FOF SATURATED

STEAM STERILIZER

Powered by
Thema4
process
controller
 FOF
SATURATED
STEAM
STERILIZER

FEDEGARI PHARMACEUTICAL STEAM STERILIZING AUTOCLAVE

HORIZONTAL CHAMBER TYPE
FULLY COMPUTERIZED OPERATING SYSTEM

APPLICABLE REFERENCE EUROPEAN STANDARDS

The Quality System of Fedegari Autoclavi S.p.A. has been certified as
compliant with the ISO 9001 standard and the ISO 13485 standard.
Moreover, the sterilizers presented here are designed and
manufactured in compliance with:

A. the requirements of the following European Directives:

● Directive 2006/42/EC, Safety of machinery

● Directive 2014/30/EU and amendments, Electromagnetic
compatibility
● Directive 2014/35/EU and amendments, Low-voltage
devices
● Directive 2014/68/EU, Pressure Equipment Directive - PED.

B. the following European standards:

● EN ISO 12100 - Safety of machinery. General principles for design.

Risk assessment and risk reduction
● EN ISO 13857 - Safety of machinery. Safety distance to prevent
hazard zones being reached by upper and lower limbs
● EN 55011 - Industrial, scientific, and medical equipment
- Radio-frequency disturbance characteristics -Limits and
methods of measurement
● EN 61000-4-2 - Electromagnetic compatibility (EMC) - Part 4-2:
Testing and measurement techniques - Electrostatic discharge immunity
test
● EN 61000-4-4 - Electromagnetic compatibility (EMC) - Part 4-4:
Testing and measurement techniques - Electrical fast transient/burst
immunity test
● EN 61000-6-2 - Electromagnetic compatibility (EMC) - Part 6-2:
Generic standards - Immunity standard for industrial environments
● EN 61000-6-4 - Electromagnetic compatibility (EMC) - Part 6-4: Generic standards - Emission standard
for industrial environments
● EN 60204-1 - Safety of machinery – Electrical equipment of machines. Part 1: General requirement.
● EN ISO 13849-1 - Safety of machinery - Safety-related parts of control system - Part 1: General principles
for design

Note: for installation countries outside of Europe, refer to the quotation regarding possible different pressure vessels
and electrical system construction codes.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

GENERAL SPECIFICATIONS

The base-level version is complete with the THEMA 4

computerized process controller installed in the unit fascia.

Standard design pressure = 2.5 bar allowing a max sterilization

temperature of 136°C.

Pressure vessels built according to ASME Code VIII Div.1:

FOF with square chamber = design pressure 2.2 bar - max
sterilization temperature 134°C.
FOF with cylindrical chamber = design pressure 2.5 bar - max
sterilization temperature 136°C.

Technical features

Quadrangular
STERILIZATION CHAMBER chamber

The pressure vessel of the sterilizer is defined as a double-walled chamber

(quadrangular chambers and cylindrical chamber dimensions FOF1 and FOF2
only). Cylindrical chambers for larger autoclaves (FOF3-4-5-6-7-8) are
single-wall type and are provided with internal plate heat exchangers instead
of a jacket.

The lower part of the internal chamber slopes

appropriately toward the drain to drain condensate during the process.
The discharge outlet is equipped with a line filter, which can be easily removed
from inside the chamber and is meant to retain any objects that might damage
the vacuum pump that lies directly downstream. The internal chamber is made
of 316Ti stainless steel, which is mirror-finished (Ra ≤ 0.4 µm), ensuring the
cleaning and sterilization and increasing its resistance to corrosion.

The external chamber or jacket, which provides temperature control, is made of

304 stainless steel plate and completely covers the outer surface of the internal
chamber.In sterilizers with a quadrangular cross-section, where thermal
expansions during the process are more impactful on the pressure vessel, the
external chamber has a structural function whose profile contributes
significantly to mechanical strength and does not have any particular tension
points.
This eases fatigue stresses which would cause failure of the chamber over time. Carbon steel profiles with a U-
shaped cross-section are welded to the outside of the quadrangular jackets. These profiles have a purely
structural function and do not make contact with any process fluid.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

The pressure vessel and its doors are insulated with a layer of insulation to minimize
heat loss and avoid the risk of accidents caused by contact with hot surfaces.
This insulation layer is made of rock wool enclosed in an aluminum plate.
Each hole for the passage of the ports welded to the internal or external chamber is
insulated by means of a silicone gasket to prevent loss of fibers.

The chamber is always protected by one or more

safety relief valves, depending on the size and
requested certification of the unit.

All machines are provided with 2 ports that can be used to connect to the
chamber temperature and with pressure sensors that are used during initial
validation and periodic testing.
The adapter for inserting validation sensors in the chamber is available as an
option (refer to Feed-through for validation sensors).

Nozzle welded to the

chamber and sealed
with silicone gaskets

OPTION

Feed-through for validation sensors

To insert the thermocouples in the chamber (up to 16) there is a special connection kit available, which uses
a threaded ring to compress the sensors between two silicone membranes without compromising the
tightness of the sterilization chamber in vacuum.
The connection kit simply replaces the plug installed on the validation port.
The silicone membranes should be replaced whenever the thermocouples are removed from the port
adapter.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

CHAMBER DOORS

The basic version of the sterilizer has a single loading door. The door is always quadrangular, even for cylindrical
chambers. All doors are based on an original construction model perfected and patented by Fedegari in the early
1980s, which stands out with respect to all alternative solutions in terms of simple construction, reliability,
operating safety and the need for minimal maintenance.
The doors have an appropriately cambered cross-section to increase mechanical strength but have no external
reinforcements except for a single perimetric reinforcement located at the chamber sealing gasket. With this
structure, the door can expand freely during the heating process without generating tension at the welded
reinforcements that might compromise its reliability.

The doors are made of 316Ti stainless steel plate, with a perimetric reinforcement made of 304 stainless steel.
In the closed position, the door is retained by 4 brackets. Depending on the type and on the chosen
configuration, these brackets can be obtained by milling the frame on the chamber or can be welded to the door
itself.
As an additional safety system feature, the 2 diametrically opposite brackets are sufficient to ensure the
tightness of the door in the closed position at the maximum testing pressure. Compared to alternative solutions
that compress the door against the chamber, obtaining a seal by means of a static gasket (like doors with radial
levers or with bayonet closing systems), this solution automatically compensates for any deformations of the
door that might occur during the active life of the sterilizer, avoiding the need to perform periodic mechanical
adjustment.

Door sealing gasket

One of the key components of the door assembly is the special
pneumatic gasket, which has a dovetail cross-section and is
accommodated in the seat milled in the door frame. The main
features of this system are:

● supply with instrument-grade compressed air: thanks to

the special cross-section, the compression fluid cannot
penetrate into the sterilization chamber, which would
compromise the sterility of the chamber and its load;

● no vacuum: thanks to the specifically designed cross-section

and the mechanical characteristics of the material of the
gasket (silicone rubber), the door can be opened simply by
discharging the compression fluid, as this makes the gasket
retract uniformly into its seat;

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

● simple maintenance: no periodic lubrication or

maintenance is required, except for ordinary
cleaning of the surfaces and removal of any foreign
objects that might be crushed between the gasket
and the door;
● useful life of the gasket: the method of operation
and the compression fluid produce very low wear on
the gasket. Depending on the use of the sterilizer,
the average lifespan of the gasket is 1 to 5 years. The
material used for the gasket is in compliance with
FDA 21 CFR part 177.2600 (specific material in
compliance with USP Class VI can be quoted as
option);
● safety: electromechanical and electronic safety
interlocks managed by the process controller prevent
Gasket in inactive position Gasket in use (door is
the opening of the door if the gasket is still (door is open). closed)
pressurized and/or if there are conditions indicating
danger for the operator and/or the load.

Depending on the type of installation and on the chosen sterilizer model, two different door types are available:

● automatic sliding door

● semiautomatic hinged door

Automatic door
The automatic door is available in two configurations depending on the
sterilizer model: a vertical sliding door and a horizontal sliding door.
Up to and including the FO.2 model, the door is always vertically-sliding.
For all larger models, sliding doors are always horizontal. In the vertically-
sliding configuration, the door, when operated, opens downward, being
moved by a stainless steel lubrication-free chain which is connected to the
pinion of a gear motor, where it slides along 2 parallel guides on self-
lubricating bushes.

In the horizontally-sliding configuration,

the door hangs from two brackets with
wheels that travel on a guide located
above the chamber.

It runs, at its base, on a cylindrical guide

with self-lubricating bushes. The door is
moved by means of a pinion which acts on
a rack and is mounted on a gear motor which Vertically sliding door
in turn is installed on an elastic footing
provided with springs to adjust the pressure between the pinion and the rack.
It also acts as a safety clutch, so that if the door encounters an obstacle
Horizontally sliding during closure the force applied by the gear motor is not sufficient to damage
door whatever is being compressed by the door.
The pinion and the rack are made of synthetic material.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

For sterilizers installed in a pit (with the loading surface at floor

level in order to facilitate load handling), the automatic door is the
only applicable solution.

