• en
FEDEGARI STORE
STORE
en
    Fedegari Training Academy Strengthens Local Support in the U.S.
    12 September 2025
    HOME NEWS  SOLVING SPACE LIMITS WITH THE FOB5

    Solving Space Constraints: Why the FOB5 is the Smart Choice for Modern U.S. Labs

    Sterilization isn’t just another box to check in pharmaceutical and biotech labs, it’s the backbone of patient safety, product integrity, and compliance, which is a central focus at the Fedegari Americas Tech Center. As cleanrooms evolve and expectations tighten, many U.S. manufacturers are rethinking what they need from their sterilization partners.

    Why It Matters for U.S. Labs

    We’ve entered a new era of cleanroom design where every square foot matters. The rise of robotics and automation within cleanrooms, stricter containment requirements, and rapidly shifting regulatory demands are putting new pressure on manufacturers to do more with less. For many U.S. labs, space is now as critical a resource as time or budget. That’s why sterilizers can no longer be treated as bulky, one-dimensional utilities, they need to be compact, flexible, and built with compliance at the core.

    The FOB5: Compact Power for Modern U.S. Labs

    The FOB5 stand-alone steam sterilizer isn’t just another piece of equipment. It’s Fedegari’s response to these new realities: a compact, high-performance sterilizer that scales with evolving needs in today’s space-limited environments. The FOB5’s vertical sliding door minimizes footprint, while built-in safety sensors prevent accidental locking. Its self-contained design houses all key components internally, removing the need for bulky skids and streamlining installation.

    By combining seven decades of precision engineering with features tailored for U.S. regulations, the FOB5 provides a strategic advantage to manufacturers:

    • Accelerate cycle development and reduce time-to-market
    • Maintain compliance with evolving regulatory demands
    • Optimize cleanroom space with self-contained construction
    • Minimize downtime and maintenance through durable materials and smart design
    • Adapt sterilization processes as research, production, or containment needs change

    With modular design options, a wide range of chamber sizes, and both single-door and pass-through configurations, the FOB5 supports applications across pharmaceutical, biotech, food, cosmetics, packaging, and microbiology labs. Typical loads include culture media, glassware, syringes, blood bags, machine parts, and large-volume parenterals.

    Designed for Performance and Compliance

    Every component inside the FOB5 is engineered with quality and purpose:

    • Durable materials: 316L stainless steel for all chamber-contact parts and 304 stainless steel for structural elements, ensuring strength and corrosion resistance.
    • Seamless construction: TIG-welded and precision-polished for contamination control and easier validation.
    • Smart thermal design: The domed door reduces mechanical stress and improves energy efficiency.
    • Sanitary piping and in-line stainless steel filters: Simplify inspections and maintenance.

    This commitment to detail and compliance ensures reliability in environments where failure is not an option.

    Control and Compliance You Can Trust

    At the heart of the FOB5 is Fedegari’s DCS20PLUS process controller. Developed in line with GAMP5 guidelines, it provides full validation, lifecycle documentation, and multi-user customization. Key features include:

    • Support for FDA 21 CFR Part 11 and EN285 compliance
    • Audit-ready data management with end-to-end traceability
    • Remote monitoring via Ethernet and a large, intuitive touchscreen interface
    • Up to 30 customizable cycles

    This gives labs confidence that their sterilization processes are not just reliable, but also regulatory-ready.

    Built for Labs That Can’t Compromise

    From small-scale production to pharmaceutical research, the FOB5 enables applied learning, proof-of-concept testing, and cycle development, all in a system that adapts to diverse loads and environments. Its compatibility with Fedegari’s FGW Glassware Washers further streamlines workflows, ensuring seamless cleaning and sterilization integration.

    This sterilizer offers a strategic advantage in sterility assurance, empowering customers from established pharma leaders to startups. In an era where sterility assurance is non-negotiable, the FOB5 empowers U.S. pharma and biotech innovators to move faster, stay compliant, and operate with greater confidence. For customers, that means fewer compromises, more flexibility, and stronger assurance that products and patients are protected at every step.

    Explore the full FOB5 specifications here and see how its compact design can support your lab’s growth across the U.S. and beyond.

    0English