Container Holder Assembly for Aseptic Large-Volume Drug Connection
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Solution Overview
Problem
Existing large volume injection devices face challenges in establishing a sterile or aseptic connection between the medicament container and the fluid flow path, which is complicated and expensive, and current solutions require assembly in clean rooms or highly sanitized environments.
Innovation Solution
A medicament delivery device with a container holder that moves forward under pressure to advance a cap, piercing the container and establishing a fluid connection with a delivery path, maintaining aseptic conditions without the need for all assembly steps to be performed in clean rooms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional assembly methods are used to establish connection between medicament container and fluid flow path, then sterile connection is achieved, but manufacturing complexity and cost increase significantly
Solution Approach 1:
The device is divided into separate sterile components (container holder, piercing member, fluid path) that can be manufactured independently and assembled without requiring complete clean room environment, reducing manufacturing complexity while maintaining sterile connection reliability
Solution Approach 2:
The container holder and piercing member are pre-configured in a sterile state before assembly, allowing the actual connection to be made without requiring the entire assembly process to occur in a clean room, thus reducing manufacturing complexity while ensuring sterile connection
2Reliability
If traditional assembly methods are used to establish connection between medicament container and fluid flow path, then sterile connection is achieved, but manufacturing cost increases
Solution Approach 1:
By segmenting the device into independently manufacturable sterile components, the patent allows assembly to occur in less restrictive environments, reducing the need for expensive clean room facilities and specialized assembly procedures while maintaining sterile connection quality
Solution Approach 2:
The container holder assembly appears to be designed as a disposable component that can be manufactured more economically and discarded after single use, reducing overall manufacturing costs while ensuring sterile connection for each use
3Reliability
If all assembly steps are performed in clean rooms, then sterile connection is ensured, but manufacturing flexibility and location options are limited
Solution Approach 1:
The patent divides the device into components that can be manufactured separately in different locations with different sterility levels, then assembled to create the final sterile product, enabling manufacturing flexibility across multiple locations while ensuring sterile connection in the final assembly
Solution Approach 2:
By performing preliminary sterilization and preparation of components before final assembly, the patent enables the actual connection assembly to occur in less restrictive environments, expanding manufacturing location options while maintaining sterile connection reliability
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 aseptic connection of the medicament container to the fluid path, allowing for convenient and cost-effective manufacturing while maintaining high sanitation standards, and flexibility in manufacturing locations.
Implementation Method 1
a piercing member to pierce the cap of the medicament container to put the medicament container in fluid connection with a delivery fluid path
Data Source
AI summary
A medicament delivery device is provided. The device can include a container holder configured to provide a mechanism for establishing a fluid connection with a fluid path for delivery to a patient.