Preformed Lyophilization Containers with Segmented Compartments

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Solution Overview

Problem

Lyophilization containers face challenges in achieving efficient freeze drying due to induced stress in flexible films, leading to failure modes such as peel seal separation, which affects the geometry of thin solid layers and vapor movement during the sublimation process.

Innovation Solution

The development of a lyophilization container with preformed three-dimensional shapes and a breathable membrane section, along with a movable occluding section, allows for controlled vapor flow and minimizes stress on the flexible materials, enhancing the lyophilization process by maintaining the desired geometry of ice layers and facilitating efficient sublimation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Shape

If gas pressure is applied to inflate/stretch the flexible lyophilization structure, then the desired geometry of thin solid layers is achieved, but induced stress causes failure modes including peel seal separation

Engineering Contradiction:
Improvegeometry of thin solid layersVSAvoidpeel seal integrity
Core Design Contradiction:
ShapeVSReliability

Solution Approach 1:

The flexible lyophilization structure is divided into multiple sealed compartments separated by partition walls. This segmentation allows each compartment to be inflated independently and controls stress distribution, preventing peel seal separation while maintaining the desired geometry of thin solid layers.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The partition walls are designed with different properties at different locations: stronger materials or reinforced structures at locations subject to high stress, and more flexible sections where vapor flow is needed. This local differentiation maintains seal integrity while allowing geometric formation.

Inventive Principle:
Principle #3Local quality

2Productivity

If the flexible lyophilization structure is inflated to achieve thin solid layer geometry, then vapor movement is facilitated, but the induced stress affects the reliability of the container

Engineering Contradiction:
Improvevapor movement efficiencyVSAvoidcontainer integrity
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

By dividing the container into sealed compartments with partition walls, the system maintains container integrity under inflation stress while still allowing efficient vapor movement through controlled pathways in the partition structures.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The partition walls and flexible structure are constructed from composite materials that combine high strength-to-weight ratio materials with flexible properties, enabling the structure to withstand inflation stress while maintaining vapor permeability and structural integrity.

Inventive Principle:
Principle #40Composite materials

3Stability of the object's composition

If a rigid outer box is used to define the lyophilization container, then structural stability is improved, but the ability to conform to shelf geometry and achieve thin solid layers is reduced

Engineering Contradiction:
Improvestructural stabilityVSAvoidconformity to shelf geometry
Core Design Contradiction:
Stability of the object's compositionVSShape

Solution Approach 1:

The container system combines a rigid outer box with internal flexible sealed compartments. This segmentation allows the outer box to provide structural stability while the internal flexible sections can conform to shelf geometry and achieve the desired thin solid layer configuration.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The flexible sealed compartments are nested within the rigid outer box structure. The flexible sections can inflate and conform to the shelf geometry while being contained within the stable rigid outer box, achieving both structural stability and geometric conformity.

Inventive Principle:
Principle #7Nested doll (Nesting)

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 design improves the lyophilization process by maintaining the geometry of ice layers, reducing stress on flexible materials, and ensuring efficient vapor movement, thereby enhancing the efficiency and effectiveness of the freeze drying process.

Implementation Method 1

The second section (508) may include a breathable membrane (512)

Methodology Applied
Scientific EffectSemipermeable membrane: Semipermeable Membrane

Implementation Method 2

Lyophilization is carried out below the triple point to enable conversion of ice into vapor without entering the liquid phase. This conversion from ice to vapor is known as sublimation.

Methodology Applied
Scientific EffectSublimation: Sublimation

Data Source

PatentUS20240375840A1Preformed lyophilization containers and methods of preparing the same
Publication Date: 2024.11.14 TERUMO BCT INC
  • US20240375840A1 patent drawing
  • US20240375840A1 patent drawing
  • US20240375840A1 patent drawing

AI summary

A lyophilization container includes a first section having a first layer, a second layer aligned with the first layer, and a cavity defined by the alignment of the first and second layers, where at least one of the first and second layers is preformed to have a three-dimensional shape. A lyophilization fixture includes a base member and a lid member. The lid member is movable between a first position and a second position relative to the base member. The base member and lid member together define a housing that receives at least a portion of a lyophilization container.