Pre-Filled BFS Vial Assembly for Aseptic Multi-Liquid Mixing
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Solution Overview
Problem
Ineffective immunization programs in developing countries due to inadequate vaccine administration devices lead to the reuse of non-sterile syringes, increasing the risk of blood-borne disease transmission, particularly for vaccine-preventable diseases like Hepatitis and HIV.
Innovation Solution
A pre-filled blow-fill-seal (BFS) vial system with separate chambers for liquid agents, which are maintained sealed until use, and a connection assembly to breach seals and provide fluid communication for mixing and administration, allowing for a single dose of combined therapeutic agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If reusable syringes are used for vaccine administration, then device reusability and cost-effectiveness are improved, but sterility and risk of blood-borne disease transmission deteriorate
Solution Approach 1:
The vial is divided into multiple separate sealed chambers, each containing a different liquid agent. This segmentation allows the vial to be reused while maintaining sterility, as each chamber can be individually accessed and mixed with its counterpart without compromising the integrity of other chambers or the overall system.
Solution Approach 2:
The liquid agents are pre-filled into separate sealed chambers during manufacturing. This preliminary action ensures that the agents remain sterile until the moment of use, eliminating the need for on-site preparation and reducing the risk of contamination during administration.
2Reliability
If multiple liquid agents are mixed in separate sealed chambers, then sterility and aseptic mixing are improved, but device complexity and structural complexity deteriorate
Solution Approach 1:
Multiple liquid agents are combined within a single integrated vial structure, with each agent contained in its own sealed chamber. This merging approach maintains sterility by keeping agents separate until use, while the unified vial design avoids the complexity of multiple separate containers and their individual handling.
Solution Approach 2:
The vial serves multiple functions: it stores multiple liquid agents, maintains their sterility through sealed chambers, enables aseptic mixing through controlled chamber access, and facilitates administration through integrated ports. This multi-functionality reduces the need for separate devices and components.
3Manufacturing precision
If sealed chambers are used to maintain liquid agents separate, then purity and prevention of premature mixing are improved, but ease of operation and accessibility to liquid agents deteriorate
Solution Approach 1:
A connection assembly acts as an intermediary device that interfaces with the sealed chambers. This assembly includes piercing members that can breach the seals of the chambers, allowing controlled access to the liquid agents. The connection assembly mediates between the need to maintain sterility and the need for easy access during administration.
Solution Approach 2:
The vial design incorporates self-service features where the connection assembly can be coupled to the vial and automatically pierce the sealed chambers to access the liquid agents. This eliminates the need for complex manual procedures to access the agents while maintaining their purity until the moment of use.
4Ease of operation
If a connection assembly is used to breach seals and provide fluid communication, then ease of operation and controlled mixing are improved, but device complexity and number of components deteriorate
Solution Approach 1:
The connection assembly serves as an intermediary that simplifies the interaction between the user and the sealed chambers. It provides a standardized interface for breaching seals and establishing fluid communication, making the operation easier and more controlled while consolidating multiple functions into a single assembly rather than requiring multiple separate components.
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 system ensures sterile and aseptic mixing and administration of multiple liquid agents without specialized skills, reducing the risk of disease transmission and improving vaccine delivery efficiency.
Implementation Method 1
Using a blow-fill-seal (BFS) fabrication technique, a BFS component (such as a vial) is pre-filled with respective fluid (e.g., liquid) agents, which are maintained in separate sealed chambers within the BFS vial
Implementation Method 2
a connection assembly can be coupled to the BFS vial to breach seals of the BFS vial and to provide fluid communication between the respective chambers
Implementation Method 3
The liquid agents from the separate chambers can thus be combined prior to or during (e.g., en route) administration to a patient
Data Source
AI summary
A pre-filled medical delivery system can have a blow-fill-seal (BFS) component and a connection assembly. The BFS component can have first and second chambers, and first and second sealed ports. Each chamber can have a respective liquid agent therein. Each sealed port can be in fluid communication with a respective one of the chambers. The connection assembly can be constructed for coupling to the BFS component. When coupled to the BFS component, the connection assembly can breach the seals of the first and second ports and provide fluid communication therebetween. The disclosed systems, when assembled, can combine the liquid agents from the first and second chambers of the BFS component and deliver the combination as a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) to a patient.