109478439_Fermentation_DOC_PCS7_V90SP1_en

SIMATIC PCS 7 in the
pharmaceutical
industry
"Fermentation”
(demo project)
Siemens
SIMATIC PCS 7, SIMATIC BATCH Industry
Online
https://support.industry.siemens.com/cs/ww/en/view/109478439 Support
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Table of contents
Table of contents
Legal information ......................................................................................................... 2
1 Introduction ........................................................................................................ 4
1.1 Overview............................................................................................... 4
1.2 Mode of operation ................................................................................ 5
1.3 Components used ................................................................................ 6
2 Preparation and commissioning ...................................................................... 7
2.1 Preparation ........................................................................................... 7
2.2 Tasks on the multiproject ................................................................... 11
2.3 Commissioning ................................................................................... 17
2.4 Description of the individual functions ................................................ 21
Overview of recipe control .................................................................. 24
2.5 Operation of the application ............................................................... 25
4 Engineering ...................................................................................................... 32
4.1 Equipment modules and control modules .......................................... 32
4.1.1 Level control ....................................................................................... 32
4.1.2 Temperature control ........................................................................... 33
4.1.3 pH value control ................................................................................. 33
4.1.4 Controlling the airflow rate.................................................................. 34
4.1.5 Stirring (agitation) ............................................................................... 34
4.1.6 Hygienic status ................................................................................... 34
4.1.7 Hot steam cleaning (steaming) .......................................................... 35

4.1.8 Pressure control ................................................................................. 35
4.1.9 Transfer .............................................................................................. 35
4.2 Sequencers (SFC type instances) ..................................................... 36
4.3 SIMATIC BATCH recipe ..................................................................... 37
4.4 Smart Alarm Hiding ............................................................................ 39
5 Additional information .................................................................................... 44
5.1 Background ........................................................................................ 44
5.1.1 P&I diagram ........................................................................................ 46
5.1.2 Process engineering ........................................................................... 47
5.1.3 SIMATIC BATCH functions ................................................................ 48
5.1.4 User administration and log of changes (SIMATIC Logon) ................ 48
5.2 Project structure ................................................................................. 49
5.2.1 CFC chart naming convention ............................................................ 49
5.2.2 Plan view ............................................................................................ 50
6 Appendix .......................................................................................................... 53
6.1 Service and support ........................................................................... 53
6.2 Links and literature ............................................................................. 54
6.3 Change documentation ...................................................................... 54
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1 Introduction
1 Introduction
1.1 Overview
In the pharmaceutical industry, active ingredients that are manufactured on a
biotechnological basis (Bio API) will become more and more important in the
future.
In general, these active ingredients are high-priced products that are highly
sensitive to temperature and shearing. Manufacturing them demands complex
concentration and separation processes. In this case, fermentation is a key
element in the production process of these substances.
The process comprises the following steps:
When dosing the culture medium, the system fills the fermenter with the necessary
amount of growth-stimulating substances. These substances contain carbon and
nitrogen sources that are necessary for the sustenance and further-development of
the cell culture. The dosing process is controlled by a sequential function chart
(SFC) that specifies the sequence and conditions for carrying out the individual
process steps.
In parallel with dosing the culture medium, the fermenter is prepared for cell
culture. In this process step, an optimum environment is created for cell growth.
Typically, the stirrer is started, the temperature is set and the airflow rate is
checked.
If an optimum environment has been achieved, the cell culture is dosed into the
fermenter. In this connection, the cell culture must have a volume that is suitable
for fermenter use. This volume is achieved in a pre-fermenter that has a smaller
capacity.
After the last fermentation phase, the product is harvested and transferred for
separation and purification.
At separation, the desired active ingredient molecules are separated from the rest
of the fermentation broth in several steps. Configuration and description of
separation is not part of this application example.
Failed batches or the broth resulting at cleaning of the fermenter are discharged
from the fermenter via a separate pipe.
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1 Introduction
1.2 Mode of operation

To meet the requirements of manufacture, it is necessary to standardize the
processes and to automate them in a consistent way. This includes system
modeling in accordance with ISA-88, which can be completely covered using
SIMATIC PCS 7 and SIMATIC BATCH. The plant, unit, equipment module and
control module of the plant model are configured in SIMATIC PCS 7. The model
that is configured in the SIMATIC Manager is displayed in SIMATIC BATCH in the
form of recipes. The use of SIMATIC PCS 7 and SIMATIC BATCH offers to depict
and control the fermentation process manage with the required high level of
efficiency, quality, and performance.
This application example contains typical equipment modules for controlling a
fermentation system, e.g.:
• Dosing substances
• Controlling the stirrer
• Controlling the temperature, the pressure, the airflow rate and the pH values
• Cleaning the fermenter and transferring the materials
In the application example, the sequence of the entire process is controlled via
SIMATIC BATCH.
Implementation with SIMATIC PCS 7 and SIMATIC BATCH

The "Fermentation” application example is implemented as a SIMATIC PCS 7
multiproject in accordance with ISA-88 and consists of an AS project (user

program), an OS project (visualization with process images) and a SIMATIC
BATCH system (recipes for controlling the fermentation processes).
The AS project was created using the APL library (Advanced Process Library) and
SIMATIC BATCH blocks.
The user rights and roles for SIMATIC BATCH are defined in SIMATIC Logon,
which is the central user management system of SIMATIC PCS 7.
Required knowledge
Fundamental knowledge of the following specialist fields is a prerequisite:
• Configuring with SIMATIC PCS 7
• User management with SIMATIC Logon
• Configuring with SIMATIC BATCH
• Basic knowledge of process technology
• An understanding of the concept of the control modules/ equipment modules
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1 Introduction
1.3 Components used

