Krka is a major supplier of pharmaceuticals and chemical products in Slovenia, and their final products are mainly mass-marketing drugs. In order to lay the foundation for competitiveness and future development, Krka decided to establish a new modern factory to produce solid medicines in the mid-1990s. The factory is named NotoL and consists of three connected buildings: the production building, the administrative reception center and the packaging building. In the production building, a new concept of production has been realized, and the production of semi-pigments (sugar-coated tablets and capsules) forms areas based on spatial isolation and climate segregation. The so-called “production island†is used together with the independent docking station, the internal transmission between the production islands, the vertical flow of raw materials and the injection of standard containers.
Determination of the plan
The huge production building has five floors. The clean rooms are on the second and fourth floors; the technical rooms are on the first, third and fifth floors, behind an independent production island. In this way, the separate materials required for various production stages can be provided by high-rise floors, and the production processes in different production islands can be submitted to the next floor of the island for the next transfer and processing. The interface between the production island and the technical room is achieved by the feeding and receiving of the docking station and provides a clean and safe way to exchange materials with the clean room. Therefore, these docking stations are a key part of the concept of cleaner production, which represents one of the most important innovations of the Notol plant. The transfer of all materials is done by the Automated Navigation Transfer Tool (AGV), which transmits the powder tablets in sealed units.
Because of the wide-ranging and demanding nature of the project, the company has appointed experts from various fields to form a project team to ensure that every NotoL goal can be achieved. The project team includes Krka employees and internationally renowned domestic and foreign companies with extensive experience in pharmaceutical engineering, logistics and production processes.
Most of the automation of the NOTOL plant was designed by Samo Somrak, Krka's electrical engineering and automation department. Together with the Krka project team, he started with a comprehensive requirements analysis, describing how the system and its individual components work, and describing the hierarchy of the entire system. And the task of each individual component. The main focus is on the new concept of automated material transfer and the use of docking stations to transport materials and items to each production island.
The Production Execution System (MES), together with the independent SCADA system and the entire logistics system, forms the key automation component of the NotoL plant.
The purpose of the MES system is to monitor the complex operation of internal transmission, weighing systems, particle dosing systems, turning machines, cleaning stations, weight verification and mobile in-place cleaning (CIP) devices. However, the integration of these two systems is based on the premise that the SCADA system can still work independently if the MES system is not available.
The main goal of the SCADA and control systems of each independent production island is to automate the in and out of the production island. It mainly includes the docking and unloading of packing and conveying materials between different locations. Other tasks include distribution, crystallization, filming, and the like. However, the actual production of different production islands is based on an independent SCADA system.
For the development of these SCADA systems and all HVAC systems, Krka selected GE Fanuc distributor and system integrator Metronik. GE Fanuc's iFIX HMI/SCADA products are used in all SCADA systems.
The following tasks are intuitive and SCADA systems based on dynamically changing the user interface is related specifically to lead the operator interface:
â—† Visualization of the status of the successor device;
â—† Step control (determined by the purpose of each independent production island);
â—† Local error handling;
â—† Establishment of MES system and PLC interface;
â—† Extend the relational database with data reporting.
The SCADA system covers the operator level and is responsible for operating docking stations, production machines, in-place cleaning (CIP) and in-situ drying (DIP) systems. The SCADA system also handles the physical execution of production, reporting, historical data, alarms, and events. Therefore, SCADA stations are the main system for most work events.
The main interface of the MES system is based on a database implementation. In this way, each command is forwarded to the SCADA system and the return information is sent back to the MES system. As a result, production is fully computer-assisted and an efficient multi-layer system integrates the automated subunits into the system's system monitoring, control and operation.
