1 - FVG - Section 1 - ENG
1 - FVG - Section 1 - ENG
1 - FVG - Section 1 - ENG
SECTION 1
GENERAL DESCRIPTION
1.1. INTRODUCTION
The FVG range is composed of compact, top-loading, assembly-line-built vertical saturated steam sterilizers.
The innovative and sensible design, the new intuitively usable process controller, the high-quality finish and
materials give this sterilizers a higher functional performance than any other sterilizer in the same category.
FVG models are suitable for treating solids and liquids (if the liquids are in open or unsealed containers) and
are the latest generation of small automatic sterilizers for microbiology laboratories, research institutions,
universities and food industries.
The FVG sterilizer family consists of the following models, which differ in terms of useful loading capacity:
FVG1 50 liters
FVG2 75 liters
Vertical steam sterilizers of the FVG family are identified by means of an appropriately provided identification
plate, which is fixed to the body of the autoclave and bears all the key information of the sterilizer. The markings
on the plate are indelible, as prescribed by applicable product standards. Figure 1.3 shows a facsimile of the
CE identification plate of the sterilizer.
1 ) Notified Body Code for release according to 2014/68/EU
2 ) Not used
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
− Sterilization chamber;
− Lid and sealing system;
− Technical area cabinet;
− Electrical system;
− Electrical panel;
− Hydraulic and pneumatic system;
− Process controller with integrated operator panel;
− Electric compressor for gasket pressurization;
− Steam generator;
− Condensate heat recovery system;
− Devices for loading/unloading the product.
! WARNING
During the operation of the sterilizer, the
temperature of the lid’s internal parts
can reach high values. During the
loading/unloading operations, use the
suitable personal protective equipment.
The cylindrical vertical single-walled sterilization chamber is made of 316L stainless steel, welded with a TIG
process and polished with an electrochemical process, including the welds, so as to obtain a mirror finish to
ensure its cleanliness and sterility and increase its resistance to corrosion.
The lower part of the internal chamber slopes suitably toward the drain in order to drain condensation during
the process. The drain port is provided with a line filter, which can be removed easily from inside the
chamber.
The pressure vessel and the lid are insulated by means of a suitable thermal insulation layer, in order to
minimize heat loss and avoid the risk of accidents caused by contact with hot surfaces.
The insulating layer for the chamber is made of expanded synthetic rubber (a material which withstands high
temperatures and is free from CFC, PVC and dioxin), contained by an aluminium plate on which each hole
for the passage of the ports welded to the inner or outer chamber is insulated by means of a silicone gasket.
The lid is covered by a specific covering made of expanded polyurethane, which has thermal insulation
characteristics.
A safety valve, suitably sized according to the capacities, is installed on the chamber.
The lid rotates horizontally and is coupled to the chamber by means of a C-shaped band.
This band, under the effect of even the slightest pressure inside the chamber, prevents rotation and therefore
prevents opening. The lid of the chamber is provided with a handle that facilitates its opening and closing, both
of which are performed horizontally.
During the closure maneuver, a safety lever mechanism (Fig 1.4.2 a) installed on the lid forces the operator to
use both hands (Fig 1.4.2 b, Fig 1.4.2 c), avoiding any injuries of fingers.
Figure 1.4.2.a – Safety lever mechanism of lid Figure 1.4.2.b – Lid closure system: use of both
closure system hands required
Figure 1.4.2.c – Lid closure system: use of both Figure 1.4.2.d – Lid sealing system: sealing
hands required gasket
Sealing system
Tightness of the sterilization chamber when the lid is closed is achieved by introducing compressed air in the
gasket seat. In this way, the gasket is pushed outward and compressed against the lid.
The external cabinet, made of 304 stainless steel and polyurethane resin panels, is meant to enclose the
hydraulic, pneumatic and electrical systems.
The electrical system of the sterilizer is built in accordance with European standards EN IEC 60204-1 and EN
ISO 13849-1. The system includes the electrical panel, all the control lines of the electrohydraulic and
electropneumatic actuators of the motors, of the electronic process controller and of the steam generator.
This system also connects the process controller to all the sensors and transducers (e.g. pressure switches,
heat probes, et cetera) and to the devices for interfacing with the operator. Finally, it provides the primary
power supply line and the corresponding protection system.
The electrical panel is located in the front part of the sterilizer containment cabinet. This panel contains the
main electrical and electronic devices for power supply, disconnection and distribution, including the main
power switch. This switch, in particular, also acts as an emergency stop.
