Dome-Loaded Pressure Regulator With Bonded Diaphragm for Single Use
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Solution Overview
Problem
Existing pressure regulators in bio-pharma industries face high overhead costs due to cleaning and validation requirements, necessitating a design suitable for single-use applications that minimizes material waste and ensures sterility.
Innovation Solution
A pressure reducing regulator utilizing a ball as a valve element in conjunction with a diaphragm for pressure sensing, featuring a centerbody assembly with a valve chamber, outlet and inlet ports, and a flexible control diaphragm bonded to the centerbody, allowing for a simple, economical, and disposable design.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional pressure regulators are used in bio-pharma industries, then pressure control function is achieved, but overhead costs increase due to cleaning and validation requirements
Solution Approach 1:
The patent applies the disposable principle by designing a pressure regulator intended for single-use applications in bio-pharma industries. The entire regulator assembly including centerbody, valve elements, and housing is designed as a disposable unit that is discarded after one use, eliminating the need for cleaning and validation overhead while maintaining sterility. This is explicitly stated in the background section which identifies the need to reduce overhead costs associated with cleaning and validation of sterile work environments.
2Ease of manufacture
If a disposable design is implemented, then cleaning and validation overhead is reduced, but device complexity must be managed for single-use compatibility
Solution Approach 1:
The patent applies segmentation by dividing the pressure regulator into distinct functional components: a centerbody assembly containing the valve mechanism, a housing, and associated elements. This segmentation allows each component to be optimized for single-use compatibility while maintaining overall functional simplicity. The centerbody assembly is designed as a separate disposable unit that can be manufactured independently and assembled with the housing.
Solution Approach 2:
The patent merges multiple functions into the disposable centerbody assembly, combining the valve body, valve seat, and valve elements into a single integrated component that is discarded with the housing. This merging simplifies the overall design by eliminating the need for separate reusable and disposable components, reducing assembly complexity while maintaining single-use compatibility.
3Reliability
If a ball valve element is used, then valve performance is improved, but manufacturing precision requirements increase
Solution Approach 1:
The disposable nature of the regulator allows for the use of ball valve elements with standard manufacturing tolerances. Since the entire assembly is discarded after one use, there is no need for high-precision machining that would be required for reusable valves. The ball valve can be manufactured using cost-effective processes such as molding or simple machining, and its performance is sufficient for single-use applications without requiring ultra-precise fabrication.
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 solution provides a cost-effective, single-use pressure regulator that maintains sterility and reduces material waste, with components compatible with bio-pharma processes and capable of withstanding pressures up to 1000 kPa (150 psi) while ensuring minimal pressure pulsations and compliance with industry standards.
Implementation Method 1
a diaphragm for pressure sensing
Implementation Method 2
a flexible control diaphragm facing the process surface
Implementation Method 3
a spherical valve element disposed in the valve chamber and moveable between an open position in which it is spaced away from the valve seat, and a closed position in which it seals against the valve seat
Implementation Method 4
wherein the perimeter of the control diaphragm is bonded to the centerbody so as to define a seal that blocks the passage of fluid
Data Source
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AI summary
A centerbody assembly for a pressure regulator includes: a centerbody having a process surface, at least one outlet orifice disposed in the centerbody; an outlet port positioned in fluid communication with the at least one outlet orifice; an inlet port; a valve chamber positioned in the centerbody in fluid communication with the inlet port, the valve chamber including a valve seat positioned in fluid communication with the process surface; a spherical valve element disposed in the valve chamber and moveable between an open position in which it is spaced away from the valve seat, and a closed position in which it seals against the valve seat; 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; and wherein the valve element is mechanically interconnected with the control diaphragm.