Production Process
The internal transmission mechanism is interrelated with various automatic production islands to process products from raw materials to finished products. The specific process is as follows:
The planning for mass production and finished product production is centrally planned for Krka commercial applications. Once the plan is confirmed, go to the factory to implement it. The planning director of the NOTOL plant checks all available resources and assigns manufacturing orders. After the batch is confirmed, the weighing process is initiated in the weighing compartment. The operator selects the production task through the MES system and orders the required raw materials and packing for weighing. The box is placed on the ground below the weighing compartment and parked in the docking station. There are two dust compartments in the weighing compartment, and the raw materials needed will be sent there. A special transfer handlebar in the technical room places the pallets of raw materials to be used in the dust compartment. After the dust removal is completed, the pallet is retracted into the weighing room by the manual trailer. After receiving the raw materials, the operator identifies the raw materials and then begins weighing. Weighing is controlled by the SCADA system to ensure accuracy and record results. After the batch is weighed, the loaded raw materials are packed out of the box and taken by the AGV to a fully automated homogenization system flipper. Once the homogenization is complete, the boxing can proceed to the next stage of production: granulation.
By using the MES, the operator can select the workload, order the packing with the ingredient mixture and the box for the sieved powder. The box containing the mixture is placed in the docking station on the granulated production island, and the empty box is placed on the floor below. When the drying operation is completed and the granulation operation is also completed, the dried granules are sieved into the box on the ground. After the addition of the tableting additive, the tableted mixture is completed. The box containing the mixture of tablets is placed in a docking station on a sheet-forming island, and the resulting tablets are taken into smaller tablets. The tableting process is performed by a high-performance tablet press computer equipped with automatic components for process control.
Batch packaging is carried out on an automated production line with a special control system to ensure the perfect quality of the finished product. The docking station that transfers large materials to the packaging line is completed by the AGV, and the AGV is also responsible for transferring the material to be packaged to the packaging line. After the packaging is completed, the AGV delivers the finished product to the distribution office of the finished product warehouse.
The production equipment is cleaned by an automatic cleaning station and CIP unit in a closed system. All used containers are cleaned in an automatic cleaning station. The AGV places the box on the conveyor belt in front of the washing station. The automatic cleaning stations that are sent in and out are fully automatic. The post-zui identification is carried out in the washing station and the cleaning recipe is obtained from the MES system via SCADA.
After cleaning, the box is dried in the station. The AGV sends the cleaned, dry, closed containers from the front of the house to the dedicated parking area for cleaning. When a production is over, the operator in a production island initiates the cleaning process. The mobile CIP component in the central CIP unit supply station is filled with water, washing liquid and pure water according to the prescription formula. The AGV brings the CIP components to the selected production island.
Docking stations and docking stations have different CIP units because of the different construction and docking methods. After the cleaning is completed, the AGV sends the CIP unit back to the replenishment station and brings the mobile DIP unit to the production island. After the drying is completed, the production island and the docking station are ready for the production of the next product.
The development of these mobile CIP and DIP units has taken a lot of effort and is unique in the pharmaceutical industry.
In addition to operating and controlling the production island, iFIX is also used in HVAC in the NotoL plant. Here, values ​​such as temperature, air pressure and humidity in 510 rooms are monitored by three iFIX SCADA servers.
The NOTOL factory was founded in 1998. * The stage is mainly the construction of 20 production islands and about 40 iFIX SCADA systems, which was completed in early 2002. It was put into production in May 2002. The NOTOL plant is still growing month after month, and Zui will eventually include 50 production islands and 80 iFIX SCADA systems. All of these SCADA systems are added to the existing Krka network. So, through this network, you can access a total of 2,500 computers and 200 iFIX SCADA servers, all over the Krka factory.
Different iFIX SCADA applications have different complexity due to different tasks at different production stations throughout the plant. The zui complex is the monitoring of the central CIP. The station is responsible for preparing the CIP medium, the "washing machine" for fully automatic cleaning and packing, and the replenishment of the mobile CIP unit in the "replenishment station". The AGV then transfers the mobile CIP unit to a different docking station where the CIP of the docking station takes place. After that, the docking station is dried by using a mobile DIP unit. Mobile CIP and DIP units come with their own systems, including containers, valves, heaters, sensors, and their own PLC controllers. These units are located in the docking station and are connected to the power supply, gas supply and local network, and are supplied by the battery during transportation. Therefore, the monitoring of all mobile CIP and DIP units is performed by the SCADA system in each station where the unit is currently located.
iFIX SCADA system features
The iFIX SCADA system that controls each production island is a major part of the functionality described in the previous production process. The iFIX features described next are important to meet the needs of implementing the TOP technology of the NotoL plant.
