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.

Related sections

EU GMP Annex 1 §§2–10 21 CFR 211.42 21 CFR 211.113

Related terms

Isolator9 casesAseptic Processing1,530 casesCleanroom146 cases

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

  1. 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
  2. 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
  3. You identified your aseptic processing lines as Restricted Access Barrier Systems (RABS).
    FDA · FDA Warning Letter · 2022-10-04
See 3 findings that mention this term

Source

EU GMP Annex 1 (2022), Glossary, Restricted Access Barrier System
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