Glossary
Closed System
A system connected and sealed so that the product is not exposed to the surrounding environment.
Source · EudraLex Volume 4, Annex 1 (2022), §11 Glossary: Closed system
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.
Related sections
Related terms
Real inspection findings
See 1 findings whose text contains this termCounted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
EudraLex Volume 4, Annex 1 (2022), §11 Glossary: Closed systemGRM Regulatory Glossary
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