DOCS-#165534-v13-Technical Manual FOB4-5 TS Sezione 1 - General Description

FOB4-5/TS
TECHNICAL MANUAL
SECTION 1 – GENERAL DESCRIPTION
FOB4-5/TS TECHNICAL MANUAL
SECTION 1
GENERAL DESCRIPTION
ID N° 165534 Rev. 13 1 / 46 September 2013

FOB4-5/TS
TECHNICAL MANUAL
CONTENTS OF SECTION 1
1. GENERAL DESCRIPTION OF THE STERILIZER .................................................... 5
1.1. INTRODUCTION .................................................................................................................. 5
1.1.1. REFERENCES TO STANDARDS .......................................................................................... 5
1.2. MODEL IDENTIFICATION .................................................................................................. 5
1.2.1. BIOSEAL SPECIAL SEALING FLANGE ................................................................................ 6
1.3. STERILIZER IDENTIFICATION .......................................................................................... 6
1.4. KEY COMPONENTS OF THE STERILIZER ....................................................................... 7
1.4.1. STERILIZATION CHAMBER .................................................................................................. 7
1.4.2. STERILIZATION CHAMBER IN PASS-THROUGH VERSION (2 DOORS) .......................... 7
1.4.3. DOORS AND SEALING SYSTEM .......................................................................................... 8
1.4.4. AUTOCLAVE FRAMEWORK AND TECHNICAL AREA ...................................................... 10
1.4.5. ELECTRICAL SYSTEM ........................................................................................................ 10
1.4.6. ELECTRICAL CABINET ....................................................................................................... 11
1.4.7. HYDRAULIC AND PNEUMATIC SYSTEM .......................................................................... 11
1.4.8. PROCESS CONTROLLER WITH INTEGRATED OPERATOR PANEL .............................. 11
1.4.9. PRODUCT LOADING-UNLOADING DEVICES ................................................................... 12
1.5. MAIN OPTIONAL COMPONENTS OF THE STERILIZER................................................ 13
1.5.1. STEAM GENERATOR (KX10).............................................................................................. 14
1.5.2. VACUUM PUMP (KX20) ....................................................................................................... 15
1.5.3. CONDENSATE COOLING UNIT (KX30) .............................................................................. 16
1.5.4. INTERNAL AIR COMPRESSOR (KX40) .............................................................................. 16
1.5.5. STERILE AIR FILTER (KX50) .............................................................................................. 17
1.5.6. INLET FOR AIR IN CHAMBER FROM EXTERNAL MAINS (KX51) .................................... 18
1.5.7. FAST COOLING UNIT (KX52).............................................................................................. 18
1.5.8. CHAMBER PRESSURE TIGHTNESS TEST (KX61) ........................................................... 19
1.5.9. DECONTAMINATION CYCLE (KX62) ................................................................................. 20

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TECHNICAL MANUAL
1.5.10. DECONTAMINATION CYCLE HIGH TEMPERATURE (KX62HT) ...................................... 20
1.5.11. DECONTAMINATION CYCLE WITH DISCHARGE AIR FILTER (KX63) ............................ 21
1.5.12. SLOW VACUUM (KX67)....................................................................................................... 22
1.5.13. SUPER DRY (KX68) ............................................................................................................. 22
1.5.14. AIR/STEAM COUNTERPRESSURE CYCLE (KX69)........................................................... 22
1.5.15. KIT EN285 CONFORMITY EUROPEAN MEDICAL DEVICES DIRECTIVE (KX70) ........... 22
1.5.16. MAINS STEAM SUPPLY (KX72) .......................................................................................... 23
1.5.17. EXTERNAL STEAM SUPPLY KX72 AND STEAM GENERATOR KX10 (KX72A) ............. 23
1.5.18. AIR FILTER STERILIZATION CYCLE (KX73) ..................................................................... 23
1.5.19. AIR DETECTOR TEST (KX74) ............................................................................................. 24
1.5.20. EN285 STEAM QUALITY TEST ACCESSORIES (KX75) ................................................... 24
1.5.21. ADDITIONAL PT100 (KX80)................................................................................................. 25
1.5.22. PROCESS PRINTER (KX81) ............................................................................................... 25
1.5.23. INDIPENDENT PAPERLESS RECORDER NANODAC (KX82) .......................................... 26
1.5.24. SAFETY THERMAL LOCKING DEVICE (KX84) .................................................................. 27
1.5.25. EXTERNAL INDIPENDENT PAPERLESS RECORDER 6100A (KX85).............................. 28
1.5.26. SECOND DOOR SOFTWARE MANAGEMENT (KX90) ...................................................... 29
1.5.27. PORT ADAPTER FOR VALIDATION SENSORS (KX91) .................................................... 29
1.5.28. HYGIENIC GMP CONNECTIONS FOR CHAMBER PRESSURE TRANSDUCER AND

GAUGE (KX93) ..................................................................................................................... 30
1.5.29. EXTERNAL RECORDER SIGNAL (KX102) ......................................................................... 30
1.5.30. EXTERNAL UTILITIES SIGNAL (KX103) ............................................................................. 30
1.5.31. INLET UTILITIES CONTROL SYSTEM (KX104) ................................................................. 30
1.5.32. OPTIONAL BIOSEAL SPECIAL SEALING FLANGE (TSX2 AND TSX3) ............................ 30
1.5.33. F0 FUNCTIONAL CALCULATION AND CONTROL (SWX1) ............................................... 31
1.5.34. DCS LINK (SWX2) ................................................................................................................ 31
1.5.35. CYCLE REPETITION (SWX3) .............................................................................................. 31
1.5.36. DCS LOGGER WITH CFR21 PART11 CONFORMITY (SWX6).......................................... 31
1.5.37. PHARMACOPOEIA CYCLES (SWX7) ................................................................................. 32
1.5.38. TEMPERATURE HOLD PHASE (SWX8) ............................................................................. 32

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1.5.39. I-BUTTON (SWX9) ............................................................................................................... 32
1.5.40. CYCLE ARCHIVING (SWX10) ............................................................................................. 33
1.6. CONTROL AND MONITORING COMPONENTS.............................................................. 33
1.6.1. PROCESS CONTROLLER ................................................................................................... 35
1.6.2. MAIN CHARACTERISTICS .................................................................................................. 36
1.6.3. SIDE 2 OPERATOR INTERFACE ........................................................................................ 37
1.6.4. MAIN SWITCH ...................................................................................................................... 37
1.6.5. EMERGENCY BUTTON ....................................................................................................... 38
1.6.6. MONITORING VACUUM GAUGES...................................................................................... 38
1.6.7. MANUAL CHAMBER DISCHARGE VALVE ......................................................................... 39
1.7. SAFETY SYSTEMS ........................................................................................................... 39
1.7.1. DESCRIPTION OF CHAMBER CLOSURE AND OPENING SYSTEM................................ 39
1.7.2. DOOR CLOSURE AND OPENING SYSTEM....................................................................... 39
1.7.3. SAFETY VALVES ................................................................................................................. 41
1.8. CONFIGURATION OF STERILIZERS AND PROCESS CYCLES.................................... 42
1.9. TECHNICAL DATA ........................................................................................................... 44
1.9.1. DIMENSIONS AND WEIGHTS ............................................................................................. 44
1.9.2. TECHNICAL PARAMETERS AND CONSUMPTIONS......................................................... 45
1.9.3. CONSTRUCTION PARAMETERS ....................................................................................... 46
1.9.4. EMC AND LVD SPECIFICATIONS ...................................................................................... 46

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TECHNICAL MANUAL
1. GENERAL DESCRIPTION OF THE STERILIZER
1.1. INTRODUCTION
The FOB4-5 TS horizontal sterilizers series consists of serially produced, saturated-steam, front loading
sterilizers with either a single or double door configuration. Their innovative and rational design, new process
controller with intuitive touch screen, and high quality materials and finishing make the functional
performance of these sterilizers superior to that of any others in the same category. Thanks to the extensive
series of options offered by the modular system, these sterilizers can be configured to the Customer’s
requirements for different applications and the treatment of a considerable variety of loads. These would
include porous loads, wastes with high pathogen risks as well as solids and liquids, both open and sealed
containers.
Furthermore, the FOB4-5 TS range is suitable for use in microbiological and quality control laboratories,
research institutes, universities, pharmaceutical companies, hospitals and medical applications where
sterilization processes are an essential requisite.
The software is fully validated, thus allowing its utilisation by the most demanding users.
1.1.1. REFERENCES TO STANDARDS

The contents of this document comply with the requirements of the following standards:
• EN 12100 ISO 12100
• EN 61010-1 IEC 61010-1
• EN 61010-2-040 IEC 61010-2-040
and with the following European Directives:

• MD 2006/42/EC (Machinery Directive);
• LVD 2006/95/EC (Electrical Safety);
• PED 97/23/EC (Pressure Equipment);
• MDD 93/42/EEC (Medical devices1);
• EMC 2004/108/EC (Electromagnetic Compatibility).
1.2. MODEL IDENTIFICATION
The FOB4-5 TS range of sterilizers are available in different layouts with the following aspects:
• presence of one or more loading/unloading doors
• useful load capacity
Floor Standing Sterilizers

• FOB4-TS single door, with useful load capacity of 147 l
• FOB4L-TS single door, with useful load capacity of 210 l
1
Sterilizers “used in a sanitary/hospital environment to process medical devices before their reuse” must comply with EN285 standards.
To meet these requirements fully, option KX70 – MDD compliance kit – has to be selected, so that the sterilizer will be supplied with a
CE mark and a declaration of conformity in compliance with Directive 93/42/EC (mandatory in EU countries) and pertinent hardware
options.

