Small-Scale 3D Printed Mixer for Pharmaceutical Shear Stress Testing
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Solution Overview
Problem
Current methods for studying the effects of shear stress on pharmaceutical products are economically inefficient due to the large volumes of material required and the high costs of expensive pharmaceutical materials, as well as the short timeline for completing these studies.
Innovation Solution
The development of a small-scale mixer system using 3D printing technology, which replicates the mixing operations of a larger mixer, allowing for more economical and efficient testing of pharmaceutical products by reducing material usage and shortening the testing time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If large volumes of material are used for shear stress studies, then the accuracy and reliability of study results are improved, but the cost and time required for the studies increase significantly
Solution Approach 1:
The patent creates a scaled-down replica mixer (small-scale mixer) that copies the essential mixing characteristics and shear stress profile of a full-scale industrial mixer. By using geometric scaling principles and maintaining similar mixing dynamics, the small-scale mixer enables accurate shear stress studies with minimal material consumption while preserving the reliability of study results.
2Reliability
If large volumes of material are used for shear stress studies, then the accuracy and reliability of study results are improved, but the time required to complete the studies increases
Solution Approach 1:
The small-scale mixer replica enables accelerated testing by maintaining geometric and dynamic similarity to full-scale mixers while operating with much smaller volumes. This copying approach allows rapid iteration and completion of shear stress studies without sacrificing the accuracy needed for reliable process development decisions.
3Device complexity
If traditional mixing equipment is used, then the mixing operation is simple and device complexity is low, but shear stress risks to biopharmaceutical products increase
Solution Approach 1:
The patent modifies mixing parameters by using a magnetically driven impeller system that enables precise control of mixing speed, acceleration, and shear rate profiles. By changing the driving mechanism from traditional mechanical transmission to magnetic coupling, the system achieves lower and more controllable shear stresses while maintaining effective mixing, thereby protecting sensitive biopharmaceutical products from degradation.
4Reliability
If expensive pharmaceutical materials are used in large quantities for studies, then comprehensive testing is achieved, but the economic efficiency of the manufacturing process deteriorates
Solution Approach 1:
The small-scale mixer replica enables comprehensive pharmaceutical testing to be conducted with minimal material consumption. By creating a functional copy that preserves the essential mixing characteristics, the system maintains the reliability and completeness of testing while dramatically reducing the quantity of expensive pharmaceutical materials required, thereby improving economic efficiency.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The small-scale mixer system enables cost-effective and time-efficient characterization of pharmaceutical products, minimizing the risks of degradation and immune response associated with shear stress, while maintaining the accuracy of mixing conditions compared to larger mixers.
Implementation Method 1
at least one three-dimensional printer, configured to produce a first and second set of components with a respective first and second quality attribute of the small scale-mixer that replicate operation of corresponding components of the second mixer
Implementation Method 2
at least one smoothing apparatus configured to smooth a surface of the components of the small-scale mixer produced by the at least one-three dimensional printer
Implementation Method 3
a fusing apparatus configured to fuse the smoothed components of the small-scale mixer to produce the small-scale mixer
Data Source
AI summary
Disclosed herein are systems and methods for producing a small-scale mixer based on an at-scale mixer that may be used for pharmaceutical product manufacturing. In particular, disclosed herein are methods that involve use of a three-dimensional printer to produce components of the small-scale mixer, a smoothing apparatus to smooth a surface of the small-scale mixer, and a fusing apparatus to fuse the components of the small scale-mixer to produce the small-scale mixer.