STERIVAP HP IL Large Steam Sterilizer for Disinfections, Sterilisation and Decontamination in the Science, Research and Industry Area

Transcription

1 STERIVAP HP IL Large Steam Sterilizer for Disinfections, Sterilisation and Decontamination in the Science, Research and Industry Area rotecting human health

2 Tradition, Quality, Innovation Universal, Actively Demonstrable Quality Original without Comromises Since its establishment in 1921, the comany BMT Medical Technology s.r.o., a traditional manufacturer of medical equiment, gradually changed from a small region-oriented comany Chirana to the international comany BMT. 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. STERIVAP h il is the reresentative of a new generation of big steam sterilizers meeting without excetion the basic EU technical-legislative 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+A2 and EN ISO standards and is also fit to the individual needs of each working laces. Both the ressure chamber and the steam generator are designed and manufactured in the certified quality system according to the Euroean Directive for ressure equiment No. 97/23/EC or, in case of an individual requirement, according to the standards ASME Code, Section VIII, We offer many other otional services to our clients, contributing to the sterilisation rocesses quality increasing: For the uroses of fulfilling 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 qualification, OQ oerating qualification and PQ rocessing qualification (validation) to the STERIVAP h il steam sterilizers users. We also offer the making of FAT and SAT sterilizers takeover tests. 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 PLC 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 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 influence the develoment, design and roduction of our devices. A large variety of atents, utilization models and industrial designs and an easy modification of devices according to individual requirements confirm the high quality of our work. MMM Grou erfection in laboratory and medical technique. 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. The tests and validations according to the EN ISO and customer s secifications 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 sterilizer line with chamber volume litres. The steam sterilizers are intended for sterilization of solid objects without liquids 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 quality insulation, Coherent Constructional Solution, Production 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 just a touch content, liquid sterilization solutions, cultural and boiling soils, susensions and emulsions, liquid medical forms; steam decontamination. The STERIVAP HP IL sterilizer safe, quick, ergonomically designed, easy to handle, with ossibility of individual modifications and with versatile use. 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. which reduces substantially the heat losses, saves the energy standard built-in device for saving of water for suction um, which saves ca 15% 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 redefined 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 filters on the media inuts for the valve and air um rotection bacteriologic filter for filling 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 4 5 BSL 3 / BSL 4

4 Modular Arrangement Wide Range Of Otions 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 secific 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 after-cooling of condensate, a ossibility of adatation for decontamination of materials, Bio- Seal gastight version, ressure gauges, a range of individual rogrammes modification, ) 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. 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 Power 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 thermal de-aeration of the demi-water for minimizing the content of noncondensed gases in the steam generator 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 PLC control consisting from two microrocessor control systems (Master-Slave) for indeendent evaluation, control and documentation of working cycles Pressure Sterilization Chamber the massive chamber, door and the heating jacket are made from highquality 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 Ra,8 μm (Ra 32 μinch) or olishing into the mirror-lustre with the function of water filling and the steam generator ower are controlled and monitored by the control system Master-Slave for harmaceutical use, we offer a secial equiment instead of standard delivered steam generator 6 7

