UNISTERI HP IL. medium steam sterilizer for labs and pharmacy - sophisticated and simple, with high performance. protecting human health

Transcription

1 UNISTERI HP IL medium steam sterilizer for labs and harmacy - sohisticated and simle, with high erformance rotecting human health

2 MMM Grou Leading Service Sulier for Health Care Individually Built Sterilization Engineering Technical and Legislative Standards 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. The newest modular line of steam sterilizers UNISTERI HP IL is suitable for the field of microbiology, molecular biology, bio technology and waste decontamination. Line of sterilizers with chamber volume of 73, 16 and 254 litres. The steam sterilizer is designed for sterilization of solid objects without contents of liquids, for sterilization of liquids solutions, cultivation and boiling soils, susensions and emulsions, liquid medicament forms; steam decontamination. Steam sterilizer UNISTERI HP IL safe, fast, ergonomic design, easily controllable, ossibility of individual adjustments and multi-urose use. To quality roduction, modern electronics and high quality materials of UNISTERI HP IL is the reresentative of the new generation of medium steam sterilizers meeting basic technical and legislative EU regulations without any excetions. The device concet is based on requirements of Euroean regulations No. 214/35/EU, 214/3/EU and 214/68/EU and related standards, mainly ČSN EN 285. The device is also adjusted to individual needs of individual work sites. The ressure chamber and steam generator are designed and manufactured within certified quality system according to the Euroean regulation for ressure devices or in case of individual requirements according to ASME Code standards (for the USA and Canada) or according to licence regulations AQCIQ (for China). The device construction meets requirements of GMP and GLP. The device corresonds with recent requirements in health care industry, in labs, in harmaceutical, chemical and food rocessing industry. So as to meet the GMP requirements towards roving the ermanent quality of the sterilization rocess in comliance with device arameters as declared by the device manufacturer, it is ossible to arrange for users of UNISTERI HP IL steam sterilizers rearation of documents for the urose of the rocess validation: IQ installation qualification OQ oeration qualification PQ function qualification We offer erformance of FAT and SAT tests and sterilizers take over. The validation tests according to the ČSN EN ISO standard are erformed using the otential of our accredited testing laboratory. laboratories harmacy BSL 3 / BSL 4 bio-models Knowledge and exerience obtained in realisation of individual sulies to our clients all over the world together with technical innovation ermanently and ositively influence the develoment, construction and manufacture of our devices. The number of atents and utility and industrial designs, sohisticated construction and easy realisation of individual adjustments of our devices further confirm high levels of our works. the device UNISTERI HP IL are as natural as user features or excetional level of safety and reliability. 2 3

3 Laboratories, harmacy, BSL 3, BSL 4, bio-models Comlete made to measure systems Peole in veterinary and research laboratories, harmaceutical lants and hosital harmacies work with highly sensitive laboratory materials requiring extremely resonsible handling. Safety, reliability, seed and comfort in everyday use these are the decisive criteria for use of sterilization and disinfection automats. Modular rincile of devices construction allows us to offer to you the line of roducts with unique characteristics using various oeration media, various rinciles of heat transfer, in several volume sizes, with safe oeration rocedures. Steam sterilizer UNISTERI HP IL reresents a sterilization resonse to challenges of micro-organisms in the lab. Nutrient media, solutions in oen or closed bottles, highly athogenic samles of micro-organisms, solid or orous materials or materials sensitive towards ressure changes, contaminated material, used filters, animal boxes, animal food, food and other materials all these items set the wide sectrum of our requirements towards materials that may be quickly, erfectly and reliably disinfected and sterilized by the steam sterilizer UNISTERI HP IL. UNISTERI HP IL variable use, modular construction of the steam sterilizer with wide range of its use. Unique Characteristics of Otional Equiment gastight version of the device Bio-Seal with ossibility of indeendent and ermanent sealing of the chamber door with ressure air and with ossibility of indeendent control of door at any side stainless steel frame of the device, ressure sterilization chamber with mirror shine comlete stainless steel design of iing (tri-clams, valves, safety valve) secial stainless steel sterilizable filters with integrity test at the inut / outut from the sterilization chamber Fo control of sterilization rocess, forced cooling of the shell with suorting air ressure, ossibility of charge sraying air comressor including air jet and cabinet basic documentation for validation according to GMP and GLP (DQ, FAT, SAT, IQ, OQ, PQ) Air-detector wide range of secial laboratory rograms with the ossibility of individual modification using a secial software UNICONFIG or directly from the touch dislay documentation of sterilization rocesses with ossibility of the device connection to comuter network (LAN) BSL 3 / BSL 4 4 5

