FOB4 TS

TECHNICAL MANUAL
SECTION 2 – INSTALLATION SPECIFICATIONS

FOB4 TS TECHNICAL MANUAL

SECTION 2

INSTALLATION SPECIFICATIONS

ID No. 165537 Rev. 7 1 / 10 July 2011

 FOB4 TS
TECHNICAL MANUAL
SECTION 2 – INSTALLATION SPECIFICATIONS

CONTENTS OF SECTION 2

1. INSTALLATION SPECIFICATIONS ....................................................................... 3

1.1. ENVIRONMENTAL CONDITIONS ACCEPTABLE FOR USE ......................................................... 3

1.2. REMOVAL OF PROTECTIVE MATERIALS ..................................................................................... 3

1.3. PLACEMENT ..................................................................................................................................... 3

1.4. CONNECTION TO POWER SOURCES AND TO UTILITiES........................................................... 5

1.4.1. HYDRAULIC CONNECTIONS ........................................................................................................ 6

1.4.2. CONNECTIONS TO THE ELECTRICAL POWER SUPPLY .......................................................... 7

1.4.2.1. 400 Vac THREE-PHASE VERSION WITH NEUTRAL ............................................................ 8

1.4.2.2. 230 AND 400 Vac THREE-PHASE VERSION WITHOUT NEUTRAL .................................... 9

1.5. CHECKING INSTALLATION AND INSTALLATION REPORT ...................................................... 10

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TECHNICAL MANUAL
SECTION 2 – INSTALLATION SPECIFICATIONS

1. INSTALLATION SPECIFICATIONS

1.1. ENVIRONMENTAL CONDITIONS ACCEPTABLE FOR USE

The place of installation must be well-aired and have adequate lighting. The environmental conditions
suitable for the correct operation of the sterilizer and its operating system are as follows:

Environmental parameters
Equipment for use
Maximum altitude
Ambient temperature for operation
Relative humidity for operation
Ambient temperature for storage
Relative humidity for storage
Maximum mains voltage variation
Installation category
Pollution degree
indoors
2000 meters
minimum 10°C - maximum 40°C
maximum 85% no condensing, with T ≤ 40°C
minimum 4°C - maximum 50°C
maximum 80% with T ≤ 40°C
+/-10% of nominal voltage +/-2% frequency
II
2

! WARNING

The sterilizer has one or two TFT touch screen panels. Do not align and arrange the touch
screen so as to produce reflections and glare on the viewing planes of the operator.

1.2. REMOVAL OF PROTECTIVE MATERIALS

The sterilizer is transported in appropriate containers (packing) wrapped in material designed to protect it
from external agents during transportation and while in storage. The packing materials must be removed with
great care to avoid incorrect interaction with the structures and surfaces of the sterilizer during these
operations. The external cabinet containing the sterilizer consists chiefly of stainless steel panels and
adequate care must therefore be taken to preserve it from scratches and scrapes.

NOTE

Do not discard the original packing container, in order to ensure correct transport of the
sterilizer if it has to be moved.

1.3. PLACEMENT

A correct positioning of the sterilizer allows the system to operate in a perfectly functional manner and
ensures its easy use by the operator. For placement, consider that the space available around the sterilizer
must be provided so as to ensure that the operators and the maintenance technicians can perform the
following activities:

) the movements required to operate comfortably the control and monitoring devices;

) all the movements needed for loading/unloading operations, including the use of any accessories;

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SECTION 2 – INSTALLATION SPECIFICATIONS

) ordinary maintenance, particularly for cleaning and purging;

) extraordinary maintenance.

The sterilizer must be arranged on a flat surface and proximate to an extractor hood. While placing the
sterilizer, follow strictly the information given in detail in the installation drawings and documents provided by
FEDEGARI. All the FOB4 TS models are equipped with a suitable set of 4 standing supports that grant an
easy handling during the installation phase or maintenance and emergency. The definitive positioning of the
sterilizer on the installation site is usually performed by two operators. In order to ensure a proper and safe
handling of the sterilizer it is recommended to perform the following steps:

1. Remove the casing that protects the sterilizer.

2. Transport the sterilizer, still fixed with the packaging pallet, on the installation site.
3. Remove the locking devices between the sterilizer and the package base. (Fig. 1.3.a)
4. Lift the sterilizer from the package base by using the appropriate lifting points available on the
chamber (Fig. 1.3.b).
5. Place the sterilizer on the installation site and level it acting on the standing supports.

