STERIVAP HP IL

STERIVAP^® HP IL is a representative of a new generation of large steam sterilizers complying with EU technical legislation without exceptions. The concept of the devices is based on the requirements of European directives No. LVD 2014/35 / EU, EMC 2014/30 / EU, RoHS 2011/65 / EU and the provisions of standards EN 285+A1 and EN ISO 17665 and is further adapted to the individual needs of individual workplaces. Both the pressure chamber and the steam generator are designed and manufactured within a certified quality system according to EN ISO 9001 and the European Pressure Equipment Directive PED 2014/68 / EU or on individual request according to ASME Code, Section VIII, Division 1 standards (for USA, Canada, etc. ) or according to AQSIQ licensing regulations (for China), or local requirements of other countries. The design of the device meets, among other things, the requirements of the US FDA cGMP, FDA CFR 21 part 11, GAMP 5 and the requirements of other standards and regulations were applied in the development process, e.g. DIN 58951, DIN 58950, ASME BPE, ANSI \ AAMI - ST 8 and others. The device meets the latest requirements in the pharmaceutical, chemical and food industries and is also very popular in the field of laboratories.

In order to meet the GMP requirements for proving the permanent quality of sterilization in accordance with the device parameters declared by the manufacturer (importer), users of STERIVAP^® HP IL steam sterilizers are supplied with documentation containing optional IQ, OQ, DQ, FS, HDS, SDS, PQ (validation) and others according to specific customer requirements. We offer FAT and SAT tests and acceptances of sterilizers.

• sanitary generator or steam exchanger made of 316Ti/316L with microprocessor automation, with unique design, with high output, with thermal degassing of feed demi-water to minimize non-condensable gases and with automatic desalination ensures short sterilization cycle times and consistently high steam quality
• special two-chamber shell of the sterilization chamber for better and more accurate course of the sterilization cycle with independent and stable preheating of the chamber reducing the consumption of demi-water or steam by approx. 20%
• thermal insulation of the chamber consisting of high-quality mineral wool covered with an outer solid washable insulating shell, which significantly reduces heat losses and saves energy supplied
• standard built-in devices for saving feed water for the pump, saving about 15% of operating costs for water
• the "Automatic morning start" function is another in a series of energy-saving products that will save the operator's working time; the device starts at a preset time without the presence of the operator, automatically preheats and performs a vacuum test, so it is ready for operation at the beginning of the user's working hours
• optional function "Energy maximum" enables mutual regulation of steam sterilizers operation in cases of built-in steam generator in connection with monitoring of energy maximum of electricity consumption of the workplace from the user's technical headquarters, thus saving costs for increased electric power consumption

• 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)

• two built-in microprocessor control PLC systems (Master-Slave) for independent evaluation, control and documentation of work cycles in accordance with the requirements of FDA CFR 21 part 11 and GAMP 5. The sterilizer software is validated with available validation documentation.
• the highest possible operational safety, double system of collection and evaluation of process information and their continuous comparison and evaluation
• any detected deviation greater than allowed will cause an error message
• four levels of access rights:
  -     User
  -     Administrator
  -     Service technician
  -     Developer
• registration of up to 20 individual users with unique rights and responsibilities with an electronic signature in accordance with FDA CFR 21 part 11
• automatic recording of sterilization cycles on the built-in SD card with the possibility of exporting the coded data to external systems ("PrinterArchiv")
• automatic recording of changes (Audit Trail) on the built-in SD card with the possibility of exporting the coded data to external systems ("Audit Reader")
• unique error log for accurate and fast error diagnosis
• up to 20 standard programs in the basic software with the possibility of changes, archiving and expansion of the number of programs using chip cards
• easy implementation of individual program modifications
• more than 80 service programs for easy setup, calibration, diagnostics and service

