third-generation bench-top saturated-steam sterilizers · the lid gasket, like pneumatic valves, is...

FOBTHIRD-GENERATION BENCH-TOP SATURATED-STEAM STERILIZERS

The key difference between a small vertical or bench-top sterilizer andindustrial sterilizer is performance. Small saturated-steam sterilizers withvertical or horizontal chambers were devised many years ago to processsmall amounts of solid and liquid products, as required mainly by analysislaboratories surgeries.

Through the years, owing to the gradual expansion of the field ofapplication of sterilization processes, which has made them indispensablein many important context of human life, these machines bear ever-increasing responsibilities.However, perhaps because of limited applicable standards issuing andlegislation in this field, their relatively low cost or the scarcely diversifiedexperience of some manufacturers, these sterilizers have not benefitedfrom the considerable technological evolution that has affected industrialmachines, especially those used by the pharmaceutical industry, and haveremained - so to speak - glorified pressure cookers.Although some manufactures have proved their worth by offering differenttechnical principles, on the whole, small laboratory sterilizers were (and stillare) purchased when limited financial resources do not allow, or do notjustify, the installation of a more sophisticated machine.

In early 1994 Fedegari, aiming to devise a future generation of laboratorysterilizers, started a highly rewarding dialog with users and vendors in orderto understand the main shortcomings or critical aspects observed throughdaily use of these machines.

Careful analysis showed demand for the following characteristics:fully automated operationprocess flexibilityhigher productivitylow maintenancehigher process performancebetter ergonomicslimited cost.

Using its vast experience, acquired by meeting the ever-increasing demandsof pharmaceutical industries, Fedegari accordingly started to develop theprototypes of what can now be considered as the third generation oflaboratory sterilizers, which is herein described.Even the external structure of the machines is altered with respect to theprevious generation: the technical area meant to accommodate theactuators and the control equipment is in fact larger, in order to installall the electrical, electronic and piping devices required to perform thevarious processes.

Sterilizers of the FOB series, with the aid of suitable equipment options, canperform sterilizations of solids with initial vacuum and with final vacuum fordrying the load; sterilizations of liquids in open or closed containers, withindirect cooling by means of an internal heat exchanger and a fan (with amagnetic-drive coupling) and sterile air counterpressure; sterilizations ofhigh-pathogen loads with no external treatment of the infected effluents;chamber vacuum or pressure tightness tests; the Bowie & Dick test; moni-toring and control of processes based on the F0 value, etc...The technical area now also includes a small independent electrical steamgenerator which is equipped with a pump for automatically feeding thedeionized water. Therefore, the steam required for the process is no longerproduced inside the sterilization chamber or inside the jacket but isconstantly supplied by the generator.This solution offers significant advantages, such as reduction of bad odorsand elimination of any corrosion caused by stagnation of water, which maybe contaminated by the leakage of product from the load, on the bottomof the sterilization chamber. If the user has steam available, this optioncan be eliminated.


Amongst the various options is available (for the FOB2S only) even a second door forunloading the sterilizer in a controlled environment, such as a surgical theater.

Installed on a bench, loading/unloading of the sterilizer is a far more comfortable forthe operator.

The door for closing the chamber has also been completely redesigned: inorder to reduce maintenance and increase operator safety, the door isconceptually identical to the doors of industrial sterilizers, without closurelever systems and with the now thoroughly tested dovetail pneumaticgasket, patented by Fedegari for its sliding doors.The safety of this solution is absolute, also by virtue of a system ofmechanic interlocks between the lid and the chamber which preventsopening in the presence of residual pressure.

The piping is entirely made of AISI 316L stainless steel and has beenengineered in the same way as that of industrial sterilizers, using sanitary-type quick-couplings and pneumatic valves with a special PTFE membrane.The lid gasket, like pneumatic valves, is fed by a small electric air com-pressor, which is also located in the technical area.This option, too, can be eliminated if the user has compressed air available;compressed air is any way indispensable to perform processes whichinclude the above described forced cooling of the load.

From the point of view of process control, Fedegari has succeeded inachieving a high level of modularity, flexibility and performance also byusing a PLC and appropriate sensors.The process software has been designed by Fedegari, starting from thesoftware developed a few years ago for controllers of the SUPERSPECTRAseries.


