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Case 07

Pharmaceutical

High-Torque Mixing Solution for High-Viscosity Filler Production for Cartilage and Plastic Surgery Applications

Project Overview

Company G, specializing in human tissue repair and aesthetic medical devices, manufactures high-viscosity fillers used for shoulder cartilage regeneration and cosmetic surgery applications. Due to the nature of the high-viscosity process, the material instantly changes into a gel-like form with a viscosity of tens of thousands of cP as soon as the raw materials are introduced.
The existing impeller was repeatedly damaged because it could not withstand the high load. To handle the extreme torque requirements while ensuring the highest level of uniformity and biocompatibility required for injectable materials, Company G selected SEDNA ENG’s powerful magnetic mixing solution.

Challenges

1. Instant High-Viscosity Change and Torque Load

Immediately after the cross-linker is added, the filler material rapidly changes from a liquid into a gel-like form within seconds. If the mixer cannot withstand the extreme viscosity resistance and torque load generated at this stage, serious issues such as mixing stoppage may occur.

2. Limitations of Conventional Turbulent Mixing

High-viscosity materials cannot be properly mixed with a conventional propeller, which may simply rotate without generating effective mixing. A special low-speed, high-torque blade was essential to move the entire material, including the material adhered to the tank wall.

3. Biocompatibility for Implantable Materials

As the product is directly injected into the human body, even the smallest impurities or extractables were not acceptable. All wetted parts had to meet USP Class VI medical-grade requirements.

SEDNA Solution

1. High-Torque SRFT Magnetic Mixer

SEDNA ENG selected the SRFT model, optimized for high-viscosity processes. Even during rapid viscosity changes, the mixer successfully delivered massive torque without magnetic decoupling.

2. Helical Ribbon Blade (High-Viscosity Mixing Blade)

A large helical ribbon blade was applied to achieve effective laminar flow mixing, rather than turbulent mixing. Its spiral structure continuously moves material from the tank wall toward the center and lifts material from the bottom to the top, achieving complete mixing without dead zones.

3. USP Class VI Certified Materials

All wetted elastomers, including O-rings, were made only with USP Class VI certified materials. This ensures excellent biocompatibility by preventing harmful extractables, even under harsh process conditions.

PROBLEM

SOLUTION

  • Results

01

Perfect Mixing
in High Viscosity

The helical ribbon blade and powerful torque maintained a uniform mixing state even when the material instantly transformed into a gel-like form, resulting in zero defects.

02

Biocompatible
& Safe

USP Class VI certified materials fundamentally blocked extractables and leachables risks, meeting the strictest medical device approval standards.

03

Stable
Operation

Stable operation was achieved without shutdowns, even under sudden load fluctuations, ensuring reliability in continuous production processes.
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