Restricted Access Barrier System (RABS)
Restricted Access Barrier Systems (RABS) are advanced containment systems used in the pharmaceutical and biotechnology industries to create controlled environment for aseptic processing. These systems are used to provide a physical separation between the sterile environment for the operations and the operator, ensuring product integrity and operator safety.
Key features
- Aseptic processing
- Product protection
- Operator safety
When using Restricted Access Barrier System
RABS are primarily used in the bio-pharmaceutical industry for critical processes requiring aseptic environment, such as for manufacturing of sterile pharmaceutical products (injectable products), filtration of injectables, filling and capping operations, and transfer of sterile materials.
RABS are designed to provide a high level of sterility and protection for both the product and the operator. They are typically used in situations where full isolation, as provided by isolators, is not necessary, but when higher level of contamination control is required than that provided by standard laminar air flow hoods or biosafety cabinets.
Applications for RABS
- Bio-pharmaceutical manufacturing in the production of sterile biological products such as injectable products filtration, filling and capping, or transfer of sterile materials (vaccines, monoclonal antibodies, cell therapy products),
- Parenteral drug production such as preparation of injectables, ophthalmic products, and other sterile dosage forms,
- R&D laboratories for new sterile products development and QC laboratories for sterility and quality assessment of pharmaceutical products.
Customized RABS to meet your needs
BECARV has demonstrated its capabilities to customize equipment for the bio-pharmaceutical industry to meet process requirements when high level of contamination control is required such as for sterile operations.
BECARV Restricted Access Barrier Systems (RABS) are constructed with durable materials (stainless steel and glass). They include ‘High-Efficiency Particulate Air’ (HEPA) filtration and ventilation to generate positive partial pressure in the working space, they are equipped with controlled access features guaranteeing sterile environment while protecting operators and ensuring regulatory compliance.
Why choose BECARV RABS?
Safety and reliability
BECARV produces RABS that are robust and reliable. The equipment creates a controlled and sterile environment for aseptic processing operations in the bio-pharmaceutical industry, ensuring product and operator protection.
Modular design and Compliance
BECARV designs and constructs RABS that are customized to meet process requirements and client expectations. BECARV RABS have different configurations to fit a wide range of pharmaceutical operations ensuring the same level of controlled and sterile environment for process quality and product safety.
Frequently asked questions about RABS
What are the differences between a Restricted Access Barrier System (RABS) and an isolator?
RABS provide an ISO 5 environment and an ISO 7 environment in passive and active operation, respectively, for the preparation of sterile compounds with manual disinfection of the working space. The isolator provides complete isolation from the surroundings with an integrated decontamination system and over-pressure in the working area.
What are the benefits of a RABS versus other systems that also control the contamination risks?
RABS provides a controlled interaction with the sterile environment while maintaining product integrity and operator safety. They are typically used in situations where full isolation, as provided by an isolator, is not necessary but where higher levels of contamination control are required than that provided by a laminar air flow hood.