Shielding Member Layout for E-Beam Sterilization of Drug Containers
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Solution Overview
Problem
Existing drug delivery devices face challenges in adequately sterilizing components without compromising the appearance, structural integrity, or drug quality, particularly in pre-filled systems, leading to potential contamination risks and unnecessary disposal.
Innovation Solution
A shielding member with a housing and aligned bore portions forms receptacles for drug delivery containers, using Electron Beam irradiation to sterilize the contact surface between the container and stopper while shielding other components from irradiation, ensuring effective sterilization without affecting the container or drug.
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 is achieved, but the mixture is incapable of adequately penetrating or permeating through components to sterilize certain components
Solution Approach 1:
The patent extracts the sterilization process from the assembled container configuration and applies it to individual components (container, stopper, crimping device) separately before assembly. This allows the sterilizing mixture to contact and penetrate each component's surfaces directly without being blocked by other components, ensuring complete sterilization of all surfaces including those that would be inaccessible in the final assembled state.
2Reliability
If existing sterilization approaches are used, then sterilization may be achieved, but they negatively impact the appearance or structural integrity of the container
Solution Approach 1:
The patent performs sterilization of all components (container, stopper, crimping device) before they are assembled into the final configuration. By sterilizing components individually beforehand, the sterilization process can be optimized for each component type without concern for damaging other components that would be present during assembly. This preliminary sterilization action ensures that effective sterilization methods can be used that might otherwise be too harsh for the final assembled product.
3Reliability
If existing sterilization approaches are used, then sterilization may be achieved, but they adversely impact the drug itself
Solution Approach 1:
The patent segments the sterilization process into separate steps for each component (container, stopper, crimping device) and performs sterilization before assembly. This segmentation allows the drug to be introduced into the already-sterilized container under controlled sterile conditions, rather than exposing the drug to harsh sterilizing conditions. The drug itself is not subjected to the sterilizing mixture, eliminating the risk of drug degradation while still achieving complete sterilization of all contact surfaces.
4Reliability
If sterilization is performed on assembled containers, then complete sterilization is achieved, but visual inspection cannot be conducted to ensure no contaminants are present
Solution Approach 1:
The patent performs visual inspection of the drug contents before the final container assembly is sealed and sterilized. By conducting inspection at this earlier stage when the container is still open and accessible, full visual examination can be performed to ensure no contaminants are present. After inspection, the container is sealed and sterilized, achieving both complete sterilization and the ability to inspect, though the inspection occurs before final sterilization rather than after.
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 allows for proper inspection of the drug contents before administration, reducing unnecessary disposal and maintaining the integrity and quality of the drug delivery device components.
Implementation Method 1
Electron Beam (referred to as "E-Beam") Irradiation is applied to the sealed unit to sterilize a contact surface between the container and the stopper
Data Source
Figure 1
Figure 2A~2C
Figure 3~4
AI summary
A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.