Snail Secretion Depyrogenation via Charged Nylon Filtration
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Solution Overview
Problem
Current methods for sterilizing snail secretion to remove pyrogenic substances like bacterial endotoxins are either costly, aggressive, and risk denaturing the biologically active components, or fail to meet regulatory standards for apyrogenicity and sterility, limiting its use in medical and cosmetic applications.
Innovation Solution
A mechanical filtration process using positively charged nylon membranes with a filtration degree of 0.04 to 0.45 µm, which interacts with phosphate groups of bacterial endotoxins, reducing their content to below 0.25 EU/ml, preserving the bioactive molecules and ensuring sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sterilization processes are used to remove endotoxins, then pyrogen-free products are obtained, but the biologically active components are denatured and unique properties are lost
Solution Approach 1:
The patent extracts and removes only the harmful endotoxin components from the snail secretion using specific filtration membranes, while leaving the beneficial biologically active components intact. This selective extraction resolves the contradiction by eliminating pyrogens without denaturing the secretion's active properties.
Solution Approach 2:
The patent introduces filtration membranes with specific pore sizes (0.04-0.45 µm) and surface charges as intermediary elements that selectively interact with endotoxins. These membranes act as mediators that capture harmful substances while allowing beneficial components to pass through, resolving the contradiction between pyrogen removal and biological activity preservation.
2Reliability
If mechanical sterilization with microfiltration is used, then bacteria are removed, but bacterial membrane lysis occurs releasing endotoxins into the secretion
Solution Approach 1:
The patent changes the parameters of the filtration process by using membranes with specific pore sizes (0.04-0.45 µm) and surface charge characteristics. These parameter changes enable the membranes to capture endotoxins through adsorption and electrostatic interactions, preventing their release while maintaining sterility.
Solution Approach 2:
The patent employs filtration membranes with composite properties combining specific pore structures and charged surface materials. These composite materials provide both mechanical filtration for sterility and chemical adsorption for endotoxin removal, resolving the contradiction between bacterial removal and endotoxin prevention.
3Reliability
If complex heating systems with heat exchangers are used for sterilization, then pyrogen-free products are obtained, but the equipment complexity and management costs increase significantly
Solution Approach 1:
The patent replaces complex thermal mechanical sterilization systems with a simpler mechanical filtration system. By using filtration membranes as the primary sterilization mechanism, the patent eliminates the need for complex heating equipment, heat exchangers, and pressure control systems, thereby reducing device complexity while maintaining apyrogenicity.
Solution Approach 2:
The patent uses porous filtration membranes with controlled pore sizes (0.04-0.45 µm) as the core sterilization element. These porous materials provide effective pyrogen removal through physical filtration and adsorption, replacing complex thermal systems with a simpler, more manageable filtration-based approach.
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 process effectively produces pyrogen-free snail secretion that meets regulatory standards for medical and cosmetic use, preserving bioactive molecules and reducing endotoxin levels, making it suitable for applications like ophthalmic and injectable products without the need for complex or aggressive treatments.
Implementation Method 1
positively charged nylon membranes with a filtration degree of 0.04 to 0.45 µm, which interacts with phosphate groups of bacterial endotoxins
Implementation Method 2
mechanical filtration process using positively charged nylon membranes with a filtration degree of 0.04 to 0.45 µm
Data Source
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AI summary
The present invention relates to a process for making pyrogen-free the snail secretion and reducing the endotoxin content contained therein to a value equal to or lower than 0.25EU/ml, said process comprising a mechanical filtration step with a filtering system comprising at least one, preferably three, filtering cartridges with a nylon membrane, preferably positively charged, with a filtration degree in the range from 0.04 to 0.45 µm.