Class III isolator AFL series

for the pharmaceutical industryasepticdispensing

Product introduction
The Aseptic Filling Isolator is a custom-designed cGMP Class A / ISO 5 isolator system for batch production of injectable pharmaceutical products used in preclinical and clinical studies. It features a three-chamber layout (transfer chamber, filling chamber, capping chamber) and an integrated vaporized hydrogen peroxide (VH2O2) sterilization system capable of sterilizing chambers together or separately. The modular, automated design enhances aseptic preparation efficiency and process traceability.

Features

• Sterility assurance: H14 HEPA filtration for intake and exhaust to maintain ISO 5 air quality in the work zone.
• Energy efficiency: System can be installed in a surrounding Class D environment to reduce facility requirements; low-voltage inverter-controlled fans reduce energy consumption.
• Automated leak testing: Integrated automated leak test per ISO 10648-2; each chamber individually tested, leakage <0.5% volume/hour at 2× working pressure.
• Glove integrity testing: Built-in automated glove integrity tester performing independent tests per ISO 14644-7; detectable breach down to 100 µm diameter.
• Data management & compliance: IPC-based control with multi-level login, audit trail and e-signature; FDA 21 CFR Part 11 capable with real-time recording of filling operations.
• Ergonomics: Operator-oriented layout to maximize productivity and reduce handling errors.
• Maintenance & remote support: Centralized control module for direct maintenance access; supports secure remote access for updates and diagnostics.
• Modular & customizable: Configurable options and add-on modules to match process requirements.

Applications
Designed to isolate and protect critical aseptic filling, stoppering and capping operations, minimising contamination risk during handling of sterile injectable products.

• Aseptic processing
• Vaccine production
• Pharmaceutical R&D and clinical trial manufacturing

Technical specifications

• Air flow: Vertical unidirectional laminar flow
• VH2O2 leakage: <1 ppm (in isolator vicinity during sterilization)
• Control system: Siemens PLC control, 12" Siemens industrial panel PC
• Cleanliness level: GMP Grade A / ISO 5
• Microbial reduction: ≥ log 6
• Noise: <75 dB(A)
• Power supply: AC 380 V / 50 Hz
• Lighting: LED, 500 lux
• Airtightness: leakage <0.5% volume/hour at 2× working pressure
• *Customizable according to user requirements