Application range: Sampling with high biological activity of sterile products, products and packaging, weighing needs aseptic operation process; equipped with built-in set of equipment can also be used in the sterility test of bacteria products and positive bacteria control checks. With Chinese < >2015 edition Pharmacopoeia appendix sterile examination method, suitable for aseptic preparation, sterile APIs, sterility test of sterile medical devices etc. all kinds of sterile products (including direct inoculation method and membrane filtration method). Performance characteristics: The whole stainless steel plate as cabin materials, with a full weld polishing treatment, and then integrated the ventilation filtration system, glove accessories, control system composed of an intelligent isolator. 1, cabin materials for the thickness of 2~3mm316L stainless steel plate overall full welding polishing, internal cabin fillet, the door is 15mm thick white glass, with good transparency and mechanical strength, the gas spring can not influence on the opening angle, the cabin cleaning operation. 2, air filtration and air inlet and outlet mechanism is mainly composed of low noise fan H14 HEPA filter and flow membrane and air (exhaust) filter, electric butterfly valve and pipe, ensure to achieve a dynamic isolator cleanliness standard, at the same time in the air exchange process inside and outside the cabin not outside the cabin of microbial and particulate with the isolator. 3, through the programmable controller (PLC) and inverter of wind turbine automatic control and isolator, ensure the cabin internal to the environment has certain pressure, conventional products produced by 10~40Pa positive pressure, maintain sterile cabin, and when the production operation of high biological activity of drugs such as antitumor drugs, sex hormone drugs) when -40~-10Pa can be used. Negative pressure operation, both to maintain a sterile cabin, ensure products from microbial contamination, and to ensure that the drug does not leak to the cabin body, causing injury to the operator. The import cabin air flows through the H14 level high efficiency filters do not appear because of cabin pressure loss caused by pollution inside of the cabin. 4, the integration of the vaporized hydrogen peroxide generator, to achieve control, PLC integrated isolator host automatic sterilization, automatic pressure operation. 5, the built-in cleaning water and compressed air spray gun interface for cabin cleaning, set aside a multifunctional real-time monitoring interface and interface verification, can carry out the real-time wind speed, dust particle monitoring and detection of planktonic bacteria and verify. 6, all units adopt modular design, can be composed of different configurations and different specifications according to customer process requirements, such as one or both with airlock or RTP system (laminar flow with hydrogen peroxide sterilization) can also be composed of a plurality of isolators according to the requirement of process connection, and set the mutual pressure gradient, different requirements operation function. 7, with the 2010 edition of GMP requirements on the isolator. Basic parameter Power supply: AC 380 + 38/50Hz three phase power supply Power: about 4000W Touch screen: SIEMENS 7 inch color touch screen Compressed air source: clean compressed air or nitrogen gas, air pressure 0.3~0.6MPa Air mode: vertical laminar flow, wind speed 0.36~0.54m/s High efficiency filter: H14 level, filter efficiency 99.95% Purification level: Class A The cabin pressure control range: -80~80Pa Hull tightness: Hourly leak rate is less than 0.5% Temperature display resolution: 0.1 Humidity display resolution: 0.1% Pressure display resolution: 0.1Pa Exhaust pipe diameter: diameter 150mm
Application range: Sampling with high biological activity of sterile products, products and packaging, weighing needs aseptic operation process; equipped with built-in set of equipment can also be used in the sterility test of bacteria products and positive bacteria control checks. With Chinese < >2015 edition Pharmacopoeia appendix sterile examination method, suitable for aseptic preparation, sterile APIs, sterility test of sterile medical devices etc. all kinds of sterile products (including direct inoculation method and membrane filtration method).
