STERIVAPHP IL. Disinfections, sterilisation and decontamination in the science, research and industry area. protecting human health

Transcription

1 STERIVAPHP IL large steam sterilizer Disinfections, sterilisation and decontamination in the science, research and industry area rotecting human health

2 Tradition, quality, innovation Universal, actively demonstrable quality Since the foundation of the comany in 1921, the STERIVAP HP IL is the reresentative of a new Original without comromises BMT a.s. had exanded from a small, regionally oriented comany into an international comany. In 1992, it became the member of Euroean MMM Grou, oerating on the world market as a sulier of systems acting in health, science and research since The MMM Grou has established with its comlex offer of roducts and services for hositals, science institutes, laboratories and harmaceutical industry as an excellent quality and innovation holder over the worldwide market. generation of big steam sterilizers meeting without excetion the basic EU technicallegislative rules. The device s concetion is based on the requirements of the Euroean directives No. 6/95/EC, 89/336/EEC, 97/23/ EC and on the rovisions of EN 285:6 and EN ISO :6 standards and is also fi t to the individual needs of each working laces. Both the ressure chamber and the steam generator are designed and manufactured in big, colour, tilting control anel touch-screen 12 with maximal oerating and service comfort two-stage, high-erformance, suction um for short charges times, quick and accurate cycle rocessing double-rocessor control by two indeendent Master and Slave systems for quick and accurate cycle rocessing unique, atented, double chamber jacket with an indeendent and stable reheating for economical oeration and low media consumtion the device is roduced from a high-quality stainless steel inclusive the solid, divided frame for the long-term lifetime and reliability thermal deaeration for higher oeration reliability and sterilization safety the certified quality system according to the laboratories harmacy BSL 3 / BSL 4 biomodels Knowledge and exerience, acquired during the individual delivery for our customers, as well as new technical innovations continuously ositively infl uence the develoment, design and roduction of our devices. A large variety of atents, utilization models and industrial designs and an easy modifi cation of devices according to individual requirements confi rm the high quality of our work. MMM Grou erfection in laboratory and medical technique. Euroean Directive for ressure equiment No. 97/23/EC or, in case of an individual requirement, according to the standards ASME Code, Section VIII, Division 1 (for the USA and Canada) or according to the license regulations AQCIQ (for China). The construction of the device meets the GMP and GLP requirements. The device meets the latest health service, laboratories, harmaceutical, chemical and food industry requirements. We offer many other otional services to our clients, contributing to the sterilisation rocesses quality increasing: For the uroses of fulfi lling the GMP requirements for roving of ermanent sterilisation quality in line with device arameters declared by roducer (imorter), we offer also the service making of Q installation qualifi cation, OQ oerating qualifi cation and PQ rocessing qualifi cation (validation) to the STERIVAP HP IL steam sterilizers users. We also offer the making of FAT and SAT sterilizers takeover tests. The tests and validations according to the EN 285:6 and EN ISO :6 standards are erformed with use of our accredited testing laboratory otential. 2 3

