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https://support.industry.siemens.com/cs/ww/en/view/109480213 Application Example 12/2015 SIMATIC PCS 7 in the pharmaceutical industry "Freeze Dryer" (demo project) SIMATIC PCS 7, SIMATIC BATCH

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https://support.industry.siemens.com/cs/ww/en/view/109480213

Application Example 12/2015

SIMATIC PCS 7 in the

pharmaceutical industry

"Freeze Dryer" (demo project) SIMATIC PCS 7, SIMATIC BATCH

Warranty and liability

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Warranty and liability

Note The Application Examples are not binding and do not claim to be complete regarding the circuits shown, equipping and any eventuality. The Application Examples do not represent customer-specific solutions. They are only intended to provide support for typical applications. You are responsible for ensuring that the described products are used correctly. These Application Examples do not relieve you of the responsibility to use safe practices in application, installation, operation and maintenance. When using these Application Examples, you recognize that we cannot be made liable for any damage/claims beyond the liability clause described. We reserve the right to make changes to these Application Examples at any time without prior notice. If there are any deviations between the recommendations provided in these Application Examples and other Siemens publications – e.g. Catalogs – the contents of the other documents have priority.

We do not accept any liability for the information contained in this document.

Any claims against us – based on whatever legal reason – resulting from the use of the examples, information, programs, engineering and performance data etc., described in this Application Example shall be excluded. Such an exclusion shall not apply in the case of mandatory liability, e.g. under the German Product Liability Act (“Produkthaftungsgesetz”), in case of intent, gross negligence, or injury of life, body or health, guarantee for the quality of a product, fraudulent concealment of a deficiency or breach of a condition which goes to the root of the contract (“wesentliche Vertragspflichten”). The damages for a breach of a substantial contractual obligation are, however, limited to the foreseeable damage, typical for the type of contract, except in the event of intent or gross negligence or injury to life, body or health. The above provisions do not imply a change of the burden of proof to your detriment.

Any form of duplication or distribution of these Application Examples or excerpts hereof is prohibited without the expressed consent of the Siemens AG.

Security informa-tion

Siemens provides products and solutions with industrial security functions that support the secure operation of plants, solutions, machines, equipment and/or networks. They are important components in a holistic industrial security concept. With this in mind, Siemens’ products and solutions undergo continuous development. Siemens recommends strongly that you regularly check for product updates.

For the secure operation of Siemens products and solutions, it is necessary to take suitable preventive action (e.g. cell protection concept) and integrate each component into a holistic, state-of-the-art industrial security concept. Third-party products that may be in use should also be considered. For more information about industrial security, visit http://www.siemens.com/industrialsecurity.

To stay informed about product updates as they occur, sign up for a product-specific newsletter. For more information, visit http://support.industry.siemens.com.

Table of contents

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Table of contents Warranty and liability ................................................................................................... 2

1 Task and solution .............................................................................................. 4

1.1 Task ...................................................................................................... 4 1.2 Solution................................................................................................. 4 1.2.1 Freeze dryer ......................................................................................... 4 1.2.2 Overview of the complete solution ....................................................... 5 1.3 Description of the individual functions .................................................. 8 1.3.1 Process functions ................................................................................. 8 1.3.2 SIMATIC BATCH functions ................................................................ 11 1.3.3 User administration and log of changes (SIMATIC Logon) ................ 12 1.4 Components used .............................................................................. 12 1.4.1 Hardware and software components ................................................. 12 1.4.2 Example files and projects ................................................................. 13

2 Basics ............................................................................................................... 14

3 Structure and principle of operation ............................................................. 16

3.1 Project structure ................................................................................. 16 3.1.1 CFC chart naming convention ............................................................ 16 3.1.2 Technological view ............................................................................. 16 3.2 Equipment modules and control modules .......................................... 18 3.2.1 Cooling/heating circulation and condenser ........................................ 18 3.2.2 Hydraulics ........................................................................................... 19 3.2.3 Vacuum system .................................................................................. 20 3.2.4 Hygienic status ................................................................................... 20 3.3 EPH .................................................................................................... 21 3.4 SIMATIC BATCH recipe ..................................................................... 22