5 New Control Panel With An Intuitive Control Charge Documentation 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 5,7 ensures the transarent and easy oeration PLC control anels located outside the thermally exosed zone PLC consisting from two microrocessor control systems (Master-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 sterili-zation 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 visual and acoustical signalisation of states and rocesses function Automatic morning uttingon enables to ut the device on at the redefined time without the oerating ersonnel resence, its automatic reheating and making the vacuum test otional accessory for secial laboratory alications choice and start of rogramme also from the clean side Records history this function allows to choose the required record from the history (last 1 records) and to rint it, or to dislay the ressure and temerature record (either in grahical or numerical form) Errors history this function allows to dislay the last 2 error messages Additional comments the device allows the oerator to add additional comments to the individual rogrammes and/or cycles (such as the roduct name, no. of the load, batch no. etc.), t he comments will then be rinted together with the record Login (access rights) the device enables to set the user rights for the device use Free Use mode and Individual Access Rights mode standard batch counter and another otional daily batch counter A clear documentation of work cycles can be ensured by: indeendent documentation of working cycles with ressure and temerature recording, allowing the storage of the last 1 records in the sterilizer memory (u to tens of thousands otionally SD card); connection to a PC and storing the records in the comuter memory by means of the Printer Archive software; connection of the sterilizer to a comuter network (LAN) together with the software alication Ecosoft and DP 3.5; integrated rinter allowing to select one of two grahic oututs Service Accessories The PLC control 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.). We offer ON-LINE internet diagnostics and monitoring of sterilisation device, roviding fast and direct communication with the engineering and it arranges fast and fluent, trouble-free oeration of the work site. That all guarantees low oeration costs and long service life of the device. The device allows detailed lanning of service acts with consequent warning on the dislay or on rinter outut. 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 figure height. As standard instrument accessories is the built-in thermo-rinter for documentation of sterilization rocesses with ossibility of rint from one of two grahical rogrammes. 8 9

6 Wide Offer Of Working Programs According To The Secific User Needs Otional Programmes Laboratories Pharmacy BSL 3, BSL 4 Bio models (laboratory animals breeding) The STERIVAP h 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 fixed 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, modified 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 u to 2 rograms on one chi card). Secial laboratory software enables to the oerating ersonnel to make individual modifications of already rogrammed sterilization rogrammes E.g. Arnold steaming C and 75 C. 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 verification 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 Programmes With Possibility 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 3 Steaming 75 C or C/1 min. (Arnold-tye rogrammes) Allolastic Passage (of the material through the chamber) for material transort from clean to nonclean side, with ossibility of disinfection by steam Agars (substrates) with sontaneous cooling Secial Programmes 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 with bacteriological filter 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 1 both single and double (interleaf) door tye, stainless steel sheets, ossibility of mounting into the stainless steel searating walls, mirror device variant, which, in case of installation of more devices close by another, enables combination of two service areas into the one 2 otional steam source FD steam suly ED steam suly from an internal steam generator FDD steam suly from internal steam/steam exchanger (steam/steam exchanger is sulied by technical steam) FD ED steam suly from an external medicinal steam source, or steam suly from an internal steam generator (original FED) ED FDT steam suly from an internal steam FD FDT steam suly from an external medicinal steam source, and heating jacket suly by technical steam and ermanent sealing of chamber door by ressurised air 9 secial stainless steel, sterilisable filters on the sterilization chamber inut and outut bacteriological, filter on the chamber outut (decontamination inclusive the condensate sterilization) bacteriological, sterilisable air-inlet filter on the air suly side with the rearation for the integrity test 1 PT temerature sensor chi cards system 12 draining bath under the device (the bath is standard for the size 96xx) 13 ossibility of mounting of an equiment for the condensate aftercooling 14 air detector for the continual monitoring of the air and noncondensable gases resence in the sterilization chamber during every sterilization rogramme for maximal sterilization security against the routine monitoring by test rogrammes (Vacuum and Bowie&Dick test) made only daily before the starting of normal oeration (HTM 21) b 21 c chamber assivation (ickling) laboratory software enables to the oerating ersonnel to realize the individual modifications of already rogrammed rogrammes secial rogrammes Solutions sterilization with the sontaneous jacket cooling and with the suorting air ressure (contains also the movable PT temerature sensor) Sterilization rocess controlled by the Fo value secial UNICONFIG software enabling to modify each sterilization cycle hase (evacuation, vacuum deth, exosition, drying) and to set the temerature and sterilization cycle time (verification with the manufacturer is necessary) mediums monitoring continual monitoring of the inut mediums arameters (ressurised air, both demi- and cooling water too) device oeration regulation watching of energetic maximum in Otional Equiment 21 transort car 22 charging car a) universal b) secial c) solution 23 stainless steel shelf olice 24 stainless steel sieve (excet for 446 and 636) 25 hook for charging cars withdrawing 26 wide scale of laboratory accessories bags and sacks for contaminated material, sterilisation baskets, lastic containers, test tubes, Petri dishes etc. 27 basic IQ, OQ, PQ documentation for validation according to GMP and GLP tests and validations according to the EN 285+A2 and EN ISO standards air comressor inclusive the air accumulator and cabinet (for devices with the aditivum Solution rogramme with comulsory jacket cooling and with the suorting air ressure is necessary the more owerful comressor eg. Ekom lus 2V) a 25 3 olishing of internal sterilization chamber surface with roughness of Ra 1,25 µm (Ra 5 µinch);,8 µm (Ra 32 µinch); Ra,125 µm (Ra 5 µinch) 4 system of transort and charging cars 15 sulementary mechanical manometers on the charging side on the withdrawal side 16 draining bath under the device 17 big touch dislay touch screen 12 on the withdrawal side too 18 bar code reader 19 secial Printer Archive software for charges documentation in the PC software for sterilizer connection to the comuter network (LAN) case of connection of more devices to the mains troical version for countries with temerature otional electrical connection deending on the requested mains arameters 2 automatic sterilizer door oening during a ower failure 32 GB memory card for the sterilization cycles recording (u to, hours of record). Audit trail system events recording on the memory card (conforms to 21CFR art 11) water treatment device for demiwater rearation monitoring starting acket of indicators otional language version for communication with the device frame for the charging car 5 system for manual material inserting sieves, shelves conduction 6 tainless steel valves with screwed or welded necks of the CLAMP tye 7 stainless steel safety valves 8 gastight Bio-Seal device version 12 with ossibility of an indeendent 13

