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PROCESSES
Sterilization
Washing
Chemical bio-decontamination
Contamination control
Dense-phase fluids plants
SPECIAL APPLICATIONS
Rotating sterilizers
Pharmaceutical closures processing
COMPONENTS
Pressure vessels
Doors
Piping
Process controllerWireless Sensors
ACCESSORIES
Un/loading conveyors
Customized racks
fedegari.comDOC. 276455.1/09.03.2012
SPAAUTOCLAVI
EN.3.4.1
Thema4 Sterilizer Process Controller
After more than fifty years in the business, Fedegari still holds an unquestionable technological supremacy among sterilizer manufacturers worldwide. This achievement stems exclusively from its tireless commitment to control every detail of its products and processes.
A unique feature of Fedegari is the extreme verticalization of the company, which has always rejected the idea of assembling sophisticated machines with standard (COTS) components rather designed for a variety of applications. Every component or sub-system is designed and produced in-house with the precise goal to understand its function and develop the solution most suitable for the specific application.
Such aspects are, typically, not adequately considered by buyers who lack hands-on experience with production machines and are often easy prey for commercial arguments that only deal with marginal logistic aspects - such as component standardization - neglecting the real reason why a sterilizer is bought: to sterilize reliably for several years.
It is easy to think that all sterilizers are capable of the same performances, especially if built using the same components. However, it is more difficult to measure and understand
what really makes a difference.
All Fedegari machines are equipped with the Thema4 process controller - independently of the type of process or technology - thus allowing to have a wide range of machines all running with the same software with the obvious advantages for the users.On such a critical machine like a sterilizer the process controller is a very sensitive component. Absolute safety cannot be compromised by improvisation and the system
must be 100%-tamper-proof. Thema4 is without any doubt the most complete and reliable controller money can buy today.
Thema4 Process Controller
Thema4 Process Controller
CONTACT US:
ItalyFedegari Autoclavi SpASS 235 km 827100 Albuzzano (PV) T +39 0382 434111F +39 0382 434150E [email protected]
GermanyFedegari GmbHLehrer-Götz-Weg, 1181825 MunichT +49 89 42044920F +49 89 42044918E [email protected]
RussiaFedegari Autoclavi SpA
c/o Goldex Group14, Dorogobuzhskaya st bld.4121354 MoscowT +7 495 6453012F +7 495 6453012E [email protected]
SingaporeFedegari Asia Pte. Ltd.8, Boon Lay Way#03-16 - Tradehub 21609964 Singapore T +65 6 3164761F +65 6 8967365E [email protected]
SwitzerlandFedegari (Suisse) SAVia alla Gerra, 116930 BedanoT +41 91 9352090F +41 91 9352099E [email protected]
USAFedegari Technologies, Inc.174 N Main StreetSuite C3, PO Box 115018917 Dublin (PA) T +1 215 2499900F +1 215 2493427
fedegari.com
Thema4 inherits the experience of Fedegari with its previous generations of electronic controllers and is still based on that general software architecture that generates a recipe by sequencing the basic elements (phases) of the process and still is in fact the only controller designed from scratch to meet the rigorous requirements of the pharmaceutical industry. It naturally integrates with the SCADA and MES systems most typically used and is natively compliant with GAMP5 and FDA 21 CFR, part 11 guidelines. It is designed on an open client-server architecture with a standard Ethernet/TCP-IP communication protocol, with the server and the first client installed in a panel-PC (HMI) located on the loading side of the machine. Additional remote clients can therefore be connected to the server over an Ethernet network in order to meet any requirement of the user.
All process data, in addition to the requirements of FDA 21 CFR, part 11, are securely retained and in a tamper-proof manner on the HMI, and can therefore be transferred to the company LAN for paperless management of the process reports of every batch.
Fedegari developed the control system software on Wind-River Platform for Industrial Devices, VxWorks Edition, which is a commercial RTOS (real-time operating system) with the ability to manage a wide range of hardware devices.
Thema4 has a intuitive GUI and requires only a short training for the operators. GUI works in MS Windows environment so our customers can easily install any relevant A4 ink jet printer. It is capable of managing multiple tasks simultaneously and can
be retrofitted on all old machines as well thus extending the life cycle of those machines difficult to be replaced.
Thema4 facts:• Fedegari has been the pioneer
in developing controller software in the early 80s
• Totally immune to viruses because not based on Windows or similar OSs
• The only controller assigned to control every Fedegari machine
• User-friendly, color touch screen with Windows-like operation
• Based on COTS hardware• Practically unlimited memory
and storage capacity• Full functionality open to customers
under password control• Exporting data in Flat File standard
format (PDF)• Automatic backup facility• Integration with customer’s system• Many different software options such as:
Golden Cycle Package, Parametric Release Table, Validation Package, Handling System Monitor, Electronic Signature, Thema4 Recorder and much more.
