Dialyzer Sterilization Using Peroxide Solutions
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Solution Overview
Problem
Current methods for sterilizing and integrity testing of dialyzers are time-consuming, costly, and leave toxic residues or require external logistical efforts, especially with chemical and radiation sterilization methods.
Innovation Solution
A method involving the use of aqueous solutions containing peroxides, ozone, chlorine, bromine, or iodine for simultaneous sterilization and integrity testing of dialyzers, where the solutions decompose without leaving residues, allowing for a single-step process that combines sterilization and testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If chemical sterilization methods (ethylene oxide or formalin) are used, then sterilization effectiveness is improved, but toxic residues remain in the dialyzer requiring thorough rinsing
Solution Approach 1:
The patent changes the chemical parameters of the sterilization agent by using peroxide-based solutions (hydrogen peroxide, peracetic acid) instead of traditional ethylene oxide or formalin. These peroxide solutions decompose into water, oxygen, and acetic acid, which are non-toxic or low-toxicity substances that do not require thorough rinsing, thus resolving the contradiction between sterilization effectiveness and toxic residue generation
Solution Approach 2:
The patent employs strong oxidizing agents (peroxides, peracetic acid) as sterilization agents. These substances achieve effective sterilization through oxidation mechanisms while decomposing into harmless byproducts, eliminating the toxic residue problem associated with traditional chemical sterilization methods
2Reliability
If radiation sterilization is used, then sterilization effectiveness is improved, but logistical effort and costs increase due to external service requirements
Solution Approach 1:
The patent enables manufacturers to perform sterilization in-house using peroxide-based solutions that can be applied and decomposed on-site without requiring external radiation sterilization services. This self-service approach eliminates complex logistics and external service dependencies while maintaining sterilization effectiveness
Solution Approach 2:
The patent replaces the complex radiation sterilization system (requiring external facilities and equipment) with a simple chemical sterilization process using peroxide solutions that can be applied using basic liquid application methods, significantly reducing system complexity and logistical requirements
3Manufacturing precision
If separate sterilization and integrity testing steps are performed, then each process can be optimized, but production time and costs increase
Solution Approach 1:
The patent merges the sterilization step with the integrity testing step by performing both functions simultaneously using peroxide-based solutions. The same solution that sterilizes the dialyzer also serves as the test medium for integrity testing, eliminating the need for separate steps and reducing production time
Solution Approach 2:
The peroxide-based solution serves multiple functions simultaneously: it acts as both the sterilization agent and the test medium for integrity testing. This multi-functionality allows a single process step to achieve both sterilization and quality verification, improving productivity without sacrificing process optimization
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 method reduces costs and logistical efforts by enabling a single-step sterilization and integrity check without toxic residues, allowing manufacturers to perform the process internally and ensuring effective sterilization of dialyzers with improved hemocompatibility.
Implementation Method 1
aqueous solutions containing peroxide and/or ozone, where the peroxide is selected from peroxides that decompose to water, oxygen and/or volatile organic compounds
Implementation Method 2
wet the dialysis membrane of the dialyzer with the sterilization liquid
Data Source
AI summary
The present invention relates to a method for the combined sterilization and integrity testing of dialyzers such as hollow fiber dialyzers, comprising the following steps: treating the dialyzer with a sterilizing fluid to sterilize at least the blood-side space of the dialyzer and to wet the dialysis membrane of the dialyzer with the sterilizing fluid, and performing an integrity test of the dialysis membrane wetted with the sterilizing fluid, wherein the sterilizing fluid is selected from aqueous solutions containing peroxide and/or ozone, wherein the peroxide is selected from peroxides that decompose to water, oxygen and/or volatile organic compounds; and aqueous solutions containing chlorine, bromine and/or iodine.