FEDEGARIAUTOCLAVI SSPPAA

Fortunato Fedegari

Our corporate vision is based on passion, commitment,

spirit of sacrifice, work ethics.The end result: machines, components and solutions

as unique as the peoplewho design and build them.

‘‘

1953196119731982

“Metal craftsmen”, brothersGiampiero and Fortunato,start up the Fedegari Company in Pavia.

A bold choice: to fully focus on the productionof sterilizers for thepharmaceutical industry

Fedegari Autoclavi SpA relocatesto the facility in Albuzzano, 8 km from Pavia, covering an overall surface of 42.000 m2

Fedegari produces the first sterilizer equippedwith an electronic processcontroller

1991199420013006

Fedegari tackles a new industrial challenge:manufacturing supercriticaland liquid CO2 plants

The Italian Association ofIndustrial Designers (AIPI)awards the prestigious Leonardoda 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 futurewith competence and passion.

hen all the technologies and knowledge we now take for granted and access so easily were unavailable, expertise, tra-dition 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 andrecognizing the handcraft finish.Nowadays, these distinguishing features are much harder to recognize in an industrial product. Culture today, lacking the practicalapproach of the past, leads to diminished appreciation of tangible values and takes the ability of machine tools to produce the samefinish for granted. But while this is true for products manufactured in runs of thousands of units, it cannot apply to one-of-a-kindproducts, 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 othermachines. 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 rele-vant standard features, but rather the result of the people whose minds and hands designed and built them. The skilful alchemy crea-ted by many human talents, co-ordinated and guided towards an apparently simple goal:

manufacturing the best sterilizers in the world.

W

traditionpassion for‘ ‘

Each Fedegari product is the re-

sult of extensive research, design

and manufacture, our way of do-

ing things here for the past 50

years, with professionalism and

dedication.

Being considered one of today’s

leading sterilizer manufacturers

worldwide stems from the distin-

guishing 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 fac-

tors with the requirements of

industrial production.

Fedegari was the first to introduce

an absolutely innovative strategy in

the field of sterilization: to exclusively

design machines according to spe-

cific user operating requirements.

Our sterilizers are highly custom-

ized industrial products, designed to

satisfy the needs of our Customers.

They are based on specifically en-

gineered functional modules minim-

ising risks connected to production

of ever-differing machines, while

guaranteeing top performances.

Precisely thanks to constant collab-

oration 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.

flexibilitypassion

for‘ ‘

For Fedegari safety does not just

mean operator protection but

above all a guaranteed result.

Only complete control over tech-

nology allows achieving superior

performance and ensuring oper-

ator safety, an impossible feat with

mass-produced or particularly com-

plex solutions. Safety mainly der-

ives from simplicity. Creating sim-

ple solutions often requires the

courage to look at things from a

different perspective, without wor-

rying 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.

safetypassion

for‘ ‘

originalitypassion for

Originality is perhaps Fede-

gari’s most characteristic trait:

originality in design, in production

process and manufacturing criteria,

but also in development strategies and

rewarding alliances.

We are a unique example on the inter-

national scene of sterilizer manufact-

urers: we have in fact chosen to design

“custom-made” machines, to build

each component in-house, to test in-

novative 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 evol-

ve from a small workshop to one of

the world’s leading companies.

‘ ‘

At Fedegari, the ongoing in-

novation of production pro-

cesses 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

leadership and worlwide standing.

Almost a kind of “obsession” generat-

ing 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 manufact-

urers, becoming true trendsetters and

the technical solutions developed with-

in our company are so effective as to

often be imitated.

innovationpassionfor‘ ‘

For Fedegari research is a synonym

of entrepreneurial courage. So as to

enhance this activity, the company

has made substantial structural in-

vestments, through acquiring ef-

ficient and powerful resources.

Over 2.000 m2 accommodate

R&D: this is where the future is

designed, new frontiers of evolu-

tion explored, and tomorrow’s

technologies anticipated.

Our great commitment to research

and continuous adaptation of both

structures and technologies are tan-

gible proof of our pioneering spirit:

we are pursuing new frontiers with

enthusiasm and creativity.

researchpassion for ‘‘

Fedegari Autoclavi SpA

Our truepassion

is to be unique

‘ ‘

‘Today Fedegari is a highly dynamic industrial group, ready to tacklethe challengesof a global technologicalscenario.

