Disposable Spray Drying Chamber for Aseptic Dried Plasma
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Solution Overview
Problem
Existing spray drying systems are impractical for use by untrained operators and lack the capability to aseptically manufacture dried plasma for medical applications, particularly in remote or emergency settings, and current methods fail to provide a stable, easily accessible dried plasma product.
Innovation Solution
A spray drying disposable device with a spray drying head and chamber, utilizing a drying gas source, plasma source, and pressurized aerosol gas source to atomize and evaporate plasma into dried particles, which can be stored and rehydrated quickly, ensuring system integrity and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If complex spray drying systems are used to manufacture dried plasma, then manufacturing capability is improved, but device complexity increases and ease of operation deteriorates
Solution Approach 1:
The system is divided into a reusable spray drying apparatus and a disposable drying chamber assembly. The disposable chamber contains all necessary components (nozzle assembly, drying chamber, filters, collection container) in a pre-assembled unit that is inserted into the apparatus, eliminating the need for operators to handle complex individual components.
Solution Approach 2:
The disposable drying chamber assembly is pre-configured with all necessary components and settings before insertion. The system performs self-alignment through locating features on the chamber and apparatus, and the pre-assembled nature eliminates the need for operator assembly or adjustment of complex components.
2Reliability
If conventional spray drying methods are used, then dried plasma can be produced, but aseptic manufacturing capability deteriorates and reliability worsens
Solution Approach 1:
The critical aseptic processing functions are extracted into a separate disposable drying chamber assembly that is discarded after use. This isolates the plasma processing environment from the reusable apparatus, ensuring that any potential contamination sources in the reusable components cannot affect the plasma product.
Solution Approach 2:
A disposable drying chamber assembly is used for each plasma processing operation. This single-use chamber contains all critical components (nozzle, drying chamber, filters, collection container) and is discarded after one use, eliminating the need for cleaning and sterilization of complex components while ensuring aseptic conditions.
3Quantity of substance
If frozen plasma storage is used, then plasma availability is improved for long periods, but loss of time increases during thawing in emergencies
Solution Approach 1:
The plasma is transformed from a liquid state (requiring freezing and thawing) to a dried powder state through spray drying. This parameter change in physical form eliminates the need for freezing and thawing operations, allowing the plasma to be stored at ambient temperatures and reconstituted quickly when needed.
Solution Approach 2:
The plasma is dried and packaged in a disposable chamber before being needed for transfusion. This preliminary processing allows the plasma to be stored in a stable dried form and then rapidly reconstituted when required, eliminating the 30-45 minute thawing time associated with frozen plasma.
4Productivity
If large machinery is used for spray drying, then manufacturing capability is improved, but device complexity increases and ease of operation deteriorates for untrained operators
Solution Approach 1:
The system separates the complex reusable apparatus from the disposable chamber assembly. The disposable chamber contains all the complex components (nozzle assembly, drying chamber, filters, collection container) in a pre-assembled unit, so operators only need to perform the simple action of inserting and removing the disposable chamber.
Solution Approach 2:
The disposable drying chamber assembly serves as a self-contained copy of all necessary processing functions. Instead of operators needing to understand and control complex apparatus settings, the disposable chamber is pre-configured with all necessary components and settings already in place.
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 device enables aseptic manufacture of dried plasma by minimally trained operators, providing a stable, easily accessible product that can be rehydrated in minutes, overcoming the limitations of existing systems and ensuring plasma availability in emergency situations.
Implementation Method 1
the pressurized aerosol gas flows in a vortex pattern, wherein, when in use, the pressurized aerosol gas atomizes the plasma entering the drying chamber to obtain atomized plasma droplets
Implementation Method 2
the drying gas resides in the plenum with uniform air pressure, wherein the plenum supports the nozzle assembly... drying gas jet provides drying gas to the drying chamber... 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 present invention includes a spray drying disposable device for use in a spray drying system. The disposable has a spray drying head and a plasma drying chamber. The head has a spray dry nozzle assembly in fluid communication with the plasma source and the pressurized aerosol gas source. The pressurized gas flows in a vortex pattern that atomizes plasma droplets in the chamber. The head also includes a plenum has uniform air pressure of the drying gas. A baffle plate forms the floor of the plenum having drying gas jets that supply drying gas to the chamber. The atomized plasma droplets evaporate in the presence of the drying gas emitted from the jets to obtain dried plasma particles and humid air. A capture filter captures the dried plasma particles and allows the humid air to pass. The humid air passes through the gas outlet and the exhaust port.