Elastomeric Article Packaging for Sterilization Degradation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Elastomeric articles, particularly those made from synthetic polyisoprene, undergo degradation due to ozone and other degradants, which is exacerbated by radiation-based sterilization techniques like gamma irradiation, leading to cracking and discoloration.
Innovation Solution
The method involves packaging elastomeric articles with antidegradants such as antioxidants and antiozonants in a low-oxygen environment, achieved by using a vacuum to reduce oxygen levels within the package to 20 cm3 or less, and sealing them in low-oxygen-permeable materials to prevent ozone attack during sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radiation-based sterilization techniques (gamma irradiation, electron-beam processing) are used to sterilize elastomeric articles, then sterilization effectiveness is improved, but degradation, cracking, and discoloration of the articles worsen
Solution Approach 1:
The patent applies inert atmosphere by packaging elastomeric articles in a controlled environment with reduced oxygen levels (less than 20 cm³ of oxygen). This low-oxygen environment acts as a protective atmosphere that prevents oxidative degradation and reduces the harmful effects of radiation sterilization, allowing effective sterilization while minimizing damage to the elastomeric articles.
2Device complexity
If elastomeric articles are packaged in conventional materials, then packaging simplicity is maintained, but ozone penetration and degradation increase
Solution Approach 1:
The patent employs composite packaging materials that combine multiple layers with different properties. The packaging comprises an outer layer and an inner layer with specific oxygen transmission rates, creating a composite structure that provides superior ozone and oxygen barrier protection while maintaining packaging functionality. This composite approach balances protection requirements with practical packaging considerations.
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
This approach significantly reduces degradation, cracking, and discoloration in elastomeric articles, especially during radiation sterilization, by creating a protective reduced-oxygen environment that minimizes ozone exposure.
Implementation Method 1
removing oxygen from within the package to form a reduced-oxygen environment inside the package, preferably by exposing the package to a vacuum of 250 mbar or less
Implementation Method 2
sealing the package to provide the elastomeric article within the reduced-oxygen environment inside the package
Data Source
AI summary
The present invention relates generally to methods of sterilizing elastomeric articles in a manner that prevents and/or reduces degradation to the articles, particularly degradation that may be caused and/or accelerated by sterilization techniques such as gamma irradiation, x-ray irradiation, and electron-beam processing. The methods include packaging the elastomeric articles in order to improve their resistance to degradation. In certain aspects of the invention, packaged elastomeric articles, optionally containing one or more antidegradants, such as antioxidant and/or antiozonant compounds, are also provided. The methods of providing degradation-resistant elastomeric articles in accordance with the present invention may also be used to reduce the occurrence of cracking and discoloration in elastomeric articles, regardless of whether they are subjected to sterilization.