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:
| Model | LYQCL80+LYASMR620/48+LYKGF8 | LYQCL1000+LYASMR620/48+LYKGF10 | LYQCL120+LYASMR620/55+LYKGF12 |
| Adaptive Spec | 2-30ml national standard vials | 2-30ml national standard vials | 2-30ml national standard vials |
| Capacity | 6000-12000pcs/hr | 6000-18000pcs/hr | 6000-26000pcs/hr |
| Clarity | >99% |
| Breakage rate | <0.5% |
| Filling Torlerance | 1.5 % |
| Fresh Water consumption | 0.2-0.4Mpa/0.6-1.0 m3/hr |
| Clean compressed air consumption and pressure | 0.3-0.6Mpa/35-80 m3/hr |
| Pass rate of stopping | > 99% |
| Pass rate of capping | > 99% |
| vacuum pumping speed | 60m3/h(external distribution) |
| Exhuast volume | 3500-4800m3/h |
| Weight | 9300 KGs |
| Total Power | about 90kw 380v 50Hz | about 93kw 380v 50Hz | about 110kw 380v 50Hz |
| Size | about 12600 X 2260 X 2445mm | about 12600 X 2260 X 2445mm | about 13200 X 2260 X 2445mm |

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.