Aseptic Probe Assembly for Bioreactor Sensor Insertion
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Solution Overview
Problem
There is a challenge in sterilly inserting sensors into flexible disposable bioreactor bags or tubing used in biopharmaceutical manufacturing, as existing methods fail to ensure a clear signal transmission and often damage the sensor, making it difficult to obtain real-time data and requiring costly sterilization processes.
Innovation Solution
A probe assembly with a distal aseptic connector and a rigid probe sheath that allows longitudinal movement of the probe body, enabling aseptic insertion and removal of sensors from flexible or semi-rigid vessels or tubing, along with methods for forming a welded flexible tubing to facilitate sensor insertion without damaging the sensor.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a sensor is inserted into a flexible bioreactor bag or tubing, then real-time data can be obtained, but the sensor may be damaged during insertion or removal
Solution Approach 1:
A rigid insertion tool with a hollow needle or tapered bore acts as an intermediary device to facilitate sensor insertion into flexible bioreactor bags or tubing. The tool provides structural support during insertion, preventing sensor damage while enabling access to the flexible container. The sensor is inserted through the rigid tool's opening, which maintains its shape and protects the sensor during the procedure.
2Reliability
If sterilization processes are applied to sensors for reuse, then infection risk is reduced, but sensor damage and cost increase
Solution Approach 1:
The system is divided into disposable and reusable components. The bioreactor bag or tubing with the sensor inserted is designed as a disposable unit that can be sterilized as a complete assembly, while the sensor itself can be protected within a sterile barrier or inserted through a sterile membrane, allowing the sensor to be reused without direct exposure to harsh sterilization conditions.
3Loss of information
If optical, electrical, or pH sensors are positioned inside flexible bags or tubing, then real-time monitoring is enabled, but signal transmission becomes difficult
Solution Approach 1:
A rigid insertion tool with a hollow needle or tapered bore acts as an intermediary device to facilitate sensor insertion into flexible bioreactor bags or tubing. The tool provides structural support during insertion, preventing sensor damage while enabling access to the flexible container. The sensor is inserted through the rigid tool's opening, which maintains its shape and protects the sensor during the procedure.
Data Source
AI summary
A probe assembly for inserting a probe into a flexible or semi-rigid object is provided. The probe assembly includes an aseptic connector for coupling to the object, a probe sheath that extends longitudinally from the aseptic connector, and an actuator for deploying the probe within the object. The probe sheath has a plurality of concentric sheath elements and an inner longitudinal volume that is configured to permit longitudinal movement of the probe within the probe sheath. The actuator moves the probe longitudinally within the probe sheath by telescoping a first sheath element of the plurality within another sheath element of the plurality such that the probe is moved to a position sufficient to measure at least one parameter within the object.


