3D Lyophilization Container Fixture for Peel Seal Stability

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Solution Overview

Problem

Existing lyophilization processes face challenges with flexible lyophilization containers due to induced stress from gas pressure, leading to failure modes such as peel seal separation and occlusion, which affect the geometry of thin solid layers during freeze drying.

Innovation Solution

The development of a lyophilization container with preformed three-dimensional shapes and breathable membranes, along with a lyophilization fixture that supports and secures different sections of the container, allowing for controlled movement and vapor transfer.

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 pre-formed with a three-dimensional shape that matches the desired geometry before the lyophilization process begins. This preliminary shaping eliminates the need for post-formation inflation, thereby preventing stress-induced peel seal separation while maintaining the required geometry of thin solid layers.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The harmful inflation step is completely removed from the process sequence. Instead of inflating a flat structure to achieve the desired geometry, the patent uses a pre-formed three-dimensional structure that requires no additional gas pressure application, thereby eliminating the source of induced stress and peel seal failure.

Inventive Principle:

Principle #2Taking out (Extraction)

2Shape

If gas pressure is applied to inflate the flexible lyophilization structure, then the desired geometry is achieved, but stress is induced in the flexible films

Engineering Contradiction:

Improvethree-dimensional shapeVSAvoidinduced stress in flexible films

Core Design Contradiction:

ShapeVSStress or pressure

Solution Approach 1:

The three-dimensional shape is pre-formed during manufacturing before the lyophilization process. The flexible structure is shaped into the desired configuration and maintained in that shape throughout the process, eliminating the need for stress-inducing inflation during the actual lyophilization operation.

Inventive Principle:

Principle #10Preliminary action

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 complex geometries is reduced

Engineering Contradiction:

Improvestructural stabilityVSAvoidgeometric conformance

Core Design Contradiction:

Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The patent employs a flexible lyophilization structure that is pre-formed into the desired three-dimensional shape. This flexible structure can conform to complex geometries while maintaining structural integrity during the lyophilization process, eliminating the need for rigid outer boxes that cannot adapt to varied shapes.

Inventive Principle:

Principle #30Flexible shells and thin films

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 solution enhances the stability and efficiency of the lyophilization process by maintaining the desired geometry of thin solid layers, reducing stress-induced failures, and facilitating effective vapor removal.

Implementation Method 1

breathable membranes, along with a lyophilization fixture that supports and secures different sections of the container, allowing for controlled movement and vapor transfer

Methodology Applied

Scientific EffectVapor transfer: Permeation

Implementation Method 2

preformed to have a three-dimensional shape... maintaining the desired geometry of thin solid layers

Methodology Applied

Scientific EffectGeometric stability:

Implementation Method 3

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

PatentUS20260029195A1Lyophilization Container Fixture

Publication Date: 2026.01.29 TERUMO BCT INC

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.