover from abnormal events. Specific system states are created
to temporally stop the process if an abnormal condition exists. This allows operators or engineers to
correct the situation and then resume the process when ready.

Track data in the context of the process

It can often be difficult trying to correlate process events with the appropriate sequence event in a
batch. Batch software will track events that occur during the process and relate them to specific steps
in the batch recipe. This makes it easy to determine which part of a recipe a certain event occurred.
It also helps in determining a possible root cause if a contamination occurs.

Simplified Validation Activities

The concept of reusable modules and the separation of the recipe from equipment provide validation
departments an opportunity to reduce the quantity of testing required when changes are needed.
Changes that are limited to process steps and do not necessarily affect equipment will only require
high level testing to validate the recipe. Usually the same equipment module will be used over and
over again for several recipes and only needs to be validated one time.

Process Engineers Can Now Make Automation Changes

Traditionally a process engineer would have to work closely with an automation engineer to imple-
ment a change to the control system. S88 separates the process from the equipment and as a result
a process engineer and re-define a recipe without regard to how the equipment is arranged or pro-
grammed. A process engineer can simply add a new ingredient, adjust cook times, or temperatures
from the recipe development tools, with which they are familiar.

Other Possible Benefits to a System Designed With S88

• Reduced Batch Cycle Time
• Increase the Number of Successful Batches Per Year
• Reduced Change Over Time
• Improved Batch Consistency or Yield
• Improved Recipe Development Time
• Reduce Batch Costs
• Improved Material Tracking
• Improved Equipment Utilization
• Improved Data Capture
• Reduced Time To Edit Recipes
• Improved Up Time

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S88 Diagram Nomenclature

Relationships
S88 breaks the process down into separate modules that relate to one another. These relationships
are described using E-R diagrams (Entity – Relationship Diagrams). The following section describes
the definitions of the diagrams used in this paper.

Crows Foot Notation

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Sequential Function Chart

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Process Example
In our example we will use the following equipment to produce a batch of media needed for a phar-
maceutical product

Make Media Procedure

1. Add 500 kg of ambient WFI
2. When level is greater than 20% run the agitator at 20%. Let agitator run until the end of the
procedure, adjust agitator setpoint as instructed.
3. Add 300 kg of liquid media, and 400 kg of solid media through the manhole.
4. Adjust agitator setpoint to 80%, add 1500 kg of hot and ambient WFI.
5. Heat solution to 80°C and mix for 120 minutes while recirculating material
6. Cool the solution to below 30°C.
7. Transfer to the destination reactor

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Recipe Model
The amount of detail required in a recipe depends greatly on who is reading the recipe. An R&D
group may be concerned about specific properties and procedures to create a product, but may not
care about the specific equipment used to execute the recipe. A site engineering group may need to
the type of equipment needed but may not need to know exactly which equipment is needed for each
batch. Operators will need to know the materials, procedures, and the exact equipment needed to
produce each individual batch.

To include all the information required by everybody in an organization in a single recipe becomes
overwhelming and cumbersome to maintain. To resolve this problem S88 include four types of reci-
pes: general recipe, site recipe, master recipe, and control recipe.

General Recipe
• Processing information
• No equipment listed
• Can be used for planning or investment decisions or activities

Site Recipe
• Site-Specific information
• In local language
• Based on local raw materials
• Considers sire storage constraints

Master Recipe
• Process cell-specific information
• Dependent upon equipment types or classes
• Required in any S88-aware solution to be template for control
recipes

Control Recipes
• Equipment specific information
• Batch-specific information: batch ID, batch size, raw material
used, processing steps

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General Recipe
The general recipe is used at the company level and defines raw materials and their quantities
as well as the process required to produce the product. The general recipe does not take into
account the requirement to make the product at any particular site or any of the variations from
local sources of raw materials. Often a general recipe will come from R&D for a particular prod-
uct and can be used at various sites throughout the enterprise.

Site Recipe
The site recipe, as its name suggest contain more detailed information regarding a specific site,
the general equipment at that site and local raw materials. Site recipes may differ from site to
site based on geographical locations. For example two site recipes may be created for a site in
Germany and another in the U.S. The site recipe in Germany would be written in German while
the site recipe for the U.S. would be written in English.