In this version of the machine,

the door, during its stroke,
can also lower or lift a small
bridge that covers the gap
between the floor and the
chamber, allowing easy
insertion of trolleys.

In both configurations the door slides inside a containment cabinet, avoiding

accidental exposure of the operator to moving parts. In case of emergency it
is possible to manually open the door, after having depressurized the gasket,
by means of the steering wheel on the motor reducer shaft.
An active protection for the operator is provided for the door closing by
means of continuous press on the button (in case of release of the button the
door automatically reverses the translation direction); the passive protection
is accomplished by a photocell installed at the end of the sliding area, which if activated opens the door
instantaneously.

Semiautomatic door
The hinged door is called “semiautomatic” because its opening motion is divided into 2 separate steps. The first
step is automatic: a gear motor coupled to a cam which, when activated, lifts the door by 45°, releasing it from the
brackets that retain it. The second step is manual and requires the intervention of the operator to release the
safety bolt and then turn the door on its hinges. A manual door locking device is also provided on the door and
prevents any process from starting if the door is not closed perfectly.
In this configuration, a protective housing is also installed to prevent the operator from accidentally accessing the
moving parts that make up the door opening mechanism.

Semiautomatic Semiautomatic
door in the door in the open
closed position position

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Two-door pass-through version

If the application requires installing the sterilizer so that it faces a sterile or
controlled-contamination environment, the options include a second door of
the same type as main door.
The process controller interlocks the second door with the first one, so as to
avoid contaminations of the “clean” environment through the sterilization
chamber (clearance for simultaneous opening of both doors or in case of
failed/incomplete sterilization) by virtue of the Sterilok function. If necessary,
however, the Sterilok function can be programmed in order to unload the
sterilizer from the same side from which it was loaded.

Automatic door with

airtight partition
Hermetic partition for the second door

For all double door’s version sterilizers of the FOF series, the absolute
separation of the two environments is guaranteed by the installation of an
airtight partition on the unload side. This contains all the mechanisms and
devices of the door to protect the operator. The airtight partition is made
of 304 stainless steel.

It is the responsibility of the installer of the machine to ensure that cross-

contaminations between the two environments cannot occur through the
partition.

Semi-automatic door
with airtight partition
OPTION
Isolation system
Pass-through version with connected to sterilizer
flange for isolation system coupling

Since isolation systems connected to sterilizers are increasingly used,

specific constructive solutions for this application have been
perfected.
There are variables related to the various door types of the sterilizer
(vertical or horizontal automatic doors and semiautomatic doors) and
to the consequent problems in sterilizing the outer surfaces by means
of the devices used to sterilize the isolation system. In choosing the
various solutions it is necessary to also consider the space occupation
(in static terms but most of all in dynamic terms) of the various kinds of
doors available.

To prevent load contamination, an interlock can be provided on the

door opening system in case of lack of overpressure in the isolation
system chamber.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

CABINET

GENERAL DESCRIPTION
The purpose of the cabinet is to contain and protect all the
components of the sterilizer against tampering and involuntary
contact with moving mechanisms, hot surfaces or any other
possible cause of danger to personnel.
The basic model listed in the catalog only includes the paneling
on the front wall, on which the operator interface of the
process controller, the thermal printer, and the analog pressure
indicators are installed. The two sides and the back, if the
second door is not provided, are not protected by any panels.
According to the specific installation requirements, optional
additional infilling panels can be added to the order. These
panels are made of 304 stainless steel plate with fine satin
finish (Ra ≤ 0.4 m, Scotch brite), which are appropriately
formed on a bending press so that the entire structure is self-
supporting.
The sterilizer second door option includes the corresponding
front wall on the second side/L2, on which the door opening
buttons and the chamber pressure indicator are installed.
Infilling panels made of 304 stainless steel plate with fine satin
finish can be designed and manufactured for specific installation
requirements of the sterilizer.

Technical area inspection door

For safety reasons (to protect the operator or to prevent from equipment violation) it is recommended to
restrict access to the sterilizer technical area. Depending on installation requirements, access to the
technical area can be either from the side or from the front (loading side/L1) of the machine.

In general, it is always recommended to install an inspection door (equipped with a lock and with a device
allowing opening from the inside).

We offer two alternatives:

● side inspection door
● front inspection door

Side inspection door

This solution is suitable for most installations and provides the best
protection and access to the sterilizer technical area. It covers the
whole side of the machine and, depending on the overall depth of the
sterilizer, it is provided with one or two leaves.
The side panels on the opposite side of technical area are optional
and, if required, they must be ordered.
Sterilizer with side
inspection door

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Front inspection door

If required by installation constraints, such as lack of lateral access to the
technical area, the front of the sterilizer can be widened by adding a specifically
designed module for containing the door for access to the technical area (which
as usual is equipped with a lock and with a device that allows to open it from
inside).
If this option is chosen, a small increase in overall dimensions allows to
installation of the machine to be adjacent to a wall or to another machine without
sacrificing easy access to the components contained in the technical area.
However, it is evident that the useful width of the door cannot be smaller than
the largest installed component or smaller than the personnel who needs to
access it. The usual recommended minimum useful width is 800 mm.
Sterilizer with front
inspection door
OPTION

Construction of paneling in 316 stainless steel

For special applications requiring higher corrosion resistance, the machine cabinet and the eventual
additional panels can be manufactured in 316 stainless steel (instead of 304 stainless steel). This option
includes the same surface finish level provided as standard (Scotch Brite satin finish).

STAND

GENERAL DESCRIPTION

The stand is the structure that supports the sterilization chamber on the floor. The supports of several
components of the sterilizer, such as the door sliding guides, the vacuum pump or the steam generator are
also fixed to the stand.

The stand is entirely made of 304 stainless steel square tube with a
cross-section appropriate for the model and size of the sterilizer.
In order to reduce the specific pressure applied to the floor by distributing
the weight over a larger surface, and in order to strengthen the structure,
the stand is built to discharge the weight onto a base frame, also made
of the same square tube.
To ensure correct leveling of the machine, the supporting structure
is equipped with adjustment screws at its corners.

For machines that can be disassembled, the stand of the chamber

can be separated from the stand of the technical area for transport.
The two or more components are reassembled with the appropriate
plates with screws.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

STAND OPTION

Knockdown versions

Since sterilizers sometimes have to be disassembled in order to pass through tight spaces at the installation
or if the machines are larger than allowed by the carriers, various disassembly options are available.
In all versions, the stand is provided with suitable connecting plates, and the hydraulic components can be
separated by means of quick connectors in the appropriate positions, so as to remain within the profiles
specified by the buyer for transport.

Connectors are used wherever possible to minimize the possibility of errors in electrical rewiring and
pneumatic reconnection during reassembly. More generally, the entire technical area is designed and
manufactured so as to allow faster reassembly.

Accordingly, it is advisable to specify these options at the time of the order, since the chosen version can
entail different construction variations. It is also advisable to specify whether the sterilizer has to be shipped
assembled or disassembled and whether the assistance of technical personnel from the manufacturer or of
one of its local representatives is required for the reassembly operations.

OPTION
Sterilizer disassembled
Knockdown version A according to version A

This version allows the buyer to separate the chamber from the technical
area. All the main components remain attached to the technical area.
This version is suitable for most needs. The time required to reassemble
the 2 parts can vary according to the dimensions of the sterilizer and to
the complexity of its systems.
The approximate overall dimensions of the 2 parts are given on the
Installation Drawing.

OPTION

Knockdown version B

In the rare situations where disassembly of the sterilizer in version A is

Sterilizer disassembled
according to version B
not sufficient, the profiles can be further reduced by entirely removing
the external cabinet and separating the chamber from the relevant
supporting frame. This version obviously requires a more complicated
transport of the individual parts as well as proportionally longer
reassembly times.
The approximate overall dimensions are given on the Installation
Drawing for this version as well.
Installation Drawing.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

PIPING AND FUNCTIONAL CHARACTERISTICS

Technical Area

All the components of the hydraulic and electrical systems are located on the left side of the chamber (as
seen from the non-sterile side/L1) and above and below the chamber, in a section called technical area. The
technical area can be located on the right side of the chamber.

This layout avoids the need to provide an additional access for maintenance personnel on the opposite
side, thus significantly reducing the overall footprint (physical dimensions and clearances) of the sterilizer,
making maintenance operations easier.

The electrical cabinet also is contained within the technical area in the basic configuration.
Depending on installation constraints, the technical area can be provided on the opposite side of the
chamber as an option.

Components Technical area

The hydraulic system of the sterilizer is entirely made of 316L/EN 1.4435 stainless steel with sanitary execution.

