Medical Rubber Packaging With Oxygen Indicator for Gamma Sterilization
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Solution Overview
Problem
Gamma ray sterilization of medical rubber products leads to polymer cleavage and crosslinking, resulting in low-molecular components that elute and cause product adherence, complicating manufacturing, and adding antioxidants may impair elution characteristics.
Innovation Solution
A package with oxygen impermeable material and divided sections for the medical rubber product and oxygen detecting agent, allowing visual confirmation of oxygen concentration through color change, ensuring quality assurance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gamma ray sterilization is applied to medical rubber product, then sterilization is achieved, but polymer cleavage occurs and low-molecular components are formed
Solution Approach 1:
The patent applies inert atmosphere by filling the package with nitrogen gas to replace oxygen. This creates an oxygen-free environment that prevents oxidative degradation of the rubber polymer during gamma ray sterilization, thereby maintaining polymer composition stability while achieving sterilization.
Solution Approach 2:
The patent implements preliminary action by removing oxygen from the package before sterilization and adding oxygen-scavenging packets. This preparatory step ensures that the polymer is protected from oxidative cleavage before the gamma ray treatment occurs, preventing the formation of low-molecular components.
2Reliability
If low-molecular components are formed from polymer cleavage, then sterilization is achieved, but elution performance deteriorates
Solution Approach 1:
By maintaining an oxygen-free inert atmosphere during sterilization, the patent prevents polymer chain scission that would generate elutable low-molecular components. This preserves the elution performance while achieving sterilization.
Solution Approach 2:
The preliminary removal of oxygen and addition of oxygen scavengers before sterilization prevents the formation of elutable degradation products, thereby maintaining elution performance standards.
3Reliability
If low-molecular components bleed out from rubber product surface, then sterilization is achieved, but product adherence occurs causing part feeder clogging
Solution Approach 1:
The inert nitrogen atmosphere prevents oxidative degradation that produces sticky low-molecular components. This eliminates adherence problems and part feeder clogging while maintaining sterilization effectiveness.
Solution Approach 2:
By preparing the oxygen-free environment before sterilization, the patent prevents the formation of adhesive degradation products, ensuring smooth manufacturing processes without feeder clogging.
4Stability of the object's composition
If oxygen concentration in package is reduced before sterilization, then polymer degradation is prevented, but quality assurance becomes difficult
Solution Approach 1:
The patent uses oxygen-sensitive color-changing packets that visually indicate oxygen concentration levels. These packets change color based on oxygen presence, providing simple visual verification of the oxygen-free environment without complex measurement equipment.
Solution Approach 2:
The oxygen-sensitive color-changing packets act as intermediaries that translate invisible oxygen concentration into visible color signals, enabling easy quality assurance verification of the polymer protection condition.
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
Facilitates quality assurance by visually confirming oxygen concentration, preventing polymer degradation and product adherence during gamma ray sterilization.
Implementation Method 1
an oxygen detecting agent which changes a color tone depending upon an oxygen concentration
Implementation Method 2
the package is formed of an oxygen impermeable packaging material
Implementation Method 3
the first space section and the second space section are divided by an oxygen permeable divider
Data Source
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AI summary
[Problem to be solved] An object of the present invention is to provide a novel package having a medical rubber product stored therein and capable of keeping the oxygen therein at a predetermined concentration or lower. Another object of the present invention is to make it possible to visually confirm the oxygen concentration in the package, thereby facilitating quality assurance by sterilization treatment. [Solution to solve problem] The present invention is a package having a medical rubber product sealed therein, wherein the package is formed of an oxygen impermeable packaging material and has a first space section and a second space section, the first space section has the medical rubber product stored therein, the second space section has an oxygen detecting agent stored therein, the oxygen detecting agent changes a color tone depending upon an oxygen concentration, and the first space section and the second space section are divided by an oxygen permeable divider.