Gas-Permeable Packaging Container for Low-Particle Sterilization
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Solution Overview
Problem
Existing containers for storing and transporting primary packaging units, such as vials and syringes, face issues with particle generation from gas-permeable materials and inefficient sterilization processes due to manipulation of these materials, which can contaminate the contents.
Innovation Solution
A container design featuring a body with gas-permeable material integrated into side walls and a flexible cover that can be peeled away without contacting the gas-permeable material, allowing sterilant entry and exit while minimizing particle generation, and including a support tray for secure packaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gas-permeable material is used to allow sterilant entry and exit, then sterilization efficiency is improved, but particle generation and contamination increase
Solution Approach 1:
The gas-permeable material is segmented into discrete inserts rather than a continuous layer. These inserts are placed at specific locations (e.g., in the flexible cover or on side walls) to provide localized gas permeability for sterilization while minimizing the total surface area of gas-permeable material exposed to manipulation, thereby reducing particle generation.
Solution Approach 2:
The gas-permeable material is extracted from the flexible cover during the peeling process. The flexible cover is designed to be peelable from the upper rim, and the gas-permeable inserts remain attached to the body or are removed separately, allowing the flexible cover to be discarded without contaminating the sterile interior with particles from gas-permeable material manipulation.
2Ease of operation
If flexible cover is peeled away to access contents, then ease of operation is improved, but gas-permeable material integrity is compromised
Solution Approach 1:
The sealing system is segmented into the flexible cover and discrete gas-permeable inserts. The flexible cover can be peeled away from the upper rim without affecting the gas-permeable inserts, which remain intact and attached to the body or are positioned to avoid contact during the peeling operation.
Solution Approach 2:
The flexible cover is extracted (peeled away) from the upper rim during access operations, while the gas-permeable inserts remain in place. This separation allows the flexible cover to be removed for access without compromising the integrity of the gas-permeable material, as the inserts are not attached to the flexible cover.
3Reliability
If gas-permeable material is manipulated during sterilization, then sterilization process is improved, but particle contamination increases
Solution Approach 1:
The gas-permeable material is extracted from the flexible cover, eliminating the need to manipulate it during sterilization operations. The flexible cover can be peeled away without disturbing the gas-permeable inserts, which remain stationary and intact, thereby preventing particle generation from manipulation.
Solution Approach 2:
The flexible cover is designed as a disposable component that is peeled away and discarded after use. The gas-permeable inserts remain attached to the body or are designed to stay in place, avoiding the need to manipulate them. This disposable approach to the flexible cover eliminates particle contamination from manipulating gas-permeable material during sterilization.
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 reduces particle contamination and enhances sterilization efficiency by maintaining gas-permeable material integrity during manipulation, ensuring effective sterilization and quick access to sterile contents.
Implementation Method 1
gas-permeable material through which gas can enter and exit the interior space of the body
Data Source
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.