RABS: Restricted Access Barrier System or Isolator
We support you in the study and design of RABS barrier technologies for the compliance upgrade of your production tools.
Annex 1 of the Good Manufacturing Practices (EU GMP) sets out the rules for the manufacture of sterile medicinal products. After several years of consultation and revisions, a new version was officially published in August 2022. It imposes stricter requirements to minimise the risks of microbial, particulate and pyrogen contamination using RABS or isolators. This update will naturally trigger many changes for sterile medicine manufacturers. AVN puts all its experience at your disposal to enable a fast and effective compliance upgrade of your production tools. AVN combines every mechanical and automation skill within its engineering department and carries out manufacturing and assembly in-house. This end-to-end control of the design and production chain is why AVN can respond with confidence to your various needs.
RABS — Technical details of pharmaceutical isolators
The term Barrier Technologies is a generic label that covers RABS and Isolators. Thanks to their design and their tightness, isolators create a controlled aseptic containment space in which critical operations can take place with maximum safety. Contamination risk control is further enhanced through the integration of a decontamination system. RABS are classified into open or closed systems and into passive or active systems. The diagram below graphically highlights the specific features of each system:
To guarantee an ISO 4.8/5 laminar environment, a RABS comprises several equipment items or functionalities:
- Unidirectional airflow (laminar flow)
- Rigid barriers
- Gloves and glove integrity testing
- Sterile material transfer
Our specialist teams take all your challenges into account to propose customised, turnkey solutions tailored to each of these issues. After approval of the 3D design, AVN can validate the ergonomics on a full-scale mock-up (in our workshop or on site).
Advanced functionalities for a smart and compliant RABS
Beyond the physical barrier, a modern RABS integrates digital and safety functionalities to meet the growing requirements of pharmaceutical and regulated environments. At AVN, we deliver systems that are ergonomic, connected and auditable at once.
Control via HMI or Panel PC: ergonomics and centralised control
Our RABS can be controlled through a touch-screen Human-Machine Interface (HMI) or an industrial Panel PC integrated into the equipment. This allows the operator or supervisor to:
- Monitor critical parameters in real time (pressure, airflow, filtration, temperature…)
- Manage start-up, purge and alarm cycles
- Access user-specific operating modes
- Facilitate diagnostics and maintenance (error codes, event log)
💡 Benefit: simple, intuitive and secure control, with the possibility of integration into an existing industrial network (SCADA, MES…).
Interlocking: operator and process safety
We integrate mechanical or electronic interlocking systems to secure accesses and prevent inappropriate openings during a cycle. Typical features:
- Door locking when laminar flow is not operational
- Prevention of simultaneous opening of two airlocks (entry/exit)
- Position sensing of small doors with status feedback to the HMI
💡 Benefit: reduced risk of cross-contamination and secured aseptic process without compromising ergonomics.
Traceability and 21 CFR Part 11 compliance: guaranteed auditability
Our solutions are compatible with electronic traceability requirements, for pharmaceutical environments subject to 21 CFR Part 11 (FDA) and Good Manufacturing Practices (GMP/cGMP). You benefit from a full audit trail (time-stamped recording of user actions, parameter changes, openings, alarms…), user profile management with authentication and hierarchical access rights, electronic signature to validate critical actions, and data export in compatible formats (CSV, PDF, XML…).
💡 Benefit: full documentary and regulatory compliance, easing quality inspections (ANSM, EMA, FDA…).
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