This application example has been created with the following hardware and
software components:
Component Note
SIMATIC PCS 7 ES/OS For the PCS 7 V9.0 SP1 example project
IPC547G W7
SIMATIC PCS 7 V9.0 Part of SIMATIC PCS°7 ES/OS IPC547G W7
SP1
S7-PLCSIM Not part of SIMATIC PCS 7 V9.0 SP1; appropriate licenses are
required.
CFC 7 V9.0 SP2 License is part of SIMATIC PCS 7 V9.0 SP1; the Update can
be download under follow Link:
https://support.industry.siemens.com/cs/ww/en/view/109756832
Advanced Process Part of SIMATIC PCS°7 V9.0 SP1
Library V9.0 SP1
Note In case of different hardware, please take heed of the minimum requirements for
installing the software components. The minimum requirements can be found in
the Readme of the PCS 7 under follow link:
https://support.industry.siemens.com/cs/ww/en/view/109750097.
This application example consists of the following components:

Component Note
109478439_Fermentation_DOC_PCS7_V90SP1_en.pdf This document
109478439_Fermentation_PROJ_PCS7_V90SP1.zip PCS 7 V9.0 SP1 example
project and batch recipe
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2 Preparation and commissioning

2.1 Preparation
The following instructions describe how to launch the application example by
emulating the controller with the "S7-PLCSIM" program. If there is a real controller,
you must configure existing hardware components in HW Config.
Preparation in Windows
The following instructions describe the steps that must be performed in Windows:
1. Click on "Start".
2. Right-click on "Computer" and open the menu item "Administrative Tools".
"Computer Management" will be opened.
3. On the left side of the screen click on the menu item "Local Users and Groups
> Groups". Select the menu item "New Group" The "New Group" window
opens.
4. In the "Group name" field enter "FermentationUser".
5. Add the user name with which you are currently logged in to Windows, to this
group.
6. Click on "Create".
7. On the left side of the window, select the item "Local users and Groups >
Users". On the right side, right-click the user name with which you are currently
logged in. Select the "Properties" menu item. This opens the "Properties"
window.
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8. Go to the "Member of" tab and check whether the user is a member of the
following groups:
If the user is not included in all the groups, add him to the missing ones.
Preparing the project

1. Copy the file "109478439_Fermentation_PROJ_PCS7_V90SP1.zip" and
"109478439_Fermentation_BATCH_V90SP1.sbb" to any folder on the
configuration PC and then open SIMATIC Manager.
2. In the menu bar click "File > Retrieve" and select the file
"109478439_Fermentation_PROJ_PCS7_V90SP1.zip". Then confirm with
"Open".
3. Select the folder in which the project will be saved and confirm with the "OK"
button.
The project will be extracted.
4. In the "Retrieve" dialog, click the "OK" button and then click "Yes" in the dialog
to open the project.
5. Right-click "UT_Ferm_OS > PCS7901" and click the "Object Properties" menu
item.
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6. Enter the name of your PC in the "Name" field and click "OK".
7. Right-click "UT_Ferm_OS > Name of your PC > WinCC Appl > OS" and click
the "Open Object" menu command.
8. Confirm the "Configured server is not available" dialog with "OK".
9. In the WinCC Explorer, open the properties of your computer and, in the open
Properties dialog, click the "Use local computer name" button. Confirm the
"Change computer name" message with "OK".
10. In WinCC Explorer, click on "File > Exit" and in the subsequent dialog select
"Terminate WinCC Explorer and close project". Confirm your selection with
clicking on the "OK" button.
11. Reopen the WinCC Explorer as described in step 7.
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12. Open by double-clicking the "OS project editor".

13. In the "Layout" tab under "Available Layouts", select the "SIMATIC Standard"
screen corresponding to the screen resolution that is set.
Click "OK" to apply the settings and close the "OS project editor".
14. Exit the WinCC Explorer as described in step 10.
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2.2 Tasks on the multiproject

The following instructions describe the tasks that must be performed on the
multiproject. The prerequisites are that SIMATIC Manager must already be open
and the project must have been selected in the component view.
1. Right click on "UT_Ferm_AS > AS01 > CPU 410-5H > S7-Program > Charts"
and click the menu command "Compile".
2. In the "Compile program" dialog, select the "Entire program" item and activate
the "Generate module drivers" option then confirm this dialog with "OK".
3. Close the compiler log.

4. Right-click on "UT_Ferm_OS > PCS7901 (name of the PC station) > WinCC
Appl > OS" and click the menu item "Compile". The compiler dialog opens.
5. Click "Next".
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6. Ensure that all areas are selected and click on "Next".

7. Select the following settings and click "Next".
8. Click on "Compile".
9. Confirm the "Compile OS" dialog with "OK".
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10. In SIMATIC Manager, right click the "UT_Ferm_MP" multiproject and select the
"SIMATIC BATCH > Open configuration dialog" menu command. The SIMATIC
BATCH configuration dialog opens.
11. Select the "UT_Ferm_MP" multiproject and click on "Settings".
The "Settings" window opens.
12. In the "Distribution" tab, click "Update".
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13. In the "OS objects" tab, click on "Update".

14. In the "Process cells" tab, click on "Update".
15. Click on "OK" to exit the "Settings" window.
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16. Select the "BATCH types" item and click "Generate".

18. Click on "Close".
19. Select the "BATCH instances" item and click "Merge".

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22. Select the "BIO_API_PLANT" item and click "Download".

