Cleanroom restricted-access barrier system OPEN RABS

for the pharmaceutical industry

Overview
Open Restricted Access Barrier Systems (Open RABS) provide a physical aseptic barrier that separates operators from Grade A (ISO 5) critical zones while operating within a Grade B environment, supporting unidirectional airflow and first-air principles in line with EU GMP Annex 1. Open RABS are designed for integration on aseptic fill–finish equipment to reduce direct operator interventions and contamination risk without requiring full isolator infrastructure. They are suitable for many sterile drug applications when designed, qualified and operated with robust procedures.

Highlights

• Regulatory alignment: Supports compliance with EU GMP Annex 1 and FDA expectations by minimising operator exposure to critical zones.
• First-air and airflow control: Maintains unidirectional airflow in the critical area; typically fitted with anemometers or airflow monitoring for continuous verification.
• Modular flexibility: Configurable to multiple machine types and line layouts to meet production and footprint constraints.
• Brownfield compatibility: Simple installation for existing aseptic filling lines when full-room HVAC upgrades are impractical.
• Operational monitoring: Designed to support in-process environmental monitoring (viable and non‑viable particle detection) in the critical zone.
• Cost and energy efficiency: Lower CAPEX and reduced energy use compared with full isolator solutions in many applications.

Applications
Commonly used for aseptic processing of injectables, ophthalmic solutions and other sterile pharmaceuticals where partial operator separation is acceptable. For high-potency or high-biohazard products, closed RABS or isolators are recommended.

Cleaning & Decontamination
Designed to support controlled-access manual disinfection protocols and routine surface cleaning. Where available, integration with cleanroom VPHP (vaporized hydrogen peroxide) cycles can be used for enhanced routine decontamination.

Notes & Limitations
Because the barrier is not fully sealed, Open RABS are less suited for potent compounds or high-biohazard material that require full containment. Appropriate risk assessment should determine whether closed RABS or isolators are required.

Technical specifications

• Maintains Grade A (ISO 5) conditions in the critical zone using unidirectional airflow.
• Operates within a surrounding Grade B environment (design aligned to EU GMP Annex 1).
• Typically equipped for first-air operation with continuous airflow-speed monitoring.
• Cleaning methods: controlled manual disinfection; optional VPHP cleanroom cycle integration.
• Modular design for retrofit to existing aseptic filling lines; suited to brownfield upgrades.
• Not intended for potent/high-biohazard applications where a fully closed isolator is required.
• Supports continuous environmental monitoring (viable and non‑viable particles) in critical areas.
• Lower CAPEX and reduced energy consumption compared with traditional isolators in many use cases.