Glossary
Restricted Access Barrier System (RABS)
A barrier system that separates a Grade A interior from the surrounding cleanroom by rigid walls and integrated gloves.
Source · EU GMP Annex 1 (2022), Glossary, Restricted Access Barrier System
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Rough metal surfaces and an incomplete (b)(4) were observed on the Line (b)(4) Restricted Access Barrier System (RABS) framework in the area above the stopper loading chute.
FDA · FDA Warning Letter · 2025-01-07 -
These poor practices, included but are not limited to: Operators inserting their upper torso into the (b)(4) restricted access barrier system ( (b)(4) RABS) during interventions, breaching the ISO 5 barrier.
FDA · FDA Warning Letter · 2026-08-18 -
You identified your aseptic processing lines as Restricted Access Barrier Systems (RABS).
FDA · FDA Warning Letter · 2022-10-04
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
EU GMP Annex 1 (2022), Glossary, Restricted Access Barrier SystemGRM Regulatory Glossary
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