STERIVAP HP IL

STERIVAP^® HP IL is the representative of a new generation of big steam sterilizers meeting without exception the EU technical-legislative rules. The device’s conception is based on the requirements of the European directives No. 2014/35/EU, 2014/30/EU, 2014/68/EU and on the provisions of EN 285+A1 and EN ISO 17665 standards and is also fit to the individual needs of each working places. The pressure chamber and the steam generator are designed and manufactured within the certified quality system according to ISO 9001 and the European directive for pressure device or – in case of an individual request – in compliance with the ASME Code, Section VIII, Division 1 standards (for the USA and Canada) or according to license regulations AQCIQ (for China). The construction of the device meets the GMP and GLP requirements. The device meets the latest health service, laboratories, pharmaceutical, chemical and food industry requirements.

For the purposes of fulfilling the GMP requirements for proving of permanent sterilisation quality in line with device parameters declared by producer (importer), we offer also the service making of Q – installation qualification, OQ – operating qualification and PQ – processing qualification (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 ISO 17665 and customer´s specifications standards are performed with use of our accredited testing laboratory potential.

• unique divided double sterilization chamber jacket for better and more accurate sterilization cycle processing with an independent and stable system of chamber preheating, which reduces the demi-water consumption by approx. 20%
• outer insulating jacket of the sterilising chamber with high quality insulation, which reduces substantially the heat losses, saves the energy
• standard built-in device for saving of water for suction pump, which saves ca 15% of water running costs
• steam generator with the microprocessor automatic, with the unique construction, with the high performance, 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 permanently high steam quality
• function “Automatic morning putting-on“ is other from many economical products, which will save the operating personnel working time; the device will be put on at the predefined time without the operating personnel presence, it will be automatically preheated and makes the vacuum test, and so it is prepared for operation on the start of user working time

• well-arranged, ergonomic placed control panels
• easy intuitive control and service
• modern and ergonomic horizontal chamber positioning
• possibility to use the comfortable transport and charging equipment for all types
• automatic sealing and motoric door movement
• service only from the front and one optional side wall
• possibility of the right and left version for optimal space use
• robust divided stainless-steel skeleton, with possibility of door opening of 1 000 mm
• motoric sterilisation chamber door control with an unique spring mechanism without counterweight, with double security door protection (security bar and coupling)
• simple mechanical filters on the media inputs for the valve and air pump protection
• bacteriologic filter for filling the sterilisation chamber by air (0,1 µm)
• watertight outlet supply – for the reason of humidity elimination in the instrument area are all pipes connected into a common reservoir, insulated from the ambient
• tubular distributions and the valves transporting steam into the sterilisation chamber and demi water into the built-in steam generator are standard made from the stainless steel
• powerful, noiseless air pump for higher efficiency and reliability (two-stage for the 446 to 669 types)

• the highest possible operational safety, double system of process data collection and evaluation and continual comparison and evaluation of these data
• any detected deviation above the permitted value activates the error message
• PLC control consisting from two microprocessor control systems (Master-Slave) for independent evaluation, control and documentation of working cycles
• unlimited number and easy modification of programs by means of chip cards
• unique error protocol for precise and quicker error diagnostics
• up to 20 standard programmes in basic software
• easy individual programme modification
• more than 80 service programs for easy set-up, calibration, diagnostics and service

• 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 perfect drying
• standard surface of the sterilizing chamber– polishing of the chamber internal surface Ra 1,25 μm (Ra 50 μinch); optional polishing with roughness Ra 0,8 μm (Ra 32 μinch) or polishing into the mirror-lustre with surface roughness Ra 0,125 μm (Ra 5 μinch)
• perfect Rockwool thermal insulation with thikness of 125 mm together with the third external insulating jacket
• as a standard, all chambers are provided with two easily accessible input nozzles for validation with the diameter of 25 and 50 mm
• the motor driven door with a spring system without counterweight is provided by two independent safety systems – a contact bar and clutch with an adjustable slip force
• on demand, we make the chamber passivation (pickling)

• 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 non-condensed gases in the steam generator
• the function of water filling and the steam generator power are controlled and monitored by the control system Master-Slave
• for pharmaceutical use, we offer a special equipment instead of standard delivered steam generator

