O-Ring-Sealed Sensor Fitting for Biotech Process Bags
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Solution Overview
Problem
Existing fluid handling systems in biotechnology face challenges in measuring fluid characteristics like conductivity and temperature within biotech process bags due to bulky in-line gauges, contamination risks, and incompatibility with single-use bags and sterilization methods, necessitating a sensor that is easily removable, compatible with gamma or ETO processing, and maintains a contamination-free environment.
Innovation Solution
A sensor fitting with probes and a threaded, snap-fit, or detent structure for secure attachment to a port plate, using high-performance polymers and O-rings for a fluid-tight seal, allowing easy installation and removal while maintaining sterility and compatibility with biotech process bags.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional in-line gauges are used to measure conductivity in fluid streams, then measurement capability is provided, but the devices become bulky, weighty, and too intrusive for lightweight flexible tubing
Solution Approach 1:
The patent employs a single-use sensor designed for disposable application in biotech processes. The sensor is intended to be used once and then discarded, eliminating the need for sterilization and complex cleaning procedures. This disposable approach allows for a simpler, lighter sensor design that can be easily attached to flexible tubing without the weight and complexity constraints of reusable sensors.
Solution Approach 2:
The sensor is divided into separate functional components including a body portion, probe elements, and attachment mechanisms. This segmentation allows each component to be optimized independently - the probe for measurement, the body for housing, and the attachment portion for secure mounting - resulting in a lighter overall design compared to traditional integrated in-line gauges.
2Measurement precision
If traditional gauges are inserted into vessel ports to measure conductivity and temperature, then measurement capability is provided, but the insertion into lightweight collapsible thin-walled vessels is not optimal
Solution Approach 1:
The sensor incorporates a flexible, collapsible body portion that can dynamically adapt to the vessel port opening size. This dynamic design allows the sensor to be easily inserted into lightweight collapsible vessels without requiring rigid mounting structures or complex installation procedures, significantly improving ease of operation compared to traditional fixed-design gauges.
Solution Approach 2:
The sensor body is constructed using flexible polymeric materials that can conform to the vessel port geometry. This flexible shell design eliminates the need for rigid mounting brackets or complex sealing mechanisms, allowing simple insertion and secure attachment to thin-walled vessels while maintaining measurement accuracy.
3Measurement precision
If sensors made with polymers that cannot be heat sealed are used, then measurement capability is provided, but the sensors cannot be securely attached to film material in single-use bags
Solution Approach 1:
The sensor body is made from polymeric materials specifically selected for their compatibility with heat sealing processes. By changing the material parameters (selecting polymers with appropriate melting points and sealing characteristics), the sensor body can be heat-sealed directly to the flexible tubing or vessel port, providing reliable attachment without requiring adhesives or mechanical fasteners that could contaminate the process fluid.
Solution Approach 2:
The sensor employs composite construction combining polymer materials for the body with metal or conductive materials for the probe elements. This composite approach allows the polymer body to provide heat-sealable attachment capability while the embedded conductive elements maintain measurement functionality, solving the contradiction between attachability and measurement capability.
4Reliability
If adhesives or glues are used to attach sensors to film material, then attachment is achieved, but contamination-free environments are compromised and adhesion may fail under sterilization conditions
Solution Approach 1:
The patent replaces chemical adhesion (adhesives/glues) with thermal bonding (heat sealing) to attach the sensor to the flexible tubing or vessel port. This mechanical/thermal bonding method eliminates the introduction of adhesives that could contaminate the process fluid or fail under sterilization conditions, while still providing reliable attachment that can withstand gamma or ETO sterilization processes.
5Object-affected harmful factors
If sterilization is required for critical processes, then contamination-free environment is maintained, but many single-use process bags are not compatible with heat sterilization temperatures requiring gamma or ETO processing
Solution Approach 1:
The sensor is designed with universal compatibility across multiple sterilization methods including gamma irradiation, ethylene oxide (ETO) gas sterilization, and heat sealing processes. The polymeric materials and construction are selected to withstand these sterilization conditions without degradation, making the sensor adaptable to various single-use bag sterilization protocols and enhancing its versatility for different biotech applications.
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 sensor fitting provides accurate measurement of fluid properties within biotech process bags, ensuring sterility and compatibility with sterilization processes, while being universally adaptable and cost-effective.
Implementation Method 1
an O-ring is provided between the sensor fitting and the port plate so as to provide a fluid-tight seal therebetween
Implementation Method 2
the body portion of the sensor fitting includes a threaded portion for threadable engagement with a threaded portion provided in the receptacle of the port plate
Data Source
Figure 1~2
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AI summary
A fluid process application bag includes a flexible film body having an opening, a port plate sealed around the opening of the flexible film body, a sensor fitting and a sensor contained within the sensor fitting. The port plate has a receptacle defining a passage in fluid communication with an interior of the flexible film body and the sensor fitting has a body portion seated within the passage of the receptacle and is coupled to the receptacle. The sensor has at least one probe communicating with the interior of the flexible film body. A collar includes first and second semi-circular members that are connected via a living hinge.