Restricted Access Barrier System (RABS) for Ampoule Filling and Sealing Lines
The RABS system for ampoule filling and sealing lines is a specialized barrier solution intended to minimize operator intervention in the critical aseptic zone. The system creates a controlled barrier between personnel and product, significantly reducing contamination risk while maintaining technological flexibility of the line.
The frame and functional components are manufactured from stainless steel AISI 304 or AISI 316L and complemented with transparent panels for visual inspection. Integrated glove ports allow routine operations, format changeovers, and maintenance without compromising the sterile boundary. The design is engineered according to the specific layout of the ampoule filling and sealing line, including feeding, filling, sealing, and discharge areas.
The RABS system operates in conjunction with Grade A laminar airflow and is intended for installation in Grade B or C cleanrooms. Optimized geometry, minimal gaps, rounded corners, and high surface finish quality ensure effective cleaning, sanitization, and convenient visual control.
🧠 Proprietary Software and Control System
The RABS system can be equipped with proprietary software developed by our engineering team for comprehensive real-time monitoring and control of aseptic process parameters.
The software platform provides:
- continuous monitoring of laminar airflow velocity and direction;
- differential pressure monitoring across HEPA filters with deviation logging;
- control of opening and closing of RABS enclosure doors;
- management and monitoring of access to glove ports;
- integration of safety light curtains preventing unauthorized operator intervention;
- recording of all personnel actions, interventions, and service operations.
All parameters are recorded with the generation of a complete audit trail. The software supports data storage, visualization, and export for validation, deviation investigations, and regulatory audits. The system is designed in accordance with data integrity principles and can be adapted to the customer’s internal SOPs.
🔧 Technical Specifications:
- System type: Restricted Access Barrier System (RABS)
- Application: ampoule filling and sealing lines
- Construction material: stainless steel AISI 304 / AISI 316L
- Transparent panels: tempered glass or polycarbonate (project-specific)
- Operator access: glove ports
- Integration: existing and new ampoule lines
- Cleanliness class of working zone: Grade A (with laminar airflow)
- Installation environment: Grade B / C cleanrooms
- Design: customized, project-specific
- Compliance: GMP, EU GMP Annex 1, ISO 14644
✅ Key Advantages:
- Significant reduction of microbiological contamination risk
- Restricted access to the critical zone without full process isolation
- Compatibility with existing ampoule filling and sealing lines
- Safe execution of operations via glove ports
- Simplified cleaning and enhanced visual inspection
- Compliance with current EU GMP Annex 1 requirements
- Flexible adaptation to ampoule formats and equipment layout
📩 Contact us to receive professional consultation, a 3D concept, and a technical RABS solution optimally tailored to your ampoule filling and sealing line.