Plunger Alignment Device for Sterile Pharmaceutical Container Closure
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Solution Overview
Problem
The process of closing containers filled with pharmaceuticals, particularly lyophilized products in dual chamber syringes, is cumbersome and costly due to the complexity of maintaining sterility and efficiently sealing the containers during preparation.
Innovation Solution
A device comprising a plunger, plunger seat, container carrier, and spacer that aligns the plunger for easy insertion into the container opening, allowing for efficient sealing while maintaining sterility and simplifying the process of lyophilization and reconstitution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If plungers are automatically pushed or sucked into container openings in a sterile environment, then container sealing reliability is improved, but device complexity and operational effort increase
Solution Approach 1:
The plunger is pre-positioned in the plunger seat in a ready-to-insert state, aligned with the container opening. The spacer pre-defines the position and alignment of the plunger seat relative to the container carrier, so that when the container is placed on the carrier, the plunger is already positioned for immediate insertion without requiring complex sterile handling operations.
Solution Approach 2:
The device structure itself provides the alignment and positioning functions through the spacer and container carrier arrangement. The plunger seat automatically aligns the plunger with the container opening when the container is placed on the carrier, eliminating the need for additional alignment mechanisms or complex sterile manipulation procedures.
2Device complexity
If plungers are manually inserted into container openings, then device complexity is reduced, but manufacturing precision and alignment accuracy deteriorate
Solution Approach 1:
The plunger seat acts as an intermediary component that holds the plunger in a predefined alignment. The spacer serves as another intermediary that pre-defines the position and alignment of the plunger seat relative to the container carrier. These intermediary components ensure precise alignment without requiring complex manual manipulation or additional alignment mechanisms.
3Stability of the object's composition
If dual chamber syringes are closed during lyophilization preparation, then pharmaceutical product stability is improved, but processing time and operational effort increase
Solution Approach 1:
The plunger is pre-positioned in the plunger seat with alignment already defined by the spacer. When the container is placed on the carrier, the plunger is ready for immediate insertion without requiring additional alignment or positioning steps, reducing the time required for the closing operation while maintaining product stability.
Data Source
AI summary
A device for closing a chamber of a container having an opening for accessing the chamber comprises a plunger, a plunger seat, a container carrier and a spacer. The plunger seat releasably holds the plunger in a predefined alignment. The container carrier is arranged to be connected to the container in a predefined position and alignment in relation to the opening of the container. The spacer is arranged to position and align the plunger seat adjacent to and distant from the container carrier such that the opening of the container is open when the container is connected to the container carrier.


