Flexible Container Membrane for Contamination-Free Freeze-Drying
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Solution Overview
Problem
Existing freeze-drying processes face challenges with contamination of biological materials during processing and repackaging, leading to increased labor and costs due to the need for sterilization of equipment and exposure to contaminants.
Innovation Solution
A system and method utilizing a flexible container with a membrane and column members that maintain the membrane above the biological material during freeze-drying, allowing solvent vapor escape while preventing liquid and contaminant entry, followed by sealing the freeze-dried material within the container for aseptic storage and use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If open containers are used during freeze-drying to allow solvent vapor removal, then the freeze-drying process can proceed effectively, but the biological material is exposed to potential contamination
Solution Approach 1:
The patent uses a flexible membrane that acts as a selective barrier during freeze-drying. The membrane allows solvent vapor to pass through while blocking liquid and particulate contaminants, enabling the container to remain closed throughout the process. This resolves the contradiction by maintaining both freeze-drying efficiency and contamination protection simultaneously.
Solution Approach 2:
The flexible membrane incorporates porous structure with specific pore sizes that permit vapor transmission while preventing contaminant ingress. The porous material enables selective permeability based on molecular size and phase, allowing water vapor to escape during freeze-drying while blocking larger contaminant particles and liquid droplets.
2Object-affected harmful factors
If sterilization treatment is applied to the operating area and equipment before each batch, then contamination risk is minimized, but labor and costs increase
Solution Approach 1:
The system employs self-sterilization through the use of a pre-sterilized flexible container with integrated membrane. The container is sterilized separately before use and sealed, eliminating the need for sterilization of the entire freeze-drying equipment and operating area. This shifts the sterilization burden to a component-level process, significantly reducing time and labor requirements while maintaining contamination protection.
Solution Approach 2:
The invention extracts the sterilization requirement from the main freeze-drying system by using a pre-sterilized disposable or reusable flexible container. The container serves as an isolated sterile environment that can be prepared independently, removing the time-consuming sterilization step from the critical path of each freeze-drying batch.
3Duration of action of stationary object
If repackaging is performed after freeze-drying, then the biological material can be stored, but additional contamination risk and labor are introduced
Solution Approach 1:
The invention merges the freeze-drying container with the storage container by using the same flexible membrane-sealed vessel for both purposes. The container serves dual functions: enabling freeze-drying through vapor-permeable membrane and providing long-term sterile storage through the same sealed structure. This eliminates the repackaging step entirely, preventing additional contamination risk and reducing labor.
Solution Approach 2:
The flexible container with membrane is designed as a multi-functional unit that performs both freeze-drying and long-term storage functions. The same container structure that facilitates solvent removal during processing also provides sterile barrier protection during storage, eliminating the need for separate repackaging operations.
4Object-affected harmful factors
If the membrane is positioned close to the biological material to prevent contaminant entry, then contamination protection is improved, but solvent vapor transmission is hindered
Solution Approach 1:
The invention resolves the spatial conflict by transitioning from a two-dimensional plane constraint to a three-dimensional configuration. The membrane is positioned above the biological material at a distance, and solvent vapor is removed through vertical sublimation and condensation cycles. The collapsible container walls allow the membrane to approach the material closely after drying without compromising vapor transmission during the drying phase.
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 effectively reduces contamination risks, minimizes labor and costs, and ensures the biological material remains sterile throughout the freeze-drying, packaging, and storage processes, enhancing the convenience and shelf life of biological materials like blood plasma.
Implementation Method 1
a membrane configured to transmit air or solvent vapor out of the flexible container
Implementation Method 2
freeze-drying the biological material
Implementation Method 3
at least one column member configured to maintain the membrane and the membrane frame a spaced distance from one or more contents receivable within the flexible container
Implementation Method 4
Upon application of a downward force, the at least one column member can assume a collapsed configuration
Implementation Method 5
lyophilization is a process for drying heat-sensitive substances, such as biological materials, by freezing the substances and then subliming the ice or other frozen solvent in a high vacuum
Data Source
AI summary
A system and method for protecting biological or other material from contamination through the steps of filling, freeze-drying, packaging, storing and use are disclosed. A system can include a flexible container, a membrane configured to transmit air or solvent vapor out of the flexible container, and a membrane frame supporting the membrane and engaged with at least one column member. The at least one column member can be configured to maintain the membrane and the membrane frame a spaced distance from one or more contents received within the flexible container. Upon application of a downward force, the at least one column member can assume a collapsed configuration. A method can include inserting a biological material, for example, into a flexible container, freeze-drying the biological material, moving the freeze-dried biological material to a portion of the flexible container that includes at least one port, and sealing the biological material within the portion.