The hydraulic and pneumatic system is constituted by piping and electric valves.
NOTE
The details of the hydraulic and pneumatic system are described in the P&ID Diagram 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.
The sterilizers of the FVG series are equipped with a PLC with 13 digital inputs, 16 digital outputs and 2
analogical inputs in order to manage the parameters of the various sterilization cycles memorized in the
controller. The software has been developed in order to obtain 14 easy to use and freely configurable
programs, where is possible to enable or disable different phase and modify their parameters. All this
operations are protected with different passwords in order to block unauthorized users. The operator panel
integrated in the electronic process controller is constituted by an 3,5” TFT colour display and by a 10 buttons
membrane keyboard, by means of which the operator manages the interactive communication with the
sterilizer.
NOTE
The details of the electronic process controller with integrated operator panel are described in
the Section 4 of the technical manual.
The electric compressor integrated in the sterilizer generates the compressed air required to supply the lid
gasket: a 304 plenum chamber with a capacity of 2.7 liters is sufficient to ensure its correct operation.
In order to reduce electrical consumption, on the discharge of the chamber there is a coil-type heat exchanger,
which allows to reduce the temperature of the effluents to less than 100°C and to preheat the water that
supplies the steam generator, ensuring an energy saving of approximately 15% of the total. It is also possible
to preheat the air introduced in the chamber (if the KG41 option is provided) in order to improve product drying.
The loading/unloading system of the sterilizer is based on the use of wire mesh or steel plate baskets provided
with a folding handle (see Figure 1.4.11.b).
The sterilizer in its basic configuration can be fitted with a series of optional components (kits), which are listed
below and are identified by means of a reference number.
NOTE
For further information on the additional component kits, please refer to the documents cited in
the note field of each component.
NOTE
The details of the components that constitute the KG41 kit are described in the associated data
sheets contained in Section 6 of the technical manual.
NOTE
This option also includes the kit KG55.
NOTE
The details of the components of the KG50 kit are described in the corresponding data sheets
contained in Section 6 of the technical manual.
By this option, at the end of cycle, the ambient air is introduced into the
chamber, to provide by this option the final pressure balancing, after passing
through a sanitary air filter. This bacteria retention PAL air filter has an absolute
retention capacity of 0.22µm for liquids and 0.003µm for gases and it
guarantees sterilization of the air entering the chamber. This enables the
atmospheric pressure in the chamber to be re-established after sterilization by
using sterile air instead of ambient air. The filter may also be removed and
sterilized with saturated steam in an autoclave at a maximum temperature of
138°C, before disposal.
! WARNING
The tank must contain at least 10 liters of water in order to ensure complete execution of the
sterilization cycle
NOTE
The details of the components of the KG66 kit are described in the corresponding data sheets
contained in Section 6 of the technical manual.
The vacuum pump must be used every time when the presence of air pockets not removed from the load could
compromise the successful sterilization process or where a perfect drying of the load is required, such as with:
NOTE
In this kit is included the KG55 Sterile air filter and a coil condenser installed on suction pipe of
vacuum pump for improving its efficiency and correct operation.
This is an alphanumeric printer, which is installed close to the operator panel and is intended to generate
detailed process documentation. The printer has a 203-dpi thermal printing system, uses 57.5 mm-wide paper,
and is connected to the PLC controller by means of an RS232 serial output. The printer is connected directly
to the process controller and has the primary function of documenting in real time the execution of the
sterilization program in progress. The printer is also used to obtain the reports, parameters and data related
to the finished sterilization cycle. The operator has to load fresh paper and remove the printed report at the
end of the sterilization process.
DEVICE FUNCTION
“Feed” button
When pressed, causes the paper to advance.
NOTE
The details of the components of the KG81 kit are described in the corresponding data sheets
contained in Section 6 of the technical manual.
This is a semiautomatic device that facilitates loading and unloading of the baskets for containing materials.
The kit is composed of an electric winch, which has a motorized vertical motion and a horizontal arm that can
be orientated manually and is complete with a mechanical accessory for fastening the material loading baskets.
The motor is controlled by means of a manual keypad with two interlocked buttons and allows the vertical
movement of the arm.
! WARNING
! WARNING
To ensure safe and balanced lifting of the
material containing baskets, it is
recommended to use the FEDEGARI
basket fastening accessory.
