Fedegari Group - Company profile - Passion for sterilization

COMPANYP R O F I L E

CIP-274307

Fedegari Autoclavi SpA • SS 235 km 8, 27010 Albuzzano (PV) Italy • Tel. +39 0382 434111 • Fax +39 0382 434150 fedegari.com

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1. BRIEF PRESENTATION OF THE GROUP Fedegari Autoclavi SpA is the holding company of an Italian industrial group manufacturing customized 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 Giampiero 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 then 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. 300 people with consolidated revenues of 50 MEUR (ref. FY 2013), 85-90% of which is exported mainly towards Western Europe, the USA, India and China. For many years now, Fedegari has been considered a world-class reference manufacturer in the field of sterilization by virtue of the many innovations that it has introduced in its machines and processes. A unique feature of Fedegari is the extreme verticalization of the company, which always rejected the idea of assembling sophisticated machines with standard components (designed for a variety of applications) but always sought to develop and produce components and technologies in-house, so as to acquire always deeper knowledge of the machines and innovate them always than anybody else. Fedegari sells through an international network of independent representatives, specialized in supplying machines and services complementary to sterilizers.

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2. ORGANIZATION OF THE GROUP Today Fedegari is a highly dynamic industrial group controlled by the family, ready to tackle the challenges of a global technological scenario. Fedegari is capable of offering innovative solutions for clean and sterile processes (from sterilizers to decontamination units, through washer-sterilizers and special systems for elastomeric closures) both in terms of products and in terms of pre- and after-sales support all over the world. In fact, in recent years Fedegari has extended its products range, thanks to the acquisition of Bio Com Srl, a company specialized in chemical bio-decontamination processes and contamination control. Nowadays, Fedegari is still investing in the development and acquisition of innovative technologies, expansion of services, innovation in production facilities and in ongoing training of its personnel. Besides Fedegari Autoclavi SpA, the group is composed of the following companies: 2.1 Fedegari (Suisse) SA (former Fedegari Autoklaven AG) Originally established in the Seventies near Lugano (Switzerland), in 2001 the company moved into the current headquarters in Bedano, with 3500 m2 of indoor production floor-space and about 30 personnel employed. Fedegari (Suisse) manufactures all the serial production machines like the complete range of laboratory sterilizers. These machines are assembled with all the critical components manufactured by the mother company in Italy. Moreover, Fedegari (Suisse) is responsible for the sale of the aforesaid machines and for the relevant after-sales services world wide. Fedegari (Suisse) also manufactures other components and accessories for the mother company. 2.2 Fedegari GmbH Founded in 2011 in Munich, Fedegari GmbH was created with the specific purpose of supporting directly a strategic market like Germany. Fedegari GmbH is the official distributor for all Fedegari products (industrial & laboratory) in Germany and supports the other German-speaking markets. Fedegari GmbH, through its own commercial and technical personnel, provides in a more direct way all the support needed to offer, sell and service any Fedegari product in these countries. 2.3 Fedegari Technologies, Inc. Since the early Eighties Fedegari has been operating on 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. has the goal to support North American customers directly with its own commercial and technical personnel.

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In 2012 Fedegari Technologies will move into its new facility with a brand new technical center suitable to simulate sterilization processes with dedicated equipment as well as specialized training to all local customers. 2.4 Fedegari Asia Pte. Ltd. Fedegari Asia was founded in 2008 in Singapore in order to improve the insight of Fedegari into Asian markets. Although Fedegari has operated for a long time in this part of the world with its widespread network of local representatives, the company now offers even more direct support to this market, which is currently the most dynamic one with the fastest growth rate. Other than commercial support, Fedegari Asia guarantees the presence of skilled technical personnel for after-sales support and a spare parts warehouse. 2.5 Qualitech Srl Established in 1999 with two experienced partners, the company provides all after-sales services to Fedegari products worldwide. It is impossible to attain the highest performances from any machine without a solid understanding of the same and a regular maintenance. Qualitech personnel is the most skilled you can find on the market, simply because every single technician or engineer is trained on Fedegari products only. Qualitech can provide the complete range of services from installation to qualification/validation to any customized service agreement. 2.6 New Inox Srl New Inox was opened in 2003 as a joint venture with partners of Fedegari with the goal of providing specialized field services where structural works are needed. This specialization is requested where special machines and plants are installed or where structural modifications (like those typical of a revamp) are carried out. 2.7 Strategic partnerships Besides the companies belonging to the group, Fedegari can rely on 2 commercial partners (Steritech Ltd. in the UK & Steritec SA in Belgium) and on about 50 regional representatives all over the world that act as system integrators and are a benchmark in their own countries for Fedegari philosophy, values and products. For further information: www.steritech.co.uk and www.steritec.be Moreover, Fedegari is also partnering with other companies and organization on different projects around the world, such as for instance The Pharmopolis project in Russia for the development of a pharmaceutical production cluster not far away from Moscow. What all these projects share is the continuous development of technology for the achievement of new goals. Fedegari is always present where the bio-/pharmaceutical industry is looking at new investments providing support and advise about future developments of sterilization technology.

