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국내 최대 CDMO 전문기업

제조공정

제형별 설비

  • 주사제 [Pre-Filled Syringe]

PICS GUIDELINE 에 준하여 운용하고 있고 Ready To Use Sterilized TUB(Nest)의 무균 포장 및 자동화 system(로봇 ARM)과 충전 자재 자동 이송 시스템, RABS(Restricted Access Barrier System)로 충전 환경을 구성하여 Syringe 브리스터/수축포장 모두 가능한 System을 갖추고 있습니다.

  • step. 01

    조제

    CAPA : 150L
    • 로드셀 (METTLER TOLEDO)
    • CIP/SIP
    • 자동 이송시스템
    • 고점도용 Agitator 및 Blade
  • step. 02

    여과

    CAPA : 150L
    • 로드셀 (METTLER TOLEDO)
    • CIP/SIP
    • 자동 이송시스템
    • 고점도용 Agitator 및 Blade
  • step. 03

    Debagging

    CAPA : Semi Auto
    • 전기 Blade로 Active RABS 내부 Cutting
  • step. 04

    PFS충전

    CAPA : 18,000syringe/h
    • 1mL, 3mL, 5mL
    • 고점도 제재 충전 가능
    • Tyvek 제거 로봇 암
    • 진공 제어 장치
  • step. 05

    사후멸균

    CAPA : 8,000 Syringe/1회
    • Steam + Air fan mixture Type
  • step. 06

    이물검사

    CAPA : 8,000 Syringe/1회
    • Steam + Air fan mixture Type
  • step. 07

    라벨링

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

    수축포장

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

    중량 선별

    CAPA : 6,000Case/h
  • step. 10

    2D 바코드 공정

    CAPA : 6,000Case/h
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