4 Modular layout system New design, new construction single-door and double-door (interlaying) version with ossibility of building into the stainless steel wall otional steam source own, external, combined otional roughness of inner surface of the sterilization chamber system for manual insertion of materials and system of transort and charging carriages wide range of otional rogram equiment various ossibilities of batch documentation rocessing wide range of otional equiment for minimization of oeration costs ossibility of secific additives selection (e.g. ossibility of chamber equiment with a flexible sensor PT for safe and recise control of cycles while working with microbiological cultures and solutions, ossibility of building-in the device for additional cooling of condensate, ossibility of adjustment for decontamination of materials, gastight version Bio-Seal, ressure manometers, wide range of individual adjustments of rograms, ) wide sectrum of services (incl. ON-LINE internet diagnostics, various tyes of tests, validation, etc.) touch-screen 8,4 control anel with maximal oeration and service comfort new, unique, revolving door hanging with user-friendly servicing, automatic system of door locking and sealing movable door sealing low-inut gas generator for lower oeration costs (from 7,5 kw) owerful suction um for short times of batches, fast and exact course of cycles two-rocessor control by two indeendent Master-Slave cycles for fast, exact and safe course of cycles Secial method of control of continuous steam filling into the steam sterilizer chamber the device is made of high-quality stainless steel for long service life and reliability a touch is sufficient Powerful and Comfortable 6 7

5 Unique Microrocessor Control Pressure Sterilization Chamber Steam Generator UNISTERI HP IL the highest ossible oeration safety, double system of sensors for rocess information collection and assessment and for their continuous comarison and assessment two built-in microrocessor control systems (Master-Slave) for indeendent assessment, control and documentation of oeration cycles any established variation exceeding allowed limits induces an error message unique error rotocol for exact and fast diagnostics of errors the basic rogram equiment includes u to 2 standard rograms easy realization of individual adjustments of rograms ressure chamber, steam-heated via heating shell, made of high quality stainless steel DIN (AISI 316 Ti) and DIN (AISI 316 L) secial method of control of continuous steam filling into the steam sterilizer chamber down bottom of the sterilization chamber for erfect drying sterilization chamber with ground surface with roughness of Ra 1,25 μm (Ra 5 μinch); otional olishing with roughness Ra,8 μm (Ra 32 μinch) or olishing to mirror shine with surface roughness Ra,125 μm (Ra 5 μinch) the steam generator and the heating bodies are made of high quality stainless steel DIN (AISI 316 Ti) high quality insulation Rockwool with AL foil significant reduction of heat losses the water intake function and the steam generator outut are controlled and checked by a two-rocessor control system Master-Slave, with unique construction, with thermal degasification of feeding demi-water, for minimization of non-condensable gases (otional equiment) and with automatic desalting guarantee short times of sterilization cycles and ermanently high steam quality. modular construction system rovides the ossibility of individual device construction simlicity and urosefulness of shaes, high-quality surface of stainless steel lining sheets for erfect cleaning lining sheets fixed to the device frame they rovide silent oeration and rolonged service life of the device ergonomic osition of touch control anel automatic system of door locking and sealing with movable sealing for user-friendly servicing maximally efficient use of inner sterilization sace manual and transort and charging system is a guarantee of simle work of the staff with sterilized material easy ugrade of software equiment the device features may be adjusted to new requirements in the future wide range of otional equiment according to individual needs unlimited number of rograms and their easy changes using chi cards easy and intuitive access for service allows a technician to comfortably set all and any calibrations and configurations and to erform fast diagnostics of the device thanks to high-quality insulation materials Rockwool used (no chlorides), equied with an Al foil, there are reduced the radiated heat losses and requirements towards air-conditioning as a standard, all the sterilization chambers are equied for validation with two easily accessible inlet necks new, unique, horizontally revolving, automatically lockable door fixed in four oints if required, we erform chamber assivation (staining) High Utility Value 8 9

