Elastomeric Closure with Internal Barrier Film for Drug Stability
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Solution Overview
Problem
Conventional elastomeric closures allow for the transmission of water vapor and gases, which is problematic for storing moisture-sensitive drugs like lyophilized and biotech products, as it affects their stability and shelf life.
Innovation Solution
Incorporating a barrier film layer within the elastomeric closure that spans its width, which is plasma treated and bonded to the elastomeric material using methods like hot pressing and vulcanization, to create a robust moisture and gas barrier while preventing the barrier material from contaminating the contents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional elastomeric closures are used for sealing medicament vessels, then excellent sealing properties are achieved, but water vapor and gas transmission occurs which compromises drug stability
Solution Approach 1:
The closure combines elastomeric material with a barrier film layer to create a composite structure. The elastomer provides sealing properties while the barrier film (made from materials like aluminum foil, polyester, polyamide, or PVDC) blocks water vapor and gas transmission, resolving the contradiction between sealing effectiveness and moisture barrier performance
Solution Approach 2:
A thin barrier film is integrated into the elastomeric closure structure. This film acts as a moisture and gas barrier while maintaining the flexibility and sealing capabilities of the elastomeric material, effectively preventing water vapor transmission without compromising the closure's ability to seal the medicament vessel
2Object-affected harmful factors
If a barrier film is introduced to prevent water vapor transmission, then moisture barrier performance is improved, but the barrier material may become a secondary source of contamination
Solution Approach 1:
The barrier is implemented as a thin film that is fully encapsulated within the elastomeric closure structure. The film is positioned between the closure and the drug product, preventing direct contact and eliminating the risk of the barrier material becoming a contamination source while maintaining effective moisture and gas barrier properties
3Object-affected harmful factors
If a barrier film layer is added to the elastomeric closure, then water vapor and gas transmission is reduced, but the device complexity increases
Solution Approach 1:
The barrier film is integrated into the elastomeric closure during the manufacturing process, combining multiple functions (sealing and barrier protection) into a single unified component. This merging approach reduces the number of separate parts and assembly steps, thereby minimizing device complexity despite the enhanced functionality
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 internal barrier film effectively minimizes water vapor and gas transmission, enhances the shelf life of sensitive drugs, and eliminates the barrier material as a source of contamination, providing a reliable and long-lasting seal.
Implementation Method 1
plasma treating a top surface and bottom surface of the barrier film to increase its surface energy
Implementation Method 2
hot pressing and vulcanizing the plasma treated barrier film and the first layer of uncured elastomer together
Implementation Method 3
hot pressing and vulcanizing the plasma treated barrier film and the first layer of uncured elastomer together to form the bottom portion of the elastomeric closure bonded to the plasma treated barrier film
Data Source
AI summary
An elastomeric closure (10) having an internal barrier film (16) is provided. The elastomeric closure includes a top portion (12) and a bottom portion (14) formed together with a barrier film (16) disposed between the top and bottom portions. The barrier film may span the overall length and width of the elastomeric closure and preferably includes an aluminum foil as the barrier film material.