Elastomeric Stopper with Full Fluoropolymer Film Lamination
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Solution Overview
Problem
Conventional elastomeric stoppers and pistons face issues with extractable and leachable substances, frictional forces leading to poor operation, and manufacturing complexities, particularly in silicone-free systems where silicone oil is not present to aid sealing and reduce static friction. Additionally, partial film lamination is prone to gas and fluid percolation due to imperfections, compromising container closure integrity (CCI).
Innovation Solution
A method for manufacturing elastomeric articles involving a one-step process where an uncured elastomeric sheet is placed in a mold with a first inert fluoropolymer film fully covering it, and a second release film on top, allowing for full film lamination over the elastomeric body, including external sidewall and crown surfaces, enhancing sealing and reducing friction without silicone oil. This process ensures a silicone-free system with improved CCI and manufacturing efficiency by eliminating the need for a two-step curing process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If the elastomeric article is made silicone-free to avoid interactions with biological drugs and laser outgassing, then drug safety is improved, but sealing performance and friction reduction are worsened
Solution Approach 1:
The patent applies a thin fluoropolymer film (such as PTFE) laminated onto the elastomeric piston surface. This film acts as a flexible barrier that provides both sealing functionality and low friction properties without requiring silicone oil. The film thickness is controlled to be thin enough to maintain flexibility and conformability while providing adequate barrier properties against drug interaction and laser outgassing.
Solution Approach 2:
The patent creates a composite structure combining elastomeric material with a fluoropolymer film layer. The elastomer provides structural integrity and elasticity, while the fluoropolymer film provides non-stick, low-friction, and chemically inert properties. This composite approach allows the system to achieve sealing performance without silicone oil by leveraging the complementary properties of the two materials.
2Ease of manufacture
If partial film lamination is used to reduce manufacturing complexity, then manufacturing steps are reduced, but container closure integrity is compromised due to gas and fluid percolation through imperfections
Solution Approach 1:
The patent implements full film lamination covering the entire elastomeric piston surface, including areas that would otherwise be exposed. This ensures uniform protection and sealing across all surfaces, eliminating localized imperfections that could serve as percolation paths. The film is applied to maintain consistent thickness and adhesion properties across the entire contact surface, preventing gas and fluid leakage while maintaining manufacturing feasibility through a single-step lamination process.
3Adaptability or versatility
If conventional two-step curing process is used for partial film lamination, then manufacturing flexibility is maintained, but productivity is reduced due to additional manufacturing steps
Solution Approach 1:
The patent merges the film lamination and curing operations into a single integrated process step. The fluoropolymer film is laminated onto the elastomeric piston and cured simultaneously in one operation, eliminating the need for separate lamination and curing steps. This consolidation maintains manufacturing flexibility by allowing adjustment of process parameters while significantly improving productivity by reducing the total number of manufacturing steps and cycle time.
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 provides a silicone-free elastomeric article with enhanced sealing properties and reduced friction, maintaining high container closure integrity and improving manufacturing efficiency by ensuring the entire elastomeric article is film-laminated, thus preventing gas and fluid leakage and reducing manufacturing steps.
Implementation Method 1
a first inert fluoropolymer film fully covering it, and a second release film on top, allowing for full film lamination over the elastomeric body
Implementation Method 2
the first film is laminated onto the elastomeric sheet thereby forming the at least one elastomeric article
Implementation Method 3
curing the assembly in the mold, such that the first film is laminated onto the elastomeric sheet
Implementation Method 4
enhancing sealing and reducing friction without silicone oil
Data Source
AI summary
An elastomeric article for sealing a container includes an elastomeric body having an external sidewall surface and an external crown surface and a first fluoropolymer film layer having an internal surface and an external surface. The internal surface of the first fluoropolymer film layer is laminated to an entirety of the external sidewall and crown surfaces of the elastomeric body. The external crown surface of the first fluoropolymer film layer includes a drug contact surface configured to contact a drug contained in the container and the external sidewall surface including a sealing surface for contacting an interior surface of the container. The external surface of the first fluoropolymer film layer is substantially free of striations.