Pharmaceutical RABS

Custom Restricted Access Barrier Systems

RABS with person ContentMany pharmaceutical applications require localized Restricted Access Barrier Systems within the cleanroom. RABS provide separation between personnel and product. These units offer many flexible options for aseptic processing when a Pharmaceutical Isolator is not required. Germfree designs, engineers and manufactures custom RABS to meet your specific demands

RABS mitigate the risk of contamination to sterile materials, containers, vials or surfaces that may come into contact with the product. This significantly enhances aseptic conditions as compared to conventional cleanroom operations.

Germfree’s RABS are custom manufactured for each biopharmaceutical application. They range in size, process-flow, and requirements for air filtration. While each model may vary, it is critical that the units are built to appropriate guidelines and standards. We also specialize in the integration of components with complex designs.

RABS Provide Critical Aseptic Processing Control

Germfree offers both Closed and Open RABS. A key consideration is the proper engineering of air handling and filtration systems. RABS are ideally suited for handling sterile, non-hazardous products. However, with enhanced containment and SOPS some applications that include materials with limited levels of toxicity can be processed in a properly designed Closed RABS.

Our Closed – Active RABS incorporate onboard unidirectional HEPA filtration that provides ISO 5 air to the critical zone. These units operate within a cleanroom environment with a minimum standard of ISO 7. An integrated entry system or MAL (Material Airlock) allows for aseptic transfer. Interlocking doors are utilized if a rare open-door intervention is required.

Biopharmaceutical applications that involve handling highly potent products, toxic APIs or dangerous pathogens are conducted in Pharmaceutical Containment Isolators.

Multiple-chamber Pharmaceutical RABS

Germfree offers multiple-chamber RABS that can also be combined with isolator lines. This allows you to separate your materials, processes and improve workflow. Filtration systems and airflow controls are configured to prevent cross contamination or provide containment between chambers. This facilitates the handling and transfer of materials between barrier systems and allows sterile products to remain under isolation.

Pharmaceutical RABS – Rigorous Engineering Standards and Features:

Pharmaceutical applications range significantly in their scope and requirements. Germfree has extensive experience in manufacturing custom barrier systems that meet the most stringent fabrication standards.

  • Fast-track design process; 3D modeling
  • 316L all stainless steel construction
  • Radiused corners and seamless surfaces allow for ease of cleaning and decontamination
  • Open and Closed RABS configurations available
  • Filtration systems to meet the specified ISO class and demands of the process
  • Advanced ergonomics for the individualized requirements of your workflow
  • Integrated aseptic material transfer systems
  • Controlled environments for specified set points including temperature and RH
  • Continuous monitoring controls for critical conditions
  • Decontamination/sterilization systems available
  • IQ/OQ; complete documentation and validation package
  • Factory Acceptance Testing
  • Units meet or exceed all cGMP and other relevant standards and guidelines including: ISO classes, USP, GAMP 5 and FDA CFR Title 21 Parts 210 & 211
  • Streamlined Manufacturing ⎯ Germfree Completes your Project Faster

    We have a proven track record of delivering advanced products. Our leading-edge fabrication technology, engineering team and subject-matter experts are all located on-site, in our US factory. We provide an efficient and collaborative design process and coordinate all logistics. From concept to completion, we deliver advanced solutions in an accelerated timeline.

    Read more about Validation Services offered by Germfree.

    Contact Germfree to discuss your specific application and requirements for Pharmaceutical RABS.

    Germfree also manufactures Pharmaceutical Isolators and Class III Biosafety Cabinets for containing a wide range of potentially hazardous materials.

    We also offer Unidirectional – Laminar Flow Glovebox Isolators (LFGI) and Compounding Aseptic Containment Isolators (CACI).

    Contact Us

    Four Sunshine Blvd
    Ormond Beach, Florida 32174
    +1 386-265-4360