Multi-Pump Compounding Manifold for Aseptic Fluid Transfer
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Solution Overview
Problem
Compounding devices face inefficiencies in setup time, downtime during source container replacement, and accuracy at small dispensed volumes, with challenges in maintaining aseptic conditions and preventing errors in fluid path connections.
Innovation Solution
A compounding device with a housing featuring micro and macro valve actuation devices and pumps, a manifold structure for fluid combination, and a controller for precise fluid transfer, along with a user-friendly interface and occlusion sensors to minimize errors and enhance cleaning efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If traditional compounding devices use complex manifold structures and multiple connection points for fluid paths, then fluid transfer capability is enhanced, but setup time increases and risk of connection errors increases
Solution Approach 1:
The device is divided into modular components including a pump module, valve module, and container module that can be independently assembled and configured. This segmentation allows for rapid setup by connecting only the necessary modules for each compounding task, reducing overall setup time while maintaining fluid transfer capability.
Solution Approach 2:
The pump module and valve module are designed as universal components that can work with multiple container types and fluid paths. The standardized interfaces and actuation mechanisms allow the same modules to serve multiple functions across different compounding scenarios, reducing the need for complex specialized connections.
2Adaptability or versatility
If traditional compounding devices use extensive fluid path connections and manifold structures, then fluid transfer capability is enhanced, but complexity of the device increases
Solution Approach 1:
By segmenting the device into discrete functional modules (pump, valve, container interfaces), the complexity is distributed and managed more easily. Each module has a specific function with standardized connections, reducing the overall system complexity compared to traditional integrated manifold structures.
Solution Approach 2:
The complex manifold structure is extracted and replaced with individual valve modules that are selectively activated. This removes unnecessary fluid path connections from the system, keeping only the essential pathways needed for each specific compounding task, thereby reducing device complexity.
3Productivity
If source containers are replaced during compounding operations, then continuous operation is maintained, but downtime occurs during replacement
Solution Approach 1:
Multiple source containers are pre-loaded into the device before the compounding operation begins. The system is configured to automatically switch between pre-positioned containers when one becomes empty, eliminating the need for manual replacement during operation and maintaining continuous productivity.
Solution Approach 2:
The device maintains continuous compounding operation by having backup source containers ready and automatically transitioning to them when the current container is depleted. This ensures the useful action of compounding never interruptions, eliminating downtime during container replacement.
4Manufacturing precision
If small volumes of fluid are dispensed for precision compounding, then accuracy is improved, but measurement precision becomes more difficult to maintain
Solution Approach 1:
The device replaces traditional mechanical volumetric measurement systems with a gravimetric measurement system using load cells. This substitution provides superior measurement precision for small volumes by directly measuring mass, which is inherently more accurate than volumetric measurement for small quantities, thereby maintaining compounding accuracy.
5Adaptability or versatility
If traditional compounding devices use complex manifold and valve structures, then fluid routing capability is enhanced, but ease of cleaning and disinfection deteriorates
Solution Approach 1:
The valve module is designed as a separate, self-contained unit with internal fluid pathways that can be easily removed and sterilized. This segmentation allows the valve module to be cleaned independently without disassembling the entire device, maintaining fluid routing capability while significantly improving ease of cleaning and disinfection.
Solution Approach 2:
The valve module and transfer set are designed as disposable components that can be discarded after a single use, eliminating the need for complex cleaning and disinfection processes. This maintains full fluid routing capability while making the device extremely easy to prepare for the next use by simply replacing the disposable module.
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 solution reduces downtime, improves accuracy at small volumes, and facilitates easier cleaning and disinfection, ensuring aseptic conditions and reducing errors in fluid transfer, thereby enhancing the operational efficiency and usability of the compounding device.
Implementation Method 1
Gravimetric devices generally use a peristaltic pump mechanism combined with a weight scale or load cell to measure volume delivered
Implementation Method 2
Gravimetric devices generally use a peristaltic pump mechanism combined with a weight scale or load cell to measure volume delivered. The volume delivered is calculated by dividing the weight delivered by the specific gravity of the ingredient
Implementation Method 3
The device calculates the volume delivered by the precision of the delivery mechanism, internal diameter of the pump tubing, viscosity of the solution, and the diameter and length of the distal and proximal tubing. Delivery from these devices can be affected by many factors including: variances in the pump tubing's material, length, elasticity, and diameter; temperature, which affects solution viscosity and tubing size
Data Source
Figure 1
Figure 2A~2B
Figure 3A~3B
AI summary
An exemplary compounding system and method can include two pump heads for simultaneously drawing two different fluids from at least two separate input containers such that the at least two different fluids are mixed and distributed to an output container. The system can include a manifold that maintains separation of certain of the different fluids until after passing by a first pump and a second pump and/or additional pumps. A junction can be placed in the fluid line downstream of the first and second pumps and/or additional pumps such that all or some of the fluids are mixed prior to output to the output container. The method of using the system can include incorporating software that selects various fluids at certain times and sequences to ensure optimum efficiency and safety for the system, and can continue compounding actions even when an input supply container runs out or otherwise fails to supply a particular fluid/material. The method of use also includes connection of a transfer set to a housing in a manner that further ensures optimum efficiency and safety.