Cost-effective manufacturing: how integrated systems are changing the Bio-Pharma Scenario

10 July 2017

Innovative engineering solutions worldwide. With passion, dedication and originality, Fedegari Group continuously innovate to increase process efficiency and reliability that fully meet the high standards required by the pharma industry.

 Francesco Goi, ICF Industria Chimico Farmaceutica

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For several decades, Fedegari has been a reference for the pharmaceutical industry on a global scenario. Recently, the company’s core business in Pavia has been extended from processing machines to integrated systems in order to increase the efficiency of the ever more proposed solutions tailored to customer needs. Aiming to achieve cost-effectiveness and to propose solutions tailored on customers’ needs, the Italian company has extended its core business from processing machines to integrated systems.  We interviewed the president, Giuseppe Fedegari.

ICF – Mr. Fedegari, what have been the milestones of your business history?

Fedegari Autoclavi was founded in 1953 by Fedegari brothers – Fortunato and Giampiero -, “metal craftsmen”, who undertook general processing of stainless steel sheet metal. After working on parts of sterilization autoclaves for some local builders, the brothers made the courageous choice of giving birth to a reality focused on the production of sterilizers for the pharmaceutical industry. In short, the company succeeded in winning some important commissions also on foreign markets, starting with the Russian one. In the early 1990’s Fedegari affords a new challenge building up a few extraction plants. This experience represents a real milestone in the history of the Group, not only from the diversification point of view, but above all from the experiential one. It demonstrated us that there are no challenge that cannot be overcome. In fact, even without specific expertise upon liquid CO2-based processes, the company managed to develop completely new technological solutions.
In the early 2000s, begins our diversification process, leading to the currently business structure. Washing and decontaminating processes based on vaporized hydrogen peroxide have been introduced. Gradually, Fedegari started to offer much more than process machines, but cost-effective integrated solutions with robotized handling systems. This last step represents a crucial turning point since the company is transforming itself from a stand-alone machine manufacturer into a system developer. In this new perspective, we are currently working on different projects, including various technologies. No more offers are required for specific machines, but our collaboration starts directly from the customer’s layout. Clients often abandon conventional solutions to consider a complete system able to suits their specific needs and achieve best results.

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ICF – Does the production of integrated systems today play an important role on the business?

Machinery can still be considered our core business as it keeps playing a key role. However, the demand for our special projects is growing fast. In other words, we are using our pharmaceutical process know-how to combine different machines with different functions in a unique and original system. The relationship with the customer has changed from the past. Consulting and collaborating are the main factors of loyalty both in the field of engineering and automation, but also in the development of the process.

ICF – Has the international market appreciated this new approach, probably different from that of most qualified international competitors?

In fact, today, we are the only company in our segment who builds up all the components of the machines “at home”. Since we have started to offer complete solutions, assembling different components in a single system, we can provide the same components throughout the entire supply: same valves, same process controllers, and so on. Some other competitors have made mergers and acquisitions, but the synergies between different companies belonging to a Group are generally less effective than those achieved by a single structure. In most cases, the integration obtained is superficial, represented by a system where the machines have the same label but are not made with the same components or with the same logic of manufacturing and maintenance.

ICF – In your segment, as a supplier of integrated systems, would be possible to consider Fedegari as an engineering company?

Basically, yes. Our products are not standard, so each solution has to be calibrated and molded on customer needs. In the past, customers used to ask us for a machine with some characteristics to sterilize certain products with certain volumes. Today customers’ needs are more complex: there are upstream and downstream processes connected to our machines. Fedegari provides, for example, robotic handling systems, which requires a very careful examination of the product, the treatment to be handled and its destination.

ICF – Regarding to the relationship with the customer, what role does the R&D plays?

When we have accepted new market challenges (washing, decontamination …) our motivation to achieve new goals has not been satisfied with the knowledge available on the market. We have created our own background with different experiences. Without understanding the processes and technologies, you cannot control them. We have the ambition to sell a product that ensures the highest performance ever. This requires an effective control of technology. Interaction with customers allows us to deliver much more cost-effectiveness than in the past – when traditional systems were applied.
Today, in some cases, using only one machine, we obtain performances that previously required much more complex systems – this is the case for Fedegari washer-sterilizer (FOWS). In our industry, productivity does not increase just because the process has become shorter. Cost-effectiveness comes from the integration of different process machines, from layout optimization and logistics.

ICF – Referring to this kind of approach, human resources also gain a decisive role

Sure. The core value of this company lies in human resources. Today, the Group can count on about 500 employees operating in the various locations. In the headquarters of Albuzzano (PV), Italy, are located the Engineering and R&D department, Software House, manufacturing of industrial machines and components, as well as customer service. In the early 2000s, the manufacturing of standard machines (laboratory autoclaves) was transferred to the Swiss branch, while we have opened other locations abroad (United States, Singapore, Germany and China) to offer commercial, after-sales and technical support to local customers. In order to carry out these tasks efficiently, you need to “create” people with the right experiences and skills. Once integrated, they will produce and develop innovation. Our team is composed of mechanical engineers, but also electronic and computer engineers. Our automation division autonomously develops the process controller for all our machines and systems.

