Medical Rubber Product Sterilization via Radiation Shielding
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Medical rubber products sterilized with gamma rays face issues of uneven absorbed doses leading to potential degradation and eluting characteristics, which can result in clogging and adverse effects on medical preparations, and the use of antioxidants may compromise eluting performance.
Innovation Solution
A medical rubber product formed from a halogenated isobutylene-isoprene rubber composition with polyethylene and a triazine derivative, sterilized by gamma or electron rays, where specific infrared absorption peak ratios are maintained to ensure non-eluting characteristics and prevent polymer degradation, using attenuated total reflection Fourier transform infrared spectrophotometry to assess surface and internal properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple medical rubber products are packaged together and sterilized with gamma rays, then sterilization is achieved, but uneven absorbed doses occur leading to potential degradation and eluting characteristics
Solution Approach 1:
A radiation shielding member is introduced as an intermediary element between the gamma ray source and the medical rubber products. This shielding member selectively blocks or attenuates gamma rays to create a more uniform radiation dose distribution across all products in the package, preventing both under-dosed and over-dosed regions that would otherwise occur with direct irradiation of multiple products simultaneously
2Stability of the object's composition
If antioxidants are added to prevent polymer degradation from gamma ray exposure, then polymer stability is improved, but eluting performance deteriorates
Solution Approach 1:
The patent converts the harmful effect of gamma rays into a beneficial sterilization effect by using the radiation shielding member to control the radiation dose. Instead of adding antioxidants that would compromise eluting performance, the shielding member enables the use of gamma rays for sterilization while preventing excessive dose-induced degradation, thus eliminating the need for antioxidants and preserving the rubber's non-eluting characteristics
3Reliability
If high absorbed dose of gamma ray is applied to ensure sterilization, then sterilization is guaranteed, but polymer cleavage is promoted generating low-molecular-weight components
Solution Approach 1:
The radiation shielding member enables a partial action approach by selectively attenuating gamma rays to deliver an optimal dose that is sufficient for sterilization but not excessive enough to cause significant polymer cleavage. This creates a controlled radiation environment where the dose is precisely managed to achieve sterilization without generating harmful low-molecular-weight degradation products
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 solution maintains non-eluting characteristics and reduces manufacturing process troubles by ensuring minimal polymer degradation and effective sterilization, as evidenced by favorable eluting-substance and tack tests, and achieving zero viable cell count, indicating suitability for ready-to-use medical applications.
Implementation Method 1
sterilized by gamma rays or electron rays
Implementation Method 2
sterilized by gamma rays or electron rays
Implementation Method 3
measurement is performed on a surface portion of the elastic material through attenuated total reflection (ATR) by using a Fourier transform infrared spectrophotometer (FT-IR)
Implementation Method 4
measurement is performed on a surface portion of the elastic material through attenuated total reflection (ATR)
Data Source
AI summary
An object of the present invention is to provide a sterilization method for a medical rubber product in which non-eluting characteristics are maintained even after sterilization with gamma ray and with which less troubles occur in a medical product manufacturing process. The medical rubber product according to the present invention is a medical rubber product formed from an elastic material and sterilized by being irradiated with gamma ray or electron ray (beta ray), wherein, when measurement is performed on a surface portion of the elastic material through ATR by using an FT-IR, if an area of an infrared absorption peak at around a wave number of 1650 cm−1 in an infrared absorption spectrum obtained through the measurement is defined as As and an area of an infrared absorption peak at around a wave number of 1470 cm−1 in the infrared absorption spectrum is defined as Bs, Ss=(As/Bs)×100≤6 is satisfied.