3D Biopharmaceutical Container with Rigid Frame and Flexible Pouch

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Solution Overview

Problem

There is a need for sterile, disposable 3D containers that can accommodate biopharmaceutical fluids with large capacities, integrating functional means for treatment like mixing, aeration, and pumping, while being easy to produce, logistically versatile, and safe from damage during storage or shipping due to the presence of solid elements with complex shapes.

Innovation Solution

A 3D container design featuring a flexible film receptacle with a deformable side wall and a rigid hollow frame, incorporating internal elements for treatment functions, such as mixing or aeration, with airtight connections and ports for secure operation, ensuring the container can expand in volume and support functional means without risking damage to the flexible material.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a flexible pouch is used for biopharmaceutical storage, then the container is disposable and easy to sterilize, but the pouch is thin and cannot accommodate solid internal elements for treatment functions

Engineering Contradiction:
Improvedisposable and sterilization capabilityVSAvoidstructural integrity to support internal elements
Core Design Contradiction:
Ease of manufactureVSStrength

Solution Approach 1:

The container is segmented into three distinct components: a rigid frame providing structural support, a flexible pouch for fluid containment, and internal elements for treatment functions. This segmentation allows each component to fulfill its specific function without compromising the others - the rigid frame protects the flexible pouch from damage while accommodating solid internal elements.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The rigid frame acts as an intermediary between the flexible pouch and the solid internal elements. It provides a protective interface that prevents direct contact between the pouch and potentially damaging solid components, while still allowing the pouch to expand and contract as needed.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If solid internal elements are placed inside the flexible pouch, then treatment functions (mixing, aeration) can be performed, but the elements may damage the flexible pouch material

Engineering Contradiction:
Improvetreatment functions capabilityVSAvoidpouch integrity
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The rigid frame serves as a protective intermediary structure that houses the solid internal elements while preventing them from directly contacting and damaging the flexible pouch. The frame provides a rigid enclosure that isolates the pouch from mechanical stress caused by mixing propellers, aerators, or other solid treatment components.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

By separating the treatment functions into distinct internal elements housed within the rigid frame, the system allows these elements to perform their functions without compromising the pouch integrity. The segmentation creates clear functional zones: the frame contains solid elements, while the pouch contains the fluid.

Inventive Principle:
Principle #1Segmentation

3Strength

If a rigid frame is added to provide structural support, then the container can accommodate internal elements, but the overall device complexity increases

Engineering Contradiction:
Improvestructural support capabilityVSAvoidcontainer structure
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The rigid frame is designed to perform multiple functions simultaneously: it provides structural support for the flexible pouch, accommodates solid internal elements for treatment functions, and serves as a protective enclosure. This multi-functionality reduces the need for additional separate components, thereby limiting the increase in device complexity.

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

Solution Approach 2:

The invention merges the structural support function, the housing for internal elements, and the protective enclosure into a single integrated rigid frame structure. This consolidation achieves the necessary structural strength while avoiding the complexity of multiple separate components.

Inventive Principle:
Principle #5Merging (Combining)

4Adaptability or versatility

If the container is designed as a traditional rigid tank, then it can support functional means for treatment, but it loses the advantages of being disposable and logistically versatile

Engineering Contradiction:
Improvetreatment functions integrationVSAvoiddisposable and logistical efficiency
Core Design Contradiction:
Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The invention uses a flexible pouch made of thin film material to contain the biopharmaceutical fluid, replacing the traditional rigid tank wall. This flexible pouch maintains the disposable advantage and logistical versatility while the attached rigid frame provides the necessary support for treatment functions, creating a hybrid structure that combines the benefits of both approaches.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The hybrid structure segments the container into a flexible pouch portion (providing disposability and logistical efficiency) and a rigid frame portion (providing structural support for treatment functions). This segmentation allows each material to be optimized for its specific function while working together as an integrated system.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS10384848B23D container with rigid frame, deformable container and functional means for processing the content and including an inner member for biopharmaceutical applications
Publication Date: 2019.08.20 SARTORIUS STEDIM FMT SAS
  • US10384848B2 patent drawing
  • US10384848B2 patent drawing
  • US10384848B2 patent drawing

AI summary

A frame delimits an inside space and includes a peripherally closed side wall and two transverse openings or one transverse opening and a transverse end wall. It is capable of allowing the airtight engagement of the open free edge of a side wall in film form of a receptacle that is at least partially deformable. It is specially designed for the creation of a 3D container. The frame is also able to act as a support for at least one functional port or attachment port of a functional element. Its axial size is adequate for delimiting a space of a size that is at least equal to the axial dimension of the functional element, so that the latter can be completely housed within the inside space.