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TECHNICAL MANUAL
• FOB4S-TS* double door, with useful load capacity of 210 l

• FOB4SL-TS* double door, with useful load capacity of 210 l
• FOB5-TS single door, with useful load capacity of 400 l
• FOB5L-TS single door, with useful load capacity of 540 l
• FOB5S-TS* double door, with useful load capacity of 430 l
• FOB5SL-TS* double door, with useful load capacity of 540 l
• FOB5-XL single door, with useful load capacity of 730 lt.
• FOB5S-XL* double door, with useful load capacity of 700 lt.
* Model also available with Bioseal Special Sealing Flange isolator on both sides.
1.2.1. BIOSEAL SPECIAL SEALING FLANGE
The double door sterilizers can be installed between two areas with differing environmental ratings (class or
grade); in such cases it is critical to ensure the separation of the two areas onto which the sterilizer’s loading
and unloading doors open. The separation of these two environments is performed by the use of special
sealing flanges (Bioseal) placed between the body of the sterilizer and the wall from which the door of the
sterilizer opens. The bioseal is installed as standard on the sterile side of double door sterilizers, however, as
an option can also be installed on both sides.
! WARNING
If bio seals are required on a sterilizer, the installation layout of the sterilizer must be first
defined in advance with FEDEGARI technical department.
1.3. STERILIZER IDENTIFICATION
The horizontal steam sterilizers of the FOB4-5 TS series are identified by means of an appropriate
identification plate fixed to the body of the autoclave displaying the key details of the sterilizer. The markings
on the identification plate are indelible, as prescribed by product standards. Figure 1.3 shows a drawings of
the CE sterilizer identification plate.
1 ) Notified Body Code for release according to 97/23/CE

2 ) Notified Body Code for release according to 93/42/CE (With KX70=1)
3 ) Sterilizer model
4 ) Sterilizer serial number
5 ) Year of production
6 ) Allowable pressure limits [ bar g ]
7 ) Allowable temperature limits [ °C ]
8 ) Nominal Current absorption [A]
9 ) Power Tension [V]
10 ) Power tension frequency [ HZ ]
11 ) Number of power cables
Figure 1.3 – CE Nameplate

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TECHNICAL MANUAL
1.4. KEY COMPONENTS OF THE STERILIZER
The sterilizer (figure 1.4) is composed of the following main components:

• Sterilization chamber;
• Door movement and sealing system;
• Sterilizer structure and technical compartment;
• Electrical cabinet and related system;
• Hydraulic and pneumatic system;
• Process controller and operator panel;
• Devices for products loading and unloading.
Figure 1.4 –FOB4-5 TS models sterilizers
1.4.1. STERILIZATION CHAMBER
The sterilization chamber, which is single walled and horizontal, is made entirely of 316L. It is TIG welded
and electrochemically polished with a surface finish that ensures sterile cleanliness and optimal corrosion
resistance.
The door that closes the chamber is also made of 316L. It is automatic and slides vertically, and has a
unique closing/opening system. It is encased on the outside with stainless steel matching the autoclave
fascia. The chamber and door are insulated with special non-toxic material with high insulating efficiency.
1.4.2. STERILIZATION CHAMBER IN PASS-THROUGH VERSION (2 DOORS)
If an autoclave is required to “pass-through” loads between rooms of different environmental classes

(grades), then it is critical that the double door autoclave is fitted with a sealing panel (Bioseal) to prevent
cross contamination between the rooms. In addition, through software control the second door is interlocked
with the first so as to avoid any contamination of the “clean” environment through the sterilization chamber
(consent for opening both of the doors simultaneously or in the event of unsuccessful/incomplete
sterilization). Operator interfaces are installed on both the loading and unloading sides, the master is on the
loading side, and the slave is on the unloading side. The controllers are connected to each other and provide
all the essential information relative to the process under way and the sterilizer’s various loading and
unloading consents.
In comparison with the single-door models, the two-door models also include, as standard, the sterilizing
filter option KX50 that has the task of filtering the balancing air (return to atmospheric pressure) at the end of
the process.

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TECHNICAL MANUAL
1.4.3. DOORS AND SEALING SYSTEM
Door movement
The sterilizers in the FOB4-5TS series come with either one or two chamber doors. The doors are operated
automatically via the process controller.
The door is domed to increase its mechanical strength, and has no external reinforcement other than a
single perimeter reinforcement located by the chamber’s sealing gasket. With this design, the door system is
free to flex during the heating process without producing strains along any welded reinforcements that could
compromise its reliability. The door is made of 316L stainless steel plate with the perimeter reinforcement
also made of 316L stainless steel. In the closed position the door is held in place by a flange milled from the
rim onto the chamber.
In comparison with alternative solutions that require the compression of the door against the chamber with a
static gasket, this solution automatically compensates for any deformations in the door system that could
occur during the lifetime operation of the sterilizer. This avoids the need for periodic correction by
mechanical adjustment.
The opening and closing of the chamber door/s is subject to a series of hardware safety devices and
software checks that ensure that door movement can only occur under absolutely safe conditions.
The movement of the chamber door/s is vertical sliding, upwards for closing and downwards for opening.
The closing of the chamber door/s is powered by two gas (nitrogen) piston springs which are connected to
the door by a bracket. This ensures that the vertical sliding movement is gentle and progressive.
The presence of an obstacle during the closing movement of the door will actually stop the door from
moving, this is because the force exerted by the piston springs is low and just sufficient to raise the weight of
the door. The door will resume its movement automatically once the obstacle is removed.
The force necessary to block the action of the springs (i.e stop the door from closing) is very slight so as to
ensure that no damage is caused to persons or property.
The opening of the chamber door is driven by a pneumatic piston and associated solenoid valve operated by
the process controller. Compressed air at 7 – 10 bar is fed into the piston, overcoming the force of the
nitrogen springs, and drives the piston rod up. The rod is connected to the door via a cable and pulleys, and
the movement of the rod pulls the door open.
In order to check that the door is correctly positioned, the sterilizer is equipped with two door status devices.
One is mechanical, placed on the upper external part of the sterilizer chamber to determine the door-closed
state, and the other is electromagnetic, positioned on the upper part of the pneumatic piston to determine the
fully retracted position of the rod and, consequently, the complete opening of the door itself.
All the components of the door system are suitably protected and encased.
! WARNING
While the sterilizer is running the temperature of the door may become very hot. We advise
the operator to wear appropriate personal protective equipment to ensure the operation of
the door/s is in complete safety.

FOB4-5/TS
TECHNICAL MANUAL
Fig. 1.4.2 – Automatically operated door
Sealing system
A fundamental component of the door assembly is the special pneumatic gasket with dovetail cross-section,
which is used on all FEDEGARI sterilizers. This is used in place of the traditional mechanical systems with
radial levers, and facilitates the construction of the chamber and door and eliminates all the relative
maintenance problems. To inflate the door seal, compressed air at a pressure of 6 - 8 bar is fed into the door
gasket. If the location where the sterilizer is to be used does not have a compressed air line, it is possible to
install inside the sterilizer’s technical compartment an extremely silent and efficient oil-free piston
compressor (option KX40).
The main features of the sealing system are as follows:

• supply with instrument-grade compressed air: the door seals unique profile prevents the
compressed air from escaping toward the sterilization chamber, thereby eliminating the possibility
of compromising the sterility of the chamber and of its contents;
• lack of vacuum: the specifically designed contour and the mechanical characteristics of the
material of the gasket (silicone rubber) allow the seal to deflate by simply discharging the
compressed air used to inflate it resulting in the gasket to retract uniformly into its seat. No
vacuum is required;
• simple maintenance: no lubrication or periodic maintenance is required, except for the normal
cleaning of the surfaces and the removal of any foreign objects that might be caught between the
door and the gasket;
• useful life of the gasket: the design of the seal and door sealing system generates very limited
wear on the gasket, which depending on the use of the sterilizer has an average life of 1 to 5
years. The gasket material complies with the characteristics specified in the FDA 21 CFR part
177.2600 standard;
• safety: electronic and electromechanical safety interlocks, managed by the process controller,
prevent the door/s from opening if the gasket is still pressurized and/or if there are dangerous
conditions for the operator and/or for the load.

FOB4-5/TS
TECHNICAL MANUAL
Fig. 1.4.2.c – Gasket depressurized Fig. 1.4.2.d – Gasket pressurized

(door unlocked) (door locked)
1.4.4. AUTOCLAVE FRAMEWORK AND TECHNICAL AREA
The framework of the sterilizer supports the chamber and all its associated components. The frame is made
of 304 stainless steel box section, while the external autoclave panelling is 304 stainless steel sheet with
“Scotch Brite” finish. The whole autoclave stands on a set of robust feet, which are adjustable to facilitate
the levelling of the sterilizer during installation.
The hydraulic and electrical systems, automatic valves and if present, the steam generator, water
pressurisation pump and other components are all contained in the sterilizer’s technical area, which makes it
extremely compact and functional. The sterilizer’s technical area and electrical cabinet are accessed by
removing the side and front panels.
1.4.5. ELECTRICAL SYSTEM
The system is comprised of the electrical panel, all the control lines of the electrohydraulic and
electropneumatic actuators, the motors, the electronic process controller, and the steam generator (if option
is selected). The system also connects the process controller to all the sensors and transducers (e.g.,
pressure switches, temperature probes, etc) and to the operator panels. Finally, it also provides the primary
power supply and the corresponding protection system.
The electrical system of the sterilizer is built in accordance with the following standards:
• EN 61010-1: Safety requirements for electrical equipment for measurement, control and
laboratory use. Part 1: General requirements.
• EN 61010-2-040: Safety requirements for electrical equipment for measurement, control and
laboratory use -- Part 2-040: Particular requirements for sterilizers and washer-disinfectors used
to treat medical materials
As standard, the sterilizer is designed to operate on a three-phase electrical power supply (with neutral)
L1/L2/L3/N/PE at 400 Vac, 50 Hz or 60 Hz. If the voltage and/or frequency of the available power supply
differs from standard, or if there is no neutral wire, then one of the following options is available, only for
FOB4-TS series:
• Three phase without neutral wire 230 Vac 50 Hz (Only for FOB4-TS)

