Cn
EN
Platform
Introduction
Platform Introduction
The workshop adopts B+A cleanliness grade for the integrated filling-stoppering-capping line, integrating depackaging, automatic denesting, filling, sealing and crimping. It supports both flexible small-batch production and large-scale commercial manufacturing. It meets the aseptic filling requirements of pre-filled syringes in 0.2 ml–5 ml and cartridges in 0.2 ml–3 ml, with an annual filling capacity of 3.75 million units for both.
CMC
Development Services
CMC Development Services
Service
Process & Content
Commercial Manufacturing Process
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GMP Drug Substance Manufacturing
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Depackaging & Film Stripping
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Aseptic Filling
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Stoppering
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Nesting
Platform
Highlights
Platform Highlights
Platform Highlights
- Strong equipment compatibility: The same unit can produce pre-filled syringes, cartridges and vials by changing molds.
- Minimal process intervention: The machine is fitted with automatic waste disposal to reduce operator interventions during aseptic production.
- Rigorous aseptic control: All sterile filtration and filling components are gamma-irradiated single-use assemblies.
- High-standard manufacturing environment: B+A classified aseptic filling environment with oRABS (open restricted access barrier system) complying with international standards (Grade A isolator under Grade B background).
Advanced Automated Equipment
车间配备一次性配液系统、三合一灌装机、轧盖机、冻干机等核心设备，设有C级、B级及B+A级无菌灌装区，并配置搭载oRABS的全自动灌装线。
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Pre-filled Syringe Filling and Sealing Machine -
Crimping Machine -
Single-Use BDS System