Fedegari - Passion for sterilization

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Information about Fedegari - Passion for sterilization

Published on March 7, 2014

Author: FedegariGroup

Source: slideshare.net


Today Fedegari offers the market experience required to combine machines and processes into integrated projects that are truly innovative and capable of offering more efficient and economically competitive alternative solutions to an industry, such as the pharmaceutical one, that is always very cautious in accepting original evolutions.


‘ Our corporate vision is based on passion, commitment, spirit of sacrifice, work ethics. The end result: machines, components and solutions as unique as the people who design and build them. ‘ Fortunato Fedegari

1953 1961 1973 1982 “Metal craftsmen”, brothers Giampiero and Fortunato, start up the Fedegari Company in Pavia. A bold choice: to fully focus on the production of sterilizers for the pharmaceutical industry Fedegari Autoclavi SpA relocates to the facility in Albuzzano, 8 km from Pavia, covering an overall surface of 42.000 m2 Fedegari produces the first sterilizer equipped with an electronic process controller

Fedegari tackles a new industrial challenge: manufacturing supercritical and liquid CO2 plants The Italian Association of Industrial Designers (AIPI) awards the prestigious Leonardo da Vinci Prize to Fedegari Fedegari opens a new facility in Switzerland, earmarked for the assembly of all serial-production machines To this day, the family continues to steer the company on the road to the future with competence and passion. 1991 1994 2001 3006

W hen all the technologies and knowledge we now take for granted and access so easily were unavailable, expertise, tradition and perseverance of both the craftsman and the entrepreneur ensured achievement of ambitious results, well beyond the reach of others. The difference between two similar products became immediately evident on just touching and recognizing the handcraft finish. Nowadays, these distinguishing features are much harder to recognize in an industrial product. Culture today, lacking the practical approach of the past, leads to diminished appreciation of tangible values and takes the ability of machine tools to produce the same finish for granted. But while this is true for products manufactured in runs of thousands of units, it cannot apply to one-of-a-kind products, such as custom-made machines. It’s a bit like saying that all sterilizers sterilize by virtue of their name. Yet this is not so: the end result is the consequence of machine features and user know-how. With a Fedegari sterilizer, a user, having the required know-how, is aware of obtaining a performance unattainable with other machines. This is why our best clients are also the most demanding. The overall performance of a machine or of a system is not the logical consequence of a set of components itemized according to relevant standard features, but rather the result of the people whose minds and hands designed and built them. The skilful alchemy created by many human talents, co-ordinated and guided towards an apparently simple goal: manufacturing the best sterilizers in the world.

Each Fedegari product is the result of extensive research, design and manufacture, our way of doing things here for the past 50 years, with professionalism and dedication. Being considered one of today’s leading sterilizer manufacturers worldwide stems from the distinguishing features imposed by the founders from the company’s very start, in the early 1950s. Over half a century later, we have retained the “craftsman’s spirit” of our early days, the care for detail in giving shape to matter, without neglecting the rigour of those days, combining these factors with the requirements of industrial production. ‘ ‘tradition passion for

‘ flexibility passion for ‘ Fedegari was the first to introduce an absolutely innovative strategy in the field of sterilization: to exclusively design machines according to specific user operating requirements. Our sterilizers are highly customized industrial products, designed to satisfy the needs of our Customers. They are based on specifically engineered functional modules minimising risks connected to production of ever-differing machines, while guaranteeing top performances. Precisely thanks to constant collaboration with our Customers, we have been able to develop and increase our company’s know-how, something without which we would never have achieved today’s results.

‘ ‘ passion for safety For Fedegari safety does not just mean operator protection but above all a guaranteed result. Only complete control over technology allows achieving superior performance and ensuring operator safety, an impossible feat with mass-produced or particularly complex solutions. Safety mainly derives from simplicity. Creating simple solutions often requires the courage to look at things from a different perspective, without worrying about being different. The simplest solutions sometimes entail higher costs, but simplicity pays back, even economically, in terms of day-to-day use as well as of maintenance.

‘originality Originality is perhaps Fedegari’s most characteristic trait: originality in design, in production process and manufacturing criteria, but also in development strategies and rewarding alliances. ‘ passion for We are a unique example on the international scene of sterilizer manufacturers: we have in fact chosen to design “custom-made” machines, to build each component in-house, to test innovative production processes so as to anticipate market trends and gain total control over technology. Precisely the courage to be different has allowed us, in the course of half a century, to evolve from a small workshop to one of the world’s leading companies.