Sterilizer equipped with the (optional) cycle for forced load cooling by means of acentrifugal fan and internal heat exchanger.

By virtue of the computing power provided by the software of the PLC, theoperator can also choose to control the sterilization phase according to theaccumulated F0 value or to simply print it out; in any case, process docu-mentation provides irrefutable evidence and ensures the necessary trace-ability. By using appropriate security passwords, the user can customize the sterili-zation process or create new ones to treat specific products. In addition tofully automated operation, this kind of software offers a series of operatingsafeties and alarm which cannot be obtained otherwise. Fedegari has also made provisions for connecting the sterilizer to remotecontrollers by means of an RS232 serial port; this allows to integrate themachines in any monitoring and control network.

Finally, Fedegari, with the aim of extending the application range of themachine, has developed a so-called "pass-through" version with a seconddoor for unloading, equipped with all necessary functional interlocks withthe loading door (mod. FOB2S).

Detail of the special pneumatic door gasket (partially extracted), distinctive feature of allFedegari sterilizers.

The man-machine interface allows the highest flexibility for processcustomization through simple and intuitive communication.

Many other innovations, which would be lengthy to list here,have been introduced in sterilizers of the FOB series withrespect to previous ones. To appreciate in greater detail theremarkable potential offered by this new generation ofsterilizers, you should contact our Sales Department or ourlocal agents and dealers.


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2

5

1

6

4

3

6

7

5

4

3

2

1

Once removed the trim panels the sterilizer with all its components are easily accessiblefor any type of maintenance.

Pneumatic sanitary type diaphragm valves designed and manufactured byFedegari.

Piezoresistive pressure transmitter.

The electric heaters of the steam generator can be removed from above.

Pump for automatically feeding D.I. water to the steam generator.

Electric panel in the open position.

Emergency pushbutton.

Analog pressure gauges for chamber and steam generator.


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Liquid-ring vacuum pump, allowing to attain a vacuum of 70 mbarin the chamber in approximately 150 seconds.

Independent electric steam generator.

AISI 316L stainless steel piping with sanitary type quick couplings.

Manual chamber drain valve.

CHARACTERISTICS FOB2 FOB2S FOB3

The above mentioned data are to be intended as indicative. The manufacturer reserves itself the right to change them without notice.


CHAMBER INSIDE DIAMETER

CHAMBER USEFUL DEPTH

CHAMBER NOMINAL CAPACITY

MAXIMUM WIDTH

MAXIMUM HEIGTH

MAXIMUM FUORI DEPTH

MAXIMUM OPERATING PRESSURE

MAXIMUM OPERATING TEMPERATURE

ELECTRIC POWER SUPPLY

INSTALLED POWER WITH STEAM GENERATOR

INSTALLED POWER WITHOUT STEAM GENERATOR

STEAM (IF STEAM GENERATOR NOT ISTALLED)

peak flow-rate

average consumption per cycle

D.I. WATER FOR STEAM GENERATOR

peak flow-rate

average consumption per cycle

TAP WATER

for vacuum pump

for drain cooling

for load forced cooling

COMPRESSED AIR

for feeding lid gasked/valves

for counterpressure in chamber

[ cm ]

[ cm ]

[ l ]

[ cm ]

[ cm ]

[ cm ]

[ abs. bar ]

[ °C ]

[ kW ]

[ kg/h ]

[ kg ]

[ l/h ]

[ l ]

[ l ]

[ NI/min ]

40

60

75

80

90

110

15

4

15

4

70

200

40

90

110

80

90

130

3,5

138

400 V, PE

10,5

1,5

18

5

18

5

180

20

90

10

230

50

66

140

87

90

110

20

5

20

5

100

250

Pabs. bar

4,5

1-4

3,5

4,5

ALTRE UTENZE FOB2 FOB2S FOB3

3/N - 50Hz

Albuzzano (PV) - Italia - tel. +39 0382 434111 - fax +39 0382 434150 - www.fedegari.com

third-generation bench-top saturated-steam sterilizers · the lid gasket, like pneumatic valves, is...

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