Japan, like the other constituents of the ICH, has its own well-developed pharmaceutical manufacturing equipment industry, and is capable of supplying all of the equipment and facility infrastructure required for a modern aseptic processing facility. The country has also developed considerable capabilities in electronics, robotics, optics and in-process analysis. Japanese requirements for computer system validation have been pragmatic and objective, and have not prevented pharmaceutical manufacturers from using advanced process control technologies, robotics and machine automation.
[b]Some of the noteworthy aspects of aseptic processing in Japan include:
[COLOR=“blue”]•Automation of component supply feeding systems to reduce repetitive work and contamination risk. The use of automatically guided vehicles for logistics support, process line automation and automatic loading and unloading of lyophilizers is very common in new facilities.
•A high level of direct process monitoring for many production parameters such as throughput, fill volumes and component feed status. Japan has not had to deal with some of the circumstances related to 21 CFR Part 11 regarding validation of computerized process or information technology systems.
•Near paperless manufacturing with detailed operating instructions and all key inputs available on touch screens.
•Extremely high levels of process performance in terms of throughput, efficiency and reliability in all aspects of manufacturing process.
•The common use of video systems to enable direct visual monitoring of aseptic area operations. In addition, advanced facilities monitoring systems capable of measuring all key environmental parameters including airborne particle levels are also provided in a central control room.[/color][/b]