25. Exit the SIMATIC BATCH configuration dialog with "OK".

26. In the windows task bar, right-click the icon for the SIMATIC BATCH Launch
Coordinator and select the "Change start mode from > Automatic to manual"
menu command.
Note The SIMATIC BATCH Launch Coordinator starts automatically when the PC is
started. If SIMATIC BATCH Launch Coordinator does not start, proceed as
follows:
Click on "Start > All programs > Siemens Automation > SIMATIC > BATCH
Launch Coordinator".
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2.3 Commissioning
The following instructions describe how the "Fermentation" application example is
initialized.
For commissioning, SIMATIC Manager must already be open and the project must
have been selected in the component view.
Starting the simulation (S7-PLCSIM)

To start the simulation, proceed as follows:
1. Select "Options > Simulate Modules" from the menu.
The "S7-PLCSIM" dialog window opens.
2. Select the "Open PLC" option in the "File" dialog.
3. Select the file "Fermentation.plc" from the path
"<project path>\Fermentation\Ferm_AS\Fermentation.plc"
4. Change "PLCSIM(MPI)" to "PLCSIM(TCP/IP)" in the drop-down list.
Activate OS (WinCC runtime)

To activate the OS, proceed according to the following instructions:
1. Right click "UT_Ferm_OS > PCS7901> WinCC Appl. > OS" and click the menu
item ("Open Object").
2. Select "File > Activate" in the WinCC Explorer menu.

3. Log into the SIMATIC Logon Dialog using your Windows user ID.
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4. Open the PictureTree under "Fermentation" and click on "V342" in the image
area.
Activating SIMATIC BATCH

To activate SIMATIC BATCH, proceed according to the following instructions:
1. Press the Windows logo key on your keyboard to bring up the Windows task
bar.
2. There is a green "Stop" symbol in the icon for the SIMATIC BATCH Launch
Coordinator . The currently loaded "UT_Ferm_MP" project is displayed as a
tooltip text.
3. Right-click the icon for the SIMATIC BATCH Launch Coordinator and select
the "BATCH Runtime > Start" menu command to start SIMATIC BATCH
Runtime.
There will be an "hourglass" in the icon for the SIMATIC BATCH Launch
Coordinator. This indicates that the SIMATIC BATCH server is about to be
started. The "hourglass" changes to a "Play" symbol . The SIMATIC

BATCH server is now in the "Run" state.
4. Click Start > All programs > Siemens Automation > SIMATIC > BATCH Control
Center").
The BATCH Control Center opens.
5. Click "Options" menu item and select the "Restore" menu command.
The Restore dialog opens.
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6. Navigate to the storage location of the

"109478439_Fermentation_BATCHV90SP1.sbb" file and select it.
7. Click on "Open".
8. Click on the "Options" menu item and select the "Role Management" menu
command.
"SIMATIC Logon Role Management" opens.
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9. In the "Configured roles and assignment types" window, right-click "Roles >
Superuser > Groups and users". Select the "Edit" menu command.
The "Edit groups and users" window will open.
10. Click on the "List" button.

11. All the available groups and users will be listed for you.
12. Remove the User that is present.
13. Add the group "FermentationUser" to "Configured groups and users".
14. Click the "OK" button to exit the "Edit groups and users" window.
15. In the "SIMATIC Logon Role Management" window, click "File > Save".
16. In the "SIMATIC Logon Role Management" window, click "File > Exit".
17. Right click on the left window click the "BIO_API_PLANT" process cell symbol
and click the menu command "Update the process cell".
18. Confirm the "Update the plant" dialog with "OK".
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2.4 Description of the individual functions

The illustration below shows the process picture of the application example:
1 2 3 4
7
5
8 6
10
11
The fermentation process is implemented by means of the following technical

facilities:
1. Dosing the cell culture
2. Dosing the culture medium
3. Dosing the antifoam
4. Controlling the airflow
5. Controlling the pH values by means of acid and base dosing
6. Stirrer
7. Cleaning function (CIP = cleaning in place) by means of hot steam control
8. Controlling the pressure
9. Controlling the temperature
10. Overview of recipe control by SFCs
11. Emptying the vessel for separation or waste
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Level control
The dosing equipment feed the exact amounts of culture medium, cell culture, and
antifoam to the fermenter. Dosing is carried out on a discontinuous basis via a
coarse feed control with flow monitoring and setpoint specification. Once the
specified dosing amount has been reached, dosing is ended. After the entered
follow-on time has expired, the amount is checked for overdosing or underdosing
and it can be adapted appropriately.
Temperature control
The temperature of the substances in the vessel (fermenter) is a critical factor for
the quality of the products. This task is particularly challenging due to the
predetermined temperature for the growth or development of the cell culture.
This requirement is accomplished by means of heat exchangers. In this case, a
portion of the vessel contents are pumped through a cascade consisting of two
external heat exchangers. For rapid cooling with a heat exchanger, cooling water is
passed as a service medium through the heat exchanger, thereby removing the
generated heat in a targeted way. At the other heat exchanger, hot water is
circulated and thereby supplying the heat of the reaction mass.
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pH value control
Cell growth requires a specific pH value. The predetermined pH value is regulated
either by adding base or acid. During pH value control, two actuators are driven via
a control variable and the corresponding valves are opened or closed.
Controlling the airflow rate

Depending on the cell culture, fermentation can run in an environment containing
oxygen or one that is oxygen-free.
Cell cultures that grow in an environment containing oxygen are supplied with the
required amount of oxygen by the airflow rate control.
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Stirrer
The motorized mixer has the task of mixing the cell culture with the culture medium
and of distributing the material concentrations and temperature homogeneously in
the reactor.
Since a mechanical load could be put on the cultured cells by foaming during
mixing (e.g. due to bursting bubbles), antifoam is dosed appropriately in the
fermenter. The antifoam reduces the surface tension, which means that the cell
culture is maintained.
Overview of recipe control

The system displays all the SFCs of the unit in the right-hand pane. The status
display of the active SFC is shown in green.
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2.5 Operation of the application

The following section describes how to run a SIMATIC BATCH recipe and use it to
control the fermentation process. Here, operation is carried out from the SIMATIC
BATCH Control Center.
Requirements
The following points are a prerequisite:
• WinCC Runtime is active.
• The included file "Fermentation.plc" is active in the S7 PLCSIM.
• The SIMATIC BATCH server is in the "Run" state
• The included file "Fermentation.sbb" has been loaded in SIMATIC BATCH.
• The user rights are set up in SIMATIC BATCH.
Creating and starting the SIMATIC BATCH batch

