Integral Membrane Pressure Cup for Sterile Tubing Sensing
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Solution Overview
Problem
Conventional manufacturing processes for pharmaceuticals and biologics require cumbersome and complex systems with numerous conduits, valves, and sensors, which are difficult to sterilize and replace, leading to contamination risks and high costs.
Innovation Solution
A tubing assembly with an integrally formed pressure cup and membrane, allowing pressure sensing without direct sensor exposure to the system fluid, formed via injection molding for single-piece construction and sterilization suitability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If sensors are placed directly along the production stream to monitor process variables, then measurement precision is improved, but the risk of contamination increases and sterilization becomes more difficult
Solution Approach 1:
The system divides the sensing function into separate components: a pressure sensor housed in a sterile barrier membrane that prevents direct contact with the production stream. The membrane acts as a segmentation boundary, allowing pressure transmission while blocking contamination pathways.
Solution Approach 2:
A sterile barrier membrane serves as an intermediary between the pressure sensor and the production stream. This intermediary transmits mechanical pressure from the fluid while preventing direct contact, thereby eliminating contamination risk while maintaining measurement capability.
2Adaptability or versatility
If multiple individual components (conduits, valves, sensors) are used in the system, then measurement and control capabilities are improved, but device complexity increases
Solution Approach 1:
The pressure sensor, membrane, and housing are merged into a single integrated assembly that can be sterilized as one unit. This combining of components reduces the number of separate parts needing sterilization and simplifies system architecture while maintaining full monitoring capability.
Solution Approach 2:
The integrated sensor assembly serves multiple functions: pressure sensing, sterilization containment, and direct integration into the production stream. This multi-functionality eliminates the need for separate components for each function, reducing overall system complexity.
3Adaptability or versatility
If sensors are replaced when malfunctioning or when product requirements change, then adaptability is improved, but loss of time and cost increase
Solution Approach 1:
The integrated sensor assembly is designed as a disposable component that can be pre-sterilized and replaced as a single unit. This approach eliminates the time-consuming process of sterilizing individual sensors and ensures consistent performance for each production batch.
Solution Approach 2:
The sensor assembly is pre-assembled and pre-sterilized before use, with all components permanently bonded together. This preliminary preparation eliminates on-site assembly and sterilization steps, reducing replacement time and ensuring sterility is maintained.
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
Reduces contamination risks and simplifies sensor integration, enabling efficient and cost-effective monitoring of process variables while ensuring sterility and reducing material complexity.
Implementation Method 1
a flat membrane member configured to engage a diaphragm of a pressure transmitter to transmit a pressure of a fluid disposed within the pressure cup portion to said diaphragm
Data Source
AI summary
A tubing assembly includes first and second tubing segments, and a pressure cup portion formed between the first and second tubing segments. The pressure cup portion has a first open lateral side, and a second closed lateral side including a flat membrane member configured to engage a diaphragm of a pressure transmitter to transmit a pressure of a fluid disposed within the pressure cup portion to said diaphragm. The flat membrane member is integrally formed with the pressure cup portion. A mold for forming the tubing assembly, and a pressure sensing system includes the tubing assembly, a housing portion, and a pressure sensor receivable within the housing to position a diaphragm of the pressure sensor directly adjacent to the flat membrane member of the tubing assembly.