Bioprocess preparation system for vaccines and monoclonal antibodies
In pharmaceutical production, the preparation of biological products such as vaccines and monoclonal antibodies requires precise system control and high-quality materials. Challenges often include managing medium preparation, fermentation, and buffer preparation efficiently while ensuring compliance with stringent regulatory standards.
Automate production, cleaning, and sterilization
The bioprocess preparation system from Austar is designed for the preparation of culture media, fermentation, harvest, and buffer solutions used in the production of vaccines, monoclonal antibodies, and recombinant proteins. With a 3D modular design, the system features components like tanks, pumps, heat exchangers, filters, and valves sourced from top international and domestic brands. This ensures high overall quality. The control system uses Siemens 300 series PLC for process control and MP277 series touch screen for HMI. Design and inspection align with GAMP5 V-model standards. The system supports automatic control of production processes, cleaning, and sterilization, and includes a full set of validation documents to meet regulatory compliance.
Benefits
- Automates complex processes including production, cleaning, and sterilization
- Uses high-quality components from renowned brands
- Complies with GAMP5 V-model for design and inspection
- Easy-to-use HMI with Siemens MP277 series touch screen
- Includes comprehensive validation documents for regulatory compliance