Aseptic Vial Stopper Tray and Shuttle for Sterile Small-Volume Filling
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Solution Overview
Problem
Existing systems face challenges in efficiently and sterily filling small-volume medicine containers, particularly in biologic drug production, where high-quality filling is required but at a small scale, often involving manual or assisted-hand operations that can compromise sterility.
Innovation Solution
A packaging system comprising a container tray with snap-fit vial holders, a stopper holder with flexible cells, a shuttle with releasable stoppers, and a stopper clip with hinged legs, along with handling trays and tools, ensures efficient and sterile insertion of stoppers into medicine containers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If manual handling and filling operations are used, then flexibility and adaptability are maintained, but sterility and reliability are compromised
Solution Approach 1:
The patent introduces sterile barriers (films, drape materials) as intermediary elements between the non-sterile external environment and the sterile filling zone. These barriers allow manual operators to handle containers and components while maintaining sterility through the intermediary protective layers, thus resolving the contradiction between manual flexibility and sterility requirements.
Solution Approach 2:
The patent creates a controlled sterile environment (laminar flow hood, isolator) that establishes an inert atmospheric barrier against contamination. This allows manual operations to proceed with flexibility while the controlled environment maintains sterility, resolving the contradiction between operator flexibility and contamination prevention.
2Reliability
If automated filling systems are used, then sterility and reliability are improved, but device complexity and cost increase
Solution Approach 1:
The patent divides the filling system into modular components (container handling section, stopper handling section, filling section, sealing section) that can be independently managed and assembled. This segmentation allows for simplified automation of specific critical functions while maintaining manual operation in less critical areas, reducing overall system complexity while preserving sterility where needed.
Solution Approach 2:
The patent incorporates self-aligning and self-positioning features in the fixtures and tooling that guide containers and stoppers into correct positions without requiring complex automated positioning systems. This reduces device complexity while maintaining reliable and sterile filling operations.
3Manufacturing precision
If individual container handling is performed, then precision and quality control are maintained, but productivity and efficiency decrease
Solution Approach 1:
The patent combines multiple individual handling operations into integrated fixtures and tooling assemblies that can process multiple containers simultaneously or in sequence without requiring separate handling steps for each container. This merging of operations maintains precision through fixed positioning while improving productivity through batch processing capabilities.
Solution Approach 2:
The patent incorporates pre-positioning and pre-alignment features in the fixtures that prepare containers and components for filling before the actual filling operation. This preliminary action ensures precision is maintained while reducing the time required during the critical filling step, thereby improving overall productivity.
4Productivity
If batch processing is implemented, then productivity is improved, but maintaining sterility across multiple containers becomes more difficult
Solution Approach 1:
The patent extends the controlled sterile environment to cover the entire batch processing area, allowing multiple containers to be processed simultaneously or in sequence while maintaining sterility. The inert atmosphere acts as a protective barrier that prevents contamination during batch operations, resolving the contradiction between batch productivity and sterility maintenance.
Solution Approach 2:
The patent uses sterile barriers and drape materials as intermediaries that can be configured to cover multiple containers during batch processing. These intermediary protective layers allow efficient batch handling while maintaining sterility across all containers in the batch, resolving the contradiction between batch productivity and sterility maintenance.
Data Source
AI summary
A packaging system for sealing a medicine container having a filling opening with a stopper includes a container tray having a container cell for receiving and stabilizing the medicine container, a stopper tray with a stopper carrier, and a cover securable to the stopper tray to secure the stoppers to the stopper tray. The stopper carrier forms a body with a proximal opening, an interior space, a distal inner surface, and at least one stopper-locating surface.