Patterned Sealing Film for Sterile Packaging
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Solution Overview
Problem
Existing sealing films for gas or vapor decontaminable packaging applications face challenges such as limited temperature range for steam sterilization, formation of lint and particles during de-lidding, and issues with packaged items falling out of containers during transport.
Innovation Solution
A sealing film comprising a selectively permeable non-woven layer bonded with a solid polymer film having predefined cut-out regions or a needling, perforation, and/or cut pattern, which allows for broad temperature range sterilization, reduces lint formation, and prevents items from falling out of containers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a non-woven sealing film is used to maintain sterility, then microbial barrier protection is improved, but lint and particle formation during opening increases
Solution Approach 1:
The sealing film combines a non-woven layer with a film layer having a specific pattern structure. The non-woven provides microbial barrier properties while the film layer with cut-outs, perforations, or needling patterns reduces lint generation during opening by providing defined separation paths.
2Strength
If an adhesive layer is applied to improve sealing properties, then sealing strength is improved, but temperature range for steam sterilization is limited
Solution Approach 1:
The invention changes the sealing mechanism from adhesive-based to friction and mechanical interlocking-based sealing. The patterned film structure creates zones of different sealing forces, allowing effective sealing without adhesive while withstanding broader temperature ranges including steam sterilization.
3Reliability
If the non-woven is made more dense to improve microbial barrier, then sterility assurance is improved, but permeability to sterilizing gas or vapor decreases
Solution Approach 1:
The film layer introduces local variations in structure with cut-outs, perforations, or needling patterns that create specific zones for gas permeability while maintaining overall microbial barrier integrity. The non-woven density can be optimized for sterility while the patterned film provides controlled permeability paths.
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 broad sealing window for various sterilization processes, minimizes lint and particle formation, and ensures secure containment of items during transport and sterilization.
Implementation Method 1
wherein the first layer of film b1) or b2) has monoaxial or biaxial heat shrink properties, wherein the shrink in one or both directions is 20 %-55 %
Implementation Method 2
a layer of a selectively permeable non-woven being essentially impermeable for microorganisms
Data Source
Figure 1~2
AI summary
Disclosed is a sealing film for gas or vapor decontaminable packaging applications including a container having an opening to be sealed with a film before decontamination and a packaging comprising the same. These sealing films are particularly useful for sterile storage and transport of objects for medical, pharmaceutical or cosmetic uses, in particular for sterile pharmaceutical primary packaging means, like vials, ampules, syringes, or cartridges.