Preloaded Flexible Buffer Bags for Accurate On-Demand Fluid Prep
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Solution Overview
Problem
Existing methods for preparing buffer solutions in biopharmaceutical and pharmaceutical applications are labor-intensive, prone to human error, require specialized equipment, and are not feasible in resource-limited settings, and existing automated systems are costly and prone to sensor malfunctions.
Innovation Solution
Pre-loading flexible containers with solid tablets of buffer constituents, allowing for easy dissolution in water to create solutions of known concentration without the need for manual weighing or complex equipment, using a manifold system for controlled fluid flow and dilution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manual preparation of concentrated buffers is used, then solutions can be prepared with known concentrations, but the process requires specialized equipment and trained personnel which are not always available
Solution Approach 1:
The buffer constituents are pre-loaded into the flexible container in precise concentrations during manufacturing. This preliminary action eliminates the need for on-site weighing and preparation equipment, while ensuring accurate concentrations are achieved every time the container is filled with water.
Solution Approach 2:
The invention uses a disposable flexible container pre-loaded with buffer tablets or powder. Instead of requiring expensive, reusable equipment like balances and specialized labware, the system uses a single-use container that eliminates the need for complex preparation equipment while maintaining concentration accuracy.
2Extent of automation
If automated in-line buffer conditioning systems are used, then buffer preparation can be automated, but the systems require large numbers of sensors and complicated control systems that are expensive and prone to malfunction
Solution Approach 1:
The flexible container is designed to be self-filling from water sources and self-dissolving when water is added. The buffer tablets automatically dissolve when water is introduced, eliminating the need for external automation equipment, sensors, or control systems. The system performs the buffer preparation function through its own design rather than requiring external automated infrastructure.
Solution Approach 2:
The invention extracts the complex sensor and control system components from the buffer preparation process. Instead of using automated in-line conditioning systems with multiple sensors and control mechanisms, the preparation function is embedded directly into the simple flexible container design, removing the need for expensive and complex external automation equipment.
3Quantity of substance
If concentrated buffer solutions are manually prepared and stored, then large volumes of buffers can be made available, but this requires storage of large amounts of buffers and raw materials
Solution Approach 1:
The invention changes the physical state parameter of the buffer from liquid (concentrated solution requiring large storage volumes) to solid (tablets or powder that can be densely packed). This allows the same buffer capacity to be stored in a much smaller volume, and the buffer is only converted to liquid form when needed by adding water to the flexible container.
Solution Approach 2:
The buffer constituents are pre-loaded into the flexible container in concentrated form during manufacturing. This preliminary preparation allows the buffer to be stored in compact solid form and only converted to the required liquid volume when needed, eliminating the need to store large volumes of ready-to-use buffer solutions.
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
Reduces human error, eliminates the need for specialized equipment, and enables on-demand solution preparation in resource-limited settings, ensuring accurate concentrations without costly infrastructure.
Implementation Method 1
The flexible container is sterilized by, for example, gamma radiation
Implementation Method 2
The flexible containers are filled with water to dissolve the solid tablets and create a solution having a known concentration
Data Source
AI summary
A system for the preparation of fluids for bioprocess and pharmaceutical applications uses one or more flexible bags that are pre-loaded with solid tablets contained therein of various buffer/media/physiological fluid constituents. Examples include salts, acids, bases, preservatives, proteins, amino acids, growth factors, small molecules, and drugs. The flexible bag contains one or more sealed or sealable openings that are used to add water to the interior of the flexible bag as well as remove fluid from the flexible bag. The one or more sealed openings may also be used as an outlet to remove fluid (e.g., buffer) from the flexible bag. The flexible bag may be stored in a deflated state aiding in the storage and/or transport of the flexible bag. Multiple flexible bags may be coupled to a manifold with valves to selectively fill and empty the flexible bags.