6 Touch Control Panel user friendly, with intuitive control two built-in PLC microrocessor control systems (Master-Slave) with own sensors for indeendent assessment, control and documentation of oeration cycles ergonomic osition of touch control anel touch screen technology 8,4 rovides well-organised and simle servicing on charging side on discharging side of the device (in case of two-door version): LED dislay with ossibility of monitoring of current work hase, ressure in sterilization chamber and time left by the end of the cycle Emergency sto function integrated to the control anel allows for the device to be ut into standby status if needed ossibility of language selection for communication with the device well organised digital dislaying of steam ressure in sterilization chamber shell and in steam generator, ressure and temerature in sterilization chamber (reference bottle) clock an indicator of remaining time of the rogram and real time indicator error rotocol with recording of all and any arameters at the moment of a fault for the ossibility of fast or remote service visual and acoustic signalling of statuses and rocesses chi cards system (otional equiment) ossibility of building-in a rinter for sterilization rocesses documentation (otional equiment) Documentation of Batches It is ossible to arrange well-organized documentation of oeration cycles. Indeendent documentation of oeration cycles with recording of ressure and temerature and with the ossibility of saving 1 recent rotocols in the sterilizer memory (otionally u to dozens of thousands SDHC card) By connection to PC and by saving rotocols in the comuter memory using the Printer Archive software The Audit Trail function allows recording, dislaying and archiving of imortant events. By connection of the sterilizer to comuter network (LAN) together with software alication Ecosoft and DP 3.5 By built-in rinter with the ossibility of selection of one of four grahic outlets. Equiment for a Service The PLC automatics is equied with extensive software for easy control, maintenance and testing (interactive schemes of tube connection, testing rograms allowing testing of safety elements of the device, calibration settings, etc). We offer ON-LINE internet diagnostics and monitoring of the sterilization device, roviding fast and direct communication with engineering and roviding fluent and trouble-free oeration of the construction site. All these features guarantee low oeration costs and long service life of the device. The device allows detailed lanning of service tasks with consequent warning on the dislay or on harmacy statement. 1 11

7 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 UNISTERI h IL 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 EVAKUACE PROPAŘOVÁNÍ EVAKUACE PROPAŘOVÁNÍ 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 EVAKUACE VYTÁPĚNÍ STERILIZACE atmosférický tlak SNIŽOVÁNÍ TLAKU SUŠENÍ ZAVZDUŠNĚNÍ UVOLNĚNÍ 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 Dekontaminace 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 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 12 13

8 Oeration Economy All For Cost Savings You will save with us! Intelligent System of Media and Work Time Saving The low consumtion factor affects the models of the future. More and more demanding legislative requirements utting stress on launching safe roducts in the market and ermanently increasing rice of inut media reresent ressure on sterilization engineering oeration costs increase. That is why it is the hit and advantage of current era to rovide saving and comfortably equied sterilizers they reresent the very new trend in health care industry oerations. oeration, comletely eliminating the necessity of the device connection to a water source. In this way, there are no rice costs on cooling water. The sterilizer in this version is also equied with a cooling aggregate laced in the rear art of the device. The oeration of the device is fully controlled by the automatics of the sterilizer and it requires no staffing. It is sufficient for the steam sterilizer oeration to have electric ower and a source of demi-water for built-in steam generator. Steam generator feeding with demi-water may be arranged by fixed connection to a water treatment lant or in an autonomous way, using a tank with the volume of aroximately 25 litres. The device automatics controls demi-water adding from the tank. Easy Maintenance of Sterilization Chamber incl. Door The construction of the ressure vessel including the door and selection of high-quality of internal surfaces allow erfect, fast and comfortable cleaning of all and any arts of the sterilization sace. Version with Automatic Morning Switch-On Function One of the economic roduct line elements, saving your time. The function of Automatic Morning Switch-On is able to start the device in re-set time and to erform re-heating and Vacuum test without the staff resence. In this way, routine testing rograms can be erformed in a more efficient way. Accessories for documentation and indeendent data storage Use of the new Ecosoft software alication which, together with the connection of the device on the sterilisation work site to the comuter network (LAN), allows the documentation of all sterilisation rocesses and indeendent data storage, reorts rinting on an A4 aer, and connection of a bar code reader. Accessories for energy eaks watching This is a set of software and hardware sterilizer modifications that give the ossibility of a single and mutual regulation of the integrated steam generators oeration to secure the energy eaks watching and communication with the central technical office, or the ossibility to limit the electrical distribution system sizing on the installation lace. Air Detector The Air Detector is a device which monitors and detects continuously the air and/or non-condensable gasses enetration and resence in the sterilisation chamber during each rogramme of acked materials sterilisation. The equiment of the device with this aaratus reresents a higher guarantee of the sterilisation safety than the so far erformed routine checks by testing rogrammes (Vacuum Test and Bowie&Dick Test) done once a day only before the commencement of the common oeration. Version with Autonomous Oeration Steam sterilizer UNISTERI HP IL can be equied with a system for cooling water saving. Its alication leads to water consumtion decrease in aroximately 25%. In case of strict requirements towards low oeration costs of sterilizers in health care institutions, field hositals or regions with otable water absence, the rincile may be insufficient. That is why we offer the version with autonomous Door Mechanism The comfort and safety of staff s work with the device is automatically arranged by a locking mechanism of the door, including sealing. The tworocessor automatic controls the course and multile check of rocesses. The low consumtion factor is rojected into the models of future 14 15