â—† iFIX's embedded Visual Basic for Applications (VBA) is used as a general-purpose scripting language for a variety of tasks. In addition to providing normal VBA user forms and controls, it also integrates the implementation of communication and support for tables and dynamometers or triggers and upload report data on the PLC into iFIX applications. Therefore, there is no need to attach external applications. It is particularly worth mentioning that VBA is very useful for supporting standard relational databases.
â—† iFIX scheduler, VBA and Microsoft ActiveX Data Objects (ADO) support is used to implement the interface between the MES system and the SCADA system. The scheduler runs in the background, which makes the user interface independent of the communication process of the MES system and the SCADA system in the background.
â—† The use of Windows security authentication is provided by iFIX, which is important for managing iFIX SCADA systems in a large network environment, such as the one Krka is using. Centralized security management for iFIX SCADA systems can be based on Windows security certification.
â—† Efficient iFIX network interconnection enables HVAC data to be displayed in SCADA systems in various production islands. Because of this feature, there is no need to install additional hardware to regulate the temperature, pressure and humidity specifications in the production room.
â—† The Recipe builder is used to store individual recipes in the PLC. This is important for the handling of CIP and DIP, as the MES system only provides the recipe number, but not the recipe itself, and the recipe is stored in the PLC.
â—† The use of node aliases allows Krka to save separate backups of individual images of each production island type. Pictures can be easily transferred to each station. At the same time, the changes made can be quickly adjusted and applied to each station. Moreover, in this way, the confirmation of each picture can be performed more conveniently.
â—† iFIX global objects have been used in the configuration of color threshold tables, node-wide variables, and common subroutines, simplifying project configuration.
The original plan was to use the built-in iFIX historian to store historical data from various applications. At the implementation stage of the NOTOL factory, the release of GE Fanuc's iHistorian product allowed us to change the strategy and it provided a more advanced storage variety. The way the data is. Now, an iHistorian server collects the entire plant data in a centralized archive, which cannot be implemented with a standard historical database. For this feature, especially the iHistorian Client/Server architecture, it is an important prerequisite for storing plant-wide data in a central archive and for publishing historical data for each analytical purpose of the entire plant.
The value of more than 3,200 tags is now recorded in an iHistorian archive, providing information about the various HVAC aspects of the plant, as well as various data on the production islands and docking stations and the equipment used. iHistorian has an efficient compression algorithm that requires only 10 to 15 MB of disk space per day to store all data. For collecting data from each SCASA server, an iFIX collector is required.
iHistorian's centralized data collection also allows for easy data recovery. The data stored in iHistorian can be observed directly in the iFIX trend chart. To achieve this function, simply switch the display of normal historical data to display iHistorian data during project implementation (such as initial planning of the project). In addition, special iHistorian add-ons designed for MS-Excel are used in the daily HVAC report and media consumption history. As a result, the raw data is converted into executable information, which is useful for the responsible staff of the factory.
running result
The NOTOL factory demonstrates the value of this new concept. In the first five months of Zui, we only added two tablet presses and 15 production islands on the existing basis, but produced more than 300 million drugs, which exceeded our expectations. The goals that have been achieved include:
â—† Increased productivity;
â—† Achieve greater production flexibility;
â—† Ensure a higher safety factor for products and employees in a closed production process system;
â—† Prevent cross-infection;
â—† Rationalize the warehouse capacity by optimizing the transmission using standard packing;
â—† Optimize the allocation of clean production areas and technical surfaces, thus rationalizing the cost of construction and maintenance;
â—† Automation of production and transportation processes.
Samo Somrak, Krka's electrical engineering and automation division, said: "The whole project is more like a research and development plan than a standard project. Today's results prove that we are on the right path."
Metronik's sales and marketing Sasa Sokolic added: "It is Krka's automation project team and their ability to choose a suitable automation solution and integration concept, together with the certified supplier, determine the success of the NotoL plant. We all We are proud that Metronik can contribute to the success of the NotoL plant by developing an iFIX SCADA application, iHistorian server and various reporting tools that we have developed so far."
