Biotech Sensor Fitting for Contamination-Free Process Bags
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Solution Overview
Problem
In biopharmaceutical processes, there is a need for accurate measurement of fluid conductivity and temperature within flexible, single-use process bags without contaminating the environment, as traditional sensors are bulky, intrusive, or incompatible with sterilization methods, and adhesives are not suitable for contamination-free environments.
Innovation Solution
A sensor fitting with probes is designed for easy connection to a flexible film process bag, using a port plate with various attachment mechanisms such as threaded, snap-fit, or O-ring seals, allowing for secure and removable installation of conductivity and temperature sensors compatible with gamma or ethylene oxide sterilization.
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 device becomes bulky and intrusive in lightweight flexible tubing applications
Solution Approach 1:
The patent extracts the sensing function from the traditional in-line gauge and integrates it directly into the port plate structure. The port plate now contains both the sealing function and the conductivity sensing capability, eliminating the need for separate bulky in-line gauges in the flexible tubing system.
Solution Approach 2:
The patent combines multiple functions into the port plate: sealing (via O-ring), fluid connection, and conductivity measurement. This integration reduces the number of separate components and eliminates the need for intrusive in-line gauges, directly resolving the contradiction between measurement capability and device complexity.
2Measurement precision
If traditional gauges are inserted into vessel ports for measurement, then conductivity and temperature can be measured, but this approach is not optimal for lightweight collapsible thin-walled vessels
Solution Approach 1:
The port plate acts as an intermediary structure that provides a standardized interface between the flexible vessel and the sensor assembly. This mediator enables easy installation and removal of sensors without directly inserting them into the thin-walled vessel, resolving the contradiction between measurement capability and ease of operation.
Solution Approach 2:
The patent segments the measurement system into modular components: the port plate (attached to vessel), the sensor fitting, and the sensor elements. This segmentation allows the sensor assembly to be easily installed and removed as a unit through the port plate, improving ease of operation for lightweight vessels.
3Reliability
If adhesives or glues are used to attach sensors to process bags, then secure attachment is achieved, but this introduces contamination risk and is incompatible with sterilization processes
Solution Approach 1:
The patent replaces chemical bonding (adhesives/glues) with mechanical sealing methods. The O-ring provides secure attachment through mechanical compression and sealing, eliminating the need for adhesives that could contaminate the process fluid or interfere with sterilization, thus resolving the contradiction between attachment security and contamination prevention.
4Reliability
If heat sterilization temperatures are applied to process bags, then sterilization is achieved, but sensors made of certain polymers cannot withstand these temperatures
Solution Approach 1:
The patent designs the sensor assembly and port plate as disposable components that are sterilized together with the process bag using gamma or ETO methods. This approach eliminates the need for sensors to withstand high heat sterilization temperatures, as the entire assembly is sterilized using low-temperature methods compatible with polymeric materials, resolving the contradiction between sterilization effectiveness and material compatibility.
5Measurement precision
If sensors are permanently installed in process bags, then continuous measurement is achieved, but this reduces ease of removal and reusability
Solution Approach 1:
The patent creates a dynamic system where the sensor assembly can be easily installed and removed from the port plate during the process. The O-ring seal provides sufficient sealing for continuous measurement while allowing the sensor to be removed and replaced as needed, resolving the contradiction between continuous measurement capability and ease of removal/reusability.
Data Source
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.