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TECHNICAL MANUAL
1.4.6. ELECTRICAL CABINET
All electrical components, except for some used for control and measurement purposes, are contained in the
electrical cabinet. The cabinet has IP54 protection and is located inside the technical compartment. It is
suitably ventilated, and is easily accessed by removing the side panelling on the sterilizer.
The electrical cabinet is certified by the supplier and is made of stainless steel plate, powder-enamelled with
RAL 7032 colouring and orange-peel surface finish. All cables are run through cable glands to ensure
ingress protection equal to IP54. All the electrical components contained are certified and available
internationally.
The main autoclave power circuit breaker (certified component, compliant with product standards IEC 408
and IEC 204) is installed on the door of the electrical panel and, if operated, isolates all electric power from
the sterilizer. Resetting it and consequently restarting the sterilizer requires operator intervention. All the
control and monitoring circuits operate at low voltage and are identified by specific coloured cabling.
1.4.7. HYDRAULIC AND PNEUMATIC SYSTEM
The hydraulic and pneumatic system includes piping, electric valves, pneumatic valves and electropneumatic
valves. All the parts connected to the sterilization chamber are made of 316L or PTFE. All the valves and
pipe connections used in the hydraulic/pneumatic system are of a sanitary design. The supply-lines of the
process fluids, like the chamber’s discharge drain, are protected by easily inspected in-line filters made of
stainless steel.
NOTE
The details of the hydraulic and pneumatic system are described in the P&ID contained in
Section 3 of the Technical Manual.
NOTE
The details of the components related to the hydraulic and pneumatic system are described in
the component data sheets contained in Section 6 of the Technical Manual.
1.4.8. PROCESS CONTROLLER WITH INTEGRATED OPERATOR PANEL
The electronic process controller is constituted by a graphic TFT color touch screen to which a thermal
printer (option KX81) can be connected. The controller, together with specific hardware blocks and other
electronic equipment, provides total control of the sterilizer and of the activities related to interactive
communication with the operator.
NOTE
In addition to the safety devices and interlocks managed by the process controller, a fail-safe
safety circuit is also present which is active even in the event of process controller failure. It is
described in detail in the “Safety devices report” included in the pressure vessel
documentation supplied with every sterilizer.
NOTE
For details on the use of the electronic process controller, please consult Section 4 of the
Technical Manual.
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TECHNICAL MANUAL
1.4.9. PRODUCT LOADING-UNLOADING DEVICES
Depending on the type of products to be sterilized and/or the type of packaging used, it is advisable to use
the specifically designed baskets, boxes or simple trays optionally available with the autoclave. As a rule,
packed liquids and solids are placed on trays with perforated bottoms which run on slides of a frame that is
installed in the sterilization chamber. The boxes, in the various standard formats, can be used instead for
loads with no packing so that the load sterility can be preserved. Applications such as porous materials and
unwrapped surgical instruments could be sterilized in boxes. In any case, to avoid reducing the sterilizer’s
efficiency, it is important to make sure, regardless of the type of tray or box chosen, that the load
arrangement allows :
¾ the free draining of condensate;
¾ and the correct penetration of steam
¾ sufficient removal of air to permit adequate thermal penetration.
The sterilizer is supplied with slides installed in the lower part of the chamber for loading sterile units and/or
trays (not included). The internal loading accessories, such as trays, baskets, perforated shelves etc, and the
external trolley used for moving loads need to be defined on the basis of the sterilizer’s configuration and the
types of loads to be sterilized. All the loading accessories are made of 304 stainless steel, and are equipped
with handles to facilitate the ease of handling. The shape of the various loading accessories has been
carefully designed for the purpose of containing the sterilization loads normally handled in laboratories.
Every sterilizer in the FOB4-5 TS range is able to contain one or more sterile units (as defined in EN285) in
the sterilization chamber (see the Technical Data section for further information).
1. Tray made of stainless steel plate

2. Tongs for removing trays
3. Sterile unit made of stainless steel
4. Sterile unit made of steel and anodized aluminium
5. Basket made of stainless steel wire
1. FOB5-TS basic tray 2. FOB4-5 TS External trolley

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1.5. MAIN OPTIONAL COMPONENTS OF THE STERILIZER
The FOB4-5 TS sterilizer, in its basic configuration, can be fitted with a series of software and hardware
optional components (kits), which are listed below and are identified by means of a reference number.
Available kits are the following:
KIT reference KIT description

KX10 Steam generator
KX20 Vacuum pump
KX30 Condensate cooling unit
KX40 Internal air compressor
KX50 Sterile air filter
KX51 Unit for supplying compressed air from the mains
KX52 Rapid cooling unit
KX61 Chamber pressure tightness test
KX62 Decontamination cycle
KX62HT Decontamination cycle HT (Available only for HT models)
KX63 Decontamination cycle with discharge air filter
KX67 Slow vacuum
KX68 Super dry
KX69 Air/steam counter-pressure cycle
KX70 Kit for conformity with European medical directives
KX72 External steam supply
KX72A External steam supply KX72 and Steam generator KX10
KX73 Air filter sterilization cycle
KX74 Air Detector Test
KX75 EN285 steam quality test accessories
KX80 Additional Pt100
KX81 Printer
KX82 Independent paperless recorder Nanodac
KX84 Safety thermal locking device
KX85 External independent paperless recorder 6100A
KX90 Second door software management (Only for FOB4-5S-TS and FOB5SL-TS)
KX91 Port for validation sensors
KX93 Hygienic GMP connections for chamber pressure transducer and gauge
KX102 Independent recorder start/stop signal
KX103 External utilities signal
KX104 Inlet utilities control system
TSX2-3 Optional Bioseal Special Sealing Flange
SWX1 F0 Function calculation and control
SWX2 DCS Link
SWX3 Cycle repetition
SWX6 DCS Logger with CFR21 Part11 compliance
SWX7 Pharmacopoeia cycles
SWX8 Temperature hold phase
SWX9 I-Button
SWX10 Cycle archiving

FOB4-5/TS
TECHNICAL MANUAL
1.5.1. STEAM GENERATOR (KX10)
Sterilizers in the FOB4-5 TS series are designed to operate in locations where a steam supply line is not
available, as they can be supplied with an optional horizontal electric steam generator and water
pressurization pump. The steam generator is supplied at a pressure of 4 bar g by the pump, which is above
the operating pressure of the steam generator so as to ensure the inflow of water. The steam generator is
made of 316L and is fitted with all the required monitoring instruments and safety devices. The design and
manufacture of the sterilizer comply with the 97/23/EC (PED) directive. The water supply pump is a
membrane pump with an extremely low operating noise level (maximum 60 dBA). The pump is protected
against possible overpressures by means of a relief valve, which has a set pressure of 9 bar and it is self-
priming from a maximum height of 2 meters. The water used in the steam generator must at least be
deionised in order to minimize the formation of deposits. Recommended characteristics:
• Indicative consumption: 25 l/h for FOB4-TS 40 l/h for FOB5-TS 60 l/h for FOB5XL-TS
• Conductivity 1 ÷ 30 µS/cm ( suggested 15 µS/cm ) at 25°C - TOC< 500 ppb – pH: 6.0 ÷ 7.5 –
Chlorides max 30 ppm
• Pressure 1 ÷ 4 bar
NOTE
Installation of the KX10 option considerably increases the sterilizer’s electricity consumption,
which also varies depending on the model. Please consult the Technical Data section for the
precise consumption data for each model.
Fig. 1.5.1a – Steam generator FOB4-TS Fig. 1.5.1b – Steam generator FOB5-TS
NOTE
The details of the components of KIT KX10 are given in the corresponding data sheets contained
in Section 6 of the Technical Manual.
NOTE
The maintenance frequency and procedure is given in the corresponding maintenance sheet
contained in the section 5 of the Technical Manual.

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TECHNICAL MANUAL
1.5.2. VACUUM PUMP (KX20)
This is a highly efficient single-stage water-ring pump (Figure 1.5.2), including an anti-cavitation system and
solenoid valve for supplying mains water (for the liquid ring).
The vacuum pump must be installed whenever the load being sterilized has the potential to retain air which
would reduce thermal penetration and compromise the successful outcome of sterilization. Treatment of the
following loads would need an autoclave with a vacuum pump fitted:
• porous loads
• various instruments in bags/pouches
• various solids that need to be dried when removed (e.g., tubes, pipettes)
• empty containers with integrated filters
The pump is used to remove the air from the load prior to sterilization by applying single or repeated (pulsed)
vacuums. It would also be used to pull a vacuum, or pulsed vacuums, at the end of the cycle for an effective
drying process, and to meet load dryness requirements. Drying times are significantly improved if a vacuum
is applied to the load. The minimum vacuum level that can be reached in the chamber is 60 mbar if the
temperature of the water that supplies the water ring does not exceed 15°C.
NOTE
Additional utilities are required to implement this option:

• installed electric power – 0.81 kW (50Hz) – 1,27 kW (60Hz)
• water (maximum hardness 20° F and minimum pressure of 2.5 bar g) – 200 l/h.
Fig. 1.5.2 Vacuum pump
NOTE
The details of the components of kit KX20 are given in the corresponding data sheets contained
in Section 6 of the Technical Manual.

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1.5.3. CONDENSATE COOLING UNIT (KX30)
The temperature of the autoclaves drain fluids do not normally exceed 120°C. To cool the discharged fluids
to lower temperatures, it is possible to have the optional compact air condenser installed which ensures a
final temperature below 80°C. This device is designed for continuous operation.
Fig. 1.5.3a - Condensate cooling unit FOB4-TS Fig. 1.5.3b - Condensate cooling unit FOB5-TS
NOTE
The only additional utility required to add this option is a slight increase in electric power: the
additional power for the installation of this option is 47 W for FOB4-TS and 34 W for FOB5-TS.
The details of the components of kit KX30 are given in the corresponding data sheets
contained in Section 6 of the Technical Manual.
1.5.4. INTERNAL AIR COMPRESSOR (KX40)
If compressed air for treating liquids in chamber (cooling counterpressure) is not required, the oil-free
compressed air at the pressure of 7 bar is used only for the door gasket and for the pneumatic valves.
When the compressed air line is not available at the site of use, the sterilizer can be equipped with an
electric piston-type compressor, which is lubricant oil-free and extremely quiet and efficient. This compressor
is installed inside the cabinet of the sterilizer and is provided with a plenum chamber made of 316L stainless
steel with a capacity of 4,2 liters for FOB4-TS and 11 liters for FOB5-TS.
The only utility required for the operation of the compressor is electric power (required power 0.20 kW).
Fig. 1.5.4 - Internal air compressor

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NOTE
This option is indispensable if the user cannot supply directly the autoclave with compressed
air or if the air has a high content of lubricating oil or condensation, which may rapidly damage
the sterilization filter (option KX50) or contaminate the load.
! WARNING
It has to be remarked that the capacity of the selected compressor KX40 does not allow to
provide an effective counterpressure in the chamber during the cooling phase; this option,
therefore, ensures only the supply of the door gasket and of the pneumatic valves.
NOTE
1.5.5. STERILE AIR FILTER (KX50)
Air is introduced into the autoclave chamber either when performing a counter pressure sterilization cycle, or
when breaking a vacuum (at the end of a cycle) while returning to atmospheric pressure. If this air is required
to be sterile either to reduce the bio burden for sterilization, or when the load is to be passed through into a
clean room environment, the air can be filtered sterile by passing through the optional sterile air filter.
A special filter with housing in 316L and tri-clover connections is produced by FEDEGARI. Inside the housing
there is a PALL cartridge MCY4440, which has an absolute retention of 0.22 µm for liquids and 0.003 µm for
gases and it is therefore capable of ensuring a reduction of the bacterial load of Brevindimonas
(Pseudomonas) equal to 107ufc/cm2. The filter enclosure comprises the manual valves, provided with Staübli
couplings, which allows a filter integrity test (Water Intrusion Test, WIT) to be performed.
Fig. 1.5.5a – Sterile air filter FOB4-TS Fig. 1.5.5b – Sterile air filter FOB5-TS

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NOTE
If the sterilizer is used to sterilize liquids and the counter-pressure is required during the
cooling phase, this option is recommended together with option KX51.
NOTE
In models FOB4-5 TS double-door sterilizers this option is included as a standard accessory.
NOTE
1.5.6. INLET FOR AIR IN CHAMBER FROM EXTERNAL MAINS (KX51)
This option must be selected when the load to be sterilized requires air input in chamber for counter-
pressure during final cooling or for perform air pulses during drying.
The oil-free air stream must be introduced at a minimum pressure equal to 6 bar g.
NOTE
1.5.7. FAST COOLING UNIT (KX52)
The sterilizer is equipped with chamber auxiliary plates in its base configuration and their use is only allowed
as auxiliary heating by the means of steam input during pre-heating phase. With the option KX52, the
sterilizer is equipped with two cooling fans and with the possibility to insert tap water into the auxiliary plates
during cooling phases. The fans and motors are magnetically coupled (no penetration of the chamber wall)
and are used to re-circulate and cool the air contained in the chamber by bringing it into contact with the
surface of the plate heat exchangers. This cooled air is also circulated throughout the load thereby cooling it
in the process. The plate heat exchangers are made of 316L stainless steel and are cooled by mains water
of suitable quality.
Recommended characteristics:
• Required flow rate: 100 l/h
• Pressure 2,5 ÷ 4,5 bar
• Maximum hardness 20° F
This option ensures not only a faster cycle but also an improvement in the temperature distribution within the
chamber and load when running counter pressure cycles. In the case of sterilizing liquids in open containers,
this option reduces the loss of product, maintaining higher levels of filling at the end of the treatment.
This option is located inside the cylindrical sterilization chamber in such a way so as to avoid reducing the
useful volume of the chamber itself.
This solution drastically reduces the cooling time by up to 85% with respect to spontaneous (natural,
unforced) cooling, especially for liquids in bottles of considerable volume, and accordingly increases the
productivity of the autoclave. The pressure inside the chamber during the cooling phase can be set.

