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Pharmaceutical Laboratory Cleanroom Use Sterility Testing Aseptic Negative Pressure Isolator1
Air Clean Equipment, Other Air Clean Equipments, Isolator for Pharmaceutical Application, Compounding Aseptic Containment Isolator
Suzhou Pharma Machinery Co., Ltd.
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Product Description Technical characteristicsAutomatic leak detection: inflate the cabin to check if the system remains sealed. If the sealing requirements are met, enter the sterilization process. If the sealing requirements are not met, continue to inflate and seal before leak detectionCycle until the sealing conditions are met. Efficient flash evaporation method: A high-precision constant temperature system ensures zero decomposition of hydrogen peroxide during evaporation, and 100% of hydrogen peroxide forms steam. Quick residue removal: The configured hydrogen peroxide decomposer not only can quickly and thoroughly decompose spatial hydrogen peroxide, but also can decompose surface hydrogen peroxide residues.Sterilization process recording: Automatically detect sterilization concentration and draw sterilization process curves.Door interlock function: The equipment cannot open the doors during operation. Interior surface antibacterial treatment: The interior surface adopts antibacterial treatment, which can achieve sterilization and antibacterial effects, making the interior surface permanently free of microbial habitats.Compliant with computerized verification software: The system has audit tracking, electronic signature, and data integrity functions.Bottom mounted features: The bottom mounted transmission cabin has a compact structure, a small footprint, and is easy to operate.MaterialExternal all 304 stainless steel, internal chamber 316L stainless steelCleanliness levelClass AWind speed0.45m/s ± 20%Leakage rate≤ 0.5% VOL/h (below 100pa)Exhaust volume≥ 300m 3/ HPressure control range100pa~+100paSterilization efficiency6lgVHP residual removal efficiency≤ 1PPMControl methodManual or automaticNoise≤ 68dB (A)illumination≥ 350LUXTechnical feature1.PLC control, color touch screen display, stable and reliable work, intuitive and simple interface;2.With the function of dehumidification, the humidity in the sterilization space can be adjusted and controlled, and theenvironmental requirements for the sterilization space are relatively low;3.Data saving and printing;4.Sterilization parameters memory preservation function, sterilization directly out;5.Low temperature sterilization process at room temperature;6.Weighing function of hydrogen peroxide solution, warning when solution is insufficient;7.Desiccant failure alarm function, prompt the user to replace;8.Less residue, hydrogen peroxide final decomposition products for water vapor and oxygen, no toxic side products;9.Short sterilization time and low operating cost;10.Hydrogen peroxide gas material compatibility, plastic, rubber, electronic products have a good compatibility;11.Broad-spectrum sterilization, the ability to kill thermophilic fat spores is106;12.Suitable for online sterilization in closed space and freeze-drying machine.Installation and debuggingThe equipment is mainly composed of storage compartment, fan, drying oven, heater, carburetor, peristaltic pump, sensor,electrical system and control panel. Please pay attention to the following points before debugging:1.After unpacking, take the equipment out smoothly and place it in a stable room;2.Clean the outside of the equipment and do not flush with water;3.Power on the equipment to ensure that the input voltage is in line with the rated voltage of the equipment;4.After starting up, observe whether the Settings meet the work requirements;5.Open the system for trial operation, observe whether the parameters curve is normal under the working condition, and whether thefan, heater, peristaltic pump and carburetor are working normally;6.Take 35% hydrogen peroxide to the specified amount of solution;7.Connect the device input line.It is suitable for cleaning and disinfection of equipment and instruments in clean area.Model/parameterOverall dimensions(W*D*H)mmOperating cabin size(W*D*H)mmTransmission compartment size(W*D*H)mmPower supplyAir supplyExplainSTI-12001600*880*22501195*680*700 AC220V/3.5KW≥0.6MpaSingle person single cabinSTI-1200/BPB6001600*880*22501195*680*700600*680*700Single person double cabinSTI-1500D/BPB6002100*1200*22501495*1195*700600*680*700Single person, double cabin, double sidedSTI-18002200*880*22501795*680*700 AC220V/5.5KWDouble person single cabinSTI-1800/BPB6002200*880*22501795*680*700600*680*700Double person single cabinSTI-1800/PB6002800*880*22501795*680*700600*680*700Two person, two cabinSTI-1800D/BPB6002200*1200*22501795*1195*700600*680*700Double person, double cabin, double sided Applications1.Pharmaceutical IndustryUsed for sterility testing of drugs and drug products.Ensures the quality and safety of pharmaceutical preparations2.Biotechnology ResearchIdeal for testing the sterility of biological samples, cell cultures, and biopharmaceuticals.Facilitates research and development in the field of biotechnology.3.Medical Device ManufacturingVerifies the sterility of medical devices before they are released to the market.Helps meet regulatory requirements and ensure patient safety.
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