Local ingredients may result in differences in site recipes as well. Two sites producing the same
ice cream product may need to make adjustments to their site recipes because of the differ-
ence in fat content in the local supply of milk.

Master Recipe
The master recipe is the also the template for the control recipe and is the recipe used regard-
ing S88 aware software such as FactoryTalk Batch. The master recipe will depend on specific
equipment types or classes. Quantities of specific materials may be called out. It may contain
product-specific information used for scheduling, such as equipment requirements.
A master recipe is required to generate the control recipe as it is the template for the control
recipe.

Control Recipe
The control recipe is usually created by the S88 aware software from the master recipe. It is
used to direct the activities of a specific batch. It may include information such as batchID,
batch size, characteristics of raw materials on site, and the actual equipment to be used. When
an operator is following a recipe to produce a batch it is the control recipe they are using.

Most S88 aware software start managing recipe from the master recipe level and in our exam-
ple going forward that is where we will begin as well.

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Master and Control Recipe Procedures

Master and control recipes are made up of a procedural model that is broken down further into four
types of procedures: Procedure, Unit Procedure, Operation, and Phase.

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Procedure
The procedure is the highest level in the hierarchy and is required if the batch requires more
than one unit (a unit is a major piece of equipment used to process the batch) to make the
batch. It contains the general strategy for making the batch and is created using an ordered set
of Unit Procedures.
In some situations a procedure level isn’t required because processing only occurs in a single
unit, but to be consistent, it is often desirable to create a procedure level for recipe regardless
of the number of units required. We will create a procedure called SF38 Growth Media that
will contain the unit procedures we need to make the media and transfer it to the destination
reactor.

Unit Procedure
The unit procedure is created using an ordered set of operations carried out on a single unit.
S88 requires that only one unit procedure may run on unit at a time. A batch cannot be pro-
cessed on one unit then transferred to another, then back again within the same unit proce-
dure. S88 does allow multiple unit procedure to run at the same time, but the must run on
different units.
For example a batch cannot run a unit procedure to make media while at the same time run a
unit procedure to CIP the same vessel. In our example we will create one unit procedure called
Make Media.

Operations
An operation is an ordered set of phases that are executed on single unit. The S88 standard
encourages the design engineer to create the operation boundaries at points in the process
where the process can be safely suspended. The standard assumes that only one operation
will be executed at a time.
This is often difficult to accomplish without making the operations extremely complicated. For
example, it is frequently required to run an agitator and a TCM module to maintain temperature
during the entire processing time. While it is possible to include these phases in each individ-
ual operation, it is often desirable to break them out into their own operation and run them in
parallel at the unit procedure level. In our example we will create two operations: Make Media
and Transfer Media.

Phases
The phase is the smallest module in the procedural model. It is usually the level that links to
the equipment model and the devices controlling the equipment. Phases perform unique, ba-
sic, and generally independent functions. Examples of phases could be heat, pressurize, mix,
transfer, recirculate, charge, or react.
Often S88 aware software will allow the designer to give phases “multiple personalities” using
something known as control strategies. For example, instead of simply pressurizing a vessel
the equipment may be capable of several different types of pressure control. It may be able
to pressurize to a setpoint, or pressurize to setpoint using a ramp and soak profile, or instead
of pressurizing pull a vacuum. Perhaps instead of pressurizing to a setpoint, all that is needed
is to open the vessel to the atmosphere. The designer could create separate phases for each
of these functions but it is often convenient for to create a single phases with multiple control
strategies to accomplish each task.

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Example Recipe
Using our example system described above let’s put together a sample master recipe using all
the whole procedure model.

Procedure: SF38 Growth Media

Our recipe is very simple and only requires a single unit. A procedure level recipe is not re-
quired, we could start at the unit procedure level, but to keep all the recipes consistent it can be
preferable to create a procedure level recipe.
Our procedure will contain only a single unit procedure and define all the material additions that
will be passed down the hierarchy.

Unit Procedure: Make Media

The Make Media unit procedure will have two operations: Make Media and Prepare Transfer.
The Make Media operation will contain the necessary steps to mix and manufacturing the me-
dia, while the prepare transfer will contain steps required to get the unit ready to transfer the
material to a destination.