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Fig. 1.5.6a - Fast Cooling Unit FOB4/TS Fig. 1.5.6a - Fast Cooling Unit FOB5/TS
NOTE
The rapid cooling unit already includes options KX50 and KX51 in order to supply the
compressed air for counter-pressure.
NOTE
NOTE
Further details of the components of the kit KX52 are given in the relative maintenance sheet
1.5.8. CHAMBER PRESSURE TIGHTNESS TEST (KX61)
With this option, it is possible to perform an automatic cycle to check the tightness of the sterilization
chamber and of the components directly connected to the chamber (valves, gaskets, etc.). The cycle
pressurizes the chamber by using compressed air and monitors any pressure drop due to leaks over a pre
determined period of time. This cycle is proposed as an alternative to the vacuum seal test if the sterilizer
does not have a vacuum pump.
! WARNING
Test pressure results may be altered, in some cases, by temperature changes.
NOTE

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1.5.9. DECONTAMINATION CYCLE (KX62)
This is not an ordinary decontamination cycle with exhaust effluent filtration. It consists of a unique, exclusive
process developed by FEDEGARI on the basis of its accumulated experience in the treatment of materials
with high-pathogenic contamination risks. In this case the operator’s safety is of primary importance.
During this special decontamination cycle (based on air/steam mixture), the air contained initially in the load
and chamber and the condensate generated during the cycle are not discharged into the environment until
sterilization ends. The cycle begins with heating by introducing steam into the chamber, including directly via
the drain, which is the coldest point, thereby ensuring decontamination of the product and of the condensate.
The uniformity of the steam and air is ensured by fan(s) installed in the upper part of the chamber. The
maximum set temperature value that can be programmed for the decontamination cycle, as described
above, is 128°C, which corresponds to 2.9 bar g for a mixture of air/steam.
This solution ensures higher safety margins than:
• traditional decontamination cycles, performed by evacuating the effluents through a sterilizing

filter whose integrity must be checked periodically. In any case, even with periodic checking it is
not possible to 100% ensure a sufficient virus retention capacity.
• decontamination cycles performed by thermal treatment of the evacuated air, this method being
subject to failure if the temperature is not monitored accurately, and also in view of the lack of
specific studies regarding the decomposition of micro-organisms at high temperatures with
application of dry heat for short periods of time.
With this decontamination method, the penetration of steam inside porous loads placed in closed baskets or
similar containers can be very slow due to limited penetration of the air/steam mixture uniformly inside the
load. The reliability of the sterilization can be ensured, however, by placing a monitoring probe inside the
load at the most critical point of the process.
NOTE
1.5.10. DECONTAMINATION CYCLE HIGH TEMPERATURE (KX62HT)
This cycle is a single process developed on the basis of FEDEGARI experience in treating Category III°
loads. This cycle is the same performed with the option KX62, but with a maximum set Temperature at
138°C and 3.9 bar g for steam/air mixture. With the enabling of this kit, all the saturated steam cycle ranges
of Temperature and Pressure are raised up to 152°C and 4.5 bar g respectively.
NOTE
Option KX62HT (Decontamination cycle HT) also includes options KX61 (Chamber pressure
tightness test) and KX52 (Rapid cooling unit).
NOTE
The details of the components of kit KX62HT are given in the corresponding data sheets

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1.5.11. DECONTAMINATION CYCLE WITH DISCHARGE AIR FILTER (KX63)
This decontamination method uses filtration of the effluent and is recommended for the destruction of
dangerous micro-organisms, especially within porous loads. The air that is initially present within the
chamber is removed by means of vacuum pulses through a special sterilizing filter, produced by FEDEGARI,
with housing in 316L and tri-clover connections. Inside the housing there is a PALL cartridge MCY4440,
which has an absolute retention of 0.22 µm for liquids and 0.003 µm for gases and it is therefore capable of
ensuring a reduction of the bacterial load of Brevindimonas (Pseudomonas) equal to 107ufc/cm2. The filter
enclosure comprises the manual valves, provided with Staübli couplings, which allows a filter integrity test
(Water Intrusion Test, WIT) to be performed. It also allows easy access for removal for maintenance.
NOTE
The condensate generated during heating and sterilization is not discharged into the
environment until the sterilization process ends successfully. To ensure that the sterilization
conditions of the condensate are reached and maintained, steam is also introduced directly
from the bottom of the chamber via the drain. At the end of the sterilization phase, a vacuum
can be performed inside the chamber in order to obtain drying. The decontamination filter can
be heated, sterilized and dried in parallel with the chamber.
The maximum set temperature possible for the decontamination cycle with the sterilization filter installed on
the sterilizer, as described above, is 138°C.
This solution cannot guarantee 100% the decontamination of the effluents, like the decontamination method
applied in option KX62, and in any case requires the integrity of the filter to be monitored periodically.
The main advantage of this method is higher efficiency of heat penetration within porous loads with
consequently less time required for cycle completion.
Fig. 1.5.10 – Air discharge filter
NOTE

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1.5.12. SLOW VACUUM (KX67)
This option is composed by an additional system, exclusively added to the items installed with option KX20.
By the means of this option, it is possible to perform a slow vacuum in chamber for special products like
delicate filters, membranes, etc.
NOTE
The functionality of kit KX20 is described in paragraph 1.5.2.
1.5.13. SUPER DRY (KX68)
This process option is particularly recommended when porous loads (such as textiles or other special
products) are required to be totally dry at the end of the cycle.
The steam is passed through the internal plate heat exchangers for additional temperature controlled heating
inside the chamber which greatly improves the effectiveness of the drying phase.
This option is settable in every phase of the cycle (preheating/sterilization/drying) and includes all the
required automatic valves, plus a temperature probe for controlling the process and relevant software.
1.5.14. AIR/STEAM COUNTERPRESSURE CYCLE (KX69)
The exclusive air/steam counter-pressure cycle option on the new sterilizers in the FOB4-5 TS series has
been developed for the sterilization of special heat-sensitive products which could suffer structural damage
from the pressure difference between the inside of the product and the chamber if sterilized with standard
saturated steam cycles. Examples of potential loads would be, bags made of plastic materials, bottles and
containers of stiff or semi-stiff plastic (PVC, PP, PE, etc.), blister packs, contact lenses, pre-filled syringes,
carpules and sealed glass bottles. This is a complete counter-pressure cycle where the chamber pressure is
controlled independently of temperature.
The option includes all the hardware and software components necessary for the performance of the
sterilization process.
NOTE
The particulars of the components of KIT KX69 are given in the relative technical data sheets
NOTE
This option is not compatible with the option KX73.
1.5.15. KIT EN285 CONFORMITY EUROPEAN MEDICAL DEVICES DIRECTIVE (KX70)
Selection of this option means that the sterilizer will be supplied as a medical version, i.e according to the
specifications of the Medical Devices Directive 93/42/EEC, mandatory for EU countries.
The CE marking and the declaration of conformity are provided according to the requirements of the above
mentioned Directive, and the sterilization processes can be validated in accordance with the requirements of
standard EN ISO 17665-1 Sterilization of health care products - Moist heat – Requirement for the
development, validation and routine control of a sterilization process for medical devices

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NOTE
This option includes the selection of the following options, as required under the current
regulations:
• KX20 Vacuum pump
• KX50 Air sterilization filter
• KX82 Independent paperless recorder or KX85 external independent paperless recorder
6100A.
NOTE
In case that the option KX70 is selected, it is also mandatory to select the option KX81.
1.5.16. MAINS STEAM SUPPLY (KX72)
This option includes an additional special utility connection in 316L suitable for connection to an external
(site) steam source. This option should be chosen if the Customer has factory clean steam available to feed
directly the autoclave. In this case the optional steam generator (KX10) is not required.
1.5.17. EXTERNAL STEAM SUPPLY KX72 AND STEAM GENERATOR KX10 (KX72A)
The option KX72A foresees the simultaneous use of KX10 inlet for purified water and the KX72 external
steam inlet. By the means of a manual valve, it is possible to switch the steam source between the internal
steam generator and the User external line.
1.5.18. AIR FILTER STERILIZATION CYCLE (KX73)
This program is used for the sterilization of the in-line air filter. A special PALL filter with housing in 316L and
tri-clover connections is used in this kit. Inside the housing there is a PALL cartridge MCY4440, which has an
absolute retention of 0.22 µm for liquids and 0.003 µm for gases and it is therefore capable of ensuring a
reduction of the bacterial load of Brevindimonas (Pseudomonas) equal to 107ufc/cm2. The filter enclosure
comprises the manual valves, provided with Staübli couplings, which allows a filter integrity test (Water
Intrusion Test, WIT) to be performed.
Additional valves allows the sterilization of the filter in parallel with the chamber, constantly draining the
condensate from the housing and thus ensuring the ideal conditions for sterilization. In order to perform a
thorough sterilization, a dedicated probe is installed in the coldest point of the housing and records the
temperature during the process. This is monitored in parallel with the other probes fitted to the sterilizer.
This option needs the selection of the KX20 vacuum system and also includes the probe TE6 in the air filter
for temperature control.

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Fig. 1.5.15 - Air filter sterilization group
NOTE
The particulars of the components of KIT KX73 are given in the relative technical data sheets
NOTE
This option is not compatible with the option KX69.

