ABSTRACT
The global pharmaceutical industry has traditionally been considered a conservative industry slow to adopt technological advances such as computerized systems and automation. However, its conservative nature has not prevented a significant increase in the implementation of newer technologies for aseptic filling. Shibuya Kogyo Co., Ltd. introduced isolators for aseptic manufacturing into the Japanese market in 1994 and as of this writing has installed more than 175 isolators for aseptic processing, containment, and sterility testing in Japan, Asia, and the United States. Japan has become a significant center for the advancement of aseptic processing, and the variety of aseptic production applications for which isolators have been used is comprehensive and includes both large and small volume parenterals, lyophilized products, powder fills, combination products, as well as medical devices. In addition to advanced aseptic processing environments such as isolators, Japanese firms have been aggressive in their adoption of factory automation and robotics. Japanese pharmaceutical manufacturers hold themselves to very high standards regarding both overall product quality and economic performance as measured in yield and production uptime.
