Product introduction: Hangzhou hotelling biological technology co., LTD. Is devoted to the development of the isolation technique and applied research in pharmaceutical industry, from the QC department of sterile test, biological safety protection, and production with isolator technology (aseptic packing, weighing, ingredients, crushing, sampling, etc.) with RABS, we can provide a variety of isolator for product sterile protection or toxic containment to provide comprehensive technical solutions. The newly introduced QC and r&d laboratory sterile screening isolator is almost suitable for aseptic preparations and aseptic raw materials (API) aseptic testing based on pharmacopoeia statutory methods (membrane filtration and direct inoculation). Performance features: 1. The soft cabin structure composed of transparent PVC film, the overall closed structure design at the top, the integrated control unit, air inlet and outlet system, air filtration unit, etc., is more beautiful, generous and easy to clean and maintain; 2. The system supports two aseptic testing methods specified by pharmacopoeia: membrane filtration and direct inoculation. The pump unit of the bacteria collecting device is directly integrated into the operating platform. 3. The operation cabin and transfer cabin can be used in combination or separately; 4. H14 high-efficiency filter and high-performance centrifugal fan imported from Germany are used at the inlet and outlet ports of the cabin. The air flow mode in the cabin is turbulent, which can maintain positive pressure continuously. 5. System reserved hydrogen peroxide (VHPS ®) sterilizer interface with valve, internal using hydrogen peroxide sterilization steam, to hold the air and the exposed surface can achieve lg6 kill spores effect; 6. The product can be transmitted aseptically through a variety of means, such as docking with the steam-sterilizable delivery bag and the delivery chamber with RTP system; 7. The system adopts Siemens PLC control module and touch-type color display, optimizes the interface design, and the system is fully automatic in operation with the function of out-of-pressure alarm; 8. The system is equipped with multi-functional combination interface, such as 25mm standard health fast interface, public medium (electricity and gas) and verification/detection interface, etc.; 9. The system adopts multi-level user login and has electronic data storage record, export and other functions. The software design meets the requirements of FDA 21CFR Part 11 regulations. Technical parameters: 1. Power supply: AC 220V/50Hz 2. Power: 1500W 3. Touch screen: Siemens 7-inch touch color screen 4. Pressure control range in cabin: 0-80pa 5. Humidity resolution: 0.1% 6. The temperature resolution: 0.1 ℃ 7. Pressure resolution: 0.1Pa 8. Cabin cleaning level: static class A 9. Tightness: the hourly leakage rate is no more than 0.5% 10. Diameter of material door: 500mm 11. Transfer door diameter: 280mm 12. Diameter of exhaust duct: 50mm Application area: Applicable to aseptic preparations and aseptic raw materials (API) aseptic testing based on pharmacopoeia legal methods (membrane filtration and direct inoculation).
Product introduction: Hangzhou hotelling biological technology co., LTD. Is devoted to the development of the isolation technique and applied research in pharmaceutical industry, from the QC department of sterile test, biological safety protection, and production with isolator technology (aseptic packing, weighing, ingredients, crushing, sampling, etc.) with RABS, we can provide a variety of isolator for product sterile protection or toxic containment to provide comprehensive technical solutions. The newly introduced QC and r&d laboratory sterile screening isolator is almost suitable for aseptic preparations and aseptic raw materials (API) aseptic testing based on pharmacopoeia statutory methods (membrane filtration and direct inoculation).