1.5.19. AIR DETECTOR TEST (KX74)
This test, specific for porous loads, completed with its hardware configuration, is used to determine whether
the non-condensable gases contained in the steam delivered to the sterilizer and the air remaining after the
air removal stage of the sterilization cycle are sufficient to cause the sterilizing process to be of uncertain
efficacy.
For a correct utilization of the Air Detector Test within porous loads cycles it is anyway mandatory to follow
the prescription of EN285 Clause 19 and it is also mandatory to respect its prescriptions in terms of
maximum allowable percentage of non-condensable gases introduced in the sterilization chamber. It is also
important to underline that the Air Detector function is not to reveal an air loss ( the vacuum test, developed
according to EN285, is proper for this scope ) but to reveal a certain quantity of non condensable gases
within the steam produced by the steam generator or inserted by the means of an external line.
1.5.20. EN285 STEAM QUALITY TEST ACCESSORIES (KX75)
This option includes a Pitot tube, thermocouple lead through, isolation valve with hose-tail and three test
ports on incoming steam line to enable steam dryness/NCG/Superheat quality testing as per EN285. Test
equipment (burette, flask, thermocouple etc. not included).
This option also includes additional special steam pipe work that needs to be swapped with the existing
steam pipe work to undertake the testing. The steam quality test pipe work not only includes the above
noted test points, but also the pipe dimensional test requirements to meet EN285 standards.

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1.5.21. ADDITIONAL PT100 (KX80)
This is an additional flexible PT100 probe, which is identical to the load probes supplied as standard. It will
be used as a load probe and, therefore is connected to the process controller, and can be used to assist the
control of the sterilization process. The temperatures measured by this sensor are printed after the ones
measured by the main sensors.
This option can be useful, for example, when sterilizing liquid loads that reach the temperature required for
their treatment more slowly than the chamber. For this, the probe is placed in the liquid load so that the
process controller will also be monitoring the liquid temperature. The cycle will not advance until all
temperature probes (i.e the load) have attained their programmed target temperatures. Therefore, with the
additional load probe in the liquid, it is guaranteed that the load always achieves, and is maintained at, the
sterilization temperature.
Fig. 1.5.17 – Additional PT100 probe.
NOTE
1.5.22. PROCESS PRINTER (KX81)
This option consists of a thermal printer located underneath the operator panel on the main side of the
sterilizer (side 1). The printer is used primarily to print out the cycle data, in real time, on the basis of
configurable parameters, which enable the print-out and its print rate.
The following information is included in the printed report, in this order:
¾ HEADING
• FEDEGARI
• PROGRAM STARTING DATE AND TIME
• PROGRAM NUMBER AND NAME
• STERILIZER SERIAL NUMBER
• PRODUCT CODE
• LOT CODE
• SPACE FOR NOTES

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¾ LIST OF PROGRAM PARAMETERS

¾ PHASE HEADING: number and name of the current phase
¾ CYCLE DATA
• program time tp
• sterilization time ts
• temperature value TE1, TE2, TE3, TE6, TE8, TE9
• pressure P
• F0 value
¾ ALARMS RECORD
• NAME OF ALARM
• ALARM STATUS recorded (ON, OFF)
¾ FINAL DATA
• PROGRAM NUMBER (progressive number of programs executed)
• CYCLE STARTING DATE AND TIME
• CYCLE END DATE AND TIME
• PROGRAM TIME (total cycle time)
• STERILIZATION TIME (exposure time to correct temperatures during the sterilization phase)
• OUTCOME OF DECONTAMINATION (P1,P2) or STERILIZATION TEST (P3,P4)
• DATE AND TIME (program end time)
• SIGNATURE (Space for signature of operator and supervisor)
Fig. 1.5.18 – Thermal Printer
NOTE
1.5.23. INDIPENDENT PAPERLESS RECORDER NANODAC (KX82)
In the event that the regulations currently in force (in particular by those of a pharmaceutical nature) require
an independent record of the process to be kept or for sterilizers “used for the sterilization of medical devices

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before their re-use” which must comply with the specifications of Directive 93/42/EC and the EN285
standard, an independent record of the process data needs to be available to substantiate that the data from
the process controller is correct. To ensure conformity to this requirement it is possible to install an
independent paperless recorder, integrated in the autoclave’s external frame, that allows to create an
independent record of the cycle data ( by the means of one temperature probe placed in chamber and one
dedicated pressure transducer directly connected to the recorder ).
It is then possible to download and print all the records stored with the recorder dedicated software.
NOTE
The recorder does not log data, but acts as a collection point for the independent data and then
allows to print the process data.
NOTE
This option also includes the option KX102, that manages the start and stop of the recording
session.
NOTE
In case that the option KX82 is selected, it is also required to select the option KX81 in order to
get the ordinary print out of the cycles.
1.5.24. SAFETY THERMAL LOCKING DEVICE (KX84)
If the sterilizer is used to sterilize liquids in hermetically sealed containers, it is necessary to install an
additional temperature probe, which is connected to a thermal safety interlock. This device interlocks the
door opening circuit and only allows the door to open if the load has cooled below the set temperature (the
additional temperature probe is used only for thermal interlock monitoring). This is to avoid the load bursting
when the doors of the sterilizer are opened. This safety device is a requirement by the following statutory
provisions if liquids in closed containers are treated.
• EN 13445 (Unfired Pressure Vessel – part 5, section C. 5.7.3.4) in general states that “vessels
fitted with quick-opening access doors shall (…) ensure that the temperature of the process fluid
has been reduced to safe level”.
• EN 61010-2-040 (Safety requirements for electrical equipment for measurement, control and
laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to
treat medical materials; section 7.106) specifies that “equipment designed to process fluid in
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TECHNICAL MANUAL
unvented containers shall incorporate additional controls to ensure that it is not possible to open
the door until the temperature of the fluid in the containers has fallen to a safe value”. The final
temperature recommended for glass containers is 20°C below the boiling point of water at
atmospheric pressure, while 10°C are sufficient for PVC pouches.
Fig. 1.5.20a - Probe dedicated to Safety Fig. 1.5.20b - Safety thermometer

thermometer
NOTE
The details of the components forming the kit KX84 are described in the relevant technical
sheets provided in Section 6 of the Technical Manual.
1.5.25. EXTERNAL INDIPENDENT PAPERLESS RECORDER 6100A (KX85)
This option represents an enhanced alternative to the option KX82. The option KX85 external independent
paperless recorder can be ordered with multiple functions and configuration, which have to be discussed
prior the autoclave’s order.
Together with the already mentioned same EN285 characteristics of the option KX82, the option KX85
recorder 6100A can offer multiple channels control, with the possibility to organize them in groups: this
functionality opens to the possibility to use one recorder for more autoclaves, considering that it is possible to
order it configured for frame installation or externally portable.
In addition to all the above mentioned features, the KX85 external independent paperless recorder 6100A
can be supplied completely compliant to CFR21 Part 11 standard.

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NOTE
The recorder does not log data, but acts as a collection point for the independent data and then
allows to print the process data.
NOTE
This option also includes the option KX102, that manages the start and stop of the recording
session.
NOTE
In case that the option KX85 is selected, it is also required to select the option KX81 in order to
get the ordinary print out of the cycles.
1.5.26. SECOND DOOR SOFTWARE MANAGEMENT (KX90)
On all double-door sterilizers, a specific software function is implemented to ensure correct use of the
sterilizer. As well as controlling the movement and safe opening and closing of the second door, this option
prevents simultaneous opening of both doors (interlock function) and also prevents the opening of the
second door if the sterilization has been unsuccessfully completed.
1.5.27. PORT ADAPTER FOR VALIDATION SENSORS (KX91)
On all sterilizers in the FOB4-5TS range, a standard DN35 chamber port is supplied for the insertion of
sensors into the chamber for validation. This port is typically located on the upper part of the chamber and is
blanked. To insert validation thermocouples (and pressure transducer) into the chamber, a special pass-
through device is available which employs a threaded ring to compress the thermocouple wires between two
silicon membranes without inducing a chamber leak. Figure 1.5.22 shows the pass-through device used for
inserting up to 12 validation probes.

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Fig. 1.5.22 – Port adapter for

validation sensors
1.5.28. HYGIENIC GMP CONNECTIONS FOR CHAMBER PRESSURE TRANSDUCER AND GAUGE
(KX93)
This option upgrades the chamber pressure transducer and pressure gauge to hygienic GMP models. This
includes hygienic connections and separation membranes.
1.5.29. EXTERNAL RECORDER SIGNAL (KX102)
With this option is possible to obtain a normally open electrical contact in output, in order to manage the
start/stop of an external recorder.
1.5.30. EXTERNAL UTILITIES SIGNAL (KX103)
With this option is possible to obtain a normally open electrical contact in output, in order to manage the
control of an external utility like the opening/closure of a tap water loop valve.
1.5.31. INLET UTILITIES CONTROL SYSTEM (KX104)
With this option is possible to control the tap water inlet and compressed air inlet connected to the sterilizer.
1.5.32. OPTIONAL BIOSEAL SPECIAL SEALING FLANGE (TSX2 AND TSX3)
The double door “pass-through” sterilizers can operate between rooms of different environmental classes
(grades). In such cases it is critical to ensure the separation of the two areas to eliminate any contamination.
This separation is achieved by the use of a Bioseal, a special sealing flange installed around the door
opening and between the body of the sterilizer and the wall forming a barrier between the two rooms.
NOTE
This solution is installed as a standard feature on the sterile side of double-door sterilizers, and in
addition, as an option, it can be installed on both sides.
! WARNING
It is advisable to specify this option when first ordering, as it entails structural changes that
cannot be implemented once the sterilizer has been completed.

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1.5.33. F0 FUNCTIONAL CALCULATION AND CONTROL (SWX1)
With this option, the system calculates the F0 value based on the temperatures measured by the load
probes, when above a minimum set value, during all phases of the cycle. The sterilization phase can be
deemed to have successfully ended only if the expected F0 value has been achieved. The current value and
the expected F0 value are displayed and printed on the report of the program in progress .
1.5.34. DCS LINK (SWX2)
This option consists of a dedicated ethernet software which allows cycles data storage. This facilitates a
complete supervision of the sterilizer and also provides the potential for A4 format printouts of the complete
cycle report and relative graphs from a suitable computer/printer ( not supplied ).
NOTE
With the DCS Link software is possible to monitor up to 10 sterilizers simultaneously from a
single computer, even with different process controllers such as TSC09, DCS PLUS08, DCS PLUS
10 or CMA.
! WARNING
DCS Link software does not fulfil CFR21 Part 11 requirements.
1.5.35. CYCLE REPETITION (SWX3)
This option offers automatic repetition of the last cycle selected (for a selectable number of times) even when
no operator is present. This function is particularly useful for long-term repetitive special tests on products,
applicable to various industrial production fields.
1.5.36. DCS LOGGER WITH CFR21 PART11 CONFORMITY (SWX6)
This exclusive FEDEGARI option for laboratory autoclaves consists a software for data management
according to 21 CFR Part 11 protocol.
The main characteristics of the system, and the instructions, are included in the Fedegari Logger manual,
supplied with the installation CD.
This protocol allows:
• Complete remote supervision of the sterilizer with data-monitoring, Temperature and Pressure
graph, alarm/message activations and phase status of the program being executed.