1. Open the "V342" process image in WinCC Runtime
2. Click the "Key set change" button in the key area.
3. In the key area, click the "BATCH Control Center" button.
The SIMATIC BATCH Control Center opens.
4. Right-click "Orders" and select the "New" menu command
This opens the "Generate order category" window
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5. Enter a suitable name in the "Name" field and click on the "OK" button.
6. Right-click the created category and select the "New" entry in the shortcut
menu.
The "Create job" window opens.
7. Enter a suitable name under the "General" tab in the "Name" field for the job.
8. Right-click the created order and select the "New" entry in the shortcut menu
The "Add Batch(es)" window opens.
9. Click on the "New" in the window "Add Batch(es)".
10. Select the "FermFormula_FermentationBroth V1.0” recipe and click on the
"OK" button.
11. In the "Create job" window, enter a meaningful name for the batch.
12. Click on the "OK" button in the "Create order" window.
13. Right-click the batch and select the "Release" menu command.
14. Confirm the dialog window that opens with "Yes".
You have now created and released a batch
15. Double-click the batch.

The control recipe will be displayed for you.
16. Right-click the batch and select the "Start" menu command.
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17. Confirm the dialog window that opens with "Yes".

The batch starts. SIMATIC BATCH now reserves the plant sections and starts
the SFCs. All the control strategies are completed one after the other.
Operation in WinCC Runtime

1. Switch to the "Fermentation > Fermenter V342" process picture in WinCC
Runtime and observe how individual equipment modules are controlled.
2. The system displays a prompt on the status display of the V342 unit. To open
the status display, double-click on the corresponding symbol .
The message view opens.
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3. Change to SIMATIC BATCH Control Center.

The query is then displayed.
4. Confirm the query using the "Apply > OK” pushbuttons.

The system continues to execute the recipe.
The batch is fully executed and then terminated.
The SFCs that were started are terminated and reset to the "IDLE" state by
SIMATIC BATCH.
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3 Integrating the unit template in the user

project
3.1 Preparation
1. Copy the file "109478439_Fermentation_PROJ_PCS7_V90SP1.zip" to the
configuration PC and then open the SIMATIC Manager.
2. Click on "File > Retrieve" in the menu bar and select the file
"109478439_Fermentation_PROJ_PCS7_V90SP1.zip". Then confirm by
clicking on "Open".
3. Select the folder in which the project will be saved and confirm with the "OK"
button.
The project will be extracted.
4. In the "Retrieve" dialog, click on the "OK" button and then click on "Yes" in the
dialog to open the project.
5. Switch to the "Plant view".
6. At the same time, open the project in which the fermenter is to be integrated.
3.2 Copying templates
Note If you have already worked with CMTs in your existing project, then check that
they are identical before skipping to the following steps, since this can lead to
errors in your existing project or in the unit template you want to integrate.
1. Switch to the plant view.

2. Copy the "CMT" folder containing the CMTs from the master data library into
the target project.
3. Copy the Enumerations from the master data library into the target project.
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3.3 Copying units

1. Copy the hierarchy folder "BIO_API_PLANT" from the AS project of the Unit
Template to the plant view of the target project.
2. Copy the process screens "Fermenters" and "Fermenter_V342" from the OS

project of the unit template to the plant view of the target project as well. If you
wish, you can also copy the pictures "Help" and "BiotechPlants".
Note When copying the process screens, make sure that you copy the pictures to the
hierarchy level of the target project, which is configured as an OS area.
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3.4 Adapting the OS project

To facilitate the changing of colors in the process screen from a central point, a
central color palette was created in the OS project of the Unit Template. To display
these colors in the process screen of your own project, you must import the
relevant color palette.
1. Select the "OS" in WinCC Explorer and choose "Object properties..." in the
shortcut menu.
2. Choose the "User Interface and Design" tab and click the "Edit" button.
3. Import the palette into your own project by means of the "Overwrite" option.
The color palette is in the project folder of the unit template at the path:
"<Project path>\Fermenter\Ferm_OS\wincproj\OS\GraCS \
PharmaColors.xml>". All existing colors will be replaced.
Note Please note that all colors are always used when exporting/importing color
palettes. It is not possible to export partial color tables.
If you have created your own color tables in your project, you can also export them
and use an editor to merge the tables in the XML file. Otherwise you can create a
new color table in your project and configure the colors individually. Make sure, too,
that the color index does not change, otherwise you will have to adjust the color
settings of the objects in the process screen. Of course, it is up to you to change
the colors according to your requirements.
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4 Engineering
4 Engineering
4.1 Equipment modules and control modules
The "Fermentation" application example is made up of various equipment modules
and control modules. In the PCS 7 project, all the control modules, including the
control modules of equipment modules, are based on control module types of the
master data library. The control module types used in the project derive from the
APL and IL library. The SFC types used for the process control are also included in
the master data library.
In the following chapters you will find information on the structure of the individual
equipment modules. You will also find an overview of the SFCs used.
4.1.1 Level control
Level control in batch mode ("dosage control") is not implemented via continuous regulation
but by controlling the inflows of culture medium, cell culture, and antifoam.
Structure
All the necessary charts as well as the simulation and the SFC instance are in the
unit’s "FILL_MD”, "FILL_AF”, and "PREFERMENTATION” folders.
The following table contains the control modules of the level control of the medium
"FILL_MD".
Designation Description
FIC_Fill_Medium Valve control with flow detection of the culture medium in
the fermenter
YS_Fill_Medium Open and close valve for inlet of the culture medium in the
fermenter
Sim_Fill_Medium Simulation of the inflow of the culture medium in the
fermenter
The following table contains the control modules of the level control of the antifoam
"FILL_AF".
FIC_Fill_AntiFoam Valve control with flow detection of the antifoam in the
fermenter
YS_Fill_AntiFoam Open and close valve for inlet of the antifoam in the
fermenter
Sim_Fill_AntiFoam Simulation of the inflow of the antifoam in the fermenter
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4 Engineering
The following table contains the control modules of the level control from the
prefermenter "PREFERMENTATION".
FIC_PreFerm Valve control with flow detection from the prefermenter in
the fermenter
YS_PreFerm Open and close valve for inlet from the prefermenter in the
fermenter
Sim_Fill_AntiFoam Simulation of the inflow from the prefermenter in the
fermenter
4.1.2 Temperature control
Temperature control of the input material in the vessel is implemented by using two
external heat exchangers – one for cooling and one for heating. An open and close
valve in the inlet allows the service medium (cool or hot water) to be supplied to the
heat exchanger. An analog control valve in the outlet determines the flow rate.
Structure
All necessary plans, as well as the simulation and the SFC instance, can be found
in the "TEMPERATURE" folder of the unit.
The following table contains the control modules for temperature control and
regulation.
TIC_Temp Controller for the split-range control with one controller
output and two actuators
YC_Temp Analog control valve for the cooling/heating medium
YS_Temp Open and close valve for the cooling/heating medium
Sim_Temp Simulation of the temperature in the fermenter
4.1.3 pH value control
The pH of the medium in the fermenter is set at controlling of the pH value. To do

