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Single-Use Mixing System for Biopharmaceutical Applications

Complete recirculation and mixing process system

Entegris is designed to maximize simplicity, ease-of-use and affordability. It stores, recirculates and mixes all types of solutions within a sterile single-use mixing bag. The only additional equipment required is an outer rigid container, a mixing stabilizer and a peristaltic pump. The rapid recirculation design will mix to a homogeneous mixture, saving time and money without sacrificing quality or consistency.

The system works by using a disposable mixing nozzle to direct recirculation fluids throughout the single-use mixing bag. The bag is fitted inside a reusable rigid outer container. Using the mixing nozzle design, multiple tubing sizes and the conical-shaped container, the mixing system creates either a gentle or robust turbulent mixing that sweeps and lifts the contents from the bottom of the bag. The recirculation action is accomplished using an external peristaltic pump, which helps minimize capital expenses. If the system needs to be mobile, a tank dolly and cart for the pump can be utilized.

Because the bag is disposable, cleaning validation between batches is eliminated, removing the documentation burden from your quality team. The closed system design reduces cross-contamination risk between batches, supporting process validation and a defensible audit trail.

Sentinel Process Systems, Inc. has experience servicing our clients dating back to 1950, we can answer your questions about these solutions and make recommendations based on your application requirements.

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Why Choose Peristaltic Pump-Based Mixing?

Peristaltic pumps drive recirculation by compressing and releasing flexible tubing, advancing process fluid through the disposable flow path. The reusable pump minimizes capital investment and carries forward to subsequent campaigns without requalification. Its low-shear pumping action is gentle enough for sensitive cell culture media and feed components while generating sufficient force for powder-to-liquid dissolution and large-volume buffer preparation.

Single-Use Mixing Technologies: What’s the Difference?

Single-use mixing systems use different agitation approaches:

  • Magnetic stir-bar and paddle systems: These technologies offer gentle, low-energy mixing and are commonly used at lab and small-process scales. They experience scaling limitations and challenges in fully incorporating high-viscosity fluids or dry powders.
  • Rocking and wave-motion platforms: While suitable for cell culture aeration at smaller volumes, these systems are not optimized for the high-volume buffer or media preparation that commercial bioprocessing demands.
  • Recirculation-based mixing: Present in the Entegris Mixing System, this technology maintains mixing consistency across the available volume range. The peristaltic pump is reusable across campaigns.

Fast Time-to-Production

Get your single-use systems ready quickly, so you launch faster.

No Vendor Lock-In

Choose components from any supplier. Maximum flexibility, zero compromise.

Custom Solutions for Bioprocessing

Fully customized systems designed specifically for your process.

Reliable Supply

Managed inventory through stocking programs ensures you never run short on materials.

Supports Sterility Requirements

Gamma irradiation and SAL services are available.

Technical Features

Key features of the Entegris Mixing System include:

  • Single-use mixing bag sizes: Available in 50-liter, 100-liter and 200-liter sizes to support operations of diverse scales
  • Rigid outer containers: Reusable tanks sized to match each bag assembly provide the structural support
  • Multilayered film with a total thickness of 9 millimeters: Three-layer construction features a low-density polyethylene (LDPE) inner product contact barrier, a middle LDPE barrier, and an outer ethylene vinyl alcohol (EVOH)/nylon barrier that provides low gas permeability and strength for sustained recirculation
  • Flexible design: Adapts to your process to simplify integration, with a temperature-controlled tank option also available for applications requiring thermal management

Quality Standards and Documentation

Entegris manufactures its Mixing System to the most exacting standards. Your Entegris Mixing System is backed by:

  • ISO 9001:2015 certification: Mixing bags are manufactured in an ISO 9001:2015 certified facility that adheres to a documented, auditable quality management process.
  • Extractables and leachables (E&L) data available for film: E&L data is available for the bag film, supporting quality team review for IND filings, BLA submissions and routine change control.
  • Gamma irradiation validation: Entegris sterilizes single-use mixing bags and associated components using gamma irradiation between 25-40 kGy as standard, unless otherwise requested, providing sterility assurance for ready-to-use deployment.
  • Full traceability for all materials: Raw material and component traceability allows you to respond to audit queries and deviation investigations.
  • Certificates of Analysis provided for each lot: This documentation provides a ready-made data package for submissions and routine change control.

Typical Applications for the Entegris Mixing System

The Entegris Mixing System is suitable for various uses:

  • Buffer preparation: Achieve homogeneous buffer blending for downstream chromatography and filtration steps.
  • Media preparation: Whether working with liquid concentrates or powdered formulations, the recirculation design delivers uniform nutrient distribution and increased dissolution efficiency, reducing preparation time and batch-to-batch variability.
  • Recirculation of homogeneous solutions: Maintain solution uniformity throughout in-process hold and transfer steps. Continuous recirculation can prevent settling, stratification and concentration gradients for the duration of the hold period.
  • Liquid-to-liquid mixing: Blend miscible process liquids, minimize stratification in large-volume uses and support concentration uniformity.
  • Powder-to-liquid operations: Accelerate dissolution of dry media powders and buffer salts using the System’s directed nozzle action.

Choosing the Right Mixing System

Since single-use mixing systems often provide bag assemblies in different sizes, identifying your working volume range before ordering enables more efficient mixing and minimizes holdup losses at the end of each run. Thermal requirements are also worth considering. If your application involves temperature-sensitive materials or requires controlled storage conditions during mixing, choose a system that offers a temperature-controlled tank.

Take the Next Step

Experience the benefits of recirculation-based mixing with the Entegris Mixing System. Contact Sentinel Process Systems today to speak with an expert about your application needs.

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