High-Speed Vaccine Vial Filling Machine (15000 BPH) Multivalent & mRNA

Product Specification

High-Speed Vaccine Vial Filling Machine (15000 BPH) | Multivalent & mRNA

Engineered specifically for high-volume biopharmaceutical manufacturing, this high-speed vial filling machine is optimized for the precise dosing of complex biological formulations, including mRNA therapeutics, adjuvanted multivalent vaccines, and live-attenuated strains. Capable of processing up to 15,000 vials per hour (250 BPM), the system handles 2ml to 50ml tubular and molded glass vials. Designed for seamless integration into complete aseptic processing lines, it ensures strict adherence to WHO, GMP, and ISO 5 cleanroom standards.

Core System Capabilities

• Shear-Sensitive Precision Dosing: Equipped with servo-driven peristaltic or high-precision ceramic pumps. This adaptive dosing architecture is specifically designed to handle shear-sensitive multivalent biological liquids without degrading active pharmaceutical ingredients (APIs), maintaining a strict volumetric accuracy of ≤ ±0.5%.

• Aseptic Containment Architecture: The machine features an aerodynamic profile optimized for ISO Class 5 Laminar Airflow (LAF) and is fully compatible with Open Restricted Access Barrier Systems (O-RABS) or Closed RABS (cRABS). All wetted product-contact parts are machined from AISI 316L stainless steel.

• Synchronized Downstream Integration: Designed to operate continuously without bottlenecks. The system integrates directly with multi-head rotary servo capping and stoppering modules. Independent sensor arrays verify 100% seal integrity, which is critical for maintaining the cold-chain stability of vaccines.

• Intelligent Conveyor Logic: Utilizes advanced buffering and "No-Bottle-No-Action" protocols to prevent glass-to-glass impact, significantly reducing the risk of micro-cracks and vial breakage during high-speed transit.

• Complete SCADA Integration: The entire production line—from upstream vial washing and dry heat depyrogenation (up to 320°C) to downstream filling, capping, and labeling—can be synchronized via a centralized Supervisory Control and Data Acquisition (SCADA) interface.

Turnkey Engineering & Global Deployment

Lingyao Healthcare provides complete turnkey ecosystem engineering, extending beyond the filler to include the integration of large-scale formulation and storage tanks (e.g., 5000L).

• Packaging & Traceability: Systems seamlessly integrate with high-speed wrap-around labeling modules supporting GS1 DataMatrix coding and 360° vision inspection for real-time verification of lot codes and expiration dates.

• International Market Readiness: Equipment is supplied with complete documentation packages to support rigorous global customs and regulatory clearances, including SASO/SABER compliance for the Middle East and optimized environmental tolerances for varied global climates.

Technical Specifications

Regulatory Compliance & Validation Support

Our equipment is engineered to meet strict international regulatory standards, ensuring seamless integration into your facility's quality management systems.

• Complete Validation Documentation (DQ/IQ/OQ/PQ): We provide comprehensive validation protocols to support your regulatory submissions, including Design, Installation, Operational, and Performance Qualifications, alongside complete material traceability certificates for all product-contact components.

• GMP-Compliant Sanitary Design: Built strictly to Good Manufacturing Practice (GMP) principles. The equipment features crevice-free stainless steel construction and is fully compatible with CIP/SIP (Clean-in-Place / Sterilize-in-Place) procedures to eliminate contamination risks.

• Data Integrity & Traceability: Designed to support FDA 21 CFR Part 11 requirements. Our intelligent PLC systems feature secure multi-level user access, automated electronic audit trails, and real-time batch data recording that can be easily exported or integrated into your SCADA/MES systems.