The initiative aims to increase the interaction with partners and customers from process development to all levels of continuous education in the field of sterilization and contamination control. For that, Fedegari have invested $1.9 million in the building and real estate, and $1 million for the equipment installed in the new facilities.
“Our company has started working on various innovative solutions taking an original and unconvenient approach: rather than focusing on a component or a technology, we are investing in developing deeper knowledge. Our facilities in the US have been designed specifically to allow our customers to develop a much deeper understanding of our technologies and products”, explained Fedegari.
The Grand Opening ceremony received more than 60 customers and friends, including Robert Dana, VP of Education of the Parenteral Drug Association (PDA) who contributed as a moderator of the informative presentations. “It will be great to have this facility here in the US and I have no doubt that it will see much utilization by those in our industry looking for new ways to address sterilization challenges in the future”, commented Dana.
The speakers were Andrea Canepari, Italian Consul General in Philadelphia, James Agalloco, the internationally recognized expert on aseptic manufacturing, Shreekanth Mandayam, VP of Research at Rowan University, Vincent Calandra, Sales Executive, Industrial IoT of Intel Corporation/Wind River Systems and Jerry Golden, Manager of End-users, B&R Automation.
Agalloco talked about the Importance of Technical Knowledge in Pharma Manufacturing emphasizing the need for a technology center like this to enhance process innovation. “This facility is a wonder. The best equipped sterilization development center in the USA”, commented Agalloco. Vincent Calandra, from Intel Corporation/Wind River Systems had the opportunity to speak with different customers during the ceremony and said “they deeply believe in Fedegari commitment to develop products that are reference on the market. They were also very excited by Fedegari’s visionary approach to new technologies such as IoT.”
After the presentation session, the guests were guided to explore the new Technology Center, which includes various sterilizers for process development and testing, the simulator training rooms and the technical support area. Michael Bellm, sales representative for the pharmaceutical market for more than 20 years, highlighted that he “never saw a facility like this, or a company making this type of investment on training, after sales services and process and cycle development.” Chris O’Donnell, Reliability Engineering of Merck, also commented on the event: “Good speakers with interesting and relevant content. Fedegari new facility is impressive.” During the ceremony, the guests had the opportunity to taste traditional Italian delicacies and the product of Fedegari latest business venture: wines.
STRATEGIC PARTNERSHIP IN R&D AND TECHNOLOGY DEVELOPMENT
The informative presentations held during the ceremony illustrated different ways on which Fedegari is collaborating with a strategic network of partners such as Jim Agalloco, the Rowan University, Intel Corporation/Wind River Systems and B&R Automattion to offer continuos innovation and drive competitiveness for pharmaceutical industries.
“With collaborative R&D projects, Fedegari encourages end-users and researchers to work together in the new Technology Center on strategically important areas like process design and technology. This way, we expect to successfully develop and introduce new processes, products and services that will contribute to increase the cost-effectiveness in pharma manufacturing. The new technology center is an asset for the pharmaceutical community to achieve excellence through collaborative projects”, concludes Giuseppe Fedegari.
The website Sterilize.it (www.sterilize.it), an online database to share technical documents, was another initiative announced by Giuseppe Fedegari at the Grand Opening. The project developed in collaboration with authors as Jim Agalloco, Jeanne Moldenhauer and Vittorio Mascherpa, is a useful source of information making available the experts’ know-how to everyone interested in sterilization, contamination control processes and related subjects.
ABOUT FEDEGARI TECHNOLOGIES, INC.
Since the early Eighties Fedegari has been operating in the US pharmaceutical market. Considering the importance and the potential of this market, Fedegari decided to establish a commercial branch in Dublin (PA) in 2007. Fedegari Technologies, Inc. is able to provide direct support to its customers – on the whole American Continent. In 2014, Fedegari Technologies moved into the new facility in Sellersville (PA) with the goal to create a location where end-users could collaborate directly with the manufacturer without the need to fly abroad.
ABOUT FEDEGARI GROUP
Fedegari Autoclavi SpA is the holding company of the Italian industrial group manufacturing customized process machines, plants and the relevant components for the bio/pharmaceutical and food industry worldwide. The know-how of the group lies in the field of sterile and clean processes and encompasses different technologies and products.
Fedegari Autoclavi SpA was created by the will of brothers Gianpiero and Fortunato Fedegari in the early Fifties in Pavia, Italy, as a small handicraft business dedicated to the manufacture of miscellaneous sheet metal products. It soon developed into the production of sterilizers, progressively specializing in the design of these machines for applications in the pharmaceutical field. Starting from the early Nineties, Fedegari diversified its production also in the field of processes with supercritical fluids (predominantly CO2), designing and building systems and machines intended mainly for extraction processes (highly customized plants operating at pressures of 200-500 bar) and cleaning units (standard machines operating at pressures of 50-70 bar). Today, Fedegari is an industrial group controlling 6 companies worldwide employing approx. 400 people with consolidated revenues of 60 MEUR (ref. FY 2014), 85-90% of which is exported mainly towards Western Europe, the USA, India and China.
Today Fedegari has expanded the range of products to include machines for bio-decontamination processes (one of the technologies introduced after the acquisition of Bio Com in 2010), contamination control, isolators, rotary sterilizers and combined sterilizers for washing and sterilization for various applications. Another interesting development is the Thema4 process control installed on all the equipment manufactured by Fedegari. Thema4 is the only process controller developed from the outset to meet the strictest requirements of the pharmaceutical industry; it is constantly developing to ensure simplified interaction between the operator and the increasingly complex process equipment. Thema4 is also capable of integrating natively with SCADA and MES systems in use.
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