Aseptic Ampoule Filling Line for High Precision Vaccine and Biologics EU GMP Compliant, 99.9% Sterility Assurance

Aseptic Ampoule Filling Line for High Precision Vaccine and Biologics EU GMP Compliant, 99.9% Sterility Assurance

Revolutionize Your Sterile Ampoule Production with Smart Aseptic Filling
The Aseptic Ampoule Filling Line is engineered to meet Europe’s stringent pharmaceutical standards, combining cutting-edge isolator technology with AI-driven process control. Designed for critical applications like mRNA vaccines and monoclonal antibodies, this line ensures 99.9% sterility assurance through HEPA-filtered laminar airflow and real-time particulate monitoring.

Why European Clients Choose This Line:
✅ Zero Cross-Contamination – Closed-system RABS (Restricted Access Barrier System) with glove ports for operator safety.
✅ Adaptive Format Switching – Automatically adjusts between 1ml insulin ampoules and 20ml diagnostic reagents in ≤3 minutes.
✅ Green Manufacturing – Heat recovery from sterilization tunnels reduces energy waste by 18%.
✅ Blockchain Traceability – Embedded IoT sensors log every ampoule’s fill weight, seal integrity, and sterilization parameters for EU MDR compliance.

Aseptic Ampoule Filling Line Spec:

Real-World Application Spotlight
A Swiss biotech firm reduced fill-loss by 37% using this line’s pulsed volumetric filling technology, crucial for €10,000+/liter gene therapies. The machine’s anti-vibration platform also minimized liquid splashing during high-speed filling of adjuvanted flu vaccines.

Technical Edge

• Smart Alarms: Predictive maintenance alerts for pump wear or seal degradation.
• CIP/SIP Ready: Validated clean-in-place cycles meet EMA guidelines.
• Dual-Language HMI: English/German touchscreen with 21 CFR Part 11 audit trails.