Sterilizing Antiseptic Solutions via Controlled Thermal Parameters
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Solution Overview
Problem
There is no known method for sterilizing aqueous antiseptic solutions that maintains antimicrobial efficacy and purity, which is necessary to comply with regulatory requirements.
Innovation Solution
A method involving heating an aqueous antiseptic solution containing 2.0% w/v chlorhexidine gluconate to a predetermined temperature between 100°C and 125°C for a specific duration, ensuring the solution remains sterile with a post-sterilization purity of at least 90% and minimal degradation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high temperature sterilization is applied to aqueous antiseptic solutions, then sterilization effectiveness is improved, but degradation of antimicrobial molecules increases
Solution Approach 1:
The patent applies parameter changes by systematically varying temperature and time parameters to find the optimal sterilization condition. Specifically, it identifies that heating aqueous antiseptic solutions to temperatures between 100-125°C for specific durations (e.g., 100°C for 30 minutes, 125°C for 15 minutes) achieves sterilization while maintaining purity above 90%. This resolves the contradiction by transforming the sterilization process from a binary choice (sterile vs. degraded) to a optimized parameter space where both goals are achieved simultaneously.
2Stability of the object's composition
If low temperature and long processing time are used for sterilization, then degradation of antimicrobial molecules is reduced, but sterilization effectiveness is insufficient
Solution Approach 1:
The patent resolves this contradiction by changing the temperature parameter to a specific range (100-125°C) that enables effective sterilization without excessive degradation. The identified optimal conditions (e.g., 100°C for 30 minutes, 125°C for 15 minutes) demonstrate that moderate temperature elevation with controlled duration achieves both sterilization effectiveness and maintains purity above 90%, overcoming the limitation of low-temperature methods.
3Reliability
If conventional sterilization methods are applied to aqueous antiseptic solutions, then sterilization is achieved, but regulatory compliance is not met due to excessive degradation
Solution Approach 1:
The patent addresses regulatory compliance by optimizing temperature and time parameters to maintain post-sterilization purity above 90%. The identified conditions (e.g., 100°C for 30 minutes, 125°C for 15 minutes) specifically target this requirement, ensuring that the sterilization process meets both efficacy and purity specification requirements for regulatory approval.
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 method effectively sterilizes the aqueous antiseptic solution while maintaining sufficient purity and antimicrobial efficacy, ensuring compliance with regulatory standards and providing a sterile solution with a high sterility assurance level (SAL) of at least 10^-6.
Implementation Method 1
heating the aqueous antiseptic solution to a predetermined temperature, maintaining the aqueous antiseptic solution at the predetermined temperature for a predetermined time
Data Source
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AI summary
A method for sterilizing an aqueous antiseptic solution, the method comprising providing a container containing the aqueous antiseptic solution, the aqueous antiseptic solution comprising a bis-(dihydropyridinyl)-decane derivative or a biguanide, heating the aqueous antiseptic solution to a predetermined temperature, maintaining the aqueous antiseptic solution at the predetermined temperature for a predetermined time, and terminating the heating of the aqueous antiseptic solution when the predetermined time expires. The predetermined temperature and the predetermined time are selected such that after terminating the heating, the aqueous antiseptic solution is sterile.