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국내 최대 CDMO 전문기업

제조공정

제형별 설비

  • 동결건조주사제 분말 바이알

PICS GUIDELINE 에 준하여 제조 공정에서 부터 완제 포장 공정까지 자동화 라인으로 구축되어 있으며 일련번호 관리를 통한 추적 관리가 가능하도록 구축되어 있습니다.

  • step. 01

    세척/멸균/조제

    CAPA : 650L
    • 저온 냉각기능 (3℃ 까지)
    • 로드셀 (METTLER TOLEDO, MAX : 550Kg)
    • CIP/SIP 가능
    • 자동 이송시스템
    • Filter : 10inch(0.2 ~ 0.22㎛)
  • step. 02

    충전

    CAPA : 18,000V/h
    • RABS + Clean Booth 구성
    • HEPA Filter : 0.2㎛(99.997%)
    • 24Ø, 30Ø, 35Ø
    • 100% IPC 8개
  • step. 03

    동결건조

    CAPA : Ice Capa 550Kg * 3대
  • step. 04

    씰링

    CAPA : 24,000V/h
    • RABS + Clean Booth 구성
    • HEPA Filter : 0.2㎛(99.997%)
    • 24Ø, 30Ø, 35Ø
  • step. 05

    이물검사

    CAPA : 2,400V/h
    • 24Ø, 26Ø, 30Ø, 38Ø
  • step. 06

    라벨링

    CAPA : 9,000V/h
    • 24Ø, 26Ø, 30Ø, 38Ø
  • step. 07

    포장

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

    중량 선별

    CAPA : 900Case/h
    • 24Ø, 26Ø, 30Ø, 38Ø
  • step. 09

    2D 바코드 공정

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