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CDMO

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The largest CDMO in Korea

Manufacturing process

Facility by formulation

  • Powder for Injection Vial

Automation system, 100% IPC process, and RABVS (Restricted Access Barrier System) are configured according to the PICS Guidelines for GMP in Pharmaceuticals. Automation lines are established from the manufacturing process to the finished packaging process, with tracking management made possible through serial number management.

  • step. 01

    Cleaning / sterilization / preparation

    CAPA : 18,000V/h
    • Install HEPA Filter: 0.2㎛(99.997%)
    • Mesh Belt
    • Shutter equipped with automatic switch function
  • step. 02

    Filling

    CAPA: Consisting of 18,000V/h RABS + Clean Booth
    • HEPA Filter : 0.2㎛(99.997%)
    • Change Part's : 24Ø, 26Ø, 30Ø, 38Ø
    • 100% IPC 2 EA, Load cell 16ea
    • Four dosing station function
  • step. 03

    Sealing / external cleaning

    CAPA: Consisting of 24,000V/h RABS + Clean Booth
    • HEPA Filter : 0.2㎛(99.997%)
    • 24Ø, 26Ø, 30Ø, 38Ø
    CAPA : 18,000V/h
    • 24Ø, 26Ø, 30Ø, 38Ø
  • step. 04

    Foreign matters inspection

    CAPA : 2,400V/h
    • 24Ø, 26Ø, 30Ø, 38Ø
  • step. 05

    Labeling

    CAPA : 9,000V/h
    • 24Ø, 26Ø, 30Ø, 38Ø
  • step. 06

    Packaging

    CAPA : 900Case/h
    • 24Ø, 26Ø, 30Ø, 38Ø
  • step. 07

    Weight selection

    CAPA : 900Case/h
    • 24Ø, 26Ø, 30Ø, 38Ø
  • step. 08

    2D barcode process

    CAPA : 900Case/h
    • 24Ø, 26Ø, 30Ø, 38Ø