FOB THIRD-GENERATION BENCH-TOP SATURATED-STEAM STERILIZERS

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Cory Little
5 years ago
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2 The key difference between a small vertical or bench-top sterilizer and industrial sterilizer is performance. Small saturated-steam sterilizers with vertical or horizontal chambers were devised many years ago to process small amounts of solid and liquid products, as required mainly by analysis laboratories surgeries. Through the years, owing to the gradual expansion of the field of application of sterilization processes, which has made them indispensable in many important context of human life, these machines bear everincreasing responsibilities. However, perhaps because of limited applicable standards issuing and legislation in this field, their relatively low cost or the scarcely diversified experience of some manufacturers, these sterilizers have not benefited from the considerable technological evolution that has affected industrial machines, especially those used by the pharmaceutical industry, and have remained - so to speak - glorified pressure cookers. Although some manufactures have proved their worth by offering different technical principles, on the whole, small laboratory sterilizers were (and still are) purchased when limited financial resources do not allow, or do not justify, the installation of a more sophisticated machine. In early 1994 Fedegari, aiming to devise a future generation of laboratory sterilizers, started a highly rewarding dialog with users and vendors in order to understand the main shortcomings or critical aspects observed through daily use of these machines. Amongst the various options is available (for the 2S only) even a second door for unloading 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 for the operator. Careful analysis showed demand for the following characteristics: fully automated operation process flexibility higher productivity low maintenance higher process performance better ergonomics limited cost. Using its vast experience, acquired by meeting the ever-increasing demands of pharmaceutical industries, Fedegari accordingly started to develop the prototypes of what can now be considered as the third generation of laboratory sterilizers, which is herein described. Even the external structure of the machines is altered with respect to the previous generation: the technical area meant to accommodate the actuators and the control equipment is in fact larger, in order to install all the electrical, electronic and piping devices required to perform the various processes. Sterilizers of the series, with the aid of suitable equipment options, can perform sterilizations of solids with initial vacuum and with final vacuum for drying the load; sterilizations of liquids in open or closed containers, with indirect cooling by means of an internal heat exchanger and a fan (with a magnetic-drive coupling) and sterile air counterpressure; sterilizations of high-pathogen loads with no external treatment of the infected effluents; chamber vacuum or pressure tightness tests; the Bowie & Dick test; monitoring and control of processes based on the F0 value, etc... The technical area now also includes a small independent electrical steam generator which is equipped with a pump for automatically feeding the deionized water. Therefore, the steam required for the process is no longer produced inside the sterilization chamber or inside the jacket but is constantly supplied by the generator. This solution offers significant advantages, such as reduction of bad odors and elimination of any corrosion caused by stagnation of water, which may be contaminated by the leakage of product from the load, on the bottom of the sterilization chamber. If the user has steam available, this option can be eliminated.

The door for closing the chamber has also been completely redesigned: in order to reduce maintenance and increase operator safety, the door is conceptually identical to the doors of industrial

The safety of this solution is absolute, also by virtue of a system of mechanic interlocks between the lid and the chamber which prevents opening in the presence of residual pressure.

