Flexsafe® Pro Mixer Single-Use Mixer
The Fast, Flexible, and Intelligent Single-Use Mixer for All Mixing Steps in cGMP Bioprocessing
Quality and efficiency are critical when it comes to mixing operations in a bioprocessing environment, and your choice of mixing equipment affects both. A fast and flexible single-use mixer can be a competitive advantage, and help you maximize throughput and increase production.
We combined customer feedback with 20 years’ single-use fluid management experience to design the Flexsafe® Pro Mixer.
One Mixing Solution for All Mixing Steps in cGMP Bioprocessing
With the flexibility to accommodate both low-shear and rapid-mixing applications, the Flexsafe® Pro Mixer brings single-use technology to a wide range of mixing steps in upstream and downstream processes.
The Flexsafe® Pro Mixer supports quality and efficiency:
- Reduces the risk of operator error
- Allows in-line monitoring and control
- Protects shear-sensitive products
- Allows fast installation and easy setup
The Flexsafe® Pro Mixer’s efficiency has been proven with computational fluid dynamics and application testing with buffers, media, aluminum gel, and viscous products.
Flexsafe® Pro Mixer levitating impeller combined with limited shear work eliminates the shear effects that can impact product quality.
Flexsafe® Pro Mixer controls all critical mixing parameters essential for cGMP production; automated control of mixing speed and time, integrated control of volume and temperature, in-line control and monitoring of pH, and conductivity.
You can use one mixing technology for the complete drug manufacturing process.
The Pro Mixer drive unit is designed to interface with Palletank® for Mixing (50 – 3,000 L), and you can use it with multiple Palletank® for Mixing units.
Installation takes 5-10 mins for the full Mixing range. The system comes with easy-to-follow instructions for each stage of the process.
The Flexsafe® Pro Mixer solution
Flexsafe® Pro Mixer Bag
Building on 20 years of experience in single-use fluid management solutions, Flexsafe® Pro Mixer Predesigned Solutions have a proven history of process optimization in a variety of applications — from buffer and media preparation to downstream steps and final formulation.
The ergonomic design of the Flexsafe® Pro Mixer (50–3000 L) offers rapid bag installation, expedites the mixing run, and facilitates bag handling during the entire mixing process.
Predesigned single-use options provide simpler, safer, faster, and cheaper supply chain solutions.
Flexsafe® Pro Mixer Drive Unit
The Pro Mixer drive unit levitates and rotates the single-use magnetic impeller in the mixing bag with no surface contact. It is flexible, mobile, cart-mounted, and designed to interface with all types and volumes of Palletank® for Mixing units.
The Pro Mixer drive unit features automated control of the mixing parameters, offers a user-friendly touchscreen interface, and can manage multiple Palletank® for Mixing units.
Palletank® for Mixing
The Palletank® for Mixing is a stainless-steel container that’s designed to complement the Flexsafe® Pro Mixer bag and drive unit. The front doors allow easy installation of the mixing bag, and the front port gate facilitates tubing line and sensor installation, as well as manipulations during filling, sampling, and draining.
Offering rapid set-up with a mixing bag already installed, users can quickly begin mixing operations in just a few minutes. Palletank® for Mixing units are available with weighing functions and heat exchange jackets for integrated volume and temperature control.
Assurance of Single-Use System Integrity
Supplier Integrity Test
A Supplier Integrity Test (SIT) for the complete bag and line assemblies is available for Flexsafe® Pro Mixer Bags up to 650 L, providing the integrity assurance for critical applications.
- Strengthens regulatory compliance
- Improves patient safety
Point of Use-Leak Test
For critical process steps, a 100% point-of-use leak test avoids the risk of losing high-value product and enhances patient and operator safety by ensuring that no damage occurred during shipping, storage, and handling of single-use Flexsafe® Pro Mixer bags at the user site.
Learn More About Flexsafe® Pro Mixer
Optimized media formulation can have a significant impact across upstream operations. The Flexsafe® Pro Mixer combines speed and efficiency to deliver high performance mixing during media powder dissolution.
Optimized buffer formulation can have a significant impact across downstream operations. The Flexsafe® Pro Mixer combines speed and efficiency to deliver high performance mixing, preparing solution from liquid buffer concentrates and dissolving buffer powders even in worse-case conditions such as high volume and high concentration, making the buffer preparation step quick and easy to perform.
Flexsafe® Pro Mixer technology allows low shear mixing to preserve the drug during viral inactivation. The single-use sensors are integrated for safe and reliable use across the process steps. Drain valves are available to avoid hold up volumes into the tubes.
Drug substance purification is a critical process step due to the risk of impurities being introduced either during the process or with the products used in biomanufacturing – but the integrity of the drug substance can also be at risk. The Flexsafe® Pro Mixer features a levitating impeller to preserve the drug substance during low shear blending applications and a design that supports taking off-line samples for other quality control tests prior to sterile filtration.
Preserving the drug product during the final formulation is critical, not just from a quality standpoint, but also to prevent the risk of significant waste. The Flexsafe® Pro Mixer, designed with its levitating impeller, ensures the integrity of the drug product during sterile and aseptic operations. Pre-designed Solutions (PDS) for either sterile or aseptic connections and disconnections, with options of single-use or integrated sensors, ensure safe and reliable use throughout the final formulation process.