Lyophilization Loading Tray Assembly for Shelf Contact and Occlusion

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Solution Overview

Problem

Existing lyophilization processes face challenges in achieving optimal contact between the container and the lyophilizer shelf, leading to less-than-optimal performance and potential operator errors such as fouling of the breathable membrane or ingress of contaminants due to improper occlusion during the lyophilization process.

Innovation Solution

A loading tray assembly is designed to secure a multi-part lyophilization container with a peelable seal, allowing for vacuum-induced seal opening and vapor transfer, and a temporary clamp to create an occlusion, ensuring consistent and automated clamping throughout the process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If manual occlusion is performed by operator, then flexibility in operation is maintained, but operator error occurs leading to fouling of breathable membrane or ingress of contaminants

Engineering Contradiction:

Improvemanual operation flexibilityVSAvoidocclusion performance

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The system performs occlusion automatically without operator intervention. The occlusion device is integrated into the lyophilization container system and executes occlusion based on pre-programmed timing or process conditions, making the system self-sufficient and eliminating dependence on operator action.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

Manual mechanical occlusion by operator is replaced with an automated occlusion mechanism. The patent describes an occlusion device that can be actuated automatically through mechanical, pneumatic, or other automated means, substituting the manual mechanical action with a more reliable automated system.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If automated occlusion is implemented, then operator error is reduced, but device complexity increases

Engineering Contradiction:

Improveocclusion performanceVSAvoidsystem structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The occlusion device is nested within or integrated with the lyophilization container structure. The automated occlusion mechanism is incorporated as part of the container assembly, allowing the complex function to be embedded within an existing structure rather than adding separate external systems.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The occlusion device is designed to perform multiple functions: it provides reliable occlusion to prevent contamination, can be integrated with the sealing mechanism, and may work with various container types. This multi-functionality justifies the added complexity by providing multiple benefits from a single integrated system.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Productivity

If optimal contact between container and lyophilizer shelf is achieved, then lyophilization performance is improved, but container positioning precision must be increased

Engineering Contradiction:

Improvelyophilization yieldVSAvoidcontainer positioning

Core Design Contradiction:

ProductivityVSManufacturing precision

Solution Approach 1:

The container is pre-positioned or pre-aligned on the loading tray before being placed in the lyophilizer. The loading tray assembly includes features that guide or constrain the container to the correct position in advance, ensuring optimal contact with the shelf without requiring high precision during the actual lyophilization process.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The loading tray assembly serves as an intermediary device between the container and the lyophilizer shelf. It provides a standardized interface and positioning mechanism that ensures proper alignment and contact, absorbing the positioning requirements and allowing the container to be handled more easily.

Inventive Principle:

Principle #24Intermediary (Mediator)

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 optimizes lyophilization performance by reducing operator errors, minimizing contamination risk, and enhancing the yield of viable product through consistent contact and controlled vapor transfer.

Implementation Method 1

applying heat energy and a vacuum, the vacuum causing an opening of the peelable seal of the lyophilization container and allowing vapor transfer

Methodology Applied

Scientific EffectVacuum: Vacuum

Implementation Method 2

applying heat energy and a vacuum

Methodology Applied

Scientific EffectHeat energy: Heating

Implementation Method 3

freezing the liquid, applying heat energy and a vacuum... allowing vapor transfer

Methodology Applied

Scientific EffectPhase change: Phase Change

Data Source

PatentEP3937878B1Lyophilization loading tray assembly and system

Publication Date: 2026.02.18 TERUMO BCT BIOTECHNOLOGIES LLC

Figure 1~2
Figure 3A
Figure 3B

AI summary

Provided is a loading tray assembly for housing a lyophilization container and a related system and method. The loading tray assembly includes a chassis including a contact void configured to facilitate direct contact between the attached lyophilization container and a lyophilizer shelf. The method includes securing a multi-part lyophilization container including a peelable seal on a lyophilization loading tray assembly, inputting a liquid into a non-breathable section of the lyophilization container, loading the tray assembly into a lyophilizer, freezing the liquid, applying heat energy and a vacuum, the vaccum causing an opening of the peelable seal and occluding the lyophilization container to isolate the frozen liquid.