Fig. 1.3.a Locking devices on standing supports

Fig. 1.3.b Lifting points

After the sterilizer has been placed, it is suggested to verify its perfect leveling to the installation site floor.

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! WARNING

During sterilizer installation, follow the instructions given in the installation drawing supplied
by FEDEGARI, in addition to the indications given explicitly in this manual (please refer to
Section 3 of the Technical Manual).

In particular, the following issues need special attention:

) the floor of the installation room must comply with the required load-bearing
capacities, which in particular must include the additional loads that bear on the
structure as a consequence of the hydraulic tests to be performed on the sterilizer;

) all the precautions required by statutory provisions and allowed by technology must
be taken in seismic areas;

) the piping and accessories for feeding and discharging the various service fluids to
and from the sterilizer, as well as the lines and accessories for electrical connections
to the control panel and to other components of the sterilizer, must comply with the
prescriptions of the applicable statutory provisions.

NOTE

Any hydraulic testing that needs to be performed after the sterilizer has been installed at the
User’s premises in accordance with the statutory provisions applicable in the country of use
may entail an increased load that can cause precarious stability of the structures meant to
support the sterilizer. Weight and size data are available into section 1 of the Technical Manual.

! WARNING

During installation, absolutely AVOID the forming of structural links to surfaces or bodies that
are subjected to stresses or dynamic loads that originate externally with respect to the
sterilizer.
If a correlation to structures subjected to such loads is provided in the area where the sterilizer
is meant to be installed, contact FEDEGARI before order placement.

1.4. CONNECTION TO POWER SOURCES AND TO UTILITIES

Connection to power sources must comply fully with the specifications given in this chapter. In absence of
the appropriate means or accessories to allow connection according to best manufacturing practice, contact
FEDEGARI technical service.

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1.4.1. HYDRAULIC CONNECTIONS

Hydraulic connections to utilities are provided by means of flexible hoses. The connections provided on the
rear panel of the sterilizer are:

(B) WATER INLET:

Type of fluid: tap water (max 20°f).
Hint: for best performance of the sterilizer use tap
water at a temperature 15°C ÷ 25°C.
Pressure: 2,5 ÷ 4,5 bar
Service: to feed the vacuum pump and chamber
cooling.
Connection: connection for Teflon pipe 8x1 (Ø 8
external, Ø 6 internal).
Interception: interception lock next to the sterilizer.

(C) AIR INLET:

Type: dry and deoiled air
Pressure: 7 ÷ 10 bar
Service: to feed the air valves and charging set in
the chamber. (B)
Connection: connection for Teflon pipe 8x1 (Ø 8
external, Ø 6 internal).
Interception: interception lock next to the sterilizer.

(B1) PURIFIED WATER INLET:

Type of fluid: purified water (subject to
(C)
deionization or osmosis) - Conductivity: 1 ÷ 30
(suggested 15) µS/cm at 25°C - TOC< 500 ppb –
pH: 6.0 ÷ 7.5 – chloride max 30 ppm
Indicative consumption: min. 25 l/h
Pressure: 1 ÷ 4 bar (B1)
Service: steam generator feeder
Connection: connection for Teflon pipe 8x1 (Ø 8
external, Ø 6 internal).
Interception: interception lock next to the sterilizer.

(A) GENERAL DRAIN:

Type of fluid: high temperature water. When
installed KX30 the temperature is about 70°C. (A)
Pressure: atmospheric pressure.
Connection: cone coupling for pipe Ø 32 external,
Ø 22.1 internal). When KX30 is not installed, use
pipe and connection suitable to high temperature.
Position: the floor discharge has to be located
lower than the connection.

