Disposable Mixing Bag System for Sterile Fluid Processing

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Solution Overview

Problem

Conventional mixing systems for biological fluids are labor-intensive and costly to clean and sterilize, and the process of transferring fluids between containers can lead to contamination and inefficiency.

Innovation Solution

A mixing system comprising a flexible container assembly with a removable impeller and drive shaft, designed for minimal cleaning and sterilization, allowing for easy transportation and remixing of solutions, using a docking station and cart system that supports scalable and cost-effective processing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional rigid mixing systems are used, then mixing function is achieved, but cleaning and sterilization becomes labor intensive and time consuming

Engineering Contradiction:

Improvecleaning and sterilization processVSAvoidtime required for cleaning and sterilization

Core Design Contradiction:

Ease of operationVSLoss of time

Solution Approach 1:

The mixing system is divided into separable components: a reusable mixing device and disposable containers. The mixing device can be easily cleaned and sterilized while the containers are discarded after use, eliminating the need to clean entire rigid tanks between batches.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Disposable containers are used instead of reusable rigid tanks. These single-use containers eliminate the need for extensive cleaning and sterilization procedures between uses, significantly reducing time and labor requirements while maintaining sterility.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

2Ease of manufacture

If chemical cleaners are used for cleaning, then cleaning effectiveness is improved, but safety risks and disposal costs increase

Engineering Contradiction:

Improvecleaning effectivenessVSAvoidsafety risks from chemical cleaners

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

By using disposable containers, the need for harsh chemical cleaners is eliminated. The containers are discarded after single use, avoiding exposure to dangerous chemicals like sodium hydroxide while maintaining effective cleaning through simple rinsing of the reusable mixing device.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Adaptability or versatility

If fluids are transferred between containers, then transportation is enabled, but sterility breach risk increases

Engineering Contradiction:

Improvetransportation capabilityVSAvoidsterility maintenance

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

Disposable containers maintain sterility throughout the entire process from manufacturing to delivery. The containers are sealed during transport and opened only at the point of use, eliminating the need to transfer fluids between containers and thus preventing sterility breaches.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The system separates the mixing function from the containment function. The reusable mixing device is sterilized and then paired with a disposable container for each batch, allowing the mixing device to be reused while maintaining sterility through the disposable container barrier.

Inventive Principle:

Principle #1Segmentation

4Productivity

If rigid sealed tanks are used, then mixing function is provided, but device complexity and cleaning requirements increase

Engineering Contradiction:

Improvemixing functionVSAvoidcleaning requirements

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The system separates mixing functionality from containment. The reusable mixing device has simple geometry requiring minimal cleaning, while the complex containment and sterilization requirements are shifted to the disposable container that is discarded after use.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The disposable container assumes the complexity of maintaining sterility and containing the fluid, while the reusable mixing device maintains simple geometry that is easy to clean and sterilize between uses.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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 system significantly reduces the need for cleaning and sterilization, maintains sterility, and facilitates efficient processing and transportation of biological fluids, minimizing contamination risks and operational costs.

Implementation Method 1

A drive shaft with impeller is rotatably disposed within the tank. The impeller functions to suspend and mix the components.

Methodology Applied

Scientific EffectMixing: Stirring

Data Source

PatentUS20230415108A1Methods and apparatus for processing fluids

Publication Date: 2023.12.28 LIFE TECHNOLOGIES CORP

AI summary

A method for processing a fluid includes removably securing a retention member to a vessel that bounds a chamber; inserting a collapsible bag within the chamber of the vessel; securing the bag to the retention member so that the bag is supported within the chamber of the vessel; and dispensing a fluid into a compartment of the collapsible bag supported within the chamber of the vessel. The fluid can be mixed within bag while the bag is disposed within the vessel.