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title: SaniSure_CP_BrandedContent_Oct2026_LandingPage
description: A peer-reviewed study compares single-use mixer designs, showing how impeller geometry and tip speed affect dissolution time and protein integrity in biologics.
---

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Not All Mixers Are Created Equal: A Data-Driven Look at Mixing and Protein Integrity

### What’s Inside?

Mixing sounds simple — until it's your biologic drug product on the line.

Mixing supports nearly all critical unit operations in drug product manufacturing, yet most teams choose a single-use mixer based on habit, vendor relationship, or "it's what we've always used." A new peer-reviewed study, published in the Journal of Pharmaceutical Sciences, put that assumption to the test.

Researchers compared SaniSure's Mixed4Sure bottom-mounted impeller design against a conventional top-mounted impeller and a standard magnetic stirrer, across container sizes from 0.5 L to 20 L. Using conductivity-based dissolution timing, HPLC purity, protein inactivation kinetics (via a model protein, lysozyme), and CFD-modeled shear patterns, the study measured not just how fast each system mixes — but what that mixing does to a sensitive protein along the way.

The results were clear: mixer geometry and tip speed aren't just performance variables, they're product-quality variables. Statistical modeling (R² = 0.84 for dissolution time, R² = 0.99 for mechanical stress) showed that impeller design and impeller-to-vessel ratio predict both mixing speed and protein stress — with magnetic stirring falling behind on both fronts, especially at larger volumes.

What the data reveals:

- How much faster is a purpose-designed mixer at matched tip speed, and how wide is the spread?
- Which variables actually move dissolution time — and which move protein quality?
- Does running faster cost product?
- What happens at low fill volume vs. high?
- Why does any of it happen?

Formulation and process development scientists will walk away with a statistically validated, data-backed framework for choosing and scaling single-use mixers for mechanically sensitive biologics — not as an afterthought, but as a scale-up decision that directly affects product quality.

**Fill out the form to download the full study.** 

### Send me the study!

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