Glossary
Closed System
A system connected and sealed so that the product is not exposed to the surrounding environment.
Details
A closed system reduces microbial, particulate, and chemical contamination entering from the surrounding environment, but the sterility of every contact surface after connection, and integrity during use, still have to be demonstrated. Inspections cite the risk of opening at connections, during sampling, or during maintenance, and weak evidence from pressure testing or leak monitoring. Look at the system boundary diagram, sterilisation and connection validation, integrity testing, and records of use, opening, and maintenance.
