Professional Barrier Solution for Aseptic Filling of Infusion Products
The RABS system for infusion lines is an engineering-grade solution designed for local isolation of the critical aseptic zone during the production of sterile infusion products. The system minimizes operator intervention in the filling area, ensures stable Grade A conditions, and fully complies with EU GMP Annex 1, ISO 14644, and modern aseptic manufacturing principles.
RABS creates both a physical and aerodynamic barrier between personnel and product, significantly reducing microbiological contamination risks while maintaining technological flexibility of the infusion line.
Design and Integration into Infusion Lines
The RABS system is individually engineered for specific infusion filling lines (bottles, vials, bags), taking into account container infeed, filling, stoppering/capping, and discharge zones.
The frame and functional elements are manufactured from stainless steel AISI 304 / AISI 316L and equipped with transparent panels for continuous visual inspection.
The design includes:
- sealed doors and panels with position monitoring;
- glove ports for performing routine operations without breaching the sterile boundary;
- optimized geometry with minimal gaps and rounded corners to ensure effective cleaning and sanitization.
The system operates in conjunction with vertical Grade A laminar airflow and is installed within Grade B or C cleanrooms.
🧠 Proprietary Software and Control System
A key component of the RABS system is proprietary software developed in-house by our engineering team, specifically for pharmaceutical RABS and aseptic processing applications. The software provides continuous real-time monitoring, control, and documentation of all critical process parameters.
The software platform controls:
- laminar airflow velocity and stability;
- differential pressure across HEPA filters, including contamination and pre-alarm detection;
- opening and closing status of RABS enclosure doors;
- correct operation of interlock and safety logic;
- access to glove ports using safety light curtains to prevent unauthorized intervention;
- all operator and maintenance actions;
- deviations from defined setpoints and operating limits.
All events, interventions, and deviations are automatically recorded with time stamps and user identification.
Audit Trail and Regulatory Compliance
The software generates a comprehensive Audit Trail, including:
- logging of all user actions;
- recording of parameter and setpoint changes;
- documentation of alarms, warnings, and critical events;
- storage of acknowledgements and operator responses.
Data are protected against unauthorized modification and can be visualized, filtered, and exported for:
- equipment validation;
- deviation investigations;
- regulatory inspections and audits.
The system is designed in accordance with GMP, EU GMP Annex 1, and data integrity principles, and can be adapted to customer-specific SOPs and IT environments (SCADA, MES, archiving servers).
✅ Key Advantages of RABS for Infusion Lines:
- local isolation of the critical aseptic zone without full process enclosure;
- significant reduction of microbiological contamination risks;
- stable Grade A conditions during infusion filling;
- safe execution of operations via glove ports;
- full traceability of personnel actions and process parameters;
- validation-ready and audit-ready design;
- custom adaptation to specific infusion line configurations.
📩 Contact us to receive technical consultation, a 3D concept, and a RABS solution for infusion lines with integrated proprietary software and full Audit Trail functionality.