‘innovation At Fedegari, the ongoing innovation of production processes and products, further to being a genetic trait and an inborn need of our workforce, is also a conscious choice aimed at preserving our technological ‘ passion for leadership and worlwide standing. Almost a kind of “obsession” generating new solutions at a fast pace, without waiting for competitors to evolve. In fact, thanks to the absolute original- ity of solutions devised, we stand out as compared to all other manufacturers, becoming true trendsetters and the technical solutions developed within our company are so effective as to often be imitated.

For Fedegari research is a synonym of entrepreneurial courage. So as to enhance this activity, the company has made substantial structural investments, through acquiring efficient and powerful resources. ‘ ‘research passion for Over 2.000 m2 accommodate R&D: this is where the future is designed, new frontiers of evolution explored, and tomorrow’s technologies anticipated. Our great commitment to research and continuous adaptation of both structures and technologies are tangible proof of our pioneering spirit: we are pursuing new frontiers with enthusiasm and creativity.

‘ Fedegari Autoclavi SpA ‘ Our true passion is to be unique

‘ Today Fedegari is a highly dynamic industrial group, ready to tackle the challenges of a global technological scenario. ‘

At Fedegari design has an absolutely dominant role: exploring constantly new solutions, able to anticipate technological development without having to wait for market evolution, is the primary goal of the company and of the people who enthusiastically contribute to its growth. Since the early 1980s, we have applied advanced finite element analysis (FEM) programs in the engineering department, so as to find confirmation of our intuitions in science, then using them to optimize all the manufacturing models we shall continue to use in the future. Here we design

‘ ‘ the constant quest for new solutions is a genetic heritage the future

In Fedegari the inborn tendency towards evolution also affects the manufacture of machines, entrusted to systems which are always up-to-date. The factory is, so to speak, a compromise between an industrial structure and a craftsman’s workshop, in which sophisticated automatic and robotized systems ...and we build work unsupervised alongside highly qualified workers, capable of giving shape to matter in a way that the hightech system will never achieve, especially in the case of one-of-a-kind parts. Many of the production machines used are also specifically customized, so as enable achieving what a standard machine cannot do. All this fatally attracts the visitor, who is unprepared for such an experience. To improve the intrinsic requirements of the machines, we only use stainless steel. This entails higher costs than less noble materials, but enables curbing maintenance costs and eliminating chemical treatment processes of surfaces, which have a higher environmental impact.


Owning a Fedegari machine is achieving the ambition of possessing a machine with exceptional performance. In the same way a racing car can achieve above-average results in the hands of a skilled driver, a Fedegari sterilizer enables otherwise unthinkable pro- ...we achieve duction optimizations, as each machine embodies over fifty years of uninterrupted experimentation carried out together with the world’s most demanding users: our Customers.


We believe in the strength of ideas For Fedegari, ideas are the true driving force of company growth: a constant desire to improve our performance spurs us on to always seek new solutions, to allocate space and resources to creativity, to boldly propose unexplored paths. Today, like yesterday, we rely on high technology, in a constant effort towards industrialization. Most of our investments are - and always have been - earmarked for purchasing state-of-the-art production systems so as to further develop our manufacturing technologies and improve quality standards. Even production machine tools are a result of robotics at Fedegari: over 90% of our welding is performed with automatic and robotized systems and every new detail is designed to be produced by these machines.

technology ...and in the power of

...but we trust in the touch of Our men and women are the true keys of the company’s growth and success: the efforts of engineers and, over time, workers, technicians and managers, have contributed to Fedegari’s progres- man sive establishment as a prominent player on the world market. We choose them – and they choose us – not just for their skills but also for their enthusiasm and creativity, thus daily contributing, year after year, to making every Fedegari product inimitable. With passion.

‘ ‘ The whole is much more than the total sum of its parts the the the the the the the Chambers Doors Piping Components Design Process Controllers Accessories

the Chambers The chamber is undeniably a fundamental part of moist-heat sterilizers (autoclaves): its criticality arises from cyclic pressure and temperature variations, which generate dangerous fatigue of the structure over time. Fedegari was the first among manufacturers of these machines: in the early 1980s, leading innovation, Fedegari introduced the first CAD workstations equipped with sophisticated FEM programs, devising an absolutely original manufacturing model conceived with the specific goal of avoiding generation of high tensions in any point of the shell. Depending on the type of sterilizer, the chambers can have a square or circular cross-section.