3 Individually built sterilization technique The latest modularly built STERIVAP HP IL sterilizer is suitable for the microbiology, molecular biology, biotechnology and waste decontamination area. The steam sterilizers are intended for sterilization of solid objects without liquids content, liquid sterilization solutions, cultural and boiling soils, Intelligent systems of media and working timesavings unique divided double sterilization chamber jacket for better and more accurate sterilization cycle rocessing with an indeendent and stable system of chamber reheating, which reduces the demi-water consumtion by arox. 2 % outer insulating jacket of the sterilising chamber with high Coherent constructional solution, roduction machining and design well-arranged, ergonomic laced control anels easy intuitive control and service modern and ergonomic horizontal chamber ositioning ossibility to use the comfortable transort and charging equiment for all tyes STERIVAP HP IL Revolution on the big steam sterilization scene NEW 2 STM just a touch susensions and emulsions, liquid medical forms; steam decontamination. The STERIVAP HP IL sterilizer safe, quick, ergonomically designed, easy to handle, with ossibility of individual modifi cations and with versatile use. The sterilizer line with chamber volume litres. The suerior roduction quality, modern electronic and high quality materials are in case of STERIVAP HP IL equally obvious as the user roerties or extraordinary safety and reliability level. quality insulation, which reduces substantially the heat losses, saves the energy standard built-in device for saving of water for suction um, which saves ca 8 % of water running costs steam generator with the microrocessor automatic, with the unique construction, with the high erformance, with the thermal deaeration of the demi-water for minimisation of the non-condensed gases and with the automatic desalinisation secures short times of the sterilising cycles and ermanently high steam quality function Automatic morning utting-on is other from many economical roducts, which will save the oerating ersonnel working time; the device will be ut on at the redefi ned time without the oerating ersonnel resence, it will be automatically reheated and makes the vacuum test, and so it is reared for oeration on the start of user working time function Automatic morning utting-on is other from many economical roducts, which will save the oerating ersonnel working time; the device will be ut on at the redefi ned time without the oerating ersonnel resence, it will be automatically reheated and makes the vacuum test, and so it is reared for oeration on the start of user working time automatic sealing and motoric door movement service only from the front and one otional side wall ossibility of the right and left version for otimal sace use robust divided stainless-steel skeleton, with ossibility of door oening of 1 mm motoric sterilisation chamber door control with an unique sring mechanism without counterweight, with double security door rotection (security bar and couling) simle mechanical fi lters on the media inuts for the valve and air um rotection bacteriologic fi lter for fi lling the sterilisation chamber by air (,1 μm) watertight outlet suly for the reason of humidity elimination in the instrument area are all ies connected into a common reservoir, insulated from the ambient tubular distributions and the valves transorting steam into the sterilisation chamber and demi water into the built-in steam generator are standard made from the stainless steel owerful, noiseless air um for higher efficiency and reliability (two-stage for the 446 to 669 tyes) on-line device monitoring motor driven door with an unique sring system without counterweight constructional modular system gives the ossibility of individual device construction ergonomic adjustable osition of the touch control anel laced outside the thermally exosed zone secures the high quality readability and easy oerating ersonnel work regardless the figure height forms simlicity and usefulness, high-quality surface of stainless-steel facing sheets enables the erfect hygiene facing sheets, reinforced by divided, stainless steel frame grant the noiseless oeration and extended device lifetime manual and transorting and loading system guaranties the easy oerating ersonnel work with sterilizing material maximally effective use of internal sterilizing area BSL 3 / BSL 4 4 5

4 Modular arrangement single and double (assing through) door version (tye vertically and tye horizontally sliding door) stainless steel device facing sheets are against the standard solutions hardened by frame ensuring the extended lifetime and noiseless device oeration easy access into the device is secured by lockable door anels own, external and combined steam source more than 6 otional secifi c additives (e.g. a ossibility of chamber equiing by a flexible PT sensor for safe and accurate cycles controlling during the work with microbiological cultures and solutions, a ossibility of building-in the device for the aftercooling of condensate, a ossibility of adatation for decontamination of materials, Bio-Seal gastight version, ressure gauges, a range of individual rogrammes modifi cation, ) unlimited number and easy modification of rograms by means of chi cards unique error rotocol for recise and quicker error diagnostics u to 2 standard rogrammes in basic software easy individual rogramme modification more than 8 service rograms for easy set-u, calibration, diagnostics and service The highest safety for sterilization of solutions Besides the standard oeration and safety rocedures and rocesses, the sterilization of solutions is monitored also by three indeendent systems chamber temerature and ressure check, temerature in the reference bottle check and the minimum time necessary for the sterilization cycle check. Only if the conditions of all three mentioned rocesses are met, the rogram is declared as finished and the system allows to oen the chamber door. Ra,8 μm (Ra 32 μinch) or olishing into the mirrorlustre with surface roughness Ra,125 μm (Ra 5 μinch) erfect Rockwool thermal insulation with thikness of 125 mm together with the third external insulating jacket as a standard, all chambers are rovided with two easily accessible inut nozzles for validation with the diameter of 25 and 5 mm the motor driven door with a sring system without counterweight is rovided by two indeendent safety systems a contact bar and clutch with an adjustable sli force on demand, we make the chamber assivation (ickling) High ower steam generator the steam generator is made from the high-quality stainless steel AISI 316 Ti high-quality Rockwool insulation and external insulating jacket reduce the thermal losses considerably Wide range of otions gastight version Bio-Seal with ossibility of indeendent and ermanent chamber door sealing by ressurised air ressure sterilization chamber with mirror lustre stainless steel valves, sterilizable filters with integrity test Air-detector F control of sterilizing rocess with suorting air ressure, forced jacket cooling with suorting air ressure, ossibility of the charge showering e-documentation of sterilizing rocesses with the ossibility of device connecting into the comuter network (LAN) Unique microrocessor control the highest ossible oerational safety, double system of rocess data collection and evaluation and continual comarison and evaluation of these data any detected deviation above the ermitted value activates the error message two built-in microrocessor control systems (Master and Slave) for indeendent evaluation, control and documentation of working cycles Pressure sterilization chamber the massive chamber, door and the heating jacket are made from high-quality stainless steel AISI 316 Ti and AISI 316 L cambered sterilization chamber bottom for erfect drying standard surface of the sterilizing chamber olishing of the chamber internal surface Ra 1,25 μm (Ra 5 μinch); otional olishing with roughness thermal de-aeration of the demi-water for minimizing the content of non-condensed gases in the steam generator the function of water filling and the steam generator ower are controlled and monitored by the control system Master and Slave for harmaceutical use, we offer a secial equiment instead of standard delivered steam generator 6 7