8 Ensuring of Customer Services The user service and suort are fully secured by the wide-world net of BMT Medical Technology s.r.o. 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 flame galvanised sheets with high-quality insulation, which considerable lowers the thermal loses, saves the electrical energy. The two-stage, noiseless suction um with standard builtin device for water saving saves ca 15% 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 filling 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). STERIVAP HP IL Technical Parameters Model SP HP IL Dimensions (h w d) [mm] Internal dim of the chamber External dim. of the unit Number of sterilization modules Chamber volume [l] Weight [kg] Cca max. inut [kw]/ fuses [A] Total ED FD ED FD Water [m 3 ] Cca max. consumtion er 1 sterilization cycle Demineralized water [m 3 ] Steam [kg] Electric energy [kwh]** ,5/63 2/1,6,6 5 5, ,5/63 2/1,6,6 5 5, *** ,5/32 2/6,7,8 7 6, *** ,5/32 2/6,7,8 7 6, ,5/63 2/1,6,6 5 5, ,5/63 2/1,6,6 5 5, /63 2/1,7,8 7 6, /63 2/1,7,8 7 6, /8 2/1,8,9 9 7,5, /8 2/1,8,9 9 7,5, /8 3/1,9, , /8 3/1,9, , / 4/16,2, , /8 4/16,12, ,7 Electric energy [kwh]* /8 4/16,12, , / 4/16,2, , / 4/16,2, , /125 4/16,25, , /125 5/16,3, , /125 5/16,3, , /16, Model 969, 9612, 9615, 9618, 9621 with horizontally sliding door(s). Model xxx-1 single-door tye, model xxx-2 double-door tye. Connecting voltage 3P/PE 4 V, 5/6 Hz, connecting voltage of the model 559 3P/N/PE 48 V, 6Hz (for the U.S.A.) Noise level max. 78 db. Model 6618, 969, 9612, 9615, 9618, 9621 steam generator is laced above or beside the sterilizer * Model FD steam of central source. ** Model ED own integrated steam generator *** the dimensions are not standardized for the container system The values may differ deending on secific charge and media arameters. Changes in the design and make reserved. 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 l Steam sterilizer 73 l Laboratory drying devices and incubators l Stainless steel instrumentation Formaldehyde sterilizer 11 l Exchanger steam/steam Washer Disinfectors Cleaning and disinfection agents BMT Medical Technology s.r.o., Cejl 157/5, Zábrdovice, CZ 62 Brno Tel.: , fax: , mail@bmt.cz, STERIVAP HP IL_1/215_EN/PR Photo T. Benda