‘

Here we design

At Fedegari design has an absolute-

ly dominant role: exploring con-

stantly new solutions, able to anti-

cipate 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 ap-

plied advanced finite element analy-

sis (FEM) programs in the engineer-

ing department, so as to find confir-

mation of our intuitions in science,

then using them to optimize all the

manufacturing models we shall

continue to use in the future.

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

...and we buildwork unsupervised alongside highly

qualified workers, capable of giving

shape to matter in a way that the high-

tech 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 en-

able 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 mainten-

ance costs and eliminating chemical

treatment processes of surfaces, which

have a higher environmental impact.

In Fedegarithe inborn tendency towards evolution

also affects the manufacture of ma-

chines, entrusted to systems which are

always up-to-date.

The factory is, so to speak, a comprom-

ise between an industrial structure and a

craftsman’s workshop, in which sophisti-

cated automatic and robotized systems

drea

ms

...we achieve

Owning a Fedegari machine is achiev-

ing the ambition of possessing a ma-

chine 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-

duction optimizations, as each ma-

chine embodies over fifty years of un-

interrupted experimentation carried

out together with the world’s most de-

manding users:

our Customers.

ambitions

Webelieve 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 solu-

tions, to allocate space and resources

to creativity, to boldly propose unex-

plored paths.

Today, like yesterday, we rely on high

technology, in a constant effort to-

wards industrialization.

Most of our investments are - and al-

ways have been - earmarked for pur-

chasing state-of-the-art production

systems so as to further develop our

manufacturing technologies and im-

prove 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 pro-

duced by these machines.

...and in the power of technology

...but we trust

in thetouch of man

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-

sive establishment as a prominent play-

er 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 inimi-

table.

With passion.

The whole is much more than the total sum of its parts

‘‘

Chambers

Doors

Piping

Components

Design

Process Controllers

Accessories

the thethethethethethe

The chamber is undeniably a fundamentalpart of moist-heat sterilizers (autoclaves):its criticality arises from cyclic pressure andtemperature variations, which generatedangerous fatigue of the structure overtime.

Fedegari was the first among manufacturersof these machines: in the early 1980s, lead-ing innovation, Fedegari introduced thefirst CAD workstations equipped withsophisticated FEM programs, devising anabsolutely original manufacturing model

conceived with the specific goal of avoidinggeneration of high tensions in any point ofthe shell.Depending on the type of sterilizer, thechambers can have a square or circularcross-section.

the Chambers

They are made of AISI 316Ti stainless steel,with an internal mirror-finish obtained bymechanical polishing.The chambers can be equipped with a jacket,providing temperature regulation of the pro-cess, and with various stiffeners, depending onthe cross-section of the chamber, which nevercome into direct contact with any processfluid.Depending on requirements, the chambers aredesigned and certified in compliance withlocal laws or regulations.

the Doors

The doors have also been designed in the sameway as the chambers, so as to eliminate criticalstress points and ensure maximum operatorsafety and minimum maintenance.The tightness of the pressure vessel is ensuredby a special gasket patented by Fedegari in1982, which is seated in a groove milled intothe chamber frame and is pressed by compres-sed air against the door. This gasket requires novacuum for door opening.Two door types are available: automatic slidingdoors and semiautomatic hinged doors.Sliding doors move vertically in smaller machinesand horizontally in all the larger models.Hinged doors use the same construction mo-del as sliding doors, but the opening motion isdivided into two separate steps: a translationalmotion at 45° (automatic) and a rotation(manual).These solutions offer maximum flexibility andallow adaptation of the sterilizer to any instal-lation constraint or preference.All doors are equipped with various safetydevices and mechanical, pneumatic and pro-

cess interlocks, so as to prevent opening inconditions which could cause danger for theoperator and loss of tightness of the gasket incases of power or pneumatic blackouts.