NOTE
The KG83 kit is available for all models and is highly recommended for the FVG3 model.
The details of the components of the KG83 kit are described in the corresponding data sheets
contained in Section 6 of the technical manual.
On the chamber of every sterilizer of the FVG series there is a port to allow the insertion of validation sensors
in the chamber. The port is located in an easily accessible region on the side of the chamber. When it is not
being used, it is kept closed by a stainless steel plug fixed by means of a clamp. A special kit for inserting up
to 12 validation probes, developed by FEDEGARI, is available as an option.
Fig. 1.5.10.a – Assembled port adapter Fig. 1.5.10.b – Port adapter parts
NOTE
The details of the components of the KG91 kit are described in the corresponding data sheets
contained in Section 6 of the technical manual.
This option features software for remote data archiving on a PC over the RS232 serial port, which allows to
archive and print not only the printouts in A4 format but also the cycle chart.
This software option to repeat automatically the last selected cycle even without the presence of the operator.
This function is used particularly for long-term product tests, applied in many industrial productions.
This software option allows to enable, in every of the 14 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.
The sterilizer is provided with functional assembles and elements for control/monitoring, which are arranged
on the forward and front panel of the containment cabinet. The control and monitoring elements are:
− Operator panel
− Main switch
− Vacuum gauges for chamber and generator monitoring
− Manual discharge valve
The operator, by standing in the area in front of the panel that accommodates the control/monitoring elements,
is able to work easily and to access immediately any indications or messages.
All information related to the cycle is also printed by a small thermal printer (Kit option KG81) arranged to the
frontal panel of the sterilizer and connected to the serial RS232 port of the PLC.
1.6.1.2. DISPLAY
The operator panel comprises a display, which is the operator’s primary visual display unit. The display is a
3.5” LCD display with 320x240 pixel resolution with a 70.08 x 52.56 mm active area size and white backlight
colour. The display shows the various menus, which can be selected hierarchically by the operator according
to the choices made and the main commands given to the sterilizer. In particular, the display shows the values
of the parameters related to the sterilization cycle in progress and the alarm indications.
1.6.1.3. KEYPAD
The operator panel comprises a keypad, which is the primary apparatus available to the operator as command
interface with the sterilizer for operating commands. The keypad is of the membrane type, with 10 keys, which
have the following functions:
Key Function
START key:
STOP key:
ESC key:
UP key:
Key Function
LEFT key:
RIGHT key:
DOWN key:
NOTE
During the password changing, all the keys can be used for the desired combination, with the
exception of the ESC key.
Operating the main switch (position “ON”) located on the front panel of the sterilizer allows
to activate the process controller. Subordinately, the peripheral units connected to the
controller are activated; these peripherals form, together with the controller, the main
hardware of the sterilizer. By returning the switch to the “OFF” position, the process controller
and the peripherals connected to it are deactivated.
NOTE
The main switch also acts as emergency stop
The vacuum gauges installed on the sterilizer are analog mechanical pressure
indicators, suitable for displaying the pressure in the pressure vessels that are part of
the sterilizer.
One vacuum gauge (with an 0-5 bar abs scale) is dedicated to sensing the pressure
in the sterilization chamber. The other vacuum gauge (with an 0-6 bar abs scale)
indicates the pressure of the steam generator. The indicators are provided with a
pressure readout scale (bar). They are capable of indicating the presence of pressure
or vacuum even when the sterilizer is deactivated and the chamber is not operating.
Both vacuum gauges are provided with a red notch at the maximum permissible
pressure, as prescribed by standards.
This is a membrane valve, located on the front panel of the sterilizer and connected to the chamber of the
sterilizer. Its function is to allow the operator, if automatic operation is not possible, to manually check that
there really is no pressure in the chamber at the end of the sterilization process. This valve is also used to
discharge any pressure that has formed inside the chamber when one wishes to reopen the lid for another
load.
! WARNING
Opening the manual valve can cause hot steam to exit from the discharge duct located on the
rear side of the sterilizer. Beware of the risk of scalding.
NOTE
Turning the knob clockwise until it stops closes the duct for
the free discharge of the sterilization chamber. If the knob is
turned counterclockwise, the chamber can be discharged as
soon as the knob moves from the closed stop position. The
maximum cross-section available for discharge is provided
by turning the knob counterclockwise to the stop position.
