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Cost-effective Turn-key Integrated Solutions for Contamination Control
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Cost-effective Turn-key Integrated Solutions for Contamination Control - 1

COST-EFFECTIVE TURN-KEY INTEGRATED SOLUTIONS FOR CONTAMINATION CONTROL

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THE COMPANY Fedegari Autoclavi SpA is the holding company of an Italian industrial group manufacturing customized m oist - and dry-hea t sterilizers, chemical biodecontamination 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 fea ture of Fedegari is the extreme verticalization of the...

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TURN-KEY INTEGRATED SOLUTIONS FOR CONTAMINATION CONTROL 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. Process control R&D Customized Process Development Isolation technology Automatic handling INTEGRATED SOLUTIONS

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INTEGRATED SERVICES • Layout studies to meet strict space requirements • Sizing of handling solutions to achieve optimal production capacity • Highest flexibility in equipment sizinz • 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 •...

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PROCESS CONTROL Main features and functions • high performance, fully validated control system, with the highest level of First introduced at the beginning of 2004, Thema4 is today the most reliable and fastest-developing process controller in the industry, period. flexibility and configurability to fit all end users needs 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. • client-server Ethernet/TCP-IP architecture: multi-station system with local and • COTS...

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PROCESS CONTROL 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). Automatic load handling • native compliance with FDA 21 CFR, part 11 • open system for easy integration with plant network systems Golden cycle (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...

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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...

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MOIST-HEAT STERILIZATION 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...

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MOIST-HEAT STERILIZATION 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...

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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 ovens 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 tight collaboration with Camfil, the HEPA filter...

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WASHING & STERILIZATION 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 crosscontamination 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...

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