Three-Layer Liquid System for Biological Decontamination
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Solution Overview
Problem
Current decontamination methods for biological materials, particularly viruses and prions, are inefficient and difficult to scale industrially due to instability in multi-layer systems and potential damage to target molecules, limiting the achievement of the desired log 10 reduction factor for pathogen efficacy.
Innovation Solution
A three-layer liquid system is formed with an aqueous solution of biological material as the upper layer, an organic solvent as the intermediate layer to maximize stability, and a high-density inactivating solution as the lower layer, ensuring efficient migration and inactivation of contaminants without damaging the biological material.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a multi-layer system with intermediate phase is used for decontamination, then viral decontamination efficacy is improved, but system stability deteriorates and becomes difficult to maintain
Solution Approach 1:
The patent introduces an intermediate phase comprising a non-aqueous solvent (such as chloroform, dichloromethane, or toluene) that acts as a mediator between the aqueous biological material phase and the inactivating solution phase. This intermediate phase facilitates viral particle migration through its organic solvent properties while maintaining clear phase separation due to immiscibility with aqueous solutions, thereby resolving the contradiction between decontamination efficacy and system stability.
2Reliability
If harsh inactivating procedures are used to eliminate prions and viruses, then decontamination efficacy is improved, but biological material activity deteriorates
Solution Approach 1:
The patent divides the decontamination process into three distinct sequential phases: (1) an aqueous phase containing the biological material, (2) an intermediate non-aqueous solvent phase, and (3) a dense inactivating solution phase. This segmentation allows viral and prion particles to migrate through the intermediate phase to reach the inactivating phase, while the biological material remains protected in the upper aqueous phase, thus achieving effective decontamination without damaging the biological material.
3Stability of the object's composition
If a bilayer system without intermediate phase is used, then system stability is improved, but direct contact between biological material and denaturing solution causes loss of biological activity
Solution Approach 1:
The patent introduces an intermediate phase comprising a non-aqueous solvent (such as chloroform, dichloromethane, or toluene) that acts as a mediator between the aqueous biological material phase and the inactivating solution phase. This intermediate phase facilitates viral particle migration through its organic solvent properties while maintaining clear phase separation due to immiscibility with aqueous solutions, thereby resolving the contradiction between decontamination efficacy and system stability.
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 process stabilizes the decontamination system, allowing for high-yield recovery of biological materials with preserved activity and efficient removal of contaminants, overcoming the limitations of previous methods by maintaining system stability and protecting biological activity.
Implementation Method 1
solutions with decreasing density are stratified: high density urea (inactivating lower phase), sucrose (intermediate phase or 'cushion') and solution of biological material to purify (upper phase)
Implementation Method 2
the tube is centrifuged, the particulate contaminant material, present in the upper phase, migrates through the intermediate phase and reaches the lower phase
Data Source
AI summary
The invention relates to a new process for decontaminating a biological material by partitioning and inactivation techniques. The process comprises the formation of a three-layer liquid system (a-b-c), where the layers are placed one onto the other and are different from each other in density and/or miscibility properties; the upper layer (a) comprises an aqueous solution of the biological material to decontaminate; the lower layer (c) comprises the solution inactivating said viruses, prions or bacteria; the intermediate layer (b), interposed between said upper and lower layers, separates and protects the biological material from the inactivating solution; it is studied so as to maximize the stability of the three-layer system in all the steps of the decontamination process; it comprises an organic solvent (or a mixture of more such solvents), immiscible at least with the upper layer; preferred organic solvents and their mixing proportions are specified in the description. Moreover, the invention provides specific indications about the density difference between the layers in order to preserve system stability and, at the same time, protect the efficiency of decontamination and the biological activity of the material undergoing decontamination.