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국내 최대 CDMO 전문기업

제조공정

제형별 설비

  • 분말주사제 바이알

PICS GUIDELINE 에 준하여 자동화 system 과 100% IPC 공정 및 RABVS (Restricted Access Barrier System) 구성되어 있고 제조 공정에서 부터 완제 포장 공정까지 자동화 라인으로 구축되어 있으며 일련번호 관리를 통한 추적 관리가 가능하도록 구축되어 있습니다.

  • step. 01

    세척/멸균/칭량/혼합

    CAPA : 18,000V/h
    • HEPA Filter 설치 : 0.2㎛(99.997%)
    • Mesh Belt
    • 셔터 자동 개폐기 기능 적재
  • step. 02

    충전

    CAPA : 18,000V/h RABS + Clean Booth 구성
    • HEPA Filter : 0.2㎛(99.997%)
    • Change Part's : 24Ø, 26Ø, 30Ø, 38Ø
    • 100% IPC 2대, 로드셀16ea
    • four dosing station 기능
  • step. 03

    씰링/외부세척

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

    이물검사

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

    라벨링

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

    포장

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

    중량 선별

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

    2D 바코드 공정

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