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• Data Log: storage of the process reports and all cycle data, from the sterilizer, on an external PC
The software also allows all stored cycle/process data to be reviewed.
• A4 print-outs: printing the stored reports on an A4 printer connected to the PC.
• Monitoring several sterilizers from a single PC (by activating several licenses).
• Monitoring several sterilizers from a single PC (up to 10 sterilizers, which can be different
models).
1.5.37. PHARMACOPOEIA CYCLES (SWX7)
This option allows the utilization of the pharmacopoeia type cycles.

The type “Glass resistant test” has been developed according to the hydrolytic strength test criteria for glass
containers, dictated by the pharmacopoeia, in order to preheat the load for 10 minutes at 100°C and then
perform heating in saturated steam conditions from 100°C to 121°C in approximately 20 minutes and then
expose the load to 121°C for 20 minutes and then perform cooling from 121 to 100°C in approximately 40
minutes.
The type “Arsenic” has been developed in order to pre-heat the load for 10 minutes at 100 °C, and then
generate heat in a saturated steam condition from 100 °C to 121 °C in about 20 minutes, in order to expose
the load to a 121°C temperature for 60 minutes and then cooling it down from 121 °C to 100 °C in about 40
minutes.
The type “Stopper” has been developed in order to heat the load in a saturated steam condition from
ambient temperature to 121°C in about 20 minutes, then expose it to a 121 °C temperature for 30 minutes
and then cooling it down from 121°C to ambient temperature in about 30 minutes.
1.5.38. TEMPERATURE HOLD PHASE (SWX8)
This software option allows to enable, in all available programs, the phase temperature hold. When this
option is activated it is possible to enable the temperature hold phase, which allows to maintain the load in
chamber at a certain temperature and for a certain time after its sterilization.
1.5.39. I-BUTTON (SWX9)
By means of the i-button recognition technology, each user can be given an electronic key, which allows to
perform login operations, and the associated activation of rights on the sterilizer, quickly, safety and
unequivocally.

FOB4-5/TS
TECHNICAL MANUAL
I-Button
1.5.40. CYCLE ARCHIVING (SWX10)
This option consists of a USB port located on the front panel, allowing the download of the last 20 cycles to
an ordinary data storage pen drive. The data can then be transferred to a PC and printed in A4 format.
NOTE
For further details on the structure and execution of the programs, please refer to Section 4 of
the Technical Manual.
1.6. CONTROL AND MONITORING COMPONENTS
The sterilizer is controlled by a process controller consisting of a PLC with dedicated modules and a 5.7” TFT
touch screen panel as operator interface. The process controller as a whole presides over the chief
actuations and supervises and controls the hardware of the apparatus, organising the activation of the
various operative phases constituting the specific sterilization “cycle” that has been programmed. The new
DCS PLUS 10 process controller has been specifically developed to ensure the automatic operation of the
FEDEGARI saturated steam sterilizers. It is extremely easy to use, and enables even personnel who lack
computer skills to start up and control the sterilization cycle stored in its memory. Moreover, all the
information regarding the cycle can be printed out by a small optional process printer located on the operator
panel.
The sterilizer is also equipped with command/control devices which operate independently of the PLC and
supplement the latter’s tasks with regard to certain specific onboard functions.
The sterilizer is equipped with a series of functional command/control devices and units located on the
sterilizer body. The devices are as follows :
• Process controller with TFT touch screen operator panel and relevant modules.
• Side 2 operator interface consisting of a second TFT touch screen operator panel serially
connected with the main one;
• Main switch;
• Emergency push-button (2 buttons in the double door versions, one on each side of the
sterilizer);
• Pressure/vacuum control gauges for sterilization chamber and generator;
• Additional pressure/vacuum control gauge for the chamber on Side 2 of the sterilizer (for
double door versions only);
• Manual discharge valve.

FOB4-5/TS
TECHNICAL MANUAL
Fig. 1.6.a – Touch Screen process controller and printer. Fig. 1.6.b – Main switch
Fig. 1.6.d – Pressure/vacuum control gauges

Fig. 1.6.c – Manual discharge valve for the chamber and generator, and
emergency button

FOB4-5/TS
TECHNICAL MANUAL
1.6.1. PROCESS CONTROLLER

The below scheme describes the modular process control system.
User Interface
Functionalities:
• Data input
• Visualization Optional door 2 panel
M
O
D
B
U
S
Supervisor Module
Functionalities:
• Programs management
• Parameters management
• Cycles execution
Primary Analogue Module

Functionality:
Secondary Analogue Module
• Sensors management
Functionality:
• Bridge between CAN and TK bus
• Sensors management
CAN
T
K
B
... U
S
Identification Module
I/O Digital Modules Functionality:
Functionality: • Factory parameters
• Each module is dedicated to specific functions (doors, configuration
steam generator, electric valves, 230VAC loads, …)
The system architecture shows 3 levels:

• User Interface level
• Supervisor Module Level
• Analogue and I/O level

FOB4-5/TS
TECHNICAL MANUAL
This architecture allows each component to manage a specific functionality and the supervisor module to
manage the program flow. The advantages of this architecture are:
• High reliability: Every component is equipped with a microcontroller able to accomplish the auto
diagnose and to check the controls given by the supervisor module.
• Expansibility: it is possible to add optional modules or new functionalities by inserting into the
system the necessary component without to modify or exchange the pre-existent component. The
systems bus communication use protocols developed for managing future integrations.
• More safety in case of malfunctioning: the physical subdivision of the functionality into different
devices allows, in case of detection of a potentially faulty module, to start an emergency sequence in
all other working parts, hence allowing reaching the maximum safety level.
Example: in a classical IPC configuration, a communication shutdown between CPU and the I/O
peripheral modules wouldn't allow the management of any functionality; in a modular system,
instead, each module is able to activate the functionalities necessary to put in safety the system.
• Software safety: the software most critical point of a programmable electronic system. The design
and the development of every new version must always guarantee the correct development of the
program. The update are very delicate phases from the moment that it is necessary to be sure that
the changes haven't affected the functionalities not involves in the changes. The modular system
allows the software distribution on the different modules, each other physically disjoined.
1.6.2. MAIN CHARACTERISTICS
The process controller management software has been designed to memorise up to thirty programs plus five
tests consisting of sequences of phases for immediate use, and allows each of them to be personalised by
inserting or excluding entire phases and/or varying the relative parameters. All operations are protected by
passwords to prevent access and alteration by unauthorized personnel: the password management
system foresees five protection levels allowing access to different functions.
During the execution of a program, the operator interface allows the operator to view the following on the
control display:
• Main menu
• Cycles library
• Calibration and settings values, self-diagnosis with analogical and digital IN / OUT lists
• The data and parameters regarding the phase currently under way (program number, phase
name, values set, present temperature, time and pressure data and accumulated sterilization
time relative to the sterilization phase only, F0, etc.)
• Real-time graphs of the process variables (T,P,t)
• All alarms, acoustic warnings, auxiliary messages, language selection
• Information pages on the sterilizer’s configuration, software version, N° of cycles executed, etc.
During the execution of a program the controller automatically proceeds onwards to the next phase only after
the previous phase has been completed, but the operator can in any case decide to stop or skip a phase as
an option at each step (this function is allowed only if not critical from the safety standpoint). For the
sterilization phase the same exclusive regulation principle is employed in all FEDEGARI saturated steam
sterilizers, foreseeing a double control system which uses the chamber pressure value as regulation
parameter and the temperature value as monitoring parameter to detect any abnormal conditions.

FOB4-5/TS
TECHNICAL MANUAL
In the case of execution of the optional special decontamination cycle (option KX62, however, the same
relationship between temperature and pressure no longer exists, because saturated conditions no longer
prevail inside the chamber because a mixture of air and steam is present: during the decontamination phase
the system checks only that the temperature never drops below the temperature limit set to guarantee the
absolute effectiveness of the sterilization process. All the autoclaves in this range are therefore equipped
with a special analogical pressure transducer and a flexible Pt100 probe in the chamber. An additional Pt100
probe (option KX80) is also available. The steam generator is likewise regulated by a specific pressure
switch that acts on the feed of the armoured electrical resistances.
All the pressure and temperature sensors can be calibrated through the operator interface in a simple, clear
and secure manner (access to this operation is protected by a password).
NOTE
For a correct performance of the calibration operation it is necessary to use a thermostatic

bath, a sample thermometer and a reference pressure meter. The operation consists of
adjusting the values registered by the sterilizer’s sensors with reference to the readings on the
sample instruments; all the adjustments are recorded by the operating system in a specific
menu. The three calibration points with relative linear interpolation are archived quickly and
reliably. The process sensors of the FEDEGARI sterilizers have been calibrated in the pre-
delivery tests with appropriately certified instruments, and an optional on-site recalibration
service is available upon request.
1.6.3. SIDE 2 OPERATOR INTERFACE
On FOB4-5S TS sterilizers, the side 2 operator interface consists of an adjustable vertical slant Touch
Screen operator panel very similar to the process controller panel located on the main side (Side 1) of the
sterilizer but with less functions.
NOTE
For further details on the operation of the Side 2 operator interface on FOB4-5S-TS sterilizers,
see Section 4 of the Technical Manual.
1.6.4. MAIN SWITCH
By turning the main switch, located on the lateral panel of the sterilizer, to the “ON - I” position, the sterilizer
is supplied with power and consequently the process controller is activated. This is followed by the enabling
of the peripheral units connected to it, which constitute, together with the controller, the main hardware of the
sterilizer. By returning the main switch to the “OFF - O” position, the main power supply of the sterilizer is
deactivated and therefore the power supply of the process controller and of the peripherals connected to it is
also deactivated.

