R.A.B.S. Systems

Restricted Access Barrier Systems for Grade A Aseptic Processing

Ravona’s R.A.B.S. (Restricted Access Barrier Systems) provide a controlled Grade A (ISO 5) environment using physical separation and optional laminar airflow to reduce contamination risks. Available in active or passive, open or closed designs, Ravona R.A.B.S. offer flexible solutions for aseptic fill-finish, testing, and integrated production.

Key Features and Benefits

  • Active or Passive Operation

    • Active R.A.B.S.: Includes HEPA-filtered fan units to maintain ISO 5 laminar airflow.

    • Passive R.A.B.S.: Relies on cleanroom air supply for contamination control without internal fans.

  • Open or Closed Barrier Options

    • Open R.A.B.S.: Allows operator access through glove ports for manual intervention.

    • Closed R.A.B.S.: Fully sealed barrier with minimal operator interaction, ideal for higher-risk processes.

  • Stainless Steel Construction
    Rigid enclosures with glove ports ensure a robust and sterile operating environment.

  • Environmental Monitoring
    Integrated sensors track airflow, pressure, and particle counts, with real-time alarms and data logging.

  • Custom Integration
    Designed to accommodate filling lines, lyophilizers, robotics, or sampling tools.

  • Regulatory Compliance
    Built to meet cGMP, FDA, ISO, and updated EU Annex 1 standards for aseptic manufacturing.

Technical Specifications

  • Air Classification: ISO 5 / Grade A

  • Pressure Control: Positive pressure (active systems) or passive flow

  • Filtration: HEPA-filtered laminar airflow (active only)

  • Barrier Type: Open or closed configurations with glove ports

  • Monitoring: Environmental sensors with alarm-capable HMI

  • Control System: HMI with SCADA integration and audit trail

  • Construction: GMP-grade stainless steel

  • Customization: Configured per process needs; supports integration with upstream/downstream equipment

Applications

  • Aseptic fill-finish for vials, syringes, and cartridges

  • Sterility testing and quality control sampling

  • Cell and gene therapy processing

  • Containment of low-risk cytotoxic compounds

  • Pilot and clinical-scale aseptic manufacturing

  • Freeze dryer and robotic equipment integration