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.

1. FEDEGARI
AUTOCLAVI SPA

3. ‘
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

4. 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

5. 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

6. 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.

7. 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

8. ‘
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.

9. ‘
‘
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.

10. ‘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.

11. ‘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.

12. 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.

13. ‘
Fedegari Autoclavi SpA
‘
Our true
passion
is to be unique

15. ‘
Today
Fedegari
is a highly
dynamic
industrial
group, ready
to tackle
the challenges
of a global
technological
scenario.
‘

16. 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

17. ‘
‘
the constant quest for new solutions is a genetic heritage
the future

18. 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.

19. dreams

20. 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.

21. ambitions

22. 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.

23. technology
...and in the power of

24. ...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.

25. ‘
‘
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

26. 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.

27. 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.

28. 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-

29. 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.

30. 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

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. the Products
INDUSTRIAL STEAM STERILIZERS
INDUSTRIAL STEAM STERILIZERS WITH
SMALL PORTABLE STEAM STERILIZERS
FOR FIELD HOSPITALS
INTEGRATED PROGRAMS FOR COMPLETE
PILOT AND INDUSTRIAL PLANTS
ELASTOMERIC CLOSURES TREATMENT
FOR VARIOUS PROCESSES USING LIQUID
INDUSTRIAL STEAM STERILIZERS WITH
AND SUPERCRITICAL
CO2
INTEGRATED PROGRAMS FOR WASHING
LOGISTIC SYSTEMS FOR INDUSTRIAL
VARIOUS LOADS
STERILIZERS
INDUSTRIAL STEAM-AIR-MIXTURE STERILIZERS
ACCESSORIES AND COMPONENTS
INDUSTRIAL SUPERHEATED WATER SPRAY
SUPPORT SERVICES FOR QUALIFICATION
AND VALIDATION OF PLANTS, TRAINING,
STERILIZERS
INDUSTRIAL ETHYLENE OXIDE STERILIZERS
STERILIZATION AND DEPYROGENATION OVENS
PREVENTIVE MAINTENANCE
SERVICES FOR DEVELOPING AND OPTIMIZING
DEDICATED PROCESSES
SMALL VERTICAL AND BENCH-TOP STEAM
STERILIZERS
You will find many more details about Fedegari’s products by referring to the enclosed CD-Rom.
For further technical information, please contact our worldwide network of system integrators.

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

39. design: imaginare • photographs: vittorio dozio