Rubber Stopper Leakage Testing via Conical Displacement
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Solution Overview
Problem
Current methods for testing container closure integrity, particularly for drug containers sealed with rubber stoppers, lack a simple and reliable way to assess the leakage tolerance of the rubber stopper's movement relative to the container, which is crucial for ensuring the sterility and quality of stored drugs.
Innovation Solution
A device and method that utilize a displacement mechanism with a support member and a movement member, allowing for adjustable displacement of the rubber stopper relative to the drug container, enabling precise leakage testing by detecting the presence of a test medium through the dispensing opening.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rubber stopper is used to seal a drug container, then the container can be closed and stored under sterile conditions, but the rubber stopper may be displaced from its sealing position during handling, causing leakage
Solution Approach 1:
The patent changes the geometric parameters of the stopper and container interface by introducing a conical configuration. The stopper has a conical outer surface that mates with a conical inner surface in the container opening, creating a tapered interference fit that resists displacement forces while maintaining sealing integrity
Solution Approach 2:
The patent employs composite sealing by combining the rubber stopper material with a conical geometric structure, and optionally combining multiple materials in the stopper itself (such as a rigid conical core with a flexible sealing layer) to achieve both mechanical retention and leakage prevention
2Measurement precision
If the rubber stopper is displaced to test leakage tolerance, then the leakage threshold can be determined, but the testing process becomes complex and time-consuming
Solution Approach 1:
The patent applies preliminary action by pre-configuring the stopper and container with complementary conical surfaces during manufacturing. This pre-established geometric relationship automatically provides the displacement resistance characteristic, eliminating the need for complex testing apparatus to simulate or measure stopper retention
Solution Approach 2:
The conical geometry configuration enables the stopper-container assembly to self-test for leakage resistance. The tapered interference fit inherently resists displacement and maintains sealing, allowing simple visual or pressure-based testing without sophisticated equipment
Data Source
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AI summary
The invention concerns the field of container closure integrity (CCI) and the testing of CCI and relates to a device and a method for leakage testing of a connection between a rubber stopper and a corresponding drug container which can be used for storing drugs under sterile conditions and which is closed by said rubber stopper.