(D) EXTERNAL STEAM INLET (KX72 OPTION): (D)

Type of fluid: pure steam.
Pressure: 4÷4,5 bar – 21 kg/h.
Connection: coupling for pipe Ø 8 external
(preferred) or DN10 welded tipe.

NOTE

The inlet tags in the above table are shown in the P&ID drawing contained in the Section 3 of
the Technical Manual.

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SECTION 2 – INSTALLATION SPECIFICATIONS

NOTE

The option KX72A foresees the simultaneous use of KX10 inlet for purified water (B1) and the
KX72 external steam inlet (D). 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.

! WARNING

Before making the hydraulic connections (water/air) to the sterilizer, we recommend to carry
out an accurate utilities drainage.

! WARNING

The discharge fluids may reach high temperature; it is strongly recommend to use flexible
pipes suitable for high temperatures.

! WARNING

If the materials treated are potentially dangerous for the environment and/or human beings, it is
recommend that all the liquids discharged from the sterilizer (including discharge from the
safety valves) be channelled and disposed of in an appropriate manner. FEDEGARI declines all
liability due to incorrect disposal of such liquids.

! WARNING

The connection of the discharge of the sterilizer to the drain should be performed with the
“ventilated” method. Failure to comply with this recommendation may cause any reverse flow
from the drain to contaminate and/or pollute the chamber of the sterilizer. A simple check valve
is not considered an effective microbiological barrier by the international cGMP/cGLP
standards. To avoid the risk of contamination of the water mains, it is furthermore
recommended to install devices acting as barriers for protection against reverse flow on the
supply line of the vacuum pump. Perform connection to utilities and to the discharge trap so as
to keep the pipes at atmospheric pressure. Check that all the connectors have their own
specific data plate.

1.4.2. CONNECTIONS TO THE ELECTRICAL POWER SUPPLY

The standard model sterilizer is designed to operate with the following electricity feed: three-phase with
neutral wire L1/L2/L3/N/PE 400 Vac, 50 Hz; in the event that the voltage and/or frequency of the available
electricity supply are different from those foreseen for the standard model or a neutral wire is not available it
is possible to request one of the following options:

‰ Three-phase without neutral 230 Vac 50 Hz

‰ Three-phase without neutral 230 Vac 60 Hz

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‰ Three-phase without neutral 400 Vac 60 Hz

The instructions given below should be followed scrupulously in order to ensure that the connection of the
sterilizer to the electrical power supply line is performed according to best manufacturing practice.

! WARNING

Connection to the electrical mains must be performed by qualified personnel in full compliance
with all the safety requirements prescribed by applicable statutory provisions with reference to
the installation site. All the connections must be performed with the mains power fully
disconnected.

! WARNING

If the ground conductor is connected poorly or not at all, this may severely compromise the
operating safety of the sterilizer. FEDEGARI declines all responsibility arising from poor or
failed connection of the ground conductor.

! WARNING

The connection to the electrical mains requires the installation of protection systems on the
electrical power distribution panel. For safety, the installer is recommended to use a
magnetothermal circuit breaker that is sized appropriately according to the maximum electrical
power absorption of the sterilizer.

! WARNING

The sterilizer, in each version, is supplied complete with a power supply cable with a pin
terminal to connect to electrical mains. If the installer uses a connection pin to be wired we
recommend to use pins certified by the prescriptions of the applicable statutory provisions.

1.4.2.1. 400 Vac THREE-PHASE VERSION WITH NEUTRAL

The sterilizer 400 Vac three-phase 50 or 60Hz with neutral version is supplied complete with the power
supply cable, which has the following characteristics:

Length: 3 meters

Type: Five-wire (R+S+T+N+PE) compliant with the IEC 60227 or IEC 60245 standard

Terminals: Pin terminals

Connection of the power supply cable of the sterilizer to the electrical distribution mains is performed under
the responsibility and care of the client. When performing the connection, it is recommended to follow the
procedure described in the following table:

