Open RABS for Packaging and Sampling in Pharmaceutical Cleanrooms
Open RABS (Restricted Access Barrier System) is an engineered local barrier protection system designed to create a stable and controlled environment for performing critical pharmaceutical operations. The solution is applied in sampling, packaging, dosing, and weighing areas where strict compliance with GMP requirements for air cleanliness and product protection is mandatory.
The system implements a vertical laminar flow of purified air and acts as a technological barrier between the operator and the product, reducing the risk of cross-contamination and unauthorized interventions.
Open RABS is manufactured from stainless steel AISI 304 and is adapted to the customer’s specific technical requirements. The design includes transparent viewing panels, tempered glass doors, and glove ports that provide safe access to the working area without disrupting the laminar airflow regime.
All system components are optimized for operation in cleanroom environments and designed for intensive industrial use.
Proprietary Software and Automation
The Open RABS system is equipped with proprietary software developed by our engineering team to ensure full real-time control and documentation of equipment operation.
The software platform provides:
- continuous monitoring of laminar airflow velocity;
- monitoring of pressure drops across HEPA filters;
- control of door opening and closing;
- access control to glove ports using safety light curtains;
- recording of all operator interventions in the working area;
- automatic logging of deviations from defined parameters;
- generation of a complete Audit Trail with time stamps and user identification;
- export of events, parameters, and reports to the enterprise server.
System operation is managed via a touchscreen operator panel with a multi-level access rights structure, ensuring strict separation of personnel responsibilities and compliance with GMP and Annex 1 requirements.
Open RABS Components and Functional Modules:
- airflow velocity and differential pressure sensors;
- door and internal partition position monitoring system;
- Audit Trail software module with event logging;
- user role management system with action logging;
- integration into the enterprise digital infrastructure (SCADA / server).