The open Restricted Access Barrier System is designed to physically separate products and processes from the production environment to ensure full product and operator protection. Depending on the individual production and filling facility, an oRABS may be the right solution to separate and protect aseptic production in a Class B environment. Designed according to GMP guidelines, SKANs RABS meet the highest hygiene standards in terms of cleaning, design and accessibility. Due to their modularity, the predefined components of oRABS can be easily and precisely adapted to any production-specific individual requirements.

  • The features of RABS in detail
    • Creates a physical and reliable barrier between process and operator.
    • The system is designed with smooth surfaces with no cracks or edges for excellent cleanability.
    • Integrates HEPA-filtered, unidirectional airflow for aseptic production conditions.
    • The system is cGMP Class A (ISO 5) cleanroom certified in a Class B (ISO 7) environment.
  • RABS – Safety for the entire process

    Restricted Access Barrier Systems are used in typical cleanrooms to avoid direct contact with aseptic production and to increase safety. This procedure is in some processes required by cGMP regulations and serves the safety of the process and the operator.

    To ensure this, SKAN uses the latest air filter technology. The supply air is extracted from the surrounding room and returned to it. The cleanroom takes over the preparation and circulation of the air required by the oRABS.

    The oRABS is designed as a single-wall system with unidirectional airflow above the production chamber, protecting the entire underlying process.

  • Fully integrated solutions for every process

    The Restricted Access Barrier Systems are designed according to GMP guidelines and manufactured in Switzerland. SKAN uses predefined designs for the RABS components, such as HEPA filter modules, doors, walls, as well as their electrical controls and door interlocks. These components can be individually adapted and used for any process. All control, monitoring, and data collection is handled by the machine installed below or the adjacent isolator. This makes the RABS fully integrated into the facility and the process.

  • The distinctive safety features of the RABS

    The oRABS are designed to ensure aseptic processes, transfers and filling in a clean and safe environment. The design of Class A (ISO 5) laminar flow within a Class B (ISO 7) environment ensures full process and product protection. Additional product safety in case of leakage is achieved by a negative pressure filter plenum. In addition, the flow-optimized barrier design with integrated glove opening system minimizes the risk of all manual process interventions for the operator. Interlocked and access-controlled doors can also be integrated with the audit trail monitoring system.

  • Scope of SKANs RABS

    Open Restricted Access Barrier Systems are suitable to use in Class B cleanrooms (ISO 7) to avoid direct contact with aseptic production and significantly increase safety for the process and the operator. In some cases, aseptic processes require the inclusion of RABS to comply with cGMP regulations.

  • Options and accessories
    • Rapid transfer port for solids (RTP)
    • Rapid transfer port for liquids (AT-Port™)
    • Glove testing devices with position control function
    • cRABS with pneumatically sealed glass doors inclusive monitoring
    • Conditioning of cRABS for special application
    • Mechanical installation and integration at the machine supplier or at the end-user

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