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TECHNICAL MANUAL
SECTION 2 – INSTALLATION SPECIFICATIONS

Phase Activity Wire Identifier Symbol Notes

1 Connection of ground conductor Yellow/Green PE a)
2 Connection of neutral conductor Blue N
3 Connection of phase conductors Black R, S, T
4 Checking correct phase sequence Black R, S, T b)

Note a)

The connection of the ground conductor must ensure mechanical strength and correct electrical conduction
over time. For this purpose, it is recommended to use adequate means for preventing loosening, such as for
example split or toothed washers for connections to rigid structures or bars, and terminals that are certified
for this purpose in the case of connections with loose protective conductors. Moreover, if the power supply
cable is pulled accidentally, the ground conductor must be the last one to disconnect; you should provide an
appropriate excess with respect to the other conductors in order to ensure compliance with this requirement.

Note b)

It is necessary to check that the connection sequence of phases R, S, T correct on FOB4-TS single and
double door sterilizers as they are equipped with three-phase motors; in this case, we advise you to make
the motors revolve briefly to check the direction in which they rotate. If they are found to be rotating in the
wrong direction, first disconnect the sterilizer completely from the power supply system and then invert two of
the three phase wires. Do not invert the phases when live power is present for any reason whatsoever.

1.4.2.2. 230 AND 400 Vac THREE-PHASE VERSION WITHOUT NEUTRAL

The sterilizer 230 and 400 Vac three-phase 50 or 60Hz without neutral version is supplied complete with the
power supply cable, which has the following characteristics:

Length: 3 meters

Type: Four wire (R+S+T+PE) compliant with the IEC 60227 or IEC 60245 standard

Terminals: Pin terminals

Connection of the power supply cable of the sterilizer to the electrical distribution mains is performed under
the responsibility and care of the client. When performing the connection, it is recommended to follow the
procedure described below:

Phase Activity Wire identifier Symbol Notes

1 Connection of ground conductor Yellow/Green PE a)
2 Connection of phase conductor Black R, S, T
3 Checking correct phase sequence Black R, S, T b)

Note a)

The connection of the ground conductor must ensure mechanical strength and correct electrical conduction
over time. For this purpose, it is recommended to use adequate means for preventing loosening, such as for
example split or toothed washers for connections to rigid structures or bars, and terminals that are certified
for this purpose in the case of connections with loose protective conductors. Moreover, if the power supply

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cable is pulled accidentally, the ground conductor must be the last one to disconnect; you should provide an
appropriate excess with respect to the other conductors in order to ensure compliance with this requirement.

Note b)

It is necessary to check that the connection sequence of phases R, S, T correct on FOB4-TS single and
double door sterilizers as they are equipped with three-phase motors; in this case, we advise you to make
the motors revolve briefly to check the direction in which they rotate. If they are found to be rotating in the
wrong direction, first disconnect the sterilizer completely from the power supply system and then invert two of
the three phase wires. Do not invert the phases when live power is present for any reason whatsoever.

1.5. CHECKING INSTALLATION AND INSTALLATION REPORT

! WARNING

Once that the sterilizer installation has been completed and verified, it is necessary to fill-up
the start-up report enclosed to the technical documentation. The installation report, fully
compiled in all its sections, has to be transmitted to the FEDEGARI after sales service
personnel (support@fedegarisuisse.ch). The starting line of the official warranty period of the
sterilizer is subordinate to the receiving of the above mentioned report by FEDEGARI.

Before the sterilizer is used normally, a short run-in period is required. This consists in performing at least
two complete dummy cycles. During this period, it is necessary to check and search for any anomalies. The
sterilizer cannot be put into operation with normal production cycles until these checks have been
successfully completed.The sterilizer can be introduced in the normal production cycle only after these
checks have had a positive outcome. If operating anomalies are detected, it is necessary to contact the
FEDEGARI after sales service during the phase of start-up report filling.

; CAUTION

In accordance with the statutory provisions applicable in the country of destination,

connections to the water, pneumatic and electrical mains must be provided according to best
manufacturing practice and checked under the responsibility of the User.

; CAUTION

In accordance with the statutory provisions applicable in the country of destination, pressure
equipment must be checked under the responsibility of the User by an assigned inspection
authority.

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