• robust sterilization chamber and chamber door made of high-quality stainless steel AISI 316L with sanitary tri-clamp necks, heating shell made of AISI 316Ti
• sloping necks and sloping bottom of the sterilization chamber for automatic dewatering and perfect drying
• standard surface of the sterilization chamber - polishing the inner surface of the chamber Ra <1.25 μm (Ra <50 μinch); optional polishing with roughness Ra <0.8 μm (Ra <32 μinch) or mirror polishing with surface roughness Ra <0.125 μm (Ra <5 μinch)
• perfect thermal insulation from mineral wool up to 125 mm thick together with a third outer solid insulation jacket
• all sterilization chambers are equipped with two easily accessible tri-clamp inlet ports with a diameter of 25 and 50 mm as standard for validation
• motor-operated doors with a spring system without counterweights are equipped with two independent safety systems - a touch bar and a clutch with adjustable slip force
• if required, we passivate (pickle) the chamber and fittings in contact with the product

• the built-in steam generator or exchanger is made of high quality stainless steel AISI 316 Ti in sanitary design with tri-clamp necks
• high-quality mineral wool insulation and a strong outer insulation shell significantly reduce heat losses
• thermal degassing of the feed demi-water to minimize the content of non-condensible gases in the steam generator
• water filling function and generator power are controlled and monitored by a two-processor control system Master - Slave
• optional condensate sampling ports and vapour samples condenser for quality control of the steam produced

Instead of the standard built-in steam generator, we offer external independent steam generators and exchangers for pharmaceutical use produced by our subsidiary BMT USA: www.bmtusa.com/pure-clean-steam-generators

• modern 12” touch-screen technology with ergonomically adjustable panel ensures clear and simple operation on the loading side of the device
• 5.7 " touch-screen display on the unloading side (for the two-door version) of the device, providing clear and simple operation with the option of selecting and starting sterilization programs
• PLC control panels located outside the heat exposed zone
• two built-in microprocessor control PLC systems (Master-Slave) with their own sensors for independent evaluation, control and documentation of work cycles
• "emergency button" function integrated in the control panel allows the device to be put to a standstill if necessary
• built-in printer for documentation of sterilization processes
• chip cards system
• option to select the language for communication with the device
• clear digital displaying of steam pressure in the sterilization chamber shell and in the steam generator, pressure and temperature in the sterilization chamber (reference bottle)
• clock - remaining program time indicator and real time indicator
• visual and acoustic signalling of states and processes
• the "Automatic morning switch-on" function allows the device to be started at a preset time without presence of an operator, the device to be preheated automatically and the Vacuum test to be performed
• "Log history" - this function allows you to select the desired log from the history (last 10 logs) and print it or display the pressure and temperature record (in graphical or numerical form), logs are stored directly in the sterilizer memory independently of logs stored on SD card
• "Error history" - this function allows the display of the last 20 error messages on the display, error messages are stored directly in the sterilizer's memory independently of the messages stored in the Audit Trail
• "Additional comment" - the device allows the operator to write an additional comment to individual programs or cycles (e.g. product name, batch number, serial number, etc.), which will be included in the record from the printer
• "Logging" (access rights) - the device allows you to set user rights for using the device - "Free use" and "Individual access rights" mode
• standard batch counter and other optional daily batch counter

Thanks to its versatility, the STERIVAP^® HP IL steam sterilizer can be used to sterilize solid, porous and plastic materials, packaged materials, filters, plugs, hoses, filling equipment components, cages, food, bedding and other materials sterilized in animal treatment units, sterilization of solutions in open and closed bottles, processing and subsequent sterilization of cooking and culture media (agar), suspensions and emulsions, medicament forms, disinfection of materials, decontamination of laboratory waste, etc.

The device allows the installation of up to 20 fixed programs in the basic software according to the specific needs of the customer. The basic software is based on standardized programs used in medical steam sterilizers:

• Heating 134°C/ 1 min

Sterilization, validable programs

• 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 programs

• 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 programs installed in the device can then be modified at any time using the chip card system directly at the device user. New programs developed and tested by the manufacturer on the basis of an order (up to 20 programs on one chip card) are saved on the chip cards.

Laboratory software (change of program parameters)

Allows the operator to make individual adjustments to already programmed sterilization programs.

