Fedegari Autoclavi SpA is an Italian manufacturer of sterilization, bio-decontamination, and contamination control solutions for the bio/pharma and food industries. They offer turn-key integrated solutions including moist heat and dry heat sterilizers, washer-sterilizers, hydrogen peroxide vaporizers, and isolation technologies. A unique feature is their extreme vertical integration and in-house engineering/manufacturing of machine components and technologies.

1. COST-EFFECTIVE
TURN-KEY INTEGRATED SOLUTIONS
FOR CONTAMINATION CONTROL

2. Fedegari Autoclavi SpA is the holding company of an
Italian industrial group manufacturing customized
moist- and dry-heat sterilizers, chemical bio-
decontamination units, combined washer-sterilizers,
closures processing systems and contamination
control solutions for bio/pharma and food industries.
For many years now, Fedegari has been considered the
reference manufacturer in the field of sterilization by
virtue of the many innovations that it has introduced in
i t s m a c h i n e s a n d p r o c e s s e s .
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 engineer and
manufacture components and technologies in-house,
to acquire always deeper knowledge of the machines
and innovate them always faster than anybody else.
THE COMPANY

3. TURN-KEY INTEGRATED SOLUTIONS
FOR CONTAMINATION CONTROL
INTEGRATED
SOLUTIONSTrainingEngineering
WashingSterilization
Bio-
decontamination
Depyrogenation
Automatic
handling
Isolation
technology
The recent evolution of Fedegari is mostly evident in integrated projects
where various process machines interact with robotized handling systems
for fully automatic high-throughput manufacturing lines. These solutions
are totally managed and controlled by Thema4 supervision system, the
process controller engineered and developed by Fedegari, fully
integrated to SCADA system.
R&D
Customized
Process
Development
Automation
Process
control

4. SERVICES
• Layout studies to meet strict space requirements • Sizing of handling solutions to achieve optimal
production capacity • Highest flexibility in equipment sizing
• Supervision system monitors an entire manufacturing facility through one single interface • Integrated
platform with scalable architecture for adapting the installation to the ever changing requirements
• Control efficiency eliminates errors while operating cost-effectively
• Lab facilities for customized process development • Primary/secondary packaging testing solutions
• Overall process optimization
• Customized classes on any subject related to sterilization technology, chemical bio-decontamination
use or maintenance of the machines • Various Tech Centers around the globe equipped with different
machines and dedicated automation training rooms • Conference room with a capacity of up to 100 people
Automation
Training
R&D
INTEGRATED
Engineering

5. PROCESS CONTROL
Integration:
Thema4 + SCADA
Thema4
First introduced at the beginning of 2004, Thema4 is today the
most reliable and fastest-developing process controller in the
industry, period.
Thema4 is defined as a completely configurable standard product
(classified by GAMP 5 as Category 4 - Configured Products) and is
managing all the machines manufactured by Fedegari.
Rotating basket
Main features and functions
• high performance, fully validated control system, with the highest level of
flexibility and configurability to fit all end users needs
• COTS hardware (B&R, Allen-Bradley and Siemens)
• client-server Ethernet/TCP-IP architecture: multi-station system with local and
remote interfaces (MS Windows-based) for complete monitoring, control and data
collection of the machine
• PC-based process controller working with a high-end RTOS (Wind River VxWorks),
that guarantees safety, robustness, reliability and performances
• distributed I/Os with flexible solutions using active I/O blocks, through fieldbus
protocols for easier I/O configuration, connection, diagnostic and maintenance
I/Os logical view

6. PROCESS CONTROL
Process report
Main features and functions
• GUI, touch-screen, Windows-style, multi-languages, multi-user
and platform-independent
• localization: time-date format, measure units and foreign
languages (Chinese, Cyrillic and other customized languages).
• native compliance with FDA 21 CFR, part 11
• open system for easy integration with plant network systems
(SCADA, MES, DCS, recorder, PMS, database, etc.) by standard
Ethernet protocols (OPC, Modbus, TCP-IP, SOAP)
• management of remote archives (of GMP data) by means of
the SQL access to plant central database
• direct integration with plant network services: remote user
authentication for integration with central domain control by
MS Active Directory protocol, SNTP clock synchronization with
DST management, etc.
• golden cycle package & parametric release table
• automatic load handling system for any type of sterilizer.
Golden cycleAutomatic load handling
Alarm configuration

7. MOIST-HEAT STERILIZATION
Terminal sterilization & Part processing
FOF series - saturated steam sterilizers
Saturated steam sterilization is the simplest, cheapest, and most flexible process for
treating most of the products and items ordinarily used in the pharmaceutical world.
FOF-Series represent the most versatile solution in sterilizers, suitable for solids and
liquids as well. The high operating flexibility of these autoclaves arises from the
intrinsic characteristics of the saturated-steam process, from the features of the
autoclave's construction and from the process controller's flexibility.
< 100ml
Special applications
Pharmaceutical
closures processing
A special feature - one which used to be opposed but is now adopted by other
manufacturers as well - is the control of the sterilization phase according to a pressure
signal, rather than temperature. Obviously, the temperature readout varies as a function
of the position of the sensor, whilst the pressure is uniform throughout the chamber.
However, process control is performed by reading in the chamber (and from inside the
product) temperature signals whose match with the pressure value, as constantly verified
by the controller, demonstrates that the autoclave is operating correctly. This principle,
in saturated-steam conditions (when there is a two-way T/P correspondence) allows to
obtain uniformities in sterilization temperature which are far better than the currently
required level of ± 0,5 °C.

