Pharma Industry 4.0: manufacturing concepts of the future

4 April 2018

Giovanni Felice, NCF March 20th, 2018

An all-Italian story: Fedegari is a company born in the Lombardy region over 60 years ago and which has become a world-wide excellence in the field of contamination control technologies for the pharmaceutical industry. The Fedegari brand was founded in Pavia in 1953, when a family-run business was founded, dedicated to the construction of sheet metal products. Over the years, the company has specialized in the production of sterilization autoclaves for the pharmaceutical industry to become a global benchmark in the sector. Constant growth is the result of continuous technological innovation and the consequent adaptation of infrastructures.

“We have the ambition to offer complete turnkey solutions to the pharmaceutical industries, to a level of excellence not only in terms of machines, but also for processes and services.” The company’s guiding philosophy is expressed by its President, Giuseppe Fedegari who, together with his brother Paolo, collected the inheritance of his father and uncle, transforming Fedegari Autoclavi SpA in 2007 into Fedegari Group (to which several companies belong today), a highly specialized hi-tech company with a turnover of around 62 million euros (2016 data), 85-90% of which is exported to Europe, USA, India and China.

“Our team is composed of mechanical engineers, but also electronic and IT, as well as various highly skilled workers – explains Giuseppe Fedegari – To achieve these results, the company has always reinvested all the profits in the development of infrastructure, from the replacement of workstations design with three-dimensional design programs, the installation of new robotic or automatic machine tools capable of producing without the direct supervision of the operator, the expansion of the buildings to produce ever larger systems. “

The sterilization facilities of the Fedegari Group are destined for the
bio/pharmaceutical and food sectors. It is a range of products ranging from small machines for laboratory applications to fully automated and high productivity systems”.

INDUSTRY 4.0

An experience gained over decades, but with a diversification project started in the early 2000’s, when the washing and decontamination processes based on vaporized hydrogen peroxide are introduced. Gradually Fedegari starts offering the market integrated and customized solutions instead of stand-alone machines. This step represents a decisive turning point because the company is transformed from a simple machine manufacturer to a “total solution provider” for the customer. A change of approach, from a traditional organization to a real Industry 4.0, concerning both the product and the internal structure.

“The level of complexity and automation of our machines is pushing towards increasingly complex technological solutions that involve interaction with the outside world through the use of sensors and mechatronic devices – explains Fedegari. Our challenge for 4.0 is therefore carried out on two fronts: an internal one, which deals with the challenges of a custom production, the other aimed at the product we make, which must allow customers to produce at more competitive conditions”.

In this context, considering the increasing level of complexity of the machines, to ensure efficient operation, Fedegari offers the user an advanced system that supports technicians in all their interactions with the machines.

“It is a need even more felt in those situations where the maintenance of the machine is done directly by the customer with skills generally lower than those of the manufacturer – explains Fedegari – This is why our system provides the ability to manage the maintenance of multiple machines connected and real-time control of the wear conditions of the installed components. Furthermore, through the data transmitted by the field, the required interventions can be planned and the necessary spare parts analyzed “.

AD HOC OPERATING SYSTEM

All Fedegari machines use the same internally developed process controller, whose architecture is based on a real-time operating system for critical applications (Wind River’s VxWorks) that ensures unthinkable robustness for “normal” operating systems.

Today, for the current generation of controllers, solutions have been developed to simplify the maintenance of the machines that allow using a smartphone or tablet to recognize the components installed on each machine and, through augmented reality programs, to associate to each component multimedia files that provide technicians with all the information necessary for maintenance.

Additionally, more and more signals on the functioning of the actuators and sensors of the machine are collected by the controller to allow to predict when to carry out the maintenance activities before the machine stops. These “4.0” solutions are increasingly important considering the increasing complexity of the plants and the longer times for the training of technical personnel.

CUSTOMER RELATIONSHIPS

How does the relationship between customers and  Fedegari develop today?

“In the past we responded to requests for offers from customers who, by means of technical specifications (URS), described more or less in detail the characteristics of the machines they wanted to buy. However, this approach does not always allow us to fully understand the real needs of the client. We have therefore decided to commit ourselves to modify this approach by first building a relationship of trust with users with the aim of analyzing projects together and then proposing non-conventional ad hoc solutions.

An important tool to start these relationships is our Tech Center today in Italy, USA and Singapore (under construction), places to share practical experiences where to simulate and test the most efficient solutions for each application. “

GLOBAL DISTRIBUTION

Fedegari sells all over the world, in some countries directly through its sales offices such as in Germany, in the USA, Singapore and since 2017 also in China or through a network of agents and distributors able to provide both technical services and spare parts operation of the machines. Furthermore, in Switzerland, a site was reopened in 2000 where, in addition to the commercial activities, all the “standard” machines destined mainly for laboratories are also assembled.

“The experience gained in the USA with the opening of our branch in 2007 has made us reflect on the value of a direct relationship with our customers – says Giuseppe Fedegari -. After a few years we were present directly, we have in fact created the first Tech Center outside of Italy where we installed some of our machines that allow us to develop processes and training of customers who don’t have the possibility to come to Italy. This solution has had such a success in a short time that today we are doubling the surface of the site to insert new machines and increase the number of employees, mainly technicians. “

RESEARCH AND DEVELOPMENT ALWAYS GROWING

Despite the excellent results achieved so far, Fedegari continues to invest in research and development, aware that success primarily stems from the efficiency of its machines, but subsequently from the ability to interpret the real needs of customers by integrating different machines and processes into a single solution.

“The daily activities of innovation of products and technologies and the consequent adaptation of the infrastructures are fundamental for a company like ours that produces highly customized machines – explains Giuseppe Fedegari -. Conversely, these machines would soon become commodities for which the only discriminating factor between suppliers would be the price. In the customization of these solutions we see the opportunity to bring out the real value of the supplier beyond advertising slogans and in this way to continue to grow a company that, in little more than 60 years of activity, has been able to establish itself as a world reference in its industry. “

Original article