The user can edit:

• sterilization temperature ± 3 ° C from the set values, the upper limit is 135 ° C
• sterilization time in the range of 0–600 min
• length of drying phase 0–60 min
• number of drying phases in the range of 0-10 phases
• number of evacuations in the range of 0–10 phases
• for solution programs, the cooling temperature, the upper limit is 120 ° C
• for programs controlled by the Fo parameter, the Fo parameter in the range 0–600

We also offer special MOVEX software that allows you to modify all the values of the sterilization cycle (evacuation, vacuum depth, exposure, drying) and set the values of temperature and time of the sterilization cycle. The programs according to specific requirements must be validated at the customer. These values can now also be modified directly from the touch screen.

Clear documentation of work cycles can be provided by:

• independent documentation of work cycles with a record with the possibility of saving the latest logs for the entire service life of the device
• connecting to a PC and saving logs to the computer's memory using the "PrinterArchiv" software
• connecting the sterilizer to a computer network (LAN) together with the Ecosoft software application
• electronic process documentation, data archiving and the Audit Trail together meet the requirements of FDA CFR 21 part 11
• built-in printer
• possibility to exporting the batches to PDF to a USB flash drive in A4 format
• connection to external control and recording devices

The steam sterilizer is designed and manufactured so that it can be easily validated according to international quality standards for the pharmaceutical industry. The basic standard documentation can be supplemented by other documents for the full validability of the steam sterilizer. Most deliveries thus consist of the following documentation:

• Instructions for use
• Service instructions
• Pipe diagrams (P&ID) and technical diagrams
• Dimensional drawing (GA) and installation requirements
• List of materials and components
• Technical data sheets and certificates for critical components
• Calibration certificates
• Documents for pressure vessels
• Declaration of Conformity
• Protocol on the device conformity with the customer's requirements (DQ)
• Functional specification of the device (FS)
• Hardware design specification (HDS)
• Software Design Specification (SDS)
• Protocol on the device compliance with the requirements of the FDA CFR 21 part 11
• Protocol on the device conformity with the requirements of GAMP 5
• Factory Acceptance Protocol (FAT)
• Installation Qualification Protocol (IQ)
• Protocol on Operational Qualification (OQ)
• Protocol on Procedural Qualification (PQ)

In addition to the classic supply of instrumentation, we offer another range of services. User service and support are fully provided by the worldwide network of contract organizations of the company BMT Medical Technology s.r.o. We have an extensive network of branded service workplaces connected to the HOT-LINE service, which ensures a quick response to customer questions and requests. A special self-diagnostic program has been developed to ensure user comfort and the possibility of fast and high-quality service intervention.

We offer ON-LINE internet diagnostics and monitoring of the sterilization device, which provides fast and direct communication with the device technology and ensures smooth, trouble-free operation of the workplace.

Deliveries of spare parts are provided in parallel with the production of final products and are a part of the service management system. All this guarantees low operating costs and a long service life of the device.

Together with the documentation required for the validation of the sterilizer, we are also able to ensure the acceptance of the device at the customer (SAT). Depending on the location, validation is provided either by quality management staff and technicians from the production plant, or by employees of our contracted organizations operating worldwide.

The device meets all current environmental requirements. It does not burden the work and living environment. The outer insulation shell of the sterilization chamber is made of hot-dip galvanized sheet metal or stainless steel AISI 304 with high-quality insulation, which significantly reduces heat loss and saves electricity. Two-stage, quiet pump with standard built-in device for saving feed water, saves approximately 15% of operating costs. The unique design of the steam generator with high power and automatic desalination ensures short sterilization cycle times and consistently high steam quality.

Unique split two-chamber shell with a new system of filling steam into the sterilization chamber, which reduces the consumption of demi-water and steam by about 20%. The steam generator is controlled by microprocessor automation and it is equipped with an automatic sludge removal device as standard. Quality materials are used during production, guaranteeing a long service life of the device. The device can be optionally equipped with a device for after-cooling of waste water, which allows setting its waste temperature.

The device does not produce any harmful waste. Ecological processing methods are also used in its workshop production. All essential parts of the device and the packaging are recyclable. The device consists of 95% of steel, 4% of other materials, 1% of electrical materials and plastics. Ecological disposal is carried out after disassembly by an authorized person in accordance with EU regulations, which comply with the WEEE (Waste Electric and Electronic Equipment) directive.