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Platform
Introduction
Platform Introduction
The platform features a dedicated production line for sterile external gel formulations in aluminum-plastic tubes and aluminum tubes, which fully complies with sterile formulation production specifications of NMPA, EMA and FDA with a high level of automation.
The line supports mainstream international specifications from 5 g to 100 g, adaptable to protein drugs and antibody-based gel formulations of different specifications and viscosities, suitable for high-standard sterile external applications such as dermatology and wound repair.
CMC
Development Services
CMC Development Services
Service
Process & Content
Commercial Manufacturing Process
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GMP Drug Substance Manufacturing01 -
VHP Sterilization and Unpacking Conveying of Packaging Materials01 -
Robotic Feeding01 -
Positioning and Air-Rinse Filling01 -
Fold Tail / Heat Sealing01
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Automatic Solution Preparation
Modular design for automatic liquid preparation, equipped with CIP/SIP functions. -
Robotic Feeding
Robotic arms automatically grip hoses and precisely load them onto conveyor fixtures. -
High-Precision Positioning
Servo lead screw drive, color mark sensor for accurate color mark recognition and positioning, achieving high-precision automatic alignment within ±1°. -
High-Efficiency Filling
Annual output up to 12 million units with filling accuracy of ±0.5% ~ ±1%.
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Strong Compatibility
Multi-functional unit supporting both aluminum tube and aluminum-plastic tube sealing modes for convenient switching and strong adaptability. -
Heat Sealing
Saddle-type triple-fold sealing with mechanical linkage, enabling 100% in-line integrity testing for products.
Platform
Highlights
Platform Highlights
◆ Adopts Stäubli robots of internationally renowned brand for high-end, efficient and high-precision operation;
◆ Variable-pitch feeding mechanism, adaptable to different specifications without replacement;
◆ The feeding unit picks 20 units at a time for high efficiency;
◆ Row spacing controlled by servo-driven lead screws;
◆ Suction cup picking to avoid damage to packaging materials.
The workshop adopts the oRABS isolation system with cleanliness grade B+A, equipped with hose filling and sealing machines, sterile transfer chambers, GMP-compliant washers and other equipment.
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Automatic Liquid Preparation System -
Hose Filling and Sealing Machine -
GMP Vessel Washer -
VHP Transfer Chamber