Rethinking Sterilization: The FOB5 Sets a New Benchmark for Pharma and Biotech Labs
In pharmaceutical and biotechnological manufacturing, sterilization is more than a process—it’s a critical safeguard for patient safety, product integrity, and regulatory compliance. As cleanrooms evolve and compliance expectations intensify, Fedegari’s FOB5 emerges as a compact, high-performance steam sterilizer designed for the next generation of manufacturing environments.
Precision Engineering Meets Hygienic Design
The FOB5 reflects Fedegari’s seven decades of engineering expertise, rooted in Italian craftsmanship and tailored for U.S. regulatory requirements. All chamber-contact components are made from high-grade 316L stainless steel for superior corrosion resistance and durability under extreme conditions. Structural parts use 304 stainless steel, ensuring long-term mechanical strength.
Every weld is executed with TIG technology and precision-polished for seamless surfaces—minimizing contamination risk and streamlining validation. This meticulous attention to detail blends pharmaceutical precision with artisanal manufacturing quality.
Space-Efficient, User-Focused Innovation
Modern cleanrooms demand compact, intelligent solutions. The FOB5’s vertical sliding door optimizes footprint while integrated safety sensors prevent accidental locking if obstructions are detected. An innovative domed door design improves thermal efficiency, reduces mechanical stress, and lowers maintenance needs—eliminating the constant manual adjustments common in conventional systems.
Its self-contained footprint integrates all essential components internally, removing the need for bulky external skids and simplifying installation.
Performance Without Compromise
The FOB5’s cylindrical chamber delivers uniform steam distribution and precise pressure control, ensuring consistent results across diverse load types. Sanitary piping, valves, and in-line stainless steel filters support easy inspection and maintenance, while seven model sizes (325–700 liters) and both single-door and pass-through configurations meet varied lab and production requirements.
For high-containment environments, optional decontamination cycles safeguard operators and the environment. High-temperature capability—up to 152°C (305°F)—handles even the most resistant contaminants with confidence.
Compliance-Driven Control
Powered by Fedegari’s DCS20PLUS controller, developed in accordance with GAMP5 and validated for GMP environments, the FOB5 ensures end-to-end traceability. It supports FDA 21 CFR Part 11 and EN285 compliance, offering built-in lifecycle documentation and audit-ready data management—streamlining qualification and regulatory readiness.
A Legacy of Trust and Innovation
Since 1953, Fedegari Group has partnered with leading pharmaceutical manufacturers worldwide, delivering reliable, compliant process solutions where failure is not an option. With the FOB5, the company extends this legacy to smaller-scale production, QC, and R&D environments—offering U.S. pharma and biotech innovators the perfect blend of Italian engineering excellence and American compliance focus.
Conclusion: A Strategic Advantage in Sterility Assurance
In an era where sterility assurance is non-negotiable, the FOB5 redefines what’s possible in a compact sterilizer. By uniting advanced materials, intelligent design, and regulatory foresight, it empowers manufacturers to meet today’s challenges—and tomorrow’s—with uncompromising confidence.
For companies seeking more than just equipment, the FOB5 is a strategic asset—purpose-built to set a new industry standard.