this, a neutralizer (alkali/base or acid) is added to the product to achieve the
desired pH value. During pH value control, two actuators are driven via a control
variable and the corresponding valves are opened or closed.
Structure
in the "PH_CONTROL" folder of the unit.
The following table contains the control modules of pH value control.
QIC_pH Controller for split-range control with one controller output
and two actuators for feeding acid and base
YC_Acid Analog control valve for acid
YC_Base Analog control valve for base
YS_pH Open and close valve for acid or base
Sim_pH Simulation of the pH value in the fermenter
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4 Engineering
4.1.4 Controlling the airflow rate
An airflow rate control is used to supply enough oxygen to the cell culture. This
control ensures that the supply of oxygen and venting of the fermenter create an
optimum growth-stimulating environment for the cell culture without placing a
mechanical load on it. An oxygen share flow cascade is used to regulate the
oxygen share.
Structure
All the necessary plans as well as the simulation and the SFC instance can be
found in the "AIRFLOW" folder of the unit.
The following table contains the individual control modules of airflow rate control.
FIC_Airflow airflow controller for air throughput (slave controller)
QIC_Airflow Acquisition the oxygen share with specification of the
airflow amount for the slave controller.
YC_Airflow Analog control valve for oxygen feed
YS_Airflow Open and close valve for oxygen feed
Sim_Airflow Simulation of the airflow rate
4.1.5 Stirring (agitation)

The stirrer enables homogeneous mixing of the vessel contents. The stirrer, i.e. the
stirrer motor rotates in a fixed frequency and is powered by an SFC instance or a
local control possibility.
Structure
The necessary plan and the SFC instance are located in the "AGITATION" folder of
unit V342.
The following table contains the individual control modules of the stirring.
NS_Stirr Stir motor for mixing of the vessel contents
4.1.6 Hygienic status
Using defined figures, it is possible to get evidence of the hygienic status of the unit
and of whether it is necessary to carry out Cleaning in Place (CIP).
Structure
The necessary chart and the SFC instance are in the "HYG_STATE" folder of the
unit.
The following table contains the individual control modules of the hygienic status.
QI_Hyg_State Determine the hygienic status by means of defined figures
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4 Engineering
4.1.7 Hot steam cleaning (steaming)
The unit is cleaned by supplying hot steam. When doing this, a control carries out
control of the temperature. An open and close valve is installed upstream of the
analog control valve.
Structure
in the "STEAMING" folder of the unit.
The following table contains the control modules for temperature control and
regulation.
TIC_Steam Controller for temperature control with display of the
temperature value
YC_Steam Analog control valve for the steam
YS_Steam Open and close valve for the steam
Sim_Steam Simulation of the hot steam cleaning
4.1.8 Pressure control
The pressure in the fermenter is regulated in the control module pressure control.
By opening the outlet valve, the gas mixture escapes and the container pressure in
the fermenter decreases.
Structure
in the "STEAMING" folder of the unit.
The following table contains the control modules for pressure control.
PIC_Pressure Controller for pressure control with display of the pressure
value
YC_Pressure Analog control valve for the pressure outlet
Sim_Pressure Simulation of the pressure in the fermenter
4.1.9 Transfer
The cell culture is transferred for separation or waste by means of open and close
valves.
Structure
in the "TRANSFER" folder of the unit.
YS_Discharge Open and close valve for the fermenter outlet
YS_LiquidWaste Open and close valve for the liquid waste
YS_Separation Open and close valve to the separation
Sim_Trans Simulation of the transfer
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4 Engineering
4.2 Sequencers (SFC type instances)

The fermentation plant has been designed for batch operation. Within the unit,
there are various SFC type instances that have different tasks. According to ISA-
88, the SFC type instance describes the equipment module. These will be
described in the following sections.
The following table summarizes the SFC types used:

SFC type name Function
EM_FERM_PREFERM (1) Filling the cell culture
EM_FERM_FILLING (2) Filling the culture medium
EM_FERM_FILL_AF (3) Filling the antifoam
EM_FERM_STIR (4) Controlling the stirrer
EM_FERM_PRESS (5) Controlling the pressure
EM_FERM_AIRFLOW (6) Controlling the airflow rate
EM_FERM_PH (7) The pH value is regulated by adding base or acid.
EM_FERM_STEAM (8) Cleaning control by means of hot steam
EM_FERM_TEMP (9) Controlling the temperature
EM_FERM_HYG_STATE (10) Monitoring the hygienic status of the fermenter
EM_FERM_TRANS (11) Control of discharge of the cell culture from the fermenter
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4 Engineering
4.3 SIMATIC BATCH recipe