The importance of the piping in achievinghigh-level process performance is obvious.At Fedegari, the piping, as a whole, is un-questionably one of the most distinctive fea-tures of each machine.In custom-made machines, however, thissub-system becomes even more critical: eachmachine is a “one-of-a-kind” unit and, assuch, only benefits to a very small extentfrom optimization as is the case with mass-produced machines.Fedegari’s originality and flexibility set thefoundations for devising a manufacturingmodel that enables building systems withvery high-end characteristics. This result was achieved by working simul-taneously on several fronts: from design todevelopment of standardized assemblies tothe use of specific components, very oftenmanufactured in-house.

the Piping

In engineering, programs for the CAD work-stations have been fine-tuned by using stan-dard modules for specific design areas and byexclusively restricting redesign to parts of thesystem never previously built. The use of stan-dardized assemblies ensures that some parts ofthe piping are always made in the same way.The use of specific components also allowsdevising or selecting products ensuring excel-lent performance and higher overall systemreliability.

The piping manufactured by Fedegari alsostands out for lack of crevices (a factor whichcould compromise fluid sterility), for the ex-clusive use of sanitary-grade components, forthe extremely straight-forward constructionand simple maintenance. Each piping is entire-ly made of AISI 316L (DIN 1.4435) stainlesssteel.All pipings are in fact assembled by using components and techniques usually used tomanufacture sterile fluid loops.

the ComponentsFedegari is the only manufacturer in thefield designing and manufacturing all themost critical components of its machinesand plants in-house: in addition to pressurevessels, Fedegari manufactures sanitary-grade fittings, valves, manifolds, magneticcouplings for turning fans and internal

loads, various lubrication-free rolling sys-tems, pumps and compressors. In fact,having deep knowledge of details is precise-ly what enables improving the machine as awhole.In selecting components, overall low cost ofmaintenance – i.e., cost of spares and time

required to replace them and to train spe-cialized personnel – is an essential yet oftenunderestimated feature. However, this becomes highly relevant inthe overall assessment of a machine orsystem, in view of their increasingcomplexity.

the Design

the Design

An increasingly important element in thedevelopment of new products is the designof man-machine interface. In a world inwhich everything around us becomes morecomplicated every day, studying the inter-action between man and tools used by thelatter to perform his work also has an econo-mic value we can no longer dismiss.An ergonomic interface ensures better un-derstanding of the tool, correct use and lessoperator fatigue, consequently, an increasein safety.Aware of this, we have started collaboratingwith Ugolini Design, so as to humanisetechnologies undergoing continuous andaccelerated evolution. Manufacturer creativ-ity separated from the study of interfaces isno longer conceivable and has become anintegral element for innovation and research.Developing man-machine interfaces re-quires solid professional skills and leaves noroom for improvisation: indeed, despiterestrictions imposed by the production of arelatively low number of custom-mademachines, this is where human engineeringactivity has yielded highly encouragingresults.

the Process controllers

Although they cannot be entirely compared toother components manufactured in-house,electronic process controllers are also the resultof an innovative approach, introduced in theearly 1980s, when the first dedicated control-ler was made.Since then, Fedegari has always privileged thedevelopment of a single controller which couldbe assigned to the control of every sterilizermanufactured, instead of developing programsdedicated to individual machines, requiringadaptation every time.This approach, which is significantly morecostly during the initial development stage,requires availability of extremely qualified andcompetent resources, able to understand theprocess and to develop specifications and pro-grams, including, finally, to validate results.This kind of team of experts has thus suc-

ceeded not only inattaining maximumprocess perform-ance but also indeveloping a set ofskills required tofine-tune specificsolutions for theindividual customer,today enabling in-tegration of sterili-zers in increasinglystructured and com-plex productionsuper-vision andcontrol networks.These integration projects, if appropriately car-ried out, enable safe exchange of data amongdifferent systems, drastically reducing operator

or maintenance personnel activity and finallyoffering the opportunity of achieving the“paperless” company.

the Accessories Accessories completing supply, such as trolleys,automatic loading systems or product contai-ners, are another important element oftenunderestimated by the buyer, but a well-known value to those who use them every day.In this field too, deep understanding of theprocesses and of the corresponding criticalitiesin application has guided us in designing andmanufacturing components and systems thathave absolutely unique features. These pro-ducts are entirely made of stainless alloys, compatible with the pharmaceutical applic-ations for which they are earmarked and are

designed to be maintained and managed at avery low cost.Specific applications require designing custo-mized solutions which do not force the end-user to adapt process to the limitations of thecontainers or the loading systems typicallyused.Our experience is available to customers asregards the design and manufacture of therequired accessories, configured so as to per-fectly fit to machines and facilities, ensuringfull satisfaction of any integration require-ment, including with existing machines.

