Disposable Bioreactor Stirring System with Magnetic Coupling

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Solution Overview

Problem

Current single-use agitation systems are limited to specific types of disposable bioreactors, necessitating costly purchases from manufacturers and restricting adaptability, while also requiring rigorous cleaning and validation processes that increase manufacturing costs.

Innovation Solution

A disposable bioreactor with a flexible polymeric pocket containing a single-use agitation system driven by a magnetic coupling, featuring a two-layer surface coating to prevent protein attachment and a variable height adjustment mechanism, allowing the system to be adaptable to any bioreactor type and reducing manufacturing costs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a single-use agitation system is designed for a specific type of disposable bioreactor, then the system can be optimized for that specific application, but the adaptability to other bioreactor types is lost and manufacturer-specific purchases are required

Engineering Contradiction:
Improveadaptability to different bioreactor typesVSAvoidsystem design complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The agitation system is designed with a universal magnetic coupling mechanism that can interface with any disposable bioreactor containing a magnetic element, eliminating the need for manufacturer-specific systems. The drive means comprises magnetic elements that interact with a magnetic element in the bioreactor wall, creating a universal interface that works across different bioreactor types without requiring complex adaptation mechanisms.

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

Solution Approach 2:

The agitation system is designed as a compact, nested structure where the drive means, stirring means, and magnetic coupling elements are integrated within a confined space. The magnetic coupling mechanism allows the drive means to be positioned outside the bioreactor while the stirring means operates inside, with the magnetic field transmitting torque through the bioreactor wall, creating a space-efficient nested arrangement.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Reliability

If rigorous cleaning and validation steps are implemented for bioreactors and agitation systems, then contamination risks are reduced, but manufacturing costs and processing time significantly increase

Engineering Contradiction:
Improvecontamination preventionVSAvoidcleaning and validation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The invention employs a disposable bioreactor system where the bioreactor itself is designed for single use and disposal after one fermentation cycle. This eliminates the need for extensive cleaning and validation of the bioreactor between uses, as each new bioreactor is pre-sterilized. The agitation system is designed to be compatible with this disposable approach, with components that can be easily removed or are also disposable.

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

Solution Approach 2:

The magnetic coupling mechanism allows the drive means to be extracted from the bioreactor environment, positioned outside the sealed bioreactor chamber. This separation means the drive means does not require sterilization or cleaning of the bioreactor interior, as it interfaces with the bioreactor through the wall via magnetic fields, eliminating contamination risks associated with introducing drive components into the sterile environment.

Inventive Principle:
Principle #2Taking out (Extraction)

3Reliability

If manufacturer-specific agitation systems are purchased for each disposable bioreactor type, then system compatibility is ensured, but manufacturing costs increase significantly

Engineering Contradiction:
Improvesystem compatibilityVSAvoidmanufacturing cost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The agitation system is designed with a universal magnetic coupling mechanism that can interface with any disposable bioreactor containing a magnetic element, eliminating the need for manufacturer-specific systems. The drive means comprises magnetic elements that interact with a magnetic element in the bioreactor wall, creating a universal interface that works across different bioreactor types without requiring complex adaptation mechanisms.

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

Solution Approach 2:

The system allows for adjustment of operational parameters such as stirring speed, magnetic coupling strength, and drive means positioning to optimize performance for different bioreactor types and applications. This parameter flexibility enables a single agitation system design to accommodate various bioreactor configurations, volumes, and viscosity requirements without requiring custom hardware for each application.

Inventive Principle:
Principle #35Parameter changes

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 provides a cost-effective, adaptable, and safe single-use agitation system that can be used on an industrial scale, minimizing contamination risks and simplifying the manufacturing process by being compatible with any disposable bioreactor, thus reducing the need for expensive, manufacturer-specific systems.

Implementation Method 1

at least one stirring means driven in rotation by said drive means via a magnetic coupling

Methodology Applied
Scientific EffectMagnetic coupling: Magnetism

Implementation Method 2

The two-layer coating constitutes a barrier between the plastic constituting the pocket and the medium to be mixed in the pocket and prevents the attachment of proteins (advantageously cells) to the plastic

Methodology Applied
Scientific EffectProtein attachment prevention: Hydrophobe

Data Source

PatentEP2411135B1Disposable bioreactor and use-once stirring system
Publication Date: 2013.09.25 ZAMBAUX JEAN PASCAL
  • EP2411135B1 patent drawingFigure 1~2
  • EP2411135B1 patent drawingFigure 3~4
  • EP2411135B1 patent drawingFigure 5~6

AI summary

The present invention relates to a disposable bioreactor comprising a flexible bag made of a polymeric material and also a use-once stirring system placed entirely within said bag, said stirring system comprising a drive means and at least one stirring means rotated by said drive means via magnetic coupling. The invention also relates to a use-once stirring system.