The New Fedegari Group of Companies: An Innovative

Transcription

The New Fedegari Group of Companies:
An Innovative Approach to Sterilization & Sterile
Manufacturing Requirements
1. FEDEGARI GROUP OVERVIEW
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 7 companies worldwide employing
approx. 300 people with consolidated revenues of 38
MEUR (ref. FY 2011), 85-90% of which is exported
mainly towards Western Europe, the USA, India and
China.
For many years now, Fedegari has been considered
the world-class reference manufacturer in the field of
sterilization by virtue of the many innovations that it
has introduced in its machines and processes.
Fedegari Autoclavi SpA - Italy
New Inox Srl - Italy
Fedegari Autoclavi SpA • SS 235 km 8, 27010 Albuzzano (PV) Italy • Tel. +39 0382 434111 • Fax +39 0382 434150
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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 faster than anybody else.
Fedegari sells through an international network of
independent representatives, specialized in supplying
machines and services complementary to sterilizers.
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 processing pharmaceutical
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 personnel.
Qualitech Srl - Italy
Fedegari (Suisse) SA - Switzerland
Besides Fedegari Autoclavi SpA, the group is
composed of the following companies:
Fedegari GmbH – Germany
Fedegari Asia Pte. Ltd. – Singapore
Fedegari (Suisse) SA – Switzerland
Fedegari Technologies, Inc. – USA
Qualitech Srl – Italy
New Inox Srl - Italy
Fedegari technologies, Inc. - USA
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2. INNOVATIVE DEVELOPMENTS
Other innovative machines intended to provide a
truly complete and integrated cost-effective
solution to sterile manufacturing facilities are the
FOWS washer-sterilizers the BIER device and the
chemical bio-decontamination units.
2.1 FOWS Ultrawashers
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. Lots of
advantages offered by such an integrated solution
are obvious to those who must guarantee the highest
working standards of pharmaceutical and biotech
manufacturing facilities; let alone the economical
advantages of installing, validating and operating one
machine instead of two.
Compared to traditional impact washers, FOWS
ultrawashers
can
achieve
greater
process
performances thanks to use of steam for improving
cleaning capabilities (thus reducing the need of
detergents and the relevant fast process treatment)
as well as vacuum for drying the load. Eventually, no
sterilization phase is used though it is always
available thus providing an immediate backup when
the autoclave is down for maintenance.
2.1.1 Many opportunities as well as advantages
FOWS washer-sterilizers not only minimize the
negative aspects of automatic washing (such as crosscontamination risks and standardized processes with
limited customization options) but have features that
lead to higher productivity. And from today, you can:
drastically reduce total treatment times and man-hours
needed for load handling
simplify the operating procedures, with a workflow
entailing fewer stages and shorter paths
reduce the number of machines installed on controlledcontamination environments, optimizing the available
space,
reduce plant management as well as validation,
revalidation and maintenance costs
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avoid the transfer of equipment through different
classified areas, eliminating the risk of contamination
between environments
save energy, utilizing the available energy better and for
a shorter time
use loading devices for the materials to be treated, so as
to achieve a repetitive performance (standard loads),
which reduces unexpected events linked to the human
variable
reduce process data management work and provide all
necessary documentation by utilizing the still
unequalled features of the Thema4 process controller.
FOWS ultrawashers don’t offer standardized
solutions, because after many years we are still
convinced that the best results and the most
ambitious goals can only be achieved by applying
design and production skills to every specific case.
Every one of our customers is unique. That is why we
look forward to meeting you, to study together the
ideal solution to your needs and, who knows, perhaps
be spurred to invent new innovative solutions as well.
2.2 Fedegari BIER (Biological Indicator
Evaluator Resistometer)
The BIER device instead, is a patented solution that
can transform a traditional sterilizer into a so-called
BIER vessel. Contrary to the dedicated machines, the
BIER device designed by Fedegari is a component
that can be removed from the sterilizer allowing the
user to operate the machine for its intended
application and productivity. Only when it is needed
to test and characterize the biological indicators
(BIs) in a matter of seconds the sterilizer is readied
for the work. The original idea was in the use of a
sterilizer that has already been validated and whose
performances are already well known. The BIER
device in fact allows the BIs to cross the sterilization
chamber during the sterilization phase thus avoiding
the need to bring the same to sterilization
conditions in the shortest possible time. A prechamber upstream of the sterilization chamber
allows to treat in a fully automatic way any quantity
of BIs without compromising sterilization conditions.
A similar post-chamber located downstream of the
sterilization chamber allows to cool-down the BIs in
the fastest and safest way. Comparative studies
have proven that no dedicated BIER vessel can
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outperform the solution offered by Fedegari. Such
study can be provided upon request.
Furthermore, the BIER device complies with the
following standards and guidelines:
EN 866-3:1999
ISO/CD 11138-3
ANSI/AAMI ST44:2002.
2.3 High-containment doors
In the early ‘80s Fedegari introduced on its
autoclaves the first truly reliable automatic sliding
doors.
