Disposable Biopharmaceutical Fluid Transfer Pouch with Gas Compression

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Solution Overview

Problem

Current systems for receiving and transferring large quantities of biopharmaceutical fluids under controlled pressure face challenges such as complex cleaning procedures, residual volume issues, and inefficiencies in filtration processes, particularly when dealing with quantities of 10 liters or more.

Innovation Solution

A device comprising a flexible inner pouch and a sealed outer container with integrated pressurized gas injection, allowing for controlled pressure transfer and filtration without the need for complex hatch systems or pumps, ensuring sterile conditions and efficient fluid handling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a rigid receptacle made of stainless steel is used for receiving and transferring biopharmaceutical fluid, then the device can be reused with cleaning operations, but the cleaning operation becomes long, expensive and requires very great care

Engineering Contradiction:
Improvereusability of deviceVSAvoidcleaning operation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent employs a single-use flexible pouch that is discarded after one filling and emptying cycle. This disposable approach eliminates the need for complex cleaning operations while maintaining sterility, directly resolving the contradiction between reusability and cleaning time/cost.

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

2Stress or pressure

If an inner pouch with compression chamber is used, then the device can empty fluid under pressure, but the emptying tube passing through the inner pouch leaves a residual volume that cannot be emptied

Engineering Contradiction:
Improvepressure for fluid emptyingVSAvoidresidual fluid volume
Core Design Contradiction:
Stress or pressureVSLoss of substance

Solution Approach 1:

The patent extracts the compression function from the fluid-containing pouch by placing the pouch inside an outer container that receives compression gas. This separates the fluid storage function from the compression function, allowing complete emptying without residual volume while maintaining pressure application capability.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces compression gas as an intermediary substance that transmits force to compress the flexible pouch. This gas mediator allows uniform compression from all directions, efficiently expelling all fluid including the residual volume that would remain with direct mechanical compression.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Adaptability or versatility

If a hatch system is used for installing and removing inner pouch, then the device can accommodate flexible pouches, but the hatch and associated systems make cleaning the outer container more complex

Engineering Contradiction:
Improveability to install and remove inner pouchVSAvoidcleaning complexity of outer container
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent uses a disposable flexible pouch that is sealed within the outer container, eliminating the need for hatches or opening mechanisms. The entire assembly is discarded after single use, which simplifies the outer container design and reduces cleaning complexity while maintaining the ability to accommodate the pouch.

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

4Stress or pressure

If pressurized compression gas is injected into compression chamber, then the inner pouch can be compressed for complete emptying, but the gas must not contact the biopharmaceutical fluid to maintain sterile process

Engineering Contradiction:
Improvecompression pressure for complete emptyingVSAvoidsterility contamination
Core Design Contradiction:
Stress or pressureVSObject-affected harmful factors

Solution Approach 1:

The patent segments the system into two separate compartments: an inner pouch containing the biopharmaceutical fluid and an outer container containing the compression gas. This physical separation allows independent control of each environment, enabling compression with gas that cannot contact the fluid, thus maintaining sterility while achieving complete emptying.

Inventive Principle:
Principle #1Segmentation

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, sterile, and quick transfer of biopharmaceutical fluids under controlled pressure, reducing cleaning complexity and residual volumes, while facilitating filtration and formulation processes without the need for additional pumps.

Implementation Method 1

a compression chamber being provided between the outer container and the inner enclosure, an inlet for injecting pressurized compression gas into the compression chamber

Methodology Applied
Scientific EffectGas compression: Compression

Implementation Method 2

the deformation capacities respectively of the inner enclosure and of the outer container being chosen so that when the compression gas is injected under pressure into the compression chamber, the inner enclosure is compressed and the biopharmaceutical fluid which is in it is emptied under pressure

Methodology Applied
Scientific EffectPressure gradient: Pressure Gradient

Data Source

PatentEP2969902B1Reception, draining and transfer of a high quantity of biopharmaceutical fluid under pressure with a view to subsequent treatment
Publication Date: 2022.08.24 SARTORIUS STEDIM FMT SAS
  • EP2969902B1 patent drawingFigure 1~2
  • EP2969902B1 patent drawingFigure 3A~5
  • EP2969902B1 patent drawingFigure 6

AI summary

Reception, draining and transfer of a high quantity of biopharmaceutical fluid under pressure with a view to subsequent treatment. A device (1) for receiving and then draining a high quantity of biopharmaceutical fluid under pressure comprises an inner bag (3), having an inner container (6) capable of and intended for receiving the biopharmaceutical fluid and provided with a filling port (7) and a drain port (8) and a filling tube (9) having a filling inlet (10) capable of being connected to a filling line (43), and a drain tube (11) having a drain outlet (12) capable of being connected to a drain line, an outer container (4) in which the bag (3) is placed, a compression chamber (16) between the container (4) and the bag (3), an injection port (17) for injecting pressurised draining gas into the chamber (16), sealed bushings passing through the container (4) via the tubes (9) and (11), the deformation capacities of the bag (3) and the container (4) being chosen such that, when the draining gas is injected into the chamber (16), the bag (3) is compressed and the biopharmaceutical fluid is emptied, in which the container (4) comprises a receptacle (13) forming an outer container in which the bag (3) is placed, the tubes (9) and (11) pass through the receptacle (13) via permanently fixed links (35), it comprises an integrated means (42) for bleeding the gas filling the filling line (43) prior to filling, and the outer receptacle (13) and the inner bag (3) form a single-use coherent whole.