9 UNISTERI HP IL Basic Equiment 13 frame: Stainless steel 12 inner surface of the sterilization chamber ground surface, coarseness Ra 1.25 μm (Ra 5 μinch); ielines and valves transorting the steam to the sterilization chamber and demineralised water to the integrated steam generator are made of stainless steel, valves of brass technology of touch-screen dislay 8.4 ensures transarent and easy oerating on the loading side 1 control anel on the unloading side in the two-door variant LED dislay The Automatic Morning Switchingon function standard batch counter and an additional otional daily batch counter 6 rolling wheels for easy handling during assembly and/or service UNISTERI HP IL Otional Accessories media monitoring continuous checking of inut media arameters (both demineralised and cooling water) energetic Maximum function: Regulation of the device oeration energy eaks watching when more devices are connected to the electric ower mains 5 integrated equiment for condensate aftercooling to reduce the waste water temerature if lastic waste iing is used back-u ower distribution for the device automatics 7 additional mechanical gauges hases of the sterilization cycle (evacuation, vacuum deth, exosure, drying) and setting of the sterilization cycle temerature and time values (verification with the manufacturer required) 14 chi cards system otional electrical connection deending on the requested main arametrs 3-hase socket stainless vat under device according to the ASME, AQSIQ testing and validations according to EN ISO monitoring indicators starting ackage 32 GB memory card to record the sterilization cycles Audit trail system events recording to a memory card (conforms to 21CFR art11) rotary door lock with userfriendly oeration; automatic door closing and sealing system UNISTERI HP IL System for manual loading 2 stainless steel wire insert for shelves and sieves 21 stainless steel wire insert for containers and baskets 22 stainless steel shelf (max. 4 cs) 23 stainless steel sieve (max. 4 cs) 24 dri tank for solutions ut inside the sterilization chamber 25 sterilization basket 1 STU, ½ STU Transort loading system 15 transort cart loading cart 16 container-tye 17 cassette-tye 18 for solutions 19 frame for the loading cart hook for unloading of the loading carts 24 2 Modular System of The Device Arrangement Unique Solution for Your Individual Requirements 1 both one-door and two-door (ass-through) variant 7 stainless-steel face metals of the 3 sterilizer ossibility to built the device into stainless steel artition walls 8 15 mirror variant of the device allowing joining of two service areas into one if more devices are installed side by side 4 2 otional steam source FD Steam from a central source, ED Integrated steam generator 9 (from 7.5 kw) FDED Combined steam suly either from a central source or an integrated steam generator 12 inner surface of the sterilization 18 chamber ground surface, coarseness 13 Ra.8 μm (Ra 32 μinch); on the loading side Ra.125 μm (Ra 5 μinch) on the unloading side chamber assivation (acid cleaning) troical version for countries with only in ground/olished surface high temerature of cooling water 8 stainless steel valves transorting the integrated rinter for the sterilization steam to the sterilization chamber cycle record rinting... and other 9 and demineralised water to the Printer Archive software for batches integrated steam generator documentation in a PC 1 3 control anel on the unloading side software (Euro SDS and DP 3.5) touch screen 8.4 for the ste-rilizer connection to 4 otional language version for a comuter network (LAN) 11 communication with the device flexible PT temerature sensor air Detector for a continuous control in the chamber of air and uncondensable gasses secial rogrammes allow the resence in the sterilization chamber oerator individual adjustments of Thermal degassing of the steam already rogrammed rogrammes thermal degassing of the steam from the sterilizer screen generator for higher oeration (e.g. microbiological laboratories) reliability and sterilization safety secial UNICONFIG software allows the modification of the individual 16 17