5 New control anel with an intuitive control modern technology of the touch dislay touch-screen 12 with ergonomically adjustable anel ensures the transarent and easy oeration on the charging device side on the discharging device side (in case of two-door version) the dislay touch-screen with ossibility of monitoring the actual working hase and ressure in the sterilization chamber control anels located outside the thermally exosed zone two built-in microrocessor control systems (Master and Slave) with own sensors for indeendent working cycles evaluation, control and documentation total sto function integrated into the control anel, enables, in case of need, the device utting into the idle condition built in rinter for sterilization rocesses documentation ossibility of choosing the language for communication with the device transarent digital dislaying of vaour ressure in the sterilization chamber jacket and in the steam generator, of ressure and temerature in the sterilization chamber (reference bottle) clock indication of remaining rogramme time and indication of real time error reort rint with registration of all arameters in moment of the fault for ossibility of quick and remote service too visual and acoustical signalisation of states and rocesses otional accessory for secial laboratory alications choice and start of rogramme also from the clean side function Automatic morning utting-on enables to ut the device on at the redefi ned time without the oerating ersonnel resence, its automatic reheating and making the vacuum test Charge documentation The transarent documentation of working cycles could be secured by: an indeendent documentation with ossibility of storing of more reorts into the sterilizer memory a standard built in rinter with a ossibility of selecting one of four grahic oututs connection of an external A4 rinter connection to a PC (RS 232) and by storing of reorts into the comuter memory by the Printer Archive software sterilizer connection to a comuter network (LAN) together with the software alication using of the bar code scanner Service accessories The automation is equied by large software for easy monitoring, maintenance and testing (interactive charts of ie interconnection, testing rogrammes enabling the testing of device safety features, calibrating adjustments etc.). The lastic and constructional shae of the device control art with ossibility of a tiing adjustment of the touch control anel gives to it the unique form of the working desk, which, in standstill hases, returns automatically into its original rest osition and therefore it could not be damaged during the normal oeration. It secures the high-quality readability and easy oerating ersonnel work regardless the fi gure height. As standard instrument accessories is the built-in thermo-rinter for documentation of sterilization rocesses with ossibility of rint from one of four grahical rogrammes. 8 9

6 Wide offer of working rograms according to the secific user needs Otional rogrammes Laboratories Pharmacy BSL 3, BSL 4 Bio models (laboratory animals breeding) The STERIVAP HP steam sterilizer can be used for sterilization of solid, orous and lastic materials, rocessing and subsequent sterilization of agars (substrates), sterilization of solutions in oen and closed bottles, disinfection of materials, waste decontamination, etc. The instrument enables the installation of u to the 2 fi xed rogrammes in the basic version, according to the secific customer needs. Standard rogrammes Heating 134 C/ 1 min Sterilizing rogrammes with ossibility of validation Universal 134 C/ 7 min, with following drying Universal Containers 134 C/ 7 min, with intensive drying Rubber 121 C/ 2 min, with following drying Instruments Quickly 134 C/ 4 min, with following short drying, for non acked instruments for immediately following use Testing rogrammes Bowie&Dick Test Steam enetration test 134 C/ 3,5 min Vacuum Test Chamber air tightness test comensatory hase length is 5 min, test length is 1 min The installed rogrammes could be later, anytime, modifi ed by a chi card system directly at the user. On the chi cards, the rogrammes develoed and tested by roducer are saved, based on the order. Secial laboratory software enables to the oerating ersonnel to make individual modifi cations of already rogrammed sterilization rogrammes. The user can modify: sterilisation temerature ± 3 C from the set values, the uer limit is 135 C sterilisation time within 6 min drying hase length 6 min number of drying hases within 1 hases evacuation number within 1 hases in case of solution rogrammes, the cooling temerature, the uer limit is 12 C in case of rogrammes controlled by Fo arameter, the Fo arameter within 6 We also offer secial UNICONFIG software enabling to modify all values of the sterilisation cycle (evacuation, vacuum deth, exosition, drying) and to set the values of the sterilisation cycle temerature and time. (The verifi cation by roducer is necessary.) Secial rogrammes (without necessity of using of PT sensor) 3 EVACUATION STEAMING EVACUATION STEAMING EVACUATION Endoscoes Prions Creutzfeldt Laaroscoes Waste decontamination laboratories (with using of the bacteriological filter and with the condensate sterilisation); BSL 3, BSL 4 cabs; waste in the laboratories Disinfection 15 C Otical instruments Plastic cells Wooden dust HEATING STERILIZATION atmosheric ressure PRESSURE DECREASE DRYING AERATION RELEASE Legend (suitable for BSL 3, BSL 4 oerations) 1. chamber evacuation through the bacteriological filter 2. condensate accumulation with continuous sterilisation 3. air sucking through the bacteriological filter Decontamination with secial charge testing (illustrative charts) Methylene test Crash test / Showering Secial rogrammes with ossibility of use of the movable PT sensor with sontaneous cooling Animal food (ossible individual sensor use according to the food tye) Solutions with sontaneous cooling Solutions with evacuation Solutions controlled by F arameter with forced cooling and air back-ressure Steaming Allolastic Agars (substrates) with sontaneous cooling Solutions with forced cooling and air back-ressure Solutions with forced cooling and air back-ressure and air back-ressure controlled by Fo arameter Amoules Agars (substrates) with forced cooling, with ossibility to boil in soft 3 Passage (of the material through the chamber) for material transort from clean to non-clean side, with ossibility of disinfection by steam Secial rogrammes with bacteriological fi lter on the sterilisation chamber inut/outut and with continuous condensate sterilisation (suitable for BSL 3, BSL 4 oerations) with wide scale of following secified otional accessories 1 11

