Firm foundation for pharmaceutical plant

Krka's new Notol pharmaceutical plant uses GE Fanuc iFIX Scada systems and iHistorian for data collection and reporting.

Founded in 1954, Krka is a major pharmaceutical and chemical products supplier based in Novo Mesto, carrying out production in accordance with international standards initiated by the European Union and the United States Food and Drug Administration (FDA).

The company's primary end product is generic drugs for human consumption but it also produces veterinary and cosmetic products.

To build the basis for competitiveness and future expansions, Krka decided in the mid 1990s to build a modern plant, called the Notol Plant, for the production of solid dosage forms.

For the development of these Scada systems, as well as the development of all the HVAC systems, Krka selected the Slovenian GE Fanuc distributor and systems integrator Metronik.

Notol uses GE Fanuc iFIX Scada systems and iHistorian for data collection and reporting.

The Notol plant consists of three interconnected buildings: a production building, an administrative-reception centre and a packaging building.

Within the production building, a completely new concept for the production of semi-finished tablets, coated tablets and capsules has been implemented based on spatially and climatically separated areas.

The so-called "production islands" are used together with individual docking stations, an automated internal transport between production islands, a vertical flow of material and the introduction of standard containers.

The production building has five floors.

Individual materials required for the various production phases can be provided from the upper floor, and the production process in the different production islands can be sent to the floor below for further transportation and processing.

The interface between the production islands and the technical rooms is implemented by feeding and receiving docking stations, offering a clean and secure way to exchange material with the clean rooms.

These docking stations represent one of the most important innovations of the Notol plant.

The transportation of all material is done through automated guided vehicles (AGVs), which transport the materials in bins.

The manufacturing execution system (MES), together with the individual Scada systems and the complete logistic system, are the key automation components of the Notol plant.

The purpose of the MES system is to supervise the intricacies of internal transports, weighing systems, dosing systems for granulation, tumbler, washing stations, weigh checks and mobile cleaning in place (CIP) units.

However, the integration of both systems is done in such a way that the Scada systems can also work independently in case the MES system becomes unavailable.

The main purpose of the Scada and control systems of the individual production islands is to automate the material transfer into and out of the individual production islands.

Additional tasks also include dispensing, granulation, tableting etc.

Based on an intuitive and dynamically changing user interface, the Scada systems provide visualisation of equipment status, control of procedures, local error handling, interfaces to the MES and the controller.

The Scada systems are responsible for handling docking stations, production machines, CIP and DIP systems.

They also deal with the physical execution of production, reports, historical data, alarming and events.

Therefore, Scada stations are the main system for the majority of work issues.

The primary interface to the MES system is via a database.

In this way, individual orders are forwarded to the Scada systems and information is sent back to the MES system.

Thus, the production is fully computer-assisted, with an efficient multilevel system that integrates the automated subunits into the system supervision, control and running of the plant.

The internal transport mechanism interlinks the various automated production islands, taking the product from raw material to finished goods in AGVs.

The planning of the production of bulk and finished goods is done centrally.

After separate plans are confirmed, they are transferred to the plants.

The planner in the Notol plant checks all the available resources and releases individual manufacturing orders to be carried out.

The operator selects the manufacturing order via the MES system.

Weighing is controlled by the Scada system, ensuring accuracy and registering the results.

After fully automated homogenisation, the material in its container is ready for the next production phases: granulation and tableting.

The final version of the Notol plant will eventually consist of 50 production islands and a total of about 80 iFIX Scada systems.

The implemented iFIX Scada systems controlling the various production islands are a major part of the functionality of the production process.

The most complex iFIX Scada application is the supervision of the central CIP station which is responsible for preparing the CIP media and the refilling of the mobile CIP units.

Mobile CIP and DIP units are self-contained systems, including vessels, valves, heaters, sensors etc, as well as their own controller.

They are connected to a power supply, air supply and the local network while sitting on the docking stations and are battery operated while in transport.

Thus all supervision of the mobile CIP and DIP units is delegated to the Scada system of the individual station, where the unit is currently located.

Besides using iFIX for operating and controlling the production islands, iFIX is also used for HVAC purposes.

Values such as temperature, pressure, and humidity in 510 rooms are monitored using three iFIX Scada servers.

The following iFIX features have been essential to realise the cutting edge technology of the NOTOL plant.

iFIX's embedded Visual Basic for Applications (VBA) provides a common scripting language for a wide variety of tasks.

Functionalities such as the implementation of communication drivers, or triggering and uploading report data from the controller, are integrated within the iFIX application.

The VBA support of standard relational database interfaces proved very useful.

Data Objects (ADO) support is used for implementing an interface between the MES system and the Scada systems.

The Scheduler is executed in the background, which makes the user interface independent from the communication process between the MES system and the Scada system.

Windows security and authentication provided by iFIX is essential, providing centralised security and authentication.

Efficient iFIX networking enables HVAC data to be presented to the Scada systems of the various production islands.

This avoided a need to install additional hardware for temperature, pressure and humidity indicators inside the production rooms.

Recipe builder is used for storing individual recipes in the controllers.

The use of alias node names required only a single copy of the individual pictures for the various production island types.

Modifications can be quickly adjusted and applied to different stations.

iFIX global objects have been used for the centralised configuration of colour threshold tables, node-wide variables and general subroutines, which simplified the deployment of the projects.

The implementation of GE Fanuc iHistorian enables just one server to be used to collect data throughout the complete plant in one archive, and to distribute the historical information for individual analysis purposes throughout the plant.

For data collection from the individual Scada servers, iFIX collectors are used.

Data stored in iHistorian can be viewed directly in iFIX trend charts.

Special iHistorian add-ins for MS-Excel are used for daily HVAC reports and media consumption history.

As a result, raw data is translated into actionable information, which is useful for the responsible plant staff.

While production and transport systems have been automated, other goals achieved include increased production capabilities, greater production flexibility and a high level of protection and safety of products and staff.

Also cross-contamination has been prevented.

Transport and warehousing systems have been optimised, as has the relationship between clean production areas and technical surfaces.

Samo Somrak, the Krka Department Manager responsible for Electrical Engineering and Automation recalled the implementation of the Notol plant: "The complete project has been more a research and development scheme rather than a standard project".

"Today, the results prove that we have taken the right steps".

"With the Notol plant, we have made a major step forward towards our future production".

And Sasa Sokolic, Sales and Marketing Manager of Metronik added: "Along with recognised suppliers, it was Krka's automation project team and their ability to choose appropriate automation solutions and integration concepts that were a key for the success of the Notol project".

"We are proud that Metronik could contribute to the success of the Notol plant by developing and integrating one of our most sophisticated iFIX Scada applications so far, as well as the iHistorian server and various reporting tools".

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