Single-Use Mixing Study
Researchers tested three mixers in the same bottles, on the same drive: a conventional magnetic stirrer, a bottom-mounted single-use mixer, and a top-mounted one with a fixed baffle. They measured how long each took to dissolve a salt load. They measured how much damage each did to a model protein over four hours. The paper runs fourteen pages in the Journal of Pharmaceutical Sciences.
ten23 health AG, Basel, Switzerland. Andrea Allmendinger is additionally affiliated with the Institute of Pharmaceutical Sciences, University of Freiburg.
Ali D, Plaga JF, Adler M, Mahler HC, Allmendinger A. J Pharm Sci. 2026;115:104448. Published by Elsevier Inc. on behalf of the American Pharmacists Association. DOI: 10.1016/j.xphs.2026.104448
A Few Questions the Study Answers
- How much faster is a purpose-designed mixer at matched tip speed, and how wide is the spread?
- Which variables actually move dissolution time?
- Which variables move protein quality?
- Does running faster cost product?
- What happens at low fill volume, and what happens at high?
- Why does any of it happen?
Mixed4Sure Single-Use Mixing Systems
Two of the mixers evaluated in the study are the Mixed4Sure bottom-mounted mixer and the Mixed4Sure top-mounted mixer, both run in standard PharmaTainer bottles.
Both are magnetically coupled with a suspended mixing device. The bottom-mounted unit uses a four-blade impeller across bottle formats from 0.5 to 20 liters. The top-mounted unit pairs a large bar-style impeller with a fixed baffle, and is offered in the larger formats where water contact does the most work.
To learn more about these products and how either behaves at your fill volume or with your formulation, contact us or explore more.
Requesting the Single-Use Mixing Study
What exactly do I receive?
The complete 14-page paper as a PDF, exactly as published in the Journal of Pharmaceutical Sciences. It is delivered on the next page immediately after the form, and a copy is also sent by email. It includes both regression tables, the dissolution and protein data, the flow simulation figures, the authors’ limitations, and the funding and competing-interest statements.
Which mixing systems does the study compare?
Three. A conventional magnetic stirrer, a bottom-mounted four-blade single-use mixer operating between 200 and 600 rpm, and a top-mounted bar impeller with an integrated fixed baffle operating between 80 and 400 rpm. All three were magnetically coupled with suspended mixing devices, run in the same PharmaTainer bottles on the same stirrer plate, and compared at matched tip speed rather than matched rotational speed.
What scale does the single-use mixing study cover?
Four PharmaTainer bottle sizes: 0.5, 2, 5 and 20 liters, at fill volumes from 0.1 to 20 liters. The magnetic stirrer and the bottom-mounted mixer were tested across all four sizes. The top-mounted mixer is only available in larger formats, so it appears in the 5 L and 20 L configurations only.
Does the study cover my formulation?
Almost certainly not, and the report says so. The experimental protein was lysozyme at 0.1 mg/mL in phosphate buffer with polysorbate 80, held at 72 °C, and the flow simulations used aqueous fluid properties rather than real formulation viscosity. Lysozyme is a surrogate chosen because it is known to be sensitive to mixing at that temperature. The study characterises mixing behaviour; it does not predict the stability of a specific therapeutic protein.
Who is this report for?
Process development, MSAT, and fill and finish teams selecting or defending a mixing system, and qualification and validation groups who need to establish which conditions a published comparison actually covers before citing it. It assumes familiarity with mixing terminology such as tip speed and impeller-to-bottle diameter ratio, and it reports statistics rather than summarising them.