Pharmaceutical Closure Stopper Sealing Projection Design
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Solution Overview
Problem
Existing closure stoppers for pharmaceutical containers face challenges in achieving a durable and secure seal, particularly during freeze drying processes, where a reliable sealing mechanism is crucial to prevent contamination and ensure the integrity of the medicament.
Innovation Solution
The closure stopper design features a sealing projection that vertically overlaps a set-back region on the sealing flange, with a radially outward configuration and a concave curvature, providing a high-stress sealing effect both axially and radially, and includes a sliding projection for enhanced sealing and ease of insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional sealing flange design is used, then the structure is simple, but the sealing action is insufficient and not durable
Solution Approach 1:
The sealing flange is divided into multiple functional regions: an active sealing region with enhanced radial protrusion for primary sealing contact, and a set-back region for structural support. This segmentation allows each region to perform its specific function optimally, improving overall sealing reliability without excessive complexity.
Solution Approach 2:
The invention introduces axial dimension variations to the sealing flange by creating a set-back region that recesses axially relative to the active sealing region. This axial offset creates a stepped configuration that enhances sealing performance by concentrating sealing forces on the active region while maintaining structural integrity through the set-back region.
2Reliability
If the sealing flange is made more robust, then sealing durability improves, but flexibility and tear resistance decrease
Solution Approach 1:
The sealing flange exhibits local quality variations with different regions having different thicknesses and mechanical properties. The active sealing region has enhanced radial protrusion for durable sealing contact, while the set-back region provides structural support. This localized differentiation allows the flange to be durable where needed while maintaining overall flexibility and tear resistance.
Solution Approach 2:
The invention incorporates a concave curvature in the set-back region of the sealing flange. This curved geometry distributes stress more evenly, preventing stress concentration that would lead to tearing, while still providing sufficient structural support for durable sealing action.
3Reliability
If a sliding projection is added for enhanced sealing, then sealing performance improves, but manufacturing complexity increases
Solution Approach 1:
The sliding projection is merged with the sealing flange as an integrated feature rather than a separate component. The projection extends radially outward from the active sealing region and is formed as part of the same molding process, combining sealing and sliding functions in a single structural element to minimize manufacturing complexity.
Solution Approach 2:
The sliding projection serves multiple functions: it provides enhanced sealing contact through its radial extension, facilitates smooth insertion through its sliding action, and maintains structural integration with the sealing flange. This multi-functionality reduces the need for additional components while improving sealing performance.
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
This design achieves a robust and secure sealing action, ensuring the container remains sealed during freeze drying and maintaining the integrity of the medicament, with improved flexibility and tear resistance.
Implementation Method 1
the sealing projection (5), at least with respect to its base portion, vertically overlaps a set-back region (Rb) which is formed on the sealing flange (3) and is set back with respect to the boundary plane (E5)... providing a high-stress sealing effect both axially and radially
Data Source
AI summary
A closure stopper for pharmaceutical applications has a sealing flange seating in a sealing manner on an end face of the container's closure mouth. The sealing flange has a lower sealing surface and a boundary plane contacting an area protruding farthest downwardly and extending perpendicularly to the closure stopper's center axis. An engagement portion extending below the sealing flange is formed with a smaller radial extent than the sealing flange. Preferably a handling portion extends above the sealing flange. A circumferential sealing projection also is formed on the engagement portion and protrudes by a radial dimension with respect to an axial portion of the engagement portion initially adjoining the sealing flange from underneath and having a portion-radius. The sealing projection, at least with respect to its base portion, vertically overlaps a set-back region formed on the sealing flange and set back with respect to the contact plane.