All piping is welded and is in compliance with ASTM A 270, for

pharmaceutical applications; it is connected to the pressure vessel and
to the various components by means of sanitary couplings locked with
C-clamps and sealing O-rings made of the material FDA 21CFR, part
177.2600 approved and USP Class VI.

The few welds provided on the pipes (curves are provided by bending
in order to minimize joints) are performed with an orbital TIG process
using protective gas inside the pipe. The internal roughness of the pipes
is std. Ra < 0.8 m).
All the pipes are installed to ensure the possibility to drain them
completely and avoid condensate residuals.

All utility inlets are protected by micro stretched 316L stainless steel plate line strainers of the basket type, meant
to protect the various installed components and allow easy inspection.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

The piping that conveys fluids at high temperature is insulated with asbestos-
free and chloride-free materials.
All the components installed in the technical area are individually
identified and labeled so as to allow quick identification referencing the
technical documents provided as part of the
supply.

The valves used are of the sanitary type with PTFE

Sanitary connector with
clamp and O-ring
diaphragm (made of material FDA 21CFR, part
177.1550 approved and USP Class VI) and are
designed specifically and built by the manufacturer
for the most critical operating conditions, typical
of an industrial sterilizer.

Ten years’ experience in designing these components for the specific application has
allowed us to optimize system solutions related to the hydraulic system,
providing solutions characterized by minimal dimensions, optimal functionality,
Example of assembly: check-
and minimum and easy maintenance. valve, pneumatic valve and
flow rate regulator

Air Filter

Compressed air or ambient air is introduced in the

chamber, in order to ensure the required counter pressure
or to restore atmospheric pressure, by passing through a
sterilizing filter, which has an absolute retention of 0.22 m
for liquids and 0.003 m for gases. This ensures a reduction
of the bacterial load of Brevindimonas (Pseudomonas)
equal to 107/cm2.

The basic configuration uses a PALL filter with a

PTFE membrane, of the PFR or MCY4440 type
(small cartridge applied for sterilizers with
capacities up to 2200 liters).

The cartridge is contained in a housing made of

316L stainless steel (supplied by PALL with internal
roughness of less than 0.4 m), arranged for
sterilizing the air filter in place.
Air filter A suitable valve system allows the buyer to sterilize
the filter in parallel to the chamber, constantly
draining the condensate from the housing and thus ensuring the ideal conditions for
sterilizing the filter and the associated system.

In order to prove a correct sterilization, a dedicated RTD is installed in the coldest point of the housing and records
the temperature during the process, in parallel with the other RTD’s of the sterilizer.
This system includes manual valves fitted with a Staübli connector, suitable to perform the filter integrity test
(Water Intrusion Test, WIT).

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Vacuum
Another original characteristic of Fedegari steam sterilizers has always
been, and still is, the use of the vacuum pump throughout the cycle.

In this type of process, the water ring pump continues to aspirate through
an adjustable intake even during the steam injection and sterilization
phases. The steam releases heat by condensing and consequently
releasing latent heat.

By constantly draining the condensate that forms in the chamber through

a valve that has a small cross-section, a dynamic condition is ensured which
allows a more uniform (indirect) adjustment of the sterilization
temperature, which leads to extremely small temperature differences
(typically ±0.5 °C for saturated steam sterilization cycles in empty
conditions) and prevents the accumulation inside the chamber of
condensate and of any incondensable gases present in the steam.

Vacuum and dynamic steam:

the difference between the two phases is determined by the
different opening of the steam loading and vacuum valves

FOF series sterilizers are equipped with a single-stage water-ring vacuum

pump, which has an anticavitation device and an electric valve on the line
for feeding mains water to the water ring; a pressure-controlled switch is
also installed to indicate lack of water in order to protect the pump.All
sterilizers allow for different rates of vacuum according to the loads being
treated.

If extraction of the air from the load is not particularly difficult, it is possible
to use processes with a dynamic pre-vacuum.

This means that while air is being aspirated from the chamber, steam is
injected from the opposite end. This not only improves air extraction due
to the resulting turbulence but also produces a gradual preheating of the
load that helps to reduce the generation of condensate during the
subsequent heating phase.

If removing the air from the load is more critical (as in the case of porous loads or
packaged instruments, for example), processes with pulsating pre-vacuum are Vacuum pump
available.

These processes alternate vacuum phases and steam injection phases in order to expand the residual air and
therefore make it easier to extract it during the subsequent pulse.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

OPTIONS FOR PIPING

Recovery of condensate for feeding vacuum pump

In order to reduce the consumption of water feeding the pump, it is
possible to install a liquid-ring water recirculation system in the technical
area. This is comprised of a condensate collection tank and a braze-
welded
plate heat exchanger for cooling the condensate. This solution may
increase the space needed in the technical area.

Drain Cooler

If local laws do not allow the discharge of high-temperature effluents or

the drain lines to which the machines will be connected are made of
plastic materials that are not suitable for high temperatures, the drain
must be cooled.

Cooling is provided via a heat exchanger with braze-welded plates,

supplied with mains water and regulated by a thermostat. This system is
used to reduce the temperature of the condensate and of the drainage
in general (to approximately 60 °C) before they flow out of the machine
to be conveyed into the sewage system.

Air/water separator on drain

If it is necessary to avoid the pressurization of the drain lines, it is
preferable to install a mixing separator on the drain, which has
the dual function of lowering the temperature of the condensate
and of depressurizing the drain lines, acting as an air/water separator.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Air Detector system

This device has been developed to meet the requirements of the
guideline HTM 2010 (Health Technical Memorandum 2010, NHS Estates).
The Air Detector consists of a blind tube. At the end of this tube there
is a pressure transducer installed; the tube is jacketed for allowing
cooling water to flow through and is installed on the most critical point
of the piping where air could remain trapped, i.e. on the drain pipe
upstream of the vacuum pump.

The process controller controls the valve (VP61) that isolates the device.
The steam sample is then condensed, and the pressure transducer reads
the residual pressure at the end of the test and it generates an alarm
if incondensable gases are detected.

Second air filter in series

An optional second air filter in series is used when there is a

failure of the first air filter.
This ensures that sterile air will have contact with the load and
provides, in addition to the second filter, the equipment required
for sterilization in place, with a second RTD for monitoring the
temperature on the condensate drain.

HTM 2010 steam sampling system

This option includes the installation of a connection on the steam
Feeding pipe which allows the installation of an appropriate device
(not included) for the execution of steam quality tests as indicated in the
HTM 2010 (HealthTechnical Memorandum 2010, NHS Estates)
guidelines
(non condensable gas test, superheated gas test and dryness test).

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Hot air drying: heat exchanger upstream of vent filter for improved load drying
If a particularly through drying of the load is required, for example in treating elastomeric closures, it is advisable
to provide a phase for drying by hot air at the end of the sterilization phase and prior to
cooling circulation. The air is heated before entering the chamber by means of a plate heat exchanger installed
upstream of the sterilizing filter.
Installation of this option includes valves for steam management and isolation to avoid the forming of
condensate during the filter sterilization phase. Control of the heated air temperature is ensured by the RTD
already provided on the air filter to log the temperature during filter sterilization.

SPECIAL OPTIONS FOR PIPING

Analysis of the internal
roughness of a pipe: example of
Internal roughness of the system 0.4 m report printout.

If required, the pipes that convey process fluids (clean steam, sterile air,
WFI) to the sterilization chamber and the pipes connected to the
chamber up to the first control valve can be provided with a surface
roughness that is lower than the standard roughness (≤ 1.0 m).
This option uses pipes made of 316L/EN 1.4435 steel, with a certified
surface roughness ≤ 0.4 m.
In this case, the indicated value is not obtained by grinding and therefore
the pipe never makes contact with any abrasive material.
This option includes the provision of the 3.1B certificates of all the materials used (certificates which cannot be
provided otherwise), which list, in addition to the characteristics of the materials, the surface roughness value
cited above.
Selecting this option does not exclude other options.

Welding log
Example of welding log

With this option, the welds performed on the pipes that convey process
fluids (clean steam, sterile air, WFI) to the sterilization chamber and on the
pipes connected to the chamber up to the first control valve are
individually identified to allow their traceability.

A specific document lists, for each weld, with reference to:

• The welding specifications used (Welding Process Specification,

WPS)
• The approval of the welding procedure issued by the Notified
Body (Welding Procedure Approval Report, WPAR)
• The welding operator who performed the operation
• The qualification of the welding operator issued by the Notified
Body (Welder Qualification Report, WQR)
• The outcome of the visual inspection of the external weld
• The calibration certificate of the orbital welding machine.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Sample welds

Cutout samples of each type of welded joint can be supplied on request.

These samples, duly identified, are taken at the beginning and at the end of welding activities.
If the activities are not completed within one working day, samples are taken with reference to a specific
day.This option also provides a control document with attached photographs of the samples.
The acceptability criteria are the ones indicated in the ASME BPE-2002 standard.

