Inline Buffer Dilution With Fill-Level Control for Biocontainers
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Solution Overview
Problem
Conventional buffer management systems in bioprocessing require large, cumbersome totes for buffer solutions, necessitating specialized equipment and occupying significant space, with inefficient liquid level detection methods.
Innovation Solution
A buffer management system utilizing a dilution skid with a single-use manifold and biocontainer assembly, incorporating a fill level sensor to control the production and storage of diluted buffer solutions, allowing for compact storage and precise volume management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If large quantities of buffer solutions are stored in totes, then sufficient buffer supply is ensured, but substantial footprint and logistical challenges occur
Solution Approach 1:
The system segments the buffer storage into multiple smaller biocontainer bags (e.g., four 50L bags instead of one 200L tote) that can be independently managed and connected to the manifold, reducing the footprint of each individual storage unit while maintaining total buffer capacity
Solution Approach 2:
The system transitions from horizontal storage (large totes occupying floor space) to vertical stacking arrangement, where multiple smaller biocontainer bags are stacked vertically on racks, utilizing vertical space to reduce the horizontal footprint
2Quantity of substance
If concentrated buffer solutions are produced in large quantities, then buffer availability is improved, but storage space and handling complexity increase
Solution Approach 1:
The system changes the concentration parameter of buffer storage by maintaining concentrated buffer solutions (e.g., 10x concentration) in the biocontainer bags, which reduces the volume required by a factor of 10 compared to storing diluted buffers, thereby reducing storage space and handling complexity
Solution Approach 2:
The system introduces dynamic dilution capability through the inline dilution skid with peristaltic pumps that can automatically adjust the dilution ratio based on demand, transforming the static storage system into a dynamic one that adapts to varying buffer requirements
3Productivity
If variable demand for buffer solutions is met with large stockpiles, then buffer availability is ensured, but storage footprint increases
Solution Approach 1:
The system performs preliminary preparation by storing concentrated buffer solutions in advance, which can be quickly diluted to meet variable demand, ensuring buffer availability while minimizing the footprint of pre-prepared stockpiles
Solution Approach 2:
The system implements self-service through automated inline dilution using peristaltic pumps that automatically mix concentrated buffer with diluent (WFI or water) based on real-time demand signals from the bioprocessing system, eliminating the need for manual buffer preparation and reducing storage requirements
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, space-saving production and storage of buffer solutions with precise volume control, reducing the need for large totes and specialized equipment, and enhancing operational efficiency in bioprocessing applications.
Implementation Method 1
The first peristaltic pump and the second peristaltic pump are configured to selectively move the concentrated buffer solution and the diluent, respectively, through the flexible tubing
Implementation Method 2
The mixing assembly includes a first static mixing element and a second static mixing element. The first static mixing element is configured to mix the concentrated buffer solution and the diluent to form the diluted buffer solution
Implementation Method 3
The first static mixing element is configured to mix the concentrated buffer solution and the diluent to form the diluted buffer solution
Data Source
AI summary
A buffer management system includes a supply of concentrated buffer solution, an inline dilution skid having a manifold in fluid communication with the supply of concentrated buffer solution and a control unit configured to operate the dilution skid to selectively dilute the supply of concentrated buffer solution in the manifold with a source of water for injection (WFI), and a biocontainer assembly. The biocontainer assembly includes a biocontainer bag defining a storage volume and a fill level sensor configured to generate a fill level signal indicative of the amount of material within the storage volume of the biocontainer bag. The biocontainer bag is in fluid communication with the manifold of the dilution skid for storing diluted buffer solution therein. The fill level sensor communicates the fill level signal to the control unit of the dilution skis, which uses it to manage the operation of the dilution skid.