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Operation: Make Media

The make media operation will contain the steps necessary to manufacture the media defined
by the recipe. The raw material quantities defined in the procedure level are passed down to
the operation through the unit procedure then passed to the individual phases of the opera-
tion. This mechanism of passing parameter values provides the process engineer the ability to
create multiple media solutions by simply copying the procedure level recipe and modify the
material amounts. The same operation is used, but different material quantities are used.

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Physical Model
The other half of the S88 standard defines the physical model or the equipment layer. The physical
model defined in S88 is broken into seven blocks: Enterprise (Company), Site, Area, Process Cell,
Unit, Equipment Module, and Control Module.

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Enterprise
The enterprise level refers to the company.
Site
The site level refers to the plant manufacturing the product. A company may have multiple sites
producing the same products. Generally sites are determined by geography, but that doesn’t
mean two sites cannot be physically adjacent.
Area
The area level refers section within a site. Not every area in a site must be associated with
the site, especially if the area doesn’t have anything to do with batch control. For example
the administration area in the site most likely doesn’t need to be included. However, process
areas can be included such as media prep, buffer prep, cell culture, and purification could be
designated as areas.
Process Cell
The process cell also referred to as a “process train” includes all the equipment required to
produce a batch. A process cell may contain more than one train, but a train cannot breach the
boundaries of a process cell.
A process cell may process more than one batch at a time, and batch need not use all of the
equipment in the process cell.
Unit
Most batching activities are focused around the unit. A unit is a piece of equipment where one
or more major processing activities take place. Generally they include equipment such as re-
actors, mixing vessels, or CIP skids. The do not include storage tanks or holding vessels. One
way to help determine if a piece of equipment should be considered a unit is to decide whether
you need it to run a recipe. All recipes require a unit to execute them. Storage tanks will gen-
erally be acquired by another unit and used in its recipe.
Some things to keep in mind about units is that they can only operate on one batch at a time.
They can only execute a single unit procedure at a time. They generally hold the entire or a
portion of the batch and perform some processing to add value to the batch.
It is helpful to consider CIP (Clean In Place) skids a unit and treat CIP activities similar to
batching activities. Technically CIP activities are not a batch process because a product is not
produced, but CIP can be recipe driven and the S88 standards and rules can be made to apply
to the CIP activities.
Control Module
The control module is model of a specific device such as a valve or pump. Control modules
may contain other control modules but this can get confusing when trying to distinguish be-
tween a control module and equipment module. The control module should be a single entity
and is the direct connection to the input and outputs to the actual device. The modules often
contain automatic and manual modes, simulation functions, the ability to set permissives and
interlocks, and process alarms.

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Equipment Module
The equipment module is a collection of control modules. The equipment module should pro-
vide a finite list of commands and perform a define set of functions. The idea is that your recipe
should not command each control module individually but the equipment will drive the control
module based on the requested commands.
The advantage of grouping control modules into functional groups is that the detail in con-
trolling each device is abstracted by the equipment module layer.
An example would be the outlet line in our example system shown in figure 8. It is displayed
again below for convenience.

The outlet line equipment module might contain the following control modules: XV-510030, PU-
510056, XV-510034, XV-510035, XV-510036, XV-510037.
The module then could provide the following functions:
• Idle – All valve closed and pump de-activated
• Recirculate – XV-510030 and PU-510056 is energized to recirculate the material
• Transfer to BRX-2000 – XV-510030, PU-510056, XV-510034, and XV-510035 is energize
• Transfer to BRX-3000 – XV-510030, PU-510056, XV-510034, and XV-510036 is energize
• Transfer to BRX-4000 – XV-510030, PU-510056, XV-510034, and XV-510037 is energize
The phase logic called by the batch control system would then simply take ownership of the
equipment module and issue the transfer to BRX-3000 command or recirculate command. The
phase logic doesn’t need to know which control modules are needed to execute the command
because the equipment module takes care of that.
Another big advantage of this architecture is that the commands to the equipment modules
can be common to all equipment modules of a similar type. That is to say all the outlet lines
may have the same set of commands so from the phase’s point of view it doesn’t matter which
module it is work with, the logic is the same.
The differences in the outlet lines from unit to unit are handled by the equipment module and
abstracted to the phase logic commanding it.