Inspecting a welded
Boroscope report joint with a boroscope
This option is meant to document the quality of the welds on the pipes that
convey process fluids (clean steam, sterile air, WFI) to the sterilization
chamber and the pipes connected to the chamber up to the first flow
control valve.
Using an endoscope, an internal visual inspection of all the welds cited
above is performed and is simultaneously recorded on magnetic media in a
digital format. At the end of the inspection, a control document is issued
together with a CD-ROM containing all the pictures related to the
inspection.
The acceptability criteria are the ones specified in the ASME BPE-2002
standard.

Roughness control report

This is a specific document intended to certify the internal roughness of the components and of the pipes that
convey process fluids (clean steam, sterile air, WFI) to the sterilization chamber and the pipes connected to the
chamber up to the first flow control valve.

This document includes:

● Item No.
● Description
● Total quantity
● No. of printouts
● No. of measurements
● Ra min [ m]
● Ra max [ m]
● Results
● Acceptance criteria.

Example of roughness
control report

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

STERILIZATION CONTROL PRINCIPLES

Sterilization, i.e. the exposure of the product
to a constant temperature, is the most critical
phase of the entire process.
It is adjusted on the basis of the pressure of
the steam measured inside the chamber by a
pressure transducer, with constant
monitoring of the temperature.

This type of control is based on the principle that the pressure of water steam,
in saturation conditions, has a one-to-one correlation to its temperature
according to the values stored inside the process controller. The advantage of
this control principle is that pressure inside a closed vessel, such as the
chamber of a sterilizer, is always uniform.

Therefore, pressure measurement is independent of the location of the sensor

whereas temperature, depending on various conditions and characteristics of Regulation of vacuum
the machine, may vary over a relatively wide real tolerance range (although this and dynamic steam.
is not always noticeable by analyzing the process documentation).

Another advantage of pressure-control is that, thanks to the features of the process controller software, the
appropriate programming of the controller allows the buyer to immediately detect abnormal operating
conditions, if the steam is not in saturation conditions.
The sterilization process adjusted in this manner is therefore monitored by Pt 100 (RTD), one of which is installed
in a fixed position at the drain trap of the chamber, which is theoretically the coldest point of the chamber.
When all the RTDs have reached the minimum sterilization temperature (+ 0.2 °C), sterilization time calculation
begins. Sterilization calculation is either based on the time for which the set minimum sterilization temperature is
maintained or on the calculation of the F0 function.

CHARACTERISTICS OF THE SENSORS

The application for which the sterilizer is used determines the choice of sensors for process regulation and
monitoring. FOF Series sterilizers use the following devices (the quantities and characteristics may differ from the
ones given here, depending on the options chosen and/or to specific requirements of the buyer):

RTD:
within the machine there are seven 4-wire Pt100 (class 0.1 according to the IEC 751 standard), with 316L
stainless steel tips and silicone cable sheathes, with a response time of
< 6 sec at 90% full scale (FS).

One of the RTD’s is installed in the chamber drain (coolest point for saturated
Steam cycles), four RTD with flexible cable are in the chamber to check load
temperature (one of these is independent from the process controller and
connected to a safety thermometer for doors opening safety interlock),
one RTD is fixed in the vent filter housing to monitor the coldest point during
vent filter SIP cycle and one RTD is fixed in the jacket to control jacket
temperature by steam valve actuation.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

PRESSURE SENSORS:

1 piezoresistive absolute transducer, 4-20 mA, with 316L stainless

steel facing membrane installed in chamber to control pressure;

Pressure transducer

PRESSURE GAUGES:
1 tubular spring vacuum gauge (class 1 according to the EN
837-1-3 standard), with a 316L stainless steel facing
membrane is installed on fascia panel side L1 and is
connected to the chamber.

For two-door sterilizers a second vacuum gauge is installed

on fascia panel side L2. The filling fluid for the capillary is
silicone oil.

Another tubular spring vacuum gauge (class 1 according to

the EN 837-1-3 standard) is installed on fascia panel side L1
and is connected to the jacket. In case the steam generator
is installed an additional pressure gauge is recommended.
The pressure gauges are provided with pressure bar scale and an indicator of the equivalent
temperature of saturated steam.

The machine is also equipped, as standard, with:

• pressure switches to detect the presence of pressure on all incoming fluids lines;
• a safety thermometer, connected to an independent temperature probe installed
on fascia panel side L1
• position sensors on all pneumatic valves.

Other sensors may be optionally installed if required by specific configurations of the

machine, like:
• sanitary manometers with membrane separator and non sanitary manometers
mounted on utilities
• additional pressure transducers and RTD’s in the chamber.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

ELECTRICAL SYSTEM

The electrical system achieves a minimum protection degree equal to IP54

(NEMA 12).
For USA and Canada, the electrical components (including the electrical panel)
installed on the machine are in compliance with UL 508A and NFPA 79 norms,
including UL/UR stamp.

Electrical supply (sag, surge, spike free): 400V 3-phase + PE + N 50 Hz (electric

power supply in accordance with the destination country can be quoted if
required).

Electrical panel

All the electrical components (except for the sensors and actuators in the field)
are contained in an electrical cabinet inside the technical area.

The cabinet is a supplier-certified component and is made of steel plate, coated

with RAL 7035 by means of an electrostatic spraying process and provided with
a textured surface. All outgoing cables are isolated by means of hermetic
grommets preventing foreign objects and fluids from entering the cabinet.
All the electrical components inside the cabinet are certified and
internationally available and are fixed to the mounting plate of the cabinet,
which is made of galvanized steel.

The reset lever of the automatic power switch is installed on the door of the
cabinet. This power switch is a certified component and complies with the IEC
408 and IEC 204 standards. If tripped, the switch disconnects all electric power
from the sterilizer and requires the intervention of the operator reset it and
restart the machine.

If the emergency button located on the front panel of the machine is operated, this automatic switch opens
instantaneously. All the electrical control and monitoring circuits operate at low voltage (24 V AC/DC, PELV) and
are identified by the specific coloring of the wires.

THEMA4 PROCESS CONTROLLER

General Description

The Thema4 process controller has been specifically designed for

controlling all Fedegari moist-heat and dry-heat industrial sterilizers.
Other Fedegari sterilizers may use different controllers.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

This new system replaces the Thema3 controller, retaining

its key features but using commercial hardware and
software that can be integrated with the user’s existing IT
systems. All the controllers software has been developed
and validated to quality-assurance standards. The relevant
certification documents can be supplied on request

Main features

Thema4 meets the requirements of users who prefer to work with commercial hardware components while
ensuring compliance with all technical regulations and standards of reference.

Thema4 differs from the previous generations of controllers in the following features:

• Open hardware architecture, implemented by means

of commercially available PC/PLC components
(Siemens or Allen-Bradley I/O linked by field bus to
controller PC; PC operator interfaces linked via
Ethernet network to remote PC(s) and customer
networks).
• Process controller based on Wind River VxWorks
real-time operating system.
• Operator Graphic User Interface (GUI) with Windows
style graphics on a panel-PC with color touch screen.
• Native compliance with FDA 21 CFR part 11 (no
external remediation tool is necessary).
• Compliance with GAMP5.

The system retains the same modular software architecture

of the Thema3 controller. The separation of kernel software
from the Phase Group library improves its maintenance and
validation, ensuring the highest flexibility and safety.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Flexibility

Thema4 uses a library of basic process steps (usually grouped by functional affinity and termed
“Phase Groups” or “PG’s”), which the user can easily and rapidly arrange in the intended sequence.

This allows the processes to be optimized without depending in any way on the manufacturer and in
complete safety. It also allows the processes to be adapted to the treatment of new products
(provided, of course that the sterilizer is equipped with the appropriate actuators and devices). PG’s
include, in addition to their characteristic variable parameters, all the conditions for starting,
managing and ending a phase safely as well as all alarms required to report any fault in the process
and of operation.

All the information related to PG’s is detailed in the Technical Manual. This allows the user to easily
select the most suitable PG’s and, if necessary, to check each individual actuation of the controller
and its conditions. This information is indispensable both for process qualification and for
troubleshooting.
Many (up to 999) different PG-sequences (“programs”) can be stored. The sequence of PG’s in any
program can be modified and new programs can be created directly from the GUI by using a specific
security level.

Safety
Thema4 software offers several safety features. The most important one stems from the fact that PG’s
are already fully programmed; this eliminates the need to be involved directly with the logic system of
the controller and avoids the consequent risks of any reprogramming performed by personnel lacking
a suitable level of knowledge regarding sterilization processes and the sterilizer.

Thema4 only requires the “programmer” to choose the appropriate sequence of phases and define the
associated process parameters.