Figure 1.6.1.6 – Manual valve
for chamber discharge
Before closing the chamber, and until the lid has reached the position provided for this purpose, the limit switch
for the closed position of the lid is open and accordingly interrupts the circuit that allows to feed compressed
air into the gasket seat. Accordingly, it is impossible – as explained below – to introduce pressurized fluids in
the chamber.
The lid of the autoclave is turned manually from the open position to the closed position by using both hands,
thus avoiding any crushing of fingers. When the lid reaches the position intended for closure, the limit switch
changes state and enables the system to send the command, allowing to introduce compressed air in the
gasket seat.
Once the clearance of the limit switch has been obtained, ensuring the correct position of the lid, the pressure
of the operator on the door locking button causes compressed air to be introduced in the gasket seat, starting
the complete closure of the chamber and locking the lid.
Propelled by the compressed air, the gasket moves upward, compressing itself against the perimeter of the
lid, which is accordingly raised from the inactive position and is retained by the two semicircular brackets. The
compression of the gasket against the lid ensures the complete closure of the autoclave and its tightness
against the action of any pressurized fluids introduced in the chamber.
The pressure of the air in the gasket seat is detected by a pressure switch. When this pressure reaches the
preset value, the pressure switch reports to the process controller that the chamber is closed and in fully sealed
conditions, enabling the start of the process cycle and the introduction of fluids in the chamber.
Clearance of the process controller to introduce fluids in the chamber is controlled in fail-safe mode by a safety
circuit, which checks that:
Starting the opening of the autoclave requires that all the preliminary conditions specified hereinafter have
been checked by the process controller:
− and, if the (safety temperature) function is set, the heat probe located in the chamber must detect a
temperature that is not higher than the set value, ensuring that any liquids placed to sterilize in glass
containers inside the autoclave have reached a temperature below their boiling temperature at
atmospheric pressure;
− Once the process controller has enabled lid opening, the release of the air introduced in the gasket
seat depends on checking that the residual pressure in the chamber is lower than 50 mbar by means
of a pressure switch. This check is performed in fail-safe mode.
Once the clearances described above have been obtained, the operator’s pressure on the door release button
cause the discharge of the compressed air from the gasket seat. The complete opening of the lid is delayed
about 15 seconds by the action of a mechanical lock driven by a pneumatic cylinder.
After the automatic discharge of the air from the sealing gasket seat,
the opening maneuver is completed manually.
To ensure total operator safety, the sterilizer is equipped with the following devices:
− A safety valve meant to discharge the excess pressure that is present inside the chamber;
− A safety valve that discharges the excess pressure in the independent steam generator.
Figure 1.7.2.a – Chamber safety valve Figure 1.7.2.b – Generator safety valve
! WARNING
These valves are set mechanically to the maximum allowed value. Tampering with these safety
valves may cause severe damage to the sterilizer and severe injury to the operator.
The person in charge of the sterilizer is required to periodically check the efficiency and correct
action of the safety valves. FEDEGARI declines all responsibility arising from tampering or
neglect of the overpressure safety systems.
! WARNING
The sterilizer is equipped with safety valves that have been calibrated and checked by the builder
at an ambient pressure of 1 abs bar. If the sterilizer is installed in a location with an ambient
pressure that is substantially different from 1 bar, it is recommended to inform FEDEGARI
qualified personnel and/or the technicians selected to install the sterilizer.
! WARNING
The safety valves have to be replaced or revised and re-calibrated every two years after the
starting apart from the using frequency or the working conditions as long as more restrictive
rules will not occur in the country of use.
! WARNING
It is not advisable to perform frequent valve opening tests to check the calibration state. The
installed safety valves are manufactured by qualified suppliers and therefore have a calibration
certificate which complies with currently applicable statutory provisions.
NOTE
For further information regarding the safety valves of the chamber and of the steam generator,
please refer to the data sheets contained in Section 6 of the technical manual.
The main dimensions of the vertical steam sterilizer, related to the FVG family, are given in the following table:
Functional parameters
Electrical parameters
NOTE
In accordance with the requirements of product standard EN 61010-1 par. 5.1.3. item (C), the power
absorption indicated on the CE data plate refers to the model of the sterilizer in its most complete
configuration, including all the possible options provided.
NOTE
The maximum project values of pressure and temperature are listed in the PED Document annexed
to the Technical Documentation.
NOTE
For further information on construction parameters, see the relative technical information pages
in Section 6 of the Technical Manual.