Vial Closure System with Laser-Sealed Puncture Holes
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Solution Overview
Problem
Existing vial closure systems fail to maintain the sterility of the outer surface after filling and prior to removal of the cover part, leading to potential contamination and loss of contents during the extraction process.
Innovation Solution
A closure system for vials featuring an elastic closure part, a clamp part, and a cover part with concentric ring-shaped seals that isolate the upper surface of the closure part from the environment, ensuring sterility and reducing content loss by sealing the residual puncture hole effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the cover part is removed to allow needle access through the closure part, then the drug substance or vaccine product can be extracted for use, but the outer surface of the closure part becomes exposed to environmental contamination
Solution Approach 1:
The closure system is pre-assembled with the cover part already in place before the vial is removed from the filling environment. This preliminary protective action maintains sterility during storage and transport, and only when intentional access is needed does the user remove the cover part, at which point the puncture hole has already been sealed by heat sealing
Solution Approach 2:
The mechanical sealing action of the elastomeric closure part being compressed by the clamp part is supplemented by thermal sealing using a focused laser beam to seal the puncture hole. This replaces reliance solely on mechanical sealing with a more reliable thermal sealing process that prevents contamination
2Productivity
If a hollow needle is passed through the closure part for filling, then the vial can be filled under aseptic conditions, but a residual puncture hole remains that compromises sterility
Solution Approach 1:
The elastomeric closure part undergoes a phase transition when exposed to focused laser energy, melting and fusing to seal the puncture hole. This thermal phase transition transforms the material from a puncturable state during filling to a sealed state after filling, maintaining sterility while preserving filling efficiency
Solution Approach 2:
The mechanical puncturing action of the needle is followed by thermal sealing using a focused laser beam. This replaces reliance on mechanical sealing alone with a more reliable thermal sealing process that ensures sterility is maintained after the needle is withdrawn
3Reliability
If the clamp part holds the closure part in a closing relationship with the mouth opening, then the vial is sealed, but the upper surface of the closure part remains exposed through the aperture
Solution Approach 1:
The closure system is segmented into distinct functional parts: the clamp part that provides mechanical sealing at the mouth opening, and the cover part that provides protective coverage of the upper surface. This segmentation allows each part to perform its specific function optimally without compromising the other
Solution Approach 2:
The cover part is placed over the closure part in advance, before the vial is removed from the filling environment. This preliminary protective action ensures the upper surface is shielded from contamination during storage and transport, while the clamp part maintains sealing integrity at the mouth opening
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 maintains the sterility of the vial's outer surface, prevents environmental contamination, and reduces content loss by providing a secure seal around the puncture hole, even without the need for additional heat sealing.
Implementation Method 1
the cover part engages with the upper surface of the closure part to provide two or more concentric ring-shaped seals which isolate a region of the upper surface of the closure within the innermost ring shaped seal from the environment
Implementation Method 2
an elastic closure part shaped to sealingly engage with the mouth opening, having a lower surface facing the interior of the vial and an opposite upper surface facing away from the vial, and capable of being punctured by a needle
Implementation Method 3
a clamp part able to engage with the vial, particularly with the rim of the mouth opening, and able to bear upon the closure part to hold the closure part in a closing relationship with the mouth opening
Data Source
AI summary
A closure system for a vial comprising: an elastic closure part to engage the mouth opening, a clamp part to hold the closure part in a closing relationship with the mouth opening, the clamp part defining an upper aperture through which a region of the upper surface of the closure part is exposed when the clamp part is engaged with the vial, a cover part to engage the clamp part to cover the exposed region, the cover part engaging with the closure part to provide two or more concentric ring-shaped seals, at least part of the cover part being removable from the vial to allow access to the closure.