4 Starting the application ................................................................................... 24

4.1 Preparation ......................................................................................... 24 4.1.1 Preparations in Windows.................................................................... 24 4.1.2 Preparing the PCS 7 project .............................................................. 26 4.1.3 Preparations for SIMATIC BATCH ..................................................... 27 4.2 Commissioning ................................................................................... 32

5 Running the application .................................................................................. 36

6 Related literature ............................................................................................. 43

7 History............................................................................................................... 43

1 Task and solution

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1 Task and solution

1.1 Task

Freeze drying (lyophilization) is an important step in the production of many drugs and plays an increasingly important role in the life science industry.

It is a particularly gentle drying process which proceeds in several complex steps and has a significant impact on the quality of the end product. Therefore, to achieve a constant product quality, it is important to ensure that the necessary process conditions and parameter values are kept throughout the process.

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 system, 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.

1.2 Solution

1.2.1 Freeze dryer

Freeze drying is a process for gentle drying of high-quality products. During the drying process, moisture is removed from a product without affecting its biological, chemical or structural properties.

In this application example, SIMATIC PCS 7 and SIMATIC BATCH are used to depict and control the freeze drying process manage with the required high level of efficiency, quality, and performance.

This application example contains typical equipment modules for controlling a freeze dryer. It provides configuration templates for automation tasks, such as:

Controlling the temperature, the pressure and the vacuum

Controlling the hydraulics of the shelves in the freeze dryer

Condenser control

Cleaning the freeze dryer

In the application example, the sequence of the entire process is controlled via SIMATIC BATCH.

Implementation with SIMATIC PCS 7 and SIMATIC BATCH

The "Freeze dryer" application example is implemented as a SIMATIC PCS 7 multiproject in accordance with ISA-88.

The multiproject consists of an AS project (user program), an OS project (visualization with process images) and a SIMATIC BATCH system (recipes for controlling the freeze drying 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.

1 Task and solution

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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 equipment and control modules

1.2.2 Overview of the complete solution

Process picture of the general overview

The figure below shows the process picture of the application example:

The freeze drying plant comprises the following main components:

1. Drying chamber with temperature controlled shelves

2. Isolation valve, which connects the drying chamber to the cooling chamber

3. Cooling chamber with condenser

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The freeze drying process is carried out with the following technical devices:

4. Pressure control

5. Temperature control of the shelves in the drying chamber

6. Hydraulics control

7. Control of the refrigeration compressor

8. Control of the refrigerant (e.g. nitrogen) and compressed air throughput

9. Warm air throughput control

10. Vacuum system control

11. Cleaning function (CIP = cleaning in place) by means of hot steam control

12. Overview of recipe control by SFCs

The process comprises the following steps:

Loading the drying chamber and freezing the product

Predefined conditions, such as temperature and pressure, must be fulfilled before loading the drying chamber (1). If the conditions are fulfilled, the drying chamber can be loaded. The chamber door is then locked manually or automatically. The locking state is checked in the course of the recipe preparation.

After loading and locking the drying chamber, the shelves on which the product is located are cooled down (5) and the product is deep-frozen under standard pressure.

The temperature of the cooling chamber (3) is lowered to around -70 °C and the vacuum system is switched on. In the next step, the isolation valve (2) is opened.

1 Task and solution

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Primary drying and secondary drying

During primary drying, the deep-frozen product is supplied with heat from shelves (5) and negative pressure is created by the vacuum system (10) of the plant. The water molecules in the frozen product transform directly from a solid to a gaseous state without liquefying (sublimation).

During the drying process, the product releases water vapor and heat. The released water vapor precipitates as ice on the coils of the condenser (3) and is removed by it. The emitted heat is compensated by the temperature of the shelves (5) in the drying chamber.

