Pharma technology that makes the difference

12 July 2017

Industry 4.0:  a technology-centered company with a prestigious position on international markets thanks to the know-how acquired through the development of automation technology in-house

By Nicoletta Buora, Notiziario Chimico Farmaceutico (NCF), June 2017



Fedegari‘s adventure begins over 60 years ago in Pavia with the handicraft production of carpentry artifacts. Today, the company, led by the second generation, is a hi-tech company that exports bio-pharmaceutical sterilization machines and plants worldwide with products ranging from small machines for Laboratory to fully automated and high-throughput plants. Italian excellence stories are very similar in the path, but each has its own distinctive element. That of Fedegari is having a “technological heart”, given the total control of technology and represented by its own Thema4 processor. This has generated profound knowledge of machines and processes allowing the company to reach the cutting edge in innovation. “The important step,” explains the president Giuseppe Fedegari, “took place around the year 2000 when we decided to replace old custom processors based on custom hardware with a new generation of process controllers installed on our machines.” At the same time, the company created an automation division and invested in VxWorks, a very reliable real-time operating system to develop everything in-house, from components to systems.

From Pharma to Food

Today, Fedegari is a Group with a consolidated turnover of about 65 million Euros (2016) and around 450 employees distributed between Pavia and Switzerland – where the production units are located, other branches in Munich – Germany, Singapore and the Tech Center of Philadelphia. “The United States is the most important pharmaceutical industry,” continues Giuseppe Fedegari, “so we have opened a Technology Center where American customers can see their machines running. This way they can work on process and train development. The US Tech Center has become a place to share experiences that have changed our business prospects. This year, the FDA (Food & Drug Administration) has asked us to repeat some training courses for its inspectors: an important experience that we can transfer as a value to our customers. “The same format will be replicated shortly in Singapore.  Asia is the other big expanding market for Pharma. The Tech Center in Singapore will offer opportunities to exchange experiences with the customers of the newly opened branch in China. Fedegari’s other business area is food processing, where high levels of efficiency are required for strong market competitiveness and reduced margins. “In the last few years we have been working on the sterilization process of tuna cans and it has been an enlightening experience,” said Giuseppe Fedegari. The customer – a large multinational – chose our machines despite the higher cost compared to other sterilizers dedicated to the food industry. The superior performance achieved with Fedegari process equipment has allowed them to drastically reduce production costs.”

When the vision is farsighted

Manufacturers create value for the customer offering something that goes beyond the functionality required in the form of new services. “We started working hard to make machines and processes more efficient – continues Giuseppe Fedegari – to provide customer benefits and differentiate our offerings from competitors, but also because machines and systems have become much more complex and companies are investing less and less in training “. To follow this “philosophy”, a change of mentality was needed at all levels of the company, starting with the way in which we build the factory, with the latest generation technology. Fedegari is focused on different applications such as Cloud, essential to understand how customers use machines and to receive feedback information, IoT, to have more sensors able to capture possible variations in system functionality, Augmented Reality, for Maintenance, because it also allows a less experienced maintenance workers to solve problems rather than wait for the supplier to arrive. “Today, all this technology became Industry 4.0, but we have started applying it when there was not a concrete definition. We have started developing this approach several years ago simply because this is the only way to increase the efficiency of our machines. Our system already born “4.0” because it was projected onto the customer and the central point of the “4.0” is the active involvement of the customer, “concludes Giuseppe Fedegari.



Industry 4.0: Fedegari Predictive Maintenance System

Industry 4.0: Fedegari Predictive Maintenance System

Industry 4.0 on the field

“Our challenge in the Industry 4.0 moves on two fronts,” says Riccardo Boatti, Global Quality Assurance Manager.  The first front deals with the difficulty of producing customized orders over standard manufacturing. The other one regards the product itself, its use by our customer and how much he understands its technological content. Talking about the product, an emblematic example aligned with the concepts of “4.0” is the system developed internally for the predictive maintenance of the machines. We have been designing more and more intelligent machines, capable of interacting with external systems via Cloud platforms and diagnosing anomalies and critical conditions before compromising machine reliability. We have developed a system that monitors the use of individual plant components and consequently scales the residual useful life. In addition, this system allows to remotely control the status of any machine installed in the world almost in real time. Fedegari systems analyze the data and, based on appropriate algorithms, give an incremental wear that takes into account real working conditions (usage times, fluid temperatures, etc.).

The benefits for the user are twofold: on one hand, he is assured on the state of the machine as Fedegari technicians can analyze it remotely. On the other hand, the customer gets better maintenance management focusing only on components that actually require intervention, which also guarantees significant economic advantage. In the productive field, Fedegari is investing in several internal business areas: from PLM, Paperless, to the use of industrial tablets for various activities. Fedegari production departments have implemented tracing of material flows through RFID systems, QR Code, integrated management of production and machines, the use of highly automated equipment. To cite an example, we have recently purchased two state-of-the-art milling machines with telemedicine systems, adaptive control and ready interconnection with corporate IT systems. Sensor equipment allows continuous monitoring of working conditions and process parameters, providing real-time adaptation of the machine to any drift due to thermal and geometric variations.

Technology & Control

Thema4 is the process controller installed on all Fedegari machines. It was developed from the beginning to meet the strictest requirements of the pharmaceutical industry and is able to natively integrate with the existing SCADA and MES systems. “Thema4 is the heart of Fedegari and encloses the company’s technological history – says Boatti. The WindRiver VxWorks on-board operating system puts us in the position to develop the software that we then upload on the hardware. “Each machine is equipped with two computers, a Graphic Panel PC used by the operator to interact with the system and a Box PC, located inside the power cabinet, running the software that manages the sterilization process. “B&R is our hardware supplier, except in some markets where local suppliers are required,” says Boatti. The choice of the Austrian multinational (now acquired by ABB) is due to the company’s flexibility. It is a key requirement for Fedegari, since our core business is based on the customization of machines and systems.

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