Restricted Access Barrier Systems (RABS)
Products / RABS

What are RABS?
Restricted Access Barrier Systems (RABS) are specially designed equipment used to protect aseptic processes in the pharmaceutical, biotechnology, and healthcare industries. These systems establish a controlled physical barrier between the operator and the sterile environment, combining rigid structures with unidirectional HEPA-filtered airflow. Thanks to this configuration, RABS significantly reduce the risk of contamination and ensure Class A conditions in the critical work area.
Equipment Overview
Litek Pharma’s RABS brings together a suite of features designed for aseptic processing excellence:
Rigid Structure: RABS can feature a robust, enclosed structure equipped with interlocked doors, ensuring a physical barrier that effectively separates aseptic processing operations from operators and external contaminants.
Unidirectional Airflow Systems: RABS integrate HEPA filters, optimizing air quality and filtration efficiency. By employing unidirectional airflow technology, RABS create and maintain a controlled Grade A environment in the critical processing area. This airflow minimizes the risk of cross-contamination, safeguarding the integrity of pharmaceutical products.
Glove Ports for Operational Access: They are equipped with strategically positioned glove ports, allowing operators to access all areas within the structure without compromising the sterile environment. This design feature enhances operator safety and process efficiency.
Internal Particle Contamination Monitoring: RABS can incorporate advanced particle counting equipment for real-time monitoring of internal contamination levels. This contamination control approach enables timely interventions and ensures product integrity throughout the manufacturing process.
Equipment Integration: Litek Pharma’s RABS offer exceptional design flexibility, allowing for the integration of third-party equipment such as lyophilizers, filling machines, autoclaves, mixers, and more. This adaptability ensures that our RABS can be customized to meet diverse processing and client-specific needs.
Basic equipment
- Made of stainless steel AISI 316L, internal polishing Ra<0.8
- Compact ventilation module with HEPA filters for unidirectional airflow
- Hinged tempered glass doors.
- Glove access.
- Integrated electrical panel.
- LED lighting
- Siemens PLC S7 1200
Optional
- Validatable Electronic Data Recording Software, 21 CFR Part 11, GAMP5.
- Viable / and non-viable particle monitoring
- Temperature and humidity monitoring
- SCADA system.
Documentation
- User Manual
- Functional Design Specification (FDS)
- Functional Specification (FS)
- Hardware Design Specification (HDS)
- Software Design Specification (SDS)
- Factory Qualification Test (FQT)
- Factory Acceptance Test (FAT)
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Site Acceptance Test (SAT)
Please do not hesitate to contact us if you require any further information.