The drying end of a phase is checked by measuring the pressure increase with SIMATIC Batch.

If the product is not dried completely, the pressure in the drying chamber increases due to the high water vapor content. On the other hand, when a product is completely dry, the increase in pressure is extremely low.

After primary drying, the agent still contains bound water, which can limit its lifespan or quality. In the secondary drying phase, the remaining moisture is removed from the product.

Venting the drying chamber and unloading the product

If the product is completely dry, the hydraulic system (6) is switched on and the product is sealed by the shelves.

The drying chamber is flooded with nitrogen or another inert gas to protect the product from oxidation. This neutralizes the vacuum and normalizes the pressure.

The product can then be removed.

1 Task and solution

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Defrosting the condenser

The condenser is defrosted under standard pressure and by the supply of hot steam (9).

When defrosting, the isolation valve is closed and the resulting condensed water is discharged through a separate line.

Cleaning the plant

After the plant defrosts, it can be cleaned on site by CIP and SIP procedures.

The current status of the freeze dryer can be checked from the hygienic block.

1.3 Description of the individual functions

1.3.1 Process functions

Cooling/heating circulation

The drying of the product takes place in temperature controlled shelves of the freeze drying plant. Depending on the phase of the freeze drying (Freezing or drying), the shelves are either cooled or heated accordingly.

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Cooler with condenser

The condenser consists of cooling coils and is cooled by means of a refrigerant at low temperatures (e.g. -70 °C). During the drying phase, the water vapor released by the agent moves to the colder condenser area and precipitates on its wall as ice.

After freeze drying, the condenser is defrosted by a supply of hot steam.

Vacuum system

After deep freezing the product, a negative pressure is generated in the freeze drying plant by the vacuum system. The vacuum is a prerequisite for the sublimation process.

1 Task and solution

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Hydraulic system

The shelves of the freeze drying plant are positioned by the hydraulic system. For instance, the shelves are moved together for sealing the product or moved to the appropriate position when loading or unloading the drying chamber.

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1.3.2 SIMATIC BATCH functions

The process operation is controlled in the application by the recipes of SIMATIC BATCH.

SIMATIC BATCH recipe

Recipe "FreezeDryer.sbb" is available with this application example:

1 Task and solution

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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, process values and setpoints as well as signature data. This process considers the data up to the latest completed recipe phase.

1.3.3 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.

1.4 Components used

1.4.1 Hardware and software components

Hardware components

The application example was drawn up and described on the basis of the following hardware components:

Component Note

SIMATIC PCS 7 ES/OS IPC547E For the PCS 7 V8.1 example project

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 file of the PCS 7.

Software components

The application example was drawn up and described on the basis of the following software components:

Component Note

SIMATIC PCS 7 V8.1 Part of SIMATIC PCS 7 ES/OS IPC547D W7

S7 PLCSIM Not part of PCS 7; appropriate licenses are required.

APL library V8.1 Part of SIMATIC PCS 7 V8.1

SIMATIC BATCH V8.1 Not part of PCS 7; appropriate licenses are required.

SIMATIC LOGON Part of SIMATIC PCS 7

1 Task and solution

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Note The PCS 7 example project is based on the PCS 7 Industry Library (IL) and the PCS 7 Advanced Process Library (APL). Whereas the APL is covered by the SIMATIC PCS 7 Engineering license, you must obtain a separate Engineering license and Runtime licenses for IL.

The download includes blocks that require a license. The usage of these blocks in your configuration environment or in the process mode obligates you to purchase the PCS 7 Industry Library licenses.

Ordering information can found under the following Entry ID: 104206371.

1.4.2 Example files and projects

The files that are listed in the table below are available with this application example:

File/project Note

109480213_FreezeDryer_DOC_PCS7_V81_en.pdf This document

109480213_FreezeDryer_PROJECT_PCS7_V81.zip PCS 7 V8.1 example project incl. batch recipe (FreezeDryer.sbb)

2 Basics

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2 Basics

ISA-88

The application example is configured in accordance with the ISA-88 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 describes the structure of the ISA-88 standard.