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Example: Physical Model

In our example system we are focused on a media vessel that is located in the Media Prep
Area in our model. Each device shown in the P&ID drawing would be considered as a control
module as shown below.

Technically input devices, flow meter, or level meter for example, are control modules as well,
but it can be beneficial not to include them in the equipment module definition unless it makes
sense to do so. It makes sense to include pressure in a pressure equipment module that also
includes valves and a controller to manipulate pressure, but level may be on its own and used
by several separate equipment modules and phase. It can be difficult where to place these
types of devices, and sometimes it is best to include them with the unit definition.
The next step is to group the control modules into functional groups. The outlet line is pretty
straight forward in our example. However, the inlet lines where the material additions occur
can be problematic. It may seem like a good idea to group all of the inlet valves together as
an equipment module, but this can sometimes make controlling transfers from the source tank
difficult. If situations like a WFI loop where the material is supplied to several vessels as a utility
and several vessels can draw on that utility simultaneously then creating a separate EM for
material makes sense. When the material is coming from a storage tank where only a single
transfer can occur at a time, it is best to include the all of the control modules in the outlet line
of the source tank. The equipment modules for our example:

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Linking Recipes to the Physical Model

Thus far we have shown how S88 isolates the process recipe from the equipment, but how do they
interact with each other?
Instructions from the recipe are delivered to the equipment layer via communication between the rec-
ipe phase and the equipment phase. The phases are mirrored in both the recipe and physical model
to facilitate communication between the models.

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Equipment Phase State Model

In our example system we are focused on a media vessel that is located in the Media Prep S88
clearly defines the command structure of the link between the recipe phase and equipment
phase modules. The recipe phase issues commands to the equipment phase, which changes
to the appropriate state. The following figure shows the state transition diagram used by the
equipment phase.

Idle
In the idle state the phase is not running and is waiting for the start command to transition into
running.
Running
The running state is the normal operating state for the phase. From the running state the recipe
phase may issue a hold, stop, or abort command to transition the phase to handle an abnormal
condition. The phase may also run to a normal completion, then transition to a complete state.
Complete
The phase transitions to complete after running through its normal operation. The phase is now
waiting for a reset command to return the idle state.
Holding
The phase receives a hold command while in the running state and executes separate logic
to place the appropriate equipment into a held condition. Once the holding logic completes the
state machine automatically transitions to the held state.

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Restarting
The phase receives a restart command while in the held state and executes separate logic to
restart the phase to safely return to the running state.
Stopping
The phase receives a stop command and executes the stopping logic. After the stopping logic
completes the state machine automatically transitions to the stopped state. A stop command
can be issued while the state machine is in running, holding, held, or restarting. Generally the
stop command is used to cleanly bring the phase to safe stop, and return the equipment to
a recoverable state. It can also be used with phases that do not have a clear stopping point.
Agitation frequently requires an external stop command to bring the phase to an end.
Aborting
The phase receives an abort command and executes the aborting logic. After the aborting logic
completes the state machine automatically transitions to the aborted state. Similar to the stop-
ping state the command can be issued during the running, holding, held, or restarting states.
Abort can be used to bring the phase to an immediate stop. Operators usually need to manually
manipulate the equipment to bring back into a useable condition.
Resetting
The phase receives a reset command while in the completed, stopped, or aborted states and
executes logic to reset the phase. After the resetting phase completes phase automatically
returns to the idle state, waiting for the run command to begin again.

A Case Study Link

To view a project example of an S88 implementation

CLICK HERE

What’s Next
We hope you will find this Guide to Batch Processing with S88 helpful. For further assistance, please
reach out to the process controls experts at Hallam-ICS.

www.hallam-ics.com/control-and-automation-systems

[email protected]

1-800-287-0800

References
Parshall, Jim and Lamb, Larry. Applying S88 Batch Control from a User’s Perspective ISA, 2006. Print
Parshall, Jim and Lamb, Larry. www.BatchControl.com Batch Control.com LLC
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