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Challenges

  • Capacity gap

    Semi-auto operation could not meet growing domestic hospital demand and export order volumes.

  • Contamination risk

    Repeated manual handling within the Grade A zone made sustained GMP compliance increasingly difficult.

  • Downstream integration

    Post-fill processes (inspection, rod locking, labeling, flow-wrap) lacked mechanical and data continuity, preventing end-to-end batch traceability.

  • A large-scale pharmaceutical manufacturer in China-Catheter Flush Syringe Filling Line
  • A large-scale pharmaceutical manufacturer in China-Catheter Flush Syringe Filling Line
  • A large-scale pharmaceutical manufacturer in China-Catheter Flush Syringe Filling Line
  • A large-scale pharmaceutical manufacturer in China-Catheter Flush Syringe Filling Line
A large-scale pharmaceutical manufacturer in China-Catheter Flush Syringe Filling Line

Client Profile

A leading Chinese manufacturer of infusion consumables, specializing in 0.9% sodium chloride pre-filled flush syringes with 3 mL / 5 mL / 10 mL plastic barrels. The products are supplied for hospital clinical applications and overseas markets. The client required high-speed continuous production with compliance to current GMP validation requirements, including complete IQ/OQ/PQ documentation, batch traceability systems, and OPC UA / Modbus communication with MES systems.
Leggenda (Shanghai) Technology Co., Ltd.

Leggenda Solution

Leggenda provided a turnkey production line centered on a 6-head filling platform, enabling fully automated production from syringe preparation to final pillow packaging.
Material Sorting → Washing → Silicone Oil Spraying → Servo Capping → Filling → Stoppering → Visual Inspection → Automatic Rejection → Labeling → Flow Wrapping

Results

Parameter Specification
Production Capacity ≥11,000 syringes/hour (up to 12,000 syringes/hour)
Filling Accuracy ±0.5% CV
Filling Heads 6 Heads
First-Pass Filling Yield >99%
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