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注射剂--西林瓶(冻干&水针)无菌制剂

可适用重组蛋白、抗体等多类型生物药
多规格一体化的注射制剂研发生产平台

Vials Pre-filled Syringes

Platform
Introduction

atform Introduction

The sterile formulation platform for vials (liquid injections & lyophilized products) integrates vial washing, oven drying, depyrogenation sterilization, filling, lyophilization, crimping and other processes.

It supports aseptic filling of liquid injections and lyophilized formulations with specifications of 0.2 ml–30 ml on the integrated filling-stoppering-capping line and 2 ml–50 ml on the small-volume injection line. It caters to diverse demands of recombinant protein and antibody biologic drugs from R&D to commercialization, and is particularly suitable for project delivery of injectable formulations with stringent sterility and quality control requirements.

CMC
Development Services

CMC Development Services

Service
Process & Content

Commercial Manufacturing Process
  • GMP Drug Substance Manufacturing
    GMP Drug Substance Manufacturing
    01
  • Washing, Sterilization and Depyrogenation
    Washing, Sterilization and Depyrogenation
    01
  • Aseptic Filling
    Aseptic Filling
    01
  • Lyophilization
    Lyophilization
    01
  • Crimping / Sealing
    Crimping / Sealing
    01
  • Single-Use Design

    All product contact surfaces use single-use disposable components to prevent cross-contamination.
  • Aseptic Assurance

    Filling, stoppering, crimping, automatic loading and unloading are performed within A-grade isolators under grade C background.
  • High-Efficiency Filling

    100% automatic weighing for fill volume, with an annual filling capacity of 12 million vials.
  • Vacuum Lyophilization

    LYO-15 (SIP, CIP) vacuum freeze dryer, with a lyophilization area of 15 ㎡ and shelf temperature uniformity of ±1 ℃, suitable for complex process requirements.
  • High-Speed Operation

    200 vials per minute, equipped with crimping pressure monitoring system to monitor sealing strength.

Platform
Highlights

Platform Highlights
Equipment Display

车间洁净级别C+无菌隔离器(A级),配备无菌灌装隔离系统、立式超声波洗瓶机和灭菌去热原烘箱、灌装加塞机、轧盖机、固定式自动进出料系统、LYO-15(SIP,CIP)真空冷冻干燥机等设备。

  • LYO-15 Vacuum Freeze Dryer
  • Vertical Ultrasonic Vial Washer
  • Depyrogenation Sterilizing Oven
  • Filling and Stoppering Machine
  • Aseptic Filling Integrated Line
  • Automatic Packaging Line