Disposable Rupture Valve for Sterile Bioreactor Fluid Transfer

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Solution Overview

Problem

Existing sterilization methods for large process vessels, such as bioreactors, require costly and time-consuming cleaning and re-sterilization of conduits and valves, which complicates the transfer of fluids and may lead to microbial contamination.

Innovation Solution

A rupture valve system is introduced that selectively restricts or allows fluid flow based on pressure direction, ensuring sterility during sterilization and facilitating aseptic connections by remaining closed to upstream pressure and opening to downstream pressure, thereby simplifying the sterilization and fluid transfer process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional valves and conduits are used for fluid transfer in bioprocessing, then fluid flow control is achieved, but cleaning and re-sterilization between uses is required which is costly and time-consuming

Engineering Contradiction:

Improvesterility maintenanceVSAvoidcleaning and re-sterilization time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent employs disposable rupture valves that are discarded after a single use, eliminating the need for cleaning and re-sterilization of valves and conduits between uses. This single-use approach maintains sterility while avoiding the time-consuming and costly repeated sterilization processes required by traditional reusable valves.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

2Ease of manufacture

If reusable valves and conduits are used for fluid transfer, then equipment cost is reduced, but cleaning and re-sterilization between uses increases cost and time

Engineering Contradiction:

Improveequipment reusabilityVSAvoidfluid transfer efficiency

Core Design Contradiction:

Ease of manufactureVSProductivity

Solution Approach 1:

The rupture valve is designed as a disposable component that is discarded after single use, eliminating productivity losses from cleaning and sterilization cycles. The low cost of the disposable valve compared to the productivity gains from eliminating sterilization time makes this economically viable despite reduced equipment reusability.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Ease of operation

If conventional valves are used to control fluid flow during sterilization, then flow control is achieved, but the valves require cleaning and re-sterilization which complicates the process

Engineering Contradiction:

Improvesterilization process simplicityVSAvoidvalve cleaning and sterilization procedures

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The disposable rupture valve eliminates the complexity of cleaning and re-sterilization procedures by being discarded after single use. This simplifies the sterilization process while maintaining ease of operation, as the valve requires no maintenance or preparation between uses.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

4Reliability

If traditional sterilization methods are used, then sterilization effectiveness is achieved, but the conduits and valves require repeated cleaning and sterilization which increases overall cost

Engineering Contradiction:

Improvesterilization effectivenessVSAvoidoverall processing cost

Core Design Contradiction:

ReliabilityVSLoss of substance

Solution Approach 1:

The disposable rupture valve maintains sterilization effectiveness while reducing overall processing costs by eliminating the need for repeated cleaning and sterilization of valves and conduits. The low cost of the disposable valve component compared to the accumulated costs of repeated sterilization processes makes this economically advantageous.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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 rupture valve system enhances sterility maintenance, reduces microbial contamination, and lowers overall costs by allowing for more efficient steam-in-place sterilization and fluid transfer, while being disposable and easier to integrate into bioprocessing systems.

Implementation Method 1

When pressure is exerted on the rupture valve in the upstream direction, the rupture valve resists rupture

Methodology Applied

Scientific EffectPressure resistance: Pressure Increase

Implementation Method 2

When pressure is exerted on the rupture valve in the downstream direction, the rupture valve selectively ruptures

Methodology Applied

Scientific EffectPressure-induced rupture: Fracture Mechanics

Implementation Method 3

expose the interior volume and interior surfaces of the process vessel to the lethal effect of steam

Methodology Applied

Scientific EffectSteam sterilization: Heating

Data Source

PatentUS8752570B2Valve for controlling the flow of steam and other fluids

Publication Date: 2014.06.17 AMGEN INC

AI summary

A device for controlling fluid flow includes a conduit that defines a channel through which fluid flows opposing upstream and downstream directions of fluid flow. A rupture valve obliquely disposed in the channel to selectively prevent fluid flow through the channel, the rupture valve resisting rupture in response to pressure exerted on the rupture valve in the upstream direction and selectively rupturing in response to pressure exerted on the rupture valve in the downstream direction.