Application scope: It meets the requirements of aseptic test in the appendix of Chinese pharmacopoeia 2015, and is applicable to aseptic test of aseptic preparations, aseptic raw materials, aseptic medical devices and other aseptic products (including direct inoculation and membrane filtration). Performance features: 1. The cabin material is 8mm thick, highly transparent polyvinyl chloride, with good transparency and sufficient mechanical strength, which can fully see any situation in the cabin outside the cabin. 2. Air filter and air inlet and outlet mechanism: it is mainly composed of low-noise fan, static pressure chamber, H14 efficiency filter, electric butterfly valve and pipe, to ensure that microorganisms and particulates out of the cabin will not be brought into the isolator during the air communication process inside and outside the isolator. 3. Automatic control of the isolator through programmable controller (PLC) to ensure that there is a certain positive pressure on the environment inside the cabin so as to avoid air reversing. 4. Integrated vaporization hydrogen peroxide generator to realize PLC integrated control of the main engine of the isolator, automatic sterilization and automatic pressure keeping operation. 5. It can be integrated and installed with bacteria collector, compatible with mainstream brand bacteria collector at home and abroad, and can also be used with customer designated brand bacteria collector according to special requirements. 6. All units are designed with modularization, which can be freely combined into different configurations and specifications according to the requirements of customer's inspection category and quantity, and can achieve the same satisfactory performance. 7. Equipped with remote control function and remote assistance system fault diagnosis and system upgrade function to facilitate customer maintenance and repair. 8. Compliance with the requirements for sterility test in the appendix of GMP 2010 and Chinese pharmacopoeia 2015. Basic parameters: Power supply: AC 220 + / 22/50Hz single-phase power supply Power: 1500W (including integrated hydrogen peroxide generator plus 2500W) Touch screen: Siemens 7-inch color touch screen Compressed air source: clean compressed air or nitrogen, air source pressure 0.3-0.6mpa Air flow mode: vertical laminar flow with wind speed of 0.36~0.54m/s High efficiency filter: H14 level, filtering efficiency 99.95% Purification level: static A Cabin pressure control range: 0~80Pa Hull tightness: leakage rate per hour is not more than 0.5% Temperature display resolution: 0.1 ℃ Humidity display resolution: 0.1% Pressure display resolution: 0.1Pa Material gate size: Φ500 mm Exhaust duct diameter: Φ75 mm
Application scope: It meets the requirements of aseptic test in the appendix of Chinese pharmacopoeia 2015, and is applicable to aseptic test of aseptic preparations, aseptic raw materials, aseptic medical devices and other aseptic products (including direct inoculation and membrane filtration).
