Restricted Access Barrier System (RABS) in Pharmaceuticals

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Restricted Access Barrier System (RABS) in Pharmaceuticals

📌 Restricted Access Barrier System (RABS) in Pharmaceuticals

A Restricted Access Barrier System (RABS) is an advanced containment and protection technology used in pharmaceutical sterile manufacturing to reduce contamination risks. It provides a physical and aerodynamic barrier between operators and critical aseptic areas without the need for a full isolator system.

🔹 Key Features of RABS:

  • Barrier Protection: Transparent barriers (usually glass or polycarbonate) separate operators from the critical aseptic processing zone.

  • HEPA Filtration: Air supplied through HEPA filters maintains ISO Class 5 (Grade A) conditions inside the barrier.

  • Reduced Human Intervention: Operators access the area only through glove ports or designated openings, minimizing direct exposure.

  • Open or Closed RABS:

    • Open RABS – allow interventions with restricted but possible exposure when panels are opened.

    • Closed RABS – remain closed during operation, providing higher contamination control.

  • Enhanced Sterility Assurance: Compared to traditional cleanrooms, RABS significantly reduces contamination risks but is less stringent than isolators.

🔹 Advantages:

  • Lower risk of microbial contamination.

  • Less costly and more flexible than isolators.

  • Improves operator safety and product quality.

  • Facilitates regulatory compliance for sterile drug manufacturing.

🔹 Applications:

  • Aseptic filling of vials, ampoules, and syringes.

  • Sterile formulation and compounding.

  • Manufacturing of high-value biologics and injectables.

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