Single-Use Flexible Bag With Sump for Recirculation and Mixing
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Solution Overview
Problem
Biopharmaceutical, pharmaceutical, and biotechnology industries face challenges with reusable devices requiring time-consuming sterilization and potential contamination issues, while moving towards single-use components that need solutions for integrated pumping, mixing, and agitation in flexible fluid containers.
Innovation Solution
A single-use flexible bag with a sump region and integrated ports for connecting pumps, allowing fluid recirculation and mixing, featuring a tapered bottom surface for fluid flow into the sump and multiple fluid ports for directional fluid control and mixing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If reusable devices are used in biopharmaceutical applications, then device cost is reduced, but sterilization time and contamination risk increase
Solution Approach 1:
The patent employs a disposable flexible bag system that eliminates the need for sterilization between uses. The bag is designed for single-use only, being discarded after one application, which completely removes contamination risk and sterilization time requirements while maintaining cost-effectiveness through the simplicity and reusability of the external pump system.
2Loss of time
If single-use flexible bags are used, then sterilization time is eliminated, but integrated pumping and mixing functionality is lost
Solution Approach 1:
The system is divided into two separate components: a disposable flexible bag containing only the fluid and necessary fluid ports, and a reusable external pump system that provides all pumping, mixing, and agitation functions. This segmentation allows the bag to be simple and single-use while the pump system provides versatile functionality across multiple uses.
Solution Approach 2:
The external pump system is designed as a universal, multi-functional device that can be coupled to different flexible bags and perform multiple operations including pumping, mixing, and agitation. The pump system's versatility compensates for the simplicity of the disposable bag, providing integrated functionality without requiring the bag itself to be complex.
3Ease of operation
If fluid ports are added to flexible bags for recirculation, then mixing capability is improved, but device complexity increases
Solution Approach 1:
The flexible bag is designed with specific local features including a sump region at the bottom with an integrated fluid port positioned to optimize fluid recirculation and mixing. This localized structural modification provides enhanced mixing capability without requiring complex modifications throughout the entire bag design, maintaining simplicity while improving operational effectiveness.
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 mixing and agitation of fluids within flexible bags, eliminating the need for sterilization and reducing contamination risks, while facilitating seamless integration with pumps for recirculation and downstream processing.
Implementation Method 1
The bottom surface of the flexible bag adjacent to the periphery of the sump region is tapered toward the sump region so that when fluid is evacuated from the main interior region of the flexible bag, fluid will naturally flow (due to gravity) into the sump region.
Data Source
AI summary
A flexible bag having one or more side surfaces and a bottom surface that includes a sump region formed by one or more side sump surfaces and a bottom sump surface. A first connecting port is disposed in the bottom sump surface. A second connecting port is disposed in a side sump surface. The first connecting port is connected to a first pump having one or more outlets while the second connecting port is connected to a second pump having one or more outlets. The flexible bag includes a plurality of fluid ports. One or more of the outlets of the first and/or second pump are connected to conduit/tubing that connect to one or more of the fluid ports. Fluid in the flexible bag can then be recirculated back into the flexible bag for mixing and/or agitation in addition to being pumped to downstream processes.