ICF – Do you also work with the Universities?

We are intensifying the relationship with the Italian and foreign universities, especially in order to identify talents. If we want to win over the competitive challenge, we must first invest in training people who have the potential to grow.

This process requires a lot of time and for that it is important to choose the right people.

ICF – What about your activity in foreign markets? Which structures do you rely on to succeed?

Ten years ago, we used to work around the world through a network of agents and distributors who maintained customer relations and, in many cases, provided support services (maintenance, spare parts, etc.). For example, after 25 years of collaboration with the local agent in the US, in 2007, we decided to open our own branch. The time has arrived for us to be present also on the American market. This experience helped us to understand the difference between being represented and having a direct relationship with customers.
With the opening of the American location, we exponentially increased contacts with users. In the US headquarter we installed some of our machines to carry out process development tests, interacting directly with customers who would not come to Italy. In this way, we are able to present new solutions capable to improve process performances. The relationship with the market has changed: first we were only submitting bids and developing negotiations. Today, the collaboration begins before that and allows us to establish a relationship of trust. After the positive experience in the United States, in 2008 we established the Singaporean branch. Today, American and Asian markets are extremely important for our business as the major pharmaceutical companies are based in this regions, supporting huge investments in the segment.

ICF – Is the relationship with suppliers also important for achieving excellence?

Collaborating with suppliers who make complementary products is, above all, an opportunity for learning: if you do not understand how these companies work, it is very difficult to provide turnkey solutions. For example, we have recently tested on our machines – in our R&D laboratory – the Ellab instrumentation, represented in Italy by Fasinternational. It was an important experience for both parties. It helped us to find new integrated solutions, especially in the validation of sterilizers with rotating loads that is considered a major challenge in our industry.

 ICF – Have you ever thought about extending your offer to other sectors, not only in the pharma?

After the experience gained in the early 1990s with supercritical fluids, we have studied some diversifications by developing systems for decontamination and washing, but also the integration of robots with our plants. It is well-known that man inside a clean room represents an element of contamination: its replacement with robots improves performance while reducing operating costs. We are also working on isolators, within which different operations can be developed by the use of robots. Some of the applications mentioned may also affect other industries. We supplied about twenty machines for the sterilization of canned food. This was an interesting experience: we got the job after the customer had worked for years in process development using our machines in the laboratory. We have thus shown that sophisticated technology could bring economic benefits also in the food industry. However, the food segment is still not showing enough sensibility to rely on advanced technology. The price is often a decisive factor.

ICF – What are your priorities in the medium term?

We want to increase the integration of different technologies combined in a single solution. In my opinion, stand-alone machines are no longer competitive. They have basically become commodities and would not allow us to grow. We are committed to develop new solutions and for that we must invest in innovation. A commodity market would suffer the self-financing, which is fundamental for the company.

ICF – In a world where communication and marketing tools keep growing, participating in trade shows is still important to maintain a key role in the market?

Next year we will be back to Achema, the industry-leading event. We are not joining other events which do not allow us to develop a deeper relationship with customers. If this connection remains superficial, our presence is not useful. Instead of developing thousands and thousands of contacts, we prefer to select them and work deeply on the ones that offer the best opportunities. More than once, instead of attending a fair, we preferred to invite potential customers to join our exclusive events. This way, we are able to spend a whole day together with them. Communication has changed, we are working more and more on our website (Fedegari.com), and with digital marketing. Our ultimate goal is to reach the customers with targeted content. If we want to grow we need to consolidate our relationships to prove how strong, we are. We need to spend more time with customers, to get to know their technologies and to carry out all the necessary tests to find the best solution and achieve the highest performances.

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ICF – Fedegari’s presence all over the world is a competitive factor, but family is a central value. In fact, Fedegari has remained a family-oriented company. How much this affects your results?

The values of a family company are still a competitive advantage. First of all, they give the chance to decide faster and better. Moreover, growing up in a family-oriented firm allows you to have the culture of problem solving and decision making. Obviously, to avoid wrong choices, it is also necessary to learn, to get informed, to travel, to go deeper into the topics, to develop your expertise and continuously improve your knowledge. The more you learn about technology the more you are able to make prudent choices.

It is paramount to work close with my brother, who is in the company while happens that I am out for my many business trips. We share responsibilities by keeping a direct control on everything we do. Of course, it is also necessary to rely on people of trust, who become an integral part of a family-society. When huge investments are made for the growth of the company – such as now, we are betting on ourselves, on our own knowledge, on the acquired information. It would be difficult to make important choices based only on the information brought by those far from our firm horizon.