Small-Volume Aseptic Filling Packaging With Releasable Stopper Shuttle
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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 at a small scale is required while maintaining sterility, and existing methods are inefficient or prone to contamination.
Innovation Solution
A packaging system comprising a container tray with snap-fit vial holders, a stopper holder with a flexible stopper cell, a shuttle with releasable stopper securing mechanism, and a stopper clip with hinged legs, along with handling trays and tools, facilitates efficient and sterile filling of medicine containers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If individual manual handling and filling of medicine containers is performed, then sterility can be maintained through careful operation, but productivity is significantly reduced due to the time-consuming nature of individual operations
Solution Approach 1:
The system divides the filling process into discrete positions within a rotating carousel, with each position equipped with specific functions (filling, stoppering, sealing). This segmentation allows multiple operations to occur simultaneously at different positions, thereby increasing productivity while maintaining sterility through controlled access to each segment.
Solution Approach 2:
The patent introduces sterile barriers, drape systems, and controlled atmosphere chambers as intermediaries between the sterile filling environment and the external handling operations. These intermediaries enable automated high-speed filling while maintaining sterility without requiring manual intervention at each filling point.
2Productivity
If automated high-speed filling systems are used, then productivity increases, but the complexity of maintaining sterility and the risk of contamination increase
Solution Approach 1:
The system incorporates self-contained sterile environments within each carousel position, with automated sterile barriers that self-seal and self-maintain without external intervention. The carousel design allows the sterile zones to service themselves through rotational isolation, reducing the overall complexity of sterility maintenance across the entire system.
3Productivity
If batch processing of medicine containers is performed, then productivity improves compared to individual filling, but the risk of contamination increases with larger batch sizes
Solution Approach 1:
The batch processing system is divided into multiple discrete positions around the carousel, each handling a small subset of containers. This segmentation allows the batch to be processed in controlled segments rather than as a single large batch, maintaining productivity while reducing contamination risk through localized sterile zones at each position.
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 shuttle has an exterior surface and an interior surface. The interior surface is configured for releasably securing the stopper. The shuttle is configured to release the stopper into the fill opening upon application of a releasing force to the exterior surface of the shuttle. A shuttle tray has a shuttle cell. The shuttle cell forms a body with a proximal opening, an interior space, a bottom inner surface opposite the proximal opening, and a side inner surface. The shuttle cell releasably secures the shuttle.