Pharmaceutical Vial Stopper Compression for Low-Temperature Sealing
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Solution Overview
Problem
Existing storage systems for pharmaceutical compositions at low temperatures face issues such as leakage between the stopper and the container, brittleness of the stopper, oblique position of the stopper, and slipping out of place during cooling.
Innovation Solution
A system comprising a container with a neck and a crown, a stopper with a flange and a plug, and a holding element that exerts a force to form a horizontal contact area between the crown and flange surfaces, ensuring a size of 30 mm2 to 300 mm2 and partial compression of the flange height by 10% to 40%, thereby enhancing closure integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If the system is closed under ambient conditions and then cooled down to low temperatures, then the pharmaceutical composition can be stored for long periods, but the pressure inside the system decreases causing leakage between the stopper and the container
Solution Approach 1:
The invention changes the physical parameters of the stopper by pre-compressing it to a defined degree before closure. This pre-compression modifies the stopper's dimensional parameters and mechanical properties, enabling it to maintain reliable sealing under subsequent low-temperature storage conditions where pressure decreases to 0.6 bar or 0.3 bar
Solution Approach 2:
The invention applies a preliminary compression action to the stopper before the actual closure operation. The stopper is compressed to a specific degree (defined by compression ratio and contact area parameters) prior to insertion, so that when the system is later cooled and pressure changes occur, the stopper maintains proper sealing contact with the container
2Reliability
If the stopper is made rigid for secure closure, then closure integrity is improved, but the stopper becomes brittle and may slip out of place during cooling
Solution Approach 1:
The invention changes the mechanical parameters of the stopper through controlled pre-compression. By applying a specific compression force that results in a defined compression ratio (10%-40%) and contact area (30-300 mm²), the stopper's mechanical properties are modified to balance rigidity for sealing with flexibility to prevent brittleness-related failure during temperature cycling
Solution Approach 2:
The pre-compression of the stopper acts as a cushioning measure that prepares the stopper structure in advance for the mechanical stresses it will encounter during cooling. This beforehand mechanical conditioning creates a more resilient stopper that can withstand thermal stress without becoming overly brittle or slipping out of place
3Reliability
If the contact area between stopper and container is increased to prevent leakage, then closure integrity is improved, but the device complexity increases
Solution Approach 1:
The invention optimizes the contact area parameter to a specific range (30-300 mm²) that provides sufficient sealing surface without excessive complexity. By defining the contact area as a parameter that can be controlled through stopper geometry and pre-compression, the system achieves reliable leakage prevention while maintaining relatively simple closure mechanism design
Solution Approach 2:
The invention applies local quality by concentrating the compression force and contact area at the critical sealing interface between the stopper and container. The pre-compression is applied specifically at the location where sealing occurs, creating a localized zone of enhanced contact quality without requiring complex mechanisms throughout the entire closure system
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 system effectively prevents leakage and maintains the sterility of the pharmaceutical composition over long periods at low temperatures, ensuring reliable storage and administration.
Implementation Method 1
a holding element configured to exert a force on the crown and the flange to form a horizontal contact area between the upper crown surface and the lower flange surface, the horizontal contact area having a size of 30 mm2 to 300 mm2 and the flange height being compressed at least partially in the horizontal contact area by 10% to 40%
Data Source
AI summary
A method for closing a container includes: providing the container including a neck and a crown, the crown including an upper crown surface; positioning a stopper including a flange and a plug, the flange including a lower flange surface and a flange height, such that the plug is positioned in the neck and the upper crown surface is in contact with the lower flange surface; exerting a force on the crown and the flange to form a horizontal contact area between the upper crown surface and the lower flange surface by a holding element such that the following conditions are fulfilled: the horizontal contact area has a size of 30 mm2 to 300 mm2; and the flange height is compressed at least partially in the horizontal contact area by 10% to 40%.