Spray Drying Process for Pathogen-Reduced Plasma
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Solution Overview
Problem
Current methods for drying blood plasma, such as freeze drying and spray drying, do not effectively reduce pathogens, leading to potential contamination and proliferation during storage and use, especially in remote or battlefield settings where plasma is scarce and pathogen risks are high.
Innovation Solution
A spray drying process using a specialized disposable device with a spray drying head and chamber that minimizes pathogen introduction by employing aseptic conditions, reducing pathogen concentration through controlled temperature and gas flow, and inhibiting pathogen growth during storage, resulting in a dried plasma product with reduced pathogens.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If freeze drying or conventional spray drying is used to dry blood plasma, then the plasma can be stored for long periods, but pathogens are not eliminated and may proliferate during storage
Solution Approach 1:
The patent applies parameter changes by controlling drying temperature, humidity, and time parameters during spray drying to achieve pathogen reduction while preserving plasma quality. Specific parameter ranges are established for drying temperature (e.g., 20-40°C) and relative humidity (e.g., 25-75%) to optimize both pathogen elimination and plasma protein preservation
Solution Approach 2:
The patent implements preliminary anti-action by adding antimicrobial agents or preservatives to the plasma before drying to prevent pathogen growth during storage. This proactive measure addresses the pathogen proliferation problem before it occurs during the storage period
2Duration of action of stationary object
If liquid plasma is stored for extended periods, then availability is improved, but pathogens can grow or proliferate in the plasma
Solution Approach 1:
The patent changes the physical state of plasma from liquid to dried form by controlling moisture content parameters during drying. By reducing water activity through controlled drying conditions, the patent prevents pathogen proliferation while extending storage duration
Solution Approach 2:
The patent employs disposable single-use containers and processing systems that are sterilized and sealed for extended storage. These disposable elements prevent recontamination and pathogen introduction during storage and handling
3Ease of operation
If dried plasma is rehydrated, then plasma availability is restored, but any preserved pathogens become viable again
Solution Approach 1:
The patent converts the harmful effect of pathogen persistence into a benefit by using the drying and rehydration process itself as a pathogen elimination mechanism. The controlled drying conditions create an environment that kills pathogens, and the subsequent rehydration restores plasma functionality without reviving pathogens
4Object-affected harmful factors
If spray drying is used to reduce pathogen load, then pathogen reduction is achieved, but process complexity and contamination risk must be minimized
Solution Approach 1:
The patent segments the spray drying process into distinct controlled stages: atomization, drying, and collection. Each stage has specific parameter controls that simplify the overall process while ensuring pathogen reduction. The segmentation allows for targeted intervention at critical control points
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 reduces pathogens in dried plasma, maintaining protein functionality and stability during storage, thereby enhancing safety and usability in transfusions, especially in resource-limited settings.
Implementation Method 1
the pressurized aerosol gas atomizes the plasma in the drying chamber to obtain atomized plasma droplets
Implementation Method 2
atomized plasma droplets evaporate in the presence of the drying gas emitted from the one or more drying gas jets to thereby obtain dried plasma particles
Data Source
AI summary
The spray dried plasma by the nature of its characteristics and the process by which it is made allows for a dried plasma with reduced pathogens. It has at least three aspects of pathogen reduction that results in a plasma product with reduced or no pathogens. The first aspect relates to a spray drying disposable and machine that eliminates or minimizes the introduction of pathogens into the spray drying process and is referred to as the anti-contamination process. The second aspect of pathogen reduction relates to the spray drying process and parameters that reduces pathogens that may be present in the donor plasma, and/or inhibit pathogen growth and/or pathogen proliferation introduced by the donor plasma. The third aspect results in reduced pathogens occurring during storage of the dried plasma wherein the manufacturing and storage conditions are such that pathogens are reduced, and/or pathogen growth and/or pathogen proliferation are inhibited.