SIMATIC BATCH is used for discontinuous production. With the aid of SIMATIC
BATCH, various products can be produced on one system. Manufacture is carried
out by means of recipes. The recipes contain the knowledge required for
production. The recipes can be changed by the operating personnel, depending on
their authorization. The complete recipe procedure with messages and
measurements, as well as the operator interventions, is logged.
In addition to the recipes for manufacturing the product, there are also recipes that
are used for cleaning the plant sections.
Fermentation recipe
The illustration below shows the SIMATIC BATCH recipe that is available with this
application example.
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4 Engineering
Among other things, the recipe contains the following information:

• Amount of culture medium, cell culture and antifoam that are filled in the
fermenter.
• The temperature, pressure, and pH concentration for an optimum growth-
stimulating environment for the cell culture
• Duration of fermentation
The fermentation process runs according to the following procedure:
Batches
The batches are created as an order in SIMATIC BATCH. When you create the
batch, the recipe to be executed is set.
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4 Engineering
4.4 Smart Alarm Hiding

With the Smart Alarm Hiding, alarms of a measuring point can be filtered or hidden
depending on the plant state. This means that the filtered and hidden alarm
messages of the measuring points are also sent to the alarm system where they
are processed and archived.
A reduction in the message traffic is thus achieved in process mode, which
simplifies the operation of a system.
Smart Alarm Hiding in the example project

The following sequence has been followed for the configuration of Smart Alarm
Hiding.
Step 1: Configuration of operating states
Step 2: Configuration of status block

Incl. compile CFC and

Step 3: Configuration of the block group download the AS
Step 4: Configuration of the hiding matrix
Step 5: Compiling the OS Incl. Download OS and

restart OS
Note Further information on Smart Alarm Hiding can be found at the following link:
https://support.industry.siemens.com/cs/ww/en/view/55699984.
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4 Engineering
Step 1:
The operating states are configured (1) in the master data library and synchronized
in the multiproject (2) as follows. The created enumeration is called "Operating
State".
2
Step 2:
The "STRep" status block is configured and the "State" inputs correspond to the
operating states created in step 1.
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4 Engineering
Note In the project, the plant state is selected via a direct interconnection of upstream
blocks. A step sequencer is also possible, however only one position (SFC or
upstream block) can be activated at any time.
The enumeration "Operating State" is assigned in the object properties of the

output "QSTATE".
The block group "PLANT" is predefined in the block properties.
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4 Engineering
Step 3:
The technological blocks are assigned to the "PLANT" block group.
The following technological blocks belong to the "PLANT" block group:
Note The block group defines which technological elements belong together. It is
recommended to define the block group at the unit level.
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4 Engineering
Step 4:
The Hiding Matrix has been configured for the following plant states:
Plant state Activation via suppressed messages
1. Operation Batch running None
2. Out_of_Operation End of batch All messages and alarms
3. Startup Starting batch Lower limit values of the temperatures,
oxygen concentration, pressure and all
alarms of pH value
4. Shutdown Finishing batch Lower limit values of the temperatures,
oxygen concentration, pressure and all
alarms of pH value
5. Product_change n. A.
6. Standby Batch hold or paused None
7. Emergency n. A.
8. Maintenance n. A.
Out of Batch finished

Operation
Starting
batch
Startup Shutdown
Batch running Finishing batch

Operation
Batch hold
Resuming
batch
Operation
Step 5:
The OS in the project has already been compiled and prepared for operation.
Fermentation
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5 Additional information
5.1 Background
ISA-88
The application example is configured in accordance with the ISA-S88 standard.
The standard describes a process with reference to the equipment available
(physical model), the defined technical process (process model) and the equipment
that is used to produce a batch (procedural control model). The figure below shows
the structure of the ISA S88 standard.
Note You will find detailed information on ISA-S88.01 in the manual entitled "PCS 7
SIMATIC BATCH V9.0 SP1 Process Control System", in the chapter entitled
"Technological basics complying with ISA-88.01". You will find this manual at the
following link: https://support.industry.siemens.com/cs/ww/en/view/109755007.
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Unit
The term Unit represents a "unit" in process engineering plants (e.g. stirred tank
reactor, fermenter) which includes the apparatus, sensors, actuators and
automation (hardware and software).
Structured units exist for both continuous as well as discontinuous processes.
Package units are a variation of a unit. For example, package units could be
separators (centrifuges), refrigeration systems, vacuum systems and packaging
machines. In this case, the manufacturer of the mechanical or technical device
includes automation, specially tailored for this device, and which is mounted locally
on the device of separate hardware. The package unit is often integrated into a
higher-level process control system.
Equipment module
A technical function forms part of a unit and contains sensors, actuators and the
automation system (hardware and software). Equipment modules are designed
and configured for use in concrete applications, such as process technology
(dosing device, level or temperature control).
The automation solution of an equipment module is structured as follows:
Connected and configured measuring points
Simulation to demonstrate the mode of operation
Each equipment module is combined in a hierarchy folder and can be integrated
into existing projects.
Control module
The control module is built up by the actuators and sensors. In PCS 7, the control
module is realized with software typicals (control module types), such as for
example a valve, motor or controller.
The realization in the CFC chart contains all relevant building blocks,
interconnections and basic parameters. A control module type is produced from the
CFC, which is then stored in the PCS 7 master data library. Any number of
instances can be created from this control module type.
Each control module name (measuring point name) is based on a consistent
naming convention. This means that the name gives information about the function
and role of the control module.
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5.1.1 P&I diagram
The following image shows the individual elements of the fermenter in a piping and
instrument flow chart.
Prefermenter Medium Anti-Foam Air Steam
FIC FIC FIC

