Open RABS — Open-Type Laminar Barrier System for Pharmaceutical Manufacturing
The Open RABS sampling system is a modern open-type laminar solution designed to protect both the product and the surrounding environment during sampling operations in filling and product preparation areas. The system design ensures a stable vertical unidirectional airflow and the formation of a localized zone with controlled cleanliness parameters.
A key component of the system is proprietary software, developed specifically for pharmaceutical RABS and isolator applications. The software provides continuous monitoring and recording of all critical parameters affecting process quality and aseptic safety.
Software Functions
The real-time control system monitors and analyzes:
- velocity and uniformity of laminar airflow;
- pressure drop across F7 and H14 filters (with contamination and pre-alarm indication);
- air temperature and relative humidity;
- status of doors and service panels (open/closed);
- correct operation of the fan and air dampers;
- access to the working area and glove ports, including intervention monitoring via safety light curtains;
- connection status and operation of external equipment, including dehumidifiers.
All deviations from set parameters are automatically recorded, classified, and displayed to the operator with warning and alarm generation.
Control and Audit
System control is performed via an industrial touchscreen panel with a multi-level user authorization system:
- operator;
- service engineer;
- administrator;
- auditor.
The software supports a full Audit Trail:
- all user actions are logged;
- all changes to setpoints and parameters are recorded;
- all system interventions and deviations from normal operation are documented;
- complete history of alarms, events, and acknowledgements is stored.
The audit log is stored in a secure environment, protected from unauthorized modification, and can be viewed, filtered, and exported to the customer’s corporate systems (MES, SCADA, archiving servers) in accordance with internal SOPs.
The system fully complies with GMP, 21 CFR Part 11, and GAMP 5 requirements and is ready for regulatory inspections.
Flexibility and Integration
Open RABS can be operated:
- as a standalone unit;
- as part of a production or filling line;
- with a connected dehumidifier for stable operation in high-humidity environments.
Each system is individually engineered and manufactured according to a specific technical specification, considering room layout, technological processes, and customer production requirements.
👉 To receive extended technical documentation, software functional diagrams, and integration consulting for Open RABS, please contact the DATAPHARM sales department.