ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Restricted Access Barrier System (RABS)

An advanced aseptic processing system that can be utilized in many applications in a fill-finish area. RABS provides an enclosed environment to reduce the risk of contamination to product, containers, closures, and product contact surfaces compared to the risks associated with conventional cleanroom operations. RABS can operate as “doors closed” for processing with very low risk of contamination similar to isolators, or permit rare “open door interventions” provided appropriate measures are taken.

Restricted Access Barrier System (RABS)

An aseptic processing system that provides an enclosed, but not closed, environment meeting Grade 5 conditions utilizing a rigid-wall enclosure and and air overspill to separate its interior from the surrounding environment.

• RABS, Active

RABS using an integral HEPA-filtered air supply to the critical area and manual high-level disinfection, usually with Sporicidal agents. Gloves and transfer ports are used for manipulation and commodity addition.

• RABS, Passive

RABS wherein the airflow to the critical area is provided by ceiling-mounted HEPA filters extending laterally outside the enclosure, and the bottom of the enclosure is open to provide for air flow through the system. Gloves and transfer ports are used for manipulation and commodity addition.

Publication Source: ISPE Baseline® Guide, Vol. 3: Sterile Product Manufacturing Facilities (Second Edition)

Publication Date: 2011

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