/ Integrated Process and Packaging Equipment & Systems / Case Study

FDA-Compliant Fill-Finish & Freeze-Drying Turnkey Line

The production line must comply with FDA requirements. Must support multi-format production (flexible changeover).

AUSTAR Solution

Provided a fully integrated sterile processing line, including: - Washing-Sterilization-Filling-Stoppering (WSFS) system - Push-rod-free automatic loading/unloading system (innovative design) - Lyophilizer (freeze dryer) Quick mold changeover for flexible production.

Highlights

Highly Flexible and Efficient Multi-Purpose Production Capability

Innovative Technology Application, Significantly Reducing Aseptic Risks

Deep Integration of Compliance and Quality Assurance

AUSTAR Value & Client Benefits

• Successfully deployed a sterile filling-lyophilization line in the highly regulated FDA market. • Implemented push-rod-free automatic loading/unloading, reducing cleaning/SIP challenges and improving sterility assurance. • Compact, modular design with 100% IPC (in-process control) for enhanced quality monitoring. • Easy disassembly/installation of molds & tooling. • Pre-loaded multiple recipe parameters for fast changeovers. • Improved equipment stability and operational efficiency.
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