Aseptic filling isolator(AFIS-3)

     The aseptic filling isolator is applied for the production of advanced therapeutic medicines (ATMP), including cell and gene therapies (CGT), and small-scale biopharmaceuticals. One-time system (SUS) and ready-to-use (RTU) product containers are transferred into the Class A filling area through non-contact transfer (NTT). It is a fully integrated solution for vial filling/finish and isolation technology, featuring its easy cleanliness, fast VHP cycle time, which minimizes batch conversion time, supports improving product quality and aseptic assurance level, and reduces the risk of contamination. The processing capacity can reach up to 2000 bottles/hour.

 Product features:

 Isolation system: Buffer compartment + operation compartment (double-sided operation) + discharge compartment, positive pressure

 Automatic control system: Integrated with industrial control computer system for pressure difference, air velocity, etc., unidirectional laminar flow, meeting Class A standards, compliant with audit tracking and electronic signature (21 CFR Part 11).

 VHP sterilization: Integrated VHP generator and concentration sensor

 Filling machine: Isolation system integrates small-batch filling machine (powder, liquid, culture medium, etc.)

Compatible with 2-100ml vials, production capacity 100-1500 bottles per hour, filling accuracy: <±1%.

Material entry: Through RTP for rubber stoppers and aluminum caps

 EM detection: Online integrated particle and airborne bacteria online monitoring