STERIVAP

STERIVAP^® is designed for the sterilisation of solid, porous, plastic materials and solutions in open bottles.
A high standard of production, up-to-date electronics and quality materials are the standards that STERIVAP^® devices adhere to as a matter of course, recognising the need for an extraordinary level of safety and reliability.

The device complies with all the European standards for steam sterilizers, in particular EN 285+A1. For this purpose, the company BMT Medical Technology s.r.o. obtained certification of the complete quality management system according to the following regulations:

• standard EN ISO 13485 and European regulation MDR 2017/745 for medical devices
• standard EN ISO 9001 for products and together with European regulation No. 2014/68/EU, module H/H 1 for pressure devices
• standard EN ISO 14001, environmental management certificate.
• The accredited Testing Laboratory No. 1325 operates at BMT Medical Technology s.r.o.

• massive pressure sterilization chamber with heated jacket, and are made of high-quality stainless steel, applied materials AISI 316 Ti and AISI 316 L
• gradient bottom of sterilization chamber for perfect drying
• ground inner surface of the sterilization chamber, coarseness Ra 1,25 µm (Ra 50 µinch)
• perfect thermal insulation of sterilization chamber with special insulation layer Rock wool in thickness of 125 mm and outer insulation jacket made of dip galvanized sheet for substantial reduction of heat losses and easy cleaning and maintenance
• all sterilization chambers are as standard, equipped with two easily accessible inlet connections for validation according to EN 285+A1
• stainless steel frame able to be divided making it possible for the sterilizer to pass through a door, minimum of 1 000 mm wide
• motor driven doors of sterilization chamber with spring-loaded mechanism, with double safety door protection (safety strip and clutch)
• integrated steam generator is made with heating elements as a standard of stainless steel
• piping distributions conducting steam into the sterilization chamber are made as a standard of stainless steel, valves are made of brass
• all piping distributions are thermally insulated
• high-performance, noiseless suction pump for higher efficiency and reliability (two-stage for types 636 to 669)
• single, mechanical filter on supply water inlet for protection of the valve and suction pump
• bacteriologic filter for vent of the sterilization chamber (0.1 µm)
• integrated drain – due to dampness elimination in the device space all pipes are led to one common sump
• single and double door (interleaving) type (type 446 – 6618 vertically and type 9612 – 9621 horizontally sliding doors)
• stainless steel cover sheets are reinforced by a frame ensuring an extended working life in comparison with other usual designs
• easy access to the device is ensured by door lockable panels
• reinforced stainless cover sheets for quiet operation

• special divided double chamber jacket of sterilization chamber for better and more accurate course of sterilization chamber with an independent and stable chamber pre-heating lowering consumption of demi-water ca 20%
• integrated device for supply water saving, lowering consumptieon of operating cost by up to 15%
• steam generator with microprocessor automatic control and unique design of steam generator with big capacity and automatic desalination ensures short times of sterilization cycles and permanently high steam quality

• PLC consisting from two built-in microprocessor control systems (Master-Slave) with own sensors for independent evaluation, control and documentation of operational cycles
• ergonomic positioned control panel at eye level, away from thermally exposed zone
• technology of touch-screen display 8.2” ensures transparent and easy operating on the loading side
• on unloading side (in case of two door type) of the device the LED display with a possibility of monitoring of actual working phase and pressure in the sterilization chamber
• “emergency stop” function integrated into the control panel
• built-in printer for documentation of sterilization processes
• system of chip cards
• possibility of language selection for communication with the device
• transparent digital description of steam pressure in the jacket of sterilization chamber and in steam generator, pressure and temperature in sterilization chamber (reference bottle)
• clock – indicator of the remaining time of the program and the real time indicator
• history of protocols – optional memory SD card allows storing of up to tens of thousands protocols
• print of error protocol with the record of all parameters at the moment of defect for a possibility of fast and remote service
• visual and acoustic signalling of states and processes
• standard batch counter and another optional daily batch counter.

As a standard, the device is equipped with the “Preheating program” (134°C/1min)

Standard programs:

• Tools - quick 134°C/ 4 min, with following short drying, for unpacked tools for immediate consequent use
• Universal 134°C/ 7 min, with following short drying
• Universal containers 134°C/ 7 min, with intensive drying
• Packed glass, rubber and plastic products 121°C/ 20 min, with intensive drying

Standard testing programs for routine checks:

• Vacuum test - chamber air tightness test, settlement phase duration 5 min, test duration 10 min
• Bowie & Dick test 134 – steam penetration test, 134°C / 3.5 min

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 PLC automatics is equipped with extensive software for easy control, maintenance and testing (interactive schemes of tube connection, testing programs allowing testing of safety elements of the device, calibration settings, etc).

Together with classic supplies of instrumentation, we offer a complete spectrum of services connected with development of central and chart room sterilizations.

• consultancy and project processing, including logistics and capacity calculations
• instrumentation supply including individual information systems “on turnkey”

Service and support of users are fully arranged by a worldwide network of contractual organisations of the company BMT® Medical Technology s.r.o. We have an extensive network of brand service work sites connected to HOT-LINE service providing fast response to clients´ questions and requirements. So as to arrange user comfort and fast and high-quality service intervention we developed a special auto-diagnostic program. We offer internet diagnostics and monitoring of the sterilization device (RMS), providing fast and direct communication with the instrumentation and it arranges fluent and trouble-free operation of a work site. All these features guarantee low operation costs and long service life of the device.

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).