Self-Aligning Coupling for Biopharmaceutical Mixing Systems
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Solution Overview
Problem
Conventional mixing systems in the biopharmaceutical industry require extensive cleaning and sterilization, which is labor-intensive, costly, and poses challenges in maintaining sterility, especially for producing smaller batches.
Innovation Solution
The development of a mixing system with self-aligning coupling systems and disposable, flexible container components that minimize cleaning and sterilization needs, utilizing a drive shaft with a self-aligning coupling mechanism and flexible, sterilizable containers made from materials like polyethylene and polyester elastomer, allowing for easy assembly and disposal after use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional mixing systems use rigid tank structures with sealed closures, then sterility can be maintained, but cleaning and sterilization become labor-intensive and costly
Solution Approach 1:
The mixing system is divided into reusable rigid components (drive shaft, motor mount) and disposable flexible components (container, impeller assembly). This segmentation allows the disposable parts to be discarded after sterilization rather than repeatedly cleaned, reducing labor while maintaining sterility for the reusable parts.
Solution Approach 2:
The flexible container and impeller assembly are designed as disposable components made from sterilizable materials. After one use and sterilization, these components are discarded rather than cleaned again, eliminating repetitive cleaning labor for parts that contact the mixture while preserving the reusable rigid structure.
2Object-affected harmful factors
If mixing systems require extensive cleaning between batches, then cross-contamination is prevented, but productivity decreases due to time-consuming maintenance
Solution Approach 1:
By segmenting the system into reusable and disposable components, the disposable parts (container, impeller) can be discarded after sterilization to prevent cross-contamination, while the reusable parts undergo simplified cleaning. This reduces total maintenance time and increases batch processing efficiency.
Solution Approach 2:
The system discards disposable flexible components after single-use sterilization to prevent cross-contamination, while recovering and reusing the rigid components after minimal cleaning. This approach maintains contamination prevention while improving productivity by eliminating extensive cleaning cycles.
3Ease of operation
If self-aligning coupling mechanisms are added to the drive shaft, then assembly ease is improved, but device complexity increases
Solution Approach 1:
The coupling mechanism uses asymmetric geometric features (protrusions and recesses) on the drive shaft that automatically align with corresponding features on the impeller assembly. This asymmetric design provides self-alignment during assembly, improving ease of operation while adding minimal complexity through simple geometric modifications.
Data Source
AI summary
A shaft coupling assembly includes a hub bounding an opening. The interior surface of the hub includes an annular coupling surface and a receiving surface, the receiving surface sloping away from opening. An alignment rib projects from the receiving surface into the opening. An elongated shaft includes a driver that is configured to be received within the opening of the hub. The driver has an exterior surface that includes an annular engaging surface, a guide surface, and a guide rib radially, outwardly projecting from the guide surface. The guide rib is configured such that when the driver is being inserted within the opening with the guide rib being aligned with the alignment rib, the guide rib contacts the alignment rib so that the guide rib must be offset from the alignment rib before the driver can be fully received within the opening.