Bridging Facility Limitations with Modular Aseptic Containment
Brownfield pharmaceutical facilities often face constraints when upgrading to current aseptic standards. Restricted Access Barrier Systems (RABS) offer a strategic retrofit solution—delivering sterility assurance, containment, and compliance without full facility reconstruction.
Why RABS Are Ideal for Brownfield Applications
- Lower footprint and HVAC dependency than isolators
- Quick installation in existing classified environments
- Cost-effective versus greenfield or isolator-based rebuilds
Types of RABS
- Passive RABS: Depend on cleanroom air supply and strict operator protocol
- Active RABS: Include HEPA units with unidirectional airflow
Design and Integration Essentials
- Gowning protocols aligned with Annex 1 (for passive systems)
- Interlocked doors and automated airflow controls
- Particle monitoring and VHP compatibility for enhanced containment
- SCADA-integrated alarm and access systems
Validation and Lifecycle Support
- Airflow pattern testing and smoke studies
- Environmental monitoring and risk-based cleaning SOPs
- User training for aseptic techniques and glove manipulation
RABS enable brownfield facilities to achieve aseptic excellence while managing cost, downtime, and infrastructure limitations.
