Japanese–English glossary
Closed system
クローズドシステムkurōzudo shisutemu
Also written 閉鎖系
A process setup in which the product is not exposed to the room environment, because materials move through sterile tubing, bags and vessels joined by tube welding or sterile connectors. Closing a process reduces contamination risk and can lower the cleanroom grade needed around it, which affects facility cost. A claim that a process is closed needs evidence, such as integrity testing and validated connections. Japanese cell therapy documents link the term closely with automation and single-use equipment.