Injection Vial Filling Machine for 2-30ml Glass Vials with Nitrogen Purging Support for Antibody and Vaccine Production

The injection vial filling machine is designed for filling 2-30ml glass vials and incorporates nitrogen purging support, making it ideal for applications involving monoclonal antibodies and viral vector solutions. Key features include:

1. Pharmaceutical-Grade Aseptic Assurance
   • Class 100 Cleanroom Standards: Equipped with a triple air filtration system that maintains microbial load control achieving SAL≤10⁻⁶ (viral inactivation level).
   • Comprehensive Contamination Prevention: Utilizes ultrasonic deep cleaning, 300℃ dry heat sterilization, and nitrogen protection during filling to meet EMA/FDA aseptic requirements.
   • International Value: Suitable for manufacturing regimens adhering to European and American standards, such as those for regenerative medicine.
2. High-Precision Filling and Flexible Production
   • ±0.5% Dosage Error Control: Features a servo-driven piston pump with a touchscreen interface for real-time adjustment, ensuring product consistency.
   • Modular Quick Changeover: Capable of switching between different vial sizes and formulations in just 30 minutes to accommodate small batch and multi-product needs.

1. Global Compliance Certification Coverage
   • Triple Certification Assurance: Compliant with GMP, ISO 13485, and FDA 21 CFR Part 11, supporting electronic batch records for audit-ready documentation.
   • EMA Virus Inactivation Validation: Process documentation is available for SAL≤10⁻⁶ verification, facilitating expeditious overseas registration of biological products.
2. Smart Technology and Traceability Systems
   • End-to-End Traceability: PLC-controlled integration with QR code tracking ensures full traceability of raw materials through to finished products.
   • Remote Operational Support: Multi-language interface (English/German/Spanish) along with IoT diagnostics mitigate the risk of downtime for international clients.
3. Lifecycle Cost Efficiency
   • Energy-Efficient Design: Nitrogen consumption reduced by 40% compared to traditional systems, and energy optimization in dry heat sterilization lowers operational costs by 30%.