They are made of AISI 316Ti stainless steel, with an internal mirror-finish obtained by mechanical polishing. The chambers can be equipped with a jacket, providing temperature regulation of the process, and with various stiffeners, depending on the cross-section of the chamber, which never come into direct contact with any process fluid. Depending on requirements, the chambers are designed and certified in compliance with local laws or regulations.

the Doors The doors have also been designed in the same way as the chambers, so as to eliminate critical stress points and ensure maximum operator safety and minimum maintenance. The tightness of the pressure vessel is ensured by a special gasket patented by Fedegari in 1982, which is seated in a groove milled into the chamber frame and is pressed by compressed air against the door. This gasket requires no vacuum for door opening. Two door types are available: automatic sliding doors and semiautomatic hinged doors. Sliding doors move vertically in smaller machines and horizontally in all the larger models. Hinged doors use the same construction model as sliding doors, but the opening motion is divided into two separate steps: a translational motion at 45° (automatic) and a rotation (manual). These solutions offer maximum flexibility and allow adaptation of the sterilizer to any installation constraint or preference. All doors are equipped with various safety devices and mechanical, pneumatic and pro-

cess interlocks, so as to prevent opening in conditions which could cause danger for the operator and loss of tightness of the gasket in cases of power or pneumatic blackouts.

The importance of the piping in achieving high-level process performance is obvious. At Fedegari, the piping, as a whole, is unquestionably one of the most distinctive features of each machine. In custom-made machines, however, this sub-system becomes even more critical: each machine is a “one-of-a-kind” unit and, as such, only benefits to a very small extent from optimization as is the case with massproduced machines. Fedegari’s originality and flexibility set the foundations for devising a manufacturing model that enables building systems with very high-end characteristics. This result was achieved by working simultaneously on several fronts: from design to development of standardized assemblies to the use of specific components, very often manufactured in-house. the Piping

In engineering, programs for the CAD workstations have been fine-tuned by using standard modules for specific design areas and by exclusively restricting redesign to parts of the system never previously built. The use of standardized assemblies ensures that some parts of the piping are always made in the same way. The use of specific components also allows devising or selecting products ensuring excellent performance and higher overall system reliability. The piping manufactured by Fedegari also stands out for lack of crevices (a factor which could compromise fluid sterility), for the exclusive use of sanitary-grade components, for the extremely straight-forward construction and simple maintenance. Each piping is entirely made of AISI 316L (DIN 1.4435) stainless steel. All pipings are in fact assembled by using components and techniques usually used to manufacture sterile fluid loops.

the Components Fedegari is the only manufacturer in the field designing and manufacturing all the most critical components of its machines and plants in-house: in addition to pressure vessels, Fedegari manufactures sanitarygrade fittings, valves, manifolds, magnetic couplings for turning fans and internal loads, various lubrication-free rolling systems, pumps and compressors. In fact, having deep knowledge of details is precisely what enables improving the machine as a whole. In selecting components, overall low cost of maintenance – i.e., cost of spares and time required to replace them and to train specialized personnel – is an essential yet often underestimated feature. However, this becomes highly relevant in the overall assessment of a machine or system, in view of their increasing complexity.

the Design An increasingly important element in the development of new products is the design of man-machine interface. In a world in which everything around us becomes more complicated every day, studying the interaction between man and tools used by the latter to perform his work also has an economic value we can no longer dismiss. An ergonomic interface ensures better understanding of the tool, correct use and less operator fatigue, consequently, an increase in safety. Aware of this, we have started collaborating with Ugolini Design, so as to humanise technologies undergoing continuous and accelerated evolution. Manufacturer creativity separated from the study of interfaces is no longer conceivable and has become an integral element for innovation and research. Developing man-machine interfaces requires solid professional skills and leaves no room for improvisation: indeed, despite restrictions imposed by the production of a relatively low number of custom-made machines, this is where human engineering activity has yielded highly encouraging results.

