Fedegari immediately realized that the autoclaves being used at the time in pharmaceutical work were hospital machines which had been modified only in a few details of their operation and proposed the first saturated-steam sterilizer specifically designed for the pharmaceutical industry, introducing

construction and process-control concepts which were absolutely innovative in those years.
This spirit has been a constant trait of Fedegari since then; the company chose to grow thanks to continuing innovation, despite being aware of the risk of being later imitated by many competitors.

Since those early years, and despite the adoption of more specific sterilization processes, such as superheated water spray or steam-air mixture methods, the steam autoclave is still among the favorite staples of Fedegari production. Even today it is still the simplest, cheapest, and most flexible process for treating most of the products and items ordinarily used in pharmaceutical work.

Faithful to its principle of innovation, Fedegari offers this folder to present its saturated-steam autoclaves in their latest development.

PROCESS

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 controller's flexibility.

Every sterilizer is equipped with a water-ring vacuum pump which operates during various steps of the process, such as:
• initial evacuation of the air by vacuum/steam pulses or by steam injection
• constant draining of the condensate which forms in the chamber, according to the principle of "dynamic steam"
• treatments at less than 100°C
• final drying of the loads.

Another special feature - one which used to be opposed but is now adopted by other manufacturers as well - is the regulation of the conditions of the chamber according to a pressure signal, acquired inside the chamber by means of a transducer, rather than on the basis of a temperature signal. 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 acquiring from 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, that is to say, 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. Fedegari can certify this uniformity also thanks to the availability of highly advanced instruments.

The flexibility of the stenlizers of the FOF series once suitable hydraulic and pneumatic accessories have been selected makes them suitable for a very wide range of treatments, some of which are mentioned below:
• Sterilizations of various solid materials.
• Sterilizations of porous materials.
• Sterilizations of filled ampoules + fast vacuum for tightness test.
• Sterilizations of filled ampoules, viols or bottles with cooling by means of a D.I. water spray under a counterpressure of sterile-filte red compressed air.
• Sterilizations as above, with cooling by means of:
- heat-sterilized and cooled D.I. water spray
- circulation of cold mains water in jacket with optional circulation of the air by magnetically driven fan(s).
• Tyndallizations, posteurizations, inactivations.
• Ampoule tightness test with penetration of colored solutions.
• Chamber vacuum/pressure tightness tests.
• Programmed developments of vacuum/steam pulsing and heating/cooling phases.
• Gravity initial air displacement phase.

When treating LVP, especially if stored in deformable containers, it is often convenient to use superheated water spray or steam-air mixture sterilization processes in order to prevent the effects of differential pressures between the inside and the outside of the containers.
Accordingly, we strongly suggest that our Customers discuss every potential application with our experts.

At the some time, Fedegari began to manufacture the fluids piping system using only stainless steel (AISI 316L) and introduced the trapezoidal-section pneumatic gasket and the HC-mill finish of all the openings of the chambers.

And more, our welding methods: by using the latest automatic and robotized systems, over 90% of all the welds on an autoclave of this kind are now performed automatically. This has led to the standardization of construction models which flawlessly withstand the repeated heat and pressure cycles as well as localized and diffuse corrosion.

Depending on the dimensions and/or kind of process, the chambers can have a circular or rectangular cross-section; they have a jacket which surrounds them almost entirely and the inside surface of the chambers is polished mechanically until a roughness Ra < 0.1 µm is achieved.

The doors can be of the automatic sliding type or of the semiautomatic hinged type (FIG. 5-6).
Both versions use the same construction model, with the characteristic outward camber and the same type of patented gasket. It is clear that these constructive solutions are highly sophisticated yet conceptually very simple, being the result of years of experience and of a fair dose of original thinking.
The difference between the two versions lies in the opening method. In the first version, a motor provides horizontal or (in smaller sterilizers) vertical sliding of the door.
In the second version, the motor moves the door through 45°, disengaging/engaging it with respect to the raised elements of the chamber provided for this purpose and leaving it to the operator to manually open/close the door by rotating it on lateral hinges. There is no difference in price between the two versions.

SPECIAL CONSTRUCTIONS

Rotating load (FIG. 1)
The load is constantly rotated by virtue of a special drum which revolves inside the chamber and contains the trolleys. The drum is rotated through a magnetic coupling and its speed, direction and intermittent motion can be adjusted. Some of the possible applications of the system are:
• treatment of suspensions and emulsions
• better performance in vacuum tightness tests for ampoules
• better transmission of heat into/from the load.

Automated loading/unloading systems (FIG. 1)
Our solution is simple and reliable like no other.
The pallets travel on conveyors which have freewheeling rollers mode of solid stainless steel. A rock-rod, coupled with a motor provided with a pinion outside the autoclave, automatically pushes the load into the chamber or pulls it out. The entire system requires no lubrication.

Loading surface at floor level
This solution is sometimes required to allow direct loading/unloading of the chamber by using external/internal trolleys and requires on installation pit.

Complete elostomeric stopper treatment
This treatment includes washing, rinsing, siliconizing, sterilization, thorough drying and automatic unloading into the sterile area.
The method uses a special drum which is slowly turned inside the autoclave chamber by a magnetic coupling. The special internal shape of the drum ensures:
• highly effective washing, siliconizing and drying
• automatic unloading of the product into the sterile area by reversing the direction of rotation and by means of the special self-sterilizing chute installed on the unloading door.

PROCESS CONTROLLER

A computerized system (described in a separate folder) is usually provided.

ACCESSORIES AND OPTIONAL COMPONENTS

• Various kinds of external and internal trolley
• Boxes for ampoules and bottles of various kinds
• Built-in electric steam generator (available up to Model FOF/4)
• Water pump for supplying steam generator and/or for spray in chamber
• Mains steam filtration system
• System for the closed-circuit sterilization/cooling of the load cooling spray water
• Air detector