7 Modular system Otional accessories suly side with the rearation for the integrity test b suorting air ressure (contains also the movable PT temerature sensor) 1. both single and double (interleaf) door tye, stainless steel sheets, ossibility of mounting into the stainless 1. PT temerature sensor 11. chi cards system Sterilization rocess controlled by the Fo value secial UNICONFIG software enabling to modify Otional equiment steel searating walls, mirror device variant, which, in 12. draining bath under the device (the bath is standard each sterilization cycle hase (evacuation, vacuum case of installation of more devices close by another, for the size 96xx) deth, exosition, drying) and to set the temerature 2. transort car enables combination of two service areas into the one 13. ossibility of mounting of an equiment for the and sterilization cycle time (verifi cation with the 21. charging car 2. otional steam source FD steam of central source, condensate aftercooling 14. air detector for the continual monitoring of the c manufacturer is necessary) mediums monitoring continual monitoring of the a) universal b) secial ED own integrated steam generator, air and non-condensable gases resence in the inut mediums arameters (ressurised air, both demi- c) solution FDT combined suly mode by technical/ sterilization chamber during every sterilization and cooling water too) 22. stainless steel shelf olice /medicinal steam, rogramme for maximal sterilization security device oeration regulation watching of energetic 23. stainless steel sieve (excet for 446 and 636) FDD integrated, own heat steam/steam against the routine monitoring by test rogrammes maximum in case of connection of more devices to 24. hook for charging cars withdrawing exchanger (Vacuum and Bowie&Dick test) made only the mains 25. wide scale of laboratory accessories bags and 3. olishing of internal sterilization chamber surface with roughness of Ra 1,25 μm (Ra 5 μinch);,8 μm daily before the starting of normal oeration (HTM 21) troical version for countries with temerature otional electrical connection deending on the sacks for contaminated material, sterilisation baskets, lastic containers, test tubes, Petri dishes (Ra 32 μinch); Ra,125 μm (Ra 5 μinch) 15. sulementary mechanical manometers requested mains arameters etc. 4. system of transort and charging cars on the charging side 26. basic IQ, OQ, PQ documentation for validation frame for the charging car on the withdrawal side according to GMP and GLP 5. system for manual material inserting 16. draining bath under the device tests and validations according to the sieves, shelves conduction 17. big touch dislay touch screen 12 on the EN 285:6 and EN ISO :6 standards 6. stainless steel valves with screwed or welded necks of the CLAMP tye withdrawal side too 18. bar code reader a stainless steel safety valves 19. secial Printer Archiv software for charges air comressor inclusive the air accumulator and 8. gastight Bio-Seal device version with ossibility of documentation in the PC cabinet (for devices with the aditivum Solution an indeendent and ermanent sealing of chamber door by ressurised air software for sterilizer connection to the comuter network (LAN) rogramme with comulsory jacket cooling and with the suorting air ressure is necessary the more 9. secial stainless steel, sterilisable filters on the chamber assivation (ickling) owerful comressor eg. Ekom lus 2 V) sterilization chamber inut and outut laboratory software enables to the oerating water treatment device for demi-water rearation bacteriological, fi lter on the chamber outut ersonnel to realize the individual modifications of monitoring starting acket of indicators (decontamination inclusive the condensate already rogrammed rogrammes otional language version for communication with the sterilization) secial rogrammes Solutions sterilization with device bacteriological, sterilisable air-inlet filter on the air the sontaneous jacket cooling and with the 12 13