Note: Proficy HMI/SCADA - iFIX and Proficy Historian (formerly iHistorian) are GE Fanuc Automation's Proficy Intelligent Production Management software components.
Determination of the plan
The huge production building has five floors. The clean rooms are on the second and fourth floors; the technical rooms are on the first, third and fifth floors, behind an independent production island. In this way, the separate materials required for various production stages can be provided by high-rise floors, and the production processes in different production islands can be submitted to the next floor of the island for the next transfer and processing. The interface between the production island and the technical room is achieved by the feeding and receiving of the docking station and provides a clean and safe way to exchange materials with the clean room. Therefore, these docking stations are a key part of the concept of cleaner production, which represents one of the most important innovations of the Notol plant. The transfer of all materials is done by the Automated Navigation Transfer Tool (AGV), which transmits the powder tablets in sealed units.
Because of the wide-ranging and demanding nature of the project, the company has appointed experts from various fields to form a project team to ensure that every NotoL goal can be achieved. The project team includes Krka employees and internationally renowned domestic and foreign companies with extensive experience in pharmaceutical engineering, logistics and production processes.
Most of the automation of the NOTOL plant was designed by Samo Somrak, Krka's electrical engineering and automation department. Together with the Krka project team, he started with a comprehensive requirements analysis, describing how the system and its individual components work, and describing the hierarchy of the entire system. And the task of each individual component. The main focus is on the new concept of automated material transfer and the use of docking stations to transport materials and items to each production island.
The Production Execution System (MES), together with the independent SCADA system and the entire logistics system, forms the key automation component of the NotoL plant.
The purpose of the MES system is to monitor the complex operation of internal transmission, weighing systems, particle dosing systems, turning machines, cleaning stations, weight verification and mobile in-place cleaning (CIP) devices. However, the integration of these two systems is based on the premise that the SCADA system can still work independently if the MES system is not available.
The main goal of the SCADA and control systems of each independent production island is to automate the in and out of the production island. It mainly includes the docking and unloading of packing and conveying materials between different locations. Other tasks include distribution, crystallization, filming, and the like. However, the actual production of different production islands is based on an independent SCADA system.
For the development of these SCADA systems and all HVAC systems, Krka selected GE Fanuc distributor and system integrator Metronik. GE Fanuc's iFIX HMI/SCADA products are used in all SCADA systems.
The following tasks are intuitive and SCADA systems based on dynamically changing the user interface is related specifically to lead the operator interface:
â—† Visualization of the status of the successor device;
â—† Step control (determined by the purpose of each independent production island);
â—† Local error handling;
â—† Establishment of MES system and PLC interface;
â—† Extend the relational database with data reporting.
The SCADA system covers the operator level and is responsible for operating docking stations, production machines, in-place cleaning (CIP) and in-situ drying (DIP) systems. The SCADA system also handles the physical execution of production, reporting, historical data, alarms, and events. Therefore, SCADA stations are the main system for most work events.
The main interface of the MES system is based on a database implementation. In this way, each command is forwarded to the SCADA system and the return information is sent back to the MES system. As a result, production is fully computer-assisted and an efficient multi-layer system integrates the automated subunits into the system's system monitoring, control and operation.
Production Process
The internal transmission mechanism is interrelated with various automatic production islands to process products from raw materials to finished products. The specific process is as follows:
The planning for mass production and finished product production is centrally planned for Krka commercial applications. Once the plan is confirmed, go to the factory to implement it. The planning director of the NOTOL plant checks all available resources and assigns manufacturing orders. After the batch is confirmed, the weighing process is initiated in the weighing compartment. The operator selects the production task through the MES system and orders the required raw materials and packing for weighing. The box is placed on the ground below the weighing compartment and parked in the docking station. There are two dust compartments in the weighing compartment, and the raw materials needed will be sent there. A special transfer handlebar in the technical room places the pallets of raw materials to be used in the dust compartment. After the dust removal is completed, the pallet is retracted into the weighing room by the manual trailer. After receiving the raw materials, the operator identifies the raw materials and then begins weighing. Weighing is controlled by the SCADA system to ensure accuracy and record results. After the batch is weighed, the loaded raw materials are packed out of the box and taken by the AGV to a fully automated homogenization system flipper. Once the homogenization is complete, the boxing can proceed to the next stage of production: granulation.