• modern technology of the touch display “touch-screen” 12“ with ergonomically adjustable panel ensures the transparent and easy operation on the charging device side
• on the discharging device side (in case of two-door version) the display “touch-screen“ 5,7“ ensures the transparent and easy operation
• PLC control panels located outside the thermally exposed zone
• PLC consisting from two microprocessor control systems (Master-Slave) with own sensors for independent working cycles evaluation, control and documentation
• “emergency stop“ function integrated into the control panel, enables, in case of need, the device putting into the idle condition
• built in printer for sterilization processes documentation
• possibility of choosing the language for communication with the device
• transparent digital displaying of vapour pressure in the sterili-zation chamber jacket and in the steam generator, of pressure and temperature in the sterilization chamber (reference bottle)
• clock – indication of remaining programme time and indication of real time
• visual and acoustical signalisation of states and processes
• function “Automatic morning putting-on“ enables to put the device on at the predefined time without the operating personnel presence, its automatic preheating and making the vacuum test
• optional accessory for special laboratory applications – choice and start of programme also from the clean side
• „Records history“ – this function allows to choose the required record from the history (last 10 records) and to print it, or to display the pressure and temperature record (either in graphical or numerical form)
• „Errors history“ – this function allows to display the last 50 error messages
• „Additional comments“ – the device allows the operator to add additional comments to the individual programmes and/or cycles (such as the product name, no. of the load, batch no. etc.), t he comments will then be printed 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 optional daily batch counter

The STERIVAP^® HP IL steam sterilizer can be used for sterilization of solid, porous and plastic materials, processing and subsequent sterilization of agars (substrates), sterilization of solutions in open and closed bottles, disinfection of materials, waste decontamination, etc.

The instrument enables the installation of up to the 20 fixed programmes in the basic version, according to the specific customer needs.

• Heating 134°C/ 1 min

Sterilizing programmes with possibility of validation

• Universal 134°C/ 7 min, with following drying
• Universal Containers 134°C/ 7 min, with intensive drying
• Rubber 121°C/ 20 min, with following drying
• Instruments Quickly 134°C/ 4 min, with following short drying, for non packed instruments for immediately following use

Testing programmes

• Bowie&Dick Test – Steam penetration test – 134°C/ 3,5 min
• Vacuum Test – Chamber air tightness test – compensatory phase length is 5 min, test length is 10 min

The installed programmes could be later, anytime, modified by a chip card system directly at the user. On the chip cards, the programmes developed and tested by producer are saved, based on the order up to 20 programs on one chip card).

Special laboratory software

Enables to the operating personnel to make individual modifications of already programmed sterilization programmes.

The user can modify:

• sterilisation temperature ± 3°C from the set values, the upper limit is 135°C
• sterilisation time within 0–600 min
• drying phase length 0–60 min
• number of drying phases within 0–10 phases
• evacuation number within 0–10 phases
• in case of solution programmes, the cooling temperature 70-98°C
• in case of programmes controlled by Fo parameter, the Fo parameter within 0–600

We also offer special UNICONFIG software enabling to modify all values of the sterilisation cycle (evacuation, vacuum depth, exposition, drying) and to set the values of the sterilisation cycle temperature and time.

It is possible to arrange well-organized documentation of operation cycles by:

• independent documentation of operation cycles with recording with the possibility of saving recent protocols for the whole service life of the device
• connection to PC and by saving protocols in the computer memory using the “PrinterArchiv” software
• connection of the sterilizer to computer network (LAN) together with software application Ecosoft
• the electronic process documentation, data archiving and Audit Trail together meet FDA 21 CFR part 11 requirements
• by built-in printer
• possibility of batches export to PDF on the USB flash disc in the A4 format

The user service and support are fully secured by the wide-world net of BMT Medical Technology s.r.o. contract partners. We have a wide net of branded service working places, 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 possibilities of the quick and high-quality service intervention, a special diagnostic programme was developed. This all grants the low operational costs and the long device lifetime.

The device meets all and any current environmental requirements. It represents no burden for the work and life environment. A powerful suction pump with built-in device for feeding water saving saves approximately 15% of operation costs. The unique construction of the steam generator with automatic desalting arranges permanently high quality of steam.

High quality materials guaranteeing long service life of the device are used for its manufacture. Optionally, the device can be equipped with an element for additional cooling of waste water, allowing its temperature setting. The device does not produce any harmful waste. Environment – friendly methods are used for its manufacture in the workshop. All the main parts of the device as well as the packages are recyclable.

The device consists of 95% of steel, 4% of other materials, 1% of electro material and plastics. Environment-friendly liquidation to be performed after dismantling by an authorised person in compliance with EU regulations, corresponding with the WEEE directive (Waste Electric and Electronic Equipment).