COST-EFFECTIVE TURN-KEY INTEGRATED SOLUTIONS

FOR CONTAMINATION CONTROL

Fedegari Autoclavi SpA is the holding company of anItalian industrial group manufacturing customizedmoist- and dry-heat sterilizers, chemical bio-decontamination units, combined washer-sterilizers,closures processing systems and contaminationcontrol solutions for bio/pharma and food industries.

For many years now, Fedegari has been considered thereference manufacturer in the field of sterilization byvirtue of the many innovations that it has introduced ini 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 extremeverticalization of the company, which always rejectedthe idea of assembling sophisticated machines withstandard components (designed for a variety ofapplications) but always sought to engineer andmanufacture components and technologies in-house,to acquire always deeper knowledge of the machinesand innovate them always faster than anybody else.

THE COMPANY

TURN-KEY INTEGRATED SOLUTIONSFOR CONTAMINATION CONTROL

INTEGRATED SOLUTIONSTrainingEngineering

WashingSterilization

Bio-decontamination

Depyrogenation

Automatichandling

Isolationtechnology

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&DCustomized

ProcessDevelopment

AutomationProcess control

SERVICES

• Layout studies to meet strict space requirements • Sizing of handling solutions to achieve optimalproduction capacity • Highest flexibility in equipment sizing

• Supervision system monitors an entire manufacturing facility through one single interface • Integratedplatform 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

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

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

MOIST-HEAT STERILIZATION

Terminal sterilization & Part processingFOF 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.

LiquidsTerminal sterilizationFOA 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 orSuperheated 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

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

DRY HEAT STERILIZATION &DEPYROGENATION

FOD ISO 5 - class DHSsFedegari 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

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.

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 unitwith built-in FHPV

FCDV/FCDM low temperature bio-decontaminationThe 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.

FHC Hepa cart

FCP Down-flow booth

FCTS Sterility test isolatorwith 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

FHPVH2O2 vaporizer

www.fedegari.com

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