8. Liquids
Terminal sterilization
FOA and FOW series
Sterilization of aqueous solutions in sealed containers (such as LVPs of
different formats, vials, PFS, blister packs, etc.) share a well-known common
problem: during the process they develop a pressure inside the primary
container higher than the pressure of saturated steam at the same
temperature. More critical than the phenomenon itself are the
consequences on the product and/or the container itself. Some of the most
important features of these sterilizers are related to the control of critical
process parameters designed to assure the highest flexibility in process
control to prevent any undesired deformation/damage of the containers,
while providing the desired thermal treatment to the product.
Steam-Air Mixture or
Superheated Water?
The final choice is dictated by process needs downstream of sterilization:
• Does the load need to be dry?
• Does the container show any sign of hydration?
• How can the highest productivity be achieved?
• Are other loads to be sterilized through the same machine?
MOIST-HEAT STERILIZATION
> 100ml

9. Rotating Loads
The load constantly rotates by virtue of a special drum
which revolves inside the chamber - which contains the
trolleys. The drum is rotated through a magnetic coupling
and its speed, direction and intermittent motion can be
adjusted.
Some of the most typical applications are the treatment
of suspensions, emulsions and various food products
FOW - Superheated Water Process
Water is continuously circulated through the
system and sprayed over the load. Fine control of
heating and sterilization is achieved by
superheating the water using modulated steam.
Load cooling is achieved by subsequent cooling of
the circulated water. Counter-pressure control is as
per the steam-air mixture process. The process is
efficient and faster than the FOA process. It is also
an ideal process for <105 °C processing. Wet loads
can be overcome using on automated drying
extension with the installation of specific drying
solutions downstream of the sterilization chamber.
FOA - Steam-Air Mixture Process
Magnetically driven fans force a high rate of
fluid circulation within the chamber. Internal
sanitary hollow plate heat exchangers add
additional heating/cooling capacity whilst
minimizing condensate creation. Steam and
air are injected according to the control
algorithms to finely control the process. This
system is the usual choice where terminally
sterilized products are to be unloaded dry.
MOIST-HEAT STERILIZATION

10. DRY HEAT STERILIZATION &
DEPYROGENATION
FOD ISO 5 - class DHSs
Fedegari depyrogenation ovens are the most performing and cost-effective
solution to discontinuous sterilization needs in the pharmaceutical industry.
The most peculiar features of FOD DHSs are extreme temperature uniformity,
regardless of dimensional variables, and particulate contamination.
Temperature uniformity is the obvious consequence of Fedegari expertise in
thermal process control. Particulate contamination control originates from
complex fluid dynamic studies and a historical technical collaboration with
Camfil, the world leader manufacturer of HEPA filters. This collaboration has
generated a much deeper understanding and the optimization of the critical
tempering process of the filters.
As a consequence, today Fedegari can guarantee the unequalled performances
at the high-temperature HEPA filters of its DHSs like no one else.
What characterizes Fedegari DHSs compared to alternative products?
• process performance (particle contamination, temperature uniformity,
process repeatability)
• specific engineering and manufacturing features of these sterilizers common
to all Fedegari machines
• the use of common components, such as the process controller, electrical and
piping devices that guarantee time and cost-savings on training and
maintenance due to standard procedures.in collaboration with

11. WASHING & STERILIZATION
Fully customized washing racks
FOWS washer-sterilizers
The FOWS is a machine capable of combining two processes in one thus
eliminating various phases related to the handling of machine parts, tanks,
hoses, etc. used in sterile environments.
 FOWS minimizes the negative aspects of automatic washing (such as cross-
contamination risks and standardized processes with limited customization
options)
 drastically reduces total treatment times and man-hours needed for load
handling
 simplifies the operating procedures, with a workflow entailing fewer stages
and shorter paths
 reduces the number of machines installed optimizing the available floorspace
 reduces plant management, validation, revalidation and maintenance costs
 avoids the transfer of equipment through different classified areas,
eliminating the risk of contamination between environments
 reduces process data management work and provide all necessary
documentation by utilizing the still unequalled features of the Thema4 process
controller.

12. FHPV - Hydrogen Peroxide Vaporizer
The Hydrogen peroxide vaporizer - totally engineered and manufactured by
Fedegari - with control loop (PID based), provides superior reliability and
process repeatability for easier validation. This innovative design provides real
time biocide concentration control (over traditional estimated calculations)
and is totally managed by Thema4.
BIO-DECONTAMINATION
FCDx Bio-decontamination unit
with built-in FHPV
FCDV/FCDM low temperature
bio-decontamination
The pass-through hatches of the FCDV and FCDM series are designed for
transferring non-autoclavable material into a clean room with a rapid and
validatable surface bio-decontamination process. This solution is
becoming increasingly critical as the regulators shift their focus away
from traditional moist- and dry-heat sterilization processes to address all
other bioburden risks. Fedegari has applied the QbD-concept to the
development of this innovative project in order to meet the current
approach required by the EMA and the FDA.

13. FHC Hepa cart
FCP Down-flow booth
FCTS Sterility test isolator
with built-in FHPV
 Superior process repeatability
 Drastically reduced validation time
 Significantly reduced operational costs
with non-proprietary consumables
 Silicon self-retractable gaskets for 100% air tightness
ISOLATION TECHNOLOGIES
Transfer hatch
Gloves and leak testing
managed by Thema4
FHPV
H2O2 vaporizer

14. www.fedegari.com
Doc. 363860.3