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The machine is designed with PLC microprocessor control for higher safety and guaranteed controllability; modern control system and high quality functioning elements guarantee best performance and high reliability of the sterilizer. CISA R&D engineers used advanced design to optimize the machine for the use of laboratories and research centers as well as industrial applications by working on quality and reliability and paying high attention to safety as well as making the maintenance limited. The structure of the machine is built in the highest quality components for perfect hygiene, perfect functionality, high durability and maximum safety. The machine is designed with user friendly system for operators and in full compliance with environmental requirements, with needs low noise emissions. Installation and maintenance of the machine are arranged in smooth and clear step by step procedures. (Effortless installation, with ease of positioning on the floor and connection to the main utilities). Compact architecture, with overall dimensions always restricted in relation to the machine capacity pneumatic operational valves for high reliability, and the possibility to supply the machine with electric valves on customer request.
Construction
The materials used in the construction of the machine are top of the range with high quality stainless steel material using AISI 316 Ti (chrome-nickel-molybdenum-titanium) for chamber, jacket and door(s) in such a way as to guarantee high performance and high durability of the pressure vessel. The Frame and front panels of the machine are manufactured using stainless steel material. All components inside the hydraulic plant, piping and Bio Seal, are manufactured using stainless steel 316L. Steam Generator and water pump and all break tanks are manufactured using stainless steel 316 L. A full Stainless steel Jacket surrounds the chamber to give support in the construction and functioning of sterilization cycles. Pressure vessel and steam generator as well all steam pipes are insulated using powerful insulation material that reduce the heat loss and increase temperature inside pressure vessel in such a way to improve quality of sterilization cycles, speed of cooling. Reducing heat loss also increases safety by reducing the surface temperature of the sterilizer. Non toxic fire resistant insulation foam, with extremely low thermal conductivity and no release of particles. Chamber is electric polished up to Ra less than 0.2 Micron (Mirror finish electrolytic polishing treatment). All welding for pressure vessel is robot controlled and checked and guaranteed to be homogenous using advanced control methods. The chamber is designed to withstand pressure from absolute vacuum up to +3.5 bars; factory tested at 5.25 bars. Steam sterilizers 3
Control Panel
The control panel is based on a modern design with a smooth surface for hygiene and for easy cleaning, installed on loading side or on unloading side as per end use and applied safety level or control and standard requirements. The control panel is provided with touch screen, built-in printer, optional chart recorder, emergency button, and some control buttons. The control panel is also equipped with pressure gauges for chamber, jacket or steam generator or all of them. The control panel is installed at eye level position to enable good view and easy control. The control panel on the other side can be either passive by providing monitoring instrumentation like cycle status and alarms or door information or could be active by giving the possibility for another control; all that is dependent on final user request.
Maintenance program for preventative maintenance Operators access level control Calibration & technical pages (password protected) Programming new cycles or modifying standard cycle (password protected)
Type of steam heating selecting Alarm Messages are in clear test and not code figures Door open/closure Troubleshooting pages Operator interface function
The touch screen allows the selection of functions such as push buttons, key board, diagram, display value, and so on. The control system is composed of a PLC microprocessor based systems with sensors for data input using accurate pressure and temperature sensors. The control system is equipped with digital and analogue input datas and output datas.
Steam Generation
The machine can be configured using one of the following solutions concerning steam generation: (E): Built-in steam generator electric heating (V): External steam supply from hospital steam network (domestic vapor). (EV): Combination between (E) & (V) which enable the user to select type of heating from touch screen as internal (E) or external (V) without hardware interface. (SV): Steam to steam converter to generate good quality of steam from bad quality of steam using heat exchanging facility. (ESV): Combination between (E) & (SV) with same selection method as explained above. The steam generator and the steam to steam converter are manufactured in stainless steel AISI 316 L. If the machine is connected to an external steam supply, then it comes with built-in filters. The external steam connecting set of pressure regulator, cutoff valves, pressure gauge and separators are optional items that can be added. The steam generator is equipped with auto cleaning and flushing for high reliability and better functionality. For large machines steam sterilizer may consume big electric load and this requires pre consultancy for the possibility to supply this load.
Alarms
Audio visual alarms are defined for operator warning; the alarms list includes multi level alarms with clear message notification; alarm levels are configured based on the level of gravity to stop the machine or stop the cycle or just warning without affecting running cycle. Alarm lists are complete for safe and perfect operation for operators and machines. Alarms history can display the last 20 alarms; each alarm sound is printed during cycle execution. Alarms are also indicated on unloading side in case of double doors execution. End of cycle alert is included for alerting the user for unloading process.
