Modular Biological Fluid Processing for Flexible Unit Operations
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Solution Overview
Problem
Current biopharmaceutical manufacturing systems lack flexibility and configurability, requiring dedicated systems for different unit operations, leading to increased complexity, capital expenditures, and operational inefficiencies, particularly in the use of single-use technology (SUT) systems.
Innovation Solution
A modular biological fluid processing system comprising a fluid processing device, processing interface, and processing control element, allowing for easy reconfiguration and adaptation to various unit operations, reducing the need for multiple systems and enabling 'one fits all' flexibility, with a processing control element that can be used across different configurations and processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If dedicated systems are used for different unit operations, then reliability is improved, but device complexity and capital expenditures increase
Solution Approach 1:
The control element is designed to be universal and configurable, capable of controlling different types of fluid processing devices (pumps, valves, mixers, reactors) through a standardized interface. The control element can be configured via software to adapt to specific unit operation requirements, eliminating the need for dedicated control systems for each device type while maintaining reliability through proven control architecture.
Solution Approach 2:
The system is segmented into modular components: reusable control elements and disposable fluid processing devices. This segmentation allows the complex control functionality to be concentrated in the reusable control element, while the fluid processing devices remain simple, single-use components. The modular architecture reduces overall system complexity while maintaining reliability through standardized connections and protocols.
2Adaptability or versatility
If multiple dedicated systems are deployed, then adaptability is improved, but loss of time and productivity decrease
Solution Approach 1:
The control element serves multiple functions across different unit operations through software configuration rather than hardware reconfiguration. A single control element can be programmed to control pumps, valves, mixers, and reactors, enabling rapid adaptation to different processes without requiring physical system changes or extensive installation time.
Solution Approach 2:
The control elements are pre-configured with standardized communication protocols and control algorithms before deployment. Software templates and predefined control routines are prepared in advance, allowing rapid configuration for specific unit operations without time-consuming setup procedures. The disposable fluid processing devices are also pre-assembled and pre-sterilized, reducing installation and preparation time.
3Adaptability or versatility
If multiple dedicated systems are used, then adaptability is improved, but capital expenditures increase
Solution Approach 1:
A single reusable control element can control multiple types of fluid processing devices across different unit operations, replacing the need for multiple dedicated control systems. This universality significantly reduces capital expenditures while maintaining the ability to adapt to various processes through software configuration and the use of different disposable fluid processing devices.
Solution Approach 2:
The system uses disposable fluid processing devices that are discarded after single use, eliminating the need for expensive cleaning, sterilization, and maintenance infrastructure. The reusable control element is the only capital-intensive component that needs to be maintained, significantly reducing overall capital requirements compared to traditional systems where all components required maintenance and sterilization capabilities.
Data Source
AI summary
The present disclosure relates to a biological fluid processing system and method. The system comprises a fluid processing device comprising at least one fluid path, a pump for providing a pressure in the at least one fluid path, a valve arranged along said fluid path and a first actuator arranged to control the valve to assume a desired opening state of said fluid path. The biological fluid processing system comprises further a processing interface comprising a pump drive for driving the pump of the fluid processing device, and a processing control element comprising a pump control system arranged to control at least the pump drive and a valve control system arranged to control the first actuator. The system is modular. The fluid processing device is comprised in a fluid processing device module having a predetermined fluid processing device configuration. The processing interfaces have a predetermined processing interface configuration. The processing control element is arranged to receive information relating to the predetermined processing interface configuration of the processing interface module and/or the predetermined fluid processing device configuration of the fluid processing device module and control the at least one pump drive and/or the valve based on the received information relating to the predetermined fluid processing device configuration and the predetermined processing interface configuration.