Sterilized Chlorhexidine Article via Pre-freezing
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Solution Overview
Problem
Developing a chlorhexidine article and method for sterilizing it effectively to reduce healthcare-associated infections by ensuring the sterility of chlorhexidine products used in medical applications.
Innovation Solution
A sterilized chlorhexidine product comprising a package with a sterilized applicator and antiseptic composition, where the chlorhexidine article is sealed within a package to maintain sterility, and a method involving cooling and sterilization processes such as irradiation to achieve a Sterility Assurance Level (SAL) of 10−3 to 10−9.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If chlorhexidine article is sterilized using conventional methods, then sterility is achieved, but the effectiveness of chlorhexidine is reduced due to degradation
Solution Approach 1:
The patent applies preliminary action by freezing the chlorhexidine article before sterilization. This pre-freezing step protects the chlorhexidine from degradation during the sterilization process, allowing effective sterilization while maintaining the integrity and effectiveness of the active ingredient.
Solution Approach 2:
The patent changes the physical state parameter of the chlorhexidine article by freezing it to a specific temperature range before sterilization. This parameter change (from liquid to frozen state) protects the chlorhexidine molecules from degradation while still allowing sterilization to occur, thus resolving the contradiction between achieving sterility and maintaining effectiveness.
2Object-affected harmful factors
If sterilization process is applied to chlorhexidine product, then pathogens are eliminated, but chlorhexidine degrades and loses effectiveness
Solution Approach 1:
The patent applies preliminary action by freezing the chlorhexidine product before subjecting it to sterilization. This pre-freezing step creates a protective state that prevents chlorhexidine degradation during the sterilization process, ensuring that pathogens are eliminated while the chlorhexidine remains effective.
Solution Approach 2:
The patent converts the potentially harmful effect of sterilization (which would normally degrade chlorhexidine) into a beneficial process by first freezing the product. The freezing state transforms the sterilization process from a degrading force into a safe and effective method that eliminates pathogens while preserving chlorhexidine integrity.
3Reliability
If chlorhexidine is exposed to heat or radiation for sterilization, then sterility is achieved, but the active ingredient degrades
Solution Approach 1:
The patent applies preliminary action by freezing the chlorhexidine composition before exposure to heat or radiation sterilization methods. This pre-freezing step stabilizes the composition and protects it from degradation, allowing the sterilization process to achieve the required sterility assurance level while maintaining composition stability.
Solution Approach 2:
The patent changes the temperature parameter of the chlorhexidine composition by freezing it before sterilization. This parameter change protects the molecular structure of chlorhexidine from degradation during heat or radiation exposure, enabling effective sterilization while maintaining the stability and integrity of the active ingredient.
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 ensures the sterility of chlorhexidine articles, reducing the risk of healthcare-associated infections by maintaining the sterility of the product from production to use, thereby effectively preventing pathogen colonization and infection.
Implementation Method 1
sterilizing the chlorhexidine product to form a sterilized chlorhexidine article
Data Source
AI summary
The present disclosure provides a sterilized chlorhexidine product for topical disinfection. The product includes a sterilized chlorhexidine gluconate composition, an applicator for facilitating application of the sterilized chlorhexidine composition, and a barrier configured to be compromised to impregnate the applicator with the sterilized chlorhexidine gluconate composition. The sterilized chlorhexidine gluconate composition includes chlorhexidine gluconate and alcohol.