10 Client service arrangement In addition to the device sulies, we offer other range of services related to the develoment of central and oerating room sterilizations: counselling and roject drawing including the logistics and caacity calculation; turnkey device deliveries including the individual information systems Service and suort of users are fully arranged by a worldwide network of contractual organisations of the comany BMT Medical Technology s.r.o. We have an extensive network of brand service work sites connected to HOT-LINE service roviding fast resonse to clients questions and requirements. So as to arrange user comfort and fast and highquality service intervention we develoed a secial auto-diagnostic rogram. We offer ON-LINE internet diagnostics and monitoring of the sterilization device (RMS), roviding fast and direct communication with the instrumentation and it arranges fluent and trouble-free oeration of a work site. All these features guarantee low oeration costs and long service life of the device. Validace Validation is one of the conditions for arrangement of sterilization rocess quality. For this urose, the steam sterilizer UNISTERI HP IL is offered with the service Validation, allowing roving of the sterilization rocesses cometence according to the EN ISO standard; the technical measuring is erformed by our own testing laboratory. Environmental awareness The device meets all and any current environmental requirements. It reresents no burden for the work and life environment. A owerful suction um with built-in device for feeding water saving saves aroximately 15% of oeration costs. The unique construction of the steam generator with automatic desalting arranges ermanently high quality of steam. High quality materials guaranteeing long service life of the device are used for its manufacture. Otionally, the device can be equied with an element for additional cooling of waste water, allowing its drainage temerature setting. The device does not roduce any harmful waste. Environment friendly methods are used for its manufacture in the worksho. All the main arts of the device as well as the ackages are recyclable. The device consists of 95% of steel, 4% of other materials, 1% electro material and lastics. Environment-friendly liquidation to be erformed after dismantling by an authorised erson in comliance with EU regulations, corresonding with WEEE directive (Waste Electric and Electronic Equiment). TECHNICAL PARAMETERS UNISTERI HP IL Chamber The values may differ deending on secific charge and media arameters. Changes in the design and make reserved. UNISTERI HP IL Dimension (mm) (height width deth) Internal of the chamber a touch is sufficient External of the unit Number of sterilization modules *** *** Chamber xxx 1 single door Chamber xxx 2 double door. Connecting voltage model 336 and 636 3P/PE 4 V, 5/6 Hz Connecting voltage model 559 3P/N/PE 48 V Noisiness: max. 65 db Chamber volume (l) Total Weight (kg) Cca max. inut (kw) / fuses (A) ED 8,5 / 16 8,5 / / / 25 24,5 / 35 24,5 / 35 FD 1 / 6 1 / 6 2 / 6 2 / 6 2 / 6 2 / 6 Water [m 3 ],6,6,7,7,8,8 Consumtion cca max. er ster. cycle Demineralized water [m 3 ]],3,3,5,5,8,8 Steam [kg] 2,7 2,7 5, 5, 8, 8, El. energy ** [kwh] 3, 3, 5, 5, 8, 8, * FD tye without steam generator,to be connected to external steam distribution ** ED tye with steam generator *** the dimensions are not standardized for the container system El. energy * [kwh],2,2,3,3,4,4 Technology in the man s service easily, economically, safely 18 19

11 For more information see our internet web site Make acquaintance with our further offers... Small steam sterilizers l Steam sterilizers l Laboratory drying devices and incubators l Stainless steel instrumentation Formaldehyde sterilizer 11 l Hot-air sterilizer 4- l Washer Disinfectors Cleaning and disinfection agents BMT Medical Technology s.r.o., Cejl 157/5, Zábrdovice, CZ 62 Brno Tel.: , fax: , mail@bmt.cz, UNISTERI HP IL 4/217 EN/PR Photo T. Benda