Medical Rubber Part Sterilization Under Low-Oxygen Gamma Irradiation
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Solution Overview
Problem
Medical rubber parts sterilized with gamma ray face issues of uneven absorbed doses leading to potential degradation of inactive resin films, which compromises non-eluting characteristics and slidability.
Innovation Solution
A sterilization method involving gamma ray irradiation of medical rubber parts within packaging articles maintained at an oxygen concentration not higher than 5%, using inert gases or oxygen adsorbers to prevent resin film degradation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If medical rubber parts are sterilized by irradiating packaging bags with gamma ray, then sterilization can be guaranteed, but uneven absorbed dose occurs among parts leading to excessive radiation exposure for some parts
Solution Approach 1:
The patent applies inert atmosphere by replacing air with nitrogen gas in the packaging bag before gamma ray sterilization. This creates an oxygen-free environment that prevents oxidative degradation of the inactive resin film during irradiation, allowing consistent sterilization dosage without excessive radiation exposure. The nitrogen atmosphere stabilizes the packaging bag and prevents harmful oxidation reactions while maintaining reliable sterilization.
Solution Approach 2:
The patent changes the chemical composition parameter of the packaging atmosphere from oxygen-containing air to oxygen-free nitrogen atmosphere. This parameter change prevents oxidative degradation of the inactive resin film during gamma ray sterilization, ensuring uniform absorbed dose distribution and preventing excessive radiation exposure while maintaining sterilization reliability.
2Reliability
If medical rubber parts with inactive resin film are irradiated with gamma ray, then sterilization is achieved, but the inactive resin film degrades leading to loss of non-eluting characteristics
Solution Approach 1:
The patent uses nitrogen atmosphere to create an oxygen-free environment during gamma ray sterilization. This inert atmosphere protects the inactive resin film from oxidative degradation, preserving its non-eluting characteristics while achieving reliable sterilization. The nitrogen gas prevents harmful chemical reactions between oxygen and the resin film during irradiation.
3Ease of manufacture
If medical rubber parts are packaged in regular packaging bags without oxygen control, then packaging is simple, but uneven sterilization occurs and non-eluting performance deteriorates
Solution Approach 1:
The patent replaces regular air-filled packaging with nitrogen-filled packaging bags. This simple modification creates an oxygen-free environment that ensures uniform sterilization and prevents degradation of the inactive resin film. The process maintains ease of manufacture while dramatically improving sterilization reliability and consistency.
4Productivity
If gamma ray sterilization is performed on packaged medical rubber parts, then ready-to-use delivery is enabled, but variation in absorbed dose occurs within the packaging bag
Solution Approach 1:
The patent uses nitrogen atmosphere in the packaging bag to eliminate oxidative degradation during gamma ray sterilization. This creates uniform conditions throughout the packaging, ensuring consistent absorbed dose distribution across all parts while maintaining ready-to-use delivery capability. The inert atmosphere prevents variable degradation effects that would otherwise cause dose inconsistency.
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
Maintains non-eluting characteristics and slidability of medical rubber parts post-sterilization by preventing resin film degradation, ensuring consistent quality.
Implementation Method 1
using packaging articles that can be sealed with inert gases or oxygen adsorbers to maintain the integrity of the inactive resin film
Implementation Method 2
irradiating a packaging article for the medical rubber part with gamma ray, the packaging article accommodating a plurality of the medical rubber parts and having an oxygen concentration not higher than 5%
Data Source
AI summary
A sterilization method for a medical rubber part is a sterilization method for a medical rubber part that can include a body made from an elastic material and that can include an inactive resin film stacked on at least a portion of a surface of the body, where the sterilization method can include irradiating a packaging article with gamma ray, the packaging article accommodating a plurality of the medical rubber parts and having an oxygen concentration not higher than 5%.