System Main Operating Features

• No computer programming expertise is required for programming the operating parameters

or for using the sterilizer to its full operational capabilities;
• no modification of permanent data can be made by operators or the servicing personnel;
• no modification of any data is possible during an already-running process;
• minimum sterilization requirements are selectable as a minimum F0 target;
• sterilization control is selectable on time basis (with or without "F(T,z)" calculation) or a F(T,z)
basis;
• "cascade" selection of sterilization parameters on the basis of minimum sterilization
temperature or of the initial temperature for F(T,z) calculation;
• automatic programmable protection against over-exposure at high temperatures of
thermosensitive products;

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

• fully programmable door interlock (sterility protection programmable for each side);
• opening sequence for doors programmable in accordance with sterility protection;
• freely programmable time and date fucntion for automatic process start;
• programmable interlock of program execution (e.g. due to chamber leak test failure);
• automatic selection of log frequency of run data on the basis of the expected duration of the
process; 2-8 quick response Pt100-RTDs for process control, plus one for the jacket;
• temperature control with 0.01°C sensitivity; temperature display and print-out with 0.1°C
sensitivity;
• one 4-20 mA pressure transducer for process control; pressure control with 0.001 bar
sensitivity;
• pressure display and print-out with 0.01 bar sensitivity;
• pressure print-out for chamber leak rate tests with 0.001 bar sensitivity;
• time display in minutes.seconds, updated every 2 seconds;
• total duration of each process phase automatically calculated,
• stored as run data and printable; actual exposure time above minimum sterilization
temperature and actual duration of the exposure phase independently calculated, stored as
run data and printable;
• full set of automatic alarms monitoring irregular process conditions;
• process data at the moment of any alarm stored as run data and printable;
• start of run, end of run, date and time stored as run data and printable.

Control unit

The Thema4 design is based on an client-server-type open architecture with the standard
Ethernet/TCP-IP communication protocols.
In this architecture, the server and the 1st client are installed on a panel-PC on the loading side/L1 of
the sterilizer.
Further optional clients can be installed on remote panel-PCs, on the unloading side/L2 and/or inside
the technical area of the sterilizer.

The panel-PC is an industrial PC (for installation on the front fascia panel of the sterilizer), with a Real
Time Operating System (RTOS) (Wind River VxWorks). All the panel-PCs are connected by Ethernet
network.

It is possible to connect further remote PCs (MS Windows-based), as remote clients. These remote
PCs can be on the customer Ethernet LAN.
The same Graphical User Interface (GUI) software is installed on all the clients (local and remote),
with the same functions.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

The server (on the panel-PC installed on the loading side/L1) is connected to the field (analog and
digital I/Os from sensors, actuators and other devices) through I/O modules of Siemens or Allen-
Bradley PLCs.
These commercial I/O modules (grouped in a rack) communicate with the server panel-PC, by a
standard field bus connection (Profibus), using a Profibus module (side I/O modules) and a Profibus
board (side panel-PC).

The local printer unit is based on a CUSTOM TPT112HP high resolution

system and is essentially a basically maintenance-free monochrome
thermal dot-line printer for digital, as well as graphical process data
print out to be installed on the sterilizer fascia front panel, under the
door service board.

All the sterilizer data (electronic records and audit trail files) are
managed in full compliance with FDA 21 CFR Part 11 and are saved on
the server Panel-PC (L1).

Operator interface
An operator interface is installed on the front panel of the machine
(loading side/L1). This comprises a panel PC with 12.1” color LCD
active-matrix touch screen (Proface, Siemens or Allen-Bradley (15”)
with 800x600 pixels resolution, capable of communicating with the
operator in various languages that can be selected.

Individual users can access the various functions of the sterilizer according to the access levels that have
been assigned to that user during the definition of the personal passwords. This setup ensures with
absolute certainty, compliance with FDA 21 CFR part 11 and controlled access to specific operations
according to the level of responsibility of the assigned personnel.
All changes to system data (parameters, process reports, etc.) are archived by recording the access code
(public key) of the author and of the changes. No IT knowledge is required in order to use the sterilizer to
the full extent of its operating capabilities, since the system has an intuitive interface in which the
individual users can use only the functions to which they have access.

Permanent archived data cannot be modified or deleted by the User and any attempt to change these
data is detected by the system. No changes can affect the process in progress.
By using “maintenance personnel” access, it is possible to access the auto-diagnostic pages of the
controller to check the status of all the digital and analog I/O signals and, according to the requirements,
manually force these signals and also perform specific maintenance activities, such as periodic calibration
of the analog sensors and sterilization filter maintenance.

Fedegari supplies backup software on a CD-ROM in order to recover the system after maintenance
activities, and the buyer can always, after making changes, save the system data and then rapidly reload
the original configuration of the sterilizer (parameters, calibration data and programs).

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Rapid display panel, safety thermostat

The rapid display panel provides the operator with basic information
regarding the status of the sterilizer and of the process by means of
a LCD display. This system also includes the door open/close buttons,
the controller power-on selector, and the emergency stop button.
The panel is located on the loading side/L1 below the panel PC; if the
configuration of the sterilizer provides for a second door, the system
is also installed on the unloading side/L2.

A safety thermostat that is independent from the controller is also mounted on the front panel of the
sterilizer (loading side/L1). This permits the doors to open only when
the variable low-temperature set point is reached.
This constitutes an additional safety level, which is
particularly important when sterilizing liquids.

Process documentation

The complete data related to the processes run by the sterilizer are saved in appropriate files, which are archived
in electronic format on the hard disk of the “server” (L1) panel PC in compliance with FDA 21 CFR part 11.
These data can be displayed during the execution of a process on all the GUIs of the system and optionally sent
to the local thermal printer. All archived process reports can be retrieved in order to be displayed and reprinted
(even on a generic A4 printer, connected to an external PC running Remote GUI software).

The following information is contained in the archive files:

● program code
• public access code of the operator who launched the cycle and of the programmer
responsible for parameter setting
● product code
● batch number
● any notes of the operator
● type and serial number of the sterilizer
● unique progressive number of the process executed
● general parameters
● sequence of phases
● variable parameters of phases
● PID parameters
● heading of the various phases of the program
● total duration of cycle (in minutes)
● temperatures (of enabled RTD), pressure (chamber) and alarms (on/off) detected during the
cycle
● any F0/FH/FT accumulated for each RTD
● summary of program development
● summary of any alarms

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

● charts with temperature and pressure trends

● clearance/denial to open the door at end of process

A parameter can be programmed by the user to increase or decrease the print interval during the process, in
order to obtain more or less detailed documentation.

INCLUDED AS STANDARD
- Thema4 process controller operating system back-up software, which includes:
- no.1 CD-Rom with Thema4 application software, Thema4 library with enabled Phase Groups,
Operating

System and used Panel PC driver and configuration files (i.e., authorization files and hardware configuration files
with remote Input and Output);
- no.1 Recovery disk for “first” software installation on a new Panel PC;
- no.1 FTP protocol disk for software installation and data back-up/restore through Ethernet;
- no.1 Hard-copy of the hardware & software installation manual;
- no.1 Soft-copy (as .pdf file) of the hardware & software installation manual;

Installation Drawing.

THEMA4 OPTIONS

TH4-Recorder
This option can execute the following functions:

- Independent acquisition of Pressure and Temperature probes

- Integration with THEMA4 allowing: data storing of independent sensors
in THEMA4 process reports and value comparisons by the configuration of
specific alarms.
- Display in THEMA4 of independent sensors data and their diagnostic.

TH4-Recorder architecture is reported in the following scheme:

SW License for Remote Graphic User Interface (GUI)

Remote GUI is a MS-Windows software that permits connection of a desktop or a laptop PC to the
sterilizer via Ethernet connection. The interface of this Remote GUI is the same as the GUI installed on
the Panel PC and maintains the same functions and features.

Remote GUI Software allows the user to control up to 4 sterilizers with one PC simulatenously and to
use a normal A4 printer connected to an external PC where this software is installed. The PC must be
equipped with an Ethernet Card to allow connection with the sterilizer (the standard Thema4 Process
Controller, on the Panel PC, is already provided with Ethernet card). For peer-to-peer connection a
cross-over cable is needed.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Additional Thema4 operator interface

If the sterilizer includes a second door, it is possible to install a second operator interface on the
unloading side/L2, which is identical to the one provided on the opposite side. Also, it is possible to
install an extra operator interface in the technical area.

Centralized Clock Synchronization under SNTP Protocol

This option allows the user to connect the control system over an Ethernet
network to an SNTP server (not included) that can act as a reference for date
and time.

Automatic Back-Up Facility

This option allows automatic back-up, which is run periodically when time expires.

Communication with an external system through OPC protocol (on Ethernet network),
control mode (read & write)

This option allows integration and data exchange between the Thema4 process controller and any
SCADA system used by the buyer.
With this configuration it is also possible to have the process controller working either stand-alone
or to launch the execution of a program from an external system or to store process report data on a
remote server.
Data are exchanged between the two systems by means of an OPC or Modbus protocol.
The Thema4 SW architecture remains unchanged.