YS YS
PreFerm Medium AntiFoam Airflow Steam
YS YS YS YC YC
PreFerm Medium AntiFoam Airflow Steam
NS
QIC FIC QIC
Stirr
YC Airflow Airflow Steam
Acid
YS PIC YC
Acid
pH Venting Venting
YC
Base Venting
QIC LI
Base pH Level
TIC
Reactor
YS YC
Cooling Cooling
Heating water YS YS YS
Discharge Separation LiquidWaste
YS YC
Heat Heat Separation
Heating water Liquid Waste
Fermentation
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5.1.2 Process engineering
Fermentation takes place in several steps in a series of fermenters with different

capacities that are shown in the top right section of the following figure.
During the fermentation phase, the cell culture reproduces until the capacity of the
respective fermenter has been reached.
After this, the cell culture is transferred to the next largest fermenter. In the last
fermentation phase – expression – the active ingredient is produced by adding
special nutrient, for example.
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5.1.3 SIMATIC BATCH functions
The process flow is controlled in the application by the recipes of SIMATIC BATCH.
SIMATIC BATCH recipe

Recipe “Fermentation.sbb” is available with this application example:
Batch report
The output of the batch report is possible during the running period or after
executing the batch job. The batch report includes for instance the messages,
measured values and setpoints as well as signature data. This process considers
the data up to the latest completed recipe.
5.1.4 User administration and log of changes (SIMATIC Logon)
The user rights and roles for SIMATIC BATCH are defined in SIMATIC Logon,
which is the central user management system of SIMATIC PCS 7 and assigned to
the Windows user groups.
Within SIMATIC BATCH additional user settings can be made, such as the
assignment of new Windows users or user groups to a user role.
The rights management in SIMATIC BATCH also allows the specification of the
user rights of each user role and the permitted user roles per work station or unit.
All changes in the rights management are documented and can be checked at any
time.
Fermentation
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5.2 Project structure

5.2.1 CFC chart naming convention
A uniform naming convention was used for identifying the measurement points,
whereby the function has been named according to the European standard EN
62424. The following figure shows the composition of a measurement point name:
TIC_Steam
function identifier
T = temperature (first letter)
I = indication (subsequent letter)
C = control (subsequent letter)
Die folgende Tabelle enthält alle in der Applikation verwendeten Buchstaben und
deren Bedeutung:
First letter: Meaning
F Flow
L Level
M Moisture
N Motor
P Pressure
Q Quantity
S Speed (velocity, rotational speed, frequency)
T Temperature
W Weight
X Freely selectable first letter
Y Control valve
Subsequent letter Meaning

C Control
F Fraction
I Indication
S Switching (binary control function or switching function)
(non-safety-related)
T Monitoring (transmitter, analog value processing)
H High
L Low
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5.2.2 Plan view
The technological hierarchy of the “Fermentation” application example is configured in

accordance with ISA-88.
In the AS project "UT_Ferm_AS" the first technological hierarchy level
"BIO_API_PLANT" is defined as a plant and includes for every equipment modules
a hierarchy folder with necessary the charts for the process control and the process
simulation.
The plant hierarchy in the OS project "UT_Ferm_OS" is derived from the
technological hierarchy of the AS project. The hierarchy folders contain the
following process images:
Hierarchy folder Subfolder Process image Description
BIO_API - BiotechPlants.pdl Overview of the
Production process stages in the
manufacture of
biological active
ingredients (Bio API)
Fermentation - Fermenters.pdl Overview as an
example of the
integration of several
fermenters.
Using this screen, you
call the process image
of the Fermenter V342

unit.
V342 Fermenter_V342.pdl Process image of the
fermenter or of the
fermentation process
that is described in this
application example
Presentation - Presentation Overview of different
scenarios for
Process Analysis ProcessAnalysis.pdl
implementing the
Scenario A ScenarioA.pdl fermenter
Scenario B1 l ScenarioB1.pdl
Scenario B2 ScenarioB2.pdl
Help - Help Explanation of the
block symbols,
Help_Static Help_Static.pdl
faceplates and graphic
Help_Dynamic_ Help_Dynamic_ representations that
Sensors Sensors.pdl are used
Help_Dynamic Help_Dynamic
_Actors _Actors.pdl
In the following figure the PCS 7 multiproject structure is depicted.
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Fermentation AS - Project
V342
AGITATION LEVEL
CFC CFC CFC CFC CFC

EM_Stirr NS_Stirr LI_Level Sim_Level V342_Unit
AIRFLOW
CFC CFC CFC CFC CFC

EM_Airflow FIC_Airflow QIC_Airflow Sim_O2Concent Sim_O2Concent
ration ration
CFC CFC CFC
Sim_Airflow YC_Airflow YS_Airflow
FILL_AF
CFC CFC CFC CFC

EM_Fill_Anti- FIC_Fill_Anti- Sim_Fill_Anti- YS_Fill_Anti-
Foam Foam Foam Foam
FILL_MD
CFC CFC CFC CFC

EM_Fill_Medium FIC_Fill_Medium Sim_Fill_Medium YS_Fill_Medium
TRANSFER
CFC CFC CFC CFC CFC

EM_Trans Sim_Trans YS_Dischagre YS_LiquidWaste YS_Separation
PH_CONTROL
CFC CFC CFC CFC CFC

EM_pH Sim_pH QIC_pH YC_Acid YC_Base
CFC
YS_pH
PREFERMENTATION HYG_STATE
CFC CFC CFC CFC CFC

EM_Fill_Pre- FIC_Fill_Pre- Sim_Fill_Pre- YS_Fill_Pre- EM_Hyg_State
Ferm Ferm Ferm Ferm
PRESSURE
CFC CFC CFC CFC CFC

EM_Pressure PIC_Pressure Sim_Pressure YC_Pressure QI_Hyg_State
STEAMING
CFC CFC CFC CFC CFC

