Dry Hydrogel-Forming Article for Sterile Low-Cohesion Drying
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Solution Overview
Problem
Existing methods for sterilizing hydrogels used in medical applications fail to achieve a sterility assurance level of 1 × 10 -6< or less, leading to potential microbial infections, and severe sterilization methods can degrade biologically active substances or hinder proper crosslinking and shape formation, while drying hydrogels can cause cohesion issues.
Innovation Solution
A dry hydrogel-forming article is produced by replacing water with an alcohol solvent, drying, and sterilizing to achieve a sterility assurance level of 1 × 10 -6< or less with a cohesion degree of 10% or less, using a crosslinked vinyl alcohol polymer with specific alcohol solvent and water content ranges.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If severe sterilization treatment (autoclave or gamma ray) is performed on hydrogel, then sterility assurance level is improved, but biologically active substances lose their original activity
Solution Approach 1:
The hydrogel is sterilized before crosslinking rather than after. This preliminary sterilization action prevents contamination during subsequent handling and eliminates the need for post-crosslinking sterilization that would damage biologically active substances. The crosslinking is then performed on already-sterile hydrogel, preserving biological activity while achieving both sterility and functional properties.
2Reliability
If gamma ray sterilization is performed before crosslinking, then sterility assurance level is improved, but crosslinking proceeds by the treatment making it difficult to obtain hydrogel molded into desired shape
Solution Approach 1:
Sterilization is performed as a preliminary step before crosslinking and molding operations. This sequence allows the hydrogel to be sterilized in its uncrosslinked state, then subsequently crosslinked and molded into desired shapes without the sterilization process interfering with shape formation. The preliminary sterilization establishes sterility that is maintained through the subsequent processing steps.
3Reliability
If severe sterilization treatment is performed, then sterility assurance level is improved, but strength of the gel is reduced due to non-uniform crosslinked portions
Solution Approach 1:
The sterilization is performed preliminarily before crosslinking, allowing uniform crosslinking to occur on already-sterile material. This prevents the formation of non-uniform crosslinked portions that would compromise gel strength, while still achieving the required sterility assurance level. The crosslinking process proceeds uniformly without being disrupted by prior sterilization damage.
4Reliability
If hydrogel is dried to prevent microbial growth, then sterility is improved, but cohesion issues occur during drying
Solution Approach 1:
The drying process parameters are controlled to achieve sterility while minimizing cohesion. Specific control of drying conditions (temperature, humidity, duration) prevents excessive cohesion during drying, allowing the hydrogel to be dried to a sterile state without developing harmful cohesive properties that would compromise its subsequent use.
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 method ensures sufficient sterilization and prevents cohesion during drying, maintaining hydrogel strength and cell adhesiveness, while preserving the activity of biologically active substances.
Implementation Method 1
a dry hydrogel-forming article comprising a crosslinked product of a vinyl alcohol polymer and an alcohol solvent
Implementation Method 2
When the dry hydrogel-forming article is swollen with water, a hydrogel can be obtained
Data Source
AI summary
Disclosed is a dry hydrogel-forming article comprising a crosslinked product of a vinyl alcohol polymer and an alcohol solvent, wherein a content of the alcohol solvent based on an amount of the dry hydrogel-forming article is 0.01 mass% or more and 15 mass% or less, and a content of water based on an amount of the dry hydrogel-forming article is 0 mass% or more and 70 mass% or less, and the dry hydrogel-forming article has a sterility assurance level SAL of 1 × 10-6 or less and a degree of cohesion of 10% or less.