Bar Code Reader

An optical bar code reader, capable of reading all the most widely used code
types, can be connected to the operator interface. This system allows the user
to select and start programs, store the product code, the batch number and any
notes without using the touch screen keyboard.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

STANDARD CYCLES

Cycle 1.01 - Automatic vacuum leak-test of the chamber, including the air intake filter housing.

Cycle 1.03 – Chamber pressure tightness test

After a program has been selected and the requested identification parameters have been input, the
phase can be initiated either manually or automatically.
The phase ends when the doors are closed and all parameters are satisfied.

The chamber is pressurized by means of compressed air, is isolated and after a stabilization phase based
on time, the test begins. The phase ends when the target time is reached. If the maximum allowable
pressure in stabilization and test phases is exceeded, the test fails and an alarm is activated. If the
minimum allowable pressure in stabilization and test phases is exceeded the test fails and an alarm is
activated.

The chamber is gradually lowered to atmospheric pressure to allow the opening of the doors.
The phase alerts when the program has been completed and enables the opening of the pre-selected door
after process and safety requirements are satisfied.The activity of the autoclave is stopped if the pressure
transmitter or the product temperature probes are out of service. After their repair and depending on the
causes of the emergency, it is possible to go ahead with the program. Otherwise, the cycle must be ended.

Cycle 1.10 - Sterilization of solids - initial mixed vacuum - final drying vacuum.
The program starts with evacuation of air from the chamber. This is done by initial vacuum, time controlled
steam injection (as in program 1.11) followed by a programmable number of vacuum steps (as in program
1.13).
After the air-evacuation, the program continues as in program 1.11.

Cycle 1.11 - Sterilization of solids - initial dynamic vacuum - final drying vacuum
The program starts with evacuation of air from the chamber. Since the load is not porous, this is done by
initial vacuum +time controlled steam injection. This prevents the load from becoming too wet.

After the air evacuation, the chamber and load are heated to sterilization temperature. The sterilization
temperature is kept for the pre-set sterilization time. The sterilization time is a parameter selectable by
tenths of a minute. Minimum, maximum and control sterilization temperature are parameters selectable
by tenths of °C. All these parameters can be changed for each sterilization program, provided the operator
has access to the right security code.

The sterilization step is followed by a post-vacuum, to dry the load before the program is ended. The
vacuum is maintained for a pre-determined time. This time is a selectable parameter. It is also selectable
whether to pull the maximum possible vacuum or to limit the vacuum level.

Cycle 1.13 - Sterilization of solids

The program starts with evacuation of air from the chamber. If the load is porous, this is done
by a programmable number (2 to 21) of vacuum-steps, with an injection of steam between
each vacuum-step. The pressure and the vacuum levels to acheive can be programmed as
progressively increasing.
After the air-evacuation, the program continues with program 1.11.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Cycle 1.15 - Sterilization of filtering systems - initial dynamic vacuum at reduced rate - final drying
vacuum at reduced rate.
Same as program 1.11 but the initial and final drying vacuum rates are reduced in order to avoid rupturing
filter membranes.

Cycle 1.18 - Sterilization of filter membranes in semi-tight holder

This program is similar to 1.13, but the pressure variations are done with programmable gradients, so that
they can be gentler.
This is done because the air and steam in the holder need time to pass through the membrane without
causing high stresses on the membrane. A time controlled pressure hold may be applied between each
steam and vacuum pulse.

Cycle 1.55 - Program for sterilization of air intake filter.

This program is identical to 1.13 but it also sterilizes the air intake filter housing and piping.

OPTIONAL CYCLES

Cycle 1.30 - Gravity cycle - Sterilization of solutions in open containers (customer tank with water).
The program begins with evacuation of air from the chamber via steam flowing without vacuum pulling.
After the air has been replaced with steam, the process goes ahead as a conventional saturated steam
treatment.

After the completion of sterilization, it is possible to proceed with either a controlled rate pressure relief
to return to atmospheric pressure or cool the load with air circulation under controlled pressure.

Cycle 1.21 - Sterilization, testing and cooling of filled and sealed ampoules.
This program is the same as 1.11 until to the end of the sterilization phase. The post-vacuum phases are
also the same as in cycle 1.11, but they don’t include drying the load.

The post-vacuum pulses are intended for leak tests of the ampoules by quickly creating a strong pressure
difference between the interior of the ampoules and the chamber.
The internal pressure of the ampoules remains between 2.5 and 3 bar abs, as the pressure chamber is
reduced towards full vacuum (the actual maximum value of this is programmable).

Under this condition ampoules with hidden defects will break or at least have a strong tendency to lose
internal liquid by evaporation.
After the vacuum, the chamber is pressurized with sterile air for a long enough time to restore the same
pressure inside the defective ampoules. The load is cooled via spray water, but water will not enter into
the defective ampoules that are at the same pressure of the chamber. It is therefore possible to discard
defective ampoules, either because they have been broken during the test under vacuum, or because the
level of liquid inside them has been strongly reduced.

A programmable number of air-vacuum pulses can be added at the end of this cycle for drying the
ampoules. Note that at the end of the program all the ampoules are cooled down to a safe temperature.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Cycle 1.31 - Sterilization and cooling of filled and sealed small bottles under pressure.
This program is the same as 1.11 until to the end of the sterilization phase.
After the sterilization, steam is removed from the chamber by circulating sterile air; the bottles are
subsequently cooled via spray water while the chamber pressure is kept constant or progressively
decreased according to the temperature of the load.
This program is in fact the same as 1.21 without the test vacuum. The maximum size of the bottles
sterilizable by this cycle varies from 50 ml up to 200 ml, depending on the quality of the glass.

Cycle 1.33 - Sterilization and cooling of open or vented bottles under pressure
- Dynamic initial vacuum and final cooling phase performed by water circulation in the jacket (R4) and
providing counterpressure inside the chamber using sterile-filtered air, suitable for the sterilization of
liquids in non-hermetically closed containers (such as Bellco stoppers, cotton wads, etc.) or in hermetically
closed non-deformable Small Volume Parenterals (containers ≤100ml).

Cycle 1.41 - Tyndallization

This program is meant to treat heat-sensitive solutions that cannot withstand conventional sterilization
temperatures. By performing repeated Tyndallization treatments in successive days, one obtains the
probable sterility of the product being treated.

The greater the number of Tyndallization treatments performed in series and the higher the lethal heat
dose given to the product during each treatment, the higher the probability. This program is similar to
standard program 1.33, except that during the Tyndallization phase (which is the counterpart of the
sterilization phase) the modulating valve feeds steam into the chamber while balancing with the vacuum
pump, allowing adjustments of the steam pressure in the chamber (and in the jacket) so that it is lower
than atmospheric pressure.
This allows temperature adjustment between 65 and 98°C. Naturally, precision in temperature adjustment
is not as high as in conventional pressure sterilization. The program ends with cooling by circulating water
in the jacket (with intervention of the fan, if installed: see “Special Items”).

Cycle 1.42 - Program for sterilization of rubber stoppers and empty open ampoules.
This program is similar to 1.13 except for the post-vacuum. In this program there is a pulsating
post-vacuum in order to dry the products more. Between each vacuum, air is entered in the
chamber. The number of air-vacuum pulses are selectable between 1 and 20.
Time controlled pressure and vacuum holds may be applied to the pulsating post-vacuum.

Cycle 1.61 – Penetration test with on-demand preparation of the dyed solution spraying, final spray
immersion washing
Performing a penetration test, which consists of filling the chamber with dyed solution until the load is
completely submerged, followed by compression via compressed air at pre-settable pressure and for a
pre-settable duration.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Cycle 1.74 - Stoppers treatment

FEDEGARI provides, among other available options, the

possibility to have an autoclave which is capable of
performing a complete treatment of elastomeric closures
which includes the ability to perform the following phases:

• washing – this consists of filling to a set level

with WFI; dosage of a detergent solution can be
provided by means of a dedicated sanitary pump
or by generating vacuum in the chamber;

• rinsing – this consists of filling to a set level with

WFI and spraying through an upper bar located
inside the drum directly onto the stoppers.
Recirculation with a sanitary pump can be provided optionally;

• siliconization – this consists of dosing the chamber with a set quantity of silicone oil from a dosage
container by means of vacuum. It is also possible to provide a sanitary dosage pump or a turbo
emulsifier for on-demand preparation of the emulsion with WFI. Once the necessary quantity of
silicone oil has been introduced in the chamber, it is diluted with WFI to ensure sufficiently uniform
contact with the stoppers to be treated, which are mixed by keeping the drum that contains them
under rotation. It is possible to recirculate the emulsion by means of a dedicated sanitary pump
through a spray bar located inside the drum directly onto the load;

• rinsing – this consists of filling the chamber to a predefined level; it is possible to perform recirculation
by means of a dedicated sanitary pump and by spraying directly onto the load;

• sterilization – this consists of performing vacuum/steam pulses, heating, sterilization with dynamic
vacuum;

• drying – can be performed by:

- alternately producing pulses of vacuum and air preheated in a dedicated plate exchanger;
- introducing, through an upper sparger, preheated air, which is discharged through the
discharge;
- introducing, through an upper sparger, preheated air, which is discharged by the vacuum
pump;

• cooling – this can be performed by means of pulses or circulation of air while performing cooling by
circulating water in the jacket.