EM_Steam Sim_Steam TIC_Steam YC_Steam YS_Steam
TEMPERATURE
CFC CFC CFC CFC CFC

EM_Temp Sim_Temp TIC_Temp YC_Cooling YC_Heating
CFC CFC
YS_Cooling YS_Heat
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BIO_API_PLANT OS – Project
BIO_API_Production Fermentation
V342
PDL PDL PDL

Fermenter_V342 Fermenters Fermenter_V342
Help
Help_Dynamic_Actor Help_Dynamic_Sensor Help_Static
PDL PDL PDL

Help_Dynamic_Actor Help_Dynamic_Sens Help_Static
or
PDL
Help
Presentation
Process Analysis Scenario A Scenario B1
PDL PDL PDL

ProcessAnalysis ScenarioA ScenarioB1
ScenarioB2
PDL PDL
ScenarioB2 Presentation
CFC CFC CFC CFC CFC

EM_Steam Sim_Steam TIC_Steam YC_Steam YS_Steam
TEMPERATURE
CFC CFC CFC CFC CFC

EM_Temp Sim_Temp TIC_Temp YC_Cooling YC_Heating
Fermentation
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YS_Cooling YS_Heat
6 Appendix
6 Appendix
6.1 Service and support
Industry Online Support
Do you have any questions or need assistance?
Siemens Industry Online Support offers round the clock access to our entire
service and support know-how and portfolio.
The Industry Online Support is the central address for information about our
products, solutions and services.
Product information, manuals, downloads, FAQs, application examples and videos
– all information is accessible with just a few mouse clicks:
support.industry.siemens.com
Technical Support
The Technical Support of Siemens Industry provides you fast and competent
support regarding all technical queries with numerous tailor-made offers
– ranging from basic support to individual support contracts. Please send queries
to Technical Support via Web form:
www.siemens.com/industry/supportrequest
SITRAIN – Training for Industry

We support you with our globally available training courses for industry with
practical experience, innovative learning methods and a concept that’s tailored to
the customer’s specific needs.
For more information on our offered trainings and courses, as well as their
locations and dates, refer to our web page:
www.siemens.com/sitrain
Service offer
Our range of services includes the following:
• Plant data services
• Spare parts services
• Repair services
• On-site and maintenance services
• Retrofitting and modernization services
• Service programs and contracts
You can find detailed information on our range of services in the service catalog
web page:
support.industry.siemens.com/cs/sc
Industry Online Support app

You will receive optimum support wherever you are with the "Siemens Industry
Online Support" app. The app is available for Apple iOS, Android and Windows
Phone:
support.industry.siemens.com/cs/ww/en/sc/2067
Fermentation
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6 Appendix
6.2 Links and literature

No. Topic
\1\ Siemens Industry Online Support
https://support.industry.siemens.com
\2\ Link to this entry page of this application example
\3\ Siemens Pharmaindustrie
https://new.siemens.com/global/en/markets/pharma-industry.html
\4\ SIMATIC PCS 7 in the pharmaceutical industry “Blood Plasma Fractionation” (demo
project)
\5\ SIMATIC PCS 7 in the pharmaceutical industry "Freeze Dryer" (demo project)
\6\ PCS 7 Unit Template "CIP - Cleaning in Place"
6.3 Change documentation

Version Date Modifications

V1.0 11/2015 First version
V2.0 08/2019 Update to PCS 7 V9.0 SP1, Integration of Smart Alarm
Hiding
Fermentation
Entry-ID: 109478439, V2.0, 08/2019 54

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SIMATIC PCS 7 in the

4.1.7 Hot steam cleaning (steaming) .......................................................... 35

1.2 Mode of operation

Implementation with SIMATIC PCS 7 and SIMATIC BATCH

multiproject in accordance with ISA-88 and consists of an AS project (user

1.3 Components used

This application example consists of the following components:

2 Preparation and commissioning

Preparing the project

12. Open by double-clicking the "OS project editor".

14. Exit the WinCC Explorer as described in step 10.

2.2 Tasks on the multiproject

3. Close the compiler log.

6. Ensure that all areas are selected and click on "Next".

7. Select the following settings and click "Next".

The "Settings" window opens.

12. In the "Distribution" tab, click "Update".

13. In the "OS objects" tab, click on "Update".

14. In the "Process cells" tab, click on "Update".

15. Click on "OK" to exit the "Settings" window.

16. Select the "BATCH types" item and click "Generate".

19. Select the "BATCH instances" item and click "Merge".

22. Select the "BIO_API_PLANT" item and click "Download".

25. Exit the SIMATIC BATCH configuration dialog with "OK".

Starting the simulation (S7-PLCSIM)

Activate OS (WinCC runtime)

2. Select "File > Activate" in the WinCC Explorer menu.

Activating SIMATIC BATCH

started. The "hourglass" changes to a "Play" symbol . The SIMATIC

6. Navigate to the storage location of the

The "Edit groups and users" window will open.

10. Click on the "List" button.

2.4 Description of the individual functions

The fermentation process is implemented by means of the following technical

Controlling the airflow rate

Overview of recipe control

2.5 Operation of the application

Creating and starting the SIMATIC BATCH batch

3. In the key area, click the "BATCH Control Center" button.

The SIMATIC BATCH Control Center opens.

4. Right-click "Orders" and select the "New" menu command

This opens the "Generate order category" window

You have now created and released a batch

15. Double-click the batch.

17. Confirm the dialog window that opens with "Yes".

Operation in WinCC Runtime

3. Change to SIMATIC BATCH Control Center.

4. Confirm the query using the "Apply > OK” pushbuttons.

3 Integrating the unit template in the user

3.2 Copying templates

1. Switch to the plant view.

3.3 Copying units

2. Copy the process screens "Fermenters" and "Fermenter_V342" from the OS

3.4 Adapting the OS project

4.1.1 Level control

4.1.2 Temperature control

4.1.3 pH value control

The pH of the medium in the fermenter is set at controlling of the pH value. To do

4.1.4 Controlling the airflow rate

4.1.5 Stirring (agitation)