Lyophilisation Container With Segmented Volumes And Permeable Membrane

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Solution Overview

Problem

Current freeze-drying technologies face challenges such as contamination risks due to open systems, time-consuming parameter adjustments for varying product quantities, and difficulties in removing lyophilisates from small containers, which complicates the freeze-drying process, especially for pharmaceutical products like proteins and microorganisms.

Innovation Solution

A container with a membrane permeable to water vapor and internal partitions forming multiple reception volumes, allowing for personalized and variable volume freeze-drying with a consistent liquid height, reducing contamination risks and simplifying the freeze-drying process by maintaining invariant lyophilization parameters, and incorporating a pre-crushing device for easy product fragmentation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If open containers are used for freeze-drying, then water vapor can escape efficiently, but contamination risk increases between products and to the freeze-dryer itself

Engineering Contradiction:
Improvewater vapor escape efficiencyVSAvoidcontamination risk
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent employs a flexible membrane that allows water vapor to pass through while blocking contaminants. This thin film structure enables the container to maintain a closed system for contamination prevention while still permitting the necessary vapor escape for freeze-drying efficiency.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The container utilizes porous membrane material that selectively permits water vapor transmission while preventing the passage of larger contaminant particles and microorganisms. This porous structure resolves the contradiction by allowing vapor escape while maintaining contamination barriers.

Inventive Principle:
Principle #31Porous materials

2Temperature

If stainless steel containers are used for good heat exchange, then thermal conductivity is high, but cleaning and decontamination complexity increases

Engineering Contradiction:
Improveheat exchange efficiencyVSAvoidcleaning and decontamination ease
Core Design Contradiction:
TemperatureVSEase of manufacture

Solution Approach 1:

The patent employs disposable containers made from materials with adequate thermal conductivity properties. These single-use containers eliminate the need for complex cleaning and decontamination procedures while maintaining sufficient heat exchange efficiency for the freeze-drying process.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The container utilizes composite material construction that combines thermal conductivity properties with ease of cleaning characteristics. This composite structure achieves both good heat exchange and simplified decontamination without requiring expensive stainless steel.

Inventive Principle:
Principle #40Composite materials

3Reliability

If the same quantity of product is freeze-dried in each container, then freeze-drying parameters remain consistent, but adaptability to varying batch requirements decreases

Engineering Contradiction:
Improveparameter consistencyVSAvoidbatch variation flexibility
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent divides the container into multiple standardized compartments, each designed to hold a specific quantity of product. This segmentation allows consistent freeze-drying parameters within each compartment while enabling flexible configuration for different batch sizes by using varying numbers of compartments.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The container design incorporates universal compartment modules that can be arranged in different configurations to accommodate various batch sizes. This multi-functional design maintains parameter consistency through standardized compartment dimensions while providing adaptability to different production requirements.

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Object-affected harmful factors

If small individual containers are used for freeze-drying, then contamination risk is reduced, but time required for filling and emptying increases

Engineering Contradiction:
Improvecontamination riskVSAvoidfilling and emptying time
Core Design Contradiction:
Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The patent employs a large container segmented into multiple compartments, each acting as an independent small container for contamination prevention. This segmentation maintains the contamination benefits of small containers while allowing bulk filling and emptying operations, significantly reducing the time required compared to handling multiple separate small containers.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention merges multiple small container functions into a single large container with internal partitions. This combination maintains the contamination isolation benefits of individual small containers while enabling efficient bulk handling operations for filling and emptying.

Inventive Principle:
Principle #5Merging (Combining)

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

Enables efficient freeze-drying of variable product volumes with reduced contamination risks and invariant lyophilization parameters, facilitating easier product recovery and minimizing handling-related losses, thus improving the efficiency and safety of the freeze-drying process.

Implementation Method 1

a container body with an upper part equipped with a vapor-permeable membrane

Methodology Applied
Scientific EffectVapor permeation: Permeation

Implementation Method 2

Freeze-drying involves drying a frozen product under vacuum through a sublimation process

Methodology Applied
Scientific EffectSublimation: Sublimation

Data Source

PatentEP3857146B1Lyophilisation container
Publication Date: 2024.07.03 MAAT PHARMA
  • EP3857146B1 patent drawingFigure 1
  • EP3857146B1 patent drawingFigure 2
  • EP3857146B1 patent drawingFigure 3

AI summary

The invention relates to a container for the lyophilisation of a liquid or semi-liquid product. The container comprises an upper portion (2) provided with a membrane which is permeable to water vapour and a lower portion (3) comprising a reservoir designed to receive the product on a bottom. The container comprises internal partitions (21) in the reservoir (19) which form a plurality of product-receiving volumes (22-27), the internal partitions (21) being configured such that introducing product into one of the predefined receiving volumes (22) causes said receiving volumes (22-27) to be successively filled in a predetermined order.