the Process controllers Although they cannot be entirely compared to other components manufactured in-house, electronic process controllers are also the result of an innovative approach, introduced in the early 1980s, when the first dedicated controller was made. Since then, Fedegari has always privileged the development of a single controller which could be assigned to the control of every sterilizer manufactured, instead of developing programs dedicated to individual machines, requiring adaptation every time. This approach, which is significantly more costly during the initial development stage, requires availability of extremely qualified and competent resources, able to understand the process and to develop specifications and programs, including, finally, to validate results. This kind of team of experts has thus suc- ceeded not only in attaining maximum process performance but also in developing a set of skills required to fine-tune specific solutions for the individual customer, today enabling integration of sterilizers in increasingly structured and complex production super-vision and control networks. These integration projects, if appropriately carried out, enable safe exchange of data among different systems, drastically reducing operator or maintenance personnel activity and finally offering the opportunity of achieving the “paperless” company.

the Accessories Accessories completing supply, such as trolleys, automatic loading systems or product containers, are another important element often underestimated by the buyer, but a wellknown value to those who use them every day. In this field too, deep understanding of the processes and of the corresponding criticalities in application has guided us in designing and manufacturing components and systems that have absolutely unique features. These products are entirely made of stainless alloys, compatible with the pharmaceutical applications for which they are earmarked and are designed to be maintained and managed at a very low cost. Specific applications require designing customized solutions which do not force the enduser to adapt process to the limitations of the containers or the loading systems typically used. Our experience is available to customers as regards the design and manufacture of the required accessories, configured so as to perfectly fit to machines and facilities, ensuring full satisfaction of any integration requirement, including with existing machines.

Dense-phase fluids Special Applications Ovens This category includes plants and machines for different processes using supercritical or liquid CO2 as a solvent (with operating pressures typically varying between 60 and 600 bars). After introducing this production differentiation in the early 1990s, Fedegari developed and improved original and particularly safe technical solutions, despite the limited knowledge available in this field, owing to the restricted diffusion of the technology at the time. For this purpose, the experience acquired by Fedegari in its traditional activities turned out to be decisive and allowed to reuse - albeit with appropriate modifications - technical solutions that had been tested over years of field operation. Unlike sterilization, Fedegari introduced this new technology successfully thanks to its co-operation with national and international research centres, with years of experience in this field and still acknowledged as benchmark organizations today. These processes mainly offer two advantages: lack of environmental impact and "purity" of the extracts, which do not contain solvent residues or show any deterioration due to high process temperatures. This category includes plants or plant sub-systems earmarked for niche applications, where standard machines are no longer sufficient. In the past, some of these machines were developed in close collaboration with customers so as to meet with particular production requirements. On verification of design and construction validity, some of these machines are now on offer as standard models, although type of application restricts their use to cases of actual need. Some of the most significant examples are steam sterilizers with a washing and sterilization cycle for elastomeric closures, processes for sterilizing high pathogen risk materials, sterilizers with rotating loads and plants with liquid or supercritical CO2 for special applications. These designs best represent the co-operation between customers and supplier, implying mutual acknowledgement of respective skills. Results achieved have enabled both to develop the technology of their own products and to thus grow over time, often imitated by those lacking the courage and passion to explore new paths while guaranteeing the final result, merely offering whatever is requested. Introduced to diversify production at the end of the 1980s, ovens are a significant percentage of Fedegari’s output. Like autoclaves, they are batch-type sterilizers, but unlike autoclaves they operate at atmospheric pressure. Since they do not have a pressure vessel, ovens do not have the design and manufacturing complexities typical of autoclaves. Nonetheless, two aspects, such as temperature uniformity and particle contamination class, are particularly critical to achieve and are distinctive of the manufacturer. In particular, as regards Fedegari sterilizers, the achievement of class 100 throughout the process is a key aspect, as well as a distinguishing factor, which also required the creation of specific air sampling devices. For manufacturing these devices, Fedegari was able to rely on collaboration with national research institutes already active in this field. As in the case of autoclaves, development of original construction and process solutions enabled Fedegari to determine new benchmark standards also for these sterilizers.


FEDEGARI AUTOCLAVI SPA ALBUZZANO (PV) - ITALIA - TEL. +39.0382.434111- FAX +39.0382.434150 www.fedegari.com

design: imaginare • photographs: vittorio dozio

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