Dense-phase fluidsThis category includes plants and machines for dif-ferent processes using supercritical or liquid CO2 as asolvent (with operating pressures typically varying bet-ween 60 and 600 bars).After introducing this production differentiation in theearly 1990s, Fedegari developed and improved originaland particularly safe technical solutions, despite thelimited knowledge available in this field, owing to therestricted diffusion of the technology at the time. For this purpose, the experience acquired by Fedegariin its traditional activities turned out to be decisive andallowed to reuse - albeit with appropriate modifications- technical solutions that had been tested over years offield operation.Unlike sterilization, Fedegari introduced this new tech-nology successfully thanks to its co-operation with na-tional and international research centres, with years ofexperience in this field and still acknowledged asbenchmark organizations today.These processes mainly offer two advantages: lack ofenvironmental impact and "purity" of the extracts,which do not contain solvent residues or show any deterioration due to high process temperatures.

Special ApplicationsThis category includes plants or plant sub-systems ear-marked for niche applications, where standard ma-chines are no longer sufficient.In the past, some of these machines were developed inclose collaboration with customers so as to meet withparticular production requirements. On verification of design and construction validity,some of these machines are now on offer as standardmodels, although type of application restricts their useto cases of actual need.Some of the most significant examples are steam steril-izers with a washing and sterilization cycle for elasto-meric closures, processes for sterilizing high pathogenrisk materials, sterilizers with rotating loads and plantswith liquid or supercritical CO2 for special applic-ations. These designs best represent the co-operationbetween customers and supplier, implying mutual ack-nowledgement of respective skills.Results achieved have enabled both to develop thetechnology of their own products and to thus growover time, often imitated by those lacking the courageand passion to explore new paths while guaranteeingthe final result, merely offering whatever is requested.

OvensIntroduced to diversify production at the end of the1980s, ovens are a significant percentage of Fedegari’soutput.Like autoclaves, they are batch-type sterilizers, butunlike autoclaves they operate at atmospheric pressure.Since they do not have a pressure vessel, ovens do nothave the design and manufacturing complexities typic-al of autoclaves.Nonetheless, two aspects, such as temperature uniform-ity and particle contamination class, are particularlycritical to achieve and are distinctive of the manufact-urer.In particular, as regards Fedegari sterilizers, the achiev-ement of class 100 throughout the process is a keyaspect, as well as a distinguishing factor, which alsorequired the creation of specific air sampling devices.For manufacturing these devices, Fedegari was able torely on collaboration with national research institutesalready active in this field.As in the case of autoclaves, development of originalconstruction and process solutions enabled Fedegari todetermine new benchmark standards also for thesesterilizers.

the ProductsINDUSTRIAL STEAM STERILIZERS

INDUSTRIAL STEAM STERILIZERS WITH

INTEGRATED PROGRAMS FOR COMPLETE

ELASTOMERIC CLOSURES TREATMENT

INDUSTRIAL STEAM STERILIZERS WITH

INTEGRATED PROGRAMS FOR WASHING

VARIOUS LOADS

INDUSTRIAL STEAM-AIR-MIXTURE STERILIZERS

INDUSTRIAL SUPERHEATED WATER SPRAY

STERILIZERS

INDUSTRIAL ETHYLENE OXIDE STERILIZERS

STERILIZATION AND DEPYROGENATION OVENS

SMALL VERTICAL AND BENCH-TOP STEAM

STERILIZERS

SMALL PORTABLE STEAM STERILIZERS

FOR FIELD HOSPITALS

PILOT AND INDUSTRIAL PLANTS

FOR VARIOUS PROCESSES USING LIQUID

AND SUPERCRITICAL CO2

LOGISTIC SYSTEMS FOR INDUSTRIAL

STERILIZERS

ACCESSORIES AND COMPONENTS

SUPPORT SERVICES FOR QUALIFICATION

AND VALIDATION OF PLANTS, TRAINING,

PREVENTIVE MAINTENANCE

SERVICES FOR DEVELOPING AND OPTIMIZING

DEDICATED PROCESSES

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.

FEDEGARIAUTOCLAVI SSPPAA

ALBUZZANO (PV) - ITALIA - TEL. +39.0382.434111- FAX +39.0382.434150

www.fedegari.com

d e s i g n : i m a g i n a r e • p h o t o g ra p h s : v i t t o r i o d o z i o