On-Body Injector Seal Sterilization With Shielded Electron Beam
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Solution Overview
Problem
Existing drug delivery devices face challenges in ensuring the sterility of pre-filled drug containers and maintaining the structural integrity and appearance of containers during sterilization processes, which can lead to unnecessary disposal of containers and potential contamination risks.
Innovation Solution
A drug delivery device with an electron beam generator that sterilizes the sealing surface between the container and the stopper using a controlled sterilizing beam, shielded from the rest of the container to prevent discoloration or chemical reactions, allowing for proper inspection and reducing unnecessary disposal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gaseous sterilizing mixture (ethylene oxide and/or saturated steam) is used to sterilize components, then sterilization effectiveness is improved, but penetration capability through components is insufficient and structural integrity of container is compromised
Solution Approach 1:
The patent changes the sterilization method from chemical/gaseous (ethylene oxide, saturated steam) to physical (electron beam irradiation). This parameter change allows effective sterilization without the harmful side effects of gas penetration and structural damage, as electron beams can be controlled to sterilize surfaces without compromising container integrity
Solution Approach 2:
The patent replaces the mechanical/chemical sterilization system (gaseous mixtures requiring penetration) with an electromagnetic radiation system (electron beam). This substitution enables sterilization through surface irradiation without needing deep penetration, thus preserving container structure while achieving sterilization goals
2Reliability
If sterilizing beam penetrates through components to sterilize internal surfaces, then sterilization completeness is improved, but appearance and structural integrity of container are compromised
Solution Approach 1:
The patent applies local quality by using a shielding member that selectively blocks the electron beam from certain areas (container body, elongated portion) while allowing it to irradiate specific target areas (sealing surface). This enables localized sterilization of the sealing surface without exposing the entire container to the beam, thus maintaining appearance and structural integrity while achieving sterilization completeness for critical areas
Solution Approach 2:
The patent segments the sterilization process by dividing the container into different zones: the sealing surface is exposed to the electron beam for sterilization, while the container body and elongated portion are shielded. This segmentation allows differential treatment - sterilizing only where necessary while preserving appearance and structure elsewhere
3Reliability
If conventional sterilization methods are used, then sterilization is achieved, but visual inspection of container is difficult or impossible leading to unnecessary disposal
Solution Approach 1:
The patent converts the potential harm of electron beam exposure (which could damage the container) into a benefit by using controlled, localized irradiation. The shielding member prevents excessive exposure, allowing the container to maintain its appearance and structural integrity while still achieving sterilization. This enables both sterilization and subsequent visual inspection, eliminating unnecessary disposal
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 solution effectively sterilizes the sealing surface while protecting the container and drug from ionizing irradiation, enabling safe and reliable drug administration while allowing for visual inspection and reducing container disposal.
Implementation Method 1
an electron beam generator disposed near the housing. The container assembly is at least partially disposed in the opening such that the second end of the container is exposed through the housing. The electron beam generator generates a sterilizing beam that penetrates the seal member to sterilize the sealing surface
Data Source
AI summary
An on-body injector system includes a drug container assembly including a container, a seal member, and a sealing interface between the seal member and the container. The container includes an opening and the seal member at least partially covers the opening in the container. A fluid pathway assembly is coupled to the drug container assembly and includes a needle that is movable between a storage position, in which a point of the needle is spaced from the seal member, and a delivery position, in which the point of the needle is disposed at least partially through the seal member. A radiation generator is configured to emit rays of radiation to sterilize and/or disinfect the sealing interface. A barrier is disposed adjacent to the sealing interface and has an opening. At least a portion of the drug container assembly is positioned adjacent to the opening in the barrier.