Single-Use Diaphragm Valve for Sterile Pressure and Flow Control
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Solution Overview
Problem
Chemical and biological manufacturing processes require valves that can control pressure and flow across wide ranges while maintaining sterility, which existing valves struggle to achieve due to the need for heavy, expensive materials that resist operating pressures and ensure accurate pressure control in biopharma processes.
Innovation Solution
A valve design utilizing a direct-sealing diaphragm with a centerbody assembly and enclosure assembly, where the flexible control diaphragm is bonded to the centerbody to create a seal, allowing for fluid control and pressure regulation while minimizing material usage and waste, suitable for single-use applications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If heavy stainless steel materials are used to maintain sterile conditions and resist operating pressures, then reliability and pressure resistance are improved, but weight and cost increase
Solution Approach 1:
The valve is divided into multiple sterilizable components including a centerbody, diaphragm, and top cap that can be separately sterilized and assembled, allowing lightweight materials to be used while maintaining sterility requirements through component-level sterilization protocols
Solution Approach 2:
A flexible diaphragm made from lightweight materials such as elastomers or polymers is used instead of rigid stainless steel components, enabling the valve to maintain pressure resistance and sterility while significantly reducing weight
2Reliability
If heavy stainless steel materials are used to maintain sterile conditions and resist operating pressures, then reliability and pressure resistance are improved, but manufacturing cost increases
Solution Approach 1:
The valve utilizes composite construction combining lightweight polymers, elastomers, and select metal components only where absolutely necessary, achieving pressure control accuracy and sterility maintenance while reducing material costs associated with full stainless steel construction
Solution Approach 2:
The valve is designed as a single-use disposable component that can be sterilized and discarded after one use, eliminating expensive cleaning and validation overhead associated with reusable stainless steel valves while maintaining pressure control accuracy during its service life
3Measurement precision
If traditional control valves are used to control pressure and flow, then pressure control is achieved, but flow range ratio is limited to approximately 20:1
Solution Approach 1:
The valve incorporates a dynamic diaphragm-based flow control mechanism that can adapt to a wide range of flow conditions, enabling a flow range ratio exceeding 20:1 while maintaining precise pressure control through the elastic deformation characteristics of the diaphragm material
4Ease of manufacture
If reusable valves are used in biopharmaceutical manufacturing, then initial investment is reduced, but overhead costs for cleaning and validation increase
Solution Approach 1:
The valve is designed as a single-use disposable component that can be sterilized and discarded after one use, eliminating expensive cleaning and validation overhead associated with reusable valves while maintaining pressure control accuracy during its service life
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 valve effectively controls pressure and flow across wide ranges while maintaining sterility, reducing overhead costs and waste by using lightweight, USP class VI certified materials, making it suitable for biopharma processes and single-use applications.
Implementation Method 1
a perimeter of the control diaphragm is bonded to the centerbody so as to define a seal that blocks the passage of fluid
Implementation Method 2
the control diaphragm is positioned between the centerbody and the top cap, and arranged such that, when the reference pressure is higher than the process pressure the diaphragm is engaged with the at least one outlet orifice, and when the process pressure is higher than the reference pressure, the diaphragm is not engaged with the at least one outlet orifice
Data Source
AI summary
A centerbody assembly for a valve includes: a centerbody having a process surface, at least one inlet orifice disposed in the centerbody and adapted to be disposed in fluid communication with a fluid at a process pressure, and at least one outlet orifice disposed in the centerbody separate from the at least one inlet orifice; an inlet port disposed in fluid communication with the at least one inlet orifice; an outlet port disposed in fluid communication with the at least one outlet orifice; and a flexible control diaphragm facing the process surface, wherein a perimeter of the control diaphragm is bonded to the centerbody so as to define a seal that blocks the passage of fluid.