Modular Pneumatic Valve Interface for Sterile Bioprocess Flexibility

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Solution Overview

Problem

Current single-use biological liquid handling systems face limitations in flexibility, cost, and physical size due to fixed pneumatic valve configurations, which hinder efficient and cost-effective processing of biopharmaceuticals.

Innovation Solution

A modular valve system with a reusable pneumatic control system and a connector unit that allows for interchangeable configurations, enabling flexible adaptation to different flow paths and processes, with the valve arrangement being pre-sterilized and made by injection molding for cost efficiency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fixed pneumatic valve configurations are used in single-use systems, then sterilization and cross-contamination prevention are improved, but flexibility and adaptability to different processes deteriorate

Engineering Contradiction:

Improvesterilization and cross-contamination preventionVSAvoidflexibility to different processes

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The system is divided into two distinct segments: a reusable pneumatic control system (non-sterile) and a disposable wetted valve arrangement (sterile). This segmentation allows each component to be optimized for its specific function - the reusable portion for cost-effective control and the disposable portion for sterilization and process-specific adaptability, thereby resolving the contradiction between reliability and flexibility.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A sterile barrier or interface mechanism serves as an intermediary between the reusable pneumatic control system and the disposable wetted valve arrangement. This intermediary enables controlled fluid transfer while maintaining sterility, allowing the system to adapt to different processes through component replacement without compromising the sterile field, thus balancing flexibility with sterilization requirements.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of manufacture

If reusable pneumatic valve systems are used, then cost efficiency is improved, but physical size and mechanical complexity worsen

Engineering Contradiction:

Improvecost efficiencyVSAvoidmechanical complexity and physical size

Core Design Contradiction:

Ease of manufactureVSDevice complexity

Solution Approach 1:

The complex pneumatic control system is extracted from the disposable component and made reusable, while only the essential wetted valve arrangement is disposed of after a single use. This extraction eliminates the need to design for sterilization and robust construction in the disposable portion, reducing its mechanical complexity and physical size while maintaining cost efficiency through reuse of the expensive pneumatic controls.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

A simple, inexpensive disposable wetted valve arrangement is designed to be replaced rather than sterilized. This disposable component has minimal mechanical complexity and small physical footprint, while the expensive pneumatic control system is reused, effectively resolving the contradiction between cost efficiency and device complexity.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Ease of operation

If fixed configuration valve arrangements are used, then ease of operation is improved, but adaptability to different flow paths and processes deteriorates

Engineering Contradiction:

Improveease of operationVSAvoidadaptability to different flow paths

Core Design Contradiction:

Ease of operationVSAdaptability or versatility

Solution Approach 1:

The system transitions from a fixed configuration to a dynamic, reconfigurable architecture where the disposable wetted valve arrangement can be replaced to match different process requirements. The reusable pneumatic control system maintains ease of operation through standardized interfaces, while the replaceable disposable portion provides adaptability to different flow paths and processes.

Inventive Principle:

Principle #15Dynamics

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 system provides high flexibility, reduced costs, and improved ease of use by allowing reconfiguration of the pneumatic control system to fit various processes and fluid flow ranges, minimizing holdup volume and back-mixing while maintaining sterility and reducing mechanical complexity.

Implementation Method 1

wherein the diaphragm is responsive to pressure to open or close the valve

Methodology Applied

Scientific EffectPressure: Pressure Increase

Data Source

PatentUS20220356959A1Remotely actuated valve for a biological liquid treatment system

Publication Date: 2022.11.10 CYTIVA SWEDEN AB

AI summary

The invention relates to valve system for controlling a process fluid within a liquid processing system. The valve system comprises a valve arrangement, a pneumatic control system, and a connector unit. When the valve arrangement is connected to the connector unit, two or more valves are formed, such that the pneumatic control system controls an open/close or pressure control mode of the valves. A pump diaphragm system is disclosed, as well as a system for purifying a biological material that comprises the valve system or the pump diaphragm system. Also discloses are methods of using the valve system or the pump diaphragm system in a process for the purification of a biological material.