无菌检查隔离器,通过硬件隔离屏障,可以为无菌检测过程提供一个操作人员可通过手套进行物理操作,但在生物侧有效隔离的检测环境,确保检验结果的真实性。
The aseptic inspection isolator, through a hardware isolation barrier, provides an environment where the operator can physically operate with gloves but effectively isolate the biological side of the sterility test process, ensuring the authenticity of the test results.
隔离器符合GMP要求,采用模块化设计,舱体主要结构为不锈钢和钢化玻璃,硬舱体结构,气流模型为层流或乱流,静态是符合A级标准。采用无菌检查隔离器在减少了洁净室的运行成本,且能确保整体样品表面的消杀完全,并防止交叉污染的一个特为无菌检测用途的气流环境,可有效提高检测工作效率。
The isolator meets the requirements of GMP and adopts modular design. The main structure of the cabinet is stainless steel and toughened glass. The use of aseptic inspection isolators in a airflow environment specially designed for sterility test can effectively improve the testing efficiency by reducing the operating cost of clean rooms, ensuring complete sterilization of the entire sample surface and preventing cross contamination