The stoppers can be contained in a cylindrical or satellite- type drum depending on the operating requirements of
the end user. The drum is supported by a trolley and turns on its own axis at a rate variable from 1 to 5 RPM by
means of a magnetic drive, which has no seals that might cause contamination.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Cycle 1.74 -with automatic stopper unloading

If automatic unloading of stoppers into the sterile area is
required, it is possible to provide a drum with a coupling for
the magnetic drive located on the door of the non-sterile side
and with an unloading chute on the sterile side door.

This drum has an internal helical screw feeder, which during

the treatment cycle (by turning clockwise) pushes the
stoppers toward the bottom of the drum where internal
mixing baffles are located. This ensures efficient
homogenization of the product.

During the unloading phase, by turning counterclockwise, the

feeder conveys the stoppers toward the outlet.

Electro-polishing of stopper drums is available as an option.

Other available options are:

● single or double-plate heat exchanger for heating
stopper washing water
● CIP execution of silicone oil dosage system
● boosted spray for the washing chamber
Nozzle in the closed position.

The special trolley

with drum

Decontamination cycle
During the decontamination cycle, contrary to what happens during the normal saturated steam
sterilization cycles, vacuum is carried out through a connection located at the top of the autoclave
chamber instead of from the bottom through the drain. This way the drawn air, before reaching the
vacuum pump and then the drain, is filtered through a 0.22 micron filter.

Therefore all the condensate that usually is eliminated through the pump when vacuum is performed
through the drain, is kept in the chamber bottom and eliminated only at the end of a successful
sterilization cycle.
In order to allow the sterilization of the condensate collected on the chamber bottom, the steam is also
fed through the drain.

It should be noted that the decontamination cycle is not suitable in case of possible viral contamination
since the characteristics of the filter do not ensure retention of viruses. For such application it is advisable
to consider using instead the High Pathogen (H.P.) cycle (see cycle 1.83).

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Cycle 1.83 - Sterilization of High Pathogen materials

These materials, generally produced by laboratories, must be sterilized to avoid environmental
contaminations due to air and to condensate, which in normal sterilization processes are removed from
the chamber without particular precautions and are actually not sterile.
Some manufacturers offer solutions based on thermal, chemical, or combined treatment of the air and of
the condensate, which are removed from the chamber. Due to the fact that these effluents form a two-
phase system, such solutions seldom give adequate assurance of being effective. The special H.P. program
that we have devised follows a different method.

1. The air initially contained in the chamber and in the materials is not removed, because the
normal removal phases at the beginning of the program are eliminated.

2. Sterilization thus occurs by using the steam+air mixture formed in the chamber; the mixture is
made uniform by the fan located on the ceiling of the chamber.

3. The condensate remains inside the chamber throughout sterilization and is collected in the
circular sector below the opening of the door.

4. An appropriate localized injection of additional steam ensures that the condensate trapped in the
chamber and up to the cutoff valve of the vacuum pump remains at the sterilization temperature.

5. The condensate is discharged, by means of the vacuum pump, only prior to the final drying phase,
when it is assuredly sterile.

6. The operating pressure of the machine (and therefore its structure) must be augmented to take
into account the partial pressure of the air present in the chamber (which also increases because
it is heated). This pressure adds to the partial steam pressure that generates the required
temperature (therefore, the maximum operating pressure is 4.5 abs bar and the maximum
operating temperature is 134 °C).

7. The additional H.P. program assumes, as a standard provision, that there is a fan in the chamber.
Therefore if this additional program is ordered, the fan provided as an option for standard
program 1.33 will be present.

8. Due to the features mentioned in the previous paragraphs (especially paragraph f), the H.P.
program must be planned for during autoclave manufacture. In other words, it cannot be added
at a later time.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

HYDROGEN PEROXIDE DECONTAMINATION PROCESS (A0010XP)

A typical cycle always includes the following steps:

Chamber Chamber Conditioning/

Decontamination Aeration
preparation dehumidification

Each cycle phase can be individually configured within the options of the supplied software.

After a saturated steam cycle, the autoclave has to be allowed to cool in order to run the decontamination cycle
with the chamber temperature lower than 35°C.

Chamber preparation
The chamber preparation step may include pre-heating with compressed air from a heat exchanger located before
the sterilizing air filter.

Dehumidification
After loading the materials into the chamber the decontamination cycle can be started. The control system checks
that all the initial parameters, necessary to control the unit, fall within the limit range (chamber pressure,
temperature, RH, compressed air pressure, gasket pressure etc.).

The unit is now ready for the decontamination cycle. The air in the chamber is dried below 15% RH (adjustable
parameter) or less.

The compressed and low dew point air is injected into the chamber to drop the RH down (<15%). After the set
point has been reached, the controller checks whether the temperature is over the minimum value to run the
cycle; if the condition has been achieved the controller allows the start of the cycle.

Conditioning/Decontamination
The vaporized hydrogen peroxide generator runs the decontamination cycle by injecting vaporized hydrogen
peroxide in the chamber. There is a first conditioning phase in which the chamber is saturated with the vapor until
it reaches the set value (in terms of ppm); once it has been achieved, then the decontamination phase starts.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Aeration
Compressed air is delivered to the enclosure to strip out residual hydrogen peroxide from the autoclave until the
concentration inside the chamber is less than 1 ppm. Depending on the load, the vacuum pump may be used to
perform this phase as an alternative.
The duration of this phase is strictly linked to the load characteristic and may require different approaches like air
pulses, vacuum, etc.

MPORTANT REMARKS

1) If this option is selected, the recirculation system of the vacuum pump (A0002TE)
and the heat exchanger upstream of the air filter (A0001XC) are mandatory.

2) If a hydrogen peroxide decontamination cycle is performed AFTER a sterilization cycle, it is

strongly recommended to add the indirect cooling option in order to reduce the waiting time
to cool down the chamber to the required temperature (approximately, depending on the
configuration of the load: with spontaneous cooling the waiting time is 6-8 hours, with
indirect cooling it is about 1 hour)

MANUAL LOADING EQUIPMENT OPTIONS

Type A external trolleys

External trolleys are also known as “carts” and are meant to carry the internal
trolleys. They are made of 304 stainless steel square tube, with 2 castors (360°
rotation) and two fixed wheels made of synthetic material and mounted on
maintenance-free roller bearings, also made of 304 stainless steel. The trolleys
are equipped with a manual device for coupling to the sterilizer.

In the transport position, this device locks the internal trolley, preventing
sliding on the guides; in the machine loading position, the device couples to the
sterilizer and simultaneously releases the internal trolley, which can be pushed
by the operator and can freely enter the chamber without the external trolley
separating from the chamber.
Type A external trolley To allow the sliding of the internal trolley, at the top of the external trolley
with 2 braked castors there are two guides made of 304 stainless steel with an H-shaped profile.

These guides are identical to the ones provided inside the chamber of the sterilizer. At the front, these guides
have a simple rubber device. If the sterilizer is equipped with automatic doors, the beam of the safety photocell
is interrupted and it prevents the closure of the door when the trolley is coupled to the sterilizer
In all applications requiring smaller internal trolleys due to the large mass of the load, trolleys that have half the
depth and do not cover the entire length are used.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Castors

Trolleys being moved in tight spaces or that

require maximum maneuverability can be equipped
with 4 swivelling castors instead of 2.

Swivelling castor
Braked castors

For trolleys that need to be locked in various

positions or near other machines for loading
and unloading, castors should be braked.

Detail of braked wheel on type A

external trolley (option).

Type B internal trolleys

These trolleys are defined as those with a perforated 304 stainlesss

steel plate with a perimetric load containment rim which is welded
at its four corners. 2 profiles shaped like an inverted U are welded
below this metal plate along the length of the trolley.

These profiles are as long as the trolley and house the four wheels
that slide on the guides of the external trolley and of the autoclave.
The wheels are mounted on maintenance-free 304 stainless steel roller
bearings and on a shaft that crosses the entire trolley transversely and therefore
prevents any deformation of the trolley even with heavy loads. Type B internal trolley
If necessary, the wheels can also be disassembled very simply and rapidly.

Generally, these trolleys are used for different loads whose height is approximately the same height of the
chamber of the sterilizer or for mutually stackable containers.

For all applications requiring more compact trolleys due to the large mass of the load, it is advisable to use half-
depth and less than full-length trolleys.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Type C internal trolleys

These trolleys are typically made of 304 stainless steel and have four
perimetric posts for installing the guides for type D trays. The four posts allow
the user to arrange the tray guides at variable heights by means of a set of
interlocking couplings. The posts are also designed to allow discharge of the
condensate into the chamber for easy cleaning.

