Bubble Column Mixing in Disposable Pharmaceutical Bags

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Solution Overview

Problem

Current pharmaceutical mixing systems require expensive equipment, stringent procedures, and a sterile environment, making them costly and time-consuming, and are often centralized, limiting their availability and distribution.

Innovation Solution

A bubble agitation system and method for mixing pharmaceutical solutions using a disposable mix bag with a recirculation assembly that creates a bubble column to mix solutes and solvents, maintaining sterility and reducing costs by eliminating mechanical components and allowing for local solution manufacturing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If mechanical agitation systems are used in disposable containers, then mixing capability is improved, but device complexity and cost increase

Engineering Contradiction:
Improvemixing capabilityVSAvoiddevice complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent replaces mechanical agitation systems (rotating impellers, moving parts) with a gas-driven bubble column system. Gas is introduced at the bottom of the container to create rising bubbles that induce liquid circulation and mixing through buoyancy-driven flow patterns, eliminating the need for mechanical components while achieving effective mixing.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention uses gas flow (pneumatics) to drive the mixing process. A gas source introduces bubbles into the liquid through a sparger or porous plate at the container bottom, creating upward gas flow that generates circulation patterns and turbulent mixing throughout the liquid volume without mechanical contact.

Inventive Principle:
Principle #29Pneumatics and hydraulics

2Reliability

If sterile environment and stringent procedures are implemented, then product safety is improved, but manufacturing cost and time increase

Engineering Contradiction:
Improveproduct safetyVSAvoidmanufacturing cost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent employs single-use disposable containers that are pre-sterilized and sealed. Each container is used once and then discarded, eliminating the need for complex sterilization infrastructure, cleanroom environments, and extensive validation procedures required for reusable systems. This maintains product safety while dramatically reducing manufacturing costs and complexity.

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

Solution Approach 2:

The containers are pre-sterilized and prepared before use, with all necessary ports and connections already in place. This preliminary preparation eliminates the need for on-site sterilization procedures and reduces the time and cost associated with setting up sterile manufacturing environments.

Inventive Principle:
Principle #10Preliminary action

3Manufacturing precision

If centralized mixing facilities are used, then quality control is improved, but distribution availability worsens

Engineering Contradiction:
Improvequality controlVSAvoiddistribution availability
Core Design Contradiction:
Manufacturing precisionVSAdaptability or versatility

Solution Approach 1:

The patent divides the mixing process into independent, self-contained disposable units. Each container is a complete, standalone mixing system that can be prepared and used independently of centralized facilities. This segmentation enables local preparation at point-of-care or distributed locations while maintaining consistent quality through standardized container design and pre-sterilization.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The disposable containers are designed to be self-contained with all necessary components (container, sparger, ports, connections) integrated into a single unit that requires no external infrastructure. Users can prepare and use these containers at any location without requiring centralized mixing facilities, cleanrooms, or complex support equipment.

Inventive Principle:
Principle #25Self-service

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 effectively mixes pharmaceutical solutions in a sterile, cost-effective manner, reducing the need for centralized facilities and enhancing distribution by using a disposable, self-contained process that maintains sterility and simplifies assembly and operation.

Implementation Method 1

activating a recirculation assembly to establish a bubble column in the mix bag

Methodology Applied
Scientific EffectBubble column agitation: Bubble

Implementation Method 2

the recirculation pump draws the gas from the headspace and delivers the gas to the mix bag through the bottom gas recirculation port

Methodology Applied
Scientific EffectGas recirculation: Convection

Data Source

PatentUS11524270B2Method of mixing a pharmaceutical solution and mixing system
Publication Date: 2022.12.13 BAXTER INT INC
  • US11524270B2 patent drawing
  • US11524270B2 patent drawing
  • US11524270B2 patent drawing

AI summary

A method of mixing a pharmaceutical solution including adding a gas into an interior compartment of a mix bag to form a headspace. The interior compartment of the mix bag includes a top portion and a bottom portion. The headspace adjacent to the top portion contains gas. The method includes adding a solvent into the mix bag, and establishing a bubble column in the interior compartment by activating a recirculation assembly. The recirculation assembly includes a connecting pathway operably coupled to a recirculation pump. A first end of the connecting pathway is coupled to a top gas recirculation port and a second end is coupled to a bottom gas recirculation port of the mix bag such that the recirculation pump draws the gas from the headspace and delivers the gas to the interior compartment via the bottom gas recirculation port. The method includes adding a solute into the mix bag.