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
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GMP Drug Substance Manufacturing01 -
Washing, Sterilization and Depyrogenation01 -
Aseptic Filling01 -
Lyophilization01 -
Crimping / Sealing01
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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.