Restricted Access Barrier Systems

At ISOFLOW, our Restricted Access Barrier Systems (RABS) provide an advanced solution for pharmaceutical manufacturing, offering a controlled environment that meets the highest standards of sterility and safety. Designed to comply with cGMP, EU GMP Grade A, and FDA requirements, our RABS ensure product integrity and operator protection for critical processes. Discover how ISOFLOW’s innovative RABS technology can elevate your facility’s performance.

RABS: Engineered for Contamination Control

ISOFLOW’s RABS are meticulously designed to create a sterile, restricted-access environment, ideal for aseptic processing and other sensitive pharmaceutical applications. Featuring a robust set of specifications, our systems deliver precision and reliability:

  • 14x HEPA Filter Units (2’ x 4’): Equipped with motorized fans providing vertical unidirectional airflow at 90 feet per minute at 12 inches, meeting ISO 5 (EU GMP Grade A) standards. Ports allow for integrity testing to ensure consistent performance.
  • Air Quality Excellence: Achieves ISO 4.8 (EU Grade A) with an air velocity of 0.45 m/s ±10%, maintaining a positive pressure of 25 Pa ±5 Pa within the chamber.
  • Durable Construction: Doors feature 3/8″ thick laminated/tempered glass windows, ready for glove port installation, with position switches, automatic interlocking, and stoppers for a 90-degree maximum opening.
  • Advanced Filtration: Open RABS louvers allow air to exit into the room, ensuring proper circulation and containment.
Our RABS are equipped with Alpha-Beta doors (8″ on left and right sides) for secure material transfer, enhancing workflow efficiency while maintaining sterility.
 

Intelligent Monitoring and Control

ISOFLOW RABS integrate cutting-edge technology for seamless operation and real-time oversight:
  • Allen-Bradley HMI Touch Screen Interface: Provides comprehensive control, including pressure adjustment, temperature and humidity monitoring, door status (open/close/locking), and alarms for out-of-range readings.
  • Magnetic Gauges: Monitor pressure for each fan filter unit and the chamber, ensuring optimal conditions at all times.
  • Lighting System: A total of 14 lighting sets installed on both sides of the chamber, positioned over each door, with individual and overall on/off switches. Designed to avoid UV radiation, ensuring product safety.

Why ISOFLOW RABS?

  • Regulatory Compliance: Meets IEST, FDA, and EU GMP Grade A standards for aseptic processing.
  • Enhanced Safety: Automatic interlocking doors and positive pressure design minimize contamination risks.
  • Operational Efficiency: Intuitive HMI interface and modular design streamline workflows.
  • Customizable Design: Ready for glove port integration and adaptable to your facility’s needs.
 
ISOFLOW’s Restricted Access Barrier Systems offer a perfect balance of advanced technology and practical functionality, making them an ideal choice for pharmaceutical manufacturers seeking reliable contamination control. Contact us at 1-800-849-3429 to learn how our RABS can support your critical operations.