2-30ml Vial Filling Line With Washing Drying Filling Stoppering Machines, GMP Compliant Aseptic Processing For Biopharmaceuticals And Vaccines

2-30ml Vial Filling Line With Washing Drying Filling Stoppering Machines, GMP Compliant Aseptic Processing For Biopharmaceuticals And Vaccines

Precision Engineering for Sterile Injectable Production & Advanced Therapeutics

⚙️ Core Innovations
✅ End-to-End Aseptic Control

• Integrates ultrasonic cleaning (99.99% particulate removal) + dry heat sterilization (340°C, SAL ≤10⁻⁶), ensuring compliance with FDA/EU Annex 1 guidelines for biologics and mRNA vaccines.
• Nitrogen-protected filling system prevents oxidation of sensitive APIs (e.g., peptides, monoclonal antibodies).

✅ High-Speed Flexibility

• Processes 2-30ml vials at 100-400 vials/min, ideal for small-batch personalized medicines and large-scale vaccine production.
• Quick-change tooling adapts to R&D trials and commercial runs within 15 minutes.

✅ Smart Process Validation

• AI-driven PLC system monitors critical parameters (fill accuracy ±0.5%, stoppering force 20-80N), generating real-time audit trails for 21 CFR Part 11 compliance.
• QR-coded batch tracking links raw materials to final products, enabling blockchain-level traceability.

Target Applications

• mRNA Vaccines: Closed-system handling of lipid nanoparticles (LNPs) with temperature-controlled zones (2-8°C).
• Biologic Lyophilized Products: Seamless integration with freeze-dryers for vial capping under inert gas.
• Ophthalmic Injections: Precision filling of viscoelastic solutions (e.g., hyaluronic acid-based therapies).

Certifications & Adaptability

• GMP, ISO 14644-1 Class 5 certified cleanroom compatibility.
• Validated for cytotoxic drug containment (OEB Level 5) with negative pressure isolators (optional).

Fill Speed=Total Fill Volume per HourFilling Time per Vial​

Below is the main spec of our vial liquid filling machines:

Why Choose This Line?

• Our patented anti-cross-contamination design reduces downtime by 40% vs. conventional systems.
• Global service network provides 72hr on-site support for EU/US/APAC clients.

This structure leverages technical rigor (validated sterilization) and industry trends (personalized medicine), positioning this vial filling line as a modular solution for next-gen drug manufacturing.