In case of particular requirements linked to load type, these posts can be

manufactured with custom-designed tray guide hole spacing.

Type C internal trolley

Type E internal trolleys

These trolleys typically made of 304 stainless steel. They are similar to type C
trolleys, except that they have more posts for supporting sliding guides.
They are meant to load boxes of various shapes or standardized sterile units.
Since they are manufactured specifically for each order, they must be
specified at order time according to the type and size of the boxes or sterile
units and to the corresponding quantity to be processed. Please note that
since the guides are fitted on the perimetric posts by interlocking coupling,
the same trolley can be used for different loads.

Type E internal trolley

Internal-external trolleys

If the sterilizer is installed in a pit in order to ensure that the bottom of the chamber
is on the same plane as the floor, it is necessary to use special trolleys that can move
both inside and outside the sterilizer.

The choice of the rolling parts, such as the wheels and their bearings, is particularly
critical for these applications, because these parts must ensure adequate mechanical
characteristics, high hardness and resistance to wear, and must be able to withstand
the operating conditions inside the sterilizer (operating temperatures up to 250 °C).
These components are lubrication-free.

Internal/external trolley

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Type D trays
These trays are designed in order to permit the loading of different material
to variable heights on type C trolleys. They are constructed with 304 stainless
steel, with perimetric edge and chines welded.

Typically the trays for the moist heat sterilizers are perforated in order to
avoid the stagnation of condensation while trays for dry heat sterilizers do not
include perforation. All the others constructive characteristics remain the
same.

Optionally for special loads, such as porous materials, it is preferrable to

reduce the surface between the load and the shelf waves to eliminate the
danger of condensate stagnation. Is is possible to acheive this with a bottom Detail of tray resting on
net inserted in the perimetric structure. Every D type tray is supplied with removable guide fixed to the
guides for the relative type C trolley. post of the internal trolley

Boxes and special containers

Aside from standardized sterile units, there are special components which are
exclusively custom-built and are designed according to the load that they are
intended to contain, taking into account any special requirements.

These components are used mainly to process ampoules, vials and various
bottles (empty and full), but they are also used for pre-filled syringes.
Their options include, in addition to shape and dimensions, a lid, a removable
door or a special perforation.
Box for vials with lid

They are available both in 304 stainless steel and in 316L stainless steel.

Special box for syringes

Lids for cassettes

With the options listed above we would like to mention the possible addition
of lids.

They are available both in 304 stainless steel and in 316L stainless steel.

Box lid

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Folding rails in chamber

This option facilitates the extraction of the internal trolley and extends
the chamber rails. For safety reasons the folding of the system is manual.
Note: availability of this option depends on the trolley’s total weight.

Folding rails

AUTOMATIC LOADING EQUIPMENT OPTIONS

Pallets
If the sterilizer is equipped with automatic loading devices (see below), the load must not be placed on pallets,
which differ from trolleys only because they have no bottom wheels. The wheels are replaced by feet in order to
allow them to be carried by lift trucks. Depending on their dimensions, they are typically made of 304 stainless
steel profiles with various cross-sections.
Like the trolleys described above, pallets are available in types B, C and E, which can be referenced above to
understand the available standard size options.

Automatic load/unload conveyors

Automatic devices are all components and systems for loading and unloading
which, as opposed to manual ones, do not require the presence of the
operator except for operations such as door opening/closing and selection of
the process with the controller.

The originality of the solution perfected by Fedegari lies in the elimination of

any load moving mechanism inside the sterilization chamber, which eliminates
virtually all maintenance and functional problem in the case of defective or
worn components.
These systems are made up of accumulation conveyors, which are made of 304
stainless steel tube with a square cross-section and are approximately as long
as the sterilizer chamber. Two parallel tracks are provided on top of the
conveyors and the load (pallet) runs on these tracks.

The tracks are constituted by a U-shaped profile made of 304 stainless steel
Figure 1Automatic load plate, inside of which several wheels are arranged. The wheels are mounted on
conveyor (without pivots and roller bearings made of the same material. The load is moved by
perimetric protections) means of a cylindrical bar, which has teeth in its lower section and is made to
slide in guiding bushes arranged along the conveyor by a pinion that is coupled
to a gear motor by means of a stainless steel chain.
For safety reasons and in order to protect the operator, 304 stainless steel panels are fixed perimetrically to the
conveyors and prevent contact with moving parts. As an alternative, other safety systems can be provided, but
they must be agreed upon with the manufacturer.
Load movement is controlled by a PLC by Siemens, to which the position sensors of the toothed bar and all the
other devices with which the handling system interacts are connected in order to load and unload the sterilizer in
the manner agreed upon with the buyer.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

DOCUMENTATION SUPPLIED AS STANDARD

Qty. 1 hard copy and 1 CD-ROM containing:

Technical manual (English)

The technical manual contains the following documents:

- As built installation drawing

- P&ID with parts list
- Wiring with electrical parts list
- Drawing of Fedegari supplied valves and devices
- Data sheets for third-party items e.g. vacuum pump
- EC Declaration of Conformity for critical instruments (safety valves, filters, etc.)
- Maintenance instruction
- Calibration certificates for temperature probes and pressure transducer
- Material declaration
- Data sheets for each phase in the library supplied (in English)
- Roughness report
- Safety valves calculation report

Operating manual (Country’s language)

The operating manual contains the following documents:

- General Description
- Warnings
- Transport, handling and storage instruction
- Installation instruction
- Operator maintenance instruction
- TH4 process controller operator manual (incl. alarms, troubleshooting, system configuration
and maintenance)

Original pressure vessel (English)

Pressure vessel documentation in original (+ 1 copy) containing:

- Manufacturer’s certifications
- Report final assessment
- Pressure Vessel Drawings
- Hydrotest Certificate
- Materials Stamping Declaration
- WPS amd WPAR approval list
- Qualified welders approval list
- Certificate of safety valves
- 3.1B certificate for chamber
- Safety valves calculations

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

SOFTWARE CERTIFICATION
With regards to the reliability of the software of all process controllers manufactured by Fedegari, the entire life
cycle of the software is developed to quality-assurance standards by means of appropriately provided procedures.
Every development or modification of the system is regulated by specific operating procedures, which include,
among others, the detailed recording of all activity. All changes are validated in “black-box” conditions and are
documented by means of a change control procedure.

Moreover, the manufacturer manages, for every system, a configuration manual that lists all the subsystems and
their possible combinations.
If required by the buyer, the manufacturer can provide public documents related to software validation, which are
grouped in the THEMA4 Validation
Package software validation documents and can be inspected by arrangement
at the manufacturer’s premises.

OPTION

THEMA4 VALIDATION PACKAGE

This detailed document certifies that the software installed on the process controller of the
specificly-purchased sterilizer was developed and controlled to quality-assurance standards.

This document is composed of these chapters:● Validation Package Letter

● Life Cycle of Process Controller – GAMP5 Approach
● Functional Design Specification
● Configuration Manual - HW and SW Configuration
● HW-SW Change Control
● Libraries Configuration Manual
● Change Control P/G Library
● Validation Activities Planning
● Risk Analysis – Methodology
● Risk Analysis - Report

This document is available only in English and is generated for each individual sterilizer.

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

PACKAGING

Standard packaging
Unless otherwise specified, the machine, after final testing, is cleaned and prepared for shipment by covering it
with a polyethylene sheet. This type of packaging is suitable for shipments on trucks and assumes that no transfers
between different freight agents or direct exposure of the goods to atmospheric agents might damage them.

Crate
For shipments that are potentially more critical, or if short-term storage is
expected, it is advisable to choose a kind of packaging that offers better
protection of the machine and of its parts.
The crate is a wood structure with a base pallet, which allows handling by
means of a crane (using a suitable harness or a fork-lift unit) and has
discontinuous side walls. Inside the crate, the machine is protected by a
polyethylene sheet.

Case for overland shipment

If more protection than offered by the crate described above is required,

it is possible to choose this type of packaging. It differs from the
preceding option in that the side walls and top, instead of being half-
open, are continuous and are made of planed and jointed wood boards or
with phenolic adhesive-bonded plywood.

Case for overland shipment,

closed and ready for shipment

fedegari.com
 FOF
SATURATED
STEAM
STERILIZER

Seaworthy package (solid box)

If the machine is to be ship-borne, stored for long periods, or in environments unsuitable for storage, this type of
packing protects the contests most effectively. Like the “overland case” (see Fig.), it is defined as a pallet and solid
walls, but the goods are contained in a waterproof bag which is fully heat-sealed and from which air is evacuated.
The bag contains salts (silica gel) for absorbing residual humidity.

Machine placed on a pallet Machine placed on a pallet

before heat-sealing its barrier with heat-sealed and
bag evacuated barrier bag

fedegari.com