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3. PRODUCTS RANGE Fedegari offers a wide range of products and innovative solutions to meet the most demanding requirements in the field of sterilization, cleaning and decontamination. 3.1 Industrial range

FOFxx Saturated steam sterilizers

FOAxx Steam-air mixture sterilizers

FOWxx Water-cascade sterilizers

FOWSxx Washer-sterilizers

Sterilizers with rotating loads

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Integrated solutions for pharmaceutical closures

processing

BIER (Biological Indicator Evaluation Resistometer)

devices

FODxx Sterilization & depyrogenation

ovens

FCDVxx-FCDMxx Chemical bio-decontamination

units

FCPxx Down flow booth

FCTSxx Sterility test isolator

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FHCxx Laminar flow mobile safe-carts

3.2 Laboratory range

FOB4/FOB5 Steam sterilizers with

horizontal chamber

FOBxx

Steam sterilizers with horizontal chamber

FVAxx Steam sterilizers with vertical

chamber

FVGxx Steam sterilizers with vertical

chamber

FVSxx Steam sterilizers with vertical

chamber

3.3 Healthcare range

FELDAUTOKLAV H2000xx Steam sterilizers for mobile

field applications

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4. AFTER-SALES SERVICES

The After-Sales Department of Fedegari is responsible for any issue that arises after the delivery of any machine. This department may support the final end-user or the local representatives by providing any part or service needed during the entire life cycle of all the machines in the field. According to the specific operation requirements of every end-user all services can be customized with the aim of assuring the highest level of productivity. Through this department proposals can be prepared for revamping older machines or for upgrading process controllers to the latest generations. All these services extend the operating life of the machines to the limits of the most critical components (such as the pressure vessels for the autoclaves) thus increasing the return of the original investment. One of the services with the highest added value is the assistance to the customers in the final phase of validation. Often in fact, sterilizers are validated by personnel that has no deep experience with the specific sterilizer and once all processes and load configurations have been validated nobody is willing to do any effort to optimize process performances. In several cases we have helped – thanks to the expertise of our service personnel – to optimize their processes before validation is complete, thus achieving the highest performances. This little investment pays big dividends during the entire life cycle of the sterilizer. 4.1 Services offered:

installation/startup/commissioning qualification (IQ/OQ/PQ) FAT & SAT process/load optimization validation preventive maintenance plans on-demand maintenance services revamping of old machines process controller updating (SW e HW) microbiological tests washing tests training courses:

- sterilization - validation of the sterilization process - chemical bio-decontamination - validation of chemical bio-decontamination processes - troubleshooting activity for specific problems - norms and regulations - deepening analysis and comprehension of phase groups present on specific Fedegari machines - metrology

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5. FEDEGARI GROUP For any further information and to better explore the world of Fedegari, do not hesitate to contact us at the following addresses: Italy, Headquarter Fedegari Autoclavi SpA SS 235 km 8 27010 Albuzzano (PV) Italy T +39 382 434111 F +39 382 434150 [email protected] fedegari.com

Germany Fedegari GmbH Leher-Götz-Weg, 11 81825 München Germany T +49 89 42044920 F +49 89 42044918 [email protected] fedegari.com

Russia Fedegari Autoclavi SpA c/o Goldex Group Dorogobuzhskaya St., 14, Bld. 4 121354 Moscow Russia T +7 495 6453012 F +7 495 6453012 [email protected] fedegari.com

Singapore Fedegari Asia Pte. Ltd. 8, Boon Lay Way #03-16 – Tradehub 21 609964 Singapore Singapore T +65 6 3164761 F +65 6 8967365 [email protected] fedegari.com

Switzerland Fedegari (Suisse) SA Via alla Gerra, 11 6930 Bedano Switzerland T +41 91 9352090 F +41 91 9352099 [email protected] fedegari.com

USA Fedegari Technologies, Inc. 174 N Main Street Suite C3, PO Box 1150 18917 Dublin (PA) USA T +1 215 2499900 F +1 215 2493427 [email protected] fedegari.com

Italy Qualitech Srl SS 235 km 8 27010 Albuzzano (PV) Italy T +39 382 480016 F +39 382 481126 [email protected] qualitechsrl.com

Italy New Inox Srl Via Europa, 3/5 27010 Filighera (PV) Italy T +39 382 583132 F +39 382 583528 [email protected] newinox.com

Fedegari Group - Company profile - Passion for sterilization

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