NovaStar, SZ140, Ethylene Oxide Sterilizer, Fully Automatic, 0-80C Temperature Control, Automatic Humidity Control
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Description
Standards And Validation
Ce standard ethylene oxide sterilizers are designed, manufactured, and validated in accordance with the following standards: manufacturing standard: european standard en1422 “ethylene oxide sterilizer”.
Validation standard: international standard iso11135-2014 “requirements for the development, validation and routine control of medical device sterilization processes”.
Sterilizer Composition
By three major components: sterilizer box, auxiliary equipment (vacuum system, heating water tank and heat circulation system, humidification system, plus eo system, gas replacement and circulation system, pneumatic system and exhaust gas processor), control system (electronic control cabinet, computer system).
Main Performance Parameters
Sterilization chamber temperature control: quantity: two temperature sensors are installed on the box body, one for monitoring and one for effect, and there is an independent ultra-high temperature alarm device; it can be set arbitrarily between 0~80℃ according to the requirements of sterilization.
Working pressure: the box is fitted with two pressure sensors, one for monitoring and one for validation, and an independent over pressure alarm device.
Automatic humidity control: there are 2 humidity sensors mounted on the box, one for monitoring and one for validation. Humidity controlled humidification or pressure controlled humidification can be selected. Humidity control humidification is generally set between 30 ~ 70% rh, can be set arbitrarily between 0 ~ 100% rh, automatically for control. Pressure control humidification can rely on the amount of pressure change control humidification, can automatically shield the humidity value.
Automatic control eo input temperature, input quantity: preset eo gasification temperature (45℃-50℃). Weight-controlled input eo volume or pressure-controlled input eo volume is available.
Pre-vacuum: -85kpa. It can be done in pulses and can be done continuously.
Warm-up/parsing (times displacement): introduce filtered air or inert gas to atmospheric pressure, then evacuate the sterilization chamber and repeat several times alternately.
Warm-up/parsing (time displacement): a continuous flow of filtered air through the sterilization chamber is used to remove ethylene oxide gas.
Maximum power of electric heating: 4 x 9kw.
Power supply: three-phase, five-wire (prc) 480v 60hz 48kw.
Computerized fully automatic control, manual control two operation modes: human-computer interface, fully automatic control of the sterilization process, automatic alarms and automatic safety alerts.
The whole process is fully automatically controlled by an industrial control computer.
Main Technical Parameters
Electricity: sterilizer working voltage three-phase five-wire 480v, frequency 60 hz.
Temperature: sterilization chamber temperature detection and control, sterilization chamber eo gas inlet temperature detection and control, vaporizer temperature detection and control, circulating hot water temperature detection and control. Two temperature detection points in the sterilization chamber, one of which is the control point and the other one that monitors the control point and acts as an independent sensor for the ultra-high temperature protection device. A pt100 temperature transmitter is used. Measuring range 0 to 100 degrees. Temperature control accuracy: ±0.1 degrees. The temperature in the sterilization chamber is controlled at <60 degrees when empty. No-load temperature uniformity error: <±3 degrees.
Humidity level: direct humidity sensors. Measuring range: 0% to 100% rh. Humidity sensor can not participate in the control of humidity, clean steam injected into the humidity regulation, by the differential pressure method to control the dynamic humidification or static humidification. Sterilization humidity range of 40% ~ 70% rh or so is more appropriate. Suggestion: due to the principle problem of the direct humidity sensor, the normal life of the humidity sensor is about 10 months. In order to prolong the life, it is suggested that the demand side should reserve 2 humidity sensors at the same time of using 1 humidity sensor, and rotate the use of the humidity sensor every 3 months, which can improve the accuracy of the humidity detection.
Pressure: two pressure transmitters, one of which is the control point and the other one monitors the control point and serves as a sensor for an independent overpressure protection device. Measuring range -100kpa~+150kpa. Sterilizer pressure operating range -90kpa~+80kpa.
Ethylene oxide injection volume: injection volume according to the demand side process standards, can choose to control the dosage by differential pressure method or weight method.
Sterilization time: automatic control, according to the demand side process standards.
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