Introduction: The sterility test isolator is composed of a sterilization experiment cabin, a transfer cabin, and a vaporized hydrogen peroxide sterilizer. The transfer cabin sterilizes samples (with packaging containers), inspection tools, culture media, and buffers. (Use vaporized hydrogen peroxide gas to sterilize the surface microorganisms), and conduct sterility inspection (or microbial limit inspection) after aseptic delivery through RTP into the experimental chamber. The isolator adopts a hard cabin (or soft and strong) body structure, the cabin body is made of 316 stainless steel or non-toxic PVC, and the cabin body is made of 304L stainless steel or non-toxic PVC. The cleanliness of the cabin meets the requirements of GMP A level. The control system can carry out automatic control operation and running detection. The transfer of internal materials is operated through the gloves that the isolator comes with (gloves need to be regularly tested for leaks, pressure decay method). After the sterilization is over, the internal purification is carried out through the high efficiency filter H14 of the inlet and outlet ports, so that the interior of the cabin continuously maintains the A-level laminar flow (or turbulent flow). A bacteria collector is integrated in the experimental cabin for drug sterility inspection and microbial limit inspection. After the inspection is over, the isolator will be transmitted through the outer door. Features: 1. The soft cabin structure composed of transparent PVC film, the top integral closed structure design, integrated control unit, air inlet and outlet system, air filter unit, etc., is more beautiful and easy to clean and maintain; 2. 4 main operation surfaces can be customized, 2 of this operation surface, 4 gloves in the transfer cabin, standard operation port design, optimizing ergonomic operation requirements, and no operation blind spots; 3. The air inlet and outlet ports in the cabin adopt H14 advanced filters and high-performance centrifugal fans imported from Germany. The airflow model in the cabin is engineering turbulence, which can continuously maintain positive pressure; 4. The system reserves an interface valve connected with hydrogen peroxide (VHP), and uses hydrogen peroxide vapor for sterilization inside, which can sterilize the microorganisms in the air and exposed surfaces in the cabin up to 6 logarithmic poles; 5. The system has a multi-functional combined interface, public media and verification/testing interface, etc.; Technical parameter: Metal material: 304 stainless steel, 316L stainless steel; Non-metallic materials: polyvinyl chloride, silica gel; Power supply: AC220V±22V; Frequency: 50Hz±1Hz; Power: ≤2500W; Touch screen: Siemens touch screen/12-inch tablet computer; Control: Siemens PLC; Pressure adjustment range in the cabin: -80~80Pa; The lowest resolution of humidity: 0.1%; The lowest resolution of temperature: 0.1℃; Minimum pressure resolution: 0.1Pa; In-cabin purification level requirements: static level A; Leakage rate: ≤0.5%vol/h; Noise: ≤65Db(A); High efficiency filter: H14 level; Illumination: ≥500LX; Isolator airflow model: turbulence; VHP sterilization cycle time: transfer window: ≤50 minutes, operation cabin: ≤2.5 hours (confirmed according to actual verification).
Introduction: The sterility test isolator is composed of a sterilization experiment cabin, a transfer cabin, and a vaporized hydrogen peroxide sterilizer. The transfer cabin sterilizes samples (with packaging containers), inspection tools, culture media, and buffers. (Use vaporized hydrogen peroxide gas to sterilize the surface microorganisms), and conduct sterility inspection (or microbial limit inspection) after aseptic delivery through RTP into the experimental chamber. The isolator adopts a hard cabin (or soft and strong) body structure, the cabin body is made of 316 stainless steel or non-toxic PVC, and the cabin body is made of 304L stainless steel or non-toxic PVC. The cleanliness of the cabin meets the requirements of GMP A level. The control system can carry out automatic control operation and running detection. The transfer of internal materials is operated through the gloves that the isolator comes with (gloves need to be regularly tested for leaks, pressure decay method). After the sterilization is over, the internal purification is carried out through the high efficiency filter H14 of the inlet and outlet ports, so that the interior of the cabin continuously maintains the A-level laminar flow (or turbulent flow). A bacteria collector is integrated in the experimental cabin for drug sterility inspection and microbial limit inspection. After the inspection is over, the isolator will be transmitted through the outer door.
