Flexible Container Lyophilization via Pressure and Infrared
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Solution Overview
Problem
The lyophilization process is inefficient, taking several days to complete and requiring improvements in speed without compromising the quality of the final product, particularly for biological materials and pharmaceuticals.
Innovation Solution
The use of containers with flexible polymeric materials and gas-permeable walls, along with a system that involves maintaining a multi-component liquid at specific pressures for evaporation, freezing, and sublimation, and the application of compressive forces and infrared radiation to enhance the lyophilization process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If conventional lyophilization process is used, then the material is preserved with good quality, but the process takes several days to complete
Solution Approach 1:
The container is pre-formed with a collapsed flexible wall configuration before the lyophilization process begins. This preliminary structural preparation allows the container to collapse and expand during the process, enabling faster sublimation and preservation without requiring extended time, thus resolving the contradiction between process speed and quality maintenance
Solution Approach 2:
The patent utilizes changes in pressure parameters (from atmospheric to reduced pressure) and temperature parameters (freezing to sublimation temperatures) to accelerate the lyophilization process. By controlling these parameters dynamically, the process time is reduced while maintaining product quality, addressing the time-speed contradiction
2Strength
If the container wall is made rigid, then the structural integrity is maintained, but the gas permeability and flexibility for pressure equalization are reduced
Solution Approach 1:
The container wall is constructed from a flexible polymeric material that can dynamically adjust its configuration. This flexible wall can collapse during lyophilization to equalize pressure and then expand to maintain structural integrity during storage, simultaneously achieving both pressure equalization capability and structural strength
Solution Approach 2:
The container wall transitions from a rigid structure to a dynamic, flexible structure that can change its volume and pressure characteristics. This dynamic behavior allows the wall to adapt to different process requirements (collapsing for pressure equalization, expanding for structural support), resolving the contradiction between rigidity and adaptability
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 approach significantly reduces the time required for lyophilization while maintaining the integrity and usability of the final product, allowing for faster preservation and storage of materials like blood components.
Implementation Method 1
a second wall attached to the first wall to define an interior volume of the container. The second wall in embodiments is made from a gas permeable material that allows gas to move from an interior of the container to an exterior
Implementation Method 2
The second layer may in some embodiments be an infrared radiator for adding energy to materials that are being lyophilized
Implementation Method 3
At least one component of the multi-component liquid may then be evaporated for a predetermined time
Implementation Method 4
After the evaporation step, the multi-component liquid may be frozen to form a solid
Implementation Method 5
A portion of the solid may then be sublimated
Implementation Method 6
A component of the solid may then be desorbed from the solid
Data Source
AI summary
Embodiments of methods, systems, and apparatuses for lyophilizing, storing, and transfusing materials are described. In embodiments, the materials may include whole blood or a component of whole blood such as plasma.