The performance of this critical component has been
so successful that short afterwards a modified
version has been developed for those machines that
required a hinge-type operation. Not only. Other
variants have been developed for all the laboratorytype autoclaves, for liquid CO2 machines (operating
at 100 bar) and for the ovens as well. The secret of
this success? An original approach to the project, a
manufacturing infrastructure absolutely unique, the
determination to explore paths that other designers
don’t even consider. On our machines the most
important features a door must have are safety (for
the operator and the process) and tightness. Though
such features seem to be obvious for all the
different makes and guaranteed by every
manufacturer, only those who have gained some
practical experience know that reality is a different
story.
When Fedegari started designing the first
decontamination stations, it was soon realized that
there was no need to re-invent the wheel. It was only
needed to refer to the old project.
The new high-containment doors have been
designed for decontamination pass-through hatches
and air-locks alike but can also be installed on
existing clean rooms or other critical facilities where
a 100%-tightness is required. The door is entirely
made of AISI 304 stainless steel (AISI 316 as an
option), fully welded and machined, free of any
sharp edge and designed for sanitary applications.
The air-tightness is guaranteed by 2 silicone selfretractable inflatable gaskets with a leak-monitor
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system. The gaskets are fed with sterile compressed
air and the system does not require any vacuum for
retracting the gaskets or for assuring tightness. The
system uses the same process interlocks found on
the sterilizers that prevent door operation when not
allowed by the process.
Furthermore, the system is designed to compensate
possible alterations generated by normal wear. Next
time you look at a door, ask yourself if 100% airtightness, safety and reliability are important to you.
If you need a solution, you know where to find it.
2.4 Chemical Biodecontamination Units
In2009 Bio Com Srl has joined Fedegari Group,
adding to this industrial network products and
expertise
in
the
field
of
environmental
contamination control. Thanks to the extended
range of capabilities, Fedegari is now structured to
offer fully integrated turn-key projects combining
innovative customized process machines and
complete solutions for highly cost-effective projects
in the area of pharmaceutical clean & sterile
production.
The most sophisticated process equipment jointly
developed is the FCDV/FCDM pass-through hatch for
bringing inside the clean rooms all those products
and instruments that cannot be thermally sterilized.
In these machines surface decontamination of the
goods is carried out with a variety of processes and
sterilants (such as vaporized H2O2) and extensive
validation studies have proven the reliability of the
equipment and the design.
Like all other sterilizers manufactured by Fedegari,
the pass-through hatches too are designed in a
variety of dimensions to match every enduser
requirements. What makes these machines unique
however, is the general design that foresees the use
of proprietary components and solutions in general
as found on all other Fedegari products. This
approach guarantees a higher degree of system
reliability (having these solutions been field tested
for years), higher performances and cost-savings due
to the standardization of the same throughout the
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various machines offered by Fedegari. Even the
process controller is the same Thema4 found on all
Fedegari machines. In fact, not only the hardware
but the software too is exactly the same, being only
the process phases different from one type of
sterilizer to the other. The consequence is that no
further training of operators is necessary and when
it comes to validation… nothing beats Thema4.
2.5 The Thema4 Process Controller
First delivered 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
industrial machines manufactured by Fedegari.
This achievement is the logical consequence of
almost three decades of painstaking work on
process controllers combined with infrastructure
investments, close collaboration with strategic
partners and uncompromised values because there
is no easy shortcut to durable success.
Thema4 in fact, is the natural evolution of the
previous generation of controllers (like Thema3 and
SuperSpectra before that), that were based on
custom-made hardware. While Thema4 has inherited
the process management principles of its
predecessor, it is absolutely different in terms of
hardware
components
(COTS),
software
architecture, HMI and general and integration
functions.
With Thema4, Fedegari assures the commercial
availability of standard components, the integration
levels required in modern pharmaceutical plants
together with functions and performances to meet
quality and safety standards of those production
processes for which the application is intended.
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In order to guarantee the highest system reliability
Fedegari has chosen Wind River VxWorks real time
operating system (RTOS). Wind River is a world
leader in embedded and mobile software. It has
been pioneering computing inside embedded
devices since 1981 and its technology is found in
more than 1 billion products. The VxWorks Edition
with a set of functional modules allows Fedegari’s
customers to choose the combination of functions
that best fits their specific needs. Fedegari adopted
VxWorks because this commercial RTOS has the
ability to manage a wide range of hardware devices
and ensures robustness, reliability and versatility
meeting
the
company’s
critical
business
requirements.
In order to meet the most demanding
pharmaceutical requirements, great care has been
taken in designing Thema4 life cycle management:
from the conception phase to components selection
and definition of system architecture and project
management, through the project phase in the
development of software according to the FDA 21
CFR, part 11, to the current operation phase and the
definition of product management procedures
(change control, configuration management,
support, repair, maintenance, etc.) according to the
GAMP guidelines.
Setup and configuration
Now, after continuous improvements of software
and hardware components, functions and processes,
Thema4 finds itself in the maturity of the operation
phase and the reference guideline for its
management is the GAMP 5.
Several new software versions are released every
year that include those developments requested or
suggested by our end users. That’s why investing in a
sterilizer with a Thema4 process controller allows
the buyer to capitalize on decades of cumulative
experience
in
managing
pharmaceutical
manufacturing processes developed for the most
demanding companies worldwide.