FOB4-5/TS
TECHNICAL MANUAL
NOTE
Deactivation of the main switch

completely disconnects the
electrical power supply of the
sterilizer. All poles are
disconnected.
Fig. 1.6.5 – Main switch
1.6.5. EMERGENCY BUTTON
The sterilizers are equipped with an emergency button located on the front panel, which can be easily
reached by the operator at all times throughout the various phases of the sterilizer’s use. The button, which
is mechanically reset and fully homologated, is colored red with a yellow background. In double-door
sterilizers a similar device is also placed on side 2 of the sterilizer so that it can be activated from both the
loading and the unloading side of the sterilizer.
NOTE
Pressing the emergency button puts

the sterilizer into a totally safe
shutdown state.
In order to restart the sterilizer
following activation of the emergency
button, it is first necessary to reset the
button by pulling and turning it.
1.6.6. MONITORING VACUUM GAUGES
The vacuum gauges with which the sterilizer is equipped are mechanical pressure indicators of the analog
type, suitable for displaying the pressure values in the pressure vessels that belong to the sterilizer. A
vacuum gauge (with a scale of 0-6 absolute bars) is dedicated to detecting the pressure inside the
sterilization chamber. The other vacuum gauge (with a scale of 0-6 absolute bars) indicates the pressure of
the steam generator. The indicators have a pressure readout scale (in bars) and are capable of indicating
the presence of pressure or vacuum even when the sterilizer is deactivated and the chamber is not
operating. Both are provided with a red notch at the maximum allowed pressure, as prescribed by the
standards. On sterilizers with double doors, an additional sterilizer chamber pressure/vacuum gauge is
provided, located on side 2 of the sterilizer.
Fig. 1.6.6.a – Sterilizer chamber Fig. 1.6.6.b – Steam generator

pressure/vacuum gauge pressure/vacuum gauge

FOB4-5/TS
TECHNICAL MANUAL
1.6.7. MANUAL CHAMBER DISCHARGE VALVE
This valve is a membrane valve located on the front panel of the sterilizer and connected to the sterilizer
chamber. Its function is to allow the operator, if automatic operation is not possible, to use a manual action to
check that there is actually no pressure in the chamber at the end of the sterilization process. The valve is
also used to discharge any pressure that may have built up within the chamber when one wishes to open the
door again for an additional load.
! WARNING
Opening the manual valve can cause the escape of hot steam from the appropriately provided
discharge duct located on the lower side of the sterilizer. Pay attention to the risk of scalding.
NOTE
By turning the knob clockwise until it reaches the

mechanical stop, the duct for the free discharge of the
sterilization chamber is blocked; by turning it
counterclockwise, as soon as it is moved from the
closed stop position, discharge of the chamber is
allowed. The maximum passage section provided to
the discharge is obtained by turning the knob
counterclockwise up to the stop position.
Figure 1.6.7 – Chamber discharge
manual valve
1.7. SAFETY SYSTEMS
All the sterilizers in the FOB4-5 TS range are equipped with specific devices to ensure their functional safety
both during normal operation and during any routine maintenance activities.
In particular, the systems for opening and closing the sterilizer chamber doors offer the highest degree of
safety. In addition, all pressurized vessels are protected by safety relief valves.
1.7.1. DESCRIPTION OF CHAMBER CLOSURE AND OPENING SYSTEM
All the sterilizers in the FOB4-5 TS range are equipped with either one or two chamber doors, with automatic
movement operated via the process controller.
The opening and closing of the chamber doors is subject to a series of hardware safety devices and software
checks that allow them to move only under conditions of absolutely safety.
The sterilizers have automatic doors that slide downwards to open and upwards to close. The opening
movement is actuated by an electropneumatic system, whereas the closing movement is driven by two gas
piston springs.
1.7.2. DOOR CLOSURE AND OPENING SYSTEM

Initial conditions of the system
Until the chamber door/s is/are fully closed then the door closed position switch/es will remain open. The
open switch interlocks all valves connected to the chamber, plus the door seal inflation system. This means
that it is impossible to inflate the door seal, actuate any chamber valves or initiate a cycle with the door open.

FOB4-5/TS
TECHNICAL MANUAL
Closing the chamber door
The operator raises the chamber door from the open position into the closed position by continuously
pressing the door-closing icon on the touch screen of the process controller. When the door reaches the
closed position, the door closed position switch is activated indicating to the process controller that the door
is in its closed position.
Chamber closure
Once the output from the door closed position switch has been received by the process controller, the
operator presses the appropriate icon on the touch screen thereby inflating the door seal and fully sealing
the chamber and locking the door.
Operation of the sealing system
The seal is pressurized with compressed air, which forces the seal gasket outwards from its seat to press
against the door perimeter. The door is thus shifted out of its rest position but is held in place by milled slots
in the door frame and door. The compression of the seal against the door locks the door in place and seals
the chamber ready for a cycle to be started.
Permission start a cycle (to introduce fluid in the chamber)
The pressure of the air behind the door seal is monitored by a pressure switch. When the pressure reaches
a preset value, the pressure switch signals to the process controller that the chamber is closed and
completely sealed. It is at this point only that a cycle can then be run. The authorisation by the process
controller to start a cycle is fail-safe, and is cut by safety circuits that checks:
• that the pressure switch indicates that the door seal gasket is inflated;
• that the door is in the correct (closed) position, as indicated by the door closed position switch.
Conditions required to open the door
To be able to open the door, all the preliminary conditions specified below must be met and checked by the
process controller:
• the processing cycle must have ended;
• the chamber pressure transducer (connected to the process controller) and the
electromechanical chamber safety device must both indicate that the pressure inside the
chamber has returned to atmospheric pressure;
• if the optional safety thermal locking device (KX84) has been enabled, then the thermal locking
device probe in the chamber must show a temperature lower than the set figure. This ensures
that any liquids put into the sterilizer in glass containers have reached a suitably safe temperature
as set by the customer.
• if the optional function (safe temperature) has been enabled, the thermal resistor placed in the
chamber must show a temperature that does not exceed the foreseen level, thus making sure
that any liquids put into the sterilizer in glass containers have reached a temperature lower than
their boiling point at atmospheric pressure;
• the door on the side opposite to the one being opened must be closed (for two door models only)

FOB4-5/TS
TECHNICAL MANUAL
Depressurization of sealing system
Once the above consents have been obtained, the operator presses the door-opening icon on the touch
screen of the process controller and the compressed air is discharged from behind the door seal.
Release of the air introduced in the gasket seat
Once the above consents have been obtained, the operator presses the door-opening icon on the touch
screen of the process controller that commands the discharge of compressed air from the gasket seat.
Opening of the chamber
Once the air has been discharged from the door seal, the door starts to open automatically. The door moves
downwards until it reaches the fully open position where it activates a door open position switch which is
connected to the process controller.
1.7.3. SAFETY VALVES
In order to ensure the safety of the autoclave and the operator, it has the following safety devices fitted:
• A safety pressure relief valve on the steam generator;
• A safety pressure relief valve on the chamber.
Figure 1.7.3.a – chamber safety valve FOB4-TS Figure 1.7.3.b – steam generator safety valve FOB4-5TS
Figure 1.7.3.c – chamber safety valve FOB5-TS
The safety valves are of a design where the seal is made between a replaceable soft seat and a metal,
spring loaded, disc. The disc is driven off the seat if the pressure is above the relieving pressure.
The special material used for the seat prevents sticking that is seen with many typical of seals made of
ordinary elastomers and also ensures the valve has a perfectly tight seal.

FOB4-5/TS
TECHNICAL MANUAL
! WARNING
FEDEGARI do not recommend performing frequent opening checks on the valve to check its
calibration. The safety valves installed are supplied by qualified manufacturers and are
provided with calibration certificates in accordance with the regulations currently in force.
! WARNING
FEDEGARI recommends that you replace these devices every three years regardless of their
frequency of use and operating conditions. Each consignment of new safety valves for
replacement purposes is accompanied by a new calibration certificate issued by the
manufacturer.
! WARNING
Tampering with the safety valves can cause serious damage to the equipment and injury to the
operator. FEDEGARI rejects all liability arising out of tampering or carelessness with the safety
systems.
NOTE
If the sterilizer is to be used at altitudes where the atmospheric pressure differs significantly
from 1 bar, then FEDEGARI needs to be informed of this fact both when ordering the sterilizer
and when requesting a replacement valve.
NOTE
For further information on the chamber and steam generator safety valves, see the relative
technical data sheet contained in Section 6 of the Technical Manual.
1.8. CONFIGURATION OF STERILIZERS AND PROCESS CYCLES
Sterilizers in the FOB4-5 TS range can sterilize both solids and liquids by using different processes. The
different processes are configured into different autoclave cycles, and these are selected by the operator
depending on the load to be treated.
The standard program structures available can be classified as programs dedicated to a specific purpose
and in general these programs that can be adapted to the most common types of load that could be
sterilized. By virtue of its high flexibility, the sterilizer can process the following loads:
¾ Solids
• Empty laboratory glassware
• Stainless steel instruments, in packages and loose
• Sterilizer parts
• Small stainless steel containers
• Sundry laboratory material made of glass or plastic (suitable for sterilization treatment)
• Delicate membranes and filters

FOB4-5/TS
TECHNICAL MANUAL
• Bagged or unpacked surgical instruments

• Solid laboratory waste in open bags or contaminated liquids (materials which can cause
virus or bacterial microbiological contaminations of the environment).
¾ Liquids
• Culture liquids and media (Agar) contained in unsealed containers
• Various solutions contained in unsealed containers

• Various solutions contained in small hermetically-closed containers.
! WARNING
If the sterilizer is to be used to treat liquids in hermetically sealed containers, it is mandatory to

install the safety thermal locking device (option KX84. In this case the additional temperature
probe is used solely for monitoring. If the sterilizer is not equipped with this option, treating
liquids in closed containers is absolutely forbidden.
NOTE
Other specific products such as porous loads, blister packs, closed bottles, bags, pre-filled
hypodermic needles etc. can be treated by implementing optional processes including any
related optional hardware.
! WARNING
Any use or treatment not explicitly mentioned above should not be undertaken.
! WARNING
The treatment of the following materials should be undertaken under any circumstances
• Flammable or explosive substances;
• Non-flammable liquids that have a high vapour pressure (halogenated hydrocarbons and the
like) even in closed containers;
• Gas in bottles and spray cans (even if the spray cans are empty after use);
• Substances which, by decomposition due to moist heat, can generate gases or vapors that
are toxic, noxious, flammable, explosive or can generate noxious, toxic or flammable
residues or solids.
Furthermore, since sterilization requires the direct or indirect contact of water vapour with the
surfaces to be treated, moist heat sterilization processes are therefore unsuitable for the
following
• closed containers that are impermeable to steam and in which the interior is to be
sterilized (or example, closed empty ampoules)
• closed containers that are impermeable to steam and contain an anhydrous material to be
sterilized (for example, ampoules containing anhydrous oily solutions and anhydrous
powders).
In case of doubt, it is in any case advisable to consult FEDEGARI beforehand.

