Aseptic Filling Isolator
A fully enclosed Grade A (ISO 5) environment for sterile filling, stoppering and capping of injectables and biologics — removing the single largest source of contamination in aseptic processing: human intervention.
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Overview
The Fenggu Aseptic Filling Isolator provides a fully enclosed Grade A (ISO 5) environment for sterile filling, stoppering and capping of injectables and biologics. By physically separating the operator from the critical zone, it removes the single largest source of contamination in aseptic processing — human intervention — while integrated VHP bio-decontamination delivers a validated, residue-free 6-log reduction before every campaign. Unidirectional laminar airflow, H14 HEPA filtration and continuous pressure and particle monitoring keep the process in a documented, reproducible state that meets cGMP and FDA Annex 1 expectations.
Each isolator is engineered around the customer's filling line, with configurable chamber length, glove-port layout, SUS316L product-contact surfaces and control interface. Turnkey integration with existing filling and lyophilization equipment is available.
Key Features
- Grade A / ISO 5 unidirectional laminar flow over the entire filling zone
- Integrated VHP cycle — dehumidification, conditioning, decontamination, aeration — for 6-log sporicidal decontamination
- H14 HEPA filtration on supply and exhaust; real-time pressure, humidity and particle monitoring
- SUS316L product-contact surfaces, radiused corners, CIP-ready design
- Siemens PLC control with data logging compliant with FDA 21 CFR Part 11
- Positive- or negative-pressure configuration to suit product and containment needs
Applications
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Tell us your filling line, fill volume and containment requirements, and our engineers will recommend a configuration.
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