Note You will find detailed information on ISA-88.01 in the manual entitled "SIMATIC Process Control System PCS 7 SIMATIC BATCH V8.1", 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/103173731.

2 Basics

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Unit

The term Unit represents a "unit" in process engineering plants (e.g. stirred tank reactor, fermenter) which includes the device, sensor technology, actuators and automation (hardware and software).

Structured units exist for both continuous as well as discontinuous processes.

Package units are variants 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 a separate hardware. The package unit is integrated as a whole 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). Technical functions are designed and configured for use in concrete applications, such as process technology (dosing device, level or temperature control).

The automation solution of a technical function is structured as follows:

Connected and configured measuring points

Simulation to demonstrate the mode of operation

Each technical function 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.

3 Structure and principle of operation

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3 Structure and principle of operation

3.1 Project structure

3.1.1 CFC chart naming convention

The following naming convention has been used to name the measuring points.

VxxFDxxT11111

Function

T = Temperature

Name/identificationUnit

Function Meaning

E / N Motor with a fixed speed

F Flow display

L Binary switch level

N Motor

P Analog and digital pressure measurement/monitoring

T Analog and digital temperature measurement/monitoring

Y Opening and closing valve

X Monitoring signal (chamber door, fuse, etc.)

3.1.2 Technological view

The technological hierarchy of the "Freeze dryer" application example is configured in accordance with ISA-88.

AS Project

In the AS project "Freeze_Dryer_Prj", the first technological hierarchy level "BIO_API_PLANT" is defined as a plant and includes the following unit and equipment modules.

Unit Equipment module Function

Freeze_Dryer (V115)

Heat transfer Temperature control of the shelves in the drying chamber

Hydraulics Hydraulic control of the shelves

HYG_STATE Hygienic status monitoring of the freeze dryer

Vacuum Vacuum system control

3 Structure and principle of operation

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OS project

The plant hierarchy in the OS project 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 Production

- Bio_API_Production.pdl Overview of the process stages in the manufacture of biological agents (Bio API)

Freeze_Dryer - V115FD01.pdl Overview picture of the freeze drying plant

Heat transfer V115FD01Heattransfer.pdl Process picture of the system for controlling the temperature of the shelves

Hydraulics V115FD01Hydraulic.pdl Process picture of the hydraulic system controller

Vacuum V115FD01Vacuum.pdl Process picture of the vacuum system controller

Presentation - Presentation Overview of different scenarios for BioAPI production

Process Analysis

ProcessAnalysis.pdl

Scenario A ScenarioA.pdl

Scenario B1 ScenarioB1.pdl

Scenario B2 ScenarioB2.pdl

Help - Help Explanation of the block icons, faceplates and graphic representations that are used

Help_Static Help_Static.pdl

Help_Dynamic_ Sensors

Help_Dynamic_ Sensors.pdl

Help_Dynamic _Actors

Help_Dynamic _Actors.pdl

3 Structure and principle of operation

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3.2 Equipment modules and control modules

The “Freeze dryer" application example is made up of various equipment modules and control modules. In the PCS 7 project, 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.

In the following chapters you will find information on the structure of the individual equipment modules. You will also find an overview of the EPH (Equipment phases) used.

3.2.1 Cooling/heating circulation and condenser

The heating or cooling capacity of the shelves is ensured by a heating medium pump, a heat exchanger and four refrigeration compressors.

The redundantly connected pump circulates the heat transfer medium. The shelves are warmed up by medium that is passed through a heat exchanger, heated by steam. To cool the shelves, the refrigerant of the condenser is diverted and passed through a valve into the circuit of the shelves.

The condenser consists of four refrigeration compressors, through which a refrigerant flows.

Structure

All necessary charts are available in the "Heat transfer" folder of the unit.

The following table contains the control modules for temperature control and regulation.