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Steam Sterilizers Scientific & Laboratory Laboratory Sterilizers (L) & Laboratory High Pathogen Sterilizers (LHP) Different Lab Classifications and CISA solution Function & application
As per modern classification of laboratories based on agents used and applications: the steam sterilizer must be designed to meet these levels: I,II,III & IV.
Considerations
Agents not cause desease to humans Agents of moderate potential hazards Agents that cause lethal desease which vaccines exit Agents are lethal and vaccines not exist
The respect for above considerations requires good staff qualification & procedures; isolation (Sealing); disposal, laboratory considerations; working conditions, documentation system, safety, oxygen supply; laboratory design as double doors access zones and double doors sterilizers, ventilation, laboratory finishing of walls, floors and ceiling, utilities and other consideration where CISA comes in is for the steam sterilizer and its compliance to the Bio Safety Level as per those considerations. CISA builds its steam sterilizers to be in full compliance with the Bio Safety Level and to be suitable to work inside this safety level environment; beside the standard quality of steam sterilizer, there are some important features and basics that must be included in the machines and those can be configured based on the Bio Safety Level.
NCS System for central data monitoring, archiving and reporting using real time data interface. Remote maintenance system RMS for external maintenance check and interface. Black Boxes for communication, data storage and data transfer system.
Bio Seal
It is a permanent barrier that divides the plant room of the equipment with the front or the back. The Bio Seal is mainly used when the standard level requires double doors sterilizer but sometime necessary even when the machine is single door: this permits the autoclave to be recessed in a closed room - like a plant room - where technicians can work without access to the infected part. The Bio Seal is tested as part of the penetration test between the two areas (Loading & Unloading areas) using vacuum leak tests for the rooms or foam test: therefore the Bio Seal must feature full closure and must comply with this test and must be welded and provided with gas-proof cable bypass connections. The autoclave offers the facility to connect the Bio Seal to the peripheral walls of the rooms in order to seal everything and not only the equipment: this Bio Seal is manufactured in stainless steel and can be customized to fit the autoclave and extended to the fit site of installation area.
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Piping: Piping can be manufactured as joint with flexibility or as one piece without joints to avoid any risk; with CISA this point is respected and it is considered based on the safety level; all piping and hydraulics are manufactured in stainless steel 316L and are leak test approved to guarantee safe performance. Documentation: the documentation and its details are an important step for different safety levels; the availability of builtin printer is basic in all CISA sterilizers but the position of this printer is customized in laboratory sterilizer to be fitted in the right side; chart recorded documentation is another point that must be considered, but the connection of the sterilizer to the available laboratory computer network system is possible using different communication ports like RS232, black box and also an external supervision system can be added and connected to the sterilizer for real time monitoring and for data archiving/ retrieving and for analysis and external data print out. The Black box: it can be added and installed inside the sterilizer enabling full data storage and different data communication ports; the black box allows to go back to stored cycle for check or can be removed for an out of machine data check. Cycles and validation: all pre programmed cycles loaded in the sterilizer are validated cycles and the software itself is validated software; the re validation of the cycles at customer end is possible and can be executed as per laboratory requirements. Liquid Cycles: all liquid, waste liquid or media cycles are subjected to different cooling methods based on type and quantity of liquid as well as type of liquid container (sealed or not sealed) Many other considerations that CISA can meet to feature full compliance with safety level and to the application of the sterilizer. Machine size and closure: this is something which is customizable to make the machine fits site of installation with possibility to add stainless steel closure panels for more safety and hygiene.
Pre Filteration: this is used when there is need to run waste or solid cycle by applying air removal for eliminating air pockets in the load for better sterilization cycles performance, without air resistance. The method requires a filteration using the HEPA filter;it can be necessary to duplicate this filter for high safety levels like BSL IV. So the machine will be provided with two filters in series, in case of non functioing of one filter the other can work as back up. Those filters are also provided of integrity test (to check if the filter is broken) and inline-sterilization (in order to sterilize it in any moment before to open it). The Other solution of Air-Steam mixture is also possible with CISA to avoid using the filtration and also to guarantee less air resistance and to increase cycle performance. The air-steam mixture recirculation is used with CISA patented system that can guarantee a better performance; this cycle using air-steam mixture will have longer time compared to pre filtration cycles.
