Pharmaceutical Closure Retaining Element for Sterile Sealing
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Solution Overview
Problem
Existing closures for pharmaceutical containers face issues with deformation forces during assembly and sterilization, which can compromise the retention of the sealing element and its original biasing, leading to potential sterility breaches and increased production costs.
Innovation Solution
A closure design featuring a retaining element that projects inward from the base of the cup-shaped closure body, forming a receptacle for the sealing element, which decouples from deformation forces and provides improved retention through a biasing stress, allowing the sealing element to be held securely without being negatively affected by thermal loading.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the sealing element is injection molded into the closure body with a large surface area connection region, then the retention of the sealing element is improved, but the production complexity and cost increase
Solution Approach 1:
The closure body is divided into functionally independent regions: the cup-shaped closure body for structural support and the retaining element for sealing element retention. This segmentation allows the retaining element to be designed specifically for sealing retention without complicating the overall production process.
Solution Approach 2:
The retaining element acts as an intermediary component between the closure body and the sealing element. It provides a dedicated interface for sealing element retention through mechanical interlocking features (protrusions and recesses), eliminating the need for complex injection molding connections.
2Reliability
If the sealing element is supported by the bottle cover, then the retention is improved, but the production requires a complicated mold
Solution Approach 1:
The support function for the sealing element is extracted from the bottle cover and transferred to a dedicated retaining element on the closure body. This allows the closure to be manufactured independently with standard molds, while the bottle cover remains simple and easy to produce.
Solution Approach 2:
The retaining element serves as an intermediary structure that provides sealing element support and retention. It features protrusions that extend into the sealing element and recesses that receive them, creating a secure mechanical connection without requiring complicated molding operations.
3Ease of operation
If the closure body is subjected to strong deformation forces during assembly and sterilization, then the closure can be assembled and sterilized, but the retention of the sealing element and its original biasing are compromised
Solution Approach 1:
The closure body structure is segmented into the cup-shaped body for withstanding deformation forces and the retaining element for maintaining sealing retention. The retaining element's integrated design with the closure body allows it to move with the closure body during deformation while maintaining its retention function.
Solution Approach 2:
The retaining element is merged with the closure body as an integrated component, allowing them to deform together during assembly and sterilization. This ensures the retaining element maintains its relative position and retention capability even when the closure body undergoes strong deformation forces.
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
The solution enhances the retention of the sealing element on the closure body, ensuring reliable sealing and sterility, while also simplifying production and reducing the need for post-inspection and additional connection expenses.
Implementation Method 1
an elastically pliant sealing element is arranged on this closure body in the region of the base of its cup shape, such that the at least one pierceable opening is closed by the sealing element
Implementation Method 2
the retaining element projects from the base of the cup-shaped closure body and is independent of the wall of the cup shape, whereby the deformation forces described above and acting in the closure body are not transferred to the receptacle formed by the retaining element
Data Source
AI summary
A closure (2) for a container for pharmaceuticals, in particular a sterile container, includes a closure body (2) that is prefabricated from a non-elastic material. The container has a crucible shape with a bottom (3) and a wall (4, 5). At least one piercable opening (8) is incorporated in the bottom (3) of the crucible-shaped closure body (2) and provided for adding or removing liquid pharmaceuticals. The piercable opening (8) is sealed by a sealing element (7). The sealing element (7) is held in a receptacle (12), which is formed by the bottom (3) and a holding element (11) protruding toward the inside in the use position of the closure (1).