Designation Description

V115DO1Exxx Motors for heating or cooling

V115DO1Nxxx Motors for pumping the conducting fluid and for the compressor

V115DO1Pxxx Pressure measurement on the compressor and management of the conducting fluid

V115DO1Txxx Temperature monitoring with alarm generation of the heating/cooling circuit and the condenser

V115DO1Yxxx Opening and closing valves to the condenser

Note The "xxxx_LOGIC" charts are required for the connection of the simulation to the automation program.

3 Structure and principle of operation

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3.2.2 Hydraulics

The hydraulic system provides for the double-sided contact of the metal plates with the product to ensure rapid dissipation of heat.

Structure

All necessary charts are in the "Hydraulic" folder of the unit.

The following table contains the control modules of the hydraulic control system.

Designation Description

V115DO1N010 Motor that pumps the hydraulic fluid to extend or retract the piston

V115DO1Y032 Opening and closing valve of the hydraulic circuit

Note The "xxxx_LOGIC" charts are required for the connection of the simulation to the automation program.

3 Structure and principle of operation

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3.2.3 Vacuum system

The control of the vacuum is provided by an analog needle valve and/or a vacuum valve. There are two options:

Control via vacuum valve: The vacuum valve opens depending on the difference between the process value and the setpoint. In this case, the needle valve is permanently closed.

Control via needle valve: The needle valve opens depending on the difference between the process value and the setpoint. In this case, the vacuum valve is permanently open.

Control via the vacuum valve and needle valve: The vacuum valve and the needle valve open depending on the difference between the process value and the setpoint.

Structure

All necessary charts are in the "Vacuum" folder of the unit.

The following table contains the control modules of the vacuum system.

Designation Description

V115DO1Nxxx Motors for drawing or compressing the contents of the condenser. Sealing gas is also drawn to protect the pumps.

V115DO1Pxxx Pressure monitoring with alarm generation in the water piping and compressor

V115DO1Txxx Temperature monitoring with motor alarm generation

V115DO1Yxxx Opening and closing valve to the condenser discharge.

Note The "xxxx_LOGIC" charts are required for the connection of the simulation to the automation program.

3.2.4 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 "CM" subfolder contains the chart with the block to determine the hygienic status by means of defined figures.

3 Structure and principle of operation

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3.3 EPH

The freeze drying system has been designed for batch operation. Within the unit, there are various EPH instances that have different tasks. The EPH describes the equipment module according to ISA-88. These will be described in the following sections.

The following table summarizes the EPH instances used:

SFC type name Function

EPHTempPlates Control of the shelf temperature

EPHCoolCondenser Condenser control

EPHIsolatorValve Isolator valve control

EPHDryerPressure Pressure control

EPHStoppering Hydraulic control/sealing

EPHVacuumsystem Vacuum system control

EPHVacuumLRPump Vacuum pump control

EPHSteam Defrosting and sterilization by hot steam

EPHDrainClean Condensate drain and cleaning function

3 Structure and principle of operation

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3.4 SIMATIC BATCH recipe

SIMATIC BATCH is used for discontinuous production. With the aid of SIMATIC BATCH, various products can be produced in one plant. 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 measured values, 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 units.

"FreezeDryer" recipe

The figure below shows a part of the SIMATIC BATCH recipe that is available with this application example.

Among other things, the recipe contains the following information:

Controlling the temperature of the shelves

Temperature and pressure in the drying chamber

Pressure rise tests and drying time

3 Structure and principle of operation

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Batches

The batches are created as a job in SIMATIC BATCH. When you create the batch, the recipe to be executed is set.

Note You can create, for instance, an additional recipe to clean the plant and run it after freeze drying. For further information, refer to the application example "PCS 7 Unit Template "CIP - Cleaning in Place"”. You will find this example at the following link: https://support.industry.siemens.com/cs/ww/en/view/78463886.

4 Starting the application

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4 Starting the application

4.1 Preparation

4.1.1 Preparations in Windows

With SIMATIC Logon, you can set access rights for PCS 7 projects and their operation, and keep a log of changes.

