Gas-Permeable Container Cover for Low-Particle Sterilization
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Solution Overview
Problem
Existing containers for storing and transporting primary packaging units, such as vials, cartridges, and syringes, face issues with particle generation from gas-permeable materials during sterilization and inefficient sterilization processes due to manipulation of these materials.
Innovation Solution
A container design featuring a body with gas-permeable material inserts and a flexible cover that allows sterilant entry and exit while minimizing contact with the cover, reducing particle generation by ensuring the gas-permeable material remains intact during removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If gas-permeable material is used to allow sterilant entry and exit, then sterilization efficiency is improved, but particle generation increases during manipulation and removal
Solution Approach 1:
The gas-permeable material is divided into multiple discrete inserts distributed across the container body rather than using a single large piece. This segmentation reduces the total surface area of gas-permeable material that needs to be manipulated and removed, thereby reducing particle generation while maintaining adequate sterilant flow paths for efficient sterilization
Solution Approach 2:
The gas-permeable inserts are designed to be removable from the container body after sterilization. By extracting only the necessary gas-permeable inserts rather than removing the entire cover or lining, the manipulation and potential particle generation is minimized while the sterilization function is fully achieved
2Reliability
If gas-permeable material is placed in contact with the cover for sealing, then sealing effectiveness is improved, but material integrity is compromised during removal
Solution Approach 1:
The container design incorporates specific localized features such as recesses or channels in the cover that accommodate the gas-permeable inserts without requiring extensive contact areas. This localized interaction maintains adequate sealing effectiveness at critical points while minimizing the overall contact between the gas-permeable material and the cover, thereby preserving material integrity during removal
3Productivity
If gas-permeable material is extensively used for sterilant flow, then sterilization efficiency is improved, but particle contamination increases
Solution Approach 1:
The gas-permeable material is segmented into multiple small inserts distributed throughout the container rather than using large continuous areas. This segmentation provides sufficient total surface area for effective sterilant flow and penetration while reducing the amount of material that can generate and release particles into the packaged environment
Solution Approach 2:
The patent specifies using porous polymeric material with controlled pore structures that allow efficient sterilant penetration and flow. These engineered porous materials provide high sterilization efficiency through their porous architecture while their controlled pore sizes and material composition minimize particle generation and contamination compared to less refined gas-permeable materials
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
Enhances sterilization efficiency by maintaining gas-permeable material integrity, reducing particle contamination, and improving sterilant flow, thus ensuring effective sterilization of contents.
Implementation Method 1
gas-permeable material through which gas can enter and exit the interior space of the body
Implementation Method 2
sterilization processes use heat, chemicals, or radiation to kill microorganisms
Implementation Method 3
a flexible cover that covers the opening of the body and is bonded to the body along the upper rim
Data Source
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AI summary
The present disclosure describes a container that includes a body having a lower surface, an upper rim, and a plurality of side walls that extend between the lower surface and the upper rim, wherein the upper rim defines an opening to an interior space of the body, a flexible cover that covers the opening of the body and is bonded to the body along the upper rim, and gas-permeable material through which gas can enter and exit the interior space of the body. The upper rim of the body is spaced apart from any of the gas-permeable material, such that the cover can be peeled away from the upper rim to expose the opening while leaving the gas-permeable material intact.