Product Description
The Fedegari FCTS Sterility Test Isolator is designed for sterility testing of pharmaceutical samples taken from manufactured drug batches. The system provides a controlled ISO 5 (Grade A – EU GMP) environment to support reliable sterility testing while maintaining strict contamination control.
FCTS isolators are suitable for testing a wide range of sterile pharmaceutical products including injectable liquids, ophthalmic ointments, sterile antibiotic powders and freeze-dried drugs.
The isolator integrates Fedegari’s FHPV Hydrogen Peroxide Vaporizer, enabling automated bio-decontamination cycles before operation. Vapour concentration is continuously monitored through H₂O₂ sensors and the Thema4 process controller, maintaining highly stable concentrations (±15 ppm) to ensure consistent and repeatable decontamination performance without the need for proprietary consumables.
Designed to meet the most stringent pharmaceutical regulatory requirements, the FCTS isolator complies with FDA, EMA and WHO guidelines, as well as applicable pharmacopoeia standards.
• Internal stainless steel trolley for transferring materials from pass-box to working chamber
• Modular configuration with selectable pass-box position, chamber layout and glove ports
• Customisable internal racking and storage to suit process requirements
• Working chamber with non-directional BA surface finishing (Ra ≤ 0.4 μm)
• Airtight chamber design with high-integrity door sealing
• EU Directives: 2014/30/EU (EMC), 2014/35/EU (Low Voltage), 2006/95/EC (Machinery Safety)
• European Standards: EN 55011, EN IEC 61000-4-2, EN IEC 61000-4-4, EN IEC 60204-1
• FDA compliant materials for non-metallic components in contact with process fluids
• GMP and GAMP5 guidelines
• 21 CFR Parts 210, 211 and 11
• UL 508A
• NFPA-79
• ASME BPE
FCTS – Sterility Isolator
Reliable, energy efficient and modular isolator engineered for stringent pharmaceutical process environments.