1. Log into the configuring PC with administrator privileges.

2. Click on "Start".

3. Right click on "Computer" and select the command "Manage". The "Computer Management" dialog opens.

4. Click on "Local Users and Groups > Users", and double-click the username you are currently logged in with. The "Properties..." dialog opens.

5. Switch to the "Member of" tab and check whether the user is a member of the listed groups:

If you are missing membership in a particular group, set it up.

6. Right click on "Local Users and Groups > Users" and select the menu command "New user".

7. Create the following users:

– Engineer

– Operator

– ShiftManager

8. Right click on "Local user group and Groups > Groups" and select the menu command "New group".

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9. Create the following user groups and assign appropriate users to them:

Table 4-1

User User group

Engineer Engineers

Operator Operators

ShiftManager Shift Managers

Currently registered users with administrator privileges

Logon_Administrator

Note For further related information, please refer to the manual "SIMATIC Logon". You will find this manual at the following link: https://support.industry.siemens.com/cs/ww/en/view/34519648.

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4.1.2 Preparing the PCS 7 project

1. Copy file “109480676_FreezeDryer_PROJECT_PCS7_V81” to a folder of your choice on the configuring PC and extract the contained files.

2. Open the SIMATIC Manager.

3. Click on "File > Retrieve" in the menu bar and select the file "FreezeDryer_PROJECT_PCS7_V81.zip". Then confirm with "Open".

4. Select the folder in which the project should be saved and confirm by pressing "OK". The project is retrieved. Once this is done, click "Yes" in the dialog to open the project.

5. Right click on "Freeze_Dryer_MP > Freeze_Dryer_Prj > ESV81 > WinCC Appl. > OS" and select the menu command "Open object". WinCC Explorer opens.

6. Confirm the "Configured server not available" dialog with "OK".

7. In the WinCC Explorer, open the properties of your PC and, in the opened Properties dialog, click on the "Use local computer name" button.

8. Confirm the "Change computer name" message with "OK".

9. In the WinCC Explorer, click on "File > Exit" and in the subsequent dialog select "Terminate WinCC Explorer and close project".

10. Then confirm with "OK".

11. Open the WinCC Explorer.

12. Double-click on "tag management" to open it.

13. In the "WinCC Configuration Studio", right-click on "Tag management > SIMATIC S7 Protocol Suite > Industrial Ethernet" and select the menu command "System parameters".

14. In the "Unit" tab, check the "Logical device names" setting. If the "S7 PLCSIM" program is used, the device name PLCSIM(ISO) is selected. If the device name is changed, the program must be restarted.

15. Restart the WinCC Explorer.

Note If the OS cannot establish a connection with the AS (grayed out faceplates), select the logical device name "CP_H1_1:" and restart the OS.

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4.1.3 Preparations for SIMATIC BATCH

1. Change to SIMATIC Manager.

2. Right-click on the "Freeze_Dryer_MP" multiproject and select "SIMATIC BATCH > Compile/Download" in the shortcut menu. The "Settings" dialog opens.

3. Compile and download the batch files with the "OK" button.

4. Right-click on the "Freeze_Dryer_MP" multiproject and select "SIMATIC BATCH > Open configuration dialog" in the shortcut menu. The SIMATIC BATCH configuration dialog opens.

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5. In the SIMATIC BATCH dialog, select the "Freeze_Dryer_MP" multiproject and click on "Settings" in the right pane.

The "Settings" dialog opens.

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6. In the "Distribution" tab, click on "Update".

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

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

9. Exit the "Settings" dialog with "OK".

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10. Select "BATCH types", click on "Generate" followed by "Start".

11. Wait until the process is complete and exit the dialog with the "Close" button.

12. Click on "Propagate" and then on "Start".

13. Wait until the process is complete and exit the dialog with the "Close" button.

14. Select the "BATCH instances" item and click on "Merge" and then on "Start".

15. Select the "CCPharmaPlant" item and click on "Transfer messages". Confirm the "Transfer messages to OS" dialog with "Yes".