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

3 The door for closing the chamber has also been completely redesigned: in order to reduce maintenance and increase operator safety, the door is conceptually identical to the doors of industrial sterilizers, without closure lever systems and with the now thoroughly tested dovetail pneumatic gasket, patented by Fedegari for its sliding doors. The safety of this solution is absolute, also by virtue of a system of mechanic interlocks between the lid and the chamber which prevents opening in the presence of residual pressure. Sterilizer equipped with the (optional) cycle for forced load cooling by means of a centrifugal fan and internal heat exchanger. Detail of the special pneumatic door gasket (partially extracted), distinctive feature of all Fedegari sterilizers. By virtue of the computing power provided by the software of the PLC, the operator can also choose to control the sterilization phase according to the accumulated F0 value or to simply print it out; in any case, process documentation provides irrefutable evidence and ensures the necessary traceability. By using appropriate security passwords, the user can customize the sterilization process or create new ones to treat specific products. In addition to fully automated operation, this kind of software offers a series of operating safeties and alarm which cannot be obtained otherwise. Fedegari has also made provisions for connecting the sterilizer to remote controllers by means of an RS232 serial port; this allows to integrate the machines in any monitoring and control network. Finally, Fedegari, with the aim of extending the application range of the machine, has developed a so-called "pass-through" version with a second door for unloading, equipped with all necessary functional interlocks with the loading door (mod. 2S). The piping is entirely made of AISI 316L stainless steel and has been engineered in the same way as that of industrial sterilizers, using sanitarytype quick-couplings and pneumatic valves with a special PTFE membrane. The lid gasket, like pneumatic valves, is fed by a small electric air compressor, 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 which include the above described forced cooling of the load. From the point of view of process control, Fedegari has succeeded in achieving a high level of modularity, flexibility and performance also by using a PLC and appropriate sensors. The process software has been designed by Fedegari, starting from the software developed a few years ago for controllers of the SUPERSPECTRA series.

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

4 Many other innovations, which would be lengthy to list here, 1 have been introduced in sterilizers of the series with respect to previous ones. To appreciate in greater detail the remarkable potential offered by this new generation of sterilizers, you should contact our Sales Department or our local agents and dealers. 3 The man-machine interface allows the highest flexibility for process customization through simple and intuitive communication Once removed the trim panels the sterilizer with all its components are easily accessible for any type of maintenance. 1 Pneumatic sanitary type diaphragm valves designed and manufactured by Fedegari. 2 Piezoresistive pressure transmitter. 3 The electric heaters of the steam generator can be removed from above. 4 Pump for automatically feeding D.I. water to the steam generator. Electric panel in the open position. 6 Emergency pushbutton. 7 Analog pressure gauges for chamber and steam generator.

9 8 10 11 8 Liquid-ring vacuum pump, allowing to attain a vacuum of 70 mbar 10 AISI 316L stainless steel piping with sanitary type

5 Liquid-ring vacuum pump, allowing to attain a vacuum of 70 mbar 10 AISI 316L stainless steel piping with sanitary type quick couplings. in the chamber in approximately 10 seconds. 11 Manual chamber drain valve. 9 Independent electric steam generator.

6 CHARACTERISTICS 2 2S 3 CHAMBER INSIDE DIAMETER CHAMBER USEFUL DEPTH CHAMBER NOMINAL CAPACITY [ l ] MAXIMUM WIDTH MAXIMUM HEIGTH MAXIMUM FUORI DEPTH MAXIMUM OPERATING PRESSURE [ abs. bar ] 3, MAXIMUM OPERATING TEMPERATURE [ C ] 138 ELECTRIC POWER SUPPLY 3/N - 0Hz 400 V, PE INSTALLED POWER WITH STEAM GENERATOR [ kw ] 10, INSTALLED POWER WITHOUT STEAM GENERATOR 1, ALTRE UTENZE P abs. bar 2 2S 3 STEAM (IF STEAM GENERATOR NOT ISTALLED) 4, peak flow-rate [ kg/h ] average consumption per cycle [ kg ] 4 D.I. WATER FOR STEAM GENERATOR 1-4 peak flow-rate [ l/h ] average consumption per cycle [ l ] 4 TAP WATER 3, for vacuum pump 180 for drain cooling [ l ] 20 for load forced cooling COMPRESSED AIR 4, for feeding lid gasked/valves [ NI/min ] 10 for counterpressure in chamber The above mentioned data are to be intended as indicative. The manufacturer reserves itself the right to change them without notice. Albuzzano (PV) - Italia - tel fax

FOF INDUSTRIAL SATURATED STEAM STERILIZERS

FOF INDUSTRIAL SATURATED STEAM STERILIZERS PROCESS In the early 1950s, the pharmaceutical industry entered a highly dynamic stage of evolution which required machines and production process that had been unthinkable up to then. Fedegari immediately