Modular Fluid Path Assembly for Compact Sterile Drug Filling
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Solution Overview
Problem
Conventional drug delivery devices with prefilled containers and needle insertion mechanisms occupy a large footprint during sterilization and filling, and have complex components that increase particulate risk and residuals from the sterilization process.
Innovation Solution
A modular fluid path assembly for drug delivery devices, comprising a container, conduit, coupling portion, needle, and needle shield, which can be sterilized and filled separately, reducing the footprint and complexity, and includes a needle shield to maintain sterility until use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional drug delivery devices use prefilled containers with needle insertion mechanisms, then the device is complete and functional, but the footprint during sterilization and filling becomes large
Solution Approach 1:
The device is divided into separate modules: a container with fluid path assembly and a needle insertion mechanism. The container can be sterilized and filled independently in a compact configuration, then the needle insertion mechanism is attached later. This segmentation allows each component to be processed separately with smaller footprint requirements during manufacturing.
Solution Approach 2:
The container, fluid path assembly, and needle are pre-assembled and sterilized together as a compact unit before being integrated with the needle insertion mechanism. This preliminary assembly reduces the footprint during sterilization and filling operations while maintaining complete functionality upon final integration.
2Reliability
If conventional devices include complex components for needle insertion and fluid delivery, then the device is functional, but particulate risk and residuals from sterilization increase
Solution Approach 1:
By separating the fluid path components from the needle insertion mechanism, each can be optimized for its specific function with fewer complex interfaces. The fluid path assembly can be sterilized more effectively as a separate unit, reducing particulate risk and sterilization residuals while maintaining functional completeness.
Solution Approach 2:
The needle insertion mechanism is extracted as a separate module that attaches to the pre-sterilized container and fluid path assembly. This extraction allows the fluid path to be sterilized more thoroughly without the complexity of the insertion mechanism, reducing particulate risk while preserving all necessary functions.
3Ease of manufacture
If the device integrates all components including needle insertion mechanism during sterilization, then the device is complete, but the complexity of components increases
Solution Approach 1:
The device is segmented into modular components that can be manufactured and sterilized separately, then assembled. This reduces the complexity of sterilization processes and component integration while maintaining ease of manufacture through standardized interfaces and independent processing of each module.
Data Source
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AI summary
Modular fluid path assemblies are provided that include conduit, coupling, and needle portions of a fluid path fluidly coupled to an outlet of a container. The modular fluid path assemblies further include a needle shield having a tip of the needle embedded therein. So configured, in embodiments, the modular fluid path assemblies can be sterilized, a medicament can be filled in the container, and a stopper inserted in the container so that the pre-sterilized and pre-filled modular fluid path assemblies can have a closed container integrity (CCI) seal.