16. Select the "CCPharmaPlant" item and click on "Download".

17. Click on "Start" and then on “Close".

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

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Changing the startup type of the SIMATIC BATCH server

In the windows task bar, right-click on the icon "SIMATIC BATCH Launch Coordinator" and select the menu command "Change start mode from > Automatic to Manual".

Note The SIMATIC BATCH Launch Coordinator starts automatically when the PC is switched on. If SIMATIC BATCH does not start, proceed as follows:

Click on "Start > All programs > Siemens Automation > SIMATIC > BATCH Launch Coordinator".

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4.2 Commissioning

The following instructions describe how the application is initialized.

For commissioning, it is required that SIMATIC Manager is already open and that the project has been selected in the component view.

Starting the simulation (S7 PLCSIM)

To start the simulation, proceed according to the following instructions:

1. Open S7 PLCSIM.

2. Click on "Simulation > Open target system" in the menu bar.

3. Select the file "FreezeDryer.plc" from the path "<Project path>\FreezeDr\FDRY_AS\FreezeDryer.plc". Simulation is started.

Activate OS (WinCC runtime)

To activate the OS, proceed as follows:

1. Right click on "Freeze_Dryer_MP > Freeze_Dryer_Prj > ESV81 > WinCC Application > OS(1)" and click the menu command "Open object".

2. To activate the OS (WinCC Runtime), select "File > Activate" in the WinCC Explorer menu.

3. Log into the SIMATIC Logon with administrator privileges.

4. In the screen area, select the process picture "Freeze_Dryer".

Note The plant is already located in the production process because the AS program execution (PLCSIM) has already started.

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Starting the SIMATIC BATCH Runtime

Right-click on the icon for the SIMATIC BATCH Launch Coordinator and select the "BATCH Runtime > Start" menu command to start SIMATIC BATCH Runtime.

You can recognize the state of the SIMATIC BATCH server from the following symbols:

Table 4-2

Symbol Symbol play

The SIMATIC BATCH Server is in the "Stop" state.

The SIMATIC BATCH Server is starting.

The SIMATIC BATCH Server is in the "Run" state.

Opening the SIMATIC BATCH recipe

1. Click on "Start > All programs > Siemens Automation > SIMATIC > SIMATIC BATCH Control Center". The BATCH Control Center opens.

2. Log into the SIMATIC Logon with administrator privileges.

3. Click on the "Extras" menu item and select the "Restore" menu command. The Restore dialog opens.

4. Navigate to the storage location of the “FreezeDryer.sbb" recipe file and select it. Click "Open".

Setting up user rights and roles in SIMATIC BATCH

1. Go to "Options" and click on "Roles management".

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2. Right click on "Superuser > Groups and users" and select the "Edit" command in the shortcut menu.

3. Assign the currently logged in user to the "Superuser" group and confirm with "OK".

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4. Right click on "Automation engineer > Groups and users" and select the "Edit" command in the shortcut menu.

5. Assign the "Automation engineer" group to the "Engineers" group and confirm with "OK".

6. Right click on "Operator > Groups and users" and select the "Edit" command in the shortcut menu.

7. Assign the "Operator" group to the "Operator" group and confirm with "OK".

8. Right click on "Shift Manager > Groups and users" and select the "Edit" command in the shortcut menu.

9. Assign the "Shift Manager" group to the "Shift Manager" group and confirm with "OK".

10. In the "SIMATIC Logon Role Management" window, click on "File > Save".

11. In the "SIMATIC Logon Role Management" window, click on "File > Exit".

Updating the plant

1. Right-click the "CCPharmaPlant" icon and select the "Update the plant" menu command.

2. Confirm the "Update the plant" dialog with "OK".

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5 Running the application The following section describes how to run a SIMATIC BATCH recipe and use it to control the freeze drying process. Here, operation is carried out from the SIMATIC BATCH Control Center.

