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CDMO

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The largest CDMO in Korea

Manufacturing process

Facility by formulation

  • 주사제 [Pre-Filled Syringe]

The production lines are under operation following the PICS Guidelines for GMP in Pharmaceuticals. Additionally, the filling environment has been configured with the ready-to-use sterilized tubing (Nest) solution for aseptic manufacturing, automation system (Robot Arm), automatic transfer system for filling material, and RABS (Restricted Access Barrier System) to equip with the system that can package everything, where both syringe blister and shrink wrap packaging are available..

  • step. 01

    Preparation

    CAPA : 150L
    • Load cell (METTLER TOLEDO)
    • CIP/SIP
    • Automatic transfer system
    • Agitator and blade for high viscosity
  • step. 02

    Filtration

    CAPA : 150L
    • Load cell (METTLER TOLEDO)
    • CIP/SIP
    • Automatic transfer system
    • Agitator and blade for high viscosity
  • step. 03

    Debagging

    CAPA : Semi Auto
    • Cutting inside the active RABS with electric blade
  • step. 04

    PFS filling

    CAPA : 18,000syringe/h
    • 1mL, 3mL, 5mL
    • High viscosity material available for filling
    • Tyvek removal robot arm
    • Vacuum controller
  • step. 05

    Post-sterilization

    CAPA: 8,000 Syringe/each
    • Steam + Air fan mixture Type
  • step. 06

    Foreign matters inspection

    CAPA: 8,000 Syringe/each
    • Steam + Air fan mixture Type
  • step. 07

    Labeling

    CAPA : 18,000syringe/h
  • step. 08

    Shrink wrap packaging

    CAPA : 12,000Syringe/h
  • step. 09

    Weight selection

    CAPA : 6,000Case/h
  • step. 10

    2D barcode process

    CAPA : 6,000Case/h