Aseptic Sensor Connector Assembly for Gamma-Sterilized Bioprocess Vessels
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The integration of single-use sensors into bioprocessing vessels is hindered by the lack of robust, radiation-stable, and reliable connection methods that maintain sterility, as existing methods expose sensors to reactive compounds formed during gamma sterilization, affecting their accuracy and longevity.
Innovation Solution
An aseptic peripheral connection assembly using a carrier, applicator, and plunger to install sterilized peripherals in bioprocessing vessels, employing a hermetic sealing tab and radiation-safe materials to maintain sterility and prevent exposure to harmful radiation byproducts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gamma sterilization is used to sterilize the bioprocessing vessel, then sterility is achieved, but reactive compounds are formed that expose sensors to harmful factors affecting their accuracy and longevity
Solution Approach 1:
The system is divided into two separate components: a bioprocessing vessel and a sensor carrier assembly. The vessel can be sterilized independently using gamma radiation, while the sensor carrier with the peripheral is sterilized separately using a gentler method (e.g., e-beam or chemical sterilization) that does not form harmful reactive compounds. This segmentation allows each component to be sterilized by the most appropriate method for its material composition, resolving the contradiction between achieving sterility and avoiding harmful radiation byproducts.
Solution Approach 2:
A removable hermetic sealing tab acts as an intermediary element between the vessel and the sensor carrier. This tab can be removed aseptically to allow connection between the sterilized vessel and the sensor carrier without compromising sterility. The intermediary enables the two separately sterilized components to be joined while maintaining the sterile barrier, thus achieving sterility without exposing sensors to harmful gamma radiation byproducts.
2Ease of operation
If single-use sensors are integrated into bioprocessing vessels, then convenience and cost-per-use are improved, but reliable connection methods that maintain sterility are lacking
Solution Approach 1:
The sensor peripheral is nested within a carrier assembly that includes integrated sealing and connection features. The carrier contains the peripheral in a protected, sterile environment and provides built-in sealing surfaces and connection interfaces. This nested structure combines multiple functions (protection, sterilization, sealing, connection) into a single integrated unit, making the system easy to operate while maintaining high reliability through engineered connection mechanisms with proven sealing capabilities.
Solution Approach 2:
The connection mechanism utilizes controlled parameter changes during assembly, such as mechanical compression or deformation of sealing elements (e.g., O-rings or gaskets) to transition from an open to a sealed state. This controlled parameter change ensures reliable hermetic sealing when the carrier connects to the vessel, maintaining sterility while enabling easy operation through a simple connection action.
3Reliability
If a hermetic seal is formed to maintain sterility, then sterility is preserved, but the complexity of the connection assembly increases
Solution Approach 1:
Multiple critical functions are merged into the carrier assembly: the peripheral mounting, the hermetic sealing interface, and the connection to the vessel are all integrated into a single carrier unit. The sealing member (such as an O-ring or gasket) is incorporated directly into the carrier structure, combining the sealing function with the connection function. This merging reduces the number of separate components and assembly steps while maintaining reliable hermetic sealing, thus preserving sterility without proportionally increasing complexity.
Solution Approach 2:
The carrier assembly is designed as a universal interface that performs multiple functions: it holds the peripheral, provides hermetic sealing, enables mechanical connection to the vessel, and facilitates aseptic removal. This multi-functional design consolidates what would otherwise require multiple separate components into a single unit, maintaining sterility through integrated sealing while minimizing overall assembly complexity through functional consolidation.
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
Enables reliable and accurate real-time sensing in bioprocessing vessels without significant drift, ensuring sterility and sensor integrity by avoiding exposure to gamma radiation-induced compounds.
Implementation Method 1
a removable hermetic sealing tab covering the component-facing opening of the applicator sleeve to maintain the sterilized peripheral in aseptic condition
Implementation Method 2
a plunger within the applicator sleeve and configured to plunge the carrier from a position within the applicator sleeve to a position engaged with the aseptic connector
Implementation Method 3
a sealing member configured to form a leak-tight seal with an aseptic connector or aseptic vessel connector on the bio-processing vessel
Data Source
Figure 1
Figure 2
Figure 3
AI summary
Disclosed herein are apparatuses and methods for installing a sterilized peripheral in a bio-processing vessel or component. One aspect is an aseptic peripheral connection assembly for installing a sterilized peripheral in a bio-processing vessel or component via an aseptic connector affixed to the vessel or component. The aseptic peripheral connection assembly may include a carrier, an applicator, and a removable hermetic sealing tab.