Single-use mixing system for biopharmaceutical production
Achieve precise blending and homogenization of shear-sensitive drug substances and viral inactivation with this advanced single-use mixer designed for seamless integration into biopharmaceutical production processes.
Mixes and Homogenizes Sensitive Biopharmaceutical Formulations
The Flexsafe® Pro Mixer by Sartorius is an innovative single-use mixing solution tailored for pharmaceutical and biopharmaceutical applications. It features a levitating impeller that minimizes shear, protecting sensitive drug substances and proteins during homogenization and viral inactivation processes. This mixer supports various applications, including monoclonal antibody formulations, mRNA vaccines, and cell culture media development, making it versatile for both upstream and downstream operations. With its intuitive design, the Flexsafe® Pro Mixer allows for rapid installation and seamless integration into existing production lines, enhancing operational efficiency. It offers continuous inline control and monitoring of pH, conductivity, and temperature, ensuring precision in cGMP processes. The mixer operates with high energy efficiency due to optimized motor function and meets stringent GMP standards. Available with corrosion-resistant materials, it accommodates various process demands while simplifying cleaning and maintenance through a user-friendly design. Sartorius provides extensive customization options and engineering support, ensuring that the equipment meets specific production requirements effectively.
Benefits
- Enhances product quality by maintaining low shear and minimizing protein aggregation.
- Increases operational efficiency with rapid setup and single-person operation.
- Ensures process accuracy through continuous inline monitoring of critical parameters.
- Reduces contamination risks with single-use design, eliminating the need for cleaning.
- Facilitates compliance with cGMP standards, ensuring regulatory adherence.
- Applications
- Drug substances,Bioprocessing,Media and buffer formulations,Sensitive proteins,Biopharmaceuticals,Viral inactivation,Cell culture media,Shear-sensitive products,Drug products,Powder dissolution,Pharmaceuticals
- End products
- Vaccine adjuvants,Cell therapy media,Viral vectors,Gene therapy vectors,Insulin,Biotherapeutic formulations,Monoclonal antibodies,Buffer solutions,Protein drug formulations,Enzyme formulations,Mrna vaccines,Antiviral drugs,Downstream intermediates,Pegylated proteins,Recombinant proteins,Cell growth media
- Steps before
- Powder dissolution,Media preparation,Buffer formulation
- Steps after
- Homogenization,Viral inactivation,Formulation of drug substances
- Input ingredients
- media powders,concentrated buffers,shear-sensitive proteins,pH sensors,conductivity sensors,temperature sensors
- Output ingredients
- homogenized products,viral inactivated substances,formulated drug products
- Market info
- Sartorius AG is renowned for manufacturing high-precision laboratory and bioprocess equipment. They specialize in filtration, fermentation, and cell cultivation systems, known for their innovation and reliability in the pharmaceutical and biotech industries.
- Mixing Method
- Levitating impeller
- Control/Monitoring
- Inline with PAT and cGMP
- Shear Performance
- Low-shear for sensitive substances
- Installation
- Single-person installation
- Automation
- Ergonomic and intuitive design
- Mixing Speed
- High-performance during powder dissolution
- Automation level
- Manual / PLC / SCADA
- Batch vs. continuous operation
- Batch / Inline Continuous
- Changeover time
- Quick setup
- CIP/SIP
- CIP 121°C / SIP 135°C
- Cleaning method
- CIP / Manual
- PH Control
- Inline monitoring
- Conductivity Monitoring
- Inline monitoring
- Temperature Monitoring
- Inline monitoring
- Installation
- Single-person installation
- Ergonomics
- Improved user experience
- Shear-Sensitivity
- Low-shear mixing
- Particle size compatibility
- 0.5–2.5 g/cm³ / 50–1000 µm
- Footprint
- Compact design for single-person installation
- Tank Shape
- Levitating impeller design
- Installation
- Single-person setup
- Access
- Front access to sensors and tubing
- Flexibility
- Pro mixer and LevMixer options
- Discharge Method
- N/A
- Drive-unit guidance
- Front access to sensors and tubing
- Ergonomics
- Single-person installation
- Mixing flexibility
- Levitating impeller / Magnetic Mixer