Process summary
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An extensive team of experts assures that the
controller is constantly innovated and manages all
new developments in accordance with the end users
needs and the adopted GMP standards.
2.6.1 Thema4 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 (Allen-Bradley, Siemens and Digital
Proface)
client-server Ethernet/TCP-IP architecture: multi-station
system with local and remote interfaces (MS Windowsbased) 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, distributed on the machine by means of fieldbus
protocols for easier I/O configuration, connection,
diagnostic and maintenance
management of wireless temperature sensors for
application requiring product loads free from wires
GUI, touch-screen, Windows-style, multi-languages and
multi-user and platform-independent
localization: time-date format, measure units and foreign
languages (Chinese, Cyrillic and other customized
languages)
product life cycle according to GAMP 5 approach
native compliance with FDA 21 CFR, part 11
full continuity with previous Fedegari controllers:
revamping policy with low impact on current process
management and validation
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
bar code reader for automatic selection of processes
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.
automatic and fully configurable export of reports and
data, in several standard flat file format: PDF, TXT, XML,
etc.
integration with plant utilities control systems
integration with external recorders: display and reporting
of recorder sensors in Thema4 process summary/report,
with configurable comparison alarms between control and
monitoring sensors
Input/Output logical view
Process report
Alarm configuration
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special architectures based on alternative interfaces
(SCADA, WIN_GUI, etc.) to meet end user requirements on
HMI and reporting standardization
Thema4-EL: entry level version of Thema4 with a reduced
number of functions, for non-GMP applications
complete validation document packages released to the
end user, to provide clear evidence of quality approach in
system life cycle management and to support end user in
system qualification
electronic signature
golden cycle package & Parametric release table
automatic load handling system for any type of sterilizer.
Online manual
2.6.2 Process:
process software architecture based on extensive and
modular library of elementary process phases, that include
all processes developed from the end of the 1980s until
today, ensuring unrivalled completeness, flexibility, safety
and performances
several fully configurable and validated processes, for
multipurpose or dedicated machines, covering all
applications: sterilization, tindallization, decontamination,
depyrogenation, washing and disinfection
user-friendly configuration of complex and sophisticated
processes, by means of simple operations (sequencing of
phases and variable parameters setting)
integrated Sartorius WIThin technology and integration
(through driver) with Palltronic devices for automatic air
filter integrity test
advanced air detector and filter maintenance
parametric release functions integrated in cycle
management:

Cycle critical parameters table: automatic
analysis during cycle execution of “critical
parameters” through user configurable phases
and verification if the values do not exceed
pre-set tolerances; generation of electronic
reports with acceptance criteria (parametric
release table available for SCADA and historian
systems)
Golden
Cycle:
comparison
of
the
temperature/pressure profiles of the executed
process (using internal and/or external
selected sensors) and the user-defined “ideal
profiles” (as based on validated processes) and
generation of an electronic report with
comparison data in graphical and analytical
format
Golden cycle
Automatic load handling
process integrated sensors auto-calibration.
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2.6.3 Maintenance:
easy, fast and reliable disaster recovery procedure
teleservice and remote access to machine by network
router-firewall (VPN tunneling), with high level of security
and reliability
manual and automatic backup/restore functions on plant
network server
Fedegari Maintenance Integrated Service workstation which,
by continuous gathering of operation data, provides an
adaptive maintenance information:

programmed maintenance plan alerts
problem warning and troubleshooting tools
based on FMECA and RCM analysis
preventive maintenance of critical components
by dedicated sensors/functions
integration
with
Fedegari
maintenance
knowledge base center for improved end usermanufacturer cooperation, for increasing the
engineering reliability and maintenance
reliability.
The panel-PC is a high-performance industrial PC,
with touch-screen (TFT color LCD) typically installed
on the front fascia of the machine.
Additional PCs (Windows) already connected to the
company Ethernet LAN can also be used as remote
clients or in special configuration, installed on the
machine (side 1 or 2). Process report can therefore
be printed on any network A4 printer.All process
data, in addition to the requirements of FDA 21 CFR,
part 11, are retained securely and in a tamper-proof
manner on the panel-PC, which acts as a server, and
can therefore be transferred from the panel-PC to
the company LAN for paperless management of the
EBR.
Rotating basket
A4 printed process report
3. LABORATORIES PRODUCT RANGE
Fedegari Group designs & manufactures not
only industrial machines, but also laboratory
sterilizers. The Swiss plant is totally dedicated
to the production of serial sterilizers, such as
the laboratory ones. All the critical components
of the lab sterilizers are produced by the
mother company in Italy.
FOB4/FOB5
Configurable steam sterilizers with horizontal
chamber
Chamber capacity: 147 l – 540 l
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FOBxx
Configurable team sterilizers
chamber
FVAxx
Configurable steam sterilizers
chamber
with
horizontal
with
vertical
FVGxx
Steam sterilizers with vertical chamber
FVSxx
Steam sterilizers with vertical chamber
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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 of 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.
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)
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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
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