Overview of the recipe control

All the equipment phases of the unit are displayed in the right-hand pane. The status display of the active equipment phase is shown in green. You can change the operating mode from the "EPH Automatic" button.

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Simulation

To open the simulation dialog you can click on the "SIM" button, in the right-hand pane:

Otherwise you can also switch to the "Simulation" process picture.

Requirements

The following points are a prerequisite:

WinCC Runtime is active.

The included file "FreezeDryer.plc" is active in the S7 PLCSIM.

The SIMATIC BATCH server is in the "Run" state.

The included file “FreezeDryer.sbb" has been loaded in SIMATIC BATCH.

The user rights are set up in SIMATIC BATCH.

Creating and starting the SIMATIC BATCH

1. In WinCC Runtime, click the "Change keyset" button, followed by the "BATCH Control Center" button.

The SIMATIC BATCH Control Center opens.

2. Right click on "Jobs" (CCPharmaPlant > Jobs) and select the "New" command in the shortcut menu. The "Create job category" dialog opens.

3. Enter a category name and click the "OK" button.

4. Right-click the created category and select the "New" entry in the shortcut menu. The "Create job" window opens.

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5. Enter a name for the job in the "General" tab.

6. Switch to the "Batches" tab.

7. Click the "New" button. The "Formula or master recipe selection" window opens.

8. Double-click the "FD_ParaSet3_Neu V01.00" master recipe.

In the "Create job" window, enter a meaningful name for the batch and click the "OK" button to accept the batch. The job with a batch is created.

9. Right click on the created batch and select the "Enable" command in the shortcut menu.

10. Confirm the prompt in the subsequent dialog by clicking the "Yes" button.

11. Double-click on the batch.

12. The control recipe is displayed.

13. Right click on the batch and select the "Start" command in the shortcut menu.

14. Confirm the prompt in the subsequent dialog by clicking the "Yes" button. The batch starts. SIMATIC BATCH occupies the plant sections and starts the SFC functions. All the control strategies are completed one after the other.

Operation in WinCC Runtime

1. Switch to the "Freeze_Dryer" process picture in WinCC Runtime and observe how the individual components are controlled.

2. The system displays a prompt on the status display of the V115 unit. To open the status display, double-click on the corresponding symbol.

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3. Change to SIMATIC BATCH Control Center. The instruction or action request appears.

4. Switch to the "FreezeDryer" process picture and open the simulation dialog.

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5. Set all the three door controls to "1".

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The display in the process picture changes by the simulated closing of the doors.

6. Confirm the query in the SIMATIC BATCH Control Center from the "Change > OK" buttons. The system resumes executing the recipe.

7. Once freeze drying is complete, the operator prompt for discharging the drying chamber is shown.

8. Open the simulation dialog and set the door controls to "0" (see step 4-5). The display in the process picture changes accordingly.

9. Switch to SIMATIC BATCH Center and confirm the query with the "Apply > OK" buttons. The system resumes executing the recipe.

10. The batch is fully executed and then terminated. The SFCs that were started are terminated and reset to the "IDLE" state by SIMATIC BATCH.

6 Related literature

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6 Related literature Table 6-1

Topic Title

\1\ Siemens Industry Online Support http://support.industry.siemens.com

\2\ Download page of this entry https://support.industry.siemens.com/cs/ww/en/view/109480213

\3\ Siemens Pharmaceutical Industry http://www.industry.siemens.com/verticals/global/en/pharma-industries/Pages/pharmaceutical-industry.aspx

\4\ SIMATIC PCS 7 in the pharmaceutical industry "Blood Plasma Fractionation" (demo project)

https://support.industry.siemens.com/cs/ww/en/view/109475708

\5\ SIMATIC PCS 7 in the pharmaceutical industry "Fermentation" (demo project)

https://support.industry.siemens.com/cs/ww/en/view/109478439

7 History

Table 7-1

Version Date Modification

V1.0 12/2015 First edition