Aseptic Fluidic Pack Assembly for Prefilled Drug Delivery Devices
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Solution Overview
Problem
Conventional drug delivery devices for subcutaneous administration face challenges in ensuring safety, reliability, compactness, and ease of use, particularly due to complex pump mechanisms, bulkiness, and the difficulty in sterilizing components with electronic parts and prefilled drug containers without damaging them, which complicates manufacturing and increases contamination risks.
Innovation Solution
A method for producing a drug delivery device that includes assembling a prefilled drug container with a fluidic pack and control unit under aseptic conditions, followed by sterilization, and then integrating these components into a housing, using form-fit connections to avoid damaging electronic parts and maintain sterility, allowing for a compact, safe, and user-friendly device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional separate manufacturing processes are used for hub, shaft, and tip components, then manufacturing flexibility is maintained, but assembly precision and production efficiency deteriorate
Solution Approach 1:
The patent merges the manufacturing of hub, shaft, and tip components into a single integrated injection molding process. The molding device includes multiple injection units that simultaneously or sequentially form different components in one cycle, eliminating separate manufacturing and assembly steps while maintaining precise dimensional relationships through the integrated process
2Reliability
If multiple separate injection molding processes are used for different components, then component quality can be optimized individually, but production time and complexity increase
Solution Approach 1:
The patent uses preliminary action by preparing all injection units with their respective materials and settings before the molding cycle begins. The system pre-configures different injection units for different components (hub, shaft, tip) with appropriate materials and parameters, then executes all injections in a coordinated single cycle, reducing production time while maintaining component quality
Solution Approach 2:
The patent implements continuity of useful action by designing the injection system to perform multiple component injections without idle time between operations. The injection units operate in a coordinated sequence or simultaneously, ensuring continuous productive action throughout the molding cycle, eliminating waiting time between separate manufacturing operations
3Strength
If conventional assembly methods are used for connecting hub, shaft, and tip, then manufacturing simplicity is maintained, but assembly precision and connection strength deteriorate
Solution Approach 1:
The patent applies the nested doll principle by forming components in a nested arrangement during injection molding. The hub, shaft, and tip are molded in their final assembled positions with interlocking features, where smaller components are formed within or attached to larger components during the same molding cycle, achieving precise alignment and strong connections without complex post-assembly operations
Data Source
Figure 1a~1b
Figure 2
Figure 3a
AI summary
Method of producing a drug delivery device comprising - a prefilled drug container (6), - a fluidic pack including a liquid flow system (7) providing a fluidic connection from the drug container to a patient during a drug delivery action of the drug delivery device - a control unit comprising electronic parts, - a housing (2), the method comprising the following steps a) assembling components of the fluidic pack to form said fluidic pack, b) sterilizing the fluidic pack, c) providing said prefilled drug container, d) assembling the fluidic pack to the prefilled drug container to form a container pack system, e) assembling the container pack system to the control unit and the housing (2) to form the drug delivery device, wherein steps c) and d) are performed in aseptic conditions.