Peelable Breathable Header for Sterilization Pouches
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Solution Overview
Problem
Conventional sterilizable medical device packages face issues with aseptic presentation upon opening, increased sterilization times due to reduced breathability from coatings, and higher production costs associated with larger openings and complex processing methods.
Innovation Solution
A sterilizable package design featuring uncoated breathable material directly adhered to the exterior surface with a peel feature, allowing for peeling without tearing, which maintains high porosity and reduces particulate matter release, thereby facilitating quicker sterilization and simpler manufacturing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If breathable material is coated to enable peeling, then ease of operation is improved, but porosity and breathability are substantially decreased
Solution Approach 1:
A peelable coating layer is applied to the breathable material to enable easy removal while maintaining the underlying porous structure. The coating acts as an intermediary that provides peeling functionality without blocking the breathability of the base material.
Solution Approach 2:
The breathability of the package is enhanced by increasing the surface area of the breathable material through the use of a header configuration, which compensates for the reduced porosity caused by the coating application.
2Quantity of substance
If size of opening is greatly increased to improve breathability, then porosity is improved, but amount of breathable material required increases resulting in higher production costs
Solution Approach 1:
The breathable material is configured as a header that is sealed to the pouch body, creating a segmented structure where the header portion provides the breathable function while the sealed portions maintain structural integrity and reduce material usage.
Solution Approach 2:
The surface area and configuration of the breathable header are optimized to provide adequate breathability while minimizing the total amount of material required, balancing performance with cost efficiency.
3Ease of manufacture
If conventional packaging methods are used, then manufacturing simplicity is maintained, but aseptic presentation upon opening is compromised
Solution Approach 1:
The breathable header is designed to be peelable from the sealed pouch body, allowing the sterile contents to be exposed in a controlled manner that maintains aseptic presentation while simplifying the manufacturing process.
Solution Approach 2:
The peelable coating on the breathable material serves as an intermediary mechanism that enables easy separation while maintaining the sterile barrier function until opening, thus preserving aseptic presentation.
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 design enables quicker gas exchange during sterilization, reduces particulate matter, and simplifies manufacturing, providing a cost-effective and aseptic presentation for medical devices.
Implementation Method 1
The porous characteristics of the breathable material allow a sterilizing medium, such as sterilizing gas (e.g., steam, ethylene oxide, etc.) to pass into and out of the pouch
Implementation Method 2
forming a sterile barrier against bacteria or other contaminants
Data Source
AI summary
The invention provides a sterilizable pouch having at least one wall formed of a flexible film and including an opening formed therein for providing communication to an interior space of the package. A breathable material is disposed on an outer surface of the wall covering the opening. The breathable material is joined to the outer surface of the wall with a continuous heat seal. The flexible film forming the wall comprises a multilayer film having a peel feature that permits the breathable material to be peelably removed from the surface of the pouch.