By using the MES, the operator can select the workload, order the packing with the ingredient mixture and the box for the sieved powder. The box containing the mixture is placed in the docking station on the granulated production island, and the empty box is placed on the floor below. When the drying operation is completed and the granulation operation is also completed, the dried granules are sieved into the box on the ground. After the addition of the tableting additive, the tableted mixture is completed. The box containing the mixture of tablets is placed in a docking station on a sheet-forming island, and the resulting tablets are taken into smaller tablets. The tableting process is performed by a high-performance tablet press computer equipped with automatic components for process control.
Batch packaging is carried out on an automated production line with a special control system to ensure the perfect quality of the finished product. The docking station that transfers large materials to the packaging line is completed by the AGV, and the AGV is also responsible for transferring the material to be packaged to the packaging line. After the packaging is completed, the AGV delivers the finished product to the distribution office of the finished product warehouse.
The production equipment is cleaned by an automatic cleaning station and CIP unit in a closed system. All used containers are cleaned in an automatic cleaning station. The AGV places the box on the conveyor belt in front of the washing station. The automatic cleaning stations that are sent in and out are fully automatic. The post-zui identification is carried out in the washing station and the cleaning recipe is obtained from the MES system via SCADA.
After cleaning, the box is dried in the station. The AGV sends the cleaned, dry, closed containers from the front of the house to the dedicated parking area for cleaning. When a production is over, the operator in a production island initiates the cleaning process. The mobile CIP component in the central CIP unit supply station is filled with water, washing liquid and pure water according to the prescription formula. The AGV brings the CIP components to the selected production island.
Docking stations and docking stations have different CIP units because of the different construction and docking methods. After the cleaning is completed, the AGV sends the CIP unit back to the replenishment station and brings the mobile DIP unit to the production island. After the drying is completed, the production island and the docking station are ready for the production of the next product.
The development of these mobile CIP and DIP units has taken a lot of effort and is unique in the pharmaceutical industry.
In addition to operating and controlling the production island, iFIX is also used in HVAC in the NotoL plant. Here, values ​​such as temperature, air pressure and humidity in 510 rooms are monitored by three iFIX SCADA servers.
The NOTOL factory was founded in 1998. * The stage is mainly the construction of 20 production islands and about 40 iFIX SCADA systems, which was completed in early 2002. It was put into production in May 2002. The NOTOL plant is still growing month after month, and Zui will eventually include 50 production islands and 80 iFIX SCADA systems. All of these SCADA systems are added to the existing Krka network. So, through this network, you can access a total of 2,500 computers and 200 iFIX SCADA servers, all over the Krka factory.
Different iFIX SCADA applications have different complexity due to different tasks at different production stations throughout the plant. The zui complex is the monitoring of the central CIP. The station is responsible for preparing the CIP medium, the "washing machine" for fully automatic cleaning and packing, and the replenishment of the mobile CIP unit in the "replenishment station". The AGV then transfers the mobile CIP unit to a different docking station where the CIP of the docking station takes place. After that, the docking station is dried by using a mobile DIP unit. Mobile CIP and DIP units come with their own systems, including containers, valves, heaters, sensors, and their own PLC controllers. These units are located in the docking station and are connected to the power supply, gas supply and local network, and are supplied by the battery during transportation. Therefore, the monitoring of all mobile CIP and DIP units is performed by the SCADA system in each station where the unit is currently located.
iFIX SCADA system features
The iFIX SCADA system that controls each production island is a major part of the functionality described in the previous production process. The iFIX features described next are important to meet the needs of implementing the TOP technology of the NotoL plant.
