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 an integrated VHP system biodecontaminates exposed interior surfaces to a specified 6-log reduction (equivalent to 99.9999% inactivation), subject to cycle validation, before every campaign. Unidirectional laminar airflow, H14 HEPA filtration and continuous pressure and particle monitoring keep the process in a documented, reproducible state designed to support applicable cGMP requirements, including EU GMP Annex 1; compliance is confirmed for the supplied configuration and its qualification documentation.
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 biodecontamination of exposed interior surfaces — 6-log reduction (99.9999%), subject to cycle validation
- H14 HEPA filtration on supply and exhaust; real-time monitoring of air velocity, temperature, humidity, differential pressure, particle counts and viable airborne contamination
- Automatic chamber leak testing by pressure decay; glove integrity testing for the installed glove assemblies
- Siemens PLC control with electronic signatures and audit trails specified for FDA 21 CFR Part 11
- Custom work-chamber dimensions and glove configuration to suit the filling line
Technical Parameters
| Rated power (filling chamber) | 4 kW | Chamber pressure control range | −80 to 150 Pa |
|---|---|---|---|
| Biodecontamination efficacy | ≥6-log reduction (subject to validation) | Biodecontamination method | Vaporized hydrogen peroxide (VHP) |
| Air velocity | 0.36–0.54 m/s | Chamber cleanliness | Class 100 / Grade A |
| Filling chamber size (L×W×H) | 1900 × 950 × 2400 mm (custom sizes available) | Transfer chamber size (L×W×H) | 700 × 950 × 2400 mm (custom sizes available) |
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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