Sterile Sensor Insertion System for Bioreactor Bags
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Solution Overview
Problem
There is a need for an improved method and device to sterilely insert sensors into flexible disposable bioreactor bags or tubing, particularly one that allows for real-time data collection without damaging the sensor and facilitates easy removal or re-sterilization, as existing methods face challenges with sterilization and sensor integration in biopharmaceutical manufacturing.
Innovation Solution
A system comprising a pre-sterilized sensor probe with a plunger and liquid-tight seals, connected via a sterile connection system, allows for aseptic insertion using a handle that directs the probe into the vessel, utilizing a septum port and a modified aseptic connection to maintain sterility and enable easy removal or re-sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a sensor is sterilized via Gamma irradiation or positioned inside a flexible bag, then sterility is maintained, but optical, electrical, and pH sensors cannot undergo such sterilization and require external attachment means
Solution Approach 1:
The system divides the sensor assembly into two separate components: a sterilizable probe portion that can be Gamma irradiated or autoclaved, and a non-sterile attachment means that remains external to the sterile field. This segmentation allows each component to be treated according to its specific requirements - the probe achieves sterility through conventional methods while the attachment means provides the necessary interface for optical, electrical, or pH sensors that cannot withstand sterilization.
2Productivity
If a sensor is inserted into a flexible bioreactor bag, then real-time data collection is enabled, but the sensor may be damaged during insertion and removal
Solution Approach 1:
The attachment means serves as an intermediary device between the sensor probe and the flexible bioreactor bag. It provides a protected interface that allows the sensor to be inserted and removed without direct contact with the flexible bag walls, thereby preventing damage to the sensor during insertion and removal while still enabling real-time data collection from within the bioreactor.
3Reliability
If a sensor is permanently attached to a disposable bioreactor, then sterility is maintained, but the expensive sensor is lost with the disposable bag
Solution Approach 1:
The system segments the sensor assembly into a reusable probe portion and a disposable attachment means that remains with the bioreactor bag. The probe can be sterilized and reused across multiple bioreactors, while the attachment means is discarded with the disposable bag, preventing sensor loss while maintaining sterility during each use.
Solution Approach 2:
The attachment means is designed to be discarded with the disposable bioreactor bag after a single use, while the expensive sensor probe is recovered and can be sterilized for reuse. This approach eliminates sensor loss with disposable bags while maintaining the sterility required for each new bioreactor run.
4Reliability
If a rigid sheath is used to hold the sterile probe, then sterility is maintained, but the sheath complicates the insertion mechanism
Solution Approach 1:
The system replaces the rigid sheath with a flexible membrane or thin film barrier that maintains sterility while allowing for simpler insertion mechanics. The flexible barrier can be pierced or penetrated by the probe without requiring complex actuation mechanisms, thereby maintaining sterility protection while reducing device complexity compared to rigid sheath designs.
Data Source
AI summary
The present invention provides a system for the insertion of a pre-sterilized sensor probe into a sterile vessel. The system of the invention provides a reliable and straightforward way to insert one or more sterile probes into a sterile vessel. The present invention also provides a sterile vessel that includes one or more of the systems of the invention. The sterile vessel can be a flexible or semi-rigid bag or tubing of the type typically used for carrying out biochemical and/or biological processes and/or manipulating liquids and other products of such processes. Furthermore, the present invention provides a method for aseptically inserting a probe into a sterile vessel where the method makes use of the system of the invention.