â—† iFIX's embedded Visual Basic for Applications (VBA) is used as a general-purpose scripting language for a variety of tasks. In addition to providing normal VBA user forms and controls, it also integrates the implementation of communication and support for tables and dynamometers or triggers and upload report data on the PLC into iFIX applications. Therefore, there is no need to attach external applications. It is particularly worth mentioning that VBA is very useful for supporting standard relational databases.
â—† iFIX scheduler, VBA and Microsoft ActiveX Data Objects (ADO) support is used to implement the interface between the MES system and the SCADA system. The scheduler runs in the background, which makes the user interface independent of the communication process of the MES system and the SCADA system in the background.
â—† The use of Windows security authentication is provided by iFIX, which is important for managing iFIX SCADA systems in a large network environment, such as the one Krka is using. Centralized security management for iFIX SCADA systems can be based on Windows security certification.
â—† Efficient iFIX network interconnection enables HVAC data to be displayed in SCADA systems in various production islands. Because of this feature, there is no need to install additional hardware to regulate the temperature, pressure and humidity specifications in the production room.
â—† The Recipe builder is used to store individual recipes in the PLC. This is important for the handling of CIP and DIP, as the MES system only provides the recipe number, but not the recipe itself, and the recipe is stored in the PLC.
â—† The use of node aliases allows Krka to save separate backups of individual images of each production island type. Pictures can be easily transferred to each station. At the same time, the changes made can be quickly adjusted and applied to each station. Moreover, in this way, the confirmation of each picture can be performed more conveniently.
â—† iFIX global objects have been used in the configuration of color threshold tables, node-wide variables, and common subroutines, simplifying project configuration.
The original plan was to use the built-in iFIX historian to store historical data from various applications. At the implementation stage of the NOTOL factory, the release of GE Fanuc's iHistorian product allowed us to change the strategy and it provided a more advanced storage variety. The way the data is. Now, an iHistorian server collects the entire plant data in a centralized archive, which cannot be implemented with a standard historical database. For this feature, especially the iHistorian Client/Server architecture, it is an important prerequisite for storing plant-wide data in a central archive and for publishing historical data for each analytical purpose of the entire plant.
The value of more than 3,200 tags is now recorded in an iHistorian archive, providing information about the various HVAC aspects of the plant, as well as various data on the production islands and docking stations and the equipment used. iHistorian has an efficient compression algorithm that requires only 10 to 15 MB of disk space per day to store all data. For collecting data from each SCASA server, an iFIX collector is required.
iHistorian's centralized data collection also allows for easy data recovery. The data stored in iHistorian can be observed directly in the iFIX trend chart. To achieve this function, simply switch the display of normal historical data to display iHistorian data during project implementation (such as initial planning of the project). In addition, special iHistorian add-ons designed for MS-Excel are used in the daily HVAC report and media consumption history. As a result, the raw data is converted into executable information, which is useful for the responsible staff of the factory.
running result
The NOTOL factory demonstrates the value of this new concept. In the first five months of Zui, we only added two tablet presses and 15 production islands on the existing basis, but produced more than 300 million drugs, which exceeded our expectations. The goals that have been achieved include:
â—† Increased productivity;
â—† Achieve greater production flexibility;
â—† Ensure a higher safety factor for products and employees in a closed production process system;
â—† Prevent cross-infection;
â—† Rationalize the warehouse capacity by optimizing the transmission using standard packing;
â—† Optimize the allocation of clean production areas and technical surfaces, thus rationalizing the cost of construction and maintenance;
â—† Automation of production and transportation processes.
Samo Somrak, Krka's electrical engineering and automation division, said: "The whole project is more like a research and development plan than a standard project. Today's results prove that we are on the right path."
Metronik's sales and marketing Sasa Sokolic added: "It is Krka's automation project team and their ability to choose a suitable automation solution and integration concept, together with the certified supplier, determine the success of the NotoL plant. We all We are proud that Metronik can contribute to the success of the NotoL plant by developing an iFIX SCADA application, iHistorian server and various reporting tools that we have developed so far."
Note: Proficy HMI/SCADA - iFIX and Proficy Historian (formerly iHistorian) are GE Fanuc Automation's Proficy Intelligent Production Management software components.
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