Flexsafe® Pro 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 the choice of mixing equipment can dramatically affect both. In fact, a fast and flexible single-use mixer can be a competitive advantage, helping manufacturers maximize throughout and increase production.
This is what 20 years in single-use fluid management has taught us — and what we heard from customers. The Flexsafe® Pro Mixer was designed with those principles in mind.
With the flexibility to accommodate both low-shear and rapid-mixing applications, the Flexsafe® Pro Mixer brings unique single-use technology to a wide range of mixing steps in upstream and downstream processes.
The Flexsafe® Pro Mixer supports quality and efficiency by reducing the risk of operator error, allowing inline monitoring and control and protecting shear-sensitive products. These benefits, along with fast installation and easy setup, make the Flexsafe® Pro Mixer a long-term investment with an immediate return.
Table of Contents
Unique and Intelligent Single-Use Mixing
Easy to Install, Ergonomically Designed
The Flexsafe® Pro Mixer has been designed from the ground up for ease of operation.
- With a single-operator installation that can be completed in less than 10 minutes, changeovers become faster and more efficient.
- The drive-unit guidance across the mixing process supports single-person operation while reducing the risk of operator error.
- A cubical design with front access to sensors and tubing help prevent handling errors while improving ergonomics and ease-of-use.
The Flexsafe® Pro Mixer is designed to reduce or eliminate the risk of shear degradation.
- The levitating impeller makes this single-use mixer ideal for a range of applications, including viral inactivation and formulation of sensitive drug substances and products.
- Its unique design eliminates shear effects that can impact product quality while avoiding the generation of aggregates and particles that can cause fouling of filters.
High-Performance and Rapid Mixing
The Flexsafe® Pro Mixer enables faster dissolution when mixing powders into liquids, saving time and expense.
- A strong vertical vortex, combined with the baffle effect of the cubical design, allows instant downward movement and efficient dissolution of floating powders.
- Its high-torque impeller is particularly effective and efficient in mixing high-concentration or viscous powders.
- The faster powder dissolution resulting from the Flexsafe® Pro Mixer's unique design saves time during buffer and media preparations and results in a more efficient process overall.
Integrated and Intelligent Process Monitoring
The Flexsafe® Pro Mixer is an intelligent single-use mixer designed to control critical mixing parameters in cGMP production.
- Inline controls that monitor pH, conductivity, and temperature help meet PAT and cGMP requirements while decreasing operator time, and the pre-assembled single-use pH probe eliminates any risk of contamination from reusable probes.
- The Palletank, the Flexsafe® Pro Mixer stainless-steel mixing tank, is available with weighing functions and heat exchange jacket for integrated control of volume and temperature.
- The Flexsafe® Pro Mixer drive unit features an automated control of the mixing parameters by reading the real impeller speed, offering mixing recipes, and managing passwords.
Flexibility of Use
The Flexsafe® Pro Mixer offers a unique single-use technology accommodating a wide range of mixing steps in both upstream and downstream processes.
- A single-drive unit appropriate for managing a range of volumes and functions offers flexibility across the biomanufacturing process.
- By accommodating the need for both low-shear and rapid-mixing applications, the Flexsafe® Pro Mixer supports mixing steps from media formulation and buffer preparations, downstream process steps to final formulation.
- The Flexsafe® Pro Mixer is a reliable option for the development of monoclonal antibodies, vaccines, and biosimilars.
Flexsafe® Pro Mixer Consists of Three Main Components
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.