Low-Solvent Separation Gel for Stable Blood Sample Isolation
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Solution Overview
Problem
Existing blood collection tubes with separating gels contain hazardous solvents like toluene and N-methyl-2-pyrrolidone, exceeding 1000 ppm, posing safety risks and contaminating blood samples, which affects the accuracy of clinical analyses.
Innovation Solution
A separation gel comprising an acrylate copolymer, silica, and silicone oil, with a low solvent content of ≤ 1000 ppm, is developed, ensuring the gel is not classified as hazardous and providing a stable, high-purity separation of blood serum or plasma, minimizing contamination and improving sample quality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional distillation process is used to remove solvents, then solvent content can be reduced, but residual solvent content remains above 1000 ppm causing hazardous classifications
Solution Approach 1:
The patent changes the parameter of solvent content by implementing an enhanced distillation process with specific operational parameters (temperature profiles, pressure conditions, multiple distillation stages) to achieve residual solvent content ≤ 1000 ppm, thereby eliminating hazardous substance classification while maintaining manufacturing feasibility
Solution Approach 2:
The patent applies continuous distillation process with multiple sequential stages where the distillation is carried out continuously to progressively remove solvent. This continuous action ensures complete solvent removal down to ≤ 1000 ppm residual content, transforming a batch process into a continuous purification sequence that achieves the required precision
2Ease of manufacture
If high solvent content is used in separation gel, then gel formulation is simplified, but health hazards increase and sample contamination occurs
Solution Approach 1:
The patent extracts and removes the harmful solvent component from the separation gel formulation through enhanced distillation. The solvent is completely extracted down to ≤ 1000 ppm residual content, eliminating health hazards and contamination risks while maintaining the functional integrity of the separation gel without requiring high solvent content
Solution Approach 2:
The patent converts the previously harmful high solvent content into a benefit by using the distillation process to precisely control and minimize solvent residues. The enhanced distillation transforms what would be a harmful excess solvent into a controlled, minimal residue ≤ 1000 ppm that maintains gel functionality while eliminating hazards
3Measurement precision
If separation gel is used to prevent blood cell contamination, then sample purity improves, but analyte stability may be affected during prolonged storage
Solution Approach 1:
The patent changes the chemical composition parameters of the separation gel by formulating it with specific polymer characteristics and excluding harmful solvents. This parameter change maintains the density and separation functionality while improving chemical inertness, thereby preserving analyte stability during prolonged storage without compromising sample purity
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 low solvent content reduces health hazards and enhances sample quality, enabling reproducible analytical results by forming a stable separation layer that maintains analyte stability during storage and transport, optimizing workflow from collection to analysis.
Implementation Method 1
During centrifugation, it separates itself between the blood cells and serum because its density lies between the two fractions
Implementation Method 2
The separating gel at the bottom of the tube has a lower density than the coagulation proteins and blood cells that aggregate during coagulation
Implementation Method 3
Due to the diffusion barrier formed by the separating gel, the determination of clinical chemistry analytes, such as steroids, hormones, vitamins, and drugs, is still possible even after prolonged refrigerated storage
Data Source
Figure 1
AI summary
The invention relates to a separation gel for blood collection tubes for separating blood serum or plasma from blood cells, comprising an acrylate copolymer, silica, and silicone oil and/or at least one polyalkylene glycol, wherein the separation gel contains ≤ 1000 ppm, preferably ≤ 300 ppm, solvent, a process for producing the separation gel, a blood collection tube containing the separation gel, and a process for producing the acrylate copolymer, wherein at least one solvent is removed by multi-stage distillation to purify the acrylate copolymer, such that a residual solvent content of ≤ 1000 ppm, in particular ≤ 300 ppm, is achieved.