FOB4-5/TS
TECHNICAL MANUAL
NOTE
For more information on the sterilization programs and relative phases, see Section 4 in the
Technical Manual.
1.9. TECHNICAL DATA

1.9.1. DIMENSIONS AND WEIGHTS
The main dimensional data for the FOB4-5 TS line of sterilizers are given in the following tables:
Model FOB4-TS FOB4L-TS FOB4S-TS

Chamber internal diameter (mm) 650 650 650
Chamber internal depth [mm] 650 950 950
Weight when empty [kg] 370 410 510
Weight when full of water [kg] 631 771 816
(0)
Loading height (mm) 860 860 860
Ext. dimensions W x H x D (mm) 842×1851×955 842×1851×1255 1030×1923×1268
Footnotes to the above table:

(0) Height from floor.
Model FOB5-TS FOB5L-TS FOB5S-TS FOB5SL-TS

Chamber internal diameter (mm) 890 890 890 890
Chamber internal depth [mm] 890 1270 1000 1250
Weight when empty [kg] 850 950 950 1000
Weight when full of water [kg] 1510 1840 1640 1845
(0)
Loading height (mm) 918 918 918 918
Ext. dimensions W x H x D (mm) 1300 x 1950 x 1328 1300 x 1950 x 1708 1300 x 1950 x 1409 1300 x 1950 x 1659

Model FOB5-XL FOB5S-XL

Chamber internal diameter (mm) 890 890
Chamber internal depth [mm] 1751 1613
Weight when empty [kg] 1050 1100
Weight when full of water [kg] 2100 2100
(0)
Loading height (mm) 918 918
Ext. dimensions W x H x D (mm) 1300 x 1950 x 1957.5 1300 x 1950 x 1909


FOB4-5/TS
TECHNICAL MANUAL
1.9.2. TECHNICAL PARAMETERS AND CONSUMPTIONS

FOB4/TS FOB4L/TS FOB4S/TS FOB5S/TS FOB5L/TS FOB5S/TS FOB5SL/TS
(1)
Max operating pressure 3.5 bar g - 4.0 bar g
(1)
Max allowable pressure 4.0 bar g - 4.5 bar g
(1)
Chamber design pressure –1/4 bar g - -1/4.5 bar g
(1)
Max. project temperature 152°C - 156 °C
(1)
Allowable temperature 0/152°C - 0/156°C
Max. sterilization (1)

148°C - 152°C
temperature
Standard electric power

400V three phase with neutral 50 Hz
supply
Absorbed power basic

0.5 kW
version
Mains water for vacuum
200 lt/h
pump option KX20
Mains water for fast
cooling option KX52
100 lt/h
Compressed air for
30 Nl/min
actuators and door/s
Sound pressure level < 75 dBA (EN ISO 3746)
FOB4L/TS
FOB4/TS FOB5/TS FOB5L/TS FOB5S/TS FOB5SL/TS FOB5XL-TS FOB5SXL-TS
FOB4S/TS
Power with
steam generator 16 kW 34 kW 38 kW 34 kW 38 kW 44 kW
option KX10
Max. steam
required
21 kg/h 38 kg/h 59 kg/h
D.I. water
consumption for 25 lt/h 40 lt/h 60 lt/h
option KX10
Compressed air 500 600 500 600 700

counterpressure
400 Nl/min
Nl/min Nl/min Nl/min Nl/min Nl/min
Kcal dissipation
850 1100 1290 1620 1420 1620 1840
heat in 24°C
environment 1000(1) 1300(1) 1535(1) 1930(1) 1690(1) 1930(1) 2190(1)

(1) HT models equipped with KX62HT options.
NOTE
The maximum project values of pressure and temperature are listed in the PED Document
annexed to the Technical Documentation.
NOTE
In accordance with the requirements of product standard EN 61010-1 par. 5.1.3. point (C), the
absorbed power indicated on the CE label is relating to the sterilizer model in its most complete
configuration, inclusive of all the available options.

FOB4-5/TS
TECHNICAL MANUAL
1.9.3. CONSTRUCTION PARAMETERS

The significant construction parameters of the sterilizers in the FOB4 TS range are shown in the following
table:
FOB4-TS FOB4L-TS FOB4S-TS FOB5-TS FOB5S-TS FOB5L-TS FOB5SL-TS

Sterilization process Saturated steam (air/steam option)
Process control Automatic with PLC
Operator interface Touch-Screen
Temperature sensors Pt 100 4 wire - class 0.1 according to IEC60751
Pressure sensors Transducer 0-5 bar absolute / Transducer 0-6 bar absolute(1)
Automatic vertical sliding door/s with automatic electro-pneumatic movement and mechanical-
Chamber closing system
pneumatic lock
Total capacity (l) 261 361 366 647 670 880 825
Useful load capacity (l) 147 210 210 400 430 540 540
Sterile units capacity
(U.S.)
2 2+½ +½ 2+½ +½ 6 6 8 8
Chamber type Horizontal, cylindrical section, frontal loading (side one and two, if present)
Number of doors 1 1 2 1 2 1 2
Certified according to European Directive 97/23/EC Pressure Equipment Directive (Notified
Pressure vessel
Body TÜV - code 0036)
Commands’ electrical
protection
IP54
Chamber material 316L

Steam generator
material
316L
Hydro/pneumatic circuits
material
316L
Stand material 304

(1) HT models equipped with KX62HT options
NOTE
For further information on construction parameters, see the relative technical information
pages in Section 6 of the Technical Manual.
1.9.4. EMC AND LVD SPECIFICATIONS
The sterilizers in the FOB4-5TS range have undergone rigorous type testing to determine their conformity
with the minimum requirements of Directive 2004/108/EC for electromagnetic compatibility and Low Voltage
Directive 2006/95/EC.
The reference standard used for EMC tests is EN 61326-1 (EMS industrial environment, EMI CISPR 11
Group 1 Class A) and the reference standards used for LVD tests are EN 61010-1 and EN 61010-2-040.

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FOB4-5/TS

FOB4-5/TS TECHNICAL MANUAL

ID N° 165534 Rev. 13 1 / 46 September 2013

1. GENERAL DESCRIPTION OF THE STERILIZER .................................................... 5

1.1. INTRODUCTION .................................................................................................................. 5

1.1.1. REFERENCES TO STANDARDS .......................................................................................... 5

1.2. MODEL IDENTIFICATION .................................................................................................. 5

1.2.1. BIOSEAL SPECIAL SEALING FLANGE ................................................................................ 6

1.3. STERILIZER IDENTIFICATION .......................................................................................... 6

1.4. KEY COMPONENTS OF THE STERILIZER ....................................................................... 7

1.4.1. STERILIZATION CHAMBER .................................................................................................. 7

1.4.2. STERILIZATION CHAMBER IN PASS-THROUGH VERSION (2 DOORS) .......................... 7

1.4.3. DOORS AND SEALING SYSTEM .......................................................................................... 8

1.4.4. AUTOCLAVE FRAMEWORK AND TECHNICAL AREA ...................................................... 10

1.4.5. ELECTRICAL SYSTEM ........................................................................................................ 10

1.4.6. ELECTRICAL CABINET ....................................................................................................... 11

1.4.7. HYDRAULIC AND PNEUMATIC SYSTEM .......................................................................... 11

1.4.8. PROCESS CONTROLLER WITH INTEGRATED OPERATOR PANEL .............................. 11

1.4.9. PRODUCT LOADING-UNLOADING DEVICES ................................................................... 12

1.5. MAIN OPTIONAL COMPONENTS OF THE STERILIZER................................................ 13

1.5.1. STEAM GENERATOR (KX10).............................................................................................. 14

1.5.2. VACUUM PUMP (KX20) ....................................................................................................... 15

1.5.3. CONDENSATE COOLING UNIT (KX30) .............................................................................. 16

1.5.4. INTERNAL AIR COMPRESSOR (KX40) .............................................................................. 16

1.5.5. STERILE AIR FILTER (KX50) .............................................................................................. 17

1.5.7. FAST COOLING UNIT (KX52).............................................................................................. 18

1.5.8. CHAMBER PRESSURE TIGHTNESS TEST (KX61) ........................................................... 19

1.5.9. DECONTAMINATION CYCLE (KX62) ................................................................................. 20

ID N° 165534 Rev. 13 2 / 46 September 2013

1.5.10. DECONTAMINATION CYCLE HIGH TEMPERATURE (KX62HT) ...................................... 20

1.5.11. DECONTAMINATION CYCLE WITH DISCHARGE AIR FILTER (KX63) ............................ 21

1.5.12. SLOW VACUUM (KX67)....................................................................................................... 22

1.5.13. SUPER DRY (KX68) ............................................................................................................. 22

1.5.14. AIR/STEAM COUNTERPRESSURE CYCLE (KX69)........................................................... 22

1.5.16. MAINS STEAM SUPPLY (KX72) .......................................................................................... 23

1.5.18. AIR FILTER STERILIZATION CYCLE (KX73) ..................................................................... 23

1.5.19. AIR DETECTOR TEST (KX74) ............................................................................................. 24

1.5.20. EN285 STEAM QUALITY TEST ACCESSORIES (KX75) ................................................... 24

1.5.21. ADDITIONAL PT100 (KX80)................................................................................................. 25

1.5.22. PROCESS PRINTER (KX81) ............................................................................................... 25

1.5.23. INDIPENDENT PAPERLESS RECORDER NANODAC (KX82) .......................................... 26

1.5.24. SAFETY THERMAL LOCKING DEVICE (KX84) .................................................................. 27

1.5.25. EXTERNAL INDIPENDENT PAPERLESS RECORDER 6100A (KX85).............................. 28

1.5.26. SECOND DOOR SOFTWARE MANAGEMENT (KX90) ...................................................... 29

1.5.27. PORT ADAPTER FOR VALIDATION SENSORS (KX91) .................................................... 29

1.5.28. HYGIENIC GMP CONNECTIONS FOR CHAMBER PRESSURE TRANSDUCER AND

1.5.29. EXTERNAL RECORDER SIGNAL (KX102) ......................................................................... 30

1.5.30. EXTERNAL UTILITIES SIGNAL (KX103) ............................................................................. 30

1.5.31. INLET UTILITIES CONTROL SYSTEM (KX104) ................................................................. 30

1.5.33. F0 FUNCTIONAL CALCULATION AND CONTROL (SWX1) ............................................... 31

1.5.34. DCS LINK (SWX2) ................................................................................................................ 31

1.5.35. CYCLE REPETITION (SWX3) .............................................................................................. 31

1.5.36. DCS LOGGER WITH CFR21 PART11 CONFORMITY (SWX6).......................................... 31

1.5.37. PHARMACOPOEIA CYCLES (SWX7) ................................................................................. 32

1.5.38. TEMPERATURE HOLD PHASE (SWX8) ............................................................................. 32

ID N° 165534 Rev. 13 3 / 46 September 2013

1.5.39. I-BUTTON (SWX9) ............................................................................................................... 32

1.5.40. CYCLE ARCHIVING (SWX10) ............................................................................................. 33

1.6. CONTROL AND MONITORING COMPONENTS.............................................................. 33

1.6.1. PROCESS CONTROLLER ................................................................................................... 35

1.6.2. MAIN CHARACTERISTICS .................................................................................................. 36

1.6.3. SIDE 2 OPERATOR INTERFACE ........................................................................................ 37

1.6.4. MAIN SWITCH ...................................................................................................................... 37