8 Ensuring of customer services The user service and suort are fully secured by the wide-world net of BMT a.s. contract artners. We have a wide net of branded service working laces, connected to the HOT-LINE service, which secures the quick reaction on the customer inquiries and requests. For securing of the user comfort and for ossibilities of the quick and high-quality service intervention, a secial diagnostic rogramme was develoed. We offer the ON-LINE internet sterilization device diagnostics and monitoring, which offers a quick and direct communication with the device and ensures the continuous, trouble-free oeration of the working lace. This all grants the low oerational costs and the long device lifetime. Environmental awareness The device meets all current environmental requirements. It does not load the working lace and the environment too. The outer insulating sterilization chamber jacket is made from the fl ame galvanised sheets with highquality insulation, which considerable lowers the thermal loses, saves the electrical energy. The two-stage, noiseless suction um with standard built-in device for water saving saves ca 8 % of oerating costs. The unique high ower steam generator construction with an automatic desalinisation ensures the short sterilization cycles times and ermanently high steam quality. The unique divided double sterilization chamber jacket with a new steam fi lling system, which reduces the demi-water consumtion by arox. 2 %. The materials assuring high device lifetime are used during the roduction. The device may be otional equied by the accessory for wastewater aftercooling, what enables the setting of its waste temerature. Also during the sho working, the ecological rocessing methods are used. All imortant device arts and acking too are recyclable. The device consists of 95 % of steel, 4 % of other materials, 1 % electrical material and lastics. The ecological liquidation is made, after the disassembly, by an authorised erson according to the EU rules, which corresond to the WEEE directive (Waste Electric and Electronic Equiment). TECHNICAL PARAMETERS Model SP HP IL Dimensions (hxwxd) Number Chamber [mm] of sterilization volume [l] Internal dim. External dim. Total of the chamber of the unit modules x45x x1x ,5/63 2/1,6,6 5, 5,, x45x x1x ,5/63 2/1,6,6 5, 5,, x35x xx ,5/63 2/1,6,6 5, 5,, x35x xx ,5/63 2/1,6,6 5, 5,, x65x x13x /63 2/1,7,8 7, 6,, x65x x13x /63 2/1,7,8 7, 6,, x65x x13x /8 2/1,8,9 9, 7,5, x65x x13x /8 2/1,8,9 9, 7,5, x65x x13x /8 3/1,9,11 11, 9,, x65x x13x /8 3/1,9,11 11, 9,, x65x x13x / 4/16,2,15 15, 15, 1, x65x x19x / 4/16,2,15 15, 15, 1, x65x x19x / 4/16,2,15 15, 15, 1, x65x x19x /125 5/16,3,25 23, 23, 1, x65x x19x /125 5/16,3,25 23, 23, 1,7 Model 9612, 9618 with horizontally sliding door(s). Model xxx-1 single-door tye, model xxx-2 double-door tye. Connecting voltage 3P/PE AC 4/5/6/Hz. * Model FD steam of central source. ** Model ED own integrated steam generator. Noise level max. 78 db. Model 6618, 9612, 9618 steam generator is laced above or beside the sterilizer Changes in the design and make reserved. Weight [kg] STERIVAP HP IL Max. inut [kw]/ fuses [A] ED FD Water [m 3 ] Demineralized water [m 3 ]** Max. consumtion er 1 sterilization cycle Steam [kg] Electric energy [kwh]** Electric energy [kwh]* Technology in the human s service comfortably, economically, safely

9 More information is available direct from our internet web site Make acquaintance with our further offers Small steam sterilizers litre Steam sterilizer 7 litre Laboratory drying devices and incubators litre Stainless steel instrumentation Formaldehyde sterilizer 11 litre Exchanger steam/steam Tests of sterilization efficiency Cleaning and disinfection agents BMT a.s., Cejl 5, CZ BRNO Tel.: , fax: , mail@bmt.cz, htt:// STERIVAP HP IL 5/7 EN/8761 Photo T. Benda