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RABS

Restricted Access Barrier System (RABS)

Effective barrier for your aseptic processes

Application type
Aseptic
Customization level
Customized
RABS at a glance

Modular RABS for controlled processes in cleanroom environments

  • ISO 5 work environment

    Unidirectional HEPA airflow for ISO 5 conditions in the process area

  • Controlled barrier

    Physical separation of personnel and product reduces contamination risks

  • Modular, retrofit-ready design

    Standardized components allow flexible adaptation and retrofitting of existing systems

  • GMP-compliant construction

    Robust stainless-steel design with hygienic-friendly surfaces

Application

Safe barrier between process and human

  • For aseptic production

    RABS are used in filling lines within ISO 7 environments and create ISO 5 conditions in the process area. They enable sterile production with controlled interventions and support validated reproducible workflows.

  • For retrofitting of existing systems

    Thanks to their modular design, existing lines can be retrofitted with RABS. Barrier function is improved without the need to rebuild the entire system, ensuring compliance with regulatory requirements.

Process

Structured process with controlled airflow and documented interventions

  • 1

    Planning and design

    Before installation, the layout, material flow, and cleanroom environment are defined. Digital planning models support alignment with operator requirements.

  • 2

    Transfer process

    RABS can be integrated with material transfer systems such as Rapid Transfer Ports (RTPs), enabling a controlled transfer process of materials.

  • 3

    Installation in the cleanroom

    Assembly takes place in a suitable cleanroom environment. The system is positioned so that a unidirectional HEPA-filtered airflow provides ISO 5 conditions in the process area.

  • 4

    Operation and airflow management

    Depending on the type, the system operates with an active or passive air supply. Manual interventions are performed through defined openings under controlled conditions. All interventions are documented to ensure traceability and process safety.

  • 5

    Cleaning and maintenance

    Cleaning is performed according to a defined wet-and-wipe procedure. Regular maintenance and filter integrity checks support long-term operational reliability.

Product highlights

Safe aseptic processes

  • Physical barrier function

    The system separates personnel and product through fixed barriers and defined access points. This minimizes direct interventions in the critical process area and supports contamination control.

  • Controlled airflow

    Unidirectional HEPA-filtered airflow creates defined cleanroom conditions in the workspace. Continuous monitoring can be applied to ensure stable process parameters.

  • Integration and monitoring

    RABS can be combined with control and monitoring solutions. Door monitoring, airflow parameter control, and documented interventions support regulatory compliance and process safety.

Regulatory requirements

The compliant alternative to open cleanrooms

  • GMP-oriented design

    RABS are designed for use in regulated production environments and support compliance with international GMP requirements. Design and documentation are aligned with validation and inspection readiness.

  • Cleanroom environment

    The process area meets ISO 5 conditions, typically within an ISO 7 environment. Controlled airflow reduces contamination risk compared to open cleanroom concepts.

  • Product protection and containment

    Closed or protected configurations support the handling of sensitive products. Airflow and barrier design are intended to minimize particle backflow and ensure stable process conditions.

Technical specifications

  • Surrounding cleanroom

    Grade B (ISO 7)

  • Process area

    Grade A (ISO 5)

  • HEPA filter

    H14 filters with DEHS-testing

  • Secure cleanroom environments

    Negative pressure filter plenums

  • Air velocity

    0,45 m/s ± 20% (reduced: 0,2 m/s)

  • Solids

    RTP system

  • Liquid transfer

    AT-Port

  • Automation system

    Siemens PLC / Sub -PLC ET200

  • Optional audit trail

    For full traceability

FAQs

  • RABS are based on physical barriers and controlled airflow but allow limited manual interventions. Isolators are fully enclosed systems with a higher level of separation. Both concepts support contamination control but differ in their degree of containment.

  • Yes. Thanks to their modular design, existing systems can be upgraded to optimize barrier performance and meet regulatory requirements.

  • Through unidirectional HEPA-filtered airflow and regular filter integrity testing. This combination supports stable cleanroom conditions within the working area.

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