Disposable Gauge Tee with Biocompatible Protector for Minimal Hold-Up Volume
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Solution Overview
Problem
Current devices for measuring pressure in disposable tubing are not reliable, require calibration, and can contaminate biopharmaceutical products due to metal contact, and have significant hold-up volume, making them unsuitable for biopharmaceutical processes.
Innovation Solution
A disposable sanitary gauge tee with a biocompatible gauge protector isolates fluid from a stainless steel pressure gauge, allowing for aseptic pressure monitoring with minimal hold-up volume, and can be sterilized for use in biopharmaceutical processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If a stainless steel gauge is used for pressure measurement, then durability and reusability are improved, but contamination of biopharmaceutical products occurs due to metal contact
Solution Approach 1:
A biocompatible gauge protector (isolation media) is introduced as an intermediary between the stainless steel gauge and the biopharmaceutical fluid. This protector diaphragm allows pressure transmission while preventing direct contact between the metal gauge and the product, thereby eliminating contamination risk while maintaining gauge reusability.
Solution Approach 2:
The gauge protector is made of a flexible, biocompatible membrane or diaphragm that transmits pressure forces from the fluid to the gauge while acting as a barrier. This thin film structure enables mechanical force transmission while preventing contamination, resolving the contradiction between gauge durability and product safety.
2Strength
If a traditional gauge tee with stainless steel body is used, then structural strength is improved, but hold-up volume increases significantly (5-50 mL)
Solution Approach 1:
The gauge tee device is segmented into a reusable stainless steel body (for structural strength) and a disposable portion containing the fluid path and gauge protector (for minimal hold-up volume). This segmentation allows the strong metal structure to be separated from the fluid-contacting components, reducing overall hold-up volume while maintaining structural integrity where needed.
Solution Approach 2:
The fluid-path portion of the gauge tee is made disposable with minimal hold-up volume, while only the robust stainless steel body is reused. This approach eliminates the need to reuse large-volume components, reducing contamination risk and hold-up volume while maintaining structural strength in the reusable portion.
3Ease of manufacture
If disposable pressure sensors with luer lock fitting are used, then cost is reduced and sterilization is simplified, but calibration before use becomes impossible
Solution Approach 1:
The gauge protector and disposable gauge tee are pre-sterilized and pre-assembled before use. The reusable stainless steel gauge is calibrated separately in advance, and the disposable components are designed to interface with it. This preliminary preparation allows sterilization of disposable parts without affecting gauge calibration, resolving the contradiction between ease of sterilization and calibration capability.
4Measurement precision
If a gauge with large body size is used for pressure measurement, then gauge readability is improved, but hold-up volume increases
Solution Approach 1:
The system is segmented into a small disposable gauge tee (minimal hold-up volume) and a separate reusable gauge with optimal size for readability. This separation allows the gauge body size to be optimized for measurement precision without being constrained by the hold-up volume of the disposable fluid-path component.
Data Source
AI summary
A disposable sanitary gauge tee with no dead zone for use in pressure measurement of fluid in disposable tubing including a body having a main fluid passageway in fluid connection with a proximal end of a pressure fluid passageway, the main fluid passageway including a fluid port and a second fluid port, wherein a hose barb is operatively attached to the body at the fluid port and the second fluid port, wherein the disposable tubing can be removably attached to the hose barbs, and the pressure fluid passageway including a distal end for removable attachment of a sanitary pressure gauge and a biocompatible gauge protector for isolation of the fluid from the sanitary pressure gauge. No dead zone is achieved within the gauge tee as the proximal end of the pressure fluid passageway is substantially the same diameter as the distal end of the pressure fluid passageway, therein providing a total transfer of fluid within the pressure fluid passageway during fluid flow. A method of measuring pressure of fluid within disposable tubing using the disposable sanitary gauge tee and a method of measuring pressure of fluid in a closed system are further included.