Multi-Part Lyophilization Container With Breathable Membrane
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Solution Overview
Problem
Current lyophilization methods for blood and blood products face challenges such as the use of breakable glass containers, prolonged drying times due to restricted vapor transmission, contamination risks, and inadequate breathable surface area, which complicate storage, transportation, and reconstitution, especially in resource-limited settings.
Innovation Solution
A multi-part lyophilization container with a non-breathable section for fluid storage and a breathable section for vapor flow, featuring a temporary occlusion zone that separates the sections to prevent contamination and enhance vapor flow, allowing for in situ lyophilization and easy reconstitution, and a method involving a temporary seal, freezing, and heat application under vacuum to facilitate efficient drying.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a breathable membrane is used in a flexible pouch for lyophilization, then vapor transmission is enabled, but the membrane becomes wetted and fouled during the process, blocking vapor flow and increasing drying time
Solution Approach 1:
The container is divided into a liquid containment section and a vapor transmission section, separated by a partition barrier. This segmentation prevents the breathable membrane from contacting liquid directly while still enabling vapor transmission through the membrane to the condenser, resolving the fouling issue that blocks vapor flow.
Solution Approach 2:
A partition barrier acts as an intermediary element between the liquid and the breathable membrane. This barrier allows vapor to pass through to the membrane for transmission to the condenser while preventing liquid from wetting and fouling the membrane, thus maintaining consistent vapor flow throughout the lyophilization process.
2Reliability
If glass containers are used for lyophilization, then product integrity is maintained, but the containers are large and breakable, complicating storage and transportation
Solution Approach 1:
The patent replaces traditional rigid glass containers with a flexible pouch construction made of layered materials including a flexible outer layer and an inner liner. This flexible structure eliminates breakability while maintaining product integrity through the sealed, multi-layer design that protects the lyophilized product during storage and transportation.
3Productivity
If current lyophilization devices are used, then vapor transmission occurs, but the total breathable surface area is inadequate, resulting in underperformance
Solution Approach 1:
The breathable membrane is configured to wrap around and contact multiple surfaces including the condenser and container walls in three-dimensional space. This spatial arrangement maximizes the effective breathable surface area beyond what a simple flat membrane would provide, significantly enhancing vapor transmission capacity and lyophilization performance.
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 solution reduces lyophilization time, minimizes contamination risks, and eliminates the need for cold chain management, making it suitable for resource-limited areas and providing a more stable and portable blood product.
Implementation Method 1
a breathable section (106) including a breathable membrane (108)... configured to accommodate only a gas
Implementation Method 2
adding heat energy to the frozen liquid under vacuum
Implementation Method 3
adding heat energy to the frozen liquid under vacuum
Implementation Method 4
an occlusion zone (114)... encompassing a boundary bridging the non-breathable section and the breathable section
Data Source
Figure 1A
Figure 1B
Figure 2A
AI summary
Provided is a multi-part lyophilization container (200) for lyophilizing a fluid, such as blood or blood components. The container includes a non-breathable section (202) including a port region (204), a breathable section (206) including a membrane (210), and an occlusion zone (216) encompassing a boundary between the two sections. The non-breathable section is configured to accommodate any of a liquid, a solid, a gas or combination thereof. The breathable section is configured to accommodate only a gas. A method of lyophilizing includes creating a temporary seal between the two sections, e.g. by manual clamping in the occlusion zone, inputting a liquid into the non-breathable section, freezing the liquid, removing the temporary seal to allow vapor transport between the two sections, and applying heat energy under vacuum. The container may then again be occluded in the occlusion zone, a permanent seam created, the container divided at the permanent seam and the breathable section discarded.