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Configuration
Discharge: the discharge in Drainage network must be limited and controlled based on the application, or on the Bio Safety Level, while the Discharge must be sterilized out before final drainage. CISA offers a system that guarantees continous sterilizations for all discharge, avoiding the use of non safe discharge accumlating devices and discreate sterilization. The other system is non safe and dangerous and can be a risk for the environment; for this reason CISA discharge self-sterilization is active and in real time; done contiuosley in high safety degree using heat exchanger for self sterilization of the discharge. The configuration of laboratory sterilizer can be done based on final application and customer or system requirements L: Steam sterilizer for laboratory: it can be different based on the Safety Level of the Laboratory Cycles per this model and machine configuration are customized to the application and bio safety level. LS: Stabularium: this autoclave - steam sterilizer is used for the support of the animal houses and research centers by providing different solutions starting from cage sterilization; waste sterilization and dead animals sterilization before final disposal; this machine is configured and equipped with sterilization cycles for all stabularium application.
Housing made in AISI 316L stainless steel body for filter, Ra0.4 m, Filter is test report 2.3 EN10204 compliance CE PED, FDA approved per 21-CFR, extensively & scientifically validated to have absolute removal of 0.2m in liquids and 0.003 m in gases, PP7 bacteriophage aerosol challange membrane double layer PTFE, Filter area 8.6ft2 (0.8m2) per 10 In (254 mm) element / 4.1 ft2 (0.4 m2) per 5 In (127 mm) element, autoclavable at 125, meets USP biological reactivity, in vivo for class VI-121C plastics, meets oxidizables and pH per USP packaged waters)
LHP: laboratory high pathogen sterilization: as explained earlier, it is used for Laboratory high pathogen sterilization, meeting different safety levels and configured in single or double doors to meet laboratory safety level and execute a full safe treatment and sterilization without releasing out any non safe drainage; air or any gaseous with Bio seal addition if required by the safety level of the laboratory.
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Steam Sterilizers Scientific & Laboratory Air Steam mixture Liquid Sterilization
The liquid cycle is one of the most important issues for any laboratory or pharmaceutical industry sterilizer: this is mainly for the cooling. CISA equips its laboratory sterilizers with different cooling methods and the cooling system can be considered part of the pre programmed cycles or as an optional phase that can be selected beside selecting the cycle. The cooling method is connected to the type of liquid and container closure and resistance; but CISA autoclave is equipped with all cooling methods. There is therefore no need for the customer to buy different autoclaves each one using only one type of cooling method. Those cooling methods are described below:
Steam Sterilizers Scientific & Laboratory Industrial Sterilization using Air - Steam mixture
This solution of air steam mixture for industrial applications is the safest sterilization process for delicate loads like I.V. bags and bulky pharamaceutical and food packed materials. CISA creates fast operations and high productivity solutions with optimum results and using the highest safety level. The system is composed of an advanced method using a fan to distribute air steam mixture uniformly inside the chamber.
Type of cooling
Natural cooling Counter drop pressure Indirect cooling
Description
Making the load liquid cool down by nature without any force until reaching safe temperature value; this requires long cycle time Make heat drop by safely controlling and reducing chamber pressure in steps; this will increase temperature drop and so reduce total cycle time Cooling is achieved rapidly by introducing water in the jacket and sterile air in the chamber for making cooling fast By applying water shower in chamber followed by sterile air in chamber to achieve high cooling speeds
Application
All liquid loads For sealed containers with solution; also as terminal sterilizer in pharmaceutical industry For open containers with solutions or non hermetically closed containers For hermetically closed containers
Superheated water
Direct cooling
Other Cycles can be used for pharmaceutical industry like: Crash test cycle Blue methylene test cycle
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Loading Filling the chamber with cold water Re-circulating the water in the chamber and heating it up using heat exchanger Looping of heated water and re-injection in the chamber through matrix of water outlets that guarantee uniform cover of all chamber points using the pressurized hot water. Circulation of water and continuous heating up using the heat exchanger as super heated water. Cooling Drying
Rotating Load
For some applications that require rotating load; CISA is ready to supply the chamber with an internal rotation facility that is speed and direction controlled. This feature is needed with some packaged pharmaceuticals for special tests or as part of production line. Any customizable solution concerning Loading or installation or functionality is possible with CISA, whose scientific team is able to discuss any project with the customer, to create optimum complete solutions.
Cooling the load using normal temperature air injection in the chamber to increase the drying The quality of air, Pressure and Temperature are calculated parameters to guarantee safe action without risking to damage containers or load The Heating Up Time, Cooling Time and drying time are calculated to ensure rapid sterilization cycle without affecting the load inside. Automatic Loading and unloading are important accessories to add to decrease process time and to ensure higher productivity Different set of Internal racks can be offered to meet the required Load requirements.
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Models
All below sizes and dimensions can be changed according to the different configurations and applications of the machines.
Chamber Dim.
(WxHxD mm)
660x660x720 660x660x1000 660x660x1280 660x660x1600 660x660x2000
Chamber Volume
314 435 557 697 871
External Dimensions
(WxHxD mm)
1424x1850x1025 1424x1850x1311 1424x1850x1585 1424x1850x1910 1424x1850x2310
6420
Chamber Dim.
(WxHxD mm)
1050x2000x1600 1050x2000x2000 1050x2000x2500
Chamber Volume
3360 4200 5250
External Dimensions
(WxHxD mm)
2800x2750x2048 2800x2750x2448 2800x2750x2948
Chamber Dim.
(WxHxD mm)
660x660x720 660x660x1000 660x660x1280 660x660x1600 660x660x2000
Chamber Volume
314 435 557 697 871
External Dimensions
(WxHxD mm)
1424x1850x1025 1424x1850x1311 1424x1850x1585 1424x1850x1910 1424x1850x2310
6412
Chamber Dim.
(WxHxD mm)
1050x1350x1600 1050x1350x2000 1050x1350x2500
Chamber Volume
2268 2835 3544
External Dimensions
(WxHxD mm)
2800x2100x2048 2800x2100x2448 2800x2100x2948
6415 6420
Chamber Volume
142 203 253
4270
Chamber Dim.
(WxHxD mm)
660x1490x700 660x1490x1000 660x1490x1300 660x1490x1600 660x1490x2000 660x1490x2500
Chamber Volume
689 984 1278 1573 1868 2458
External Dimensions
(WxHxD mm)
2000x2300x1148 2000x2300x1448 2000x2300x1748 2000x2300x2048 2000x2300x2448 2000x2300x2948
4210 4212
Chamber Volume
72 103
Chamber Dim.
(WxHxD mm)
660x1120x700 660x1120x1000 660x1120x1300 660x1120x1600 660x1120x2000 660x1120x2500
Chamber Volume
517 740 961 1182 1478 1848
External Dimensions
(WxHxD mm)
Chamber Volume
153 218
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P.O. Box 3692 Amman 11821 Jordan Tel: +962 655 16 592 Fax: +962 655 11 596 e-mail: middleeast.sales@cisagroup.it
CISA in Libya
Abdallah Alghareeb street Misrata, Libya Phone +218 51 2618401 Fax +218 51 2621240
618 SW 3rd ST SUITE 180 Cape Coral - Florida Zip Code 33991 Tel + 1 239 673 7041 Fax + 1 239673 7045 e-mail: america.sales@cisagroup.net
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CISA Africa O ce
CISA India O ce
New Delhi - India Tel + 91 9811 1838 39 Fax + 91 124 4370 397 e-mail: india.sales@cisagroup.it
BES Decon 131 South Liberty Lane Ashton Vale, Bristol BS3 2SZ, UK Tel +44 1179 666 761 Fax +44 1179 539 478 e-mail: info@besbiz.eu.com
CISA Russia O ce
Dmitrovskoe shosse, 100, stroenie 2, corp. 3, o .31116 127247 Moscow - Russia tel. +7 495 5458361 fax.+7 495 781 6112 e-mail: cisarussia@cisagroup.it
CISA in Germany
Schlumbohm Medizin-Labor-Technologie GmbH Grenzkehre 1 D-21079 Hamburg Tel + 49 40 769 150 0 Fax + 49 40 769 160 26 e-mail: info@schlumbohm-medizintechnik.de
CISA Asia O ce
CISA in France
190 Middle Road # 19 - 05 Fortune Center Singapore 188979 Tel + 65 6826 1065 Fax + 65 6826 3373 e-mail: asia.sales@cisagroup.it
Laboratoire Aldor Dechosal Sas ZI B des Forges - BP 31 08320 Vireux Molhain Tel + 33 03 24 41 81 81 Fax + 33 03 24 41 85 75 e-mail: aldor.dechosal@wanadoo.fr
Worldwide agents & distributors DPL - Serie L - GB - 00 - CISA S.p.A. reserves the right of modification without prior notice.
92, Rue 18 Janvier 1952 Tunis 1049 Tel/Fax +216 71 341 176 e-mail: lamine.ra k@cisagroup.it