LKtime Biotech (Changchun) has established an industry-leading sterile gel filling line, strictly complying with the high-standard GMP regulations of the NMPA, FDA, and EMA. This production line is compatible with both aluminum tubes and aluminum-plastic tubes for packaging, meeting filling requirements for products ranging from 5g to 20g. It can fill various types of liquid pharmaceuticals, including aqueous solutions and viscous gel-based formulations. The line is suitable for R&D, pilot-scale production, phase I-III clinical trials, and large-scale commercial manufacturing.

The filling line adopts a modular design to facilitate functional scalability and flexible development, with a maximum operating speed of 240 units/minute and a stable production speed ranging from 180 to 220 units/minute. The filling accuracy is maintained at 0.5-1%.

This filling line integrates a configuration system (with integrated CIP/SIP) and a gel filling and crimping machine. The facility is divided into the following zones:

Preparation area (grade D)

Formulation area (grade C)

Filling area (grade B + A)

Packaging area (CNC)

The gel configuration system comprises:

120L stock solution tank

750L matrix tank

150L matrix supplement tank

400L (dual-tank) CIP cleaning system

Configuration Process:

The system supports batch volumes from 45L to 750L. The drug solution undergoes two-stage sterile filtration before being transferred into the pre-sterilized and cooled matrix, ensuring aseptic product formulation.