Technological breakthrough – Towards Industry 4.0

20 February 2017

Fedegari is an Italian group with offices and customers around the world  manufacturing sterilization and decontamination systems, primarily designed for the bio-pharmaceutical sector. The company has recently carried out a technological revolution: from a traditional organization to Industry 4.0. This evolution regards both the products and the internal structure that keeps growing.


by Riccardo Oldani, Tecn’è Magazine January 2017




Steam sterilizer integrated with an isolator for sterility testing


Is it possible to transform a traditional and “single-product” oriented company into a global 4.0 industry, capable of providing complete solutions instead of stand-alone machines? When looking at the recent transformation of Fedegari, an outstanding company located in Albuzzano (Italy) the answer seems to be “yes”. Giuseppe Fedegari, who runs the company  with his brother Paolo and is the President of a group with eight companies, says that until 10 years ago “Fedegari was a company focused exclusively on the development and production of autoclaves for sterilization in the pharmaceutical industry. Then, the turning point have started with the acquisition of a manufacturer of chemical bio-decontamination units, complementary to our own machines. We faced the need to integrate different types of machines and processes: a change that has led us to a cultural leap. We shifted from the business vision of manufacturing stand-alone machines to provide completely flexible and personalized solutions”, explains Fedegari.




The breakthrough innovation

The main target of Fedegari systems remains the pharmaceutical industry, but the new approach has led to a profound organizational transformation within the company, still in progress. The first step was leaving behind the concept of “it has always been done in this way”, to create innovative and hybrid solutions, such as a revolutionary machine that combines washing and sterilization. “The first and unique on the market – says Fedegari – capable of washing, sterilizing, decontaminating and drying different materials used in pharmaceutical production in one single process.” A concept that has been extended to the treatment of elastomeric closures used for packaging, engineering another cost-effective Fedegari solution. But these are just two examples of innovation brought by the Italian company in the field.



Step 2: Cooperation

The introduction of systems that can perform innovative processes in the pharmaceutical market (but also for the food industry and research laboratories) has determined a so called “Phase 2” of the company revolution “which has led us to open international offices, such as that of Singapore or the United States, where we work closely with customers”, adds Giuseppe Fedegari. In Sellersville, Pennsylvania, the company has opened in October 2015, a Technology Center that the president himself has called “a place of innovation, cooperation and learning”. How does this collaboration with the customer takes place? “If in the past – says Fedegari – we were mainly concerned with pre and after-sales activities of our equipment, we are now highly engaged in developing new and more cost-effective processes addressing specific needs of our customers. On the one hand, therefore, we must understand exactly their requirements. On the other hand, most of the time, we have to convince the traditional pharma industry about the reliability of our innovative solutions. Although presenting truly cost-effective solutions to customers, convincing them to include it in their production process is a challenging task. However, once taken the order, we must start planning personnel training for those who will use our systems. Unless we create a real relationship of trust with our customers, this whole thing would never happen”, explains the president.  All these new global services related to the product are an essential aspect to be considered in a group that binds to exports between 85% and 90% of its production.




Towards Industry 4.0

From here to the Industry 4.0 was a short step. Fedegari explains: “Since all our systems are produced on demand and highly customized for an extremely demanding and technological sector such as pharma, we must know how to integrate our machines into highly computerized processes, in which traceability of each individual drug is mandatory. This way we started implementing the 4.0 concepts first of all on our products. Now we began to rethink our production structure toward it as well “.



Expansion of the production area with new state-of-the-art milling machines


The company is completing an expansion of 3,500 square meters in the production area, equipped with state-of-the-art machinery, in particular milling machines and new automated systems. Nevertheless, the renewal of the automation front did not prevent a headcount growth, which in a few years has passed from a hundred employees to the current 430 for a 2016 turnover of about 62 millions. “The ratio of turnover and employees may seem low – notes Fedegari – but really for us the staff is the first resource: we need employees who contribute at every stage to innovate and improve our products.” Fedegari believes in continuous experimentation: every employee is somehow involved in research and development. This way, innovation is organic and not just a part of the company.



Giuseppe and Paolo Fedegari


Unlimited potential

In the 4.0 perspective, Fedegari has developed systems to collect and analyze all the “signals” coming from their machines installed worldwide, with a view to preventive maintenance and, ultimately, also predictive. The aim, by the end of 2017, is to create a cloud system for the collection and analysis of data, for which the company is developing its own software. This cloud system will drive the remote maintenance, offering augmented reality solutions through tablets or smartphones used by operators not necessarily technical specialized. Fedegari develops all these solutions in-house, with some cooperation with specialized companies. An example regards the integration of robots, introduced by Fedegari also within special cells for the filling of injectable drugs. This project used a stainless steel robotic arm from Kawasaki, “the only one in the world designed specifically to operate in a clean room,” explains Fedegari.


The transformation program continues: focusing on engaging customers worldwide and personnel training, the company plans to open its third Tech Center in Singapore. “Never before – he concludes Fedegari – we experienced a moment so rich of opportunities to grow, facing a market that is increasingly interested in our innovative approach. Our ultimate goal is to take advantage of this opportunity to the fullest. ”
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