假阳性的终结者无菌检验隔离器讲解.docxVIP

假阳性的终结者－无菌检查隔离器 -隔离技术在无菌检查中的应用 Abstract:?As the change and update of the China GMP and Pharmacopeia, the requirement of the aseptic process and sterility testing is higher and higher. And the Isolation technology is widely used in pharmaceutical in China. More and more attentions are paid to Sterility Testing Isolator by the pharmaceutical industry. Although the sterility testing has the limitation itself, but it